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Transcript of Meeting of the Pesticide Program Dialogue
January 7 - 8, 1999
Holiday Inn Capitol
550 C Street SW, Washington, DC
Marcia E. Mulkey, OPPTS
James V. Aidala , OPPTS
Susan Wayland, OPPTS
Stephen L. Johnson, OPPTS
Robert L. Lake, FDA
Margie Fehrenbach, EPA
Jay Vroom , American Crop Protection Association
Henry Anderson, Association of State and Territorial Health Officials
Carolyn W. Brickey, National Campaign for Pesticide Policy Reform
Steven S. Balling, Del Monte Foods Corporation
Larry Elworth, Program for Strategic Pest Management
Phillip R. Benedict, Vermont Department of Agriculture, Food & Markets
Daniel A. Botts, Florida Fruit & Vegetable Association
Jacob J. Steinberg, Albert Einstein College of Medicine
Bill Tracy, National Cotton Council of America
Robert M. Rosenberg, National Pest Control Association
Jose Amador, Texas A&M Research & Extension Center
Ken Rosenbaum, Attorney and Consultant
Beth Marshall, League of Women Voters of the United States
William McCormick, The Clorox Services Company
Nelson Carrasquillo, Farmworkers Support Committee
Paula Paul, Agr-Evo USA Company
Erik D. Olson, Natural Resources Defense Council
William J. DeMare, Verdant Brands, inc.
Ken Stoller, EPA
Marion Moses, Pesticide Education Center in San Francisco
Al Jennings, USDA
Jeannine Kenney, Consumers Union
P R O C E E D I N G S
Thursday, January 7, 1999 - Day One
MS. MULKEY: A lot of history making events this week, from the stock market to the floor of the Senate. But our piece of history is to reconvene as the Pesticide Program Dialogue Committee. And we're pleased to do that. We're pleased to see all of you and to have an opportunity to spend this time together.
Fortunately, or unfortunately -- I think it's fortunately for all of us -- we've spent a fair amount of time together, but not quite everyone. And we will take an opportunity to go around the table and introduce ourselves to each other and to the members of the public who are here.
But before we do that, I wanted to mention some of the folks on my -- my fellow public servants arrayed -- federal public servants arrayed across the front of the table, starting with EPA's leadership team in the pesticide area.
All of you know Jim Aidala, who is the Associate Assistant Administrator, and who at this point in our history is also the person who represents and is a formal part of the elected Executive Branch administration. And so he speaks for and to them in ways that help assure us that we have our political leadership involved in an important way in our deliberations.
All of you have known Susan Wayland for many years and we'll come back to her, because she's going to kick us off.
And all of you have known Steve Johnson for many years. But I presume most of you know, he's taking on new responsibilities now, too, as the Deputy Assistant Administrator, while Susan is Acting Assistant Administrator. So that's the EPA team.
Now I'll let the FDA and USDA folks introduce themselves, and they may also have some opening remarks after Susan. So with that, why don't we take an opportunity to introduce ourselves and then we'll conclude by a formal opening. Bob?
MR. LAKE: Bob Lake, FDA.
MS. FEHRENBACH: Margie Fehrenbach, EPA, Designated Federal Officer.
MR. VROOM: I'm Jay Vroom, American Crop Protection Association. I'm glad to be back in an advisory committee atmosphere. You know, I've needed this fix since September.
DR. ANDERSON: Henry Anderson with Wisconsin Division of Public Health.
MS. BRICKEY: Carolyn Brickey with the National Campaign for Pesticide Policy Reform.
DR. BALLING: Steve Balling, Del Monte Foods. And I would also add that Dean Zuleger called and left a message. He was stuck in 50 mile an hour winds in Wisconsin and he apologizes for not making it. He'll try today.
MR. ELWORTH: Larry Elworth, Program for Strategic Pest Management.
MR. BENEDICT: Phil Benedict from Vermont Department of Ag, Food & Markets.
MR. BOTTS: Dan Botts, Florida Fruit & Vegetable Association.
DR. STEINBERG: J. J. Steinberg, Albert Einstein College of Medicine.
MR. TRACY: Bill Tracy, grower member of the National cotton Council.
MR. ROSENBERG: Bob Rosenberg, National Pest Control Association.
DR. AMADOR: Jose Amador, Texas A&M Research & Extension Center in Weslaco.
MR. ROSENBAUM: Ken Rosenbaum, attorney and consultant.
MS. MARSHALL: Beth Marshall, League of women Voters of the United States.
MR. MCCORMICK: Bill McCormick, Clorox Company.
MR. CARRASQUILLO: Nelson Carrasquillo from the Farmworkers Support Committee.
MS. PAUL: Paula Paul, Agr-Evo USA.
MR. OLSON: I'm Erik Olson with Natural Resources Defense Council.
MR. DEMARE: Bill DeMare, Verdant Brands.
MR. STOLLER: Ken Stoller, EPA, Region II, out of the New York area.
DR. MOSES: I'm Marion Moses from the Pesticide Education Center in San Francisco.
MR. JENNINGS: Al Jennings, USDA.
MR. AIDALA: And as indicated, Jim Aidala, EPA.
MS. MULKEY: Well, Susan agreed to set our tone today. For all of us who are stakeholders in the pesticide program, the fact that Susan has been asked to serve as our Acting Assistant Administrator should be very reassuring, because I doubt there are more than two or three people in the whole room who have spent as much time working directly on and intimately with pesticide issues as Susan. So she brings to the table a vast amount of experience, understanding, empathy and enthusiasm for pesticide issues.
So without more than that, we'll ask her to open our session.
MS. WAYLAND: Okay, great. Thank you so much, Marcia, and good morning, everybody. Welcome to the PPDC. Welcome to 1999. It's obviously going to be a very exciting year for all of us.
I wanted the opportunity to be here to welcome you today, to really introduce myself to you in my new capacity. I have known many of you for many years, and for those of you that I do know, it's great to see you again and it's great to be working with you again. For those of you I don't know, I am really looking forward to getting to know you at this meeting and looking forward in the months ahead to getting to know you a lot better.
I'm sure all of you know that Dr. Lynn Goldman, who has been our Assistant Administrator for OPPTS for over the past five years, left the agency on January 1st, and she has taken a job at Johns Hopkins University, and she is pursuing a visiting -- as a visiting scholar in environmental health issues. And we're going to miss Lynn very much, probably no one more than I, and we certainly do wish her all the best in her new adventures.
And until a permanent AA can be selected, the Administrator has asked me to serve as the Acting AA for OPPTS. I'm sure most of you know that the Assistant Administrator positions at EPA are presidential appointments. So in this case, the President is going to have to nominate a candidate to become the next Assistant Administrator and send his or her name to the hill. Then the candidate is subject to Senate review and confirmation.
So this could be a longer or a shorter process. We don't really know, depending upon when the White House is going to act, who the White House selects, and when the Senate acts. So we're in a situation where we're not really sure how long we'll have this acting team that you see in front of you, but we're going to count on probably at least a six month horizon, and that's what we're going to be planning against.
As Marcia said, I am not a newcomer to pesticide issues or to the agency. I have certainly been familiar with pesticide issues for a great deal of my career. In fact, I began my career at EPA in the registration division of OPP back in 1972. When I was writing my opening remarks, I was pretty horrified by what I discovered here.
MR. ELWORTH: You started at a very early age.
MS. WAYLAND: Well, I was going to mention that, Larry, that really from the time I was a teenager -- we'll go back that far -- I have known that I wanted to devote my career to public service. And after all these years I still believe that public service is one of the most worthwhile and rewarding careers that one can have. And I have to say that the policy and the science issues in OPPTS are, in my view, some of the most challenging in government.
Back in 1972 when I was looking for an opportunity to work at EPA, I almost literally beat the doors down at EPA. It was a new agency. I knew that I wanted to work at EPA to try to contribute to the mission of EPA, and the Office of Pesticide Programs, I found, was hiring. So I went for a job interview and I said I can start tomorrow, and I did.
I began that work learning about the new -- the brand new amendments to FIFRA, the 1972 amendments, which were about to be passed at the time I came to the agency, which really turned FIFRA into more of an environmental statute. And I was plunged into writing documents about why the agency was in the midst of canceling a pesticide widely used and very popular called DDT. And it has not been one dull moment since that time.
I have been a manager at EPA since the late 70's. I believe in good management. I believe in strategic planning. I believe in setting goals. I believe in responsible fiscal management. And I believe in accountability. I do believe that everyone, but particularly those who are charged with the public's trust, must behave objectively, fairly and with the highest degree of personal integrity. I believe that the government's business must be conducted in the open, and decisions should be fair and understandable.
I try to set a very high standard for myself and those who work with me. I also try to maintain a sense of perspective and a sense of humor, which in Washington can be a challenge at some times.
The watch words for my tenure as the Acting AA will be continuity and stability. I'm not planning any razzle dazzle or any fancy footwork. We have a full agenda. We have a course. We have a lot on our plate, and we need to see these things through to completion.
Just some of the things that we're going to be dealing with in early 1999 include the continuation of releasing the risk assessments on the organophosphates for public comment, finishing the public review on the key science policies under FQPA, the two TRAC meetings in February and May, the release of the consumer brochure, the plant pesticide rule, the tolerance fee rule, the Section 18 tolerance rule, and continued progress on implementing the 10X children's safety factor.
You know, that's just almost like an opening beginning of what we have on our plate for this coming year. I'm also extremely committed to the principles established by the Vice President in the TRAC process, transparency in decision making, sound science in protecting public health, consultation with public and other agencies -- and I'm particularly delighted that both USDA and FDA are here with us today -- and reasonable transition for agriculture.
So we have a tremendous number of important issues to be dealt with in the pesticide program. We need to stay steady on our present course as we see these through to completion. I feel very fortunate that Jim Aidala, on my left, will remain as the Associate Assistant Administrator for OPPTS during this time. Jim and I have a great working relationship. I am very confident that we're going to be a good team in continuing to lead our office through all these many issues that lie ahead.
I am also delighted that -- are you here, Steve?
MR. JOHNSON: I'm here.
MS. WAYLAND: That Steve Johnson will be joining Jim and me in the front office as the Acting Deputy Assistant Administrator. And I'm anticipating that as long as I'm the Acting AA, Steve is going to be the Acting DAA. And he will be involved in many of the issues he is currently dealing with, and he will be continuing his interaction with Agriculture, with public interest groups and with the industry in his new role.
I'm certainly very much committed to the principles established by FQPA, such as the single health based standard for pesticides, the increased protection for children in our risk assessments and our risk management, and more information to the public.
I also am a strong believer in partnerships. Partnerships amongst the federal government, state and tribunal governments, and the government as a whole, with the private sector in order to make most of our collective resources. I believe that the best public policy is made from listening and from working with the people who will be most affected by our policies.
And we're really here today and tomorrow to do some of that listening. I know that Jim and Marcia and Steve and I are looking forward to this meeting being one in which there is a real exchange of views. I don't want this to be a talking heads from Washington show. The point of an advisory committee is to get advice and to hear from you and not to talk you to death.
I do want to thank each and every one of you for your willingness to devote your energy, your time and your ideas to this committee. You are truly performing a real public service by being here, and I do want you to know how much it is appreciated.
I just want to close by saying that I am honored by the opportunity to serve as the Acting AA in OPPTS. Our people and our programs are among the best in the agency, and I truly believe that. I'm going to continue to stress professionalism, integrity and sense of excellence in everything we do. And I very much look forward to working with all of you in the months ahead.
And with that, I would like to ask Jim to say a few words.
MR. AIDALA: Well, thanks, Susan. I would just note for the record, I was at my high school prom in 1972.
MS. WAYLAND: He rubs this in all the time.
MR. AIDALA: The bad news is, I started working on pesticides in 1975, so I'm not that far behind. Just a couple of things. Happy new year to everybody and, again, welcome. Susan articulated a lot of the issues per se.
My only point would be the importance of -- and like Jay. I mean, you know, we needed some kind of FACA fix. It's been a while. But 99 will be a very, very important year. It's going to be a very busy year. Not just in sort of how FQPA and the history of FQPA is written some day, but also the history of pesticide regulation as a result.
So these kind of forums, this kind of input and these kind of opportunities are very important, and we do appreciate everybody coming forward. And with that, I will pass the microphone down to our colleague from USDA.
MR. JENNINGS: Thanks, Jim. Keith Pitts sends his apologies for not being able to be here today. He was grounded in the suburbs of Maryland by one year old twins today. He does plan to be here tomorrow morning and looks forward to the opportunity.
Back to you, Jim.
MR. AIDALA: Well, take it away somebody.
MS. MULKEY: Bob?
MR. LAKE: Well, let me just say happy new year to everyone, including my colleagues, and say that once again that I am happy to be a part of this process. FDA looks upon this as very important, and I look forward to making -- continuing with some real progress.
MS. MULKEY: Well, thank you all. And let me add my thanks to all of you. This committee is called the Pesticide Program Dialogue Committee, and as Susan said, we very much want this to be about a real dialogue. We have developed with your input two topics to -- actually three sort of major topic areas: the issue of inerts -- or as I'm told it's the ingredients once known as inerts, formerly known as inerts -- the issues relating to BT Resistance Management processes, and the issues relating to this committee, it's form, it's approach and so forth.
In each of those cases, we've set aside literally a number of hours in which our sort of initial presentation will occupy a tiny fraction, so that we can have a really meaningful dialogue.
We were mindful, however, that there are a large number of topics on which you may have information needs that we could fill. And so this long list of topics that you see set for the morning, if you will, the talking heads portion of the dialogue, was our effort to meet what we understood to be your needs -- your information needs.
We understand that many of these topics are also worthy of a robust and extensive dialogue, and it is not our agenda to prohibit that or limit that in any way. But we didn't want the inability, you know, to take any of these topics for today for an extensive dialogue to keep us from providing you with at least some basic information in these areas.
And among other things, you may want to think about providing us with input about which among these topics or other topics would be appropriate for targeting for a more extensive talk. A number of these topics, as you know, have other fora in which we are attempting to have a very broad, public oriented dialogue, notice and comment processes, that other advisory committee and other things.
So just -- this is our way of making a plea that you not accuse us of immediately reneging on our promise to make this discussion by starting the day with a number of reports. But we are hopeful that this will provide you with some information and a common ground about what we're about. And we will attempt, therefore, to move through it with the dispatch so that all the time we did save for meaningful interaction is there for us.
So without more, we will start with a set of FQPA implementation activity reports. Is Bill here?
MALE SPEAKER: Yes.
MS. MULKEY: Bill will lead us off with the nine science policy issues notice and comment process update. And we will try to give a time for some basic questions and not make this totally a one way street.
MALE SPEAKER: There will be a quiz after lunch.
MR. JORDAN: Good morning, everybody. One of the significant accomplishments of the TRAC discussions was to identify nine areas of policy development that were critical to the implementation of the FQPA, and to identify within those broad science policy areas specific topics on which EPA was either undertaking new policy initiatives or there were existing policies that were fairly critical and sensitive to the ultimate outcomes.
And as part of the TRAC discussions, there was a strong interest in taking public comment on those areas. EPA committed to issuing papers for public comment in those areas. And in October we published a Federal Register notice that we refer to as the framework notice, that laid out a schedule for identification of the comment opportunities on those areas.
Marcia Mulkey asked me to coordinate the divisions on that, and so I get to give the score card here. We had committed in the October notice to issuing two documents in October, three in November and five in December. And we did pretty well. We got nine of those ten out on schedule, and all of them are posted on the EPA web site.
The tenth document is one that addresses the fairly controversial subject of what percentile of dietary -- estimated dietary exposure will be used in making regulatory decisions for acute dietary risk, the 99.9 percentile issue. That was due out in December. We are expecting to get it out in a couple of weeks for public comment. And we're going to be working with USDA, since a lot part of that debate around that has to do with the databases that are used in generating those exposure estimates, and we want to make sure that we have accurately and objectively characterized the issues related to the use of those databases, many of which -- much of which comes from USDA sources.
In addition, we have put these documents out for public comment, and asked people to give us their comments within 60 days. The Monte Carlo guidance document which was scheduled to have the comment period closed this week, we received a request for an extension of that comment period and did grant an extension for two weeks. So it closes on the 19th.
And I think that is probably going to be an exception, attributable to the fact that the comment period had the holiday period and the holidays in it. We're hoping and expecting that we will keep to the 60 day comment period for the rest of the documents that we have been issuing and will be issuing, so that we can also keep to the fairly ambitious schedule for finalizing those documents.
I am not able to say a whole lot about the amount of comment on several of the documents, because the comment period hasn't closed, and you all seem to wait until the last day to send in your comments. Or maybe the week after the last day.
But in any event, for the one that has closed, the one relating to the mechanism of toxicity, we did receive a modest number of comments, fairly useful ones, and we are in the process of revising that and expect to issue it on schedule this month.
That pretty much summarizes where we are with regard to the schedule and what's coming up. A couple of questions, perhaps?
MS. MULKEY: Does anybody have some questions? All right, Bill. Hopefully we are making ourselves clear about how this process is going. As you know -- yes, Carolyn?
MS. BRICKEY: Phil, what about this Staff Paper 27? You're working on that as well?
MR. JORDAN: Remind me. I'm not quite sure which one is 27.
MS. BRICKEY: Do you mean I'm out tracking everybody else here?
MALE SPEAKER: You're just one up. That's all.
MS. BRICKEY: Right. The last paper? I can't remember if it was 26 or 27. There was a paper that was going to be revised, and I wondered if you're working on that also?
MR. JORDAN: I think you're referring to the one that was called the decision criteria. And I'm just the coordinator, which means that the real work gets done by other people, like the folks in HED and SRRD. And the decision criteria paper has undergone a couple of evolutions in thinking, and we are working to try to articulate what some folks around the table have referred to as commodity approach, an idea of how to make decisions that take into account the trade off across chemicals and the needs of particular commodity production schemes and that sort of thing.
It's not -- we didn't make a commitment for a specific schedule for that, but sometime in January or February is what I think we're hoping for.
MS. MULKEY: I think we have a schedule that we are distributing that includes the schedule for all the things that are -- for the non-science policies.
Margie, why don't we distribute that? It's in the package, so you have a schedule that includes all of these policy announcements, along with the next set of topics that is covered by the schedule.
BOB: Just a quick question. Once you made the revisions to the policy based on the comments you receive --
MALE SPEAKER: Bob, hold it up a little closer to you.
BOB: Yeah. You publish it again and it's essentially -- I know it's not a rule. But it's a final policy?
MR. JORDAN: Right.
MR. JORDAN: That's basically it.
BOB: And then we apply it in the context of individual chemical decisions?
MS. MULKEY: Well, it would probably be a good idea for us to go to the protocol of turning our cards. Larry?
MR. ELWORTH: Maybe you want to answer this one when Jack does his presentation. But what is going to be the connection or the intersection between the decisions on the science policies and whatever risk assessments have already been completed? And I guess my interest in this would be how would you then revise them, and revise them in a way that people could see what you did differently, depending on the science policy?
MS. MULKEY: Well, as you know, we said throughout the TRAC that we had an interim approach. We described our interim approaches and that we would apply that to all decision making that might arise during the interim period. So that's what happens as we go forward.
It is not unusual. This will not be the first time when there will be policies developed that have an impact on prior decisions as well as future decisions. And that tends to be sort of a rule of reason. Is it important to go back and revisit prior decisions. Is it the only fair way to do it. So I think it's fair to say that there is no one size fits all answer to that question, and that we would look at that at a point when it became relevant.
But we have been quite clear that we had an interim approach that would apply it to decision making.
MR. ELWORTH: Sure. So would you flag that -- let's say you do a preliminary risk assessment without the science policy being final. When you come back and then come out with a defined risk assessment, will you flag those issues that changed because of the change? I'm asking sort of a functional question. What is the best way for people to see the effect of the science policy in the specific decision.
MS. MULKEY: Well, I think -- I think that's a hard question to answer with one answer.
MR. ELWORTH: Right.
MS. MULKEY: Some may merit a specific discussion. Some may not.
MR. ELWORTH: Okay.
MS. MULKEY: I think we're going to try to be as transparent as possible.
MR. ELWORTH: Sure. Sure.
MS. MULKEY: Okay. Thank you, Bill.
MR. JORDAN: Okay.
MS. MULKEY: As you all know, at the time that we were embarking upon this we also embarked on what was called a pilot for expanded public participation in both risk assessment and risk management for the organophosphates. And that was also a very ambitious publication schedule, and Jack's going to give us an update. Jack, as many of you know, has been acting as Director of our Special Review and Re-registration Division for a period and continues in that, at least through next week. So he's here for that report.
JACK: And it can't end soon enough.
JACK: You should have a handout in your package that gives us a summary status of the review of the organophosphates. If you add up all the chemicals on that list, you'll find that there are 43 organophosphates.
We received voluntary cancellation requests for two for which we haven't completed preliminary risk assessments, specifically Phonophore and Isazophos-methyl. And on page two, the back of page one, Isazophos-methyl should indicate that there is a voluntary cancellation request in. We will publish receipt of these requests and proceed with cancellation on these. So at this time it's not our intent to produce a preliminary risk assessment for these.
This leaves 41 organophosphates that we have to produce preliminary risk assessments for. We've already done 17 of these. Nine were issued in August, seven in September and one in December. Tomorrow we plan to release another five, specifically Acephate, Methamidophos, Pirimiphos-methyl, Disulfoton and Oxydemeton-methyl.
Next Friday, January 15th, we plan to release an additional five: Ethyl Parathion, Profenofos, Chlorethoxyphos, Phosmet and Methidathion. Two more preliminary risk assessments will be released at the end of January: Tetrachlorvinphos and DDVP.
And the remaining 12 organophosphates will be completed and forwarded to the registrants for their 30 day review sometime between now and April. Of these 12, three are for OPs which have already been canceled. There are tolerances on the books. There is some indication that at least some of those tolerances want to be retained for input purposes, so we will be producing preliminary risk assessments for those.
Three others are for OPs for which REDs have already previously been issued, two are for OPs registered after 1984 and therefore not subject to re-registration, and the remaining are Chlorpyrifos, Diazinon, Dicrotophos and Malathion. And like I said, those will come out between now and April in terms of providing them to the registrants.
FEMALE SPEAKER: Say those last names again.
JACK: The four? Chlorpyrifos, Diazinon, Dicrotophos and Malathion. The preliminary risk assessments will be completed between now and April. We'll forward those to the registrants for their 30 day review. And then we'll issue them on the Internet for public comment.
Under the process established by the TRAC, after the agency completes a preliminary risk assessment, the registrant has 30 days to identify any errors that we have made and also to identify any confidential business information that may be contained in the preliminary risk assessment. We have up to 30 days to correct these errors and issue a corrected risk assessment, and then issue it for public comment for a period of 60 days. Following the closure of this period, the agency has up to 90 days to issue a refined assessment and any risk management approach to deal with the risks identified in the assessment.
The first nine OPs for which assessments were released in August are currently at this stage. We received a voluntary cancellation request for one of them, Isofenphos. A Federal Register notice is being prepared and should be published next week for comment. We are proposing to accept the voluntary cancellation in the existing stocks provisions outlined in that.
Refined risk assessments are currently being completed for the remaining eight OPs, specifically Azinphos-methyl, Bensulide, Ethion, Fenamiphos, Naled, Phorate, Profenofos and Turbufos.
We're currently developing risk management proposals to address any risk concerns identified in the assessments. These proposals or approaches to managing risks will be developed based on the certainty of the risk estimate. Consequently, definitive proposals will be made in instances where risk assessments are highly refined and still indicate problems. Conversely, options may be proposed in instances where it appears there is a risk concern, but risk estimates could further be refined.
Following publication of our approaches to managing risks, a 60 day public comment period will be provided. We expect to issue refined assessments and risk management approaches for the first eight OPs at the end of this month. The next seven are anticipated at the end of February or the beginning of March.
That concludes my comments on the update. Larry, you've already had your questions. You're done.
MR. ELWORTH: I'm done.
MALE SPEAKER: You said fairly quickly something like where there is definitive information in the risk assessment and there is defined data, then you will take definitive action, and where the risk assessment could use more data, or something to that effect, the agency is likely to -- I didn't catch it.
Could you sort of repeat what you said there and amplify on that a little bit?
JACK: Well, I -- where we know that we've refined our risk assessments to the nth degree and still have a risk concern, we're more likely to propose definitive measures on what our approach would be to mitigate that. And that may be proposing deletion of a use, or modification of a use. Whereas if we still believe that the risk assessment could be refined, for instance, we have field trial data and there may be some monitoring data out there that we don't have in our hands, we may provide options as to what's driving that risk and ask for comments on approaches to mitigating the risks.
MS. MULKEY: If I may be of help in clarifying, we're not saying that we are delaying or going through another loop of analysis. We're just saying that the approach to the way we articulate risk management, or frame the public participation in risk management, may vary a little bit, depending on the nature of the information. This is in all instances to be a public comment period on risk management.
SHELLEY: I have a question.
MS. MULKEY: Oh, I'm sorry, Shelley.
SHELLEY: Will mitigating worker risks be part of the mix in this process?
JACK: Mitigating worker risks -- ecological risks -- will be part of it, yes.
MS. MULKEY: Other questions? Jay?
MR. VROOM: Around the earlier public release of the risk assessment pilot, I think we learned a lot, and yet I don't know that we all understand precisely, you know, the process that's been followed. Is there a plan to sort of write a history on this quickly so that we can have a universal understanding of what the process was that was followed and then take lessons from that? And then what's the plan for making this permanent, and getting definition and participation and buy in for what the permanent version of the pilot is? That's a process question.
MS. MULKEY: Do you have some suggestions along those lines?
MR. VROOM: I'm sure we do, yes. I don't have them all organized. So what's the right way to do that? I mean, should PPDC members come forward or should we bring that to the TRAC?
MS. MULKEY: This has, of course, been a topic that has been at the very heart of the TRAC agenda, and I don't mean to sort of shift it to this forum.
MR. VROOM: No.
MS. MULKEY: But this would appear to be the exact kind of issue in which stakeholder involvement and stakeholder input would be useful. And by my asking did you have a suggestion was by way of saying I don't think we intend to approach that question in an unilateral way.
MR. VROOM: Yeah. But have you thought about when -- what the schedule would be?
JACK: I think -- our early thinking is that as we plan for the February TRAC meeting that perhaps one of the agenda topics ought to be what our experience has been with the pilot, lessons learned, good, bad and ugly, and then what that then tells us for the future. And then put that on the agenda for the TRAC and then have obviously the agency share its experiences as well as anybody else, for that matter, and then use that as a guide for whatever the next step would be.
MS. MULKEY: And obviously this next -- as you can tell from the schedule, this next month or two will dramatically increase the amount of experience we have. You know, we're going for the first time into sort of a second comment period. We'll have many more preliminary ones released.
MR. VROOM: Also related to this and to follow on Shelley's question, I think it's our general sense that the dietary side of this process has been more along the lines of what was expected in terms of the data that came forward. And obviously there were surprises and mistakes and things. But the more ragged side of the experience has been in general the worker and ecological splice into the rest of what now is heading toward some kind of a conclusion.
So I would just, I think, articulate the fact that registrants in general are more uncomfortable about that half of the process and less clear about what that process is and so on. And there is, I think, a lot more concern about that, and it also relates back to the overall RED schedule. You know, there are a lot of pieces that are on the schematic diagram here that we have pushed into a pilot program, and I think a lot can be learned from that. And I hope that we can get some transparency around where we go from taking those lessons forward and making a permanent solution.
MS. MULKEY: Thank you.
MR. VROOM: Another question. Jack mentioned obsolete tolerances, or obsolete tolerances that still might be of interest to importers. I think that raises an important question about what's the forum to resolve those kinds of issues which can be extremely political and have absolutely nothing to do with the interests of growers or domestic pesticide users.
Have you confronted one of those yet to have a pilot model of how you sort through that and where it's, you know, only the embassy of country XYZ that wants this preserved? I remember, Bob, you had a lot to do with the fact that we ended up with some provisions in FQPA because of import tolerance concerns and harmonization in the context of NAFTA and WTO.
But I'm really curious, because that's going to eat up in some places a big chunk of risk cup. What's the system to address those issues?
MS. MULKEY: We have been working hard on an import tolerance approach. And what triggered it for us was when we published the 1,400 obsolete tolerances, among the things that surfaced was a handful where there was an interest in retaining them for import. And we were faced, you know, right then with the reality of what kind of data are we going to require, what kind of support is necessary to retain it and so forth.
So we are, I think, on the brink of being able to publish a proposal to sort through the import tolerance issue.
MR. VROOM: That will be a stand-alone policy?
MS. MULKEY: Um-hum.
MR. VROOM: On import tolerances?
MS. MULKEY: Um-hum. It's not unique to the organophosphates.
MR. VROOM: No. Right.
MS. MULKEY: Um-hum.
MR. VROOM: Then the rest of the obsolete tolerance list -- some of us had talked earlier about how do we sharpen up, you know, and de-mystify how big is the list in opposite to the August 3, 1999, deadline. And maybe we could do that as part of PPDC or TRAC or whatever.
MS. MULKEY: Um-hum. That's a good topic. You might be able to give a little report on the status of that, Jack.
JACK: Well, we've already revoked some of the obsolete tolerances for the organophosphates.
MS. MULKEY: I meant in general, the original 1,400 we proposed. Do you want to just go --
JACK: Yeah. I can't --
MS. MULKEY: Maybe we should just get that to you.
MR. VROOM: Thank you.
MS. MULKEY: I know that's not the only point you're making, but we could at least give you hard information about the -- we propose revoking about 1,400.
MR. VROOM: Right.
MS. MULKEY: And we've gone final with about --
JACK: Maybe half that or so.
MS. MULKEY: Um-hum. We can maybe give you some status on that.
MR. VROOM: I just think for all stakeholders, given the fact that August 3rd is less than seven months away, that more clarity and de-mystifying what can be de-mystified can be helpful to the overall stakeholders.
JACK: Um-hum. The accounting rules. What accounts, because it's not just the obsolete. It's also what have we done since '96.
MR. VROOM: Right.
MS. MULKEY: Right. And we're trying to sharpen our pencil on our accounting. We can provide some sort of interim information, I think.
Okay. Thank you. Any --
MALE SPEAKER: Can I just real quickly?
MS. MULKEY: Yes.
MALE SPEAKER: To follow up on Jay, can we -- what would be an appropriate forum to discuss that import tolerance issue, the proposal? Is that a TRAC thing or is PPDC not going to meet for a while?
MS. MULKEY: Well, I think I would start with you wanting to see it and see how much of it is the kind of thing you're interested in. A lot of it is pretty esoteric stuff about what kind of residue trials have to be run, under what kind of growing conditions and how many countries. I mean, a lot of it is that kind of topic that you might not think is fruitful for discussion.
But there are some fundamental policy concepts in it. Why don't we add that to our list of sort of topics that need the benefit of stakeholder involvement that we will come to at the end on the second day.
MALE SPEAKER: And you may have suggestions about it, because the proposed discussion in the FR will mostly give, as Marcia just indicated, the sort of -- about the esoteric in laying out some of the important policy issues. But that still doesn't answer what is the right forum for this, you know, very sexy, political or whatever phrase you want to use, issue.
MALE SPEAKER: Right.
MALE SPEAKER: And the proposal is not necessarily going to fix that. I mean, is it, you know, 30 percent of the risk cup can go to foreigners versus 20 percent versus 90 percent versus whatever.
MS. MULKEY: Yeah. This policy definitely doesn't reach that.
(END OF TAPE)
MR. OLSON: That's the first time I've seen it and I think it's useful for us to have it. I have a couple of questions about that and then a bigger picture.
There are several where it indicates the agency expects to begin registrant review 1/99 through 4/99. And I'm not -- I'm still not clear on what that means. Does that mean you haven't decided when you're going to begin registrant review. It's going to be between January and April. Or does that mean registrant review and EPA response to that review is between January and April? Or what does that mean?
JACK: That means we haven't completed the risk assessment yet, and when we do, we'll forward it to the registrant. And that will be sometime between now and April.
MS. MULKEY: We have estimated times on all of them. But the further back you are in the process, the less consonants you have in your estimated time.
MR. OLSON: So you're not saying you're giving the registrant three months for review?
MS. MULKEY: No, no, no, no.
JACK: They'll get the standard 30 days.
MR. OLSON: Okay.
MALE SPEAKER: If you followed the numbers that Jack indicated, almost all of them are now or soon -- but four or five will be towards the end. And that will be -- that's what that, you know, somewhere between January and April means.
MR. OLSON: A bigger picture question is -- this is interesting for the organophosphates, here are a lot of other chemicals that are in the que before August. And I wonder for the carbamates and for everything else that you have to make decisions on between now and August 3rd, do you have a schedule for that that you can share with us?
JACK: We have a number of chemicals that we're working on that are non-OPs that are going through re-registration, yes. And we can make that --
MR. OLSON: I mean for the tolerances that are due August 3rd? For the tolerances?
JACK: Well, it would be those chemicals that are going through re-registration now plus the organophosphates tolerances.
MR. OLSON: I understand that. But do you have a schedule that you can share with us for how you're going to move forward with the carbamates and the other chemicals that you have to make decisions on by August 3rd?
MS. MULKEY: I think there's a premise in your question that not all of us share exactly the same articulation of it that you do that may be part of why Jack is having difficulty answering.
We understand that we're obligated to do one third of the tolerances by August of 1999. We also understand that we're obligated to be focussing our energies first and foremost on the more serious problems, the so called worst first, which include the organophosphates and the carbonates.
The sort of cross over that you're making, which is that all of them have to be done by August 3rd, is the part that is not exactly the way we've been articulating it. I think that's why Jack is looking at you blankly.
MR. OLSON: You mean you're saying that you never believed that you were going to finish the organophosphates and carbamates by August 3, 1999? Is that what you're saying? I'm not sure I understood what you just said.
MS. MULKEY: I think what we're saying is, we believe that we can have completed one third of the tolerances, and that we are focussing first and aggressively on the organophosphates and the carbamates.
MALE SPEAKER: But not all OPs.
MS. MULKEY: But not that each and every organophosphate and carbamate tolerance would be completed -- would be in the first third necessarily.
MR. OLSON: Okay. That sounds directly contrary to what Fred Hanson said to me when I asked exactly the same question at the last TRAC meeting.
MR. AIDALA: Well, we could dispute that, too. It is -- what Marcia just articulated is what Hanson testified before the committee -- the House Ag Committee in the hearing in whatever time that was, June or whenever it was.
Let me step back for a second, and just to also kind of directly answer your question can we get you a schedule -- get all members a schedule of everything? Yes. And we've got some congressionals on that and we will -- you know, it's a good question. Whether or not we can parry interest on August -- what's by August 1999, it still is a good question, when is atrazine due in your system, when is carbamates and so on and so forth. So that can be developed and provided. That's not -- that's underway.
In terms of the larger issue of what you're talking about in terms of what's due by August 3rd -- and we can spend some more time on that, although I think Marcia kind of articulated, you know, there's a premise there and, you know, we may have a disagreement there, per se.
MR. OLSON: So this is the first time I'm hearing there is a disagreement, that the agency now says that you don't have to finish the carbamates and the organophosphates by August 3rd.
MR. AIDALA: Not to put too sharp an edge on it, I don't think that's the first time you've heard it.
MR. OLSON: It's the first time I think I've heard it. So that's where the agency is.
MR. AIDALA: Well, again, if Hanson -- and obviously representing the agency, even though he's no longer an employee. You know, the Deputy Administrator testified before Congress almost six months ago and said, you know, kind of Marcia's articulation.
MS. MULKEY: We also --
MR. AIDALA: And it may not have been noticed. I'm sorry. But, you know, that's --
MS. MULKEY: There's a recent letter to Mr. Waxman, I think, that --
MR. AIDALA: Yeah, that's the congressional we're working on in terms of the schedule. So it's a fair question about the schedule, what we're doing when. And people can have a comment about that and make suggestions and all that. And that's very fair and that can be provided to committee members.
MS. MULKEY: We are very committed, as I understand it, to both statutory provisions. The one that says you do one third by August of 1999, and the one that says that you focus on -- I know the wording is not worst first. But that's sort of the commonplace articulation of it. And we are attempting to meet both of those obligations, and we take them both very seriously.
MR. AIDALA: And further, Erik, if you look at the schedule, if by April all the OP preliminaries are out and you then build in, albeit a pilot, the 60 days, 90 days, etc., etc., you're, you know, hopefully having whatever the timing will be, whether it will be August 3rd per se, on having second round risk mitigation plans, etc., etc., etc. That is ongoing. I mean, that's what the folks in the various divisions are working on.
MS. MULKEY: I think we remain optimistic that much of the work on the organophosphates will be completed by that date. But tolerance reassessment is a term of art, among other things.
Any other questions?
MR. AIDALA: And the important thing for us, then, in terms of driving the folks crazy down in the division, is this schedule you see before you. And you just add the other times on the end of that, plus preliminary, plus comment time, plus getting the risk mitigation package back and things.
MS. MULKEY: Bob?
BOB: Yes. Just back to the import tolerance issue again just for a moment. I think I'm recalling that one of the provisions in FQPA requires EPA to pay some attention to international PRL's established through the Kodak Salamentarius (phonetic) Commission process.
And for that reason, I think it would be interesting with regard to the ones where there is some interest in maintaining an import tolerance to know where that tolerance might stand relative to the MRL. And I'm not really asking for that information here. But I think as the discussion goes forward, it would be nice to have that information available.
MS. MULKEY: Thank you. Beth?
MS. MARSHALL: Going back to the worst first issue, are you saying that in fact the most dangerous chemicals compose more than a third of the total that you have to review, and that's why you are not in fact going to be able to complete all of the worst first in the first third?
MS. MULKEY: No, that's not what I was saying.
MS. MARSHALL: Okay. Then are you saying that it has proved to be more complex than originally estimated and that's why these chemicals won't all be completed in the first third? I guess I'm asking why won't these chemicals --
MS. MULKEY: I think we're saying we are working as hard as we know how to work to complete these chemicals, because we believe they should be completed early for reasons that have to do with public health and environmental protection, and that have to do with the statutory mandate to focus on them first.
We are also reassessing tolerances in a lot of context. We're trying to clean up the books on the obsolete ones. We have been doing re-registration. And that leads to the reassessment of large numbers of tolerances as you handle those chemicals, some of whom belong in the worst first and some of whom for all sorts of reasons were in the que for re-registration that would not have qualified for that, but were there and the work was either done or being done. So we are reassessing tolerances as we go, and we're working on the worst.
MR. AIDALA: The distinction is between the numerical counts for the clear statutory provision versus the general common sense and the statute provision about doing the most important things first. So directly answering, will we complete all the tolerance reviews and reassessments for all carbamates, all OPs and all B-2s and CQs, the answer is no, by August of 1999.
If your question is, will we meet the deadline that says one third of all the tolerances on the books as of the date of enactment will be reviewed, we fully expect to meet that deadline. A lot of the numerical count will include these obsolete pesticide tolerances. It's important to get them off the books for a number of reasons, but if you will, we would not be wanting -- you know, we would not try and claim those are the important, you know, risk issues in the world.
And in terms of the larger question that Erik asked, for example, about what is your schedule about, when are you going to get to those important things, or whatever phrase you would want to wrap around that, that's a fair question to ask and we'll have that schedule.
Does that help make some of the distinctions?
MR. OLSON: When can we have that schedule?
MR. AIDALA: Well, we're working on it as we speak.
MS. MULKEY: Right. The schedule for the OPs you have. The schedule for the REDs is available. The schedule for the --
MR. OLSON: Is the schedule for the Reds the same as the schedule for the tolerance reassessments at this point?
MS. MULKEY: They're related.
MR. AIDALA: And we're trying to formulate -- again, we know this question is going to be asked. I mean, some people are interested in counting rules, congressionals and other kinds of things as August approaches. We're trying to put together, shall we say, a simple synthesis of that as opposed to saying, go look at the Reds schedule, or go look at, you know, this document from this division and that division.
MS. MULKEY: The further out you go, the less reliable the schedules are. So the schedule for this fiscal year is essentially the schedule for the OPs and the REDs. And, you know, that gets you through September. And beyond that the schedules are just by definition somewhat softer, but we're happy to provide them.
MS. BRICKEY: Nuance is not my thing, so I don't want to get into this nuance thing here. What I want to know is this. You're assessing one third numerically by August, but that will not be necessarily one third of the riskiest. Is that what you're saying?
MS. MULKEY: I think that's accurate.
MR. AIDALA: A fair summary.
MS. BRICKEY: And in terms of this summary that you're going to provide, can you have something to us by the end of the meeting tomorrow that we can take back with us to look at?
MR. AIDALA: In terms of the full scheduling thing?
MS. BRICKEY: Rescheduling. Um-hum.
MS. MULKEY: I think that -- go ahead.
MR. AIDALA: I don't think it will be a synthesized and -- oh, yeah, because it's a simple question with not necessarily, you know, a one page answer. So I think that will take a little bit of further time. We're developing it for a number of different purposes, again including responding to the congressionals, and I would suggest we make that available. We're working on that as we speak, and I would not expect it to take a whole lot of time. But I think it will take longer than tomorrow.
MS. BRICKEY: Another thing I would like to talk about, and we don't necessarily have to talk about this now. We could talk about it before the end of the meeting. And that is, what the comments that we've just been having mean in terms of cumulative risk assessment.
MS. MULKEY: Fair. I think -- we're trying to be as transparent as we know how about our schedule, and that's one reason why you have in your list each OP separately scheduled. And then we also have a calendar in which we're trying to do that.
So if you can give us input about how this kind of information can be displayed that's more useable to you, we're receptive to that.
MS. BRICKEY: Well, if you recall, the last time we got a calendar of events I think we had a dual track with cumulative risk assessment on it and individual risk assessment. So I think some further refinement on where cumulative fits in the big picture would be helpful.
And I don't expect you to give it to us on the spot, but if we could do it before the end of the meeting that would be useful.
MS. MULKEY: That may be --
MR. AIDALA: And that's something back to Marcia's point about, you know, you obviously have to have a plan in the horizon, and we're pretty firm about what our tasks and duties and output, if you will, will be for this -- you know, until October for this fiscal year. And things get much easier going, you know, further out.
One example would be to the extent that that schedule includes, per the other TRAC discussions and things that many here have been either part of or certainly observers of, the cumulative risk determination, you know, policy and further peer review, etc., etc., that gets folded into that. We fully expect to come back to the OPs at that point. Not come back, but include the OPs where that's a very central question.
And so that may complicate schedules, say, in the next fiscal year and so on in terms of getting to some of these other things. But we don't know, because we don't have the cumulative policy out for review and gotten it all back and things like that.
MS. BRICKEY: Let's just talk about cumulative again when you've had time to think about it for a minute. Because I don't understand anything you just said, and I think it would be better if we had a little clearer discussion about it.
MR. AIDALA: Two or three things. If you don't have a cumulative policy until blank, okay, that will be essential to telling you precisely when we will be able to do a complete and final assessment of the worst first or any other category. Because, you know, that's a rather essential underpinning policy, as we've all discussed. Many stakeholders have an interest in that, number one.
Number two, for example, if it looks like we need to spend a lot of time as an agency in fiscal year 2000 given the cumulative policy on OPs, that's going to take time and energy and resources away from doing some other things. If it looks like it's not going to, then we would have a higher degree of output for fiscal year 2000 or 2001.
Is that a little clearer?
MS. BRICKEY: I'm afraid so.
MS. MULKEY: Shelley?
SHELLEY: It was my understanding from a recent meeting that you all were going to revise the scenarios for residential exposure. And I may be misunderstanding this, because I frankly haven't figured this out totally. But in your calendar of events, it looks like you have complete public comments on SOPs, which are Standard Operating Procedures, I guess, for residential exposure for April of 99.
And I'm kind of lost here. I mean, are we going to get a crack at some kind of draft? What's the deal?
MS. MULKEY: Yeah. That set of SOPs for residential exposure, which we're now trying to call non-dietary, non-occupational, because one of the things that is clear is it does go beyond residences, and part of the issue you're talking about, which is to be sure there is a focus in certain areas that are beyond residences.
MS. MULKEY: That was published this week, so we have just entered the 60 day comment period for those. Some of the revisions that you are focussed on, revisions that would incorporate more explicit consideration of incidental exposure associated with draft or near fields, are not in that current draft. There is reference to our interest in doing that, I believe, in it.
So that's in the comment period. You can -- this is the window of time for you to engage. And we're also working on it during this period, and we've tried to signal to people that we're moving in that direction.
SHELLEY: Okay. So in other words, not to put the finer point on it, but if someone were to comment that additional scenarios need to be included in this, then you might do another comment period taking those other things into account?
MS. MULKEY: Well, we've tried to signal at least around those subject matters enough now that we wouldn't feel like we would need to go through an additional comment period.
SHELLEY: Okay. Thanks.
MS. MULKEY: We tried to open this one in a way that puts those issues on the table.
FEMALE SPEAKER: And what's the deadline on it?
MS. MULKEY: It will be 60 days from this past Monday. Is that right, Bill?
BILL: It's in one of the policies.
MS. MULKEY: Jeannine has joined us from Concerned Scientists -- I mean, excuse me. Consumers Union. C's and U's I can't keep straight. Consumers Union representative.
Okay. Any other questions? We know this is -- of all of our reports, this was predictably the one that created the most interest. So I think we're still on time to move through the rest of these.
And thank you for all your input. I think it was helpful and probably rose to the level of a dialogue, even if it was not sufficiently satisfying in terms of the depth or breadth of the discussion on this topic.
And Jack's comments -- he has basically covered both the preliminary risk assessments and risk management phase. So Denise Kechner, who has -- the registration review, for those of you who need a reminder, is the provision in the statute that says -- that sets as a goal that from hence forward every 15 years pesticides will recycle for updating.
And we're happy to have you, Betty.
MS. SHACKLEFORD: That's right. I can't use the Denise Keehner -- so I'm actually Betty Shackleford. Denise isn't able to be here.
MS. MULKEY: Well, we're very happy to have you. Betty and Denise have teamed up internally to work on our planning around this area.
MS. SHACKLEFORD: Okay. What I'll do is, I'll apologize to you in advance, because I have to take off my glasses to read my notes. But if you wave your card if you have a question, I suspect I'll be able to see it.
As Marcia pointed out, the FQPA required that the agency develop implementing regulations to provide for re-registration of existing pesticides. The goal of that particular initiative was to have a review once every 15 years.
Now when Denise spoke to this particular body back in April, she essentially covered five things. Essentially the fact that the agency wanted to identify some innovative approaches to looking at the registration review program, that we wanted to incentivize the program somewhat, to ensure that there was as much of an interest on the part of industry in moving forward, and to provide timely and comprehensive review of existing registrations as there was on the part of the agency.
We talked a little bit about scheduling and the need to identify a process that provided for the review of the most hazardous chemicals first. But also a schedule that provided flexibility and the ability to tailor the review to risks. So in other words, if a chemical had been recently reviewed, if a chemical had a well defined database, if there had been new uses registered or what have you, there might be opportunities to accelerate registration review of that particular chemical. And we talked to the panel -- or she talked to the panel about being able to provide that kind of flexibility.
And perhaps one of the key components of her discussion was the need to have a more robust stakeholder involvement process in the registration review program. And those five principles that I've just identified do remain sort of fundamental tenets that we believe are our key.
Since April there has been a fair amount of progress on registration review, and I want to talk to you now about three things. Specifically, our progress on the rule making, where we are on the conceptual model, and pilots that we are looking to undertake.
First let me talk about the rule. As I mentioned, we have to put in place an implementing regulation, and there are generally two approaches that regulatory bodies take to rule making. One is you can go out with a notice of proposed rule making, or you can issue an advance notice. And we decided to go forward with an advance notice of proposed rule making, again primarily to get as much feedback on some of the basic principles that the agency is considering in establishing in the registration review program.
Right now that ANPRM is scheduled to come out around March of 1999. So within the next couple or three months you should expect to see something in the Federal Register. We are still on track to have final regulations in place around 2002. So that's where we are with the rule.
The other thing that we've done, which perhaps has been one of the most exciting parts of this entire process, is working on a conceptual model. And a conceptual model is essentially the process flow diagram of a system for actually putting -- conducting, excuse me -- registration review.
We have developed a conceptual model. It represents what we envision now. It by no means represents what the agency believes the final process will look like. And I do want to underscore that. But it is sort of our template that we're using to obtain public input.
And there are a couple of key things that I do want to mention that are sort of embedded in that model that differ from the existing re-registration process. First and foremost is the opportunity for really robust stakeholder involvement. That process envisions that at various steps along the way there will be public meetings. They may be large meetings. They may be small meetings. But it does envision a much more dynamic and robust stakeholder process.
Secondly, we're looking at a very clear sort of two prong process. One that would be an actual proposal where, again, the agency would take public comment on the re-registration initiative, and then you wouldn't have a final until after the agency has had an opportunity to consider that public comment, which is not too different from the existing process, with the exception that we only revise re-registration initiatives now if there is substantive comment on our, if you will, re-registration decision or RED.
The other thing that's being envisioned is that industry would submit an application for registration review. The application would really sort of follow a schedule that we would put in the Federal Register. And the thinking there is that it would put some discipline in the process. It would enable the agency to lay out on perhaps a three year window those things that are going to be on the horizon for the upcoming year. It would give not only industry, but the public sort of a very early heads up on that.
And, again, the narrower the schedule is, as I guess you've heard recounted here today, the more certainty there is associated with that. So we would have a cycle of publishing these notices annually, and you would get a feeling for what particular chemicals are going to be reviewed when.
And then lastly, one of the key things in the model is this notion of one size doesn't fit all. So that we would have a single process, but again there would be opportunities for chemicals to complete their review on a more expedited schedule.
So those are some of the fundamental differences between the model that's envisioned right now and the existing processes that you may all be familiar with.
Lastly, I want to talk about the pilots, and I'll try to go a little bit quicker. We have spent a lot of time thinking conceptually about what makes sense for registration review, but the proof of the pudding is always in the actual implementation. And so we thought it probably makes sense to try and identify a couple of chemicals that we could work through the registration review process.
We've looked internally and there may be some bio pesticides or antimicrobial pesticides that we can begin some early, if you will, dialogue and work with you and with the industry to try and see what the implementation looks like for this given conceptual model. We are hoping to begin some dialogue in the very near future -- the very near future meaning something like the next three or so months -- with the industry on this.
And obviously we would like to have this particular body involved to the extent that you would like to be involved. So that's one of the things that you may want to have some following dialogue on.
I think that's about all I do want to mention at this particular point. The fact that we are working on the rule, that there is a conceptual model and we can make information and the details of that model available to you, and lastly that we do hope to pilot a couple or three chemicals through this conceptual process, probably beginning that within the next quarter or so.
That's all I have.
MS. MULKEY: Do you have some questions?
MALE SPEAKER: I have a question.
MS. MULKEY: Okay.
MALE SPEAKER: Betty, I have a question -- a clarifying question. You said that in this process the agency would issue a list annually of proposed chemicals for review.
MS. SHACKLEFORD: Um-hum.
MALE SPEAKER: But prior to that you stated that registrants could submit some sort of request for review. Could you please clarify that?
MS. SHACKLEFORD: Sure. Sure. Well, what we're contemplating -- and bear in mind that there really haven't been decisions made. But what we're contemplating is that the agency would probably look at registration review on a three year cycle. And it would publish in the Federal Register a list of those chemicals annually, with the chemicals on schedule for the upcoming year being very specific, with less certainty as you go out. And that would give the registrants an early warning of when they would need to prepare and submit their application package to the agency for registration review.
So this concept of an application package is really a new one that we think would make some sense.
MS. MULKEY: Obviously that's an idea. It's not a decision.
MS. SHACKLEFORD: All of this -- these are just ideas at this point, yes. Okay, thank you.
MS. MULKEY: Yeah. Jay?
MR. VROOM: Will there be an opportunity somewhere else on the agenda to talk about new uses and new products and all the other information that is summarized in the year end report?
MS. MULKEY: That's actually our -- it's listed here. It's Fiscal Year '98 Pesticide Program Accomplishments.
MR. VROOM: Okay.
MS. MULKEY: Jim Jones.
MR. VROOM: Great.
MS. MULKEY: Any other questions? Thank you. You must have been pretty thorough. The next item and the last of the ones that are sort of sub-labelled FQPA Implementation Activities is the consumer brochure.
As you know, a work group of this group played a vital role in the initial development of all the work that ultimately led to the agency's decision making on the consumer brochures. So we assume you have a particularly keen interest in that status.
And so Ann Lindsey, whom you all know is the Director of Field and External Affairs Division, an invaluable asset.
MS. LINDSEY: One EPA person actually suggested to me that I start out by telling you all that we were going to commission a new subgroup of the PPDC to work on the next brochure and to ask for volunteers. I thought that might be embarrassing, though, because I'm a little fearful that none of you would raise your hand. So I would rather start out by reassuring you that we're not at this point re-commissioning that subgroup to work on the brochure.
I think it was at the last meeting of the PPDC, which was a while ago now, that all of you rendered what I think of as your final advice and counsel on the brochure. My memory of it -- and this may not track with yours; anything in error here is simply my faulty memory -- is that there is a very diverse range of opinions and judgments as to what the brochure should look like.
Close to being all over the map, none of that coalescence that we've talked about in TRAC meetings, except in one very specific area. Which was that the agency at that point should go away, taking all the advice that it had, all of the consumer research, seek it's own counsel and that of USDA and FDA and exercise its judgment and make a decision about what the brochure should look like.
So what I'm here to tell you is, we've done that. It's taken us perhaps a bit longer than I had hoped to mediate on what we had heard and come to conclusions. But the brochure is ready for release, and i expect it to be officially released this month.
It is definitely not the same brochure that you last saw. It is shorter by about half. I think all the messages are still there, and they're there in what I consider to be a very focussed and effective way for someone who goes to the grocery store. I know when I'm at the grocery store, I've got a lot on my mind and I don't want big pamphlets.
But I think what we've come up with will catch people's attention. It will focus them in a constructive way. And even better, it will refer them to another source of information which I think can give a lot more detail, and that's our web site. Web sites are not good for everybody, and we know that. But it is good for at least a subset of the population, and it becomes a basis for doing other things.
So when it's out, you will be among the very first to get it. We may send you a personal autographed copy, even. Gold plated ones that you can put on your desk. But once you take a look at it, and if you agree with me that it's a good document, I would like to enlist all of your support, both individually and collectively, in getting it out there. Because it's really only as good as it gets out and as people use it.
You'll probably think of other things that we could or should be doing, either with the brochure, with the web site or with other documents. Those are good, because this can be an ongoing process of consumer right to know and something that I think will get better over time.
So that really sums it up. The one kind of disappointment for me, Dan Barolo had always promised that he was going to personally distribute it, and we simply have not been able, given government contracting regulations, to do that. So we're going to be using our own government distribution center to carry it out.
MS. MULKEY: Are there questions?
MR. AMADOR: I may have. What is the schedule now for distributing the brochure?
MS. LINDSEY: The exact day to start the distribution hasn't been determined, but it should happen I think in the next couple of weeks during January. And I think it will take a little while before it actually shows up in the grocery stores. We're not sending millions of copies to all 41,000 major grocery stores. We're sending sort of a sample with a postcard that invites them to order, you know, the quantity that they think they can actually distribute.
So I think it's going to take certainly into the spring time to really get it out.
MR. AMADOR: And the other question is, is there any possibility of including any kind of information to the grocer on how to use the pamphlet? Where to put it? I mean, I know there's no obligation for them specifically in the statute how to react to it. But is there any kind of indication?
MS. LINDSEY: We're going to be trying very hard to enlist the active participation of grocery stores. I guess I don't actually feel comfortable telling grocery stores exactly where they should put it, because I think they know a little bit better about managing their grocery store and where it should go.
But one of the areas that I think we need your support is encouraging the grocery stores to really use it, and to use it prominently so people can find it. As a consumer, my favorite place would probably be in the fruit and vegetable section. That's where it would sort of reach out and grab me.
MS. MULKEY: Didn't our focus group show that that's what consumers --
MS. LINDSEY: Yeah.
MS. MULKEY: We will -- I think we do intend to provide some information to grocers about what we learned from our focus group so that they can have the benefit of that knowledge.
MR. AMADOR: Is there any plan to use the Extension Service network to help distribute the publication?
MS. LINDSEY: Yeah. We actually hope over the course of the year to be using a lot of different organizations to get it out in areas other than the grocery store. So while we're going to start with the grocery stores of the country, we will be going to, for instance, the land grant university system, the extension service, the -- I can't remember the right title of it, but the pediatricians association, libraries. There's a whole wealth of sources that we can use.
MS. MULKEY: Paul, did you want to add anything to that?
PAUL: No, other than I think we need to have some discussion about how we could put it out most effectively through the extension network. It's obviously one of the best mechanisms in the country we have for getting information. We'll certainly be talking to Ann about that.
Glad to hear you're volunteering, Jose.
MS. MULKEY: Are there other -- yes, J.J.?
DR. STEINBERG: I have no doubt that if Ann has been involved in this that this will of course be a first rate effort, and I'm delighted that there was consultation with the USDA and particularly with the FDA, who have really been terrific in getting consumer based information out. So I think that will all be very exciting.
I would like to have some assurance that there will be some type of follow up or monitoring to actually make sure that these pamphlets will indeed be available to the target audiences. I would also love to know, which the EPA has always been very good at, that this will occur in multiple languages.
And I would also like to be able to know, and to get a better sense from you, how you think the web page and the final brochure are actually the same, and how they differ, and whether there may have to be some evolution of this pamphlet in six months or a year if there is some feedback that it requires a little tinkering with.
MS. LINDSEY: Those are all actually really good ideas, and I hope our designated federal officials captured them all. I wasn't sitting here writing everything down. We are doing it in Spanish as well as English to start with. And if it looks to us that we need other languages besides Spanish and English, we'll be doing that.
The web site itself we've tried to correlate very closely to the brochure, but it provides more in depth information about various topics such as risk assessment. What are the risks associated with pesticides. How do we go about assessing them. If you want to know how many pesticides are on your banana or your kumquat. It won't tell you exactly what's there, but it will tell you what's registered and what the tolerances are.
I like your idea for sort of monitoring both is the brochure itself getting out and how well is the web site working. We put a lot of effort into trying to make the web site simple but not so babyfied, I guess, that it's not providing good information. And that's hard to do. One of the things is, after you work at EPA for a while, there are things that you think everybody knows and so you assume that you don't need to explain it. And then you discovered that the ordinary person hasn't a clue as to what you're talking about.
So it sounds like maybe at a future PPDC it would be good to come back and perhaps do a little status report as to how well we think it's been working, as well as to hear from the rest of you as to how well you think it's been working or whether you like it at all.
MS. MULKEY: Jay?
MR. VROOM: Ann, I would add something to your recollection from April. That was a long time ago. But I seem to remember that if there was one universal thread of advice from all PPDC members on this subject, it was don't do it. But given the fact that you're slightly more accountable to Congress who wrote it into the law than you are to this committee, I suppose you had no other choice, right?
MS. LINDSEY: Yeah. I feel very accountable to Congress, frankly.
MR. VROOM: The serious comment that I wanted to make probably is most appropriate for the one political appointee among you who happens not to be here, I don't think. And we have spoken to Charles Franklin in the last day or two, and also the office of General Counsel, and the message essentially is this.
Number one, I think it's good that it's done and it's out. It's coming. And this phase of the brochure is going to be over, and we can move on to finding out what real grocers and real people think about communicating in this way and also via the web. And I think that's what is really important. So I am eagerly looking forward, as is, I think, the entire membership of my organization, to that event.
But I am troubled -- and I want to express this here -- by the fact that we all care deeply about this. And I think you've made a sincere effort and struggled in the agency and with FDA and USDA since April in trying to keep your own counsel and get this job done. And it might have been helpful if you had just told a lot of us that over and over and over again, instead of being so nice and listening to us.
But at any rate, I think you did a good job up until just recently. While even though you can't give us a copy today, a copy is out. It came from a place -- and we can all guess where it came from. But, yeah, it leaked from the Environmental Protection Agency and has been spun in a major news outlet. And I don't think that helps the trust and transparency commitment that we all need to renew starting today.
MS. MULKEY: Jeannine?
MS. KENNEY: You know I have to respond to that. MS. MULKEY: It is a dialogue committee.
MS. KENNEY: Jay might be surprised. I actually agree with some of his concerns about the amount of information that does leave the agency from time to time. I shared those concerns when the organophosphate internal OPP memo was leaked last year and spread around Washington and the countryside in every chemical outlet you can possibly imagine.
In that circumstance it was done in a situation where there was no opportunity for the agency to response, or for the public interest groups to respond, and that's a concern, because that led to a lot of understandable hysteria in the countryside. And so I think there are some concerns here.
My interest in this brochure was actually peaked as a result of a letter from ACPA and other members of the food industry to EPA in August, which expressed concern, among other things, about the presence or suggestion that there might be information about web sites in this brochure, which was obviously not a prominent part of the draft brochure.
Short of divine inspiration, I'm not sure how the information about the web sites being in the redraft got out, were it not for information provided to ACPA or others in the food industry about what the draft looked like at that point in time. And I frankly don't know if it was the final draft at that point or not.
So I think this is a concern. Perhaps there does need to be more information sharing. I'm frankly very disappointed, you know, about what I know this brochure looks like. I mean, I have a lot of questions as to why things changed freely with respect to the way pesticides are described and treated, the way the tips are described and treated, and frankly with respect to the way organic food is presented as an option for consumers.
So I guess that's what I would say in reply. I share some of Jay's disappointment about the way information on FQPA generally has leaked out from EPA. And obviously it doesn't just occur to one recipient or another. So that's what I would say in response.
MS. MULKEY: I suspect that's a topic on which we could not get convergence, the topic of the undesirability of leaks. Beth, yes?
MS. MARSHALL: I do have to take issue with Jay when he states that it was a unanimous recommendation of the committee that this brochure not be done. In point of fact, it was not unanimous. Several of us considered it very important to get the brochure done and out there.
I am somewhat disappointed, to say the least, that having just learned that there was a leaked copy that I did not get a copy of it.
MS. MULKEY: Well, me, too, Beth.
MS. MARSHALL: Apparently I am far out of the beltway.
MS. LINDSEY: I was actually thinking of asking if I could use Jeannine's sources, because like the rest of you, I didn't have it either.
MS. MULKEY: I am very curious now to see what the final draft is. It won't be much longer. Any other questions on this? I think this was actually useful to have some input on this. Not because that it's still on the drawing board, but because feedback at all stages in a difficult process like this helps us learn and make adjustments.
All right. Thank you, Ann.
FEMALE SPEAKER: Marcia?
MS. MULKEY: Oh, I'm sorry. I've got a problem of peripheral vision on the right side, I think. I need to work on that.
MR. BENEDICT: I stuck it up late. It wasn't fair to you. I guess I'm concerned, too, because I think the agency has a role in providing public information. And I saw the little clip on ABC, I believe it was, which kind of shocked me a little bit. It must have been about the leak, because they were talking about --
(END OF TAPE)
MR. BENEDICT: -- information about pesticides and pesticide use. I think the public would be well served if you did more of that instead of less.
MS. MULKEY: Thank you.
MS. LINDSEY: Just to respond?
MS. MULKEY: Sure.
MS. LINDSEY: Phil, thank you for that comment. And I assure you, we're not soured on the notion of getting information out to the public. It's one of the most important things I think we can do.
MS. MULKEY: Like so much of what we do, it just isn't easy. All right. Thank you. Ann, thank you.
Okay. Jim Jones is here. Jim is not only -- Jim is part of our organization, which feels that we did accomplish a lot in fiscal year '98, notwithstanding the fact that it was a -- I won't go as far as the queen once did in calling it annus horibilis, but it was a difficult year. And notwithstanding that, we had -- we had a lot that did get done.
And we've given you our reports on that. But Jim knows that you would like to hear those numbers again and probe them a little bit, and he may have a little bit of amplification, too.
MR. JONES: Okay. Thanks, Marcia. As Marcia mentioned, that although a real top priority in the organization was OP reassessment last year and continues to be, there is a lot else that goes on in OPP, as many of you know and care about. And I'm just going to report on some of those accomplishments and highlights from FY '98.
I am the Director of the Registration Division, although I'll be speaking not only about the work that we did in registration of synthetic and non-antimicrobials, but also the work that BPPD and the antimicrobial division did as well.
Since I am the Director of the Registration Division, I'm going to start with what we did first. In FY '98 we -- EPA registered 27 new pesticides, of which 13 were conventional pesticides, 12 were bio pesticides, and two were antimicrobial pesticides.
In addition, we registered over a hundred new uses for previously registered pesticides. This involved establishing tolerances or exemptions from tolerance for 248 -- actually 258 tolerances or exemptions from tolerance were established involving the hundred new food uses that I just mentioned. That is because a single food use can have multiple tolerances associated with it.
Two hundred and forty of those 258 were for conventional pesticides, 16 were for bio pesticides, and two were for antimicrobial products.
Actually, just to sort of -- in case you're not following every number out of my mouth, what I'm basically following is an FYI document that's in all of your packages. Pesticide Program Highlights from Fiscal Year 1998.
Of the 27 new pesticides that were registered last year, 14 of them were reduced risk. And the Reduced Risk Program is something that I've spoken to this group about and I think that most of you are pretty familiar with. Of those 14 reduced risk compounds, two were conventional pesticides and 12 of them were bio pesticides.
MS. MULKEY: Some people are riffling. This may not have been in the package. It was mailed to everybody.
MR. JONES: Okay. Okay.
MS. MULKEY: So for those of you who are still --
MALE SPEAKER: They're out front. I'll just go get them.
MS. MULKEY: And there are some out front.
MALE SPEAKER: I'll just go and get them now.
MS. MULKEY: Here we go. Okay, very good. One of the lessons we need to remember is that having mailed it to you doesn't mean you'll have it with you today.
FEMALE SPEAKER: That's right.
MS. MULKEY: I mean, you know, I operate that way, too. That wasn't meant to be -- okay. So we have these copies.
MR. JONES: Does everybody have a copy? Do we still need some copies? Okay. The Section 18 program last year had what I consider to be sort of the year that got us over the FQPA hump. As you all know, the FQPA required that EPA establish tolerances with Section 18's, which previously were not required. And the first year after the law was passed, we really struggled and had to put a lot of resources into the Section 18 program, more so than pre-FQPA.
Last year that sort of resource drain came pretty much under control and our timing pretty much got back to where it was before the Food Quality Protection Act was passed. We did receive -- it wasn't a record number of Section 18's, but it was on an historical high end. Six hundred and one requests were received for Section 18's, which is about 15 or 20 percent higher than we were getting on an average before the Food Quality Protection Act was passed.
Of the 601 we received, 410 were authorized, 27 were denied, 67 were withdrawn by the states, and 97 were pending at the end of the fiscal year. The average turn around time for all of the requests that were addressed last year was 56 days. Our internal goal is 50 days. Fifty six days is second best to only one previous year.
With respect to re-registrations, first starting with product re-registration, in FY '98 OPP re-registered 169 products and 420 products were canceled. We amended 54 and we suspended 127. This is part of product re-registration, the step that comes after a re-registration eligibility document is eventually issued.
In FY '98 OPP re-registered 13 active ingredients. There were 13 REDs issued, bringing the total REDs completed for the re-registration program to 184. The remaining REDs will be completed by the year 2002.
As related to the FQPA children's safety factor in FY '98, OPP's screening process evaluated children's safety factors for 98 active ingredients. In the Antimicrobials Program last year, above and beyond their accomplishments with respect to new chemicals, they made significant progress in implementing its antimicrobial pesticides program, including reducing the antimicrobials pending actions backlog by over 90 percent from its high of 388 on December 31, 1996, right after the Food Quality Protection Act passed.
In addition, the Antimicrobials Program clarified roles between EPA and FDA on the regulation of antimicrobial pesticides that come in contact with food and issued dress guidance on treated articles.
The Bio Pesticides Program last year -- as I mentioned earlier, they registered 12 new active ingredients. In addition, they added 27 new partners to the Pesticide Environmental Stewardship Program, which I think there may be some partners here. Well, Dean's not here today. I know he's a partner.
MS. MULKEY: Yeah, the Structural Pest Control folks.
MR. JONES: Yeah, that's right. Yeah. Very good.
FEMALE SPEAKER: Florida Fruit and Vegetable Association.
MS. MULKEY: All right.
MR. JONES: Several pest partners.
MALE SPEAKER: We actually got our strategy approved.
MR. JONES: Excellent. Janet Anderson is sitting right over here, if you want to sign up, anyone in the room. I'm sure she would be happy to have you.
Our home page was significantly enhanced last year, and hits have tripled since January of 1997 -- on OPP's home page. A little bit of competition in the organization as to who gets the most hits, and Registration is falling behind a little bit because of the OP reassessments. But we're hoping to regain our status some time this year, but I don't think we'll pull it off.
The Minor Use Program. Last year we appointed a minor use team leader, Pat Chemena, who I don't think is here today. This is one of the requirements of the FQPA. His responsibilities are to facilitate minor crop and public health minor use issues for OPP.
With respect to the overall sort of -- often we talk -- when we talk about the Minor Use Program, we talk about IR-4, which is USDA's program to submit data -- residue data, TPA -- for pesticides that are not being pursued by the manufacturers. We have tried to expand sort of what the minor use service and activities involve in relation to registration, as well as other activities.
And last year we actually went through our new use accomplishments in the Registration Division and in BPTD and looked at the number of crops that had a registration due to tolerance activities in the office. And although we did about a hundred new uses, as I mentioned earlier, in FY '98, because of the crop groupings that we do, which is work we have done over the last ten or 15 years to help minimize the amount of data that are necessary for smaller crops that are very related to each other.
We actually went and counted the number of crops that had a registration after FY '98 that didn't have one previous to then. And minor uses are the ones who are most affected, because they're most likely to be involved in crop groupings. And the total of 610 additional minor crops had a registration after FY '98 than had before FY '98. And that's at somewhat -- it's related to the crop grouping that were involved in the registration activities last year.
And that in a nutshell is a real 35,000 slipped overview of some of the other accomplishments that we had last year in the Office of Pesticide Programs. Thanks.
MS. MULKEY: Any questions about this? Bob?
BOB: Well, it just wouldn't be right if I didn't say something about Section 18's, so I won't disappoint people.
There are two comments. One, in all seriousness, from my advantage point I think EPA has done an outstanding job in dealing with that provision of FQPA. I'm delighted from an FDA representative standpoint that what I think I hear you saying is you think you're over the hump in implementing that provision.
From a more personal and lighter advantage point, perhaps some people will see me as being less bad now that you have made this progress.
MR. JONES: Thank you.
MS. MULKEY: I'm going to call on all folks whose cards are up, but we are running a little behind. So we're take a break after this segment. And we'll try to get these questions going fast enough that we don't -- that we're able to really still make our lunch.
DR. BALLING: The pressure's on. I'll talk real fast. Jim, Section 18's. Two years ago many of the Section 18's that were given had two year tolerances?
MR. JONES: Um-hum.
DR. BALLING: Which probably sped up your program this past year. Do you expect that there is enough carry over again so that you'll be able to continue with fast Section 18's?
MR. JONES: Yeah. The key is that once you've made the safety finding, which was the real difference pre-FQPA than post-FQPA -- or post-FQPA from pre-FQPA -- unless something changes over time, which happens, it becomes a relatively cheap enterprise making the finding again after FQPA.
So I think we're going to continue to see that resource being constrained with respect to how much we're spending on Section 18.
BOB: Okay. And then part two, how many new registrations -- new chemicals -- are in the pipeline? How many do you have -- what's your backlog?
MR. JONES: A total? There are about 40 new active ingredients pending with us right now, and we plan on making 13 new active ingredient registrations this year. So that leaves 27 that will not be addressed. And then manufacturers have things that they just haven't submitted yet, because of the way in which we have somewhat constrained their abilities to submit.
MS. MULKEY: That was for conventional chemicals.
MR. JONES: For conventional pesticides.
BOB: Right, right.
MS. MULKEY: I don't think we have a backlog for biologicals, do we?
FEMALE SPEAKER: We have in the pipeline somewhere on the order of about 35 active ingredients where sometimes they're not exactly -- they're in the pipeline, but if we're waiting for something from the company, we can't do anything.
MR. JONES: Right.
MS. MULKEY: Okay. I don't think we have a major backlog in antimicrobials. J.J.?
DR. STEINBERG: Since this is kind of an overview of what happened over the last, I just wanted to underscore a meeting that occurred last month on ethics, and particularly which the OPP and the SAB partnered. And this was probably one of the best knock your socks off conferences that I've certainly ever been at. There are some new concerns as it relates particularly to human testing that have now crept into the research paradigm as we develop whole hosts of new agents.
And I would hope that next year -- I know that this is becoming more and more of a working model at the agency. I would, of course, like to see within the agency some standing organizations or standing groups that can monitor this in a very workmanlike fashion and make sure that this occurs almost seemingly.
And also I would love to see in next year's -- and early reports -- that the agency continues to direct significant attention to this, so that there would not be any human studies that occur after the fact presented to you without your partnering with various organizations that are now involved in this. And I think that type of partnering is very important.
MS. MULKEY: Thank you. There will be considerable next steps following that meeting.
MR. JONES: And I think one of the things to also point out, that you just raised there a little bit, is that this really is a quick overview of -- it doesn't really get to the depth and the breadth of what goes on in OPP. I didn't even get to field programs and other science policy development, as you mentioned. This really is just sort of a fly over of some of our activities.
MS. MULKEY: And it was also just the fiscal year, so it only went through September. We've registered some more?
MR. JONES: That's right.
MS. MULKEY: Active ingredients and uses since then. Jose?
DR. AMADOR: Jim, the 424 cancellations that you mentioned here, are these cancellations of crops? How do you count the cancellations?
MR. JONES: No. These are after a RED is issued to the manufacturer generally in those cancellations. Almost always. Besides, they just don't want to support that product. And it may be that they have another product that's really basically the same thing. But they don't want to support that product, so they'll cancel it.
DR. AMADOR: So those are label cancellations?
MS. MULKEY: Right.
MR. JONES: Yes. They're label cancellations, that's correct.
MS. MULKEY: Paula?
MS. PAUL: I did want to compliment you on making good progress in '98.
MALE SPEAKER: Paula, use a mic so people can hear you.
MR. JONES: Thank you.
MALE SPEAKER: Paula, use a mic so people can hear you.
MR. JONES: Did you get that on the record, Paula, for whoever is taking notes?
MS. PAUL: But there is still -- from a commercial point of view -- from a company point of view -- and I think you know this, that we need to do much better. And we can't operate in an environment where we can't get our products out of development and into the market place. That isn't an environment that's going to allow business to operate in the long term. So we need to find a way to bring forth the resources or whatever is needed to speed us up.
The backlog question was already asked, so I won't go into that. I did want to ask you what your plans were -- you were going to publish your work plan for 1999?
MR. JONES: I'm glad you asked that question.
MS. PAUL: Are you still planning to do that and when?
MR. JONES: We are just waiting on the public release of the agency's operating plan. That's the only thing that has held it up. Once the agency's FY 99 operating plan is released to Congress, which is the forum we use to release it publicly, we will then issue our FY 99 work plan. It should be soon.
MR. AIDALA: It should have been already; so therefore it should be soon.
MS. MULKEY: Marion?
MS. MOSES: Yeah. I just had a really, really quick question. Just your best guess. You might not have it. I would just like to know how many, as of today, active ingredients there are registered, and how many products? Just -- I realize you can't give me down to the last decimal.
MR. JONES: Hey, Jack, if you could tell me the number?
MS. MOSES: Yeah. How many active ingredients are there currently registered and how many products are actually registered? Six hundred and 12?
MR. JONES: And there are probably an additional 200 that were registered post-84.
MS. MULKEY: There are 175 biological.
MS. MOSES: One hundred and seventy five.
MR. JONES: Closing in on a thousand active ingredients.
MS. MULKEY: And antimicrobials is about the same number, actually.
MS. MOSES: And products?
MR. JONES: And of the 612, 180 have been canceled. So subtract that. It should be near a thousand it sounds like. We should be able to give you an exact figure, though.
MS. MULKEY: Right.
MALE SPEAKER: Right. There should be an accounting number.
FEMALE SPEAKER: -- one with 622.
MR. AIDALA: That was re-registration -- pre-84 subject to re-registration at FDA. That's what Jack just mentioned. But since then, obviously there is a large universe of products -- active ingredients that have been registered post.
FEMALE SPEAKER: The only reason I ask, is it's so hard to find this anywhere.
MS. MULKEY: We have trouble. I mean, the question is what's in and what's out, and we'll try to sort through it and do it.
FEMALE SPEAKER: Okay. Thank you.
MS. MULKEY: And these three and then we really do need to take a break. Jeannine?
MS. KENNEY: First a compliment. I do want to say that I think that the EPA home page -- the OPP home page is very good and has become easier and easier to use. So I compliment the agency on that, and I think it's making a lot of information much more accessible to people.
Just for clarification on the FQPA safety factor, you said you've evaluated it for 98 actives. Is that just for active ingredients for which there has been some regulatory decision, or does that include the FQPA safety factor? Consideration of OPs?
MS. MULKEY: It includes the OPs, I believe. Right? We evaluated that number. I think that's what that number is.
MR. JONES: I believe that that's correct.
MS. KENNEY: Okay. Would it be possible to get a breakdown of what that means in terms of tolerances? Because it's easy for people to be confused between a safety factor decision on an AI versus how many tolerances that might involve.
MR. JONES: Sure.
MS. KENNEY: That would be really helpful.
MR. JONES: So you're asking basically how many of those 98 were actually -- a regulatory action has been taken?
MS. KENNEY: Right.
MR. JONES: Sure.
MS. KENNEY: And then for how many tolerances.
MS. MULKEY: We've broken it down that way. We can do that. Jay?
MR. VROOM: Likewise, I think it would be interesting to see the additional detail on the new uses and new products. Do you have that list compiled?
MR. JONES: We do.
MS. MULKEY: You mean the names of them?
MR. VROOM: Yeah.
MR. JONES: Yes. Yeah, we can make that.
MR. VROOM: And historically if you could -- is it possible before we leave tomorrow, could you give us the counts compared to, you know, the last five years or so?
MR. JONES: I can. Yes, I can do that right now, basically with one year exception. Some previous director -- I don't know who it was -- managed to register 23 conventional pesticides. I don't know how he did it.
But with that exception, last year was the most productive for new chemical registrations in toto, and in the range of what we had historically been doing pre-FQPA for new uses. That being about a hundred new uses.
MR. VROOM: Right. I know you've got that on a chart.
MR. JONES: We've got numerical -- that's right. Sure.
MR. VROOM: If you could add the new year data in, that would be nice to have.
MS. MULKEY: Okay. Carolyn?
MS. BRICKEY: Yeah. I was wondering, Jim, if you could give us a little feedback on the characterization of that 40 that's in the new pesticide backlog in terms of whether they are replacements for the OPs or that kind thing?
MR. JONES: Oh. Yeah. One of the things that we began doing last year was expediting alternatives to organophosphates, sort of right there the way we expedite reduced risk products. And in FY 99, the year we're in right now, I believe we have three new active ingredients that are OP alternatives and have been expedited.
So of the 40, if you're an OP alternative and you've made it known to us, we've been willing to consider an expedited registration for it.
MR. AIDALA: And that generally has been granted. You'll see that the universe has also been changing the last few years, and will be especially the case in the plan that is going to be soon published. It will be safers and including -- and safers are OP replacements.
MR. JONES: Yeah. Eight of the new chemicals we're working on this year are either -- are reduced risk, actually. They are reduced risk. And three of them are also OP alternatives. And we identify that in the work plan that's going to come out.
MS. MULKEY: Okay. All right. We are going to take our break now. We're going to try to keep it to ten minutes, so we'll reconvene at 15 after. We believe if we do that we can complete the morning's agenda by noon.
(A brief recess was taken.)
MS. MULKEY: For our remaining presentations, I think it's in all of our interests to try to get back on our schedule, or something very close to it. There is, we hope, quite a lot built into the afternoon for discussion, so we may have a little bit of maneuvering room. But we do want to get started again.
The next report relates to the rodenticides. I don't know whether the failure to reconvene rapidly is a function of lack of enthusiasm for that set of issues. Actually, Steve was first going to just give us a quick update on the next TRAC meeting, but if you want to wait until we have a little better attendance.
We will do this Rodenticide report, which is a somewhat narrowly focussed issue. You all got a letter on this, basically explaining that we need for purposes of the Advisory Committee Act to have our stakeholder involvement in the Rodenticide issue characterized as a work group of this committee. And we of course would eagerly welcome the participation of anyone of you on that. But we can have a work group without any of you participating, and so it's going to be okay if our stakeholders on this aren't representative of this body.
I believe Bob has volunteered. But I don't want to take everything away from what Michael was going to say. So let's let him do that, and then we'll have Steve do an update. And we should still have room for meaningful participation on one or both of the other two topics.
MR. MCDAVITT: Good morning. I'll try to move through this quickly. It is indeed a narrowly defined topic, but I think it's also a very important one, given that it concerns children's health protection.
Just a little bit of background, my name is Michael McDavitt, again. I'm in the Special Review and Re-Registration Division. A couple other names you'll see associated with this project is Susan Jennings, who I am actually replacing while she's on maternity leave, and Dennis Diesel. For those of you who have shown interest, you've probably seen those two names. Now you've seen mine for a few months.
A little bit of history here is that in the past year we issued both the Rodenticide Cluster RED and Zinc Phosphine. And in the RED we described that we would be establishing a stakeholder work group type process to further mitigate risks associated with children. Accidental exposure incidents.
Noting that while there is a great deal in number, the magnitude being something like 15,000 reported in 1995, none of these were fatalities, but a handful did result in treatment and hospitalization. So I'm talking about a group of people, children less than six, that are obviously highly vulnerable to accidental ingestion of chemicals, such as bait materials around the home.
So it's a very important issue, and we're addressing this in two phases. The first phase is a requirement to introduce a dye embittering agent into formulations that are used around the home. That's a separate track from what I'm actually addressing today.
The second phase is going the next step further. What more can we do to reduce risk up and above making the bait not palatable and at least something that you could indicate whether indeed there has been ingestion, such as ink around the mouth of a child.
So what this group is going to do hopefully is advise the agency, and advise you ultimately, with certain recommendations that could be brought to the agency on how better to further mitigate and reduce these poisoning cases or exposure cases.
You received a letter just a few months ago from Marcia. There was a FR notice published in September announcing the formation of this group under this committee. We hope to complete the selection process of the members within the next week or so, and then convene our first meeting probably in late February. Possibly it could slip a bit into March, only because we want to make sure we give ample notice to the members on this group to get funding and whatnot.
We briefed this issue at Spy Reg last month and there was concern that we give ample advance notice, and we're going to duly note that and try to give as much advance notice as we can when this group starts to meet.
We got a lot of interest from industry to participate. I've had a little difficulty getting members from other interest groups. The group is coming together. I was hoping to see at least another member from this committee that represents other than industry to serve, but that may not happen at the current pace. But I still expect to see several public interest groups, including environmental groups, on this work group.
We're striving for an effective public participation process. I don't want to beat this to death, but I think this is a really good case where the agency needs to better understand public values, the public's perspective, on how to balance reducing the risks without damaging the public health vector controlled side of Rodenticides.
And in closing, just to mention a few things that we'll be doing. Even though there is no requirement to make this a full and open meeting, it's our intent that these will be meetings that we announce in the Federal Register, as well as meetings where we take public comment. We're trying to encourage anybody who is interested to provide their ideas on how to mitigate these exposure incidents, and we encourage everybody here, including the public -- the broader audience -- to play in this process as we move forward.
I think the best case scenario would be that we report back to you next summer when you meet again and let you know what we've come up with, and hopefully something that you could carry forward to the agency. We'll be using the Internet, and we may be holding conference call meetings, if necessary.
Unfortunately, we're having to draw a lot of membership from the Washington area. We don't have much of a budget to bring in people from across the country. But we think we can represent the major issues and the major groups from within short commuting distances of Washington. There should be some really interesting dynamic talks, and I encourage you to keep track of it as it moves forward.
MS. MULKEY: Let me just add to that. Not only an encouragement that you consider serving, but that if you know people that you would like to recommend to serve, with particular emphasis on the sort of areas that we're a little under represented on now, which includes people with emphasis on children's health in the sort of poisoning, accidental ingestion area, and folks with a special interest in vector control and especially in certain areas. Maybe areas where that kind of pest pressure is very high, perhaps inner city or urban areas, or certain kinds of institutions.
So any of you who might be able to offer suggested membership, now is -- time is of the essence. Ken, it occurs to me that New York City is not too far away and there might be some -- Region II might be in a position to suggest some membership.
MS. MOSES: Yeah. You know, whenever I hear this, you know, we don't have money to bring people in and all this, well, you know, Region IX is in San Francisco, which is an EPA office. They have a big building. They've got lots of room. They can have meetings there. And I don't know why everybody has to come here. Why can't somebody from there, if you're really -- maybe not necessarily for the Rodenticide work group, which I think is pretty clear cut. You know, beginning, middle -- it's a easy thing to do.
But for some of the other things, why don't you think about something like that. And how much does it cost to send a couple of you people out there. You know, San Francisco is full of environmentalists, if you're interested in that sort of thing. Well, we have more per capita that any place in the country, they tell me.
But anyway, I would just like to raise that as something. If you want to get away from the beltway sometime, I'm sure the Region IX people would --
MS. MULKEY: I think that's actually a very helpful suggestion.
MS. MOSES: Yeah.
MS. MULKEY: We could clearly do a better job.
MS. MOSES: I think you should circulate.
MS. MULKEY: I'm thinking about how we could do our business in other parts of the country. And we do on occasion try to think that way. But we could use the benefit of that advice.
MALE SPEAKER: Mary, what is the temperature in San Francisco today?
MS. MOSES: It's very nice. It was about 60 -- or 55 yesterday.
MALE SPEAKER: It was 72 when I left L.A. yesterday.
MS. MOSES: No earthquakes. The fog can close the airport.
MS. MULKEY: J.J.?
DR. STEINBERG: Just two quick comments. One is that historically the information -- the epidemiologic information -- and this is going to be a shameless plug for the EPA epidemiology folk who are really Jim Blondell. And I found -- Jerry Blondell, sorry. I found out that when we tried to get poison control information, he had a unique set of information that was really miraculous.
So the poison control centers have a lot of information. Unfortunately, they don't have all the information. It would be nice to see if there can be some harmonization. Unfortunately, harmonization like that requires typically more people and more funds. Monies to Dr. Blondell, I think, would be terrific.
So that's my shameless plug for the epidemiologist.
The other thing that I'm sure is built into this is the consumer protection people, who, of course, are obviously very good in this type of bickering and bait traps and things like that. And I assume that you've been working with them. They've always been helpful for some other projects that we had in the past.
MS. MULKEY: Thank you. Bob?
BOB: One question, and I think this is for you, Mike, and I think one for you, Marcia. And that is -- and this isn't so much a question as a comment. And that is, I think a lot of what the -- a lot of the concern is based on poisoning and wildlife incident data.
And my comment would be that prior to the convening of the stakeholder meeting, I think it would be useful for the folks that participate in that process to have access to that data so they could better understand the problem.
And secondly -- and I think this is more of a Marcia question. I think this raises the larger question of the -- well, the question of stakeholder consultations envisioned by FQPA implementation and other processes. If it's necessary to convene this kind of a stakeholder process under the auspices of a FACA, would it be necessary to do the same for, say, the Phosphine re-registration, or any of the stakeholder consultations that are envisioned by the tolerance reassessment process?
MS. MULKEY: Did you ask me that because in a prior life I was a lawyer? There are ways to have stakeholder involvement that don't require FACA. But if you want to get advice, if you want to develop a process by which people formally give you advice, especially consensus or group oriented advice, that's what triggers FACA. So we are -- I don't think we're going to have a FACA every time we involve stakeholders.
BOB: Yeah. But it seems like there are an awful lot of analogies, though, between this and Phosphine. Do you contemplate there may be a similar process for Phosphine?
MS. MULKEY: Well, I think we are trying to do the Phosphine workshop and other stakeholder involvements in a way that don't involve seeking collective advice.
MR. MCDAVITT: If I may address part of Bob's question, too.
MS. MULKEY: Go ahead.
MR. MCDAVITT: Yes, indeed, we will be providing information prior to the convening of the group that provides background and a description of the cases and how we see them. I might add that the group is certainly free to have their own problem formulation process as well. They may look at the data and see something different than we do.
But we plan to share that, as well as other background information on the REDs, and the authorities that the agency has, and the kinds of options that we've already been considering, but that we would just put on the table as ideas for the group to kick around.
Also, I would like to focus just a bit more and say that while indeed these chemicals pose wildlife hazards, the main purpose for this work group is to look at the children's health risk in the residential setting. That's the primary purpose. There indeed may be options that get put on the table that indirectly or also address wildlife concerns. But that's not our primary purpose for convening this group.
MS. MULKEY: Okay.
MR. MCDAVITT: And that has been a source of confusion, I think.
MS. MULKEY: Jay?
MR. VROOM: How good is the benefit information data set at the agency on these products? Or is that file just empty and the assumption is that if the market -- if there is a market, there must be some benefit? And how much of that sort of risk benefit balancing has been in the process and might be in the re-registration process going forward?
MR. MCDAVITT: I'm going to dance around just a bit on that. It clearly -- I mean, these products were re-registered per the decision. It's just that we acknowledge that there was additional work that needed to be done to address this particular risk.
Having just adopted this from my colleague, I can't say that I'm that familiar with the depth of information on benefits. But clearly there is a public health benefit side of this that some of the stakeholders will clearly bring to the table, even beyond the registrants' perspective.
We hope to have some city health types involved with us as well, so that, I think, we're going to hear from a city perspective the benefits to their communities.
MS. MULKEY: Okay.
MALE SPEAKER: I think that -- you know, this is a small enough market from a registrant standpoint that, you know, more help of that sort and focus and part of this discussion could attribute a lot to the longer view of how to sort of manage the risks as well as make sure that, you know, the benefit needs not only now, but, you know, projected in the future, are considered.
The big city perspective is critical, but there are a lot of sort of sub-markets, agriculture and farmstead that are crucial in many cases. And certainly not much in American agriculture, because of where we are at in terms of generally a temperate zone agriculture. But there are places in the world where Rodenticides and production agriculture are very important.
When I think about that, I just start thinking real broadly, way down the road whenever we figure out and start to apply a kind of mechanism of toxicity regulation, is there some convergence out there that might affect any of these chemistries. I think those are questions worth thinking about down the road.
MS. MULKEY: Well, if you have thoughts about a way to get information to the work group, that would help bring that perspective. I think that would be welcome.
MS. KENNEY: I just want to echo a little bit what Marion said earlier, which goes to, you know, the difficulty of getting public interest representatives on some of these stakeholder groups. And I know that EPA has tried very hard to do that for this particular committee. But, you know, you get to a point in the public interest community where you maximize resources, and there simply aren't any more to go around.
There are resources outside of Washington. I think EPA needs to think about accessing those when it comes to issues as important as this. And this is not a small consideration, how to reduce poisoning incidents among children from Rodenticides.
I strongly encourage EPA to think about that.
MS. MULKEY: Thank you. Phillip?
MR. BENEDICT: Yeah. I do think as you do things to protect children you can impact impacts on wildlife. And I would suggest USDA has a whole branch in damage control that deals with this issue.
MR. MCDAVITT: Well, this is a good moment to jump in and just say that as of today, we do have a USDA rep who will be on this group. We also have a CDC rep. And there is a consumer group, the Consumer Federation of America, who has agreed to serve. And we also have an local environmental justice group that's going to serve as well.
So I didn't want to paint too dismal of a picture. It has been difficult getting membership, but I think we're going to have a good broad spectrum of the right players.
MR. BENEDICT: I guess I would suggest that if the USDA member isn't an ADC member, you might want to consider a ADC member -- Animal Damage Control member as well. They have a whole team that does nothing but animal damage control issues, which this is a big part of.
MS. MULKEY: Thank you.
FEMALE SPEAKER: (Inaudible).
MS. MULKEY: Keeping animals from doing damage, I think.
FEMALE SPEAKER: (Inaudible).
MS. MULKEY: Okay. Thank you all very much. Steve can give us a brief update on the TRAC meeting.
MR. JOHNSON: This is a very brief update. The last two TRAC meetings we're currently scheduling, we have one at least currently scheduled for February 25th and 26th in Washington, and we're looking at the last TRAC meeting being May 17th and 18th.
So those are the dates. That's sort of one message. A second message, Peter Robertson, the Acting Deputy Administrator, as well as the Deputy Secretary Rominger, will be co-chairing both of these meetings. Peter is very interested in and committed to continuing the role of the Deputy Administrator position in co-chairing and participating. So he will be there, and we've actually begun active briefings of him and getting him up to speed on TRAC and the Food Quality Protection Act issues.
So that's the second message. The third message is, is that our contractor, Meridian, has begun to place phone calls to TRAC members to begin constructing an agenda for the February 25th and 26th meeting. That's notwithstanding the last comments that both Deputy Secretary Rominger and Deputy Administrator Hanson had with sort of their vision of what this next TRAC meeting would be.
But we've asked our contractor to begin talking to the TRAC members to construct such an agenda. And certainly we're all available to hear your comments and concerns as well. Obviously we don't have time today, but certainly off line would be happy to listen as we try to construct the agenda for this February meeting right now.
So that's where we're at.
MS. MULKEY: Okay. Anything on that?
MS. MULKEY: Bob?
BOB: Steve, do you expect that prior to the February meeting there will be an opportunity for the work groups to convene?
MR. JOHNSON: That's one of the issues that we've actually asked Meridian to begin, you know, talking with -- we haven't certainly ruled that possibility out. There are, you know, some advantages to doing it and obviously some disadvantages. At least our initial thoughts if we were to do it, we might do it, you know, the day before so that, you know, you come in -- everybody is coming in for the meeting, and maybe the first half of the day would be work group and then the second. That's one comment.
The second comment is that, you know, we're pretty far along, having released all the preliminary risk assessments by that time. We will also have refined risk assessments released. And so, again, our internal discussions have said well, work group II, who was focussed on risk management, is, you know, sort of now is the time of active participation, because we're seeing refined risk assessments and getting into risk management kind of things.
And then not to say that all risk assessment issues have been finished, but those risk assessment work group I members are really going to want to talk about work group II now. So maybe the best is we just have the TRAC meetings of the full TRAC with everybody there to be able to discuss both sets of issues.
So as the phone calls are placed, or as you have thoughts and ideas with regard to that, let us know.
MS. MULKEY: Okay. Okay. Is Meg Kelly here? Okay. Meg is going to provide us with an update basically of all the activities in the Office of Children's Health Protection, not just their pesticide related activities. We'll ask her to do the speedy version.
MS. KELLY: I will.
MS. MULKEY: But we think you would all be interested in sort of having an update of what that office is up to.
MS. KELLY: Okay. I'm just going to spend a couple of minutes very quickly refreshing memories on how we got to the special emphasis on children, and then briefly updating you on what we've done over a year and a half and what we're involved in.
I have to mention the NAS report that came out in 1993. I think that was really seminole in identifying the fact that we needed to consider children in a special way and assess risks for children -- assess disproportionate risks for children carefully in all of our assessments.
In 1995 our Administrator, Carol Browner, issued a policy, a statement that committed the agency to consider children explicitly every time we did a chemical assessment, a risk assessment and set standards.
Probably one of the most important things that happened in terms of children's health was the Food Quality Protection Act.
(END OF TAPE)
MS. KELLY: -- assessments. Also, I want to mention the Safe Drinking Water Act, also re-authorized in 1996, that requires consideration of disproportionately affected sub-populations, including children. And one thing that's not up there, is it required us to develop testing to identify endocrine disrupters, which is another very important point.
And there is also an international component of Children's Health. Carol Browner signed, along with the Ministers from the G-7 countries, a special declaration on children's health. So this is not just something that has emerged in the U.S., but many countries are interested in children as a sensitive population.
In 1996 Carol Browner signed a national agenda on children's health. This was part of a report on special risks to children that came out. And it identified a number of areas that EPA was going to be working on, including setting standards, research, policies that address cumulative risk assessment, expanding community right to know, basic and practical information you can give parents and other care givers in terms of protecting their kids, expanding education efforts with public health practitioners, and perhaps most importantly, budgeting, a commitment to expand the budget in areas that affected children's health.
And finally, to cap it all off, in April of 1997 the President signed the Executive Order on protecting children from health risks and safety risks. He made it a high priority to identify and assess environmental health and safety risks that disproportionately affected kids, and also ensure that all policies, programs, standards and activities address disproportionate risks to children. This did not just affect EPA, but it affects all federal agencies and departments that issue health and safety standards.
Also, it had some very specific requirements about setting -- about writing regulations. Now when we develop an economically significant regulation of something over a hundred million dollars, we must evaluate any disproportionate risks to children.
And in terms of research, it's requiring the federal government to inventory all of its research activities that support children. And we are in the process of doing that as well.
Okay. The Office of Children's Health Protection got started a little over a year and a half ago. A small office. And we decided that it was important to operate in three areas: science, regulations, and communications and outreach.
And our focus over the last year and a half has been on establishing centers of excellence. And when I say we, I'm really talking about the more general EPA here. We're involved in these things, but try to act as a catalyst. Both the Office of Research and Development and NIEHS are co-funding eight centers of excellence. They're about ten million dollars a year total. And those are focussing on a number of different areas that affect pediatric health. And they seem to have been split now between pesticides and asthma, perhaps a greater emphasis on asthma.
There is a research agenda for children of the agenda. Currently we have a lot of research going on at EPA for kids, and when that inventory of research activities comes out, that will cause us to perhaps stop and look and make sure that we are pointed in the right direction in terms of working on the areas and funding the areas that are most important to kids' health.
And, of course, risk assessment. We want to make sure that we are utilizing the most up-to-date, state of the science, approaches to doing risk assessment for children.
In terms of regulations, we now have final guidance in the agency that does the translation between the President's Executive Order and actually writing rules. It provides a step wise process that implements both the Executive Order and Carol Browner's 1995 policy, which says we have to evaluate the risk to kids in all of our standard settings. So that is out in the agency now.
We also have an effort on economic analysis and trying to more consistently assess the benefits of avoiding adverse affects in children. I'm not sure that I would call economic benefits analysis a science, but it certainly is less of a science when it comes to assessing benefits for children. And we felt there was a special need there to work on that. And so we have formed an internal working group with EPA economists, and we're working with the Office of Policy in that area.
We also have a FACA. We have a children's health policy advisory committee, our own FACA, and we have an economics group in that. And they're also advising us in this area about how to do better benefits analysis for children.
And the third prong here is communications and outreach. We are funding 11 community pilots, which we call the child health champion campaign, where we're asking communities around the country, you know, what are the problems that you have, and work with them to design some intervention. And then go back in and evaluate after a period of time.
And I have to say, every time you ask people to rank problems, health problems of children, whether you're talking to pediatric health experts or just parents and care givers in the community, asthma keeps rising to the top. The statistics seem to drive that and people just in their day to day life, that's what they see in their kids. Asthma is a huge problem in this country, and so most of those communities actually have asked to focus on asthma and interventions to try to cut down on the incidents of asthma.
We have a large inventory of EPA's health activities. It's like a 200 page document. It's a public document of everything that EPA headquarters, offices, program offices, ORD and our regions are doing to address kids' health. Really it's impressive. It's an impressive collection of activities.
We also have a web page now, and we continue to try to improve that.
Okay. When we set our goals -- I've sort of gone over this regulation. All regulations need to be protective of children. We at least need to ask the right questions when we are developing regulations to make sure that we're not missing some disproportionate risks in what we're doing.
We would like all EPA risk assessments, certainly to the extent there are available data, to explicitly consider children. Benefit and cost analyses should also consider children in our regulations. We want to increase awareness in communities so that people can take practical action. You don't need a Ph.D. to protect your kids from a lot of common environmental hazards.
And also, you know, we'd like to see some real change in the world. We would like to see reduced hospitalizations from asthma based on actions that EPA takes. So we would like to have some real measures for success here.
Okay. I mentioned regulatory guidance. It doesn't say that, but that actually was signed in mid-November. It is the final guidance in the agency. And, again, we've asked our FACA to this year take a look and see how that guidance is working in the agency in terms of comparing it to a number of economically significant rules that are scheduled to be proposed this year, to look and see is it sufficient. Is it useful for rule writers. Should it be changed. We're committed to change it and revise it in a year's time to make it more useful and more well targeted.
Public awareness and community based programs. I mentioned the yearbook, the child health champion campaign. We have a resource guide also, which is a hard copy guide that mentions a lot of places and documents people can go to. Not just EPA documents, but we made a survey of what nonprofit organizations have to offer. There are associations that put out guidance on children's health. And we have the web site.
I mentioned the FACA. That's our FACA, the Children's Health Protection Advisory Committee, of 41 people. It's a balanced FACA. Very diverse viewpoints. It's heavily weighted in terms of public health. We have pediatricians and other medical doctors. We have an optician, nurses, and state and local representation, environmental justice.
It's a good mix of people. They worked very well together over a year's period. And they put together a report for us, advising us on existing regulatory standards that should be revised, because they may be old and new science may have become available since they were promulgated that would cause us to revise them in a way that would make them more protective of children's health.
And we are in the process now of addressing that. We're going to be putting out a Federal Register notice to address those recommendations. And in fact a number of those recommendations involve pesticides, because the FACA told us that we should be looking at Atrazine, both in terms of revising the pesticide tolerances and issuing the maximum contamination level in drinking water. We need to do those two actions together.
And also the organophosphates. They mentioned three organophosphates they felt were critical to get out -- get evaluated and to get those decisions out. Those were Dimethoate, Chlorpyrifos and Methyl Parathion.
And finally, the worker protection standard. They said that was something that needed to be reevaluated to make sure that reentry intervals were most protective as they could be of children.
And so we will be responding to those in the Federal Register. It's imminent.
Science and risk assessment. We had a cancer conference a little over a year ago. It was one of the first things we worked on on preventable causes of cancer in children. We published a research agenda. And a lot of good information came from that. We had great participation and a lot of recommendations on where we needed to look to better characterize sources of childhood cancer that may be in environmental sources.
We've had internal colloquy on children's health risk assessment to identify the gaps in our understanding, and again to try to help point us in the direction of needed research, and the eight centers of excellence around the country.
And finally, we have for the first time really put a significant amount of money into the national health and nutrition examination survey, the NHANE survey. And for the first time that survey is going to measure some real environmental contaminates in children's bodies. That's a survey -- you know, it's a real world survey. It's interviews and bio monitoring. It's very long term. You know, the fourth survey, the results won't be available for four to six years. But at least they are starting now to measure certain pesticides and endocrine disrupters and some other environmental toxicants in children's bodies.
And I'm going to end with a task force that was established also in the Executive Order. It's headed up by Donna Shalala and by Carol Browner. And every agency -- about 15 agencies are represented on it. They all put out health and safety standards to different degrees. Certainly HHS and EPA are probably at the top there in terms of environmental standards and health standards.
And again, they have identified four priority areas for themselves that they need to look at very carefully. And asthma again rose up to the top. Close to six million American kids have asthma in this country. And in the over 20 years these statistics have just been explosive, actually. And it's very worrisome. The source is not fully understood. You certainly know what exacerbates asthma, but you're not exactly sure where these increased incidents have come from.
Childhood cancer is one of the four developmental disorders. And finally, unintentional injuries. Not necessarily an EPA issue, but certainly an issue for a number of the agencies that are involved in the task force.
So I think I am going to end there. I would be glad to take any questions that people have for a couple of minutes.
MS. MULKEY: Okay. Susan wants to say something.
MS. WAYLAND: Let me just -- first of all, Meg, thank you very much. I want to thank Meg for her very excellent presentation. I also want to thank Meg and her colleagues in the Office of Children's Health Protection for being so gracious in allowing us to steal one of their very best people. And that is Dr. Steven Gallson, who will be joining OPPTS next Monday. And he will be heading up an office for us of Science Coordination and Policy. And I'm sure both his knowledge and his skills in dealing with these sorts of children's issues will be a great asset to OPPTS.
So thank you, Meg, and your office.
MS. KELLY: We're going to miss him.
MS. MULKEY: All right. With that, are there any questions on this topic? Okay, Jeannine?
MS. KENNEY: I was just wondering if Meg could talk a little bit about how the office coordinates with the other offices, like the Office of Water in OPP, in terms of looking at the regulations and regulatory actions.
MS. KELLY: Okay. Well, first of all, we are a very small office. We're at the most 12 people, and that's total, everybody, when we're fully staffed, which we're not right now, thanks to Susan.
But what we've tried to focus on are systems. You know, you can't -- I mean, EPA may put out a thousand regulations a year in the pesticide tolerances. I mean, it's probably over that. So we're focussing on things like regulatory guidance, which would then sort of reverberate throughout the agency, and you would try to evaluate how effective that is, you know, in changing our regulatory process.
We can't look at every single regulation or decision that's made. So the goal we've set for ourselves is try to effect the systems. You know, another important system is the network of risk assessment guidance documents that we have. If you can make sure that those -- that's probably key, actually. If you can make sure that your risk assessment guidance is sufficiently protective or sufficiently considers children, you know, that gets used every time you write a regulation that's controlling a pollutant where you have to do a risk assessment.
So, you know, we're trying to focus on the systems pretty much.
MS. KENNEY: Have you been involved in any of the science policy guidance documents that OPP has been putting out that are relevant to risk assessment, and also the FQPA safety factor committee?
MS. KELLY: Yes. And we have a science team, and that's Steve Gallson. So, you know, in a way it's a great move for Steve, because I think what's -- whatever gets decided under FQPA -- the implementation of FQPA -- is huge implications for the way we do risk assessment in the future for children everywhere.
So, yeah, we've been involved to the extent we can, you know, cover what we can.
MS. MULKEY: Okay. Jay?
MR. VROOM: I think the last report from your office to the PPDC was October 1997. Would that be right?
MALE SPEAKER: It probably was.
MR. VROOM: At any rate, I remember the presentation and the conversation we had afterwards. And one of the points that we discussed was the fact that there didn't seem to be at that time the clear strategic and measurable objectives. And I would just like to commend you for the fact that that's now part of, you know, what you're talking about, like longer term, five to ten years from now, to want to be able to have measurable reductions in certain hospitalizations, poisoning incidents or whatever.
MS. KELLY: Right.
MR. VROOM: But I would be real interested to know more about how you're progressing in identifying those kinds of measurable, long term strategic goals and keeping track of progress. I think that's real important.
MS. MULKEY: Okay. Shelley?
SHELLEY: I was wondering if you've identified -- if any of your research efforts, or the research that you've identified, is focussing on a possible connection between environmental contamination and ADHD, and if that's an issue that has been raised in the communities.
MS. KELLY: I'm sorry. I'm not sure I understood the question.
SHELLEY: Well, I was wondering. You know, you're talking about asthma as a concern. And it struck me that another childhood condition that has, you know, greatly increased and may have a connection to neuro-toxicants, be it pesticides or others in the environment, is hyperactivity disorder.
And I was wondering if you are aware, you know, in your cataloging of the research if that issue has arisen, and if that's something that has arisen, has been identified by communities as a concern.
MS. KELLY: I can tell you -- well, first off, it may emerge as we do the research inventory, and that's not completely finished, so I don't know. To my knowledge, that has not arisen among the communities. I'm not sure if it's because people don't link that to an environmental source. You know, maybe they link that to diet or something else. I don't know.
But I can tell you it has not emerged in the conversations that I have been involved in.
MS. MULKEY: Okay. We're go to Beth and then J.J.
MS. MARSHALL: In our last discussion we had been talking about scenarios used to evaluate total exposure for children. And at that time it was not entirely clear to what extent you were evaluating exposures at schools and day care centers and this kind of public exposure.
I was wondering what the current thinking of OPP was?
MS. MULKEY: Actually this relates to a question Shelley asked earlier, although you probably didn't recognize it as such, which has to do with in evaluating non-occupational, non-dietary exposure are we looking at all those sources. We've been sort of calling that residential and focussing primarily on residential uses.
And we are working to sort of expand our scenarios, if you will, to be sure they capture those kinds of exposures. And I don't mean to say that we've not done any of that, but we're working to be more expansive.
That is one of the science policy topics which we just opened public comment on. So I would say if you're particularly interested in that topic, this would be a good time to weigh in. And Bill Jordan is here. He can help you focus a little bit on which document and what timetable and so forth.
Does anybody else want to react to that? Did I understand the question correctly, you think? Okay. J.J.?
DR. STEINBERG: Obviously this office has had a strong theme of environmental justice, and I thought I should just say the words to underscore that. And obviously a number of these issues continue to have concern within communities that are particularly poor and communities of color.
So I think that's been very good, very important, and something that has to be pursued. I think this is a great opportunity, in particular as it relates to the NIEHS, and I would like to see more partnership with the NIEHS on this. In particular, Alan Deery has put together some community health based programs that would partner perfectly with this.
I would hope that your office and the NIEHS can grow together in trying to do good science and bringing that good science in a very community way, and also with the input from the community, which is what the NIEHS is now trying to specially emphasize. And as I say, this would be a terrific partnership as it relates to that.
There was an issue related to ADHD, these hyperactive related issues, and many of the people involved in lead and mercury have had ongoing concerns. And, of course, the Children's Health has looked at those, and there are a number of programs that have looked both at not only the science of that, but also following those children with psychology testing, school based testing, and noted that when lead levels went down, their abilities to concentrate, and indeed their I.Q., went up.
And we, of course -- one of my colleagues in the Bronx -- a number of my colleagues in the Bronx, John Rosen and Murray Marcowitz, did those studies, and, of course, Phil Landrigan has historically always done those studies. So I just thought I wanted to bring those up.
MS. KELLY: Thank you. You know where that issue may come up more, though, is that we have this work group on developmental disorders. And we do work a lot actually with NIEHS, Dick Jackson and those folks. That's a good point.
I personally am not very much aware of that health issue, but I'll certainly take it back and see if that's something that's going to emerge in that group. Thank you.
MS. MULKEY: Well, thank you all. Once again you've mentioned to turn even our talking heads portion into a bona fide discussion and provided us with some useful advice as we went along.
And we're not sorely behind time. And part because I'm going to exercise a little executive privilege here and suggest that the ecological standards work group recommendations, which were presented to you in April, and the real issue around that is where do we go with that, which is a fundamental PPDC ministerial issue, which is how do we deal with moving from a work group back to the whole group, will come up again tomorrow in that segment.
So in the interest of getting us to lunch and having some logic, we'll include that issue there. If Steve's watch is correct, it's 12:15 now. We are scheduled to reconvene at 1:30. I believe that is still practical. There is a list of restaurants out front which you can -- I'm told Viva France is closed, so don't run to it. My favorite one is not on here, which is the government cafeteria in the HUD building.
So there are quite a few options here that are quick and should make it real to get back at 1:30. We will really start then. So if you're not here, we'll do it without you. See you then.
MALE SPEAKER: You didn't mention the USDA cafeteria, Marcia.
(END OF TAPE)
(A lunch recess was taken.)
MS. MULKEY: It's time. We will start. The faithful members of the public are here in goodly numbers. So this might be a good time to remind any members of the public who want to be involved in the public comment period to sign up for both today's topics, the ingredients other than registered actives, the inert ingredients, and for tomorrow's topic, the BT resistance management process.
There are a number of very important stakeholders who are not in fact represented on the PPDC and don't have real -- sort of don't have one of their type, if you like, represented on the PPDC. And so we want to be sure that the public comment process on those two topics is particularly open and receptive to stakeholders who may not be represented.
So we have prepared quite a bit of time, and if there's greater interest, we will extend the time. That should be an important part of the total discussion time on these topics, because the stakeholders -- for example, special chemical manufacturers who may not manufacture pesticide active ingredients have an interest in how we approach inerts and so forth.
So that's one of the reasons why you see so much time for public comment, and why you see a public comment period separately for both topics.
Are there any other logistic or scheduling questions that anybody wants to raise before we embark on the afternoon agenda? Is there anything any of the leadership wants to focus on before we embark?
MR. AIDALA: Are you talking to me?
MS. MULKEY: You and Steve. And Bob. I'll tell you. All of these feds are not good at getting back from lunch. I'll have to speak to them about that.
The inerts topic was something that many of you encouraged us to invest in. In my first month or two of tenure in this job, the inerts issues were raised to me. In fact, at the very first meeting I had with any stakeholder, which was while I was still in Philadelphia, the inerts issue was mentioned. And this issue has come up from -- it comes from a lot of different perspectives. It has different parts that are not always related to other parts of the issue.
And so what we hoped we could do this afternoon is bring together all of the issues implicated in this group of ingredients. To just tick them off in my simplistic way of thinking about them, they are the review and authorization of new inerts question so there can be more options available for new products.
There is the analysis and regulatory approach to old inerts. The issue of knowing more about them -- of the agency knowing more about them and acting on what we know. There is the issue of disclosure and public knowledge about inerts, the flip side of which is concerns about business interest in retaining secrecy around them. And then finally there are issues relating to data compensation which were affected by new language in FQPA.
So those are sort of the four main categories. And I don't think we need any further clarification to let the folks who have been working on all four aspects of these within EPA and who have presented the paper which was supplied to you as a way of teeing up. And many of these are areas where there is wide open opportunity for continuing public debate. Others are areas where we've gone some distance down the road in implementing issues of this, and we can have mid-course advice.
This is a really promising area for bona fide advisory reactions, including the possibility of some coalescing of some further work around your advice. So without further ado, Kerry Leifer and Cameo Smoot and Don Sudowski from our General Counsel's office. Kerry is located in the Registration Division, and Cameo in our Field and External Affairs Division, reflecting the variety of issues around this topic.
And I think Jim Jones -- are you going to kick it off or no? Just hand it right over to them, huh?
MS. SMOOT: Good afternoon. My name is Cameo Smoot. I'm with the Policy and Regulatory Services branch of OPP. Before we get started on the technical issues, I wanted to provide you with some general status update and some background material on the topic if you're not familiar with it.
A good place to start is -- with the next overhead. A good place to start is with the understanding that pesticide products contain active and inert ingredients. An active ingredient is defined as one that prevents, destroys, repels or mitigates a pest, or is a plant regulator, a defoliant, a desiccant or nitrogen stabilizer.
An inert ingredient is defined as something that is not active.
In recent years, through public surveys and other public forums with stakeholders, EPA discovered that consumers were confused and misled by the term inert. So in 1997 the Office of Pesticide Programs issued a PR notice requesting registrants to voluntarily substitute the term other ingredient in lieu of the term inert ingredient on pesticide labels.
Whether an ingredient is considered active is largely based on a label claim. If a substance is intended to control a pest in a particular product, then the ingredient is considered active in that formulation. However, the same ingredient used in a different formulation, not intended to control a targeted pest and no such label claim is made, may be considered an inert.
It's because of this definition of an active ingredient being tied to the basis of the label claim that approximately 360 ingredients on the inert listing are or have been used as active ingredients in other pesticide products.
Until 1984 most of the regulatory activities under FIFRA focussed on the data requirements for the active ingredient. In that year, however, EPA began to routinely require acute toxicity testing for the active and inert ingredients as part of the registration requirements for end use products, products commonly sold to the consumer. EPA also imposed certain labelling requirements for hazardous inert ingredients, changing some safety warnings and precautionary statements.
By 1987 EPA announced a comprehensive policy to reduce the potential for adverse affects from the use of pesticide products containing toxic inert ingredients. The policy established a base set of data requirements to determine the acceptability of an inert ingredient in a pesticide product.
The policy also established four categories of inert ingredients, ranging from the worst case to those of minimal concern. List one inerts, inerts of toxicological concern, were required to be listed on the label if they were used in a pesticide product. The remaining lists: list two, inerts that were potentially toxic with a high priority for testing; list three, the largest number of inerts of unknown toxicity, and list four, inerts of minimal concern or generally regarded as safe.
The impact of the policy basically taught registrants to specifically consider the effects of developing new pesticide formulations when using a related inert ingredient. To date, of the original 57 list one inerts, there are eight remaining. List two has been reduced to 52. There are approximately 1,700 on list three. And list four has increased to 430.
Currently the program continues to use the listing policy as a way to reevaluate and reclassify the bulk of the inert ingredients on lists two and three. The overall goal is to reclassify either to list one, mandating full disclosure, or list four, those inerts of minimal concern. Approximately 1,700 of inerts have to be reclassified one way or the other.
We are also currently working on developing new criteria and streamlining techniques to meet the new FQPA standards and target dates.
And before we get into the technical aspect, I just want to find out if there is anybody who has any questions before we move to Mr. Lifer's more intense technical discussions about what's happening with the inerts and what kinds of reviews and streamlining processes that we're doing.
FEMALE SPEAKER: Do you have any idea how many producers have changed the wording from inert to the preferred wording on their label? How many have voluntarily done that?
MS. SMOOT: Jim, do you know?
MR. JONES: No. I don't think we have a handle on that.
FEMALE SPEAKER: Okay. I notice quite a few chemicals are taken off list one. Can you give me some examples of chemicals that were removed from list one?
MS. SMOOT: Kerry can. Kerry, do you have any examples of chemicals removed?
MR. LEIFER: If it would be possible, I'll probably cover that a bit more when I get up in just a moment.
MS. SMOOT: Okay.
MS. MULKEY: Okay. Thank you.
MALE SPEAKER: (Inaudible) -- silence.
MS. MULKEY: Yeah. Our tolerance for silence is not real high, is it?
FEMALE SPEAKER: You're probably too inert from your lunch.
MR. LEIFER: Okay. Can everyone hear me? I'm Kerry Leifer. I'm going to continue the discussion on the implementation of inert ingredient strategy, basically to cover kind of the nuts and bolts of our inert ingredient operation dealing with our reviews and approvals of both new and existing inert ingredients.
This slide is taken directly from the background document. We want members of the PPDC particularly to keep in mind what it is we're trying to accomplish here today. And as we make our presentation, we would like you to think about ways to assist us in our endeavors and to provide us with some advice as to some of the methods and criteria that we are considering for our inert regulatory program.
As we have already mentioned, the inert ingredients strategy revolves primarily around our reviews of existing inert ingredients and the new inert ingredients.
We're going to begin with a discussion on the existing inert ingredients. This can be considered in a sense as a kind of re-registration of inert ingredients. What we're doing here is looking at all the chemicals that had been used and are still used in pesticide product formulations as inert ingredients, and to determine data we have on these chemicals, whether or not we need additional data, finding ways to obtain data that would allow us to make a risk determination, and to find out whether or not we feel these chemicals can be safely used in pesticide formulation.
Another of the main tenets of the inert strategy related to new inert ingredients was to establish a minimum set of data requirements for all new inert ingredients. So when we say new inert ingredients, we're referring both to chemicals that previously had not been used in pesticide formulations, as well as chemicals which were being considered for what's known as a first food use.
We also now have other issues that Marcia eluded to, such as disclosure and data compensation. We'll be covering that a little later on this afternoon. So for the next few minutes I would like to, again, focus in on our activities related to the existing inert ingredients, followed by the new inert ingredient activities.
As Cameo already mentioned, we divided up the universe of existing inert ingredients as part of our inert strategy in 1987 into these four categories, based primarily on toxicity characteristics. Now this was not any deep risk assessment done here, simply looking at the available toxicity information and categorizing inert ingredients into one of four toxicity categories.
Cameo also walked through the numbers here. This kind of graphically illustrates where we currently stand with regards to the numbers of inert ingredients across the board. As you can see quite clearly from this diagram, list three is by far the largest category of inert ingredients, and it's no small coincidence that those also happen to be the ones that are referred to as inerts of unknown toxicity.
I should take a moment here to mention that that term, an unknown toxicity, is probably somewhat of a misnomer, in that we really do know something about these chemicals. It's not that we know nothing at all about their toxicity. However, at this point we don't have sufficient information to make a definitive classification to either list one, i.e., the bad inert ingredients, or to list four, the good inert ingredients. We have a database, but just not a complete enough set of data to make that definitive determination.
Another question that has some times arisen regarding list three and the size of list three is that it looks like it's actually grown since the advent of the inert strategy. And in fact, the numbers have increased. However, there is kind of a bookkeeping type explanation for that, and namely it goes as follows.
When we initially put together the list of inert ingredients, we often had very broad categories. The biggest example of this would be fragrance. We use the term fragrance without designating the individual components -- the individual chemicals that went into this. So we had one line item that said fragrance, when in fact, as you well know, I'm sure, fragrances consist of many chemical components.
So as we've gotten a little better at going through our products and elucidating exactly what's in these constituents, we have identified those and added those to the lists. So the bulk of the addition to list three is simply us having a better handle on the actual composition of some of the components that are in these inerts, particularly mixtures of inert ingredients, which in the real world in a commercial sense, that's generally how you find them.
I've always been told to try to keep things simple, so I thought this may work a little bit. You can kind of think of our existing inerts program as the three R's. So the review, reclassification and ultimately removal. Again, we're attempting to review each of these chemicals to find out exactly what information are available, to obtain additional data so that we can ultimately do some form of a risk assessment that will allow us to reclassify these chemicals.
As Cameo mentioned, our ultimate goal is to not have four lists of inert ingredients, but to only have two lists of inert ingredients: the good ones, list four inerts, and the bad inerts, if you will, list one. And hopefully we can work to see that the bad inert ingredients would be the third R here and they would be removed from the formulation. So review, reclassification and removal.
Again, we have some 2100 inert ingredients. The tasks that we are faced with obtaining the kinds of data we would need to make a determination as to the risks propose by these chemicals is at least on its face a very daunting proposition. Using our re-registration analogy, I believe there are some 600 re-registration chemicals or cases. So here we're talking about three times that number and with what is at this point in time, at least, a limited operation, certainly nowhere near the scope of our re-registration program.
So clearly one of the big challenges facing us in finding ways to obtain the kinds of information we're going to need is a determination regarding the risks of these chemicals. Once we do have that information, then our charge is to find ways to discourage or eliminate the use of chemicals that potentially have risk concerns, and by the same token to encourage and promote uses of chemicals that we feel are safe. Again, that's our ultimate goal to have inert ingredients that are safe in formulations that don't have any concerns.
In terms of what we are doing and have done in the area of existing inert ingredients, this is kind of the current state of affairs. We are in the process of conducting risk assessments for some of the supported list one inert ingredients. When we initially put forward the policy, list one inerts were identified as inerts of toxicological concern, and we basically said two things.
One, any registrant that wished to maintain a formulation with a list one inert would need to first put it on the label. To list the presence of that inert ingredient on the product's label. And secondly, that we would require data to be presented to the agency to support the continued use of that inert ingredient.
These data requirements were very much equivalent to what we would ask for a new active ingredient. So in most of the cases, and the reason our numbers did drop quite dramatically, was the fact that companies felt that they did not want to attempt to support these chemicals that were after all known to be toxic.
But we do have a few that companies have attempted to address. An example would be Rodenmien (phonetic) B, which is a dye use and C treatment formulation. It's a chemical that's known to be Acarcentagen (phonetic). The assertion from the companies using it is that in at least C treatment uses, it's kind of a zero exposure scenario, and therefore while there may be some toxicity associated with that chemical, its use in at least certain pesticide formulations would not pose any kind of unreasonable risk. And that type of use, they feel, at least, may be permitted.
We are in the process of making determinations related to whether or not there are unreasonable risks for that type of use for three chemicals this fiscal year, and we hope to complete the five remaining of the eight current list one inerts in the not too distant future.
In terms of list two inert ingredients, these are chemicals that were high priority for testing. Most of these chemicals had some evidence of toxicity, but not enough to classify as a list one inert ingredient. In those cases, what we're attempting to do here is to see if there is the kind of quote, unquote, smoking gun study, a study that would either exonerate the chemical as being safe or would allow us to reclassify it to list one status and treat it accordingly.
Now we've already spoke about the large task of kind of tackling the list three inert ingredients. Given the large number of chemicals that are on this list, one of the things we are looking to do is to find ways to rank, order, group or cluster these to make this process somewhat more manageable.
And, again, our ultimate goal is to try to increase the number of list four inert ingredients. This allows formulators many more tools in their arsenal to formulate products with, and at the same time actually does some of our work for us, in that we have found there is a natural evolution to list four inert ingredients. The more chemicals we can put in that list naturally, the more times formulators will look to use those in their selection process.
Regarding what we have accomplished, things that we can take some solace in, we have, as we mentioned before, eliminated most of the list one inert ingredients. This would include chemicals such as Benzine and asbestos that were on the list. We found with the initial group of list one chemicals that by and large companies did not feel they could in any way, shape or form support these chemicals. And clearly the combination of the data requirements that were imposed and the stigmatization, if you will, of having to list these chemicals on the product label resulted in reformulations and removals of these chemicals from products.
The list two inert ingredients have been reduced slightly. Some of this has been the result of forces above and beyond, if you will, of the Pesticide Program. A number of these chemicals were ozone depleting substances and the Clean Air Act has helped to advance our cause. So we have seen numbers drop here slightly. Again, the fact that some chemicals are on list two, and companies recognize that there at least is a red flag raised, has caused companies again to formulate away from some of these list two inerts as well.
The list three inerts, as we've mentioned, is a vast group of chemicals. Part of what we have done to obtain information is to run these chemicals through a structure activity review process that is essentially equivalent to what is used by our Office of Pollution Prevention and Toxics in the TSCA new chemicals program. So we have gotten a lot of useful information from that exercise, and we now need to take the next steps with that information to decide just what we can do and how we can use that again to rank, order and prioritize our list three activities.
In 1995, and partly due to some of the SAT work along with some efforts that we undertook in conjunction with FDA and the Office of Water, we were able to reclassify 146 list three inert ingredients to list four. So that accounts for some of the increase in list four inert ingredients.
And this past June we were able to remove 251 inert ingredients completely from these lists. These were chemicals that were no longer used in pesticide formulations. If someone now desires to use those chemicals, they would essentially have to come through the front door of our process and be treated as a new chemical, and they would need to provide us with data to support their use up front.
We believe there are some other candidates for removal, as well as list three to list four reclassifications, and we're going to be working on that in the next few months.
One last accomplishment that I forgot to list on this slide that is turning to be a pretty big one is the fact that we have a lot of this inert information now on EPA's web site. And my understanding is that that's been a very popular web site. It has the lists of inert ingredients, many of the Federal Register notices and PR notices related to inert ingredients. And this has been very helpful to formulators and the public at large.
We've talked about some of the good things that we've done. What remains to be accomplished with regards to existing inert ingredients? Clearly there is a lot of work to be done. We need to finalize our risk assessments on the existing list one inert ingredients to make a determination up or down. Can these chemicals be used, should they be removed, and make a final call. As we add additional list one inerts, we'll have to deal with those chemicals as well and try to make some timely determinations so that we can effectuate our strategy.
The reclassification of list two inert ingredients is an area we want to closely look into. These were, as we mentioned earlier, chemicals that at least had suspect toxicity. We would like to answer that question once and for all and make again an up or down type of call. Should it be removed to list one, are these chemicals truly toxic, do they truly pose risks, or they can be safely used in pesticide formulations and reclassified to the minimal risk status.
Again, we've already covered the prioritization of list three inert ingredients. With the large number of chemicals it begs for some sort of prioritization scheme so that we can begin to tackle that task. And, again, we want as many chemicals as we can get on the list four to allow the formulators a large array of options.
We'd like to move on to a discussion of the new inert ingredients. We've talked about what we were doing and need to do with regards to the existing inert ingredients. A big part of what we do in the area of new inert ingredients in terms of the strategy is to consider new inert ingredients.
We generally divide the universe of new inert ingredients into two areas: food use inert ingredients and non-food use inert ingredients. The reason this is a significant distinction is basically twofold. Number one, with regards to food use inert ingredients, we deal with two statutes, both FIFRA and FFDCA. And the FQPA amendments to both of these statutes have dramatic impacts upon inert ingredients.
In the case of non-food use inert ingredients, generally it's only the FIFRA -- the registration requirements in the FIFRA that are impacted here with regards to non-food use inert ingredients.
Generally, most of our activity is focussed in the food use inert ingredient area. Most companies have a greater interest in getting a new food use inert ingredient approved, because generally there's a much larger market for those types of substances. They find their way into the Ag products.
Anybody who is familiar with the FQPA has probably seen this verbiage a thousand times. This takes on a particular significance with regards to inert ingredients, and this actually goes to both the new and existing inert ingredients that have food uses associated with them. The aggregate exposure provision of FQPA, when you deal with inert ingredients, speaks not only through the pesticidal uses of these chemicals, but to the non-pesticidal exposures and ultimately risks from these chemicals.
What that means is that when we consider a new inert ingredient, or a tolerance reassessment for an existing inert ingredient in any food use, we have to consider not only the exposures and risks posed by their use in pesticides, but by all the other non-pesticidal uses such as laundry detergents, commercial cleaners, etc. This has proven to be a very interesting, to say the least, challenge to us, in that we're now confronted with attempting to obtain information that will allow us to make risk determinations for areas and uses that we traditionally have not been involved in.
Just to kind of walk through very quickly some of the review processes for the new inert ingredients and where things stand and what's new and what's changed, up until the time of FQPA from about 1987 when inert strategy began until the FQPA was enacted, we had begun to hit kind of our stride, if you will, in the couple of years prior to FQPA. In particular, we had determined ways to make the risk assessments necessary to establish tolerance exemptions for inert ingredients to improve new inert ingredients.
Once FQPA was passed and the new safety criteria in FQPA, we found ourselves basically going back to the drawing board and trying to consider just what we would need to make the kinds of safety findings that FQPA requires. So, again, I eluded to the aggregate exposure provisions of FQPA. All of the other provisions of FQPA that are being dealt with with regards to active ingredients also apply to inert ingredients. So everything -- all the issues that we're faced with in terms of common mechanism risks to infants and children apply to inert ingredients as well.
We've also had some administrative changes. Again, very similar to with active ingredients. Petitioners now need to provide us with more information up front. They need to provide us with a summary of the data that they have. They need to make the arguments related to FQPA as to why we can make a safety finding. So more of the onus is placed on the petitioners under FQPA.
Certainly one of the main questions we get almost on a daily basis in my case is how we process inert ingredients, how we're doing this, what's our schedule and what's our process. We are dealing with a state of flux in this case. We have a number of petitions that were submitted either about the time after FQPA came into place -- in some cases somewhat before -- where many of the issues that FQPA now raises were not addressed.
So we are trying to determine if we have sufficient information based upon what we know to make a safety finding, or if additional data would be necessary. And in some cases whether or not this data is even available to the petitioners to submit to us, such as exposures from non-pesticidal uses, as we make an aggregate exposure determination.
The scheduling of reviews is also a major sticking point, if you will, with regards to inert ingredients. Unlike active ingredients, the priority planning process that allows for scheduling of many of the issues related to certainly new active ingredients and new uses for existing active ingredients, doesn't quite work as well with inert ingredients.
There isn't a way to come up with an inert ingredient that's going to be a Methyl Bromine substitute or an OP substitute. So many of the problematic priorities related to reduce risk active ingredients don't apply as cleanly to inert ingredients. Right now most of our prioritization for inert ingredients is simply based on kind of an aging process.
But despite what we've already discussed and the challenges with FQPA, we've actually had in FY '98 a pretty good year by all standards. We were able to establish tolerance exemptions. That is, approve new inert ingredients in probably some of the highest numbers of programs ever seen in FY '98. And you can't quite make it out on this graph, but that FY '97 food use block is a zero. So we've gone from zero to about 15 approvals in FY '98.
The non-food use numbers aren't quite as dramatic. Again, the FQPA considerations weren't -- didn't come into play as much. But again we had also a very good year in terms of non-food use approvals as well.
So what are our challenges for the new inert ingredient area? Clearly first and foremost we need to develop a risk assessment methodology that will comport with all the FQPA provisions. We need to determine internally what information -- what data -- will be needed to conduct reviews and risk assessments of inert ingredients, both new inert ingredients as well as tolerance reassessments for existing inert ingredients.
Additionally, we would like to make this process as transparent as possible. We want all the people who are submitting data to us to know exactly what it is they need to be providing to us, so that we can make these decisions.
Clearly we need to reduce our backlogs. As I mentioned before, we've had some actions that have been in here since prior to FQPA with regards to new inert ingredients. We're trying to work through some of these issues. We need to be more timely. We need to offer up additional incentives to the companies that are spending their time and money to put together packages to get us to consider these new inert ingredients. Similarly, the review times have been quite long, and we're looking at ways to shorten that process.
As I mentioned before, the priority planning process doesn't really -- isn't a great fit for inert ingredients. There may need to be ways to look at what additional incentives we could offer in terms of priority planning, since at its core priority planning is a way to kind of expedite a review. We need to consider what could be done in that area.
One possibility is reduced risk. Many times claims are made that a new inert ingredient will offer up a reduced risk in some way, shape or form, typically in that it will have some effect on the formulation that might allow a lesser amount of active ingredients to be used. Right now most of our reduced risk criteria are tied strictly to active ingredient toxicity issues and don't really embrace the kinds of benefits that inert ingredients can accrue to a formulation.
I'll be glad to take any questions.
MS. MULKEY: Okay. I know you're all dozing a little bit. There are two other pieces of topics in this area, the ones relating to disclosure and to data compensation. And we're going to provide a little information on that.
So if you'll sort of try to make your comments now -- the ones that you think really need to occur now rather than sort of when we have the whole thing on the table.
FEMALE SPEAKER: What's the whole thing again?
MS. MULKEY: The other two issues are disclosure, putting it on the label, and some other issues related to disclosure, and data compensation.
So with that, we can take some time on this part. Kerry, why don't you find a mic that's not cutting in and out? You can sit here, if you like, or over with Cameo.
And I saw you guys dozing a little bit, and I know this is in some ways a dry topic. But it is important to remember that there are some stakeholders with an awful lot at stake here, and that all of us would be totally energized around this topic if we weren't so energized around the active ingredient topic.
I did want to take a minute to say that we have these public commenters, and some of them may have a lot to add to the dialogue. So we need to sort of regroup mid-afternoon and decide if we want to have some public comment before the very end. I don't think we have to start with that. But we'll try to keep an eye on the clock and see if that makes sense.
MR. JONES: I could add, perhaps to energize some of the people around the table, we are dealing with zero sum gain here. And advice that we get to expand or contract clearly competes against things that you may want us to be expanding or contracting on.
So the struggle we have always faced is how do you fit this into the broader sense of what we do, and doing any more here involves doing less somewhere else. And I'm talking specifically in registration for new chemicals and new uses. Doing less here means doing more for those things. So that just sort of maybe gets some people who may not think they have a stake in this issue that they really actually have a very big stake.
MS. MULKEY: Okay. With that table setting, Henry, do you want to start with you?
DR. ANDERSON: Yeah. I just had one question. I mean, you've tended to deal with the toxicity of individual inert ingredients, and some of these, of course, are used to sort of maximize distribution of an active ingredient.
Do you look at whether something acts as an Adgelent (phonetic)? I mean, this is specially important for workers where skin contact and absorption is important. You could have an independently inert nontoxic chemical but it increases absorption 50 percent of the active ingredient.
Is that the kind of information that you gather and would consider, so that it's really the mixture and the exposure route that becomes very critical? And this of course could also be true in home use agents. So that's just one question.
MR. LEIFER: Basically our focus has been primarily on gathering the information on a specific inert ingredient. Considerations related to, you know, synergistic effects, and antagonistic effects, for that matter, is not something we've actively pursued in terms of the inerts program. Now there are registration related issues here at the formulation level that some of these are taken up with.
DR. ANDERSON: Okay.
MS. MULKEY: Does everybody understand the last part of his answer?
FEMALE SPEAKER: No.
MS. MULKEY: Some of these issues get analyzed because there is certain testing that is required on the formulation. It's limited testing that's required. But that might reach the issue.
(END OF TAPE)
MS. MULKEY: Okay, thank you. Carolyn?
MS. BRICKEY: Well, I guess because there's so many of these things, that what we keep thinking about, you know, what are smart approaches to tackle this hoard of chemicals.
One question I guess I have is what is to prevent you, and what would be helpful about, moving up list two to list one, and doing a data call in and getting the data in on those 52 and knocking that group out?
MR. LEIFER: It's certainly something we're considering, because we're, quite frankly, running out of options of finding data on our own. Some of the issues that have been raised just in general with that is some people think of this as the tail wagging the dog. When we request data specific to an inert ingredient in the pesticidal context, our focus is directed to the pesticide registrant who typically isn't the manufacturer of this chemical and doesn't always have that kind of information. And they seem to say, you know, basically why are you picking on me. Why don't you look at this chemical, you know, broadly.
So we're considering other ways to get information. Using TSCA authorities is a possibility.
MS. BRICKEY: But a list will --
MR. JONES: Okay. Carolyn, your question is the number one question we are asking in FY 99 as relates to old inerts. Shouldn't we just issue a DCI for the list twos and see how that plays out? And we have not answered that fully, but that is one of the major focuses of this year.
MS. BRICKEY: And what is the status -- and maybe this is to be addressed in the next segment -- in terms of availability and disclosure of information on the new inerts? Do they fall into any kind of different category than the old inerts?
MR. LEIFER: Well, certainly data related to, you know, the test data that they submit, the health and safety type information, would be publicly available. I don't know if -- usually the disclosure issues are more related to the presence of these chemicals in a formulation. And obviously as a new chemical -- a new inert -- they generally aren't yet in a formulated product.
MS. MULKEY: Is there a publication of exempt -- the tolerance exemption? Is that published?
MR. LEIFER: Yeah. Certainly we issue -- when we publish a tolerance exemption, it's done in the Federal Register. So to that extent, they're included in our public lists. We haven't routinely made available in any manner, apart from what the program normally does, the data that we're considering when we make these types of determinations, if that's your question.
FEMALE SPEAKER: You have no better ability to understand what products a new inert is in than any old inert?
MR. LEIFER: That's a good question.
MS. BRICKEY: And then finally, in terms of new approaches, maybe one way to look at this is to try to look at a mixture approach, such as the problem that comes up that Andy was talking about. Maybe you could look at a couple of categories of those and see whether that gets you at some of these inerts that we need to be concerned about.
MS. MULKEY: Steve?
STEVE: When we're looking at risk, we're looking at exposure, too. What do we know about exposure to these inerts?
MR. LEIFER: Well, we're probably -- to be honest we probably know as little about the exposures of many of these chemicals as we do about the risks. We suffer from really just a lack of an inerts program historically, in that we can identify, for example, the products that these chemicals are in, but we can't readily aggregate exposure type of information.
A given inert ingredient could be in, you know, 50 to 100 to 500 different -- completely different types of products, unlike an active ingredient that's going to have a specific use. Inert ingredients can be across the board. So we don't have a great handle on that type of information. You're absolutely right. It certainly is a necessary component in a risk assessment.
STEVE: And so we don't know anything about residues or whether it's a dermal inhalation, ingestion or how this would -- you're looking purely at hazard, right?
MR. LEIFER: Well, the listing was put together as a hazard based list, and that was designed so that we could kind of focus in on those. I mean, the assumption being that if you have a hazard concern, then there may be a risk concern. But we haven't done -- the information that we don't have, and we really have to do it in piecemeal, is to look at the exposure side of the equation on individual chemicals.
STEVE: Which would be required by FQPA in theory?
MR. LEIFER: Well, certainly if we're going to do a tolerance reassessment or establish a tolerance exemption, yeah.
MALE SPEAKER: And recognize, too, that originally the concept was that the individual product formulation test, with all its limitations or at least some kind of basic fall back as a historic kind of fail safe or a check or whatever you want to call it, that's obviously been under some review in our own questioning by the public and by ourselves for a long time. Part of this exercise is okay, now what.
The other one is kind of what Carolyn was getting at, which is just, okay. The other way is to say, if everyone moved to list four, then you don't -- you have less concern about what -- whether what route of exposure and everything else would be.
And that's why there has been a renewed emphasis on this thing the last couple of years, not just in the program here, but also working with our toxic program where you've got -- that's the folks who did the SAR stuff, number one, the Star Activity Relationship business.
And then secondly, the initiative in the toxic program for testing of about 3,000 chemicals -- 1,000 to 3,000 chemicals that are high production volume chemicals. Now just -- that may not -- that will help us with some of these, not all of those. But, I mean, we're making other efforts in trying to coordinate work that they're doing over in the toxic program with helping out with this problem.
Because of what was mentioned, which is look, it may be that the inert -- the use of this product as an ingredient in a pesticide formulation may be only three percent of the market for that chemical. So, therefore, that's the why are you picking on me issue. The issue is that may be where the exposure is. You know, there are answers, but instead of just keeping going back and forth with that very scintillating debate, let's get on with it and figure out whether, you know, these things are safe or not.
MS. MULKEY: Bill?
BILL: Thanks for your question, Steve, because that was one of mine. I have one. When you did this -- I don't understand -- or could you explain a little bit about what the -- how a decision is made that something goes from list three to list four or one? I mean, what are the data? Are there triggers -- toxicity triggers that make it go to one of these two lists?
MR. LEIFER: Yes. We have a set of criteria for inclusion on list one. Most of the chemicals on list one were put there because of the carcinogenicity. We also consider developmental toxicity -- reproductive toxicity. And environmental effects, such as a very exquisite aquatic toxicity, is the basis for list one.
Similarly, the list four is minimal risk inert ingredients. We're looking to see that something would not be of a risk concern. Some of these are what you may refer to as no-brainers. You know, they're cookie crumb type of chemicals that we can make that type of finding.
BILL: So do you use -- on list three would you have a base set that you could say, yes, now I have enough information to make a decision to go to a list four categorization?
MR. LEIFER: Well, that kind of gets to the issue. We don't -- if you applied our base set requirements, which is pretty much what we would like to have on every chemical, we just -- on list three they wouldn't have enough information there to say, that's what we're looking at to see what other information -- SAR analysis -- in order for us to make that finding.
But we just don't have enough information.
BILL: So your list of what went to list four, were those primarily chemicals that are like paper and things that have zero risk and that wasn't based on toxicity? A toxicity determination?
MR. LEIFER: Well, we've -- there were a number of different kinds of categories, if you will, of chemicals that got moved to list four. One group were palavers that meet the palaver exemption rule in the Office of Pollution Prevention and Toxics. Basically these are chemicals that aren't expected to be absorbed and therefore aren't expected to offer toxicity. So, I mean, I think you could say in that case it's a tox call.
Others were chemicals that were considered as craft chemicals by FDA and others that either -- some had data, but some were kind of just grandfathered along. But we match these up with other interests, particularly FDA, and toxics to see if there were chemicals that they felt were essentially, you know, without risk.
BILL: Okay. Thanks.
MS. MULKEY: And Bill again.
BILL: In your presentation you spoke about the challenges to reduce the back order. What is the back order today on the new inerts, split out by food use and non-food use? Do you know that information?
MR. LEIFER: I don't have the exact numbers with me. I believe we have something in the neighborhood of about 60 pending new inert ingredient actions. Now not all of these would be what we consider a backlog status. The non-food use inerts, we're pretty much current with those generally. The level of reviews needed there aren't as great and it's a little bit easier oftentimes to make the safety finding in the case of the non-food use inerts.
BILL: And how many new submissions do you receive a year? Or how many did you receive in fiscal '98, let's say?
MR. LEIFER: I believe that number was about 30 or so submissions.
MS. MULKEY: You have available to you, I believe -- I got a copy. And I understand that's why they distributed it. It's a letter to me dated today from CPDA, in which they state their understanding of what those numbers are. And while I'm not prepared to embrace them as accurate, it's probably worth your spending a few minutes over the course of the next little while to -- I'm sure -- I think they intend to seek.
MR. LEIFER: It was in your handout papers.
MS. MULKEY: And we may try to make that sooner rather than later. But this will give you their -- the focus of that letter is the backlog of new, and they use numbers very similar to what you just heard.
MALE SPEAKER: So kind of in summary, if we've got 60 -- approximately 60 backlog and 30 new ones, and we're getting 15 out a year, I can see the seriousness of the problem.
MS. MULKEY: They say 77.
MS. SMOOT: In the background paper that we gave you all, there is a small discussion, and we agree that 77 inert tolerance or tolerance exemption petitions that we've not made a final decision.
MS. MULKEY: Okay.
MS. SMOOT: And not all of those, like Kerry said, are in backlog, depending on when we received them. But 77 is the number we've got. And we get about 25 petitions a year, at least when we wrote the background paper.
BILL: I have a second question. What if a registrant submits a new pesticide that's either reduced risk or OP substitute that contains a new inert? How does that process take place, and how do we get that through the system?
MR. LEIFER: Well, typically we have kind of split it out and looked at the inert ingredient vis a viz our inert strategy to determine if it itself is safe. We certainly have a process for considering new formulations as part of the priority planning. This is a very -- I think where this question takes us is to how do you kind of tie the two together if you have a reduced risk claim for formulation and the inert ingredient.
This is something we're grappling with. We're trying to make the linkage there. Obviously it makes no sense to consider a formulation and not the inert ingredient, because you're ultimately not going to be able to issue a registration. So this is something we're trying to make that connection.
And as I mentioned in the presentation, look at what we can do in terms of reduced risk to kind of embrace those kinds of situations.
MR. JONES: My initial reaction, since I was with the benefit of having talked to, you know, a number of people who I work with, would be to expedite the review of that inert. And I think what -- that's sort of the clearest handle of -- or picture of a reduced risk determination for an inert.
And I think one of the things we're like to get some feedback on is, should we be considering just expanding the reduced risk program to new inerts in general, as opposed to that very specific case where the new inert was associated with a reduced risk compound.
BILL: Thank you.
MS. MULKEY: Marion?
MS. MOSES: I wanted to ask if you have looked-- considered prioritizing list three, which seems to be the big albatross that's on your neck or your back or in the air or wherever in the heck it is. With the work that Edstac did, we know that a lot of the Alpha Phenols and Glycloss (phonetic) ethers are endocrine disrupters. And I don't know why -- and I think a lot on that list are known endocrine disrupters, at least in agricultural use chemicals. Now I don't know about some of the home use products. So I think that would be a very good thing to look at, because Edstac has already done a lot of background work on that.
The second thing is, is there any way that you can look at that list three in terms of water contaminant problems, because that's the other area where EPA has a lot of information already. I'm just trying to think of places where you already have existing data that you could look at, because you say you're missing things. It might not be toxicology data, but it would be very significant. I think that's another place to look.
The other thing I'm kind of interested in, and, you know, don't -- chemical company people don't get steam coming out of your ears. Why can't all of list three require DCI? Would somebody answer that question for me? Is there any legal impediment to that? Because I think that would be a good way to handle it.
MR. JONES: As far as I know there's no legal impediment to it. It's clearly simply a resource issue. I mean, we started in 1988 doing re-registrations with 600 new chemicals. If we were to pursue a DCI of the same basic magnitude of what you would ask for for old chemicals under active ingredients for the 2100 or the 1700 inerts on list three, either we would need a major new influx in resources, or we would take sort of signor like projections to complete the effort.
MS. MOSES: Well, you know, I really want to talk about this. Every time I hear this about oh, well, we don't have resources or we don't have this, these are things you don't know anything about. And isn't the things that you don't know anything about the things that you need to get started learning something about?
MR. JONES: As Kerry mentioned that we use the term unknown toxicity, but we actually know as much as we've been able to determine from structural activity analysis from the Office of Toxics -- OPPT. And that is way more than we don't know anything about.
MS. MOSES: Okay.
MR. JONES: And we haven't seen any screaming red flags coming out. If we did, we would pluck them off.
MS. MOSES: You mean from the Qstars?
MR. JONES: Yeah, on list three. And we've had all the list threes run through Qstars.
MS. MOSES: Okay.
MR. JONES: And we're trying to use that process to prioritize for us. I think we were sort of hoping we would have a little more -- there would be a little more clear cut answers of these 300 we need to quickly move to one and we could start moving on them. But it hasn't been that clear cut.
So we do have some information. It's just not the kind of information we're ready to send to list one or to list four on.
MS. MOSES: Could I just ask one more question? I thought of something that Kerry said earlier. The other thing is, do you actually look at exposure in terms of the 1700? I'm only talking about list three now. Do you sort of take a look at that about which ones are used in the most high use pesticides, or the one that's more likely to drift or to be used in an area where more people would be exposed? Or does that sort of not enter into it at this point? Because that might be another way to look at it.
So the three things that I would recommend, you know, would be the endocrine disrupters, the water contaminants and the high exposure ones, would be a very good way to --
MR. JONES: They're all very good.
MS. MOSES: -- look at that list.
MS. MULKEY: Thank you. That's the essence of good advisory committee advice. Jeannine?
MS. KENNEY: Do you know -- can you tell us off of the top of your head what the breakdown is between the list three for food and non-food use?
MR. LEIFER: In terms of the numbers of that 1700 that actually fall into the --
MS. KENNEY: Right.
MR. LEIFER: Off the top of my head I would say probably about three or four hundred of that group of 1700 have tolerance exemptions. Part of the problem is kind of the way you count them. When we put that list together, we had discrete chemicals oftentimes associated with the cass registry number.
If you look at some of the tolerance exemption expressions, they would include a broad cluster of chemicals, so sometimes it's hard to do the math. But I would say probably a good third of those chemicals on -- close to a third of those chemicals on list three probably have food uses. Most of the Surfacten (phonetic) type chemicals that have tolerance exemptions fall under that list three category.
MS. KENNEY: And following up to Bill's question about -- and your comments about EPA's use of available FDA data. Obviously FDA looks at -- sometimes they've got data on a particular additive that's ingested. In other cases, if it's a cosmetic or a drug, maybe it's a dermal.
How do you -- you know, if you've got an inert in a pesticide where you could have all those routes of exposure, how do you integrate perhaps limited FDA data for a specific route of exposure? Or is that not an issue?
MR. LEIFER: Well, I think the issue actually kind of typically works the other way. Oftentimes FDA certainly does an exposure analysis in terms of FDA approval. Oftentimes most of these inert ingredients come in with kind of a -- seeking kind of a blanket approval. So our kind of exposure scenario generally goes beyond just what FDA may consider. For example, indirect food additives may have very limited use.
MS. KENNEY: That's my point.
MR. LEIFER: Usually what we've -- where we have gotten useful information from FDA, it's typically been an analysis of the toxicity of the substance. And we're generally left trying to wrestle with what the exposures may be and then ultimately do a risk assessment.
MS. KENNEY: Is the toxicity data from FDA though -- does it look at all these, you know, dermal inhalation, ingestion, or is it -- you know, I'm just thinking.
MR. LEIFER: Right.
MS. KENNEY: If it's a topical drug, they're going to look at dermal absorption. Maybe there are other issues. I'm just -- I'm concerned obviously about limited toxicity data and how it applies to perhaps all routes of exposure.
MR. LEIFER: I think it's kind of really a case by case call. Some chemicals clearly -- if it's an FDA, for example, permanently listed food additive, typically there's a wealth of tox data. If it's a nit use, indirect food additive, there may be very little data. They also, you know, have a threshold of regulation approach, where sometimes they don't even make a cut on these chemicals. So it really is kind of a case by case call.
MR. JONES: And we've been able to use FDA data to this extent largely for sort of harvesting low hanging fruit and moving things to list four, because there's just no hazard in the FDA data good enough to show there's no hazard.
I'm not sure if we've used it too much to make a full assessment of an inert ingredient to say that, you know, based on the FDA review we're able then to make the finding that there is a reasonable certainty of no harm, given that there may be some endpoint that we're pursuing further.
FEMALE SPEAKER: But you use it to move it down, but not up?
MR. JONES: Well, we could use it to move it up, but we would have done that originally in 1987. We wouldn't have used that FDA data to show that. We may have actually used some FDA data for the original lists one and two. Hopefully there is not anything on list three that we missed ten years ago, but there could be, and that would lead it to be listed on list one.
MS. MULKEY: Does that cover your topic? Jay?
MR. VROOM: Marcia, I think you said a little while ago that all formulated products are subject to a minimum battery of six toxicity tests. So bearing partly in answer to your concern, I mean, there is that over arching protection, if you will, which should alleviate some concern until you get to seeking out the answers on all individual inert ingredients.
Does that make sense? But what are those six?
MR. JONES: Acute toxicity. There's a six pack of acute toxicity.
MS. MOSES: I think if it were on the label -- if it were disclosed fully on the label what it was, I wouldn't have these concerns at all, because then we would be able -- people who know about some of this and other independent people would really know what we're talking about, what's in what.
And then we could probably even help the agency with it. There would be a lot of people out there, that if they just knew. But nobody knows where first base and home plate is. So I think I would agree with you, Jay, that yeah, that would cover me a little bit if I knew what they were.
MR. VROOM: Yeah.
MS. MOSES: But what really bothers me about --
MR. VROOM: The second question was, whose responsibility is it to collect and present the data on an inert ingredient for the uses that are not pesticide related? You talked about like soap ingredients and things. How does that burden get distributed?
MR. LEIFER: Well, we're working on that. Like I said, we're trying to develop a risk assessment methodology that we hopefully can present to would be petitioners that would tell them just what information we think we need.
I think clearly that first and foremost we would like to see the burden on the petitioners to provide us with the information we would need. In the interim, we're looking at ways of getting that information, possibly using models and things like that, that hopefully we could also make available.
For example, the toxics program has some models for consumer exposure type uses from laundry detergents that may be very helpful. It's a kind of screening level approach to us to determine whether, you know, higher tier studies may be needed.
MS. MULKEY: Okay. Steve?
DR. BALLING: Do you ever consider efficacy?
MR. JONES: Haven't you read PR notice -- no.
DR. BALLING: Gosh, I missed it. Was it in my pile? That must have been when I fell asleep on the phone.
MR. JONES: No, we do not consider efficacy, unless it's a public health pesticide or a soil liquid termiticide (phonetic). Now there are a couple of exceptions.
DR. BALLING: So even if there was no exposure and it were particularly efficacious, that would not be considered anyway. It's purely on a hazard basis?
MR. JONES: It's on a hazard exposure risk basis.
MS. MULKEY: But before we would have a complete analysis, we would do exposure estimating for food use. Probably for FIFRA, too.
MR. JONES: Um-hum.
DR. BALLING: But how can you do exposure if you don't have any measure of residues or you don't have any way of measuring exposure?
MR. JONES: I mean, let's distinguish between a new inert and an old one. For a new inert, we are making a safety finding that's a risk based safety finding.
DR. BALLING: Right.
MR. JONES: For the old inerts, we are struggling with making determinations often in the absence of the kind of data you're talking about. So we often only have hazard information. We would ultimately, though, need to have -- like for the list one inerts, you have been able to stay on in pesticide formulation. You've put it on the label and you've put this note -- you know, this little statement on the label. And you do the data to allow us to do a risk assessment.
So for those eight list one inerts, they are doing all of the data, both hazard and exposure, to allow us to do a risk assessment so that we can ultimately make the safety finding.
DR. BALLING: Okay.
MS. MULKEY: Okay. Paula?
MS. PAUL: Thank you. Just a couple of comments. One question, to what extent are you using sources outside the United States, like Canada, the EU, who also do have active programs on inerts?
MR. JONES: We've started working with the Canadians on the inerts program. It has been so far mostly dialogue and not too much sharing of information. But we're very open to pursuing that more aggressively.
MS. PAUL: Yeah. Again, I'm more of an advocate of trying to share the workload.
MR. JONES: Sure.
MS. PAUL: And there may be some opportunities in the EU as well.
MR. JONES: That's a very good idea.
MS. PAUL: You know, it's a big job, and I think the agency has done a good job in trying to prioritize the work given the resources you have.
And I guess the other recommendation I have in terms of the list three, which, you know, you're going to have to pick your way through down the road, would be to try to prioritize it by something. And maybe volume used or something that it's going to help you just work your way through that list.
MS. MULKEY: That's similar somewhat of Marion's, basically.
MS. PAUL: Yeah. Yeah. And then, you know, you may just end up having to use a data call in provision, you know, selectively. Not on the whole list at once, because there's no way you could cope with all the data. But to try to pick your way through it and just chip away.
MS. MULKEY: All very bona fide advice you folks are providing.
MS. PAUL: You might even find when you do that that there is more data out there --
MR. JONES: Right.
MS. PAUL: -- that you haven't even seen yet and that you may be surprised at how much work. I know for at least for the major inert ingredients, companies like Exxon and some of the suppliers have really done -- been proactive in supporting products that are the higher volume inert ingredients.
MR. JONES: Um-hum.
MS. PAUL: And I think you might be surprised that there is more data out there than we, you know, expected.
MR. JONES: Thank you.
MS. MULKEY: Thank you. Erin?
ERIN: Can I actually ask you a question?
MS. MULKEY: Sure. A little follow up here so we get continuity.
ERIN: I would be interested from a pesticide registrant point of view, when you're putting together new formulations and looking at, you know, what you want to pair your active ingredient with, do you go through a process yourselves of assessing the hazard and risk potential of the inert ingredients, and therefore have access to information?
FEMALE SPEAKER: Well, we're very careful always to make sure that our inerts are on the tolerance exemption list, even for non-food products, at least in our company, because you just never know when you may want to make a cross over on a formulation. And we've gotten into, you know, problems not being able to use formulations because of that. So even internationally we use the 40 C.F.R. list as our kind of source.
And then where there are choices to be made, we certainly do look at that as part of our overall hazard assessment and stewardship for our products. And I think that's probably consistent in the industry.
MS. MULKEY: Erik?
MR. OLSON: Yeah. And just sort of a common sense thing. I guess if what I'm hearing is right, that for a lot of these you don't actually have a lot of the dietary exposure -- I'm speaking specifically of the food use inerts. You don't have dietary exposure data. You don't have water or air or drift or other similar exposure data. And you're also lacking real tox data, other than Qstar data.
Has the agency -- and you're not willing to just do a blanket DCI for things that you don't have that data for. I think you're getting yourself into a serious box, because at some point you're going to have to make decisions on these inerts under the FQPA requirements. And either you are going to have to revoke all the tolerances for all those things, which I assume is what you would have to do, and you need to send that signal pretty clearly early, so that we don't hear eight years from now or whenever it is that golly, we didn't know we needed this data. You should have issued a DCI.
I guess that's -- I think the time has come to bite the bullet and start forcing the collection of the data, or sending a clear signal that if the data aren't there, we're not going to -- we're going to revoke the tolerances for these things.
MR. JONES: You make a good point, Erik. We haven't really -- we haven't touched on it at all. The food use inerts that have an exemption from tolerance right now are subject to FQPA tolerance reassessment, and they are in our third tier -- the third group of tolerances to be reassessed.
So we do need to begin to think strategically about how are we possibly going to be able to make the finding for them unless we do some kind of data call for this. So there may be some of that kind of activity going on in the very near future, because they will have to -- they're up for tolerance reassessment.
MS. MULKEY: Bill? Or, I'm sorry. Are you finished, Erik?
MR. OLSON: I was done.
MS. MULKEY: Okay.
BILL: Kind of a continuation. It seems now that's the time to reappropriate some of the funds into this inerts group. This commentary about a CPDA suggested a branch similar to probably like the Antimicrobial branch or something, in your fiscal, say, 2000 plan, the budget that you're probably working on, is there a plan on moving the inert from where it is now into a separate branch?
We've got 1700 chemicals, and everyone around the table is concerned that the data is not available. All the data that's needed. And as we talked about earlier with Jim, the numbers -- the math -- shows that you're not catching up. You're getting further behind. And I think Jim opened this comment by saying this is an important issue. And if we take funds from some place, we're going to have to reduce it some place else.
Has that issue been addressed?
MS. MULKEY: Well, I think that is one of the key questions that we're seeking your input on. If you assume, as we do, that the pie is not going to grow in some dramatic way, then taking a bigger slice out of the pie for inerts reduces the amount available. And that's true on both the review of old chemistry and the processing of new chemistry.
Just thinking simplistically, if you try to process more new inerts, you'll process less new active ingredients, and not necessarily one for one. And similarly if you try to review or speed up the review of the old chemistry inerts, that's likely to come out of the level of effort available to deal with the old active ingredient chemistries.
So that's part of what we're interested in hearing from you. Are we about right in the level of effort and pace. Do you see some sense that we are picking it up, but we're not exactly going gang busters. Are we to be stepping it up or have we gotten a little too enthusiastic about this topic in the last year relative to all the other burdens and duties.
And I think that's part of what we would like to hear your reviews on. Erik, since you kept yours up and there's not a whole lot others.
MR. OLSON: Yeah. Yeah, I just wanted to follow up on what was just talked about. I think one thing you can do without a large expense of resources is send very clear signals that if we are here five -- or whenever the deadline comes for these tolerances, and we're in the same situation as we are today and we don't have the tox data and we don't have the data on exposure, this stuff is gone.
Because if you don't send that signal now, there's no incentive to collect the data, and we'll be in the same place we are five or seven years or whenever the deadline is.
MS. MULKEY: So whatever level of effort, you think at least some long term planning?
MR. OLSON: And a signal now that, you know, if we're in the same place when we get around to this, don't expect to have these chemicals around.
MS. MULKEY: J.J.?
DR. STEINBERG: Unfortunately I still have a murky feeling about where --
MALE SPEAKER: You need a mic.
DR. STEINBERG: Unfortunately I still have a murky feeling about where we're all going vis a viz inerts. If I pretended for a minute that say I were a chemist, and I looked at these things, there's no question that unless I -- and I don't want to miss speak for any chemists around or in the audience. But if I had structure activity relationships, I believe chemists would boldly be able to categorize these things on those that are more or less deleterious.
Further, were you to take these 1700 agents, for example, in category three and, again, based on Qstar and also based on the type of solvents or emulsifiers or surfactants that they are, categorize them into smaller groups with SAR activity there and begin to make that information available, you may engender the type of criticism or the type of decisions that you may want.
As we all know, many times when we're making decisions about what solvent we will add to a solution, many times we choose one versus the other for very minimal reasons. And were we to have a better guide telling us that one were more preferable versus the other, as opposed to making that decision serendipitously, we would make the decision based on something along those lines.
Clearly I think unless a windfall is going to happen, you're looking at zero dollars. These 1700 items vis a viz what you can mix your active ingredients with are peanuts as it relates to the many millions of actual organics and other items that are out there and could next end up on your desk.
And as I say, I don't have a sense -- an organizational sense -- in the way of no dollars that you can begin to organize this. Start making some decisions and getting that information out, allowing all of the stakeholders to begin commenting and begin a quicker triage. Because I think -- as I say, I know you have a process, but I haven't yet seen it so convincingly that you're going to be in good shape two or three years from now.
MS. MULKEY: I think that the problem is not in your vision, but in what you're looking at. That is to say, I think that's probably a pretty accurate characterization of where we are.
MR. JONES: Um-hum. I think so. And I think one of the things that we -- one of the points that you make that I think is a very good one and I think we'll take back with us, is that we probably have more than we realize through these Qstars. And one of the things -- one of the interesting aspects of working in a data rich program is that you become addicted to having all the information in the world at your fingertips all the time, and you become less ready to jump on a more limited set of data.
And we may need to do a little more pushing of ourselves on what we actually have to see if we can make some decisions on it. I think that's a good point.
MR. AIDALA: You know, one other comment. For those of you who of course -- and I know that this group here loves to read lists. But I of course immediately memorized the list of the American Chemical Society of the tons of various agents that are produced in the United States on a yearly basis, and there is no question, again, within your list.
And it had been mentioned even before that I would underscore those items which are in massive production and which are clearly of greater concern versus those that may clearly be of trivial amounts, where even under worst scenarios the exposure to the American population may be very limited. And, again, triage those first so that you can come to some decisions on those more rapidly. And I think that information should be available.
MS. MULKEY: Thank you. We are coming up on the afternoon break. We still have sort of the other two pieces of this topic. We have some key public stakeholders who really have a lot to add to the dialogue, because of their perspective on this.
What I suggest we do is that we -- how long do you think this next half of the presentation will take?
MS. SMOOT: That's a good question. It should probably take the rest of the afternoon.
MS. MULKEY: No, no. I mean just our presentation.
MS. SMOOT: Oh, just our presentation? Between the two of us, half an hour.
MS. MULKEY: That long?
MALE SPEAKER: It's flexible. I can do long or short.
MS. SMOOT; We can cut it back.
MS. MULKEY: Let's do the short version.
MS. SMOOT: Okay.
MS. MULKEY: But since it's that long, let's take our break now. But let's reconvene at ten after. That's 12 minutes. That will be all right. And we will do the presentation, and then we'll look at the question whether we want to hear some members of the public fairly early in the next phase, so that we have their perspectives available to us, because I think it will enrich your advice.
Okay. We're seeing you then.
(A brief recess was taken.)
(END OF TAPE)
MS. MULKEY: -- and several said we assigned way too much time for this topic, and instead we had not. I think we're part of the reason why there hasn't been as much time for discussion as maybe we need. We're going to try to make our presentations more succinct and give you credit for the belief that you read the paper we prepared. So we're going to try to avoid as thorough an exegesis of it.
This afternoon's issues are a little less technical, or at least the disclosure one is. A little more sort of public policy rich. The data compensation one is highly technical, but we can probably hit the highlights. And those who care about it also know a
lot about it. They don't start from scratch on the issue.
So unless there is a housekeeping matter that somebody thinks we need to raise, we will punch right away into trying to tee up -- now this does not mean that you're forced from now on not to discuss the last batch of inerts issues. They're still on the table. But we'll add these other two, and then I think we'll ask these members of the public to make their presentations then. And that will allow the committee then to sort of wrap up this whole set of issues.
Okay. Cameo or Ann? Are you going to take us on?
MS. LINDSEY: Well, yeah. You've done a good job of introducing, and there's just one more thing I wanted to say. I really don't want to sound like a whiner, but just as Jim said to you with the first issue, we have sort of a zero sum game when it comes to resources. And these two other issues, the data compensation and the how we manage and handle that, and disclosure, draw from the same resource pool.
So the more resources we put into those kinds of things, the less resources the program has to actually evaluate. So keep that in mind as you listen to the presentation from Cameo and Don.
MS. SMOOT: I'm going to hand it over to Don first.
MR. SADOWSKY: Thank you, Cameo. I'm Don Sadowsky with the Office of the General Counsel. And unfortunately, because you've chosen a lawyer to speak, I'm going to have to talk a little bit of law. And in the topic of disclosure of inert ingredient identities, there is, I would say, a fair amount of confusion of just what the law allows us to do. And I want to talk about some of the basics of how FIFRA treats confidentiality of inert ingredients.
Basically Section 10(B) of FIFRA requires that inert ingredients should be protected if they qualify as trade secrets or commercial and financial information obtained from a person under the privilege of confidential. This is essentially the Freedom of Information Act, the FOIA standard, which translates into, is it likely that disclosure would cause substantial harm to the competitive position of the person submitting it. And all the looking we do at what we can disclose and what we can't will have to in part be based on how we come against that confidentiality standard.
Now FIFRA is sort of full of devices and back doors for doing things that you might not think you can do. And even in the confidentiality provision there are some authorities or abilities for disclosing information. For example, even in 10(B) it says that when necessary to carry out the provisions of FIFRA, information relating to the formulas of products can be revealed at a public hearing on findings of fact issued by the Administrator, which is rather ambiguous language, which leaves sort of interesting possibilities for exploring.
Also, Section 10(B)(1) requires that safety and efficacy data be available to the public. It does have a specific exception for a number of things, including the identities of inerts. But even that exception is not applicable if disclosure is necessary to protect against an unreasonable risk of injury to health or the environment.
Now what's a confidential inert and what's not. It was very unclear until a few years ago where we had some litigation, Northwest Coalition for Alternatives to Pesticides or End Cap, the End Cap v. Browner case, and there are a couple of important decisions on that.
The first thing it did is to establish that there is no automatic protection for the identities of inert ingredients. Where I talked a moment ago about the fact that Section 10(B)(1) excepts inert ingredients from the automatic disclosure requirement for safety and efficacy data, many people had taken that to mean that inert ingredients must always be disclosed.
MS. MULKEY: Do you mean protected?
MR. SADOWSKY: I'm sorry?
MS. MULKEY: Must always be protected?
MR. SADOWSKY: Must always be protected. Excuse me. Rather, inert ingredients are to be evaluated on a case by case basis according to the confidentiality criteria in FOIA Exemption 4.
The court also decided that inert ingredients are not trade secrets merely by virtue of being a part of a formula. And it leads us into we want to disclose information just on the basis of whether it's entitled to confidentiality treatment or not and requires a case by case analysis.
And that analysis can be a very lengthy and difficult thing. If we get a FOIA request for inert ingredient information, the first thing we have to do is figure out what is the confidentiality claim for that information. And even that is not necessarily easy. Our current confidential statement of formula has no provision for identifying information claimed as confidential.
So we have a FOIA request and wish to make inert ingredient information available to the public. We're starting from a lack of data and knowing what's claimed as confidential. There is an effort right now to revise the confidential statement of formula in concert with harmonization with Canada, where we are proposing to require that the identities of inert ingredients all be specifically claimed as confidential if the registrant wants to claim that it's confidential.
I know there is some controversy as to whether that's a resource intensive process and whether it's subject to error. But at least it's my personal feeling that it's a reasonable effort to just make it easier to give out what is not confidential.
Recognizing that there is a great interest in having the identities of inert ingredients disclosed, we are searching for means to make more information available within the constraints of law. Most of you are aware of the fact that we are in the possession of a couple of petitions by End Cap and by several Attorney Generals to require that all inert ingredients be disclosed on the label of the product. There has also been a letter received from industry, trade associations and registrants opposing these petitions. The agency has not yet made a decision on this issue.
That was as short as I could make it. Was it short enough?
MS. MULKEY: Well, let's see if it was so short that we cause more confusion than we clarified. Do we have any clarifying questions about this presentation about sort of the constraints -- the sort of legal constraints around disclosure? Constraints and opportunities, I should say.
MS. MOSES: I just want to know if these things are kind of like when somebody does a search at the National Library of Medicine, you can access somebody else's search. When somebody does a FOIA, can they share that with anybody else, or do they have to -- I mean, once it's out there as public information?
MR. SADOWSKY: Once information is released to someone under the Freedom of Information Act, it's a natural determination by the agency as to whether it's entitled to confidential treatment. So if they get it, unless there is some kind of confidentiality agreement or something not under FOIA, it will be available.
MS. MOSES: Well, then can't -- can the EPA then have a FOIA thing on their web site that anybody that has requested it -- once it's out there, then can it be made available for everybody else? Because that would be a great thing.
MS. MULKEY: Are you suggesting that every response -- FIFRA does have one specific provision, which complicates this, the 10(D).
MR. SADOWSKY: 10(G).
MS. MULKEY: 10(G). Which is that you have to not be a multinational corporation in order to get a lot of data. So that would complicate the sort of absolute publication.
MR. SADOWSKY: Right. But I should correct that, that 10(G) basically is not applying to the mere identity of the inert ingredient. So we usually don't have a problem.
MS. MOSES: No, no. I'm going to keep this -- like him. I'm going to keep this short and simply and sweet. All I want to know is what I've always wanted to know. What are these things. And, you know, once you have --
MS. MULKEY: The identity?
MS. MOSES: Yeah, right, the identity. And if that were -- is that something that's --
MS. MULKEY: Do you mean just of the subject?
MS. MOSES: Yeah.
MS. MULKEY: If somebody, let's say, requested the formula of a product.
MS. MOSES: Right.
MS. MULKEY: And we -- under FOIA. And we went through an analysis. We determined that that particular formula, or at least some of those inerts, were not -- could that then be --
MS. MOSES: Yeah. Made available to everybody?
MS. MULKEY: I think that's a reasonable question.
MS. MOSES: Well, can I make a -- is there some way that we have some kind of -- that we can ask that that be done so people would know?
MS. MULKEY: I frankly don't know whether we have revealed many by that route.
MS. LINDSEY: (Inaudible).
MS. MOSES: Okay, good. Thank you.
MS. MULKEY: Okay. Anything else in clarifying questions?
SHELLEY: We didn't hear the answer.
MS. MULKEY: The answer? The answer was we'll look into it.
MS. SMOOT: The answer was Ann Lindsey said she wrote it down.
MS. MULKEY: Yes.
MS. SMOOT: Now I don't know what that means. We'll find out.
MS. MULKEY: I mean there's just -- there's some sort of practical questions. I don't know how many we have released under FOIA.
MR. SADOWSKY: It wouldn't be very many.
MS. MULKEY: Very few, we think.
MS. MOSES: It says one percent of 1800 or something have to do with inerts. It says on this thing here somewhere.
MS. MULKEY: One percent of the requests.
MS. SMOOT: One percent of the requests annually.
MS. MULKEY: But that doesn't mean that they were answered by relief. Andy?
ANDY: Yeah. You indicated that, you know, a number of these requests have come in and you haven't responded or you haven't made a decision yet. Is there any time line on when a decision has to be made? Would this be part of some plan, or is this just hasn't been made and will be rotating off the committee and it will still not be answered?
Is there some mandate as to when you have to make a decision?
MS. MULKEY: I was talking about a petition, not a FOIA request.
ANDY: Well, a petition.
MS. MULKEY: A petition.
MR. SADOWSKY: I mean, there's no mandate as to a particular time when a decision has to be made. We've had some pretty active discussions between the Office of the General Counsel and OPP as to the disposition of these issues.
One of the problems, there are so many ways to address this. Ways of trying to disclose information, different authorities, a different scope of what might be appropriate for disclosure, and even different types of information that you might want to disclose, that it's not simple to sort of settle on a best way to disclose information.
And one of the purposes of this discussion, from my understanding, is to basically get some creative ideas as to the kind of information to disclose and how we can do it to, you know, both benefit the people who need it and not have a problem for the people who want to protect information.
MS. MULKEY: Just to tee up the question a little bit, one of the things we would like to hear from you is, what kinds of models of disclosure would you like to see, if you would like to see disclosure. Do you like the FDA model, where the ingredients are listed, I think sort of in order of amount occurring, with some amount below which they don't list them. Do you like a model that actually lays out the exact formula?
I mean, setting aside the downside, which we understand, even those who are most enthusiastic about disclosure, what models of disclosure do you like. That kind of thing in this dialogue, I think, would be helpful.
MR. OLSON: I think percentages are useful. But I have a really ignorant question, which is, I saw the table that was in the handout of inerts that are or have been used as actives. And I'm wondering how many of those are we really talking about. This is a very long list, and there are a lot of sort of nasties on here. And I'm wondering, what is the criteria for actually putting these on the inert lists -- for allowing someone to call them an inert when they also could be considered active? Maybe I'm missing something.
MR. JONES: A couple of comments on that one. We began to do some analysis on that, and in fact many of those that are on that list are either not used as an active or not used as an inert. So hopefully as we clean up our inert listings, as well as the actives, that number certainly will go down.
I think you asked about the criteria for why would something be an active versus inert?
MR. OLSON: Yes.
MR. LEIFER: As I think Cameo eluded to, a lot of it has to do with the label claim of the product. If it's claimed as an insecticide, a chemical possibly may be having insecticidal properties, but may act as a solvent in a fungicide formulation. So that may account for some that possibly may have dual activity.
I mean, I think the concern here is, are there some chemicals that are active ingredients and are also, you know, of toxicological concern because of their biological activity. And there may be a few that we have to address. Some also fall in the category of preservatives, where they have an Antimicrobial activity to preserve the integrity of, say, a herbicide formulation. Then there are others that are like sulphur or carbon dioxide that I'm not sure what their activities are regarding their inert versus active uses in terms of any, you know, concerns.
MR. OLSON: But something like Rotenone is on here. Rotenone would be considered an inert?
MR. LEIFER: I don't have the answer here. But I would venture to guess that Rotenone is not being used as an inert ingredient.
MR. OLSON: I don't know where this listing --
MR. LEIFER: This list was like once was, was ever. It hasn't been cleaned up. This was gleaned from our list. This doesn't reflect the current uses -- usages of these chemicals.
MR. OLSON: So where did this list come from?
MR. LEIFER: This was taken from a listing of -- I believe. I can't speak for -- but from a listings of kind of our listings of inert and active ingredient names. They kind of cropped them up by, I think, cass number.
What it doesn't reflect, particularly on the inert side, because we don't make that information available and speaks to some of the disclosure issues, is which products actually, if any, you know, contain those.
MR. OLSON: So I think things like this are exactly why I think labelling is absolutely called for. Because it would certainly discourage this kind of thing.
MS. MULKEY: Shelley?
SHELLEY: Well, I guess I'm one of these full disclosure types, also. Now that the veil of secrecy has been lifted by the court -- and I understand your concerns and we obviously have to follow the law and all that. But isn't there an opening here for the agency to make a determination that this information is important for health reasons to be disclosed to people who are exposed to these chemicals?
And so leaving aside anyone who is a multi national corporation, which I'm not one --
MR. JONES: I can answer that directly.
MS. MULKEY: Are you finished, Shelley?
SHELLEY: Well, just to finish the sentence. I mean, you're actually getting the drift. I mean, either by rule making, or the policy thing, or something. I mean, to me, you know, if we cross the rubicon and say the public should know this, then making these case by case determinations really seems like a nutty way to go. So anyway, go ahead.
MALE SPEAKER: That is a difficult way to go. We essentially followed that course of action ten years ago when we had our inerts policy, when we basically determined that list one inerts should be on the label. The policy wasn't all that clear as to the statutory basis for it.
But basically it was the idea that it was necessary to protect them against unreasonable risks in order to have these things on the label, and you could also include this branding argument for those particular inerts.
One of the questions you deal with is how far can you take that. Can you take that all the way to inert ingredients where we know absolutely nothing about? That's an open question at this point.
SHELLEY: But I guess that's exactly the argument that I was wanting to address, because -- and not to get into a debate with you. But just the -- you know, members of the public are allergic, probably, to every single one of those ingredients. I mean, there's somebody out there who potentially is. The fact that the agency hasn't decided on the toxic effects of the chemical doesn't mean that other people in making their health risk evaluations wouldn't be happier to avoid certain chemicals.
I mean, I think that reasonable risk arguments can be made that this information should be available to the public who is exposed to these chemicals. And to the extent possible, I would think that you would want to make that kind of blanket determination, so you didn't have to deal with it case by case.
MS. MULKEY: I think that's clear enough. I mean, do you feel the need to -- I think that adds to the dialogue that perspective.
I know Jeannine has her card up. Erik, is yours still up or is it -- okay. We have eight members of the public who want -- I think there may be even more than that, because I see two that are not counted. So ten. And we'll give each of them only five minutes, and that's 50 minutes. That's a good thing. I mean, this is a topic where there are a lot of stakeholders who are not around this table, and it's good to hear from them.
We do want to say something about data compensation. But my impression is that almost all these people want to talk to the disclosure issue. So I suggest we hear from Jeannine, and then we move into the public participation on the disclosure issue. And if someone of these ten people wants to speak about data compensation, just go ahead and we'll conclude the public participation part. And then we should still have some time left for the committee.
MS. KENNEY: In my view, the disclosure issue is very important, and I'm going to ask Steve to maybe talk a little bit about the food industry's experience with ingredient labelling. But even more important than disclosure, or equally important, is some assurance that what's in these products is safe. And I don't think you can do -- you know, say well, disclosure is a solution to our problem with 1700 list three chemicals.
So that, I think, is really critical, and I think I would agree with Erik's comment that you need a do or die policy on some of these to get the information in without straining the agency's resources.
But I am troubled by the lack of disclosure on pesticides in terms of the inerts. And I guess I don't fundamentally understand the competitive issue that I know the registrants have. And I was hoping maybe Steve could comment on the food industry's -- Steve Balling.
MALE SPEAKER: Too many Steves around.
MS. KENNEY: Yeah. I wasn't sure you knew I was talking to you. To comment maybe on --
MR. BALLING: I was hiding behind Carolyn.
MS. KENNEY: Because I know from my -- some of my experiences with consumers who are concerned about allergies in food that, you know, if you're going to change your formulation at all in terms of maybe the different oils that you use in food products or whatever, you've got to list them all, unless you want to change your label every time.
So that's a pretty hefty burden that the food industry has adapted to. And I don't know. Maybe you could just talk a little bit about that. It might be helpful.
MR. BALLING: Well, except that I'm an anthropologist. I could probably talk about it in a more general context. Yeah, I think the food industry clearly has some very specific requirements, and as well some -- owes its consuming public knowledge about what's being put in a food product. And so those are fairly critical.
One of the things we try to avoid, though, is a general listing of what might be in -- that's one of the concerns about biotechnology and having to put well, it may have a biotech product in it, because then it can also be misleading.
And I guess we have two major concerns. One is that we are not misleading in any ingredient statement, and two, that it is of value. One of the things you're always struggling with is cluttering up labels with information that is largely of little value to people.
I'm actually waiting for some discussion by -- I assume some industry members will be talking about their concerns about protection of these inert ingredients.
MS. MULKEY: It won't be just industry members, but there are definitely some people who are concerned about protection of what they regard as business important information.
So we can move to that. And Jeannine, are you trying to put yours back up?
MS. KENNEY: No.
MS. MULKEY: Okay.
MS. KENNEY: I don't -- I guess my question was in terms of what you're mandated to put in a label, not what you may have the option to put on the label. Has it been a competitive issue for you, or are you not equipped to speak to that?
MR. BALLING: Yeah. I'm probably not equipped.
MS. KENNEY: Other than bug parts.
MR. BALLING: There are no bug parts, of course. Yeah, but that means we have to spray a hell of a lot of pesticides to do it. No. It is a balancing act. I don't see it as a competitive issue, because historically -- and this is getting, again, difficult for us to answer, because we can food. You know, it's got the product, it's got salt and it's got water. That's pretty much it.
MS. MULKEY: You don't do a lot of processing?
MR. BALLING: No, not a highly refined processing. Certainly things like spices, though, which are the magic compound typically, are not required to be provided. It just says spices. So there are ways in which competitive information can be protected.
MS. MULKEY: This question of food -- FDA experience and food labelling experience is clearly relevant to this dialogue. I'm sorry Bob isn't here, although he may not be the right person at FDA to speak to that. But that's certainly one of the sets of questions we've been asking ourselves, is how much is that experience relevant and useful to us. And I think that's part of what you were trying to get at with this question.
Well, let's move to the public participation. Because there are so many of you, we don't have what I had hoped would be the opportunity to relax our timetable a little bit to take public participation. We will ask each of you to keep yourselves to five minutes, and I'll bang the gong if you don't.
Warren Stickle, do you want to start us out? As I mentioned, we have a letter in your package on the issue of processing, so I don't -- processing of new -- he used the term processing, not in the food sense. But I don't know if you want to speak to that or disclosure or both. But the time is yours.
MR. STICKLE: Well, thank you very much. I'm Warren Stickle, and I'm President of the Chemical Producers and Distributors Association.
First of all, I want to thank EPA and Marcia, Jim, Steve and all the others who helped put this forum together to talk about the inert issue, because I think it's a really very important issue that has not had a great deal of discussion over the last several years. And I think it's really important that we talk about these issues today.
One of the real concerns that we have is the inert approval process at the agency. The various documents that have been shared with us by the agency indicates that they have a backlog now of about 77 products, in 1997 zero were processed, in 1998 fifteen were processed, and the work plan for the Registration Division for this year would suggest that they are going to try to make seven decisions. Now we can do some simple math. But if you have 77 backlog and you do seven, you'll looking at an 11 year process if you continue along that same line.
In addition to that, we're under the impression that they got 25 applications in 1998. And if this level of process continues, and you're only going to do seven a year, you're going to add another two and a half years for each year you go down the road. So you may be looking at a 15 or 20 or 30 or a 35 year backlog at the end of ten years.
And I would suggest that that kind of a backlog is unacceptable, and I think it has an impact on everything else the agency does. If the agency is involved in trying to get a reduced risk pesticide approved, but you have to wait three or four years for the inert to catch up with that process, you basically have an inert policy that is in fact canceling out the real benefits that you have in a reduced risk product.
Secondly, if you're in an industry that's trying to produce and manufacture and distribute inerts, and your marketing people go to the registration people and say, how long do you think the agency is going to take to get this inert approved, and the registration person says well, it could be three years, it could be five years or it could be 15 years, how do you make any kind of reasonable business decisions or marketplace decisions if you don't have some at least certainty that you're going to get a registration or an approval of an inert in a timely manner? And I think this affects all the other products across the board.
The real issue, I think, is how can we come to grips with this type of situation. We would like to suggest three, four or five suggestions for your consideration. Now we've heard a number of discussions that there is no money. We're working on a zero budget. Well, I'm not so sure that we're talking about a zero budget for the Registration Division for the next one year, two years, three years, four years and five years, or whatever.
Secondly, within the budget factor, we're looking at a variety of other branches within OPP other than Registration. So we're looking a big picture, not a small picture. And I think if the agency really determines that it's in the public interest to try to break this kind of a backlog, I think some monies can be found from a variety of other areas to address that. And that's one of our real issues. Can we reallocate some money, some personnel and some resources to get this done?
Everybody around the table is talking about how to get more work done on inerts. And we're talking about backlogs on one hand. We're talking about tolerance reassessments on another. We're talking about FQPA review and the implementation of that with regard to inerts. We're talking about a lot more problems, and a bigger problem down the road on each of these areas.
One of the ways to address that, in our judgment, is to look at the situation where you now have inerts. And that is, you have it in the branch with minor use and with Section 18's. If you're going to deal with 2500 inerts and all the other things we've been talking about all afternoon, why not create a separate branch, with separate funding, separate accountability and focus on this particular problem.
And if you're going to do anything in the area of inerts, why not try to set some priorities. Sometimes can be easily reviewed and done. Others may take more time. But if you're going to process Palmer exemptions, for example, why not put them on a fast track. Why not try to do them in 90 days. If you have an inert that is going to be ultimately used in a reduced risk pesticide, why not fast track it and get it done in 90 days.
I can show you an example of a fast track product, that should be fast track, that is in fact for a reduced risk pesticide that's been waiting for almost three years to get done. That doesn't make any sense. How long should an inert take? Shouldn't we put some kind of a guideline as to whether -- what that time line should be? I'm not sure what that might be, but perhaps a year might be one way to do that.
And the PMN process has another very important lesson for all of us. And that is, if we can keep registrants and people who are filing the inert applications aware of what the progress is, as they do in the PMN process, on a quarterly administrative type report, you would reduce a lot of workload for EPA, and at the same time you would create assurances within the registrant community that yes, the agency is working on this. They're making progress. They're doing this or they're doing that. But just the information and the trust that that would build I think would be significant.
And lastly, what I would like to basically say is that for those of us in the agricultural chemical production, inerts are very, very important to the development of products and end use products. So we absolutely need these types of products processed in a timely, reasonable and efficient manner. Otherwise, some of the other objectives that we're trying to reach will not be achieved.
Thank you very much.
MS. MULKEY: Thank you. And if you have anything to supplement your letter in the way of written submissions, we're happy to put that into the record and take it into account, too.
MALE SPEAKER: I would like to make one clarifying point. I think you make a lot of good points, Warren. Although the work plan only identifies seven inerts, the plan for this year is to do 20 new inerts. Thirteen of them will be Palmer exemptions and seven will be basically non-Palmer exemptions. So the number is 20.
MR. STICKLE: Okay. For whatever reason, I didn't see that in the report that was put out on the Internet.
MS. MULKEY: Why don't you just take credit for it for having made it happen. Then you had a good day.
Ted Wye? Tell us your affiliation.
MR. WYE: Good afternoon. My name is Ted Wye. I'm also with the Chemical Producers and Distributors Association. As we've been discussing, EPA has received two petitions that request the full disclosure of inerts. CPDA opposes these petitions for three primary reasons.
The first is that the request violates Section 10 of FIFRA. This section protects confidential information and trade secrets by providing that unless specific criteria are satisfied, EPA cannot disclose the identity or percentage quantity of any inert ingredient. The only circumstances when EPA may release such information is after EPA has determined the disclosure is necessary to protect against unreasonable risk of injury to health or the environment.
Moreover, even after this finding has been made, there are specific requirements governing the release of this information. Yet despite these requirements, the petitions request full disclosure across the board regardless of any risk determination. This request violates both the letter and the intent of the law.
Second, both EPA and the registrants are already taking measures that respond to many of the concerns raised in the petitions. As Carrie mentioned, EPA is further evaluating many of the inerts that are listed in the petitions, and the petitions' request would simply divert EPA from these ongoing activities. In addition, registrants often provide sources of information where members of the public can request additional information on these inert products.
Third, the full disclosure of inerts would reduce incentives to develop less toxic, innovative and more effective products. Without the ability to protect confidential information, companies cannot justify the expense of resource expenditures that are necessary for development of new products.
In summary, the petitions' request is illegal, unnecessary and counterproductive. For these reasons, CPDA requests that EPA deny the petitions' request.
MS. MULKEY: Okay. Thank you. Julie Spagnoli from Bayer -- how do you pronounce it, Julie?
MS. SPAGNOLI: U.S. despair.
MS. MULKEY: Okay. That's where we are today.
MS. SPAGNOLI: That is truly our policy. In the U.S. it is Bayer. In Germany it is Buyer. I'm representing Bayer Corporation, and also I've been a representative of Riese on EPA's consumer label initiative. And Field Life was initiated as a partnership between EPA industry and any other interested stakeholders.
Bayer Corporation and Riese, along with the other trade associations and company partners, have supported the goals of the consumer label initiative, and that is to provide consumers with labelling that is both understandable and useful and thus promoting proper use and empowering consumer choice.
In the general overview of labelling that was undertaken in phase I of the CLI, one of the findings that was unequivocal was that consumers did not find chemical names useful. This finding led to the issuance of PR notice 97-5, which recommended that registrants voluntarily drop the use of chemical names in their ingredient statements and using only common names to identify the active ingredients.
Phase II of the CLI involved a broad quantitative research study of consumers in three product categories with the objective to further identify consumer's needs and preferences for label information. One of the goals of phase II was to find out what kind of ingredient information consumers wanted on products and how to best provide that information with options that may have gone beyond labelling.
The findings from phrase II included that consumers were generally satisfied with the ingredient information on labels, and only about three percent of consumers indicated that they wanted more ingredient information. They did not consider ingredient information the most important on labelling. Directions for use, what a product does, health and safety information, where the product should be used, and first aid were consistently identified as the information most important and most wanted -- that consumers most readily wanted to be able to find on labels.
Less than half of consumers look for ingredient information in making product choices. About 20 percent of the consumers identified ingredient information as information they never read on labels, but the primary reason being that it was not understood. Even those that do read the ingredient information or active ingredient statements indicated that they did not understand the chemical names. About two thirds of the consumers who did read ingredient information did so for the purposes of comparison, generally for value purposes.
When consumers were given a number of options of ingredient label statements, in all product categories, of consumers who showed a preference, nearly two to one preferred a general description of a formulation with the ingredients' purposes over a full chemical disclosure.
Ingredient information was further investigated in follow up qualitative research. Various formats and locations of ingredient information were evaluated. No clear preferences were apparent by consumers.
The Field Life research clearly indicated what kind of information the consumer wanted and was most useful, and that label space on consumer labels is limited and should be used to make sure that we clearly provide the information that consumers readily want and can find.
The Field Life current recommendations are not to prescribe any across the board changes at this time, and to recommend that the agency allow registrants flexibility in ingredient locations on the label, as long as they can be clearly found, and also to allow flexibility on how registrants may voluntarily choose to provide information on other ingredients.
The Field Life also recommends to continue to examine options for providing useful ingredient information to consumers. We encourage EPA to continue the consumer label initiative and its goals, and the industry partners intend to continue to work with the agency on this objective.
MS. MULKEY: Thank you. I think bringing to the table this consumer labelling initiative effort is something that we thought about doing, and I think Julie has added some useful information. And this was obviously a very short version of it. People would obviously -- if they wanted to take that into account and want to know about all these studies and how they were done and conducted and so forth, that information is available.
MALE SPEAKER: The analogy to food labelling is very interesting. And just off the top of my head, I would like to think out loud. One of the things on a good label, the nutrition fact summary is often much more informative to the consumer than the actual list of ingredients. People don't read the list of ingredients.
If there is some analogy that we can come up with for inerts, for instance a statement that all the inerts in this product are generally regarded as safe, or some of the inerts in this product are of unknown toxicity, would that sort of information be -- well, that would also encourage people to produce information about the inerts.
MS. MULKEY: I think -- well, we'll put that into the dialogue. I think what's beginning to emerge is that this is a very rich and difficult public policy discussion. And we'll have a chance to come back to this group and have a little bit more of that discussion.
Lynn Layo of Novartis? Did I pronounce it correctly?
MS. LAYO: Thank you, Marcia. It is Layo. And I'm with Novartis. We, as a member of ACPA for many years, have been completing CSF for FIFRA submissions for many, many years. As you may recall, the initiative to revise the CSF came about as a result of the product chemistry rejection rate analysis. Now it is our understanding that this has taken a back seat to the other issues of harmonization with PMRA and also the Freedom of Information Act disclosure.
MS. MULKEY: You may need to back up a little bit.
MS. LAYO: Okay.
MS. MULKEY: I'm not sure everybody knows what CSF is. Confidential Statement of Formula. I got that one.
MS. LAYO: Okay.
MS. MULKEY: You actually used one acronym I didn't know, and then PMRA is the Canadian regulatory agency.
MS. LAYO: Sorry.
MS. MULKEY: So maybe you could just back up a little bit.
MS. LAYO: Okay.
MS. MULKEY: And remember not everybody knows all the acronyms.
MS. LAYO: Okay. All right. Sorry. The initiative to revise the Confidential Statement of Formula came out as a result of the product chemistry rejection rate analysis. There was difficulty in completion of the CSF, and that seemed to provide the greatest rejections.
So the Confidential Statement of Formula is a vehicle for complete disclosure of composition for active ingredients, manufacturing and use products and end use products. This includes complete chemical names, common names, trade names, the AS numbers, percentages, how it's going to be used in a formula, etc. There is quite a bit of information on the Confidential Statement of Formula.
The recent draft of the Confidential Statement of Formula that has been circulating with the check boxes that I think Don Sudowski mentioned, for confidential business information, we feel will not simplify the procedure for either of the three issues that I previously mentioned. It is my contention that most companies will check almost all or as many of the boxes as may be allowed, based on their information disclosed in the MSDS. As well, these check boxes will further complicate an already complicated form.
To simplify these issues, the CSF and the product chemistry rejection rate need to be separated from the harmonization effort in the disclosure issue. We feel very adamant that we would like to work with EPA to come up with a solution for all of these issues.
MS. MULKEY: Okay. Thank you. Don actually touched on this, so if you didn't follow all of this issue of the request or requirement that registrants document the basis for their confidential business claim at the time of submission. And the points that Lynn is making relate to what she sees is the complexity of that and issues relating to that. If I understood it correctly.
FEMALE SPEAKER: (Inaudible).
MS. MULKEY: Sure.
FEMALE SPEAKER: (Inaudible) -- what she said -- what she just said. I mean, is that -- would that actually be what happens or would they just check everything, or would they have to really substantiate -- I mean, wouldn't there have to be a reason? They couldn't just check I don't want people to know this. There has to be a reason for it, right?
MALE SPEAKER: Well, the current draft of the form has a certification statement, and the certification basically indicates that there isn't disclosure of this information by the company filling out the Confidential Statement of Formula. So there has to be some basis for being able to certify confidentiality.
FEMALE SPEAKER: No. My question was -- your reaction to what she just said that what you recommended they're against. And I'm saying, do you think that's what would happen, that it would end up not being useful, because everybody would end up checking anything anyway? Or are you suggesting something that would not -- that does not involve that?
In other words, if they really checked it, they would have to have something behind it. Or is it going to take staff time to check whether they should have checked it? What are we talking about?
MALE SPEAKER: Again, that's why that certification is there. It isn't intended to be some sort of check upon --
FEMALE SPEAKER: Oh, I see.
MALE SPEAKER: -- the basis for that.
FEMALE SPEAKER: Oh, I see.
MALE SPEAKER: And if we wished to, we could look into, you know, indeed whether information has been disclosed. Yes, there is enough of a tendency where there is no barrier or cost to asserting a confidentiality claim that some companies will claim everything they can as confidential.
You really see a big disparity between how some companies do it and some don't. Some companies are very good about it. They'll only claim exactly what has to be protected as a confidential, and they'll do a lot of research on that. Then you'll have other people who just take the easy path and claim everything confidential.
MS. LAYO: And I think -- just to add to that, we believe that the boxes will be checked where that information has not been disclosed in any other location. So in other words, in general companies will check those boxes where they believe the information has not been previously disclosed. Okay. So whether it be on a MSDS or some other public document.
MS. MULKEY: Okay. Thank you. I think that helps us to focus on a narrow but crucial piece of this.
Bridget Cline, CSMA? Chemical Specialties Manufacturing Association, to be specific.
MS. CLINE: Good afternoon. My name is Bridget Cline. I'm a regulatory counsel for the Chemical Specialties Manufacturing Association. CSMA represents 400 companies engaged in the sale of non-agricultural pesticides, including Antimicrobials, for household, institutional and industrial uses.
I would like to make a few comments about inert disclosure in light of the statutory requirements --
(END OF TAPE)
MS. CLINE: This section protects against the unauthorized disclosure of particular sources of information. With few exceptions, this section prohibits EPA from disclosing trade secrets and confidential information.
In particular, Section 10(D)(1) provides that unless specific criteria are satisfied, EPA may not disclose any information that discloses the manufacturing or quality control processes, discloses the detail of any methods for testing, detecting or measuring the quantity of any deliberately added inert ingredient of a pesticide, or discloses the identity or percentage quantity of any deliberately added inert ingredient of a pesticide.
The only circumstance where EPA may disclose such information is where the Administrator has specifically found that disclosure is necessary to protect against an unreasonable risk of injury to health or the environment.
The obvious purpose of Section 10(D) is to ensure that trade secrets and confidential information are only released when disclosure is absolutely necessary and through adequately protective means.
CSMA wishes to emphasize the importance of the protections afforded under Section 10. Preserving the confidentiality of this information is crucial to the industry's ability to market and develop innovative products.
Therefore, the agency should adhere to these protections as it considers the petitions for full disclosure of all inert ingredients.
MS. MULKEY: Thank you. Cindy Smith? Tell us your affiliation.
MS. SMITH: Good afternoon. I'm Cindy Smith with C.A. Smith Consulting. I'm here today representing Vachor (phonetic) Silicones and Vachor Biochemical Corporation.
I share the comments that have been presented here today with regard to the disclosure issue. I will focus my comments today onto other aspects of inert ingredients.
On the data compensation and exclusive use topic that we really haven't gotten to yet, Vachor is a producer and data producer for inert ingredients. They are not a pesticide registrant. And in that capacity, they would want to protect their investment and would be interested in receiving data compensation and in receiving exclusive use options. Toward that end, we would be interested in not having some provision that limits data compensation and exclusive use to registrants.
With regard to project prioritization, Vachor does support the agency's current position of processing the simpler ones first so as to have a smaller backlog. We clearly recommend -- or recognize that at a future time the more difficult ones will need to be processed. But right now we're sort of in a crisis mode.
Also, Vachor does support the idea of reduced risk handling of inert ingredients. The current process for defining what is a reduced risk pesticide is actually a very labor intensity process. It requires that you gather the world of information on all your competitors.
When you're looking at active ingredients, that is a much -- it's a complicated process, but there is public information with which to gather that input for your document. However, for inert ingredients, who your competitors are and the world of data on them is a much more complicated task.
So what Vachor would recommend is that the function of the inert ingredient be subject to reduced risk consideration. So, for example, if you had a pesticide -- if you had an inert ingredient, it would allow you to produce a formulation that would allow for a reduced application rate of the pesticide, or a less frequent application of the pesticide. Then that inert ingredient brings to the marketplace a reduced risk capacity, and that inert ingredient should be processed on an expedited basis.
MS. MULKEY: Thank you. Warren Stickle is representing a different association. Well, wait a minute, Warren. Don't jump up too fast. We're going to let you take your turn, but we're going to put you at the end.
MR. STICKLE: That's great.
MS. MULKEY: Fair enough? You came up next on the card, and I wanted to be sure you knew that we knew that we're going to get to you.
And speaking to a different topic, part of this topic, Michael Surgan is here from the New York Attorney General's office. You've heard several times the Attorney General's petition mentioned. So Michael may speak to that or whatever he chooses.
MR. SURGAN: Okay. I'll speak to that. Thank you very much. I'm Michael Surgan. I should say right out that I am the Chief Scientist in the Attorney General's Environmental Protection Bureau. I'm not an attorney. But I'm here to speak for New York's new Attorney General, Elliott Spitzer, who has fully endorsed and adopted the premise upon which our petition was submitted.
And you've heard some talk about our petition and the letter that was submitted by a group of trade associations. And in fact, some of the previous speakers have already addressed the items in the letter submitted by the association.
New York and the other states, and in fact the almost 200 public interest groups that submitted the parallel citizens' petition, awaits EPA's response and analysis on this issue. And we are not dissuaded by the points that have been raised by the industry, nor do we think, for that matter, should EPA be dissuaded.
And while this isn't the proper forum for a full legal analysis, nor am I the one to do it, on behalf of the Attorney General I would like to take a few moments just to briefly respond to some of the points that were raised -- all of the points that were raised in the letter, some of which have been raised by previous speakers.
First we've heard that FIFRA Section 10 precludes EPA from disclosing inert ingredients in pesticide products. That analysis ignores the findings of the court in the case mentioned by Don Sudowski and Cathy Browner, in which End Cap sought the release of inerts under FOIA.
In the court's decision in October of 1996, the court recognized that EPA had broad discretion in its labelling regulations, regulations that were promulgated consistent with Section 10, and those labelling regulations required the I.D. -- or, excuse me -- gave the Administrator the ability to require the I.D. of inerts which may -- and I would like to emphasize the may -- pose a hazard to man and the environment to be revealed.
Indeed, EPA has already done this in requiring the identity of list one inerts to be revealed. And we've seen the net effect. There was a lot of talk earlier about how can we reduce the burden that EPA faces in evaluating and processing all of these inerts. And I think experience shows us that when list one inerts were forced to be identified, the number was reduced from 57 to eight. And so bringing the light of day to this problem may solve a lot of the issues that face EPA today.
And I'd like to just briefly return back to the language of the regulation which referred to inerts, which may pose a hazard to man and the environment. And earlier when we saw the analysis of the numbers of inerts on each of the lists, we can see that about 80 percent of those are not list four inerts. List four inerts are those which are, for the lack of a better term, grass inerts. The others -- certainly it would be easy for EPA to make a finding that they may pose such a hazard.
The court also found in End Cap v. Browner that until EPA affirmatively determines that the inerts in a particular formulation qualify for trade secret protection, the inerts do not automatically qualify for such treatment. The petition is before you. We've made the request. And to my knowledge, EPA has not affirmatively made that determination for those inerts.
In their letter the trade associations make the point that the registrants and EPA have already taken steps to provide some of the requested information. We recognize -- in fact, we recognize that there has been a requirement that the list one inerts be revealed. We recognize those efforts. We applaud those efforts. We appreciate those efforts. But they are small -- only small steps in the right direction and are not sufficient to satisfy the needs that are expressed by those petitions.
We've heard that disclosure of inerts would reduce the incentive to develop less toxic formulations. I would say that there are lots of other ways in which to encourage the development of less toxic formulations, including expedited registration.
I also believe that disclosure would provide the public -- the broad public, not just the average every day citizen, but the people who buy pesticides for professional use and for institutional use. Disclosure would provide them the means to choose less toxic alternatives, thereby providing financial incentive to the people who produce those.
There was talk in the letter that phase I of the consumer labelling initiative found that consumers want fewer technical terms on the label, and found little value in active and inert ingredient information. That may be so. I'm not sure that the questions don't reveal that people don't understand the distinction between active and inert ingredients. It doesn't mean that because value hasn't been found that value is not to be had. It doesn't mean that if the public was properly educated, or if resources were available to them to make use of that information, that they couldn't make good use of that information.
And also on this part I want to emphasize something I just eluded to, and that is, that we often think when we talk about the consumer labelling initiative about the public. We think in terms of the mass of people who are perhaps not college and university educated, and perhaps are not equipped to understand those chemical names.
But there are very many people who buy large amounts of pesticides who do so with full knowledge. There are educational and extension organizations that are asked to make pesticide recommendations. And they're asked to make those recommendations in ignorance of the full formulation of the product that they are recommending. There are people in the pest application business who are qualified to understand that information, but the information is not available to them.
And finally, the last point, and I could skip this very easily, because it was not brought up by one of the previous speakers. But in the letter -- and for completeness -- the associations alleged that our petition is factually inaccurate. And they state that the petition discussed toxic effects of two inerts which were removed from the inerts list by EPA.
I think this point is disingenuous and contrived. Our petitions were submitted in January of 1998, and the chemicals were removed from the list in June of 1998. If we as the petitioners could have divined the activity of EPA on this action, then the petition would have been unnecessary.
MS. MULKEY: Thank you. We have two -- Sue Crezency, is she here?
MS. CREZENCY: Yes.
MS. MULKEY: And Ralph Magin. You're both ready to speak today then, right? Okay. Great. Okay. Go ahead, Sue.
MS. CREZENCY: I'll try to make mine really fast. I'm Sue Crezency from Steptoe & Johnson. I'm here today on behalf of the CMA Advisory Panel.
One of the first things I wanted to say in terms of an active ingredient that's on the inerts list -- I don't know how many of these. But a number of them, as Carrie said earlier, are preservatives for the formulation. So they do not appear on the label as an active. But that preservative has been reviewed and approved for use as a preservative in the active ingredients.
So I think it's important to understand -- and they're there in the parts per million range -- low parts per million range -- and the amount that is in the formulation they're preserving is prescribed by the term other registration. So I hope that that kind of dissuades, you know, that it's a real problem here.
I'm also going to talk just a little bit about the CSF, which Lynn referred to a little bit ago. Right now we were asked to kind of come up with ideas for how to address the problem -- fix the FOIA process which is taking up a tremendous amount of resources. It's to everybody's advantage to fix a process that wastes a lot of time.
But the only thing on the table right now seems to be this Confidential Statement of Formula. And we really think it's uniquely unsuited to be a vehicle for determining what's disclosable. Some of the information on the CSF includes, in addition to the actives and the inerts, the exact amount, the purpose in the formulation, all of the suppliers of each ingredient in the formulation, the manufacturer, which could be other than the registrant, and according to the directions on filling out the CSF, the ingredients must be listed in the order in which they're introduced into the formulation.
Arguably, almost all of this information, if we get away from and not even thinking about the identity of the inerts, are either confidential business information or trade secrets. It's really hard to see why this form would be -- you know, determined to be something that would be useful for disclosure purposes, since so much of it is totally not disclosable.
And also, the form is problematic, with a very high rejection rate, wasting a lot of resources, again. And somehow the revisions of the form to address the problem of this high rejection rate have been lost, because we're now focussed, apparently, in all the meetings we've had with EPA, on revising this form on either harmonization with Canada or disclosure.
And these things are really complicated even further without addressing any of the fundamental issues that have been causing rejection in the first place. It's a pivotal form as far as chemical review is concerned. You can't get through the process without this form being approved.
So I would encourage the agency to begin to look at and work with the industry on coming up with registrants on other ways to address fixing the FOIA process that maybe would work better in the long term.
MS. MULKEY: Thank you. Ralph? Is it Megan or Magin? You'll tell us.
MR. MAGIN: On March 17 it's Magin.
MS. MULKEY: Oh, excuse me.
MR. MAGIN: I want to thank the committee for the opportunity to come here and speak before you. My name is Ralph Magin. I'm a Senior Research and Development Advisor at Alborboro Corporation. Prior to that I worked for Monsanto Company, where among other responsibilities, I headed up their formulations crew.
So I just want to make two rather simple points. Inert ingredients play a very, I think, important part in formulations. If you didn't have inert ingredients and you went to the end user and gave the end user a cup of the active ingredients, they wouldn't know what to do with it. So it's a useful thing to have inert ingredients in making useful, worthwhile formulations.
The other point I wanted to make, which has been spoken to by earlier speakers, is having an efficient way to approve inerts. A lot of effort is, I know, ongoing in development of inerts that make more efficient formulations. This translates to having less actives applied to get the job done. If you don't have an efficient way to get these things approved, then companies are not going to invest the money and the time to make these things happen, and that everyone is going to suffer for it.
Thank you very much.
MS. MULKEY: Thank you. And Warren, we'll let you bookend, but we'll ask you to stick strictly to the time so the committee can have its mics back.
MR. STICKLE: Thank you. In these remarks I would like to represent the International Sanitary Supply Association, a group that I represent. It's a group of 4100 companies based in Lincolnwood, Illinois, that manufacture, formulate and distribute pesticides that are used in the cleaning and maintenance area, largely sanitizers, disinfectants, cleansers and cleaners.
Now I really wanted to address the inert disclosure issue, because we have too frequently looked at this as a black or white situation. Full disclosure on the label on one hand, or no disclosure on the other hand. And I think there is a middle ground, and I think there's a middle ground that in fact EPA has been charting for the last ten years. And companies, many of them on a voluntary basis, have also been following along on doing a number of things.
Let's look at what some companies are doing. First of all, they are able to put on their label telephone numbers for consumers to call. Secondly, there is a working relationship with a lot of poison control centers to provide information on active inerts and anything else in the formulation to doctors and emergency rooms.
And the agency, EPA, has on a whole series of efforts over the last ten years, I think made a significant effort to disclose information on the label where the agency felt it had a toxicological concern.
Let's look at four or five things. We've already heard about the list one. We've gone from 57 products down to eight. But the bottom line is, we're taking those list one inerts and they are listed on the label. There are 1700 list three products. But there is an effort by the agency to move those products off of list three to list one or to list four. And they've made one effort to do that of 146 chemicals, and I understand there's about ready to soon be announced another effort to move some more to list -- to either list one or list four.
There's also an effort to take some of those products that have been of concern to some of the environmental groups and take those off the list of 2500 inerts. And there was a significant effort this year to take off -- I should say in 1998 -- to take off 251 inerts.
I guess the bottom line is pretty simply. The agency has been working in a reasonable way addressing those concerns that raise a toxicological concern, raise a scientific threshold. And the agency, I think, has been every responsive to addressing those particular issues. In fact, since 1996 they have released information on about 160 inerts.
So the point that I'm trying to make is that this issue is not a black and white issue. It's not no disclosure on one hand or full disclosure on the other. I think the EPA has been charting a reasonable middle of the road course based on scientific evidence and toxicological concerns, and I want to commend them for the job they've been doing.
MS. MULKEY: Well, thank you. And thanks to all the stakeholders who used this time to enrich the discussion, adding to the perspectives that we already had at the table. We have, by my count, almost -- well, a little over an hour on our calendar. I know that people are sagging a little, and we can make an effort to wind up certainly by 5:30, and perhaps before.
What I propose we do is do a shortened presentation from EPA on the data compensation issue, which is sort of the last of the four issues. That should still leave us with a very significant time for the advisory committee to try to focus on this. And as a result of a little note from Paula, we may put a proposal or two on the table to focus your discussion here.
MS. SMOOT: All right. I'm going to try to move fast and furiously through this. It's actually relatively a straightforward topic. As part of the Food Quality Protection Act amendments to FIFRA, there was a new provision that unless you were directly related to data comp and you were an inert manufacturer, you probably missed.
The general provision is on the screen and short noted. Congress passed and established new rights for data and information submitted to the agency under Section 408(I) and Section 409 in support of a tolerance or an exemption. And it extended the rights of CBTI -- confidential business treatment information or Section 10, and also Section 3 of data comp and exclusive use rights.
Basically what we've done over the last several months is take a look at the provision and do some think tanking. We have looked at the two sections, basically Section 10, but mostly Section 3, which contains a number of conditions for requiring data -- the data submitted to get the protections granted under Section 3.
Next slide. Basically we came up with three preliminary options, and we are seeking advice from the PPDC to help us determine some of the viable of these options or should we look to a different interpretation of the statute.
First of all, the agency has outlined option one as to establish rights for data submitters who also meet all the conditions in Section 3 of FIFRA. That includes being an applicant -- a FIFRA applicant. It's basically a codification of what we generally do now for registrants of active ingredients who submit data and data protection rights.
Option two would establish rights for data submitters who meet all the conditions of Section 3 of FIFRA, except they do not need to meet the requirement to be a registrant applicant.
And then finally the third option would be the broadest option. It would establish data rights for submitters using Section 3 as a guide post, meaning that we would kind of pick and choose what we thought was applicable to the stakeholders in this group, if we could define that group of stakeholders accurately. They would not have to be an applicant -- a registrant applicant. They would also not have to submit data that was related to a current registration.
And hopefully that's not too short noted for you. If not, we'll backtrack a little bit.
MS. MULKEY: That pretty much covers it all?
MS. SMOOT: That's pretty much the three options.
MS. MULKEY: Okay. What we would like to do now -- I eluded to something. Paula had -- and I hope you don't mind my attributing this to you, Paula. I should have asked, I guess. She thought that the disclosure piece of the four topics here might be lend itself to a work group attempting to develop some consensus or at least options -- I'm putting some words in her mouth here -- around this set of disclosure questions, with a time line that would be aimed at the next PPDC meeting.
What I suggest is, that you include your reaction of today's discussion, but that we also have this on the table tomorrow when we get to ministerial issues, which includes the realm of work groups. And that we use tomorrow as the time to see whether we have a clear point of view that that is a good opportunity and a good topic. And that will allow us to consider other topics and rather than just sort of limit ourselves to thinking about that.
But I wanted to mention that on her behalf and on EPA's behalf, because I think we are interested in seeing whether there is a work group approach. Not like the Rodenticide work group, which is not to diminish that in any way. But that was, you know, designed basically to do a stakeholder process as a work group of this group in order to comply with FACA.
This would rather be one, I think, because this group thinks that it, you know, would like to take ownership of this issue in some particularized way. Not necessarily that all the members of the work group would come from this, but, you know, that you would really like to embrace this as an issue you would like to run with.
So in your further comments for the remainder of the day if you will include some thoughts about your reaction of that idea, with the opportunity to come back to it tomorrow.
And that will open to the committee a reaction or a set of responses or a dialogue, which I would encourage it to be, among yourselves and not just toward us, around all four of these issues. New active ingredients -- I mean, new inert review, old inerts, old chemistry inerts analysis, disclosure and data rights.
Any and all of the above. Is everybody burned out? Paula?
MS. PAUL: Just a quick comment, and I think it really echoes one of the public comments. I think one of the best ways to encourage registrants or producers to develop data would be to give them some protection on that data, since most if not -- well, most of the inert ingredients are pretty much generic products, allowing some sort of reward for registrants that develop the data. It's a very good way for the agency to give incentives to those companies who are usually not -- I think it was correctly stated -- not pesticide producers to develop the supporting data.
And so I would recommend that you have as broad of a brush approach to data compensation for inert ingredients as you can do under the current law.
MS. MULKEY: Bill?
BILL: Having been a former business owner, I concur with what Paula says. Option C, making a broad approach to data compensation, I think is the fairest way. If someone has spent time and money to develop something, they should at least have the right to be compensated. And the way the system works is that the people who are going to use this inert in their pesticide will certainly work out an arrangement with the owner of that right.
So I think option C is probably the best approach to take. I don't know how much time and effort that's going to require of the agency, but from one perspective, I think that's the way I look at it.
MS. MULKEY: Jay? Shelley?
SHELLEY: Oh, I'm sorry. I didn't want to talk about data comp.
MS. MULKEY: That's okay.
SHELLEY: I want to talk about the disclosure, and I just want to respond a little bit to some of the public comments that were made also, especially the comments directed at explaining this consumer labelling initiative.
And that is, to me that kind of misses a point here. And what that talks about is, you know, what generally do people feel like they need to know. And that's only one issue. But I think that there are three other issues of concern.
First of all, what happens when somebody is exposed to a pesticide and becomes ill. Although somebody mentioned from the public that some manufacturers are making this information available to poison control, I can tell you from experience that when someone is actually exposed, getting that information in a timely way is not a simple matter. If somebody is acutely ill, time is of the essence. And so the immediate availability of these things is a very critical matter.
The second kind of point I made briefly before is the folks with allergies who would, of course, therefore, have particular interest in looking at ingredients.
And the third, that various people have eluded to, is as information becomes available to the public, people will have different views as to how immediate a concern is. But that's exactly what they should have. They should have the option to say I've read about this chemical, and I don't want it in my home, or I don't want it on my farm. And without this information being readily available, they can't make that determination.
I just want to raise one additional point about this topic and the Confidential Statement of Formula. And that really relates to the whole Benomyl incident. As many of you recall, in 1991 there was widespread crop damage in Florida attributable to the use of this herbicide, which resulted in about five hundred million dollars worth of claims. And many people also believed that they had become ill as a result.
And at least some folks believed that the crop damage may have been attributable to items which were in very small amounts that were put into this chemical -- into the formulation. So the fact that it's small and parts per million, that doesn't necessarily mean that it's not of concern.
And I can tell you from that particular experience, that it took roughly three or four years for the information about what all was in this formula to come out. And this is after literally hundreds of people had become ill.
So this is a struggle and this should be made easier. And I certainly urge all efforts to be directed in that way.
MS. MULKEY: Thank you. Steve?
MR. BALLING: Well, I have a question of great ignorance, which probably won't surprise anyone here. But actually Jeannine got me thinking about this, and it related to formulations of food products. And I know that in the food industry there really are very few secrets, that we know what's in Heinz ketchup, and everybody knows what's in McDonald's secret sauce.
And I'm curious, and I'm not quite sure who to ask. Maybe Ralph, if he's still here, because he was a formulator. But are these formulations really all that secret, or are they only momentarily secret until someone spends a little time in the lab and figures out what's in them?
And I don't know who to ask that. But this whole disclosure thing seems like a little bit -- I mean, I know we always tried to hide behind our secret ingredients for spices.
FEMALE SPEAKER: All salt.
MR. BALLING: But any good food technologist can figure it out. Yeah, more salt. Bill?
MS. MULKEY: Well, Bill's stepping up to the plate, and then we'll see if somebody else will too.
MR. MCCORMICK: I wanted to speak earlier to your point, because Clorox is a fairly large company that also among other things manufacturers Hidden Valley Ranch salad dressing and KC barbecue sauce. So we do have a food division.
And we successfully list ingredients on our foods and have no problems doing that, and live in a situation where under different -- you know, we have consumer products that have certain labelling for hazardous ingredients. We have food disclosure on our food products. And then we have FIFRA with active and other ingredients -- or inerts formerly. Formerly known as inerts.
And we would like to live under one labelling rubric, frankly, and for us, the one that seems to be the one that has the most disclosure in it is the food labelling idea. And that's probably where we would like to move if we could.
Regarding the idea of everybody knows what's in everything, I think to a certain extent that's true. We have 400 people in our tech center. Ten percent of them are in analytical, and a lot of what they do is competitive product breakdown as soon as we can get it.
So that's all I'm going to say.
MS. MULKEY: Paula, can you be persuaded to speak to this question?
MS. PAUL: You know, that's why I suggested that a work group might be fruitful at this point, because, you know, I think there probably is some common ground in there, and there probably -- I'm not a formulation chemist, and I don't want to pretend to have a great deal of knowledge.
I know working in registration some of the ingredients we would buy, like surfactants and things, would be proprietary mixtures from other inert ingredient suppliers. And, you know, we would have the MSDS, so we would know if there were any toxic compounds, but we wouldn't necessarily know exactly what's in them.
There may be some ingredients that you have to list a little more generically, like spices. You know, buds flavorings. But I suspect that there is a host of the most important ingredients that we could find consensus on that are the ones that are of most concern that there probably is a lot of common ground on. And we could probably find a way to list the others in a way that would satisfy the --
MALE SPEAKER: Yeah. Just to further sort of follow Steve's innocent question of sort to the people that know. And that is, is it the precise measurement -- because this has been explained over 20 years to all of us. I mean, the exact measurement, X percent versus Y percent, or is it sort of the ingredient?
I suspect it's even easier to figure out what the ingredients are, even if the percentages -- if your analytical chemist is only so good -- are precisely down. I mean, does that make a difference? And then not so much in finding it as much as the folks that are worried about disclosure. Is that the essential component?
It's probably easier to figure out trample something is in my mix. But the real trick to my competitive nature, or the real trick to what makes my magic pixie dust magic as opposed to the other guys, is it's exactly .02 percent or whatever. You know, some number.
And one of the questions in the general debate is that question about that general disclosure like on food for people who are allergic or other kinds of things compared to the precise number, and is that something that either makes the medicine go down easier, to the extent of greater disclosure for those that fear disclosure as a competitive issue, versus it's just hard to do.
MR. MCCORMICK I'll give you one example where Soft Scrub with Bleach, which is a product that took us pretty -- several years to develop, and one of the -- it actually hits on everything you're talking about.
MALE SPEAKER: Not easy to register.
MR. MCCORMICK: It is a registered product, by the way,
MALE SPEAKER: Soft Scrub with Bleach.
MR. MCCORMICK: It's 5813-22, I think, available in Safeway. This product has a unique chemistry. It has unique -- it has performance ranges where .02 and .03 make a difference in the formula and the addition order of the ingredients when you're making the product, which is a manufacturing process issue.
So some of that we would want to protect. And, you know, Proctor or SCJ or anybody can go and they can breakdown what's in there, and they can tell you probably to a part per million basis how much of those ingredients is there. But they don't have the addition order, you know, and in that particular product that's really valuable.
I would say a lot of that is not particularly critical to a consumer. It's very critical to Proctor or to Clorox, and we would want to have certain amounts of protection regarding those things. So we would not -- we would be advocating in some instances that some of this in fact trade secrets. Some of this should be protected in a generic basis so that we could list on a label that it's a class of surfactant, but maybe not the specific one.
I mean, that's where we would be on this, which is similar to where we are with foods.
MS. MULKEY: Bill?
BILL: Yeah. I think we're getting to the heart of the subject right now. Earlier Marion asked about how many pesticides are out there. What was the number of them. I think the majority of them -- and there's probably thousands -- are ME-2's. I think you could disclose almost everything on that, because it's not a trade secret.
But I think the newer pesticides coming out, the low odor, where they've masked certain pungent odors, I think is confidential. Water based pesticides where they've been able to stabilize an active ingredient. I think the basic manufacturers are going to feel that's trade information.
But I think like Bill just stated, you can probably put certain information in groups that might satisfy part of the requirement by still keeping the trade secrets. But I think the majority of the pesticides registered today are ME-2's, and I don't think there's a whole lot of confidentiality in those pesticides, and I'm sure you guys have seen them all and they're pretty simple.
MS. MULKEY: Beth?
MS. MARSHALL: Something I wanted to bring up is actually going to change the subject, so before I do that, I want to say this has been a really eye opening discussion to me.
Based on what I've been reading on what we got as background material, I would never have guessed that there was anywhere near this much potential for consensus on this particular issue. And I'm very much encouraged that it exists. I'm surprised, also.
Part of -- one of the things that was sent to us is a list of inert ingredients that are also listed as hazardous on CIRCLA lists, Sara lists and Super Fund lists. And quite a few of these are list three inerts. It would seem to me that this particular list would be useful in prioritizing how you want to -- which of these you should look at first.
If they're already identified by another EPA agency as hazardous or toxic, possibly -- certainly that other agency should have some information and possibly you've already gone to them.
MS. MULKEY: At the risk of a little knowledge being a dangerous thing --
MS. MARSHALL: Is that it?
MS. MULKEY: RCRA wastes often get listed because of their PH or their flammability. So some of these inerts may be either flammable or high or low PH in ways that given the use of the chemical puts a very normal -- I mean, maybe it's a toilet bowl. You know, it's suppose to be whatever -- gross or -- I'm rapidly showing my ignorance.
But having said that, that doesn't mean that you're not on to something about that as a starting point for prioritization. I think -- in fact, I have heard a number of very constructive suggestions today. I hope we had thought of some of them. But even the ones we thought of, it's good to hear them reinforced and others may very well be additions.
MR. VROOM: I think that what Paula said about the data compensation question is correct, and that we might be able to go to the drafters of that provision of FQPA and get a letter from the helm of the agency that could clarify this question of intent of Congress.
MR. AIDALA: I bet you can.
MR. VROOM: Oh, we don't have to have another work group?
MS. MULKEY: Well, is there a -- one question that came to my mind --
MR. VROOM: Do you think that's a controversial thing, Jim?
MR. AIDALA: No, no. I don't think -- I think that as one of the persons in the room, the intent was to cover broadly -- like if you pay for it and you're not the only one benefiting from it --
MR. VROOM: Right.
MR. AIDALA: (Inaudible).
MR. VROOM: And there was some recognition even then that there was going to be a need for more of this kind of data, and the only way to keep these important products available is to provide some incentive to the people who are going to do the work.
MR. AIDALA: And the only thing harder than to ask somebody to pony up very many dollars for data is to say, by the way, why do other people get to be a free rider out of it. I mean, you know.
MS. MULKEY: It is important to remember that we're talking about exclusive use and not just data compensation, which means, of course, monopoly pricing and so forth. So there is a public policy issue with regard to scope.
Having said that, I think that our struggle with it has not been around sort of what is the interpretation we think we could win a lawsuit on. I think -- it won't surprise you that our issue is what can we manage. How can we establish a process that we can live with that can be a relatively low transaction cost for us.
And the one that most closely mimics existing Section 3 is sort of the starting point for the easiest for us in terms of management. And I just -- it's no secret that's really what drives us. So that help in sorting through that question, rather than interpreting the law, is really where we need the help in terms of making that choice.
MALE SPEAKER: TSCA, which is intended for a broader kind of -- (inaudible) -- of compound, is that the same notion of cost sharing for the same reason.
MR. VROOM: Yeah.
MS. MULKEY: Um-hum.
MR. VROOM: Yeah. You don't want to create a whole new set of problems.
MS. MULKEY: Right. That --
(END OF TAPE)
MS. MULKEY: -- you have the phone, if you will, and I'm wondering -- and I don't know whether you would have insight into this, but maybe somebody will -- whether there is a connection between being eligible for data compensation and exclusive use and RES activity to disclosure at all?
I understand that there's a difference between who the submitters are. But if part of the issue of trade secret is a fear that competitors will too readily take advantage of the good idea of an inert, and if these are, you know, entitled to some marketplace protection derived by the exclusive use, I'm just asking whether anybody thinks that disclosure is more palatable in a --
MALE SPEAKER: Are you saying is there a difference between a discovery company and a generic company, or between pesticide registrants in general and other companies that might be manufacturers of inerts only?
MS. MULKEY: I think what I'm asking is, is if -- well, let's just take new inerts as a sort of simplifying question. If they were clearly eligible for exclusive use by data compensation, would that have any effect on the system RES activity to disclosing them?
MALE SPEAKER: I would think not, but we ought to more broadly test that question.
MS. MULKEY: I think Jeannine then had the next card?
MS. KENNEY: Well, listening to the public commenters sort of -- and in listening to Steve and Bill comments, something sort of struck how much that we require Steve's company and Bill's company to label Cannola oil in their products, which you would generally believe is pretty safe to consume. And yet we're having a discussion about whether or not we should disclose ingredients in consumer products the safety for which has not been established.
And that's sort of a troubling concept to me. I think this is something the agency needs to resolve sooner rather than later in addition to establishing the safety of these products. But just to put this into perspective, that just seems, you know -- and this is not a religious subject to me. But it just seems really, really strange for both EPA and FDA to have these sort of conflicting policies where you do have this troubling difference of a safe food product versus a potentially unsafe -- or maybe safe, we don't know -- ingredient.
MS. MULKEY: Any further input on this set of topics? Yes, Marion?
MS. MOSES: I just wanted to very quickly mention something I thought of when Warren was congratulating EPA, and I think that's fine, you know. I guess every once in a while we should stop driving you guys.
But he mentioned about the fact working with poison control centers and whether people get ill or whether people don't get ill. And I think this is one of the single biggest problems we have, that people feel that what I want to know about this from this label is what might happen to me immediately, or some acute effect, which has been really the basis of a lot of pesticide regulation.
And I think -- and I want to -- I had already said what Jeannine said earlier, and I want to say it again. Whenever I hear that -- I mean, I know that we have to label products in such a way that people can avoid immediate harm, and know what to do if something immediate happens.
But I frankly don't think that that's the really big problem. I think what we're really talking about are possible long term effects from very low levels of continuing exposure over time for maybe multiple different sources. And that is my main reason for being concerned about what's on the label.
And I want to respond to something that Paula said or people are mentioning. I don't know if this is a good idea or a bad idea, but I was thinking of -- I think they kind of do this in food labelling, but I'm not quite sure.
If something is below a certain percent, don't they just have to say maybe what the group was, or the chemical group was, and they don't have to actually give -- I don't know if that's a good idea or not a good idea. But if that's something that people think about. It hasn't been brought up, but I guess that's sort of what -- is that what you're talking about, Paula?
MS. PAUL: I'll take a look at it.
MS. MOSES: Yeah.
MS. MULKEY: I think that is the FDA model.
MS. MOSES: Um-hum.
MS. MULKEY: Or something close to that.
MS. MOSES: Well --
MS. MULKEY: Go ahead.
MS. MOSES: I just want to make sure that this whole risk thing that people are concerned about is not it's just going to make me sick right away. That is of some concern, but if that's the only thing we had to be concerned about, well, then we could be very happy with what we've got right now, I think.
I think it's really the long term potential of effect and putting -- particularly children. You know, we haven't talked about children for quite a while. But if we're talking about the home products, we know that the home products have the highest percentage of inert ingredients, and we know that those are also the ones where children are going to have the most exposure.
MS. MULKEY: Um-hum.
MS. MOSES: So I just wanted to make that point. Thank you.
MS. MULKEY: Carolyn?
MS. BRICKEY: Yeah. I don't think we've given you any advice about these options. I read these options the first time last night about 10 o'clock and I fell asleep as quick as I could right after I read them. So I don't really -- you know, I haven't thought through enough what all the public policy implications are of one option versus another.
But if the idea is that more people will develop and submit data because they have this data comp protection, then it seems like the broader option, which I guess is option three, is the one that would most further that objective.
Do you have a time line for when you want feedback on these options or what your next steps are?
MS. MULKEY: Well, that's a perfect segue to the set of points I was going to make next, which is that an advisory committee is sort of the -- if you're going to tier the value of an advisory committee sort of it's valuable but the first tier is when each individual takes his opportunity and tells us what they think, that's useful to us and we welcome that.
But you get well up into these higher order tiers when there is some synergy or interaction that occurs and that the sum of the advice is more valuable than its parts. And we begin to have that -- begin to emerge on this disclosure issue. And I don't mean by that to leave the impression that the bias toward disclosure that we may have begun picking up made it more valuable. And we understand that there are stakeholders who are as the public but not necessarily at the table who might have pulled it back, but just the fact that you began to see some synergy occurring, and some ideas that were more than the sum of a set of individual ideas.
Paula's idea of a work group around that topic seems to fit with the notion that there is this synergy. I also sat here thinking about that on all these topics, although you've been very forthcoming, you may very well want to marshall your thoughts, even individually, and find some way of articulating them real time.
Because you know we have pending petitions. You know we have real discussions we have to make. And I've been a little disappointed that we haven't heard more from you about this question of just how important is this topic from a workload point of view relative to other things. I would think that there are very different stakeholders who might have common ground on that issue. We would rather you be working on, you know, actives instead of inerts. And that might very well be true well across the spectrum of concerns and interests about actives.
So I was sitting here struggling and would wonder if any of you have any suggestions about the next steps in terms of harvesting your advice. Would you like, for example, us to hold the record open for a couple of weeks -- we don't have to answer these questions right now; we can focus on them in the ministerial part tomorrow -- so that you can sort of supplement your oral reactions in writing.
Would you like to see work groups on some of these topics, and if so, which ones. Would you like to see something short of a work group? Well, it would have to be styled as a work group, but it's not really a multi person -- maybe two people put together something and, you know, share it in a paper exchange.
So I think that we're -- we want you to be -- you're putting a lot of work into this. You're taking a lot of your time. We're putting a lot of work into this. We would like to maximize the effectiveness of this kind of exchange, and I think we would like some ideas. And if you want to save those until tomorrow, that's okay. If you have instant reaction to those questions, that's okay, too.
While you're thinking about it, let me do my -- what I think is my last ministerial task from today, which is to see if any member of the public who didn't understand they needed to sign up or neglected to, would like to participate as a public commenter today. But we'll have opportunities again tomorrow.
MR. SESSA: Hi. My name is Carmine Sessa. I'm with Roddia. It's a chemical company and we manufacture inerts. And just on your comment regarding work groups, I don't know that there is anybody on your committee that actually is from an inert company. So I would recommend that.
MS. MULKEY: We have been mindful that we did not necessarily have a representative committee on this topic. We've been trying to react to that.
Ann reminds me that everybody may not understand that a work group does not have to consist solely of existing members, and it can include persons and entities that are not -- not only not themselves on the committee, but that don't have an analog on the committee.
FEMALE SPEAKER: (Inaudible) -- talking about a work group?
MS. MULKEY: Sure.
FEMALE SPEAKER: I just wanted to make you aware that we do have an ingredient information work group as part of the CLI. So I would say if there is another work group formed that they should try to coordinate those efforts, or work as part of that group.
MS. MULKEY: And that partnership includes governmental entities and industry and EPA, I believe. But essentially the membership of that partnership.
Yes? We're not going to -- we'll do this and then we'll stop.
MS. SMITH: Cindy Smith, again. This sort of is a reality check to all of this. There was discussion earlier about data call in options. It's important to remember that within the inert ingredient area there are a number of commodities. And the producers of those commodities are not necessarily the producers of any pesticide.
So if you were going to issue a data call in, you have to say who receives the data call in. And if there are ten producers of a commodity chemical, and two choose to participate, then do you then reward the eight who chose to not participate? And if you're not the registrant, how do you compel an unrelated company to respond on your behalf? It may be important to you, but it may not be a high priority for the other company.
Also, with regard to aggregate exposure, I can understand how the Food Quality Protection Act came into being, but I'm not sure that the authors really understood the consequence of they wrote.
MS. MULKEY: I'm sure you don't. You're the only person in America who thinks that.
MS. SMITH: I have personally be in a situation where you have to gather aggregate information for a product you don't produce. Even if you did produce it, you probably sold it to a distributor. The distributor knows how much they sell, but they don't know how the end user actually uses it.
So how do you measure exposure of a product -- or an entity that is so far removed from the producer, and even further removed from the pesticide registrant?
MS. MULKEY: Well, you have some folks at EPA who are saying amen to your difficulty. All right. Well, with that, and thank you again. I think that the public participation has enriched our afternoon.
Larry has something he wants to contribute. I think this is the longest I've ever been in a room with Larry that he -- I will say no more.
MALE SPEAKER: Larry's been quiet, Marcia. I can clarify that.
MR. ELWORTH: One of the things that occurs to me, though, when I look at how much time we've got for ministerial issues on here -- and specifically back to your question, Marcia. In my experience on this and the other two advisory committees with FQPA, I don't think there's any situation in which we've really tried to come up with a consensus on a set of advice to the agency beyond diverse people felt diversely.
And so if we're going to do this, we should just tomorrow que up the idea --
MS. MULKEY: Right.
MR. ELWORTH: -- of coming to some sort of consensus. But to figure out how we would actually do that and what that would mean I think is a somewhat longer conversation that we have time for tomorrow. I think it's worth talking about.
MS. MULKEY: To be even to the point of designing a consensus process you think is too ambitious for tomorrow. Is that what you're saying?
MR. ELWORTH: Well, unless we can come to a consensus quickly. But I'm just saying, we might want to think it through, and I think it's worth queuing up.
MS. MULKEY: Okay. Thank you. Anything else? Very good. Well, that's good. We've earned ourselves a half hour of goodwill, and we'll see you all bright and early in the morning. I believe it's an 8:30 start time. That's an early start time in Washington. Out there, you know, where people produce real things that's not so early a start.
(The meeting was adjourned.)
P R O C E E D I N G S
Friday, January 8, 1999 - Day Two
MS. MULKEY: Greetings. Time to convene. We're very glad to see you hardy souls able to slide through the daunting Washington weather. My husband is in Indianapolis this morning. He said that they had eight inches and were getting four. But they were coping just find. Everybody was out and about. No problems.
MALE SPEAKER: They're more use to it, I think.
MALE SPEAKER: Actually it helped with my commute. There weren't too many people in the way this morning.
MALE SPEAKER: There was less traffic.
MS. MULKEY: I'm pleased to see all of you taking to your seats. Thank you all for rejoining us after yesterday's hard day's work. You can see I'm doing mindless time filling here.
MALE SPEAKER: You just switched the names around to see how long it takes us to find our new seat.
MS. MULKEY: That's an idea.
MALE SPEAKER: It's kind of a test, right.
MS. MULKEY: There's an idea.
MALE SPEAKER: We would be wandering around.
MS. MULKEY: One thing that became apparent to me yesterday in the course of the day was that we left ourselves too little time for the so-called ministerial issues. There is actually quite a lot of discussion that may be necessary and appropriate.
So what I'm hoping is that we can have a little bit of opportunity to squeeze the morning's calendar, but that of course is challenged by whatever time we continue to dawdle now.
All right, we are in session. Steve had already alerted me that he had a little piece of old business, and I think an appropriate thing to do is to call for any issues, concerns, points of personal privilege or old business. And we'll take, you know, five or so minutes to try to accomplish that.
And, Steve, we'll let you start it.
MR. JOHNSON: Well, this is probably not anything new and I just -- I was challenged by your question yesterday at the end of our meeting about inerts and the whole issue of zero sum gain. And certainly this issue of resources is pretty critical. The issue of having available to growers new compounds is even more critical.
And I certainly don't want to get on the bad side of the inerts makers and the whole inerts issue. It is a very important issue. But I would just like to emphasize that in a limited resources situation, continuing to move on new compounds, new chemistries and new registrations, is absolutely critical.
And so if I have a vote in the process, I would strongly suggest that resources continue to be put toward new registrations, and we'll get to inerts when we can.
MS. MULKEY: Well, thank you, for speaking -- you know, stepping up to that issue, which is of course one that we definitely appreciate advice on.
MR. VROOM: I would second what Steve just said, and also suggest that maybe as we get farther into the particulars of how to begin to set a process together to address the inerts concerns, that we also have to remember that those are very real and that those products are also important for the existing and new active ingredients. So it's not like we can ignore them either.
And I would suggest that maybe we think about some creative ways to approach dealing with and resourcing these issues dealing with and including, you know, is there an opportunity to outsource some of that review by the agency.
A lot of the things that we talked about in process improvements for the Registration Division's discussion around active ingredients back and forth over the many years, maybe we could pilot them on the inerts question.
So the other thing you said, other new business or old business, I am reminded that a number of ACPA members who are engaged in the seed treatment business have had some concerns that have been lingering for a long time, principally as they relate to harmonization and the trade of seed internationally as that is treated. And that might be a subject for another PPDC meeting.
MS. MULKEY: Okay. Well, you correctly identified one of those issues that we've tried to focus on and would appreciate help on.
BOB: Just a question. Is this the time when we talk about other topics that we think ought to be discussed at future meetings?
MS. MULKEY: Well, we are going to try to deal with that under the PPDC ministerial issues. So you don't have to assume this will be your last clear chance.
MS. MULKEY: Bill?
BILL: Regarding the full disclosure of inerts, I was kind of thinking a little bit about how it would affect our company. For information for the group, I think there is about 20,000 end use products out there. And of the 20,000, there's probably another 60 to 80 thousand alternate formulations.
And what happens is that when you use an active ingredient, it may come from two or three different suppliers, and they may have different levels in terms of active percent. So you may have to alter your inerts accordingly.
So when you think about disclosure, and I think disclosure is a valid point, especially if we can, you know, save one life or reduce the pain and suffering of someone -- it's important to consider that you may be looking at upwards to 50 to a hundred thousand different formulations and alternate formulations that could vary significantly the percent of the inerts.
Chlorpyrifos is a good example. One manufacturer, 62.5 percent; other manufacturers are 99 percent. You use both actives. You just have to alter the number of the solvents and your multipliers. To try and list all of these, and change labels every time you change supplier, would be probably almost an impossible task.
So somehow we have to maybe think about using parameters or using some kind of percentages of between 20 and 60 percent, or something, if we decide to disclose this information.
MS. MULKEY: Thank you. I think that helps everybody understand some of the complexity of what we're dealing with.
Any other old business or points of personal privilege? Very good. Well, we can then launch into the next topic.
MALE SPEAKER: Marcia, what's a point of personal privilege? Because it sounds like good. I don't want to miss my chance.
MS. MULKEY: Well, this is like if you needed to have a break because you needed to go to the.... As all of you in this business know, the biological pesticides have a much more significant place in the pest management portfolio than they had just a few years ago.
I was myself startled to see what had happened in the ten or so years I had been away from pesticide issues. The chemical issues didn't seem to have changed that much, but the role of the biologicals and the extent of them and the future implications for them has really undergone a major sea change.
And in many ways this is very exciting and positive for all stakeholders. The ultimate OP alternative is probably BT. And in many other ways this approach to pest management is a big part of the future and has been enthusiastically embraced by the growing community in places where it has been available to them.
I think my impression is that the manufacturers, the growers and the regulators are surprised at the pace of adoption of the BT technology in cotton and corn, where it has started and initially been so widely available.
So it makes all of that dynamic, together with the fact that nothing is ever easy. And so even this technology presents a set of issues and challenges to its users, has brought it increasingly to the forefront as a topic with significant stakeholder interest, issues that are not -- around which no perfect consensus instantly formed, and otherwise challenging.
So we have been attempting to work with all the affected stakeholders in several different ways. We have had scientific advisory panel meetings around this. The industry has convened work groups and involved the ILSE experts. And we have registrations and we have the normal dynamic of working through the terms of registration.
And we have felt now for some time that it is time for a more transparent, comprehensive stakeholder involved dialogue around this set of issues. Several of you -- several stakeholders suggested this as an appropriate topic for this meeting. It ultimately became clear that what folks were saying was that they wanted to talk about how we're going to deal with it, rather than the technical details of the answers.
And towards that end, we've prepared a -- well, we started out by working with our colleagues at USDA, who bring to the table, of course, enormous expertise in this area and are appropriately co-leaders with EPA in this area. And we worked toward a very brief presentation for this session about our ideas about a more public process around this.
And we've tried to let all of the stakeholders know that this was an opportunity for us to all begin to increase our transparency around this issue. And I think there's been a very good responsiveness to that so that we expect to hear from key stakeholders, some of whom are represented on this committee, and unlike yesterday's topic, significant ones of which are not actively represented on this committee.
So toward that end, if Janet and Harold -- is he here from USDA -- will join us and we can get it kicked off and then hopefully move into your part of it rather than the government's part.
You're speakers, so you're safe. You may want to introduce yourselves. Nelson?
MR. CARRASQUILLO: Would it be possible for her to sit up front?
MS. MULKEY: So you can see them? Sure. We can move down. We've got plenty of room of here. Steve is stuck in Frederick in the snow, so we can wipe him out. And I'll move down. Here we go.
MS. ANDERSON: Good morning. I'm Janet Anderson and I'm a plant pathologist. I want to say in starting this discussion today that I'm also the Director of the BioPesticides and Pollution Prevention Division at EPA. And beside me is Dr. Harold Copel, who is a wheat scientist, as well as he is the IPM Coordinator at USDA right now and also a professor in North Carolina.
By telling you that we're a plant pathologist and a wheat scientist, we want to tell you about a topic on insect resistance management, and that we're clearly not going to talk about the biology, the ecology and the entomology today. We're really looking much more at process and things like that, and hope that you can work with us on this and provide us some good input and ideas.
We also have, though, with us, that we have asked and encouraged some special participation from some of the outside groups who have worked very closely with us, both on the industry side and on the public interest side. So we're anticipating some extra participation from those groups today and hope that you will find this of valuable, too.
I'm going to start off and give a little bit of background to set it in case all of you have not spent the last few years immersed in BT crop, and then give some time for Harold to talk, especially about some of the exciting things we think that are going on in USDA with some of the future aspects.
And Bill is going to help me out a little bit with an overhead that seems to be kind of curly over there. I hope that you can all read it.
MALE SPEAKER: We have this, don't we?
MS. ANDERSON: No, you don't. You don't have that. It just says on the top of your paper that there are eight registered products. And those are the eight registered products. There is one potato. There is one cotton. That's at the bottom of the sheet. And the other six are corn. So there are six BT corn products.
There is a little bit -- one of them has -- one of these products has field corn. Most all of them have field corn associated with them except one which is sweet corn only. And then there's popcorn on one of these registrations. They are slightly different proteins, but some of them are identical. And it gives you the range and that the focus and major interests have actually centered around corn more than they have around potatoes or cotton.
Resistance management has been an issue that we have been concerned with for a long time. Before these crops were ever registered, we worked with industry in what kind of data we wanted to look at to make sure that we were not threatening BT Microbial pesticides from the loss of their efficacy. We recognize the inherent value of these, and in fact we brought this subject to the very first PPDC meeting. Some of you charter members of PPDC will remember that discussion, and you strongly supported us keeping BTs as a prime and highly safe product, and protecting it by various resistance management activities.
The prime one that you're going to hear about as you listen to this is something called refugia (phonetic). And it's probably a bad term. It really means a set aside of acreage. It's a refuge almost for the insects, and that's kind of a strange thing. I've heard farmers talk about growing bug gardens in a sense.
But it's the concept that you would have an area where the insects that survive in that can breed with any insects that are resistant that come out of the BT treated crops or the BT plant pesticides. So that when they breed, you will have a very, very low probability of having any insects that are truly resistant to BT.
It's one of the foundations of a resistance management plan, but by no means is it the only one. There is a number of elements that we have identified that we think are appropriate in resistance management plans. We've taken that to scientific advisory panels, and they've agreed with us, and the companies have worked with us on those elements.
We have done a lot of public outreach, a lot of public meetings, and held hearings. We've held workshops. We've held some cooperative meetings with USDA for the public. We've written a number of papers. We've certainly read a great deal of literature. We keep in very close contact with an excellent group of academics working in this area.
One of the groups that we work with very closely is something called NC205, written in there. NC refers to North Central. I don't know what the 205 does. You'll have to ask the USDA person. But this group is an excellent group of scientists that was already in place that we could go to and work with on issues related to the European corn borer and resistance management in that crop in corn. And then they've also helped us a little bit with the corn/cotton combination, where you have some insects that are the same.
As Marcia mentioned, we had a SAP meeting last year that had a significant paper that the EPA produced in advance of that. We had a fairly hefty response from the SAP that came out in April. There was a Union of Concerned Scientists book, where they had asked for a panel to work with them and make recommendations about resistance management. And the industry and academics have convened a panel under the International Life Sciences Institute, or ILSE, and they have also been working on a report. So there is lots of material out there.
What this really means is, since we started in 1995, we really learned a lot. And there are differences in the registration. A lot of it reflects that. The other piece it reflects is that in this process when we began, industry makes recommendations to us of how much they think will be adoptive, or the kind of acreage in this particular case would represent.
We looked at it. We agreed. We were all looking at the order of about five percent by the year 2000 or 2001. Well, we're at 15 to 17 percent now in corn, and we could be at 25 percent in next year or the year after. That's dramatically different and it really meant to us that we needed to do some real looking at what we were doing and probably making some refinements to these resistance management plans.
As I said, we've been working closely, especially with the academics and the USDA people at NC205 and others around them. We've been also working very much with the people at headquarters, including Harold and Al Jennings' shop.
And being mindful of all of this, what we're looking at is what are we going to do in the short term and what should we do in the long term. If we look at a short term approach, we are looking for consistency across these various BT registrations, so that it's easier for growers to know exactly what they have to do and then implement it. We certainly have aggressive programs in education so growers will do these various activities that are needed to maintain resistance management plans.
And together USDA and EPA are planning to write a paper looking at the various aspects. We want to issue this paper probably, if we can, in February, and then in early March hold a workshop for all the stakeholders, everyone who is really interested in hearing implementation questions and issues from growers, as well as what we can better do in the future.
We're looking for flexible plans, because it's different in different places and different things are going to happen. We are going to start seeing things like what are called stacking of genes. In other words, more than one BT gene in a crop and how that changes the needs for resistance management.
We are also going to see non-BT genes, something else in that crop that is able to give a very different mode of action and what does that mean for resistance management. We are also looking at -- one of these registrations is for a rather unique protein called Crynine C (phonetic), and we're looking at what the implications are for that. Can we really demonstrate that there is not cross resistance to the other proteins.
So there is lots we are going to see in the science. It's going to change what we need to do. We also have different insects, different crops and different cropping systems, and the pink boll worm (phonetic) situation in Arizona really calls for differences.
So looking to that, we really turned for some help from our USDA people. In the recommendations coming out of the SAP in February, was one that we really work at a regional level. We think that USDA has a great idea. At least we think it's a great idea. And we would really like to start off and have a little discussion from Harold about these virtual centers they're talking about.
Hear a little bit more about it. And then Marcia, do you want to hear from industry and the public interest groups before we have comments from PPDC?
MS. MULKEY: I guess we may want to do that. We'll take the consensus of the group.
MS. ANDERSON: Okay.
MS. MULKEY: But let's finish with Harold.
MS. ANDERSON: Okay. So, Harold?
MR. COPEL: Okay. Thank you, Janet. There's one more hat that I wear that hasn't been talked about, and that's that I'm a grower. And I can tell you that that colors my attitude quite a bit on these issues.
One of the main things that I see if that we need to maintain some flexibility in these types of programs. This is a wonderful technology. From my perspective as a grower, we want to preserve that technology. And we also want to preserve the other uses of BT. We understand, you know, the interactions of that.
My colleagues as growers also understand the need for resistance management programs. So don't think we don't understand that as growers, and that's one of the reasons we're using so much of it, Janet, I think.
Also, we understand that -- when I grow corn in North Carolina, I don't have to manage that corn the same way if I were growing it in Iowa or Illinois. Things are different. And the development of information is different. The dissemination of information is different.
And that's one of the reasons that we started kicking around some ideas of how do we decentralize the development and dissemination of information. And the resistance management programs are a really good example of a situation in which we really need to decentralize the focus on an issue, and this issue being resistance management.
So we started talking about the potential for development of what we're going regional pest management centers. And these are not brick and mortar. These are virtual centers in which you put really very little resources into management of the center, except for someone who has to direct it and maybe a couple of clerical people to organize things. So we're not talking about building big buildings and this kind of stuff.
We're also talking about regions that we're referring to as having wavy lines. They don't necessarily go by any geographical boundary or political boundary such as a state line. We're talking more about agro ecological zones with similar cropping patterns and similar weather patterns. Those kind of things that determine management issues such as resistance management. We're looking more at regionalization from that perspective, rather than state lines, for instance.
Certainly there could be some overlap among centers. If we have six or eight centers in the country, surely there will be some overlap for some of the lines that we draw for the centers. We don't know where those lines are yet. We don't really know how many centers we're talking about yet, because we haven't adequately defined those agro ecological zones. But we're talking about probably six or eight various centers to start with.
One of the models that we're considering for these centers is the National Science Foundation Industry University Cooperative Research Center model. There are several reasons for considering that model. It is kind of a virtual center model that involves some support from NSF, and we, you know, would like to garner that support. We know there's going to have to be some support from USDA, and perhaps EPA, Janet, and tap your budget a little bit. But the support coming from government could actually be fairly small.
There is a possibility for industry support and for commodity support. There is membership in these centers that involves all stakeholder groups from industry to environmental justice groups to growers to whoever has a stake in the issues that we're dealing with in the centers. So that's kind of how the centers are set up.
Let's go to that next overhead and give you kind of an idea of what we're talking about doing within these centers. First of all, there is a capability to develop and evaluate new technologies for pest management. This is kind of an organizational structure for scientists and for development of information. We can manage and dissemination information. We can set up web sites. We can distribute written materials. Whatever is needed in terms of the issue at hand.
One of the big issues is to identify and organize expertise. We've just been through a lot of organization and gathering of information in developing crop profiles for the Food Quality Protection Act issues. If we had had these centers developed before we started this, that would have been a much easier task, because they could have gotten that done a lot easier than we could have in a central location. Even though we had a lot of help, and a lot of good help, from states and from commodity groups, we think it would have been simpler had this been a decentralized effort.
They can also provide input for policy and regulatory matters. As we said at the beginning, things are not the same in North Carolina as they are in Texas or in California. And so the regulatory issues and policy issues aren't the same from place to place. And if we can decentralize the focus on these issues, perhaps we can get things done in a little more appropriate manner. And then we can also manage and fund research projects out of the centers.
This is just kind of a thumbnail sketch, an overview. It's really still in the concept stage, and if any of you have any thoughts or ideas on this, positive or negative or whatever, we would be glad to take them.
MS. MULKEY: Do any committee members have any clarifying questions for these folks? The question Janet asked me at the outset, which was ought we to include the sort of key stakeholder perspectives, which would include industry/grower perspective and public interest perspective, before we have a full discussion. And I saw a lot of heads nodding. I thought yesterday's experience probably taught us that improves the dialogue.
So we will do that. But let's take any just sort of basic clarifying questions of these two. They're going to stay around, so this won't be your only change to do that.
Steve, since I started with you, I'll start with Jose this time.
DR. AMADOR: Well, could you be a little more specific on the composition of the center? I mean, who will be the people who would be invited? I mean, we mentioned industry. We mentioned -- how will you go about selecting or inviting people? What will be the qualifying criteria that we use for the people who will be part of those centers?
MR. COPEL: Basically any stakeholder. The model that's out there now involves industry. It involves commodity associations, both local and national commodity associations. It involves environmental groups. It involves government, both federal and state government groups.
So basically any stakeholder could be a part of that group. Now the model that's out now with the National Science Foundation has a membership fee. And I don't remember exactly what that is. It depends on whether it's an industry group or a commodity group or a government group. But it's relatively low, I think.
So basically it's any interested stakeholder can become a part of that center in terms of direction, in terms of setting priorities and those types of issues.
MS. MULKEY: Okay.
MALE SPEAKER: Do you envision the centers having any sort of regulatory role, or just sort of advisory and research centers?
MR. COPEL: They certainly wouldn't have a regulatory role. That's EPA's bailiwick. And they certainly could have an advisory role in terms of developing information that's used in the regulatory process or in policy making.
MS. ANDERSON: Maybe I can just add a little bit. One of the things that we would like to discuss in this March workshop is the concept by which the center might advise what size of refugia and how they would be implemented, etc., would be needed. I mean, the idea of these resistance management plans is just one of the things these centers would do, obviously.
But if you had one in the Arizona area, they might set up and recommend to EPA what ought to be there. And EPA could have enough flexibility in our regulations and registration of these products, such that if this was the consensus of an area, then based on sound science, etc., then that could be what it would be and that would be the resistance management plan for that area.
So essentially they can be flexible enough to set it up. We want to have that discussion with lots of stakeholders in a meeting. Hopefully in March we can do this.
MS. MULKEY: Marion?
MS. MOSES: I wanted to -- when you said initially that you were going to talk about the future, I guess you meant the centers. What I was interested in, what about other products, non-BT products, and also herbicides? I mean, where are they going to fit? Because they are certainly also engineered crops, if you will.
And I was just wondering if you could just give a little idea of where they fit into -- is this strictly a BT thing right now and that's all you're focussing on? And include the centers. I would like to know where that fits in with the centers as well.
MS. ANDERSON: Let me answer the herbicide question. We're talking about what we term plant pesticides. And we do not consider the herbicides as plant pesticides. Yes, the crops themselves are genetically engineered. But what they are, is engineered to resist the pesticides.
Under the pesticide program, what we regulate is the pesticide, so that what we are regulating is the roundup or the Glycephate (phonetic) or Vermoximillan (phonetic) or whatever the herbicide happens to be.
We make a determination whether or not it's allowable to use it on soy beans, corn, tomatoes, potatoes or whatever is the crop. And that's the determination made within EPA. These products of genetic engineering are actually regulated by USDA through the ATHIS program, whether or not it would cause it to be a plant pest. And also by FDA. They look at it for the food supply, as well as EPA.
But it's not a pesticide the crop is actually producing at that point in time. It's actually producing a protein that breaks down the pesticide. So we regulate the pesticidal part, so herbicide tolerate plants are not regulated per se by EPA. We don't regulate plants. They're regulated by other agencies.
So what we're talking about today, we're aiming really at BT resistance management, because this is an area that BT has been recognized as special, unique, its high safety, its use by lots of growers and certainly it's important in organic and sustainable. But used by lots of growers in IPM and other programs.
We don't want to lose that product. It's efficacy out there. And so there have been special measures put forth to protect the susceptibility of insects to BT.
Does that help?
MS. MOSES: Well, I was interested in the resistance. You called it refugia or something? What did you call it in the beginning? What was that word? I never heard it before.
MS. ANDERSON: Yeah. It's one of these unfortunate --
MS. MOSES: Is that what you said?
MS. ANDERSON: It's refugia or refuge.
MS. MOSES: Oh, refugia. Oh, okay.
MS. ANDERSON: You know, we might think of something like a bird refuge.
MS. MOSES: A haven.
MS. ANDERSON: A haven, right. And that's why I like to think of them as acreage set asides. It's a much better idea.
MS. MOSES: No, no. What I'm really getting at --
MALE SPEAKER: A safe haven for the bugs.
MALE SPEAKER: Maybe it's a bug brothel.
MS. MOSES: No. What I'm getting at, I'm interested in what EPA -- where EPA is on this whole resistance management. I understand with BT, and thanks for explaining that.
MS. ANDERSON: Um-hum.
MS. MOSES: But I'm thinking about what if you're using a product more resistant, weeds end up coming and then you have to use more pesticide, which is really against what we're really trying to do.
MS. ANDERSON: Right.
MS. MOSES: And it may -- current products are out there that will control. These may no longer control these other -- so is that something that's part of what you're -- or is that more USDA? I would just like to know where EPA is.
MS. ANDERSON: It's actually a NAFTA -- I'll let Harold speak to that. But there is a NAFTA project right now to try and bring a set of -- voluntarily on labels -- a set of -- oh, it's a numbering system that would tell people you're in this mode of action from using this pesticide. It's a sulfon herbicide that you can tell whether or not they're all in the same mode of action. Because you're looking at a trade name, and a grower may not be able to tell the difference whether or not they're altering it.
So we are trying to -- we have a NAFTA project that will identify by a code -- a numbering code is what we're proposing -- what mode of action the pesticide is, and recommend to a grower that they alternate modes of action. Okay?
This project we are working not only with our Canadian and Mexican counterparts, but there are international organizations that look at insect resistance, fungi resistance and herbicide resistance. And we're working with those three organizations also, so that we're coming up with the same kind of coding system. And some of this is already being accepted into Europe. So it may end up to be quite an international system before we're finished.
MS. MOSES: What part of EPA does this? Who's doing this?
MS. ANDERSON: It's actually --
MS. MOSES: Your department?
MS. ANDERSON: Yes. It's a NAFTA project under a subcommittee that I happen to be one of the co-leads for and one of my staff people here is writing the paper. So we're doing it, but we're certainly working with the Registration Division very actively within EPA. And Jim Jones is a big supporter of this idea, too.
MS. MULKEY: I'm going to let USDA or Harold talk about that.
MS. ANDERSON: Yes.
MS. MULKEY: Because the leadership in that is primarily there.
MR. COPEL: Marion, there's also a lot of information already out there on, for instance, weed resistance. You know, it's not a new issue and growers are aware of it.
You asked about what role the centers might take in this, and the obvious role would be in development of best management plans utilizing these transgenic crops with herbicide tolerance, for instance, or any other type of pesticide resistance, and looking at how is the best way to use these things.
We know that you can't spray every field every year with roundup and get by with it. And growers know that, too. Part of that is going to take care of itself, because any time you use the same product for two or three years in a row, you develop a series of weeds, for instance, that that product is not going to be very good at. So growers are going to obviously switch to something else.
And what Extension mainly is trying to do is to get those programs out to begin with, and let growers understand that you really can't do the same thing on the same field every year. Whether it's using a pesticide, whether it's cultivating, hand hoeing or whatever it is, if you do the same thing every year, you'll run into a problem. And growers understand that.
MS. MULKEY: Okay. Jeannine?
MS. KENNEY: I think this is kind of an interesting and appealing concept, the notion of a virtual center. To sort of follow up on Marion's question, and recognizing that this is still in developmental stages at USDA and EPA, are you looking at this beyond the resistance issues to broader pest management concepts, including FQPA transition issues that are regionally specific?
MR. COPEL: Absolutely. Resistance management is just one and it's a good example of how the centers might function in a broad issue. But we're looking at them as test management centers, not just resistance management, and not even just integrated pest management, but broader than that even.
MS. KENNEY: Okay. And the second question is, obviously as a public interest group we're concerned about balance on these panels. How do you plan to deal with the balance question in terms of membership?
MS. MOSES: What was your question? Deal with the what?
MS. KENNEY: Balance. Membership balance.
MR. COPEL: We haven't gotten to that point, but I can tell you that we believe in diversity on these panels. We like all stakeholder input. And I think you're hearing that from government from top to bottom now in terms of stakeholder input. So, you know, we're going to be wide open to everybody.
MS. KENNEY: And I assume you will probably also include the innovative growers and growers who are relying on BT full year products, not just the transgenic products, in terms of the membership?
MR. COPEL: Oh, certainly. Growers would be the first group we would go after.
MS. MULKEY: Steve?
DR. BALLING: I like to hear you say, first you go after. Six years ago we made a proposal on integrated pest management centers. The centers without walls, as we called them. We didn't have virtual back six years ago.
And beyond the funding issue, the primary barrier to moving forward on that -- and this was in support of the Administration's IPM initiative -- was land grant colleges and the deans, and their concern that there is only X amount of money, so you're going to take our money away and put it into virtual centers that we cannot control.
I'm going to guess that it hasn't changed a bit. So, Harold, how do you propose to get by this one this time? And good luck, because I think it's a fabulous idea.
MR. COPEL: That's a good point, Steve, and I can assure you that I've talked with our dean about that particular issue, and, of course, you know, he's very sensitive to it.
On the other hand, we've got an example out there of a center that has been running for some time and has ended up bringing a great deal more money into that university than it ever cost. In fact, it's no cost to the university, because the money came from somewhere else. It comes from industry. It came from NSF. The money did not come through the normal USDA route.
Now we are talking about perhaps putting some USDA funding into that. We don't know how much. We don't know where it's coming from. You know, we're talking concept, and obviously that's an issue that we'll have to face. We are aware of it.
And maybe six years ago you should have said virtual, Steve.
DR. BALLING: Yeah.
MS. MOSES: You didn't use the right word.
MS. MULKEY: Okay.
MR. COPEL: We did remember that you had done that, believe it or not, and we're going back and saying hey, that was a good idea.
MS. MULKEY: Dan's been waiting a while, so we'll go there and then come back.
MR. BOTTS: I'm going to show my ignorance on this particular issue, and apologize before you even start, relative to going back in history just a little bit and trying to figure out exactly what we're trying to talk about here.
BT products are important to a whole universe of people. And I appreciate the fact that you had registrations of these pesticides in certain crops first. I'm going to put my minor use hat on again, because we ran into an issue when the first sweet corn BT crop came forward, in that essentially our crop was being looked at as the refugia for the field corn crop.
And we were lucky in that the fact where we grow our sweet corn in Florida, even though we still don't have, as I understand it, the BT sweet corn available to us in Florida, we didn't have field corn or cotton or other things where the insect was a cross over or the issue was there.
This whole philosophy, is it crop driven? Is it pest driven? Is it area potentially treated driven? And how does it work? And if we don't design this right, are we precluding the ability of this technology, which reduces environmental exposure to these pesticides by having the plant itself be the vehicle of delivery and not having to worry about aerial application issues or worker protection issues?
Are those kinds of things associated with it? Are we precluding crops from having access to this technology by doing a set aside based on a percentage of acreage? And is that the type of thing that we're being asked to comment about this morning in this whole issue?
MS. ANDERSON: Are you talking about -- the this. Are you talking about resistance management rather than the virtual center?
MR. BOTTS: I'm talking about resistance management.
MS. ANDERSON: Okay.
MR. BOTTS: Which is what I thought this topic was.
MS. ANDERSON: All right.
MR. BOTTS: Not necessarily USDA's organization of how to deal with it.
MS. ANDERSON: Resistance management, we know we actually have -- it's not a minor crop, but we have experimental use permits out for BT tomatoes. And we anticipate -- the one I always talk about is BT artichokes that I expect to come, because 97 percent of the crop is treated with BT and it would make some sense to be doing that.
And we do expect that there will be minor use crops that are definitely going to be coming in with BT. We actually hope there will be lots of other things other than BT that we're looking at as plant pesticides. They may come in with very unique proteins. They may come in with just the same, and we will have to look at where there are insect overlap. How the crop is grown will be definitely considered.
And in the case of sweet corn, you probably aren't -- because you can't use it, maybe you haven't focussed on it. But for sweet corn, we have actually proposed -- we have actually required no refugia whatsoever, because of the particular way this sweet corn in this registration is used. And that is, that it's grown only for processing and it can be closely controlled by the grower. In other words, it's not going into home markets, etc., in the fresh market.
It's only processed corn. They harvest it before the insect can mature, and they dip in the crop so that the insect can never -- will never reach maturity and will never produce an adult, so you don't have a resistance issue associated with it.
And we can work with the various commodities. But it will be true, that just as it is true now where you have already other registrations for the same pesticide, you have to put it all into perspective together. You have to make the whole thing fit in as much as you can and still, in this particular case, protect that --
(END OF TAPE)
MS. ANDERSON: -- under Florida sweet corn production systems in reducing some of the compounds that we spent a whole tremendous amount of issues over the past 12 months in Tolerance Reassessment. If BT sweet corn was available for fresh market production in Florida then the very restrictions you just talked about preclude us from having access to it.
MS. MULKEY: You are going to have to look at ways to do -- for protection for resistance management. And we work -- we work --
MALE SPEAKER: I don't disagree with you, but I -- what I'm saying is --
MS. MULKEY: We'll be glad to work with people on it, but we're going to work on, we're going to consider it.
Okay. Thank you. And now, Larry.
MR. ELWORTH: Well, I think we're -- I am going to just raise an issue on the center thing now. I thought that we'd hold a larger discussion till later.
MS. MULKEY: Um-hum.
MR. ELWORTH: And I would like to congratulate Bill Jordan on a fine job with the overheads.
I guess my question is: Do you all have any idea how much this is going to cost? Have you costed it out even a little bit?
MALE SPEAKER: Keith told me earlier this week to put together figures on that and I'm working on it. I think we can develop eight centers with no more than $2 to $3 million of government funding.
MR. ELWORTH: Are you talking new money?
MALE SPEAKER: Well, there's no such thing as new money, Larry. So --
MR. ELWORTH: Then if we're not talking new money and we've got -- the rough count at the university level on pesticides, we've got a pesticide applicator training coordinator, we've got an IR-4 coordinator, we have a NEPA coordinator, we have an IPM coordinator, each of them with their own relatively small but -- but identifiable funding.
Are you somehow going to deal with that issue at the same time? Because, I mean, the word -- in my -- what I'm wondering about first of all is the money that's being used in those programs useful in this situation and able to be oriented towards this kind of task, and secondly, now do you want a fifth coordinator out there. I mean, because it's a little hard with the four we've got already. You know what I --
MALE SPEAKER: You're trying to --
MR. ELWORTH: We've talked about this. You know what I'm asking.
MALE SPEAKER: You're trying to make me get in trouble with what I'm about to say, aren't you? I see that.
MR. ELWORTH: But I know your dean and -- (inaudible).
MALE SPEAKER: Thank you -- (inaudible). He's here. I didn't see him come in. Keith can talk next.
MR. ELWORTH: This problem has never come up before. I just raised it at first.
MS. MULKEY: This would be a good time to thank Keith for coming today.
MR. PITTS: Let me say that a lot of our attention, since I've come on board anyway, has been trying to get the headquarters shop in order and structured in such a way to deal with FQPA implementation in better ways, and also we're starting to look at a lot more about our technology at the department and realizing we don't have a good strategy in place, and that's also part of what we're pulling into this. And now that we're comfortable where we're moving here in D.C., we are looking at these centers and what we have out there as far as field structure and how we can try and work with those two separate entities right now and make them one.
There's certainly an effort to try and decentralize a lot of what is going on now as far as research programming and look to these centers to try and deal with things on a more reasonable basis. And in doing that, I think we all are going to have to look at the NEPA infrastructure that's out there and a lot of the other four or five folks we may have at one university and see what we can do to maximize there as well. So, that is part of what we're looking at.
MR. ELWORTH: And my reason is -- and again, this will sound familiar, but the reason is not because of some -- you know, some abstract sense of managerial efficiency. But if you just add one more thing to the puzzle, all you're doing is just basically taking a real good idea but taping it to the side of the building and it makes it much less likely that it will be effective. You all know this.
But this may not be the time or the issue on which we deal with this, but at some point, we just can't keep stacking stuff --
MR. PITTS: It's -- the concept of virtual centers has got to work. The two structures have got to work well together. They can't operate independent of each other.
MALE SPEAKER: There is an opportunity, Larry, for some efficiencies at wherever the centers are developed with those programs.
MR. ELWORTH: Yeah, I'm not arguing the idea, I'm just trying to figure out how to do it.
MS. MULKEY: Okay. J.J.?
DR. STEINBERG: I -- this may be obvious, I just want to --
MS. MULKEY: You need a mic because of the people behind you.
DR. STEINBERG: I just wanted to underscore one or two points as it relates to some of the centers. I'm -- I love that there's NSF involvement. In my mind that there's NSF involvement -- and maybe you could speak to that for a few seconds -- this is not historically something that they have bought into in the past and I think that that's great.
In my mind, it almost follows if there's NSF involvement one would expect that there would be university partnership, and clearly, if this is going -- if this is out already as a proposal, I would love to see if the proposal could either be amended or that future proposals include university membership, which when the EPA and other organizations have issued these requests for proposals, they can almost mandate that.
I'd also say just as a plug for all the universities, that if there's any membership fee, they should be waived for the university. I think the bank for the buck that you get in the way of involvement for universities become critical in both the longevity and in the success of not only these centers but in many other centers.
I'd also love to be able to see that -- BT seems to be a very nice part of IPM in general. I'd like to be able to see some of those proposals actually clearly monitor what types. I know that you have a minimum of six variations or -- when you list your IPM in the way of crop management and rotations and other things in IPM. I'd like to be able to see when you have a university center, which of those are being used, how consistently they're being used and we have some sense of outcome as it relates to all of these parameters which is another very good reason to have the universities involved because they, of course, are very sensitive to these altering parameters.
MALE SPEAKER: I agree with you. The universities obviously have to be a part of these centers. Now, please understand that we mentioned the NSF centers as only an example and, you know, we know that they do participate in one IPM center in the country and the opportunity is there to stretch this out to other centers with NSF funding, through the Industry University Cooperative Research Center's Engineering Directorate at NSF.
So, you know, participation from universities is critical. You mentioned the measurement issues and that's one of the big things I didn't talk about earlier, but one of the big reasons we'd like to have some regionalization so we can do a better job of measuring impact of what we're doing.
MS. MULKEY: Anything? Yes, go ahead.
MR. ELWORTH: Just one further thing. And also, I assume that as proposals these would come and therefore there would be study sections involved to look at this. Is that a correct assumption or --
MALE SPEAKER: I think it certainly would be. We haven't gotten that far frankly.
MR. ELWORTH: All right. Because --
MALE SPEAKER: But I'll take that as an input.
MR. ELWORTH: All right. That would be a good input, and they, of course, I assume, would be sensitive again to having universities as partnership. And I think looking at it in kind of that peer review realm would be quite nice and certainly very appealing to NSF.
MALE SPEAKER: Sure.
MS. MULKEY: One thing that's evident is that this virtual center question is an overlapping question with the BT resistance management and that there is a lot of interest in it. I don't want to chill that discussion, but I would suggest that you not only find an opportunity to come back to it here, if that seems appropriate, but that we -- you look for other opportunities. I'm sure USDA is looking for other opportunities, to be sure that it gets the kind of stakeholder involvement that it wants and that we support.
Okay. Marion, and then we'll --
DR. MOSES: Yeah, just real quick. I just remembered reading an article where we've kind of, in terms of the health aspects and worker safety of BT and BT products, sort of maybe had an easy ride for a number of years.
I'm starting to see some things now where this may be some problems, and I'm wondering if -- because these are going to be new proteins and you've got to think of things that might be happening in terms of river exposure, is there going to be any health impact monitoring or any attempt to look at these products, and if so, how is that going to work with NEPA or even these centers maybe, because you mentioned the environmental justice groups.
MALE SPEAKER: We did a risk assessment, a human health risk assessment with this protein for each of these areas of -- there's a test that's made in a -- because it's a protein, it's an acute test, an acute toxicity test made with it. One of the tests we often look at it is digestibility, that these proteins -- most of these proteins break down extremely rapidly. These proteins have been known for an extremely long time. We know exactly how they work, most of them by binding into the -- an insect gut, and again, we're going to get into entomology that I'm not an expert in.
But we've known a lot about them. We did not only human health testing, we did an ecological effects testing, non-targets and beneficial insects when we did the -- before we did the approvals. But they continue to be looked at like any other --
DR. MOSES: My question is proteins and allergens always surprise us.
MS. MULKEY: Yes.
DR. MOSES: And insects have a phenomenal capacity to do things that we don't predict that they're going to do.
MS. MULKEY: Right.
DR. MOSES: As farmers probably know this better than anybody else. And I'm just saying, is there something built into this, that's all.
MS. MULKEY: Yeah. It's built --
DR. MOSES: Not we've registered it, we already looked at it, everything is okay. But what about what might be happening further down the pike and getting feedback into the system if this turns out to be a worker or a human health problem.
MS. MULKEY: Right. Well, as with every pesticide there is a requirement that if any adverse effects are recognized they must be reported to the agency under what's called 682 of FIFRA. And in this particular case, these products all come with an 800 number on the bag of seed for the companies so that there's a direct line of where they can talk to the companies if they have some kind of adverse effect.
And we would certainly be looking at -- the issue with proteins that we most often look at one -- when we've done some of these testings, we're looking at allergenisty, but finding an allergen is an extremely difficult thing as you probably know better than I do.
DR. MOSES: That's why I asked the question.
MS. MULKEY: Yeah. They are tough because it's --
DR. MOSES: Okay. (Inaudible).
MS. MULKEY: Okay. Thank you very much. This would seem to be a good time to frame the rest of our discussion by hearing from some of the key stakeholders who are not necessarily fully represented, and we have some representatives from the folks who are most familiar with these products on the commercial side, and we have one or more representatives from the Union of Concerned Scientists, which is probably the most comprehensively active public interest group in this area, although there are others with an interest. And we'd like to hear from both those groups.
We also have some folks signed up and we'll see how much overlap there is after we hear from whoever is going to speak for each of those two and see where we go from there in order to tee up our round table thereafter.
MALE SPEAKER: May I sign up also?
MS. MULKEY: Yes, you may.
MALE SPEAKER: (Inaudible).
MS. MULKEY: Um-hum.
MALE SPEAKER: Thank you. I'll give this back to you.
MS. MULKEY: Okay. Does somebody want to speak for the industry perspective?
MALE SPEAKER: They're all leaping.
MS. MULKEY: I'm not distancing myself. We're going to try to add another chair here.
MR. DEEBIS: Thank you. I'd thank this committee for the opportunity to present our views on insect resistance management forum, BT 11 Mon 810 (phonetic) and Event 176 based corn products. You've seen earlier a list of the approved corn products.
My name is Ed Deebis (phonetic). I'm Director of Global Regulatory Strategy at Monsanto, but I'm here today representing a group of companies, Novartis, Mycogen, Dow Agro Sciences, Pioneer and Monsanto Dekalb, which currently account for more than 90 percent of the BT corn sold in the United States through more than 150 individual seed companies. We are the industry leaders in this new beneficial technology and for the development of new products in the future.
I understand that the focus of your agenda today is on the process of defining IRM plans. As a result of the events over the past months and years as you've heard described generally and because of our commitments for responsible protection of this technology, we've continued to work to try to find middle ground on
IRM framework for BT corn. I'd like to pause just a moment -- and I know this is a dialogue group and dialogue committee, but the agreement in principle I'm about to mention to you from these -- representing these companies is a very recent outcome, a matter of hours.
So, I'm going to try to stick very closely to the text this morning and I'm not going to be able to go much further in terms of detail due to the nature of finalizing the details that's currently in progress. So, I hope we have your indulgence with respect to that and we'll proceed with the information that I'd like to present.
I'm pleased to report today that this group of companies has reached agreement in principle on a unified industry position on the key IRM program elements for the current BT corn products I noted above. While details are still being finalized, we believe it's important to communicate our progress in this critical area this morning.
This achievement represents, I believe, a new paradigm for industry cooperation and leadership in full support of the economic and environmental benefits of this new technology. Again, some of that you've heard about this morning.
We're well aware of the confusion in the grower community when different companies and organizations communicate different opinions on what constitutes an appropriate IRM plan. Growers want to do the right thing, they want to have confidence in the direction that they're provided. At the same time we want to ensure that our plans are grounded in the science and that they responsibly balance product use with product protection.
Again, while details are being finalized, our group has reached agreement in principle on the following key IRM elements that we believe will lead to a clear, protective, unified IRM plan for BT 11 Mon 810 and Event 176 Based Corn Products: One single protective and practical refuge requirement for the primary corn growing area of 20 percent; one for the corn cotton growing area of 50 percent; a clear and consistent IRM grower agreement; more powerful grower education programs; and finally, appropriate surveys to track grower adoption.
These are key elements on what we have been working on for the last few years in terms of comprehensive IRM plans. All companies have compromised from previous positions to achieve a consensus. All companies are committed to both product adoption and protection of the technology and we will continue to follow this closely in the years ahead both in field support and in research.
Given the evergreen nature of this issue as has been discussed, as additional information and experiences are gained, we anticipate future refinements. We believe that the key IRM program elements that I've mentioned to you will be supported by the stakeholders. Feedback from a number of commodity, seed and other organizations has been very supportive, and we expect that this will grow in the few weeks ahead.
We believe that it meets the interest of EPA in having a practical required program consistent across industry formed by listening to the views of others. We expect that the force of major BT corn seed producers and registrants communicating a set of consistent messages on key IRM messages and elements through numerous channels to the grower community will be effective and will be well-received.
So, I appreciate this opportunity. I'm very pleased to present that to you. It's been an effort that several of us have been working on for a number of years and I really am confident that in the next two months ahead we'll be able to complete the details and complete the conversations with stakeholders and move forward on this issue.
So, thank you.
MS. MULKEY: Thank you for such a meaty presentation this morning. We -- mindful that you're reluctant to go much beyond your remarks in the way of details and that we need a little bit more comprehensive perspective before we embark upon wide discussion, we still should take -- should we just try to limit ourselves here to clarifying questions. And, Larry, are you --
MR. ELWORTH: When this agreement was reached, were -- in the discussions, were the growers directly involved in the discussions?
MR. DEEBIS: We've been in discussion with the grower organizations and local grower groups constantly really over the last 6 to 12 months. You know, there's sort of a first time -- you have to go and take steps through a process and the agreement that was reached this week was an agreement of the companies sitting together and saying we can come together, and there was immediate communication back out to the grower organizations.
MR. ELWORTH: So, this was a meeting of -- just of the companies or was the agency involved?
MR. DEEBIS: It was the first step to reach the conclusion that we can come together on these issues.
MR. ELWORTH: But was the agency in the room?
MR. DEEBIS: Was the agency -- no. This was a meeting -- a group of the companies.
MR. ELWORTH: Just simply the companies?
MR. DEEBIS: Right.
MR. ELWORTH: Okay.
MS. MULKEY: Jeannine? And then Jose.
MS. KENNEY: This is really a clarifying question. Could you read the five elements again?
MR. DEEBIS: Yeah. There were four elements and I will read them again. It's the meat of -- so to speak.
One single protective and practical refuge requirement for the primary corn growing area of 20 percent and one for the corn cotton growing area of 50 percent. Second is a clear and consistent IRM grower agreement. Third is a more powerful grower education program, and fourth is appropriate surveys to track grower adoption.
MS. KENNEY: And by primary corn growing region, I assume you mean the corn belt. But would this apply nationally?
MR. DEEBIS: Generally. But that detail is a detail we are finalizing as we speak and it will be very clearly defined.
MS. KENNEY: And in terms of the agreements, you're talking about a voluntary agreement between the company and the grower, or are you talking about something that would be a regulatory requirement or label requirement?
MR. DEEBIS: We're focusing on the fact that the grower will read and sign an agreement to follow IRM practices.
MS. KENNEY: Thank you.
MS. MULKEY: Thank you. Jose?
DR. AMADOR: I'd just like to get the company view of some of the things that Johnny was talking about, the other alternatives for the refuge, the gene stocking, the non-BT --
MS. MULKEY: Can we hold that a little bit until we get into more of the discussion so that we have all the stakeholder perspectives, since that goes beyond just some clarification of this one. We will come back to it.
DR. AMADOR: Will he be available for that?
MS. MULKEY: Yes. He's going -- unless he gets upset with hanging out with us too long, we're going to ask him to stay at the table through this discussion. Is that okay with you, Ed?
MR. DEEBIS: I'd be glad to, yeah.
MS. MULKEY: Okay.
MR. DEEBIS: I want to point out in those kind of discussions in that particular situation, I want to be sure we understand I'm representing Monsanto at that point, not this coalition, this group of companies.
MS. MULKEY: Right. But even -- I think Jose would probably find your answers, even on behalf of Monsanto, helpful on those subjects. Okay, thank you. Thanks for being patient.
DR. BALLING: I just want to clarify on the refuge. In corn-cotton growing areas then, every grower would have 50 percent of his corn and cotton in refuge by acreage.
MALE SPEAKER: He's talking about corn, I think.
MR. DEEBIS: Let me just -- this is --
DR. BALLING: Corn only?
MR. DEEBIS: This is a corn -- yeah, a corn program. A corn focus program.
DR. BALLING: So, in a corn-cotton growing area, 50 percent of that growers corn would be in non-BT corn.
MR. DEEBIS: Yeah. And there is some --
DR. BALLING: Would he be allowed to spray it or she?
MR. DEEBIS: And there is some detail needed in that discussion which we are finalizing. So, I can't -- I can't go to that level this morning. I hope you can appreciate that. But I can say that subject area is being covered in the detail which we have -- which we are finalizing.
MS. MULKEY: Bill?
MR. TRACY: Just a bit of clarification from the growers' perspective. Like Harold, I sit in kind of a unique position as a cotton grower. I'm here as a cotton grower today, but I served four years as a state regulator, so understand not only the growers' perspective, but being a regulator also.
The grower community fully embraces refugia, totally believes in compliance to make this work and education of the growers. Cotton -- I speak for the National Cotton Council right now. Cotton has in places refugia that has worked. Our concern is that corn's announcement today of these numbers are premature. That Marcia, it's my understanding from the paper that I read that this committee was asking more how to implement rather than the details, and I think that we're getting a little bit ahead of the curve with these announcements.
My concern as a grower is that this is sending the wrong signal out to the growing community in there.
We have an educated group of growers. It's not the public concept of the 1930s rouge with a pitchfork and straw in his mouth, especially our young growers coming back are exceptionally well-educated in our colleges and universities.
So, I do want to send that signal out that while there have been meetings with the grower community and the -- (inaudible) -- the formulators that there is not agreement.
MS. MULKEY: Well, as you know, Bill, part of our presentation was that we do hope to have some meaningful further public process around these issues, and we're mindful that corn is not the only, you know, set of registrations that we need discussions about. Dan's points about the sort of -- the ones that aren't at the table now, but have a future stake, also I'm sure.
But we appreciate that impact and I'm sure the companies are very carefully listening to input from your organization.
Any other -- okay. Well, is somebody going
to -- if you don't mind staying up here and we'll try to add a chair. Would the Union of Concerned Scientist folks like to give us a perspective based upon their long and extensive involvement in this vital issue. Good to see you, Jane.
DR. RISSLER: Nice to see you.
Good morning and thank you for the opportunity to speak. I'm Jane Rissler (phonetic), senior staff scientist at the Union of Concerned Scientists, and we're a non-profit organization that works to advocate for responsible public policies in areas where technology plays a critical role. And as Ms. Mulkey indicated, we have been following the BT resistance issue for some years now.
I'm admittedly thrown a bit off by the announcement about the 20 percent refuges in corn, and I'm thrown off in a good way because if -- depending on the details, and the devil does reside there, this is at least a major step in the direction that we had hoped for in one major BT crop. But I -- I think I will go ahead and essentially make the remarks that I had in mind because we don't know about the devil yet, and I want to try to portray as well as I can how people in parts of the public interest community feel about this problem of BT resistance and the potential loss of BT.
In looking at your charter, it became obvious to me that this committee could make recommendations and UCS wants to urge today that this committee support EPA in moving immediately to strengthen all resistance management plans not just those in BT corn, but in BT cotton and in BT potato. That is that all of these crops should have refuges of 20 to 50 percent, those already approved and those that will be approved in the future.
It is satisfying to be able to acknowledge that EPA has done some good work in the past couple of years. It has taken two important steps. First, after the first registration of BT potato in 1995, EPA subsequently required resistance management plans in all BT crops. Unfortunately, these plans were too weak.
A second good step that EPA took this year was to require substantial refuges in its most recent approvals of BT corn and popcorn. Those were steps in the right direction.
But I'd like to describe where UCS sees the situation with BT, and I think a metaphor -- an overused metaphor -- is apt. And that is that we have felt that Nero, in the form of industry, USDA and EPA are fiddling, and they must stop fiddling before a fire consumes Rome. The metaphorical fire is the evolution of BT resistance and the loss of BT biological insecticides. The dry highly flammable tinder that will feed the fire is the use of BT crops on millions and millions of acres with inadequate or non-existent resistance management plans -- I'm sorry, inadequate or non-existent refuges.
That tinder could have been doused with enough water to keep the fire from spreading if only the fiddlers had listened to the fire experts, the entomologists. Despite the advice of group after group of entomologists, including its own panel that you have heard about today, EPA has not poured anywhere near enough water on the tinder.
The water needed to douse the tinder is the resistance management plan that you've heard about today including large refuges in all BT crops, potato, cotton and corn. Short of banning these crops, the only hope that we have to delay the evolution of resistance significantly is through the use of strong scientifically sound resistance management plans.
There has been a consensus for a time now among non-industry scientists in this country that the current plans in all three crops are not up to the task of delaying resistance. EPA can give you reports, they have been mentioned today. There's its own SAP report, there's a report from the NC205 Committee, there is a -- this summer's revision of the NC205 Committee calling for large refuges. There is the report that we produced that has been mentioned. There is plenty of information from scientists to justify moving now to larger refuges.
Even an industry-sponsored report which has been mentioned in a preliminary draft came out in favor of larger refuges in BT corn.
The situation is critical. We're about to enter the fourth year, the fourth growing season for BT crops planted with inadequate refuges. There's no controversy on this point. Some insects could easily have begun to evolve resistance. The population simply may not have been detected. When insects become resistant to BT toxins in engineered crops, they will also be resistant to those toxins in sprays. Resistance will mean that organic farmers, the best agricultural stewards that we have, and other growers who use spray BTs will lose their most valuable biological insecticide through no fault of their own.
In 1992, the last year for which we have data, BT sprays were used on over two million acres of crops. As Janet said, 97 percent of the artichokes, nearly half the cabbage, and many other high value crops, such as apricots, grapes and strawberries.
The potential loss of BT to organic growers is not trivial. While they do not typically use BT frequently in a growing season, the sprays are often their last resort for intractable insect problems. Moreover, conventional farmers who used BT crops will be back to synthetic chemicals if BT is lost. As far as we can tell, there are no transgenic back-ups nearing commercialization if BT is lost.
We want to be very clear about this. If BT is lost, the full responsibility rests on industry and on the government. The avoidable loss of BT will show the world that the U.S. regulatory scheme is weak, that the Federal Government is unwilling to take the regulatory steps necessary to prevent environmental risks. There are international trade implications here. Already Europe is deeply troubled, to put it mildly, by U.S. transgenic crops in its markets. Failure to regulate, to protect BT will only exacerbate the troubles in Europe and elsewhere.
You have heard today that EPA has held to SAP meetings, it has held hearings here and elsewhere, it has had countless discussion, issues reports, read reports. EPA has heard enough. We don't need more deliberations on process to move ahead in the short term. Longer term discussions or discussions of longer term process, say five years -- beginning in 2005, perhaps we do need to discuss process on resistance management plans after 2005. But if we don't act now in the short term, based on the science that we have now, we may well not have any BT to save in the long run.
What we want to say is don't hold short term necessary steps in BT resistance management hostage to discussions about long term processes. EPA must act now to have strong resistance management plans in BT cotton where they are particularly weak and in BT potato and BT corn.
We believe EPA knows what to do, but it needs political support to do that against very strong opposition. We hope that this committee will help to give the agency the support it needs to make sure that in the short term BT is protected and that discussions about long term resistance management continue apace.
It is time for industry and USDA and EPA to stop stalling, and at least in one regard, as we've heard this morning, industry has that message. That message needs to be extended to all BT crops.
MS. MULKEY: Okay. Do we have some clarifying questions? We'll do that. We do have some other members of the public --
MS. MULKEY: (Inaudible).
MS. MULKEY: Okay. Do you want to submit those for the record?
DR. RISSLER: I can do that.
MS. MULKEY: We can also have them copied so that --
DR. RISSLER: I can read them. I'd be glad to read them.
MS. MULKEY: Well, let's at least take clarifying questions for your remarks and then I think we can look into having her comments copied so that everybody has real-time access to them and see how much more time we need to take up from some other members so we be sure that we get all the perspectives in front of people.
Do we have some clarifying questions for Jane? You got your message across apparently.
Margie, can we get these copied? And while we do that --
DR. RISSLER: I'm not sure they're in good enough shape. I suspect I had better fax them back to you and have you -- yeah. Okay. There's some changes on the back.
MS. MULKEY: Okay. If there's some thoughts there that weren't included in yours, we want to be sure we get them -- (inaudible). If you'll stay with us, too.
DR. RISSLER: All right.
MS. MULKEY: So that if people want to -- I think we have time if we keep it limited, in addition to Ed, we have three other members of the public who signed up to make comments on this topic. Why don't we just hear from them and then we'll sort of close that phase and the committee can then go into a discussion. You can stay here, I think that's fine. They'll come to the mic.
We can start with Scott McFarland of the National Corn Growers Association. It seems like an appropriate perspective at this point to hear from.
MR. McFARLAND: Thank you, Marcia. And again, I'm Scott McFarland representing the National Corn Growers Association, and as it was articulated earlier, I represent a rather confused marketplace. The registrants who have been involved in bringing BT corn products to the commercial marketplace have had different plans, different programs, and it has left the marketplace somewhat confused as to what exactly qualifies as a refuge and what exactly is the appropriate way to sustain this technology for the future.
Corn growers across the country are very concerned and do want to do the right thing and applaud the registrants for coming together in the last couple days and we look forward to more details of what's coming forth. Also, we expect to be involved in what's coming forward. The next elements of your process include grower agreements, grower education programs, grower adoption and tracking who exactly is complying and that is going to be absolutely critical, and without grower organization involvement, it will not occur.
We look forward to discussions and being involved in that process and we look forward to working with the regulatory community at National Corn Growers and the registrants in assuring that the BT technology will be viable for years to come.
MS. MULKEY: Thank you. Allen Noe from American Crop Protection Association.
MR. NOE: Good morning, and thank you. I'm Allen Noe with the American Crop Protection Association and I repeat the pleasure of having the opportunity to come before the PPDC to offer some comments.
We and our member companies with an interest in BT plant pesticides have invested a great deal of resources in evaluating insect resistance potential and in developing a workable and effective resistance management plan. It's important to point out that we view this as a product stewardship issue. There's been no indication to date that could categorize this as a risk issue.
Key to the development of a viable IRM plan is our relationship with our customers. We have a strong mutual interest in creating a plan that's science-based, practical and functional. The needs of growers must be integrated into a workable plan if it is to be accepted and utilized.
We've already devoted considerable effort to the RN plan concept. Since '95, biotech research units of the crop protection chemical industry had supported both internal and external research programs aimed at establishing scientifically sound RNPs for corn and for cotton. These studies are part of an ongoing program that should be viewed and evaluated over several years. In fact, the current RNP research efforts were required by EPA as part of the multi-year program.
The understanding between industry and EPA was that results would be submitted after the '98 growing season for evaluation and recommendations prior to the 2001 growing season. Well, concurrently other suggestions for evaluating resistance and setting standards for IRM have been proceeding and some of these you've heard about this morning, the NC205 working group, the report from Dr. Rissler's Union of Concerned Scientists, now or never, the soon to be released panel report facilitated by ILSE, all of which have been discussed this morning.
Well, in keeping with these proceedings, ACPA strongly urges EPA to allow us the time and the opportunity to fine tune a workable RNP. We support the concept being developed by BT corn registrants that you heard about this morning that will establish a uniform resistance management strategy that promises to be simple, practical and effective, and this includes a plan, as you heard, for grower education and adoption.
Well, part of the fine tuning is a willingness on our part to listen to all stakeholders with an interest in RNPs. But we believe the focus should be on insect resistance matters with regard to BT crops, not peripheral issues such as organic farming or concern about possible loss of BT in conventional spray applications.
ACPA also supports the joint EPA/USDA plan to advance the public dialogue. We believe that USDA can offer to EPA the scientific expertise in agriculture and well establish relationships with the grower community that are really essential to the development and implementation of effective RN plans.
Accordingly, we look forward to participating in the proposed workshop in early March. Meanwhile, we recommend that the plant biotech industry and its customers be given the time, as I said, to develop a workable realistic RN program.
I appreciate the opportunity to comment. Thank you.
MS. MULKEY: Thank you. And Vern Highly?
MR. HIGHLY: Thank you, Marcia. I'm Vern Highly. You've seen me around here a lot. I've been at nearly all of your meetings, hundreds and hundreds of hours, and I don't get paid by the hour either.
But I'm here on behalf of about nine different farmer-based organizations that produce watermelons, asparagus, plums, cotton and one area that grows about 75 different crops in Southern California. I'm going to -- I want to get a copy of these proceedings so I can make a more thoughtful response rather than just being incentivized by hearing some comments sitting in my chair over there.
But I want to say that after all those hundreds of hours that I've sat and heard these deliberations, both here, in TRAC and other where, I'm hearing something that I really think is good. I see something that I think we can really tie into with a positive force, and Janet and Harold, you're going to be hearing more from me.
This is where the whole pest management thing is going to go someday, and I know that a lot of Jay Vroom's members are diversifying and getting into plant breeding and I'm -- it wouldn't surprise me if Jay didn't have a section in his membership sometime for biotech if not already, because they're going to be a part of this as we all move along together with the farmer. We're going to need Jay's group, we're going to need the environmental people, we're going to need everybody is we're going to continue to eat and have the affluence that we have.
And I want to tell you, American agriculture is in dire straits today. You cannot name one major crop element that is not in very difficult financial straits. So, I think we all need to get together and get off the farmer's back and got to decide, and this seems to be an area in which we can start doing some good.
Janet mentioned about the pink boll worm situation in Arizona, and I just want to address that because we're going to be --
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MR. HIGHLY: -- in mass some cotton and get on top of this pink boll worm.
Many years ago, Imperial County in Southern California used to be able to grow about four bales of cotton to the acre, but the problem was that the pink boll worm, there was an open flyway there with Mexico, the pink boll worm would come and lay an egg on the bloom of cotton and the minute that they did, the farmer started spraying. So, it was 25 weeks until that bowl formed. And so, he would spray once a week for 25 weeks. And what happened? We just killed the ecology there.
So, that was 20 years ago, and now we've started to come back and we've changed our farming practices. But then about eight years ago, we got hit by the white fly. But since then, with the help of USDA and an interagency task force and some funds from the Congress, we've made great strides down there in a tremendous area where they can grow 75 different crops. And cotton is a balance wheel to California agriculture which is the number one farm state for output in the world.
Cotton is a balance wheel. If we can grow cotton down there, we can keep out of other areas that -- and not upset that economic balance in cold crops and in vineyards and in tree crops and so forth. And Imperial County has an unemployment rate of about 35 percent. When we had cotton, we had all kinds of employment, a whole herd of industries that come with it in cotton ginning, in compressing, in shipping and so forth.
So, we need your help to help us develop this BT cotton and get on top of the pink boll worm down in Imperial County. And I'm going to go to Keith and ask if they get another coordinator over there in their pesticide shop with Allen and that is a coordinator for biotech. I think we need it. I'll help you. I'll get other grower groups together and we'll help you get some funding for it.
And one other comment. On these centers, be certain that you get the farmer involved in them.
Thank you very much.
MS. MULKEY: Thank you.
MALE SPEAKER: Can I just add something? Vern, you just walked by our biotech coordinator. He's Michael Sheckman (phonetic). Michael, could you stand up. So, you need to talk with him. And he is residing in our shop. So --
MS. MULKEY: Well, there you go. Now, you can claim credit for that Vern. (Inaudible).
MR. HIGHLY: (Inaudible) -- biotech coordinator.
MALE SPEAKER: He here's to help.
MS. MULKEY: Bill? Yes?
MR. TRACY: If I may just footnote a comment that Vern made when he alluded to the pink boll worm program. I don't know how many people are aware of it. The State of California has had a grower supported self-assessing pink boll worm control program in the San Joaquin Valley which produces about 800,000 acres of cotton. This program is 30 years in existence and rough farm -- pink boll worm control is controlled through cultural practices and through certain biological controls and trapping and using synthetic pheromone traps in there.
Through that program over 30 years, I estimate there has been 100 million pounds of pesticides that have not been applied because of this program. It was one of the greatest stories never told about insect control, through cultural practices.
MS. MULKEY: Great, thanks. Well, there is a certain air of optimism in this area infusing all of this, notwithstanding some clear clarion cautionary calls.
One other person has been added and we may as well conclude the public participation on this issue. Mark Keating? Some of you will recognize Mark.
MR. KEATING: Thank you, Marcia.
I'm Mark Keating. I work with the Henry Wallace Institute for Alternative Agriculture.
My comment today is simply in the form of a question and it refers to a subject that a number of the speakers have addressed already, and I'd like some follow-up, please, from Janet Anderson on what EPA is currently doing and what they anticipate doing on the issue of grower compliance with the refugia requirements. There's obviously ongoing discussion about what is appropriate, what's needed, but I'd like to hear more about how the requirements that do exist are enforced. Thank you. V
MS. ANDERSON: Mark, I'll do my best. I think I still want to hear some of the devil and the details and things that will come out of the corn one. But in the particular case in cotton and for potatoes actually, both of these have -- there is only one registration for them and under both of those there is a grower agreement by which they track very closely what growers are doing. They survey a number of growers and have a process of doing -- reporting then to the EPA what is actually happening on the ground. So, that's the situation right now of how that's being tracked.
As you well know, we do have an enforcement organization within EPA. They have a process by which they come up with an enforcement plan and they've never actually done that yet with the BT crops themselves specifically, but they have talked about it, and it's probable out of some of the meetings that we will have -- we've been talking about this March workshop, et cetera -- that it will be possible to come up with some ways of looking at the grower adoption.
You've heard them mention for cotton -- I'm sorry, for corn in the new one, that an aggressive survey to really look at what the adoption rate is in doing these refugias and other resistance management activities.
MS. MULKEY: But as with all requirements imposed by whomever, the issue of compliance is always a challenge. So, it's a good issue to put on the table.
MS. ANDERSON: Maybe Carol could --
MALE SPEAKER: Let me mention also that the extension is very actively involved in outreach in terms of our end programs, and we think that's been very effective, too. So, there's a combination of the regulation and the education going on already.
MALE SPEAKER: Just to follow-up, enforcement is one of the things that I look at sometimes from time to time as part of my work, and I don't know a huge amount about BT, but this situation -- reading about it just gave me the willys from a compliance standpoint. All the factors that make enforcement tough -- it's tough to enforce use by the label. That's one of the things in FIFRA that is hardest to enforce.
When you use something contrary to the label usually there's some bad thing that might happen to you. To you particularly. You might get sick, you might spray your neighbor's lawn and have a liability suit. Some of your workers may get sick. That's not what happens. In fact, good things happen to you if you don't set up a refuge. You don't have to spray that area.
Just -- the whole way this is set up, I don't know how hard it is to detect whether someone is not -- has not set up a refuge. That sounds very -- that sounds a little dicey to me, but I don't know what's going on there.
If -- this whole plan seems to sit on this idea that people will follow the refuge guidelines. You've got to have a compliance plan in place, not just an enforcement plan, but a compliance plan. It's very heartening to hear that you're going to be tracking what actual growers are doing, but with millions of acres in use and enforcement so hard and enforcement in the agriculture sector -- sorry, guys, in the agriculture sector, I know you're all good guys here, but there are a couple of bad apples out there. Enforcement in the agriculture sector historically tough and historically a lot of resistance to enforcement efforts by the agriculture community.
This really worries me, and I'd like to see something from EPA on the agricultural plan, the fact that the guys over in Enforcement and Compliance Systems are thinking about a plan but just haven't gotten around to it is even more worrisome.
FEMALE SPEAKER: Well, let me tell you some of the things that I can have a handle on -- I can't make enforcement do those things. So, one of the things that we've been working with the companies on and talking to some other people about, education is the key, but there are also some incentives.
So, one of these companies has put in place -- that I assume will still be happening, I don't know yet. But for corn, one of them has an incentive package in the way they sell their product. So that you essentially get your non-BT crop with -- corn seed with your BT corn seed when you buy it as a unit. And when you bring it back, if you have extra corn seed, you have to bring it back in that same ratio. So, there's some incentives that way.
There's also a group working on insurance in which they will insure the non-BT acreage for crop loss, and that would be a very powerful one if that's accepted as an activity.
MALE SPEAKER: But it's not enough, is it, as I understand it. First of all, if I have my refuge and I go and spray it with BT, I've ruined it as a refuge even though I'm using non-BT corn. And if I mix my seeds, as I understand it, as I understand the biology, then I have to -- I really have to plant my refuges as separate acreages. If I mix seeds, then I've reduced its value as a refuge.
MALE SPEAKER: You're not going to mix seeds.
MALE SPEAKER: You're not? Okay.
MALE SPEAKER: Never.
MALE SPEAKER: Okay.
MALE SPEAKER: They'd have to treat everything.
MALE SPEAKER: The largers you can, you're exactly right to me. This is the problem of my cow wants to eat, but if everybody's cows eat -- it is the -- the exact -- (inaudible). I mean, the original -- you know, the original problem.
MALE SPEAKER: Right.
MALE SPEAKER: And as Janet just indicated something that's everything from incentives to education. Everyone has -- the only good news is, and I think some people have already mentioned it, obviously there's an incentive not to kill the goose that lays the golden egg if this is a technology that does have lots of benefits and lots of different perspectives.
But -- and the point is this. We have thought about everything from -- okay, for example, even if you had a strong compliance plan from EPA, given that the resources we have to do such a thing, that's probably not going to do it either. So, it's everything from the surveys to the economic incentives. Janet kind of alluded to some registrants may want to take more of that incentive approach as opposed to putting it specifically in the contracts and specifically -- you know, and all those other things.
And I think that's -- but again, other people have already talked about those tricky little things called the details. But that's kind of what all that is about.
So, we're very aware of that exactly for the problems that you mentioned. Even if we did have "a great plan" from headquarters, it's a big country, lots of acreage, as you just indicated, and that's the same kind of problem we have with any kind of label restrictions. The label can be the greatest thing since sliced bread, but what really goes on out there and what's the net impact on the environment and on the food that's produced.
MALE SPEAKER: Yeah. I just wanted to ask -- it's got us all scratching our heads right now that we've got to start thinking differently about how to approach this and I think ultimately they'll be other benefits. But the core issue that's got to be dealt with is having working information available to growers who demonstrate it's the right thing to do and that there are going to be benefits that derive from it.
So, that's a lot of why we have these regional centers being dusted off again and working through that and then having it be something that would be collaborative with EPA and USDA there as well as industry and other stakeholders. I think that's ultimately going to be the key is convincing growers that it's in their best economic interest to take whatever recommendations come out of these processes.
MS. MULKEY: Philip brings an obvious perspective to this issue. We must not forget that the states are critical and essential and basic players on the whole issue of compliance. So, that's a perspective we can hear from now.
MALE SPEAKER: Yeah. I'm concerned, too, about the compliance issue. I'm concerned for a bunch of reasons. We've had discussions for a long time about we're not dealing with label -- well, the agency says we're not dealing with labeling here. Several of us in the states still feel we are dealing with labeling here, which is enforceable.
But, you know, it's a lot more than just set asides. It's practices that have to occur even in the area to maintain the viability of these products. To me, it's kind of like the plant back restrictions that we had on labels at one point. We've only spent 15 years now debating how to deal with those issues. These are a lot more complicated and have a lot more potential to disrupt American agriculture if we don't get it right.
So, I really think the agency needs to go back and think about a strategy. You know, we do 50,000 inspections a year, not all in ag, but a fair share in ag, for use inconsistent for the labeling and I think in general that works. But yet we have no mechanism here that mimics that. It's a little strange to me.
So, I think the -- I really think the agency needs to sit down and think about that. Why do we do and for all of those other products when we have -- you know, and why don't we do something here, especially if this technology is catching on at the rate it is. I think it's a great technology. I think it would be too bad to lose it. But I've been a regulator for 27 years, and I'm from ag, so I know what goes on on a wink and handshake occasionally and I think we need to be concerned.
MS. MULKEY: Larry?
MR. ELWORTH: Well, I want to offer a couple of observations on this, and one is that things have changed a lot since the last time I raised a crop, and when I was still raising apples, we were accustomed to having fairly significant restrictions and demands from the processors and the people that handled our products and we had to meet them because we were selling our product to them. What I hear changing in this is that not only do growers have the demands of their buyers, but now they've got the demands and the restrictions of their suppliers who ostensibly they're customers for.
I think it's a real change in the bach that we're putting farmers in. At the same time, the truth is that the people who are actively going to implement these resistance management plans or refugia or whatever, are not farmers in general, but individual farmers on their individual farms across the country. And because of that, I want to offer a couple of suggestions in addition to observations. One is that I think the agency really needs to seriously consider not just the regulatory impacts that come under the statute, but what this is going to do to farmers and agriculture in general.
I mean, basically, if I'm sitting there as a farmer, I'm looking at the loss of pesticides, an increase in cost for the remaining materials, increased demands on what I have to do with the existing materials or the materials coming down the pike in the future and more control out of what happens in my field being taken out of my hands every day. Now, if that's good or bad, I don't know, but I think it's something an agency needs to consider as they implement any kind of regulation.
I think it's especially important in thinking about that because the people that are going to do insect resistance management are farmers. It's not going to be you guys, it's not going to be Jane or the EPA or the registrants. And so, in that situation, especially given some of the things that Ken has said, the foundation of compliance with pesticide regulations is the understanding in the grower community of what needs to be done, the reasons for it and their full cooperation. I mean, in reality, that's where compliance comes from. You have a compliance and enforcement system to catch the egregious outliers who are regularly violating the law.
But in general, the good things happen because they make sense to the grower community. And I think that means that we have to do more than just education here. I don't think that's really enough. I think it matters who does the education and I think what we're looking at is the application of information and skills on a wide scale to meet both farm -- reasons that exist on the farm, public benefits, environmental benefits and the requirements of the people that have invested in this technology, and that's going to take a heck of a lot more than education. It's going to take a real focus on implementation and on documenting the value of this.
I mean, I think in the long run the best system that's going to come out here is one that strengthens the hands of the farmers, because in the final analysis, they're the people that are going to be doing this, and if it succeeds or fails, it's going to succeed or fail on the efforts of the farmers and not necessarily on the best conceptual structure.
MS. MULKEY: I heard in your comments, at least the -- who does the education is the germ of a recommendation. Do you see these centers as an important part of the answer? Is there something that's not being talked about now that you think is an important part of the answer?
MR. ELWORTH: Well, I think two things are not being talked about. One is it's not just -- I mean, we do pesticide applicator training and it's basically to provide a basic and relatively minimal level depending on the producer -- level of information about how -- what to do and what not to do. This is not just sort of a general understanding of resistance management, which growers may or may not have. This is something that really -- well, we're talking about how do you implement it, how do you document it, how do you evaluate it in your field, and that's a step beyond just basic education.
The other thing that I would argue is here that we've got a real opportunity with BT to do the kind of education implementation work that we're only going to face in spades as we come up with new technology. I mean, we're talking about corn root worm technology that's coming on. We're going to have to take at least as active of steps with corn root worm technology as we are with this. And so, I think there's a lot we can do now in figuring -- and I understand Jane's comment or at least appreciate Jane's comment on not just focusing on process until we all pass out.
But on the other hand, the way we set this up now could be very useful on the succeeding technology. Does that answer you question? Because I'm really talking about implementation and documentation here above and beyond just basic education.
MS. MULKEY: I mean, I'm trying to figure out sort of something I can do about your suggestion.
MR. ELWORTH: Okay.
MS. MULKEY: Is part of what you're saying is that maybe an important focus of this upcoming
workshop would be this set of issues we're talking about now, the issues around whether you want to call them compliance or education or, you know, building of embracing in the grower community? Are you saying maybe we need to put some of our focus there and not just on refuge size and form of the registration and --
MR. ELWORTH: Yeah, I think the way in which this happens -- I mean, I was glad to hear Bill mention the bowl worm project in California because I think that's a model of how you do this on a wide scale with an enormous amount of grower participation with the affected industries involved in it.
I think that, by in large, is the most effective way. You know, I know that some of the grower groups have been looking at this. I think in terms of the credibility within a grower community, their grower organizations have as much or more than people from outside. There must be -- I think there's some way of harnessing that credibility in order to get the practices that you want and need implemented in the field.
MS. MULKEY: Scott, I see you standing there. It looks like you think you can -- (inaudible).
MR. McFARLAND: Yes, thank you. There is certainly one alternative that has not been surfaced yet today and we at the National Corn Growers at the behest of our membership have put together an NCGA insect resistance management education plan and have shared that with all of the registrants at two -- at least two meetings and have solicited their input and perspectives and we are moving that forward through our process.
We've also applied for different types of monies to help support that type of educational program and we are looking forward to putting that into play. Not just educating National Corn's 31,000 members, but all people who are growing commodity commercial corn here in the United States. And we looked at that to be the model, not just for BT, but we want to have success and experience with BT education and emphasize the responsibility the grower has in making sure that he is managing that technology correctly, but also as the prototype model for the additional technologies that are even more exciting for corn growers to take advantage of in the future.
We are very engaged in this issue. We have a very constant and open dialogue with the registrants and look forward to going with the registrants to the regulatory community to demonstrate that the nation's corn growers and the nation's farmers can comply with these types of programs once they are educated via institutions and organizations such as extensions and the virtual centers that you discussed today, but also from the grassroots, heads-on approach that NCGA and growers like the cotton growers and soy bean growers can do as well.
MS. MULKEY: Okay, thanks. Carolyn?
MALE SPEAKER: (Inaudible).
MS. MULKEY: Oh, sure, go ahead.
MALE SPEAKER: Let me just follow up on that. I think what's been brought up by Larry and Scott just recently indicates the importance of all of the players in this telling the same story. As a grower, if I listen to extensions say one thing and marketing say something else from a company, I'm going to go do what I want to do. But if I'm listening to the dealers and the distributors and the major companies and extensions and the commodity associations all tell the same story, I would say, hey, that's pretty good stuff and I'm going to do that.
It's vitally important that we all get on the same track and I think what we've heard here today is the start of everybody getting on the same track with this particular issue.
MS. MULKEY: Just a little -- (inaudible) -- because we have some people here that have been -- Jay?
MR. VROOM: Carolyn?
MS. MULKEY: I intended to skip Carolyn because you guys have been waiting awhile and I was going to come back to her.
MR. VROOM: I -- Larry and Scott have said much of what I wanted to point out which is that from the perspective of the membership of ACPA that we really need to keep in focus the involvement of the growers and other stakeholders as we move forward. And it is absolutely important that we recognize that the adoption of BT technologies in a commercialized sense has gone much faster than any of us expected in the last couple of years.
I know that's caught every -- a lot of people by surprise and it's stressed the system to keep up from a regulatory standpoint, but it is crucial that we get this right because this is just the tip of the iceberg. In fact, I would imagine that in five or ten years that there will be other such dramatic evolutions in -- or evolutions in other technologies for crop biotechnology that we will think of this as a tiny part of what is being contributed.
So -- and I think that this was first emphasized to us, Janet, when we met with you and Dr. Goldman back in August along with a number of the commodity organizations and Dr. Goldman really made that point at that meeting.
I also wanted to clarify a point that was raised in the comments that my colleague, Allen Noe, delivered on behalf of the ACPA Biotechnology Committee, and I just want to make sure that this is clear, Jane, in particular to you. In that statement as I recall Allen said that it is our view that the process going forward here in dealing with IRM right in terms of regulatory approach not be sort of overwhelmed by peripheral issues including BT spray use by organic farmers.
MS. MULKEY: Organic, too. I -- (inaudible).
MR. VROOM: We don't mean to disregard that by that statement. That was probably too much of shorthand and we recognize that that's important, but what we mean to say by that is that we think that there's so much -- so many acres planted to BT resistant groups that that's where we ought to focus in terms of the data that's coming in and use the scientific data there to impact the regulatory decision of -- I don't know, there are what, five or six million acres of BT crops planted, maybe more, and I don't know how many acres there are treated with BT sprays, and most of those are not corn acres, they are other crops.
So, we just don't think that, you know, in terms of scientific evidence with regard to insect resistance that that ought to be the overwhelming consideration, but we recognize that that's important and we respect that perspective, and we are not against the ability of organic farmers to be in the marketplace and to have access to technologies like BT sprays. So, I wanted to clarify that.
DR. RISSLER: I appreciate that. Thank you.
MR. VROOM: Okay. Thanks.
MS. MULKEY: Okay. Jeannine, and then we are going to come back to Carolyn.
MS. KENNEY: Thanks. Well, I am not the staff expert at Consumers Union about this, but I do want to convey that Consumers Union does have very deep concern about BT transgenic crops and the resistance issue predominantly based on our concern about dietary residue -- residue exposure in the diet.
Getting to some of Dan's comments earlier, I mean, if -- obviously, pesticide exposure issues from corn and cotton are not insignificant from the standpoint of water or air or secondary residues from animal feed, but we are very concerned about the loss of BT for use on crops, the -- (inaudible) -- BT for use on crops where there is the potential for significant dietary exposure from more toxic chemicals if this technology is not available.
And I was thinking about this issue, and you know, that I am not the expert, but recalling that in it was either 1993 or 1994 when I was a lowly Capitol Hill staffer, and one of the registrants came in to talk to me about a particular registration issue they were having, and that registrant shall remain nameless. But I raised the issue of resistance being sort of -- (inaudible) -- well, what about resistance, and the answer I got as I recall, it was sort of shocking now as I consider this discussion we're having, and it was something to the effect of oh, we expect resistance, we think we've got eight to ten years and we're working on secondary technologies.
So, thinking about where we were then and where we are now, it seems extremely important to me that EPA work on this problem sooner rather than later. I think the idea of the virtual centers is a very good one. I'd like to see more details obviously. But this is not something you can study for a few years as resistance develops, and I think we share many of the Union of Concerned Scientists' concerns in that regard.
Other things I would urge the agency to do is really look at this issue of compliance that Phil raised. That really concerns me. And another recommendation that we have made is that the registrants submit annual reports on resistance and use and that those reports be independently verifiable, at least certain aspects of them.
But this is a serious concern for our organization and we'd like things to move forward more quickly rather than studying this to death while a problem develops.
MS. MULKEY: We're well past our break time, but if we take the three cards up now, then we might be able to take a break, have a wrap-up on this and get on schedule nicely. So, I think that makes sense since I'm seeing some nods and not too many daggers. Carolyn?
MS. BRICKEY: Well, I'm a member of the National Organic Standards Board, so I feel like I ought to at least represent my board and the concerns that we have about the impact that this particular problem could have on organic production. And I also had a few questions for a couple of our speakers.
Ed, I realize you're not at liberty to discuss the details of your group, that that's evolving, but do you have any time sense you can give us about when you might conclude your work, so that we do know the details?
MR. DEEBIS: Yeah, I can, and it's my hope that we'll have this concluded within the next two months.
MS. BRICKEY: So, you might be able to report back to us at our next meeting about where you've come.
MR. DEEBIS: Yeah. We certainly plan to be in touch with the EPA as we move forward, and we're certainly amenable to all the discussion.
MS. BRICKEY: Okay. And I also wanted to say that I appreciated the remarks that Jane made because I was concerned also about that issue.
Jane, one thing that you could help me out with is, as we look toward this agreement being finalized and the details being provided, can you help us understand what some of the indicators or details are that we should look for in terms of understanding the value of the agreement?
DR. RISSLER: One is that it should be enforced this session, 1999. That's the first thing. We shouldn't delay another year. Second, we need to ask the question about what this 20 percent is. Is it 20 percent sprayed or it is 20 percent unsprayed? Frankly, if it's sprayed, it should be much larger. It should be 40 percent at least if it's going to be sprayed. If it's not going to be sprayed, 20 percent is pretty good. So, we need to look at those details.
The -- I don't know very much about grower agreements, but one needs to look at those in terms of compliance issues. Now, we need to know whether this is going to remain the bottom. For the last couple of years, the bottom of this standard for BT resistance plans has been very low, that is zero required refuges in BT corn up until this spring. It has been no required refuges in BT potato. It has been either 4 percent or 20 percent in BT cotton. That is a very low place to start.
I want to raise that. I want this 20 percent to be the bottom for further movement toward larger refuges if need be.
So, that leads to what are the resistance management refuges going to be when the conditional registrations expire in 2001? So, we not only have to be concerned about this year and next year, but we have to be concerned about this minimum refuge as these conditional registrations expire and as we go into the next two, three, four years of crops.
MS. BRICKEY: And are all the registrations conditional?
DR. RISSLER: The potato is not. There are no requirements for refuges in potatoes and that's what
we -- we would like the agency to go back and make that condition -- that registration conditioned on required refuges.
Now, the conditional refuges on corn, the early ones done in '95, '96, '97, there were no required certain sized refuges. Instead, we were to rely on so-called unstructured refuges, that is random plantings of non-BT corn that would occur for lack of penetration of the market. So, the BT corn and the BT cotton are conditional registrations.
MS. BRICKEY: Okay. And Janet, where is enforcement in terms of coming up with a plan where they could please these outliers that we've talked about?
MS. ANDERSON: I don't know. I can't answer the question. I can tell you though just in explaining the BT potatoes, while there is not a requirement on the registration, there is a grower agreement that is with every BT potato sale that's 20 percent refugia.
MALE SPEAKER: Is that sprayed or unsprayed?
MS. ANDERSON: I don't -- I think it's sprayed because it's Colorado potato beetle and you lose the crop otherwise.
FEMALE SPEAKER: But ask the question, if Monsanto did not want to impose that grower agreement, would it have to? No.
MS. ANDERSON: Not the way the registration is structured right now, and we have been in discussions with the registrant about it.
MR. DEEBIS: There are two points I really need to address first of all as a spokesperson for the group and secondly as a Monsanto person. First as the group, relative to timing, I think this group should be aware that starting in a matter of weeks, the decisions are made for the subsequent year. So, starting in the spring, seed producers decide how much BT and non-BT varieties are going to be produced and available for the programs.
Starting in the fall, the information comes together, the grower guides, the brochures, the agreements go out, growers also make their decisions. Growers also order seed and so forth. So, our urgency is to get this done and get it done quickly in focus to get everything together to be prepared for next year, not 1999. And that's been noted in the SAP and other documents.
The second thing -- and I'm going to change hats over to my Monsanto hat -- I think it's very important because there isn't another industry spokesperson yet that has said anything. Monsanto has had and has developed over the last six to eight years that I've been involved in very, in my view, rigorous comprehensive IRM plans. We have read every piece of information that has been put out on this. We've attended all the dialogue discussions on this issue.
As an individual scientist, I am totally confident in our current plans in terms of a protective nature of those plans and relatively conservative levels that have been proposed in those plans. They are protective and they are conservative in our view. And I am absolutely convinced over the next two years or three years that data and experiences we get in the field will permit us to come back and buttress the cases for lower refuges.
Now, I want to make sure we get that on the record to help balance all the other conversations that have been put out there. We have listened to experts, we have entomology experts. I'm very convinced of that. So --
MS. BRICKEY: And what kind of experience and information do you have already that you can report to us? You've had three -- what, two crop years?
MR. DEEBIS: Yeah. The experience is there's been nothing observed that detracts from the conclusion that I just presented to you. The current plans are effective. For all the reasons we've talked about, we have agreed to move forward in a compromised position at the level that's being worked out, so --
FEMALE SPEAKER: I could rebut some of those things -- (inaudible).
MS. MULKEY: One of the things we were trying to avoid was to talk too much about the science. It is very complex and there are a number of forums in which -- including this workshop -- can have a component that involves that. But the whole question of what the science tells us is itself a very dense and complex set of questions for which both of these people sitting here are expert along with some other people here, but this is really not an expert forum from that point of view.
Steve, and then we'll go to Paula and then we will take a break, honest, folks.
DR. BALLING: A good story that will please Janet, but distressed me somewhat, and that is that we had spoken with a seed company earlier this year about producing some BT sweet corn down in Texas and they told us that, in fact, they didn't have sufficient support staff in Texas to allow us to grow it down there because they wouldn't be able to monitor the resistance management program, which is a good story for you.
However, it's a little bit like the Federal Government telling you they're here to help you. The idea of a seed company telling us how to manage our resistance programs was a little on the scary side and we immediately told them that we could do a better job than they could and just sign the product over and we would be happy to sign the contract to meet any of their needs.
I do have a fundamental concern with removing that layer of control that growers have over their product, and we do have to be very cautious about the way in which seed companies and regulators, enforcement people are involved in that. We've got to find some ways in which those can work well.
The other thing is to -- let's be sure to remember that this is not dissimilar to integrated pest management where the crop, the target pest and the geographical region are very different and will -- and the resistance management program will be very different depending on those three situations. And therefore, again, the concept of virtual centers has great value, I think, because EPA from Washington cannot be mandating how a resistance management program might work in the Imperial Valley versus Florida, versus Texas, versus North Central states.
MS. MULKEY: Okay. Paula?
MS. PAUL: I'll do it quickly. Just a couple of comments that, you know, I'd like to echo Steve's -- the comments he just made that -- supporting the virtual center concept. This is an area that there is a lot of ongoing research. There's going to continue to be.
There's going to be a lot of innovative development in products that we need to have flexibility and ability to react quickly on what the appropriate recommendations are, and it just is something that really can't happen in a regulatory context where there's just really too much process to get the appropriate recommendations into the marketplace. So, the virtual center is a great idea and really the only way that we can manage this in future.
But I also just wanted to comment to raise something you mentioned, Marcia, to make sure that we as -- that we get ahead of the curve as the technology is developing and to make sure in the efforts where we're developing, that we consider sort of new technological developments that are coming along and what the appropriate recommendations would be such as stacked genes, which is probably one of the, you know, best strategies for resistance management, and that we get our recommendations in place ahead of the game so that we aren't discussing this, you know, post product registration and that we're ready so that this should be hopefully dealt with in your March forum.
MS. MULKEY: All right. Well, it's -- Jeannine, can you wait till after the break?
MS. KENNEY: Actually, I just want to clarify.
MS. MULKEY: Okay. Why don't you do it.
MS. KENNEY: Talking about the science of BT resistance in the context of this new agreement -- is the corn agreement -- the agreement that you reached then is not based on a concern by the companies that they do have a resistance issue, but more on what? I guess I mis -- I didn't fully understand your response to that issue.
MALE SPEAKER: Absolutely. We need to be clear on that. It's based on our interest to allow the technology to be used and to protect it for the future.
MS. KENNEY: So, it is based on --
MALE SPEAKER: It's not based on any observable real situation that we're dealing with.
MS. KENNEY: But based on concerns for the future.
MALE SPEAKER: And being able to use the technology to get the benefits.
MS. MULKEY: Okay. Well, thank you. We will take a break. We will try to reconvene as close to 11:00 as the -- about 11:05 at the latest.
(A brief recess was taken.)
MS. MULKEY: Well, we gave you a lot of extra time because we made you work hard and late and long. But the downside of that is that we have created pressure on our time table now. That's always the price you pay.
As I mentioned out the outset this morning, these PPDC ministerial issues are significant and demanding and we don't have a lot of time. So, after a quick round up -- boy, that was certainly not intended to be product reference. After a quick round the table for any unfinished business on BT, and understanding that that might seem quite as satisfying a conclusion of that very rich discussion as would be perfect, we would like to move to these ministerial issues.
We should acknowledge that Susan Wayland has been able to join us again and we appreciate her being here for these key -- this key discussion of whence this committee -- because she is very interested, concerned, committed to the issues relating to whence this committee and may very well want to help guide our discussion on those areas.
So, do we have some parting remarks on BT? Marion?
DR. MOSES: I just wanted -- is the person from the Corn Growers Association still here? No? He's gone.
FEMALE SPEAKER: He left.
DR. MOSES: Okay. Because I had a question I wanted to ask him. Okay.
MS. MULKEY: Okay. Well, we'll try to get your question to him.
MALE SPEAKER: I'm a big fan of adaptive management, which is the idea that when you're making government decisions where there's a lot of scientific uncertainty, you frame those decisions so that they'll teach you more about the system you're dealing with and that they give you feedback. And it seems to me that this area of transgenics and resistance management is just such a situation.
In the decisions to register these pesticides, there ought to be monitoring and programs built in. We should be looking now at things like the genetics of the species, the target species to see if they're changing, so that we understand whether we've made good decisions or bad decisions and so that next time we have to make a decision on a pesticide like this, we'll make better decisions.
And I haven't heard much about that other than sort of an ad hoc, oh, we're going to put these -- we're going to do things and look at things and they'll be researched and there will be foundations. These things ought to be, I think, built in to the registration decisions.
MS. MULKEY: Thank you. All right. Then we can move, I think, to the so-called ministerial issues. That's a very sort of trivializing label for a very vital set of issues.
What we would like to cover in this area, and not in order of importance, the first is the -- a set of questions relating to membership. I'll try to sketch the scope of those questions. The next is meeting planning, not necessarily everybody get your calendars out meeting planning, but some sense of what kind of frequency, scope, topic coverage and approach. We're ready now for feedback about whether the kind of agenda planning that went into this meeting is the kind of thing you want to see.
The whole question of work groups. There are certain specific work groups, one of which emerged from yesterday's discussion as an idea, which is a work group on, as I understood the discussion, inerts disclosure issues or other ingredients disclosure issues. And then just a little bit about how work groups would work and what would happen after a work group, because we have this ecological standards work group which did a great deal of work, reported to us last April and we've, as a group, not done anything with that, you know, not developed a way of sort of taking it to the next step. So, we need discussions around that.
There has been -- there came out of the TRAC some discussion about a feeling in certain significant parts of the stakeholder community, but not of course absolutely every part of it, that USDA and EPA needed to partner more clearly that there needed to be more common accountability to advice and advisory committees and that the TRAC scenario, in which there was a joint chairing and joint ownership was something that had been welcomed and so there are some questions about whether this group could be more effective in that regard. And we don't mean to neglect FDA either in that regard. So, those are the topics.
To kick them off, let us start with membership. We really have sort of two types of issues relating to membership. One is our existing membership. This advisory committee is chartered through September and so there is this committee which runs until September, and then it will have to be rechartered, and although obviously one doesn't -- if one intends to recharter, it doesn't contemplate, you know, terminating all existing memberships and starting entirely from scratch. It is a window in which you can look more fundamentally at the question of membership terms, membership staggering, general scope.
But in the shorter term, and what might affect no more than two meetings at the most and maybe only one, there are issues about whether our existing membership needs any revisiting and that includes the question of whether we have some existing members who simply can no longer serve for some reason or another. Ralph Lightstone, for example, I just learned yesterday -- and it's his seat that Shelly has been taking this week -- has gone to public service. He's gone to the state legislature. I don't think he's been elected, I think he has --
SHELLY: He's been appointed.
MS. MULKEY: -- an appointed position in the legislature in California. So, while we do have state government representatives on the committee, it's not an obvious that you should take somebody who is representative of the farm worker community and say that just because that individual is now in an entirely different role that you'd sustain the individual membership. So, there's that issue.
We gave you a list of all the existing PPDC members. That wasn't just so you'd know each other's names. We hoped that you would look at that to inform yourself about whether you think there is appropriate balance, whether the stakeholders that should be at the table are at the table and have sort of the right people at the table.
We don't expect you to take off with each other about why you're not representative of your organization or something like that, but we thought there might be some argument that there are some significant unrepresented constituencies, bearing in mind that balance is both a legal requirement and a good thing when it comes to organization advisory committees, and balance includes who you represent as well as where you live and what you bring to the table in terms of variety and diversity. We don't want too many entomologists or, God forbid, lawyers regardless of what perspective they represent.
So, all kinds of diversity matter when you're talking about balance and to kick off that membership discussion to see if any of you have any thoughts, it's come to our attention that -- people have -- various people have argued at least with respect to four groups that we might consider some broadening of the representation.
One is the State's Attorney's General who are very different from the State Pesticide Regulatory or State Ag folk who have a big responsibility in pesticide enforcement and also a lot of perspective in these larger areas and who have been very active and interested. It might be a way of bringing more state representation, but get differentness and variety.
The second is that a public interest group with more of an ecological or wildlife focus, not to say that the current public interest membership doesn't care about that, but it is pretty focused on public health issues, and so the possibility of a public interest group with more that focus or a water resources focus or, you know, a habitat focus, that kind of thing.
The third thing that's been pointed out is the small business part of the pesticide industry, especially the manufacturing, distribution as opposed to the use is arguably underrepresented. In fact, if you just count the numbers, the manufacturing component of the industry is arguably underrepresented.
And finally, there has been some feeling that maybe we don't have as robust a representation of agriculture as we might, you know, the growers.
So, those are four groups that somebody, at least, has mentioned as not adequately at the table and you may have others in your mind or you may think that's crazy. One thing that we have learned, I think, is that this is a nice size, that this number of people interacts in a truly meaningful way and that, you know, it's one thing to contemplate adding one, two, three, four. It's quite another to start talking about 10, 15 additions to our current 27. But not to preclude that discussion either.
So, have your thoughts on this set of topics relating to membership. Oh, let me -- finally, one quick thing. I don't want to spend any more time talking then I need to to frame this up. We have done some preliminary thinking about what we would do in September, and our preliminary thinking is that we would reappoint some significant fraction of the existing membership, that is the same individuals, some for one year terms and some for two years terms so that we get some staggering going, and that we take some fraction of the existing membership and turn it over so that we, you know, begin to, again, get some staggering going sooner and begin to get that.
Okay. So, with those thoughts on the table, how about comments? Bob, I saw you go up --
BOB: Well, yeah, and it's just -- it's an obvious comment and that's this meeting differed from any other PPDC meeting or TRAC meeting or FACA (phonetic) meeting that I have seen in that there appeared to be a looser set of rules about the involvement of non-members in the discussions, and I think in some sense, that probably allayed some of the concerns about people who aren't represented on the committee, and that's not to say it shouldn't be expanded, but I think it's less of a problem after this meeting than perhaps in the past.
MS. MULKEY: So, you liked that paradigm?
MS. MULKEY: Quite frankly, we adopted that because we happened to have picked two topics where we felt we had a particularly less than fully representative committees.
BOB: Oh, yeah, I'd say that, too.
MS. MULKEY: But you liked it, you think it's a good paradigm for --
BOB: Yeah, absolutely. I don't know of any reason why it shouldn't be done if there's people with expertise involved.
MS. MULKEY: Jose?
DR. AMADOR: I think that we ought to have some representation from growers. We've got representation from grower organizations, but not, you know, any farmer or grower himself. I think that's lacking. In the TRAC meeting, I think that some of those growers have been very helpful on giving us the views and the things that they have in mind that's important to them.
I second Bob's comment on the looseness of this group. I think it's a good idea to have people like -- you know, like some of the ones that we had this morning that are non-members of this committee to be able to come in and talk to us the way they did. This issue about technology and transgenic crops is going to get to be so important I think maybe we ought to consider having somebody with that kind of expertise also in the committee.
MS. MULKEY: Could you think of a way to have one grower who sort of captures enough of that perspective? I mean, if you do a major group then they don't know anything about minors. Have you given any thought -- even two, I mean, that would really be representative? Do you have any thoughts about that?
DR. AMADOR: It would be difficult to pick, you know, the right person, but I think it can be done. I think, you know, you can look at it in a different way. You can look at it in field crops and you can look at it maybe in smaller crops, a vegetable, which are very, very critical. Maybe one of each or somebody in the field crop area. And I think a field crop person, even though he might be corn or he might be cotton, you know, most of these people usually grow more than one crop anyway. So, they'd be talking, you know, for more than one crop.
MS. MULKEY: Do you think there's any geographic choice of grower that sort of is more representative?
DR. AMADOR: I don't know. I'd like to hear what some of the other people think about it.
MS. MULKEY: Okay.
DR. AMADOR: But I think definitely we ought to have some grower representation.
MS. MULKEY: Okay, thank you. Beth?
MS. MARSHALL: I would like to suggest that it's time to have someone from the organic alternative agriculture, sustainable agriculture paradigm that -- it seems to me that's one of the areas that has been somewhat lacking.
MS. MULKEY: An organic grower? Is that what you mean when you say that?
MS. MARSHALL: Organic and sustainable or alternative agriculture. They're not all necessarily organic growers, but they do have direct interest in alternative technologies of food growing.
MS. MULKEY: Um-hum. Bill?
BILL: I -- (inaudible).
MS. MULKEY: Okay.
MALE SPEAKER: Yeah, my plug is down.
MS. MULKEY: Oh, I see, oh. Okay.
MALE SPEAKER: I would like to support about the organic, the sustainable community representation. I think it is lacking here and I feel that their perspective is very important to have.
Also, in terms of the public interest perspective and within the environmental community, I feel that it is important to have a perspective in terms of the relationship between the urban and rural growth, the interrelationship between one and the other, and an interest group that is -- in terms of its function deals with that interaction will -- I believe will help provide a perspective that is lacking also here in this group.
MS. MULKEY: Are you talking about what we sometimes call the environmental justice community, people who focus on the cities and -- are you talking about the --
MALE SPEAKER: Yes. More or less, yes.
MS. MULKEY: Okay.
MALE SPEAKER: But it is in terms of the relationship between like the urban growth and the rural growth.
MS. MULKEY: Okay. Land use planning kind of -- I don't mean --
MALE SPEAKER: But from the environmental perspective.
MS. MULKEY: Okay.
MALE SPEAKER: Also in terms of the numbers of the groups. I feel there is an adequate number. The only problem I'm having is with the layout. Not necessarily when people are sitting on this side, you can see them when they're making presentations. I believe that is important. So, to consider some other kind of layout so that everybody could see each other.
MS. MULKEY: Maybe some kind of circle if we could do it.
MALE SPEAKER: A circle or something like that.
MS. MULKEY: Um-hum. Thank you. Erik? Wow, the mics are a long way. We weren't trying to tell you anything.
MR. OLSON: I would like to add support to adding a State Attorney General's office. I think that would be an interesting perspective and certainly important on enforcement and related issues. And I'd also add support to getting an organic or sustainable agriculture farmer or organization here.
The other area that we're kind of lacking is with FQPA being so focused on pediatric issues. I think it would be useful to have someone that is from a pediatrician's organization to represent that viewpoint.
MALE SPEAKER: I'd like to add support for the small business member, someone in formulation and distribution. Many of their labels, these small businesses may have as many as 100, 200, 500 labels. So, a lot of the decisions that are made affect them and it's important that they at least have an opportunity to express their thoughts and concerns about some of these issues.
DR. MOSES: I want to -- my first thing to say was an organic farmer or someone who represents organic farming interests or however one wants to do that I think is very, very much lacking. And I don't quite know how to put these two other areas. I think a -- something like a green marketing group or somebody who does alternatives and markets them. People keep talking -- because I really do think entrepreneurial and business groups are really, really important because they know more about what the world is like out there and what --
MS. MULKEY: Are you talking about maybe somebody who sells biological products?
DR. MOSES: Yes.
MS. MULKEY: Is that what you mean?
DR. MOSES: Or runs a store that sells organic food. I mean, I don't know. Some --
MS. MULKEY: So, you're talking about marketing food?
DR. MOSES: Well, either food alternative, does non-toxic lawn care. I mean, there are big companies starting to do that now national -- that are going national, and have someone who's not necessarily committed to chemicals. We need to get the alternative, the other side, what other people are doing. How we do that, I'm -- I just want to raise the issue. I don't know who's best to do that, but I think it's very sadly lacking in this -- in everything that we see, because we know it's there. It's that other side that's not being brought up and I think it needs to be brought up from a producer's point of view, like a farmer, and from somebody who's actually in the business of selling these products. I mean, I think the business aspect of it is very, very, very important. Otherwise, we just get too much academic ivory tower kind of stuff that's not really based in reality in terms of alternatives.
The other thing, I want to support and agree with Erik about the State Attorney General and you had already raised that. I think that's an excellent nomination of a type of person.
And the other thing -- and please people, don't put in the PC, politically correct and all of this, but you know, I'd like to see gender balance. I'd like to see more minorities. And I'm not saying let's just
have them because they're this color or they're that whatever, and I know the world is run by white males and, you know --
MALE SPEAKER: We wish.
MS. MULKEY: Not for much longer, Marion.
DR. MOSES: Well, every group I'm on -- and I'm not saying anything against that, but I would like -- there are really very competent people, qualified people and I talked to you about someone yesterday who I would like to recommend, who -- I think, in other words, I'd like to see more people from minority -- from the minority community here.
MS. MULKEY: I'd suspect you'd get some agreement for that from a lot of people.
DR. MOSES: Yeah. The only -- one other group is -- this may be inappropriate, but it keeps coming up all the time particularly in terms of talking about importers and NAFTA. Wouldn't it be good to maybe have an NGO or some group, not an industry group, but some environmental or public interest group that works on international pesticide issues. Maybe I'm putting it wrong or -- but somehow, I don't think we're really addressing it. It comes up. People worry about marketing residue. But we don't really have anybody that really knows about it or really works with it on a day by day basis.
And so, that's the only other thing that I would like to think about.
MS. MULKEY: Okay. Before we go the rest of the way around the room, and we will, if you've been counting, I think we're probably up to ten different ways in which we could enrich ourselves, which is not to discourage any of this dialogue, but to sort of point out the dilemma we face in trying to think about this.
MS. KENNEY: I think all of the suggestions have been pretty good. I am concerned, however, about the size of the committee. And one concern I expressed to Marcia when Consumers Union was invited to serve on the PPDC was, is this going to be another TRAC where everyone has to make their comment, say everything they want to say in one comment and make a speech because you may never get called on again. And that, I think, in addition to other concerns I have about the TRAC, really limits the usefulness of that forum. I would hate to see this group turn into that.
So, I would just caution that maybe one way to deal with this is as you, you know, rotate membership, address some of these issues. I think also EPA has to grapple with the question of do you have an association representative, you know, who actually works on overall association issues for industry or grower groups or whatever, or do you have an actual member of that association participate or like -- or like person. And I think the concern is that then you run into balance issues. If you have an association representative and then you have a member, you're going to raise balance concerns, at least you would for me.
So, those are just some concerns that I would raise. I really would hate to see the usefulness of this committee decline. I actually really liked Marion's comment about diversity. I think you really do get much different perspectives even within the same community when you encourage that.
MS. MULKEY: Okay, thank you. Jay?
MR. VROOM: I was refreshed when I walked in yesterday morning and realized the size of this table is so much smaller than the TRAC table. It just -- you could actually look across the room and see somebody and recognize them. So, I think what ought to be a very high priority is to keep the size as close to this as possible.
Secondly, with regard to the comment that Bob led us off with about, I think, the value of having outside speakers enrich individual topics is a way to have a larger group without having a larger permanent group.
My only reflection on our experience yesterday and today with regard to the speakers who came to us was that it's obvious that a number of them were anticipated a while ago or even if only a day or two in advance, if we, as members of the committee, could know they're coming, who they are, what they represent, we would spend less time sitting here trying to figure out, well, who is this person and -- as they're introducing themselves. If there's a little advance information about who they are or if there's an outline of their remarks just like the EPA staff provides to us, that would be another enhancement to that.
MS. MULKEY: Okay.
MR. VROOM: And then lastly, I'm not going to ask for more pesticide manufacturer representatives, but with only Paula and I here at the table, I think that we struggle at times to make sure that we do cover all of the bases, but I would not advocate that in favor of any sheer enlargement of the committee. That's all part of the balance and struggle that we all have to go through.
MS. MULKEY: Okay, thanks. Andy?
DR. ANDERSON: Yeah, I just want to underscore if you're going to add members, don't add more than two or three, and if we could -- I mean, you're never going to cover all the bases, and I think it's good to have a smaller sized group.
I also think it's important to have some, you know, be it institutional memory on the committee that the committee doesn't meet often enough, if you're really going to get productivity and working together, it's important -- those that are in Washington may know each other and you may see them a lot, but for the rest of us that aren't here quite as often, I think it's important to forge some of those relationships. In addition -- I mean, it's beneficial outside of EPA to have some of the groups getting together during the meeting.
So, you know, having a one year term where you attend a meeting twice, that might be helpful to you, but, you know, that's -- why not just send in written comments with a picture.
MS. MULKEY: Um-hum.
DR. ANDERSON: Oh, yeah, I remember him. So, I would try to not add too many more people. I think it's important to have other perspectives. We focus very heavily on agriculture. Those have been the issues discussed. I think there are some consumer groups that are more focused on, you know, consumer products in the urban area, the residential area. We have the residential pesticide applicators represented. I think there may be some of those issues that might then lead to additional discussion on the committee than if you were to focus -- that might help with some of the diversity as well.
MS. MULKEY: Okay. Carolyn?
MS. BRICKEY: Yeah, I think I would also just urge you to use the slots that you have available to you to try to do a little more in terms of balancing the group, and I would argue for diversity in the group as well.
I also think it's important that we do bring in outside speakers to bring their perspective in. I thought what we did this morning was very useful, and I thought that it kept the process moving and everybody involved, and I thought that was good. I think that's a good format.
I also urge you to have people on our group make presentations, too. Not me, but other people in the group who want to work harder, because I think that also adds to our dialogue and our talking to each other. I think that's a good thing.
In terms of meeting frequency, you may not be ready to discuss that yet, but I did want to say that I thought the group ought to meet every three or four months or you just do lose that continuity and it's almost like starting over again when you meet again.
MS. MULKEY: Larry?
MR. ELWORTH: Well, I think the general reminders here are for you folks to figure out what is useful to you folks in doing your business as the Office of Pesticide Programs, and to the extent there are people who could offer relevant input on your daily business, I think there are -- or long term business, I think that's the most important part of this.
I do think the way we set up the dialogue this time with people coming in was very helpful. I think it's important that we focus on issues, again, relevant to your daily business. I wouldn't be anxious to increase necessarily the size of the committee. I think it's real important that, again, there be some stability at some level for everybody to have a baseline of information and knowledge about what you folks do.
If the next meeting we have 10 of the 20 some people on here asking what a RED is, then it -- then our value to you -- this committee's value to you is somewhat limited.
I think also if we're going to look at the possibility of moving towards recommendations, consensus recommendations, having a fairly stable group in here that has sort of the same basis of information. If that's where you want to go or if that's useful, then again that argues for a relatively smaller committee that has some stability.
As far as the Attorneys General go, I thought the presentation and the comments yesterday were good. I think if they're willing to bring some of the money they got from the tobacco companies in that settlement to the table, I think that would be a real plus and I would just argue for the Attorney General from Minnesota to be appointed to this committee.
MS. MULKEY: That should be interesting.
MR. ELWORTH: Oh, I think it would be great.
MS. MULKEY: Shelly?
SHELLY: Well, just to clarify, we haven't lost Ralph yet, not quite yet, but he is moving on. And I really think it would be a terrible shame to lose this slot for the farm worker community.
I think that farm workers should have, you know, more than one seat at this table. They are on the front lines of pesticide exposure. Somebody from the farm worker advocacy community brings a lot to this discussion. Really, you know, how all this regulatory stuff plays out in the -- literally in the fields, on the ground, to bring a little practical perspective, I think, is very important, because sometimes it's too easy to think that, you know, everyone reads the Federal Register over coffee in the morning. You know, my folks sure don't.
So -- and also in terms of bringing diversity, which I think is very important, they certainly would. And there are a number of candidates that have a lot of knowledge about pesticide issues, who could really bring the farm worker perspective forward and I would really urge you to add one of them.
MS. MULKEY: Okay. This is some of the most useful input we're getting. But time is moving along, so we'll call on the -- then we'll try to wrap this phase up and cover some of the other ministerial issues.
DR. STEINBERG: Environmental justice, of course, has to be underscored, which a number of people have. In future make-ups obviously, this is an important theme to all of you and it's something we just have to reiterate. I'm going to make a prediction and tell you that environmental ethics, both as it relates to humans and also as it relates to other creatures that have DNA and things like that, will be a larger and larger issue for EPA. Mark my words, within five years, EPA will have standing internal committees simply related to ethics, and as you look at each policy, it will go to a standing ethics committee.
I will be making one or two more predictions. Scientists and academic health physicians, you can't have enough pointy headed academic university based scientists and physicians.
MALE SPEAKER: Oh, yeah you can.
DR. STEINBERG: Let me repeat that. Let me repeat that. You can't have enough pointy headed academic scientists who go back to the lab and broadly think about scientists. If you can bring us a Jane Lupchenko (phonetic) here, if you can bring us an Eea Wilson (phonetic), yes, yet another entomologist, if you can bring us a Stephen J. Gould, this committee would be greatly enriched. Find us those paradigms, people who go back to the lab and the hospital and practice their craft on a day to day basis.
I'm going to make another prediction here. Labeling. Labeling will be one of the great issues for EPA within the next few years. Grab on and hold on to your FDA people because with my dear colleague, David Kessler, they have brought us into the light as it relates to labeling and EPA and USDA will be there in a few years. Again, my second major prediction. I won't make any more.
MS. MULKEY: All right. Thank you. Phil?
MALE SPEAKER: Who's going to win the Superbowl?
DR. STEINBERG: Jim, for you, I'll tell you that later.
MALE SPEAKER: Okay.
MALE SPEAKER: That's a hard act to follow. I want to underscore the size and the diversity issue. I think that's important. I want to remind everybody that this is a Pesticide Program Dialogue Committee. It's not an ag committee, and the drift here is, you know, organic farming and more agricultural concerns. There are very few members of the non-ag committee -- non-ag community here, and we are still affected by pesticide programs and I would advocate what Henry was saying which was we need a little bit more, that this is a pesticide program committee not strictly agriculture. That's all.
MS. MULKEY: And Bill?
BILL: Regarding the staggering of terms, I serve on several board of directors of different companies and I think the most important thing is continuity. I would recommend not only a one and a two year, but maybe a one, a two and a three. That means about eight or nine people would be gone every year and you would keep the majority and you would keep the continuity. It's very important that you stagger terms.
MS. MULKEY: Margie says that the FACAs are only authorized for two years, but you could reappoint approximately. You could accomplish that.
All right. Well, thank you. That was extremely useful. Keith or Susan, do you want to -- or Jim, I didn't mean to leave him out.
MR. AIDALA: I'm just hiding behind Susan.
MS. WAYLAND: You know, I think it was a great conversation.
MS. MULKEY: Yes.
MS. WAYLAND: And I think that we've heard some excellent advice and I thank you very much. In thinking of continuity and stability, which I said would be the watch words for our tenure here at EPA and our transition, I think that those are excellent watch words for this committee, too, and I think that somebody has shown extremely good judgement in having selected you all, because I think these are excellent comments.
MALE SPEAKER: My only comment would be the size. A lot of people talked about size. For a while there, we weren't, but many people talked about that. I think that's -- this is a good size group even though -- and then you have that trade-off issue of how you bring everything to bear with this kind of size.
MS. MULKEY: Thank you. The meeting planning actually illustrates some of the struggles some of you raised as issues. The -- I think that if it were -- I want to be very careful how I say this. If it weren't for the fact that we do have two more TRAC meetings, we would be talking about our meeting schedule in a different way, and some of that's just simply the practical reality of our resources. But, of course, many of you also overlap with service on that and there's also issues on sort of what has jurisdiction over what.
So, we've been operating on an assumption that the next meeting of the PPDC would be after the two TRAC meetings. Not necessarily long after. The last TRAC meeting is currently scheduled for, I believe it's late May. So, we were assuming that we'd start looking, you know, in late June and that by the -- that we wouldn't BE so late that we got into August and had this issue about whether you can do anything in Washington in August.
So, that's sort of our first operating principle. I think we're receptive to the idea that we ought to make it possible to have a second -- another meeting relatively soon after that, maybe September or early October. Of course, we'd have to have a reauthorized charter if it's October, but that's -- we hope and expect to be able to manage that part of the process. It would be awkward to formally schedule something that wasn't yet chartered, but we could try to do some things to position ourselves to do that.
FEMALE SPEAKER: (Inaudible) -- meeting again?
MS. MULKEY: Well, we've been operating on the assumption that the next meeting would need to be after the two TRAC meetings. So, that would be -- I mean, if the last track meeting is late May, the earliest you could be talking about would be late June and probably you're talking about the month of July. That's sort of where we've been operating. Although we're open to any, you know, new way of thinking about that.
We also are -- depending on your feedback and your feeling that we really need to get out of the chute and get this going, we're receptive to talking about aiming toward yet a -- one -- at least one other meeting relatively soon after that. The earliest, of course, would be September. That would be very soon after that. October, more likely. But those are -- that's what we started with based on what we thought were the constraints we were operating with.
So, we need some reaction to that. We also need some reaction to sort of long term frequency planning. Three a year, four a year, one a year? I deliberately didn't go too far outside those parameters, but we could -- we can hear anything you have to say on that.
I've been starting over here every time, so I'm going to start over here this time and move this way. I'll go clockwise for a change.
MR. CARRASQUILLO: If it is possible, if we could set the dates today, that would be helpful. You know, if we could come out of here with the dates, that would be perfect for the next meetings. And for the second question, I would just say that three PPDC meetings a year, that would be more than enough.
MS. MULKEY: More than enough?
MR. CARRASQUILLO: Yes.
MALE SPEAKER: You're on TRAC, too, right?
MR. CARRASQUILLO: Yes, right.
MS. MULKEY: J.J.?
DR. STEINBERG: That -- Nelson is, of course, right. Three PPDC meetings a year sounds right. However, the caveat to that is, I think, what the group needs is development of these working groups, which of course is the next issue. And I think if we could subdivide into smaller groups, focus on some of those areas that require development, obviously there is the public's right to know and that has to be worked out with the working groups.
But then those working groups working at nodal points where they can communicate with the rest of the organization and have some other working documents and agendas that could be worked upon and obviously public comment would be important for those things. But three a year with working groups would be terrific and would be an evolution of this committee in getting things done.
MS. MULKEY: Larry?
MR. ELWORTH: Well, it's interesting you raised the issue of working groups because I think that does have an impact on the number of meetings you have. And actually, I think we need to spend a fair amount of time, and again, this morning is not probably the best time to do it, but you know we've got a pretty checkered history on the way these work groups operated. Some met for a very short period of time, were focused, got done, had a very clear, concise report. Some went on forever.
It's -- if you think it's hard to get people to this meeting, I'm sure you know it's hard to get people on conference calls. So, you have this rolling set of people involved in the conference calls. Rarely were the same people involved in consecutive conference calls.
And the other concern for me in that was, okay, so we've got work groups who report to you about what we learned about ecological standards or you name it, I think we really need to clarify what you folks would find valuable out of work groups and also have some correspondence between what you want and what this group thinks it can provide you. The work -- the idea of a work group is a good idea, but our experience is all over the map with this.
MS. MULKEY: And we'll try to spend a little more time on that topic, too.
MR. VROOM: I would agree that three or four a year is, you know, probably all that could be productive. It ought to be issue oriented and unfortunately I don't think the issues are going to diminish to the point where fewer meetings would be justified.
Marion's gone, but I thought I heard her say yesterday that she was volunteering to convince the San Francisco Regional Office to host us. I'm not sure that if we go all the way to California to meet that I wouldn't prefer going to Fresno or someplace just so we can really prove that we're working. I'm not sure that going to San Francisco sounds like work, you know.
MS. MULKEY: You think it would be suspect if we go to San Francisco.
MALE SPEAKER: Walnut Creek.
MR. VROOM: Walnut Creek, okay. Or Steve, you know, he can help guide us. But the point is I think it would be useful, since we're all together, that some of us might help organize a field trip that might be, you know, optional, but to give an opportunity to see something like the production agriculture around Walnut Creek or Fresno or wherever, or we could go to Kansas City. You've got a regional office there and there's a lot of good production agriculture just on the doorstep of Kansas City.
MS. MULKEY: And it's maybe not a suspicious destination.
MR. VROOM: Right. If you've ever been to Fresno, you know that that's a working town. So --
MALE SPEAKER: In August.
MR. VROOM: In August, right.
MALE SPEAKER: With all due respect, I'm not sure that saying we came to Washington proves we're working either.
MR. VROOM: Right. Are we going to come back and talk about additional subjects or should we mention those now?
MS. MULKEY: Well, work groups and USDA are scheduled, although we're running out of time. So, if you have some concise points you want to include, go ahead.
MR. VROOM: I mentioned seed treatment earlier and another one that I'd like to suggest is a discussion around -- educating us first and then discussing input to the agency on SAP process issues, how do SAP members get selected, how do they get rotated, how are agendas set up, questions posed, and so on.
MS. MULKEY: Interesting. Bob?
BOB: I was going to simply support the idea that fewer than three meetings is not enough. More than four I think is getting to be too many. So, three or four I think is fine.
MS. MULKEY: Wow. All of a sudden, the cards have bloomed. Well, let's -- go ahead, Erik.
MR. OLSON: I just wanted to raise an issue which is with the TRAC going forward, continuing to go forward and this committee, I have -- I just wanted to raise at least a yellow flag about EPA resources dedicated to this. I'm concerned -- we heard yesterday that we're going to be missing the deadline for organo-phosphates and -- (inaudible). I wonder if we're not diverting some of EPA's resources and USDA's and FDA's and whoever else's and ours where they might be better spent -- maybe some of them better spent on actually doing the work that the agency is charged with doing.
It's a counterbalancing consideration that I think we all need to keep in mind, and not the least of which is I'm sure we all have a lot of meetings to go to. But I think we do need to think about whether we're not diverting EPA's resources to the point where the agency can't do its job by having seven major meetings in a year.
MS. MULKEY: Bill? Beth, yes, she has been waiting a while.
MS. MARSHALL: I want to agree with everyone who is saying that three meetings are about right. I also was on a couple of very active work groups and my experience was that with three evenly spaced meetings, it allowed enough time for work groups to actually get something done in between the meetings. So, if we're going to use a work group structure, I think that that's about right.
MS. MULKEY: Okay. Now, Bill.
MR. McCORMICK: This is about future items to meet on.
MS. MULKEY: Um-hum.
MR. McCORMICK: I like the idea of the SAP process and how that works. That would be a good point. I have two other ones. 682, the new 682 reporting rule and what kind of compliance issues we have going on with that and how that information is being utilized at this point, and finally within the registration division, the priority setting process and HED resources that seem to be the limiter on people getting their registrations through if they require HED review.
I think that's holding a lot of people up and if there's a way to get movement on that, that's something I'd like to see us discuss.
MS. MULKEY: Bob?
BOB: Marcia, this -- I've got this long list of things, but I'll confine it to two issues on which I think that input from this committee would be especially productive, and these are, number one --
(END OF TAPE)
BOB: -- not ever talked about or not much talked about in this group. One concern we have as a new partner is ways to create incentives for EPA partners, one, to enter the program, and two, to embrace the program. I think there's a lot of input that could come and a lot of synergy that could occur here in that area.
The second area and one that -- I think EPA is almost notorious in neglecting over the years --
MS. MULKEY: Only one?
BOB: Well, that's probably being a little generous. But the most obvious issue in our minds is the whole issue of applicator training and there was a big effort to get much more involved in that issue some number of years ago.
MS. MULKEY: Um-hum.
BOB: And it was largely abandoned, and again, I think this is a group that could contribute a lot to that discussion.
MS. MULKEY: Okay. (Inaudible) -- I'm going to skip you to go to Carolyn because she's been waiting a while.
MS. BRICKEY: She has a short attention span. I think an interesting topic, and I realize you're going to kind of weigh, you know, what kind of responses you get on different topics, but one interesting topic would be to look at some of the concerns that farm workers have out in the field, what kind of enforcement activities we have going on out there, what kind of complaint responses we're having. I think that would be an interesting thing. Maybe we could have some farm worker representatives come in and present to us or maybe we can do a field trip at some point.
MS. MULKEY: Um-hum.
MS. BRICKEY: And I like Jay's idea of a field trip, too.
MS. MULKEY: Well, this list of topics that you all are generating is very rich. We do letter calls for topics, too, and we're not getting much response. I don't know whether it's just that it's harder to focus when you get a letter call, but we will certainly weigh these suggestions. But let me encourage you that as we do agenda building that you bring some of this -- get these synapses going that you've got going today when we do our -- other times when we're doing agenda building as well.
MALE SPEAKER: One thing that would help is just -- rather than just ask us cold what we might want to think about is to send a proposed agenda with some ideas or options.
MS. MULKEY: And let you react to it?
MALE SPEAKER: So, what we're cuing up is not our thought process abstractly, but here are some agenda things we'd like to look at.
MS. MULKEY: Okay. That's helpful. And it can include this list, for example, on that. And we do some of that. I mean, we have tried to do at least some of that. I think inerts was something we posed to you rather than just garnering from you.
SHELLY: I'd actually like to build on Carolyn's suggestion. I think it might be helpful to form a subgroup around farm worker issues, because I think there are really a cluster of them. The Worker Protection Standard and how well it's being enforced and how adequate it is, you know, presents one set of issues.
I also think there are issues around the registration process, how adequately are these REDs really protecting farm workers, and that we in the farm worker community have a lot of questions about some of the decisions that get made, and I think that this would be a good opportunity for us to present focus reports, if we could meet as a subgroup, you know, and then present to the whole group.
MS. MULKEY: Okay. We'll come back around
the horn here. Well, starting with Jeannine and then we'll -- and then we do need to -- our time is --
MS. KENNEY: I'll be brief. I see an interesting theme developing. The Bill McCormick suggestion on the 682 and Carolyn's suggestion on the farm worker issues. One I'd like to add is something that J.J. alluded to yesterday, which was pesticide poisoning incident data from the poison control centers and how EPA uses that and learn a little bit more about maybe what the shortcomings are and how we can better use that data. I think that's sort of an interesting subset of issues that are fairly weighty.
MS. MULKEY: Thank you. Bob?
BOB: One of the things that FQPA added is authority for EPA to set tolerances for pesticides that are -- whose tolerances have otherwise been revoked, and it seems to me that one of the things that we need to think about as EPA goes through the tolerance reassessment process is that there will be situations where many pesticides are no longer being used, but the residues, because of past use, are still going to be there.
And it seems to me also that it's worth talking about whether there is some way instead of totally, you know, eliminating a tolerance, going from a tolerance that is based on use to a tolerance that's based on the unavoidable residue, so that farmers are not caught in a situation where their product is potentially subject to regulatory action, even though they're not using the pesticide, and I think that would be worthy of some discussion.
MS. MULKEY: Beth? And then we'll try to make this the last sweep on this topic, so we can --
MS. MARSHALL: I'd like to suggest a topic that is water-related. The EPA has a new program called Source Water Protection Program. It's designed to gather information for localities so that they can develop ways to protect the public water supplies. I would think that in the future, this is going to be a pretty significant topic for pesticide users.
MS. MULKEY: Okay. You've got some of our synapses, I can hear them over here.
DR. STEINBERG: I just wanted to refocus on how the -- I'm very pleased with how this group has been working this time. I'm going to give you all very high marks. I think it's been -- I think it's been very nice, very good and very effective. I think the way to capitalize on that remain the work groups, and though I adore Larry, I only need a virtual Larry to really work. And I would recommend that e-mail, not only e-mail but indeed chat rooms as it relates to some of these things, may be a way of transacting business and also fulfilling public information.
I would ask our dear colleagues, the many lawyers at the table, to look into that to see if that fulfills that requirement. But what that may require is some forward thinking and some help from the important computer people that reside at EPA, and I would recommend that not only this group as a paradigm look at that, but that other groups get more technologically advanced in how we transact the business of the group and ultimately the public's business.
MS. MULKEY: So, Jay, instead of Fresno, we'll go to the chat room. We'll take a virtual trip to Fresno.
MALE SPEAKER: They have a great web page.
MS. MULKEY: Steve?
DR. BALLING: Procedure recommendation. When we first started PPDC lots of talking heads and we finally got away from that and actually got to the point of discussion. But at this point, discussion still is not necessarily focused and possibly for EPA, since it is an advisory committee and we should be providing some advice in theory and maybe even trying to achieve some -- maybe consensus is the wrong word -- but something focused, is to look at a more facilitated discussion relative to individual topics by the EPA staff or whoever does the presentation, instead of just -- I mean, we'll talk about anything as you can tell.
So, there is value in trying to focus and really gain some specific recommendations.
MS. MULKEY: Um-hum.
MALE SPEAKER: Sort of focus the questions or -- I mean, a facilitator doesn't make --
DR. BALLING: Both.
MALE SPEAKER: -- amorphous discussion less amorphous per se.
DR. BALLING: Well, you set up a series of questions that you want to answer, and actually some of our material did that and that was very nice.
MALE SPEAKER: That answers the question.
DR. BALLING: But then when we had our discussion, we didn't focus on any of those questions.
MS. MULKEY: Right.
DR. BALLING: So, I don't know if we answered any of EPA's questions. And again, this is not supposed to be informational for us, and I know a lot of us want to hear, wow, I want to know more about what you guys are doing on blah blah. Well, that's not really the point. The point is you guys should be coming up with some of the agenda topics and saying, we have some specific concerns about public policy and how we generate decisions and have us advise on what -- you know, on that.
So, in some ways I think the onus is a little bit put back on you.
MS. MULKEY: That's fair.
MALE SPEAKER: Now, suppose if we cue up the policy issues that are important to you and kind of do them upfront -- I mean, God knows, I love receiving lots of paper, but it would help in those situations to cue up the main policy issues upfront and doing that I think would help focus our -- to the extent that we're familiar or unfamiliar with the issues.
MS. MULKEY: Well, from our point of view, the inerts topic fit that paradigm -- (inaudible).
MALE SPEAKER: Absolutely.
MALE SPEAKER: Um-hum.
MS. MULKEY: Andy?
DR. ANDERSON: I would just underscore, I think it would be very helpful to take a look at some of the evaluation issues or how you are evaluating the effectiveness of the various programs, and I would put into that a broader sense of the surveillance issue of disease as well as exposure. There's a number of data elements out there, the poison centers, there's the 800 numbers that each of the companies uses. I would think it would be worth discussing how can that information be used, how is it being used, is there additional efforts. We heard Jerry Blondell's name used and I think how the -- it would be interesting to -- we could provide some input to you as to how could you use this information to better evaluate or show that programs are, in fact, being effective. Then I'll throw out the last dreaded word, the whole -- (inaudible) -- issue if you're being forced to evaluate and I think we can help you on some of those issues as well.
MS. MULKEY: Jose gets the last word on this and we'll try to focus a couple questions on work groups and USDA so we can --
DR. AMADOR: I'll be right quick. This is related to the last three persons who were talking. I don't want to create any more work for Margie or anybody else, but would it be appropriate that we get a one page or a page and a half of what were the things that we're discussing that are important to you, that you can benefit from. You know, we hear you saying, oh, that's good, but we never know what some of the things are.
MS. MULKEY: So, after the fact feedback you mean?
DR. AMADOR: Well, we're talking about, you know, getting the topics of the agenda ahead of time. I think it would be appropriate to have something after the fact saying what were some of the things that we said here that made an impact on you.
MS. MULKEY: Um-hum.
DR. AMADOR: And that would help everybody on the committee to focus next time, after we get a hint of what are some of the things that you like out of the committee, then we will be better trained, I guess in a way, to see what -- you know, what are things that are important to you. We just -- (inaudible) -- as Larry was saying, you know, what are the things that we can do that are significant.
If we can get it back from you after the meeting, these are the things that were said that were important to us, I think that would be good for everybody.
MS. MULKEY: Okay. Well, based upon our remaining time --
DR. AMADOR: I don't want the whole minutes of the deal.
MS. MULKEY: No problem. No, we understand.
Based upon our remaining time, let me pose two or three questions and see if my colleagues have any questions they want to add to them and ask you to answer those as the last way. We have only two members of the public who have signed up to speak who have not yet, and we have until 1:00 and we'll give them the last 10 minutes. So, we have basically 30 minutes left.
The questions that I will pose to you is: Do you think we should have narrow, very specific subject work groups? Do you have any thoughts about what number of work groups we should have? Do you think we should have two, one, three or more standing work groups, which involve some of you and that might take on a variety of topics over time? In other words, do you like the idea of sub-units of yourself who are, you know, sort of stay together for some cluster of topics?
Do you think we ought to have a variety of types of work groups, the kinds that we do to meet our needs like the rodenticide, the kinds that you sponsor because you see something coming together among you that warrants it, like seems to have happened with regard to the inerts disclosure topic? Do you think the work groups ought to grow out of your meetings or be designed sort of independent of your meetings or prior to you tackling a topic?
So, that's a set of questions about work groups, and I'm sure you can think of others to answer.
And with regard to USDA, other than the obvious, and FDA, are we getting -- one way to ask that question, are we getting it about right now? Do we need -- if we need either greater or lesser involvement from them, what form should that take? What kind of personnel, what kind of involvement, what kind of role would you like to see played? Is it for all purposes or for certain subsets of our agenda?
Do you have any questions that you want to pose to them particularly, Keith, in that area? Bob?
BOB: No, not really.
MS. MULKEY: How about Susan or Jim? Have I put enough questions out there to have this last 30 minute discussion?
All right. Let's let everybody get them up -- so I'm pretty sure you're ready, so I don't have to keep worrying about who's ahead of who.
Well, we'll start over here again. Erik?
MR. OLSON: I want to again raise the issue about resources and numbers of meetings with work groups. I think it probably does not make sense to have a standing set of subcommittees that are just there to discuss issues. I think if there is an important issue that you can focus attention on and you're asking for advice on it, that it makes sense to have a short term, discrete work group just to discuss that and bring a recommendation to the full committee.
I also think that it's very useful to have questions posed to the work group and to this group before the meeting so that we can focus our thoughts beforehand, and I -- having participated in a lot of these EPA sessions, I always find it to -- every one of these meetings -- and this isn't just a criticism of this one -- but most of them tend to be a lot of EPA talking to us and less of us talking back. I think that's a balance you need to be thinking about.
I just think it's more useful to have short EPA presentations for a sort of orientation and then more focused discussion of here are the two questions EPA needs advice on if it is -- there's a dentist upstairs or something -- if it is really an effort to get advice from this group rather than you're educating us.
MS. MULKEY: Paula?
MS. PAUL: Thank you. One of the purposes, I think when this committee was originally set up was to -- with the hopes of identifying areas that there could be consensus rather than having public interest groups and industry groups and other groups sort of hitting EPA individually to try to identify those areas. So, I would like the work groups to support that objective.
But also I think that if -- you need to consider the process that any work group result has to have a benefit to the agency and it has to achieve some result. To come up with some recommendations or thoughts that aren't really going to be used is probably not a good use of anyone's time. So, we should try to identify initially what the end result should be and how we should use it in the end so we all have a target to --
MS. MULKEY: Well, you prompted me to add to my questions, which is, with regard to the work group that has completed its work, the Ecological Standards Work Group, and any we go ahead with, what do you want to see in the way of process coming back through this organization? So, I don't know if you want to speak to that while you've still got the microphone or --
MS. PAUL: No.
MS. MULKEY: Okay. Nelson?
MR. CARRASQUILLO: Yeah. I want to follow up in terms of Carolyn's recommendation. In terms of the organization that I represent, we are in the process of producing a report on research that we have done on the implementation of the Worker Protection Standards, and we are going to be submitting that report within the next month or so to the EPA.
I would like to take on Carolyn's suggestion about sharing that report here with the PPDC and opening it up for discussion as part of the process of sharing the perspective that we have in terms of the research that we have done. And probably to frame that also within the context of the work -- of the work group, that it could be formed, if possible, to address that.
MS. MULKEY: Beth?
BETH: I actually sat on two work groups that had reached their goals. One was the Brochure Committee, the infamous Brochure Committee, and one was the Ecological Standards Committee, which has furnished a final report. Part -- the Ecological Standards Committee, in particular, gathered many outside reports to look at for its members to study and to provide input into what we were talking about, and I thought that was very useful.
There was some confusion, I think, in that committee and some concern about where we go with our recommendations. So, I certainly hope that we can indeed come up with some ideas about the -- what happens to the work that the work group does. But I think it was -- I think having a work group with a specific goal and a limited time was a very effective way to do it.
MS. MULKEY: Ken?
MR. ROSENBAUM: An observation, when the committee first set up work groups, there were how many? A dozen? There were too many, I think, in the beginning. It's a limited committee and having -- sitting on more than one work group at a time really dilutes your ability to participate. So, I'd caution against having too many work groups.
The groups that I have been on, the Ecological Standards Work Group worked not because it was a pressing program that everyone was screaming about, but because there's a very dedicated staff from EPA and a group of folks here who are interested in the topic. And that trading back and forth of interest and momentum carried us through, whereas other groups who had perhaps more pressing topics, but less interested staff, didn't produce much.
So, it's -- I don't know how helpful that observation is, but there it is.
In terms of follow-up, assuming for instance that we, as a group, adopt the recommendations of the Ecological Standards Work Group today, the kind of thing I'd like to see is perhaps a short memo coming back to us in three months outlining concrete steps that EPA intends to take in response to the recommendations and then perhaps a follow-up one a year or so later reporting on what steps were actually taken.
MS. MULKEY: That's very helpful. Dan?
MR. BOTTS: At the risk of being accused of saving up all my comments to the very end by not having said much before, I'd like to take on several of the issues that have been laid in front of us this morning. And as one with a little institutional memory about this process, having been a charter member of PPDC, even for the first year that it was inactive because somebody shut down the government, we've been struggling since day one on what PPDC's function, role and responsibility was supposed to be, intended to be or what direction it was going to be taking.
And we've gone through office administrators and changes in administration that has led to some changes in the focus of PPDC and some of the questions that are on the table today, I think, came as a result of the last TRAC meeting when there was a discussion of the relationship between TRAC and PPDC and how the two committees function either together, separately or in the place of one another.
I'd like to just throw some suggestions out in hopes of making the process work better for both us as committee members and the agency as a way to utilize everybody's valuable resources, because none of us have enough time to attend all the meetings we get asked to go to. I apologize, Margie, if this means somebody's got to do some more work than they're currently doing.
But even the meeting today, this meeting, which I think was a much better meeting because of the interaction that we had from people who aren't specifically on the committee itself, would have been a lot better if maybe once the agenda was set, a small group of PPDC that the agency identified might possibly be interested in those items were given the opportunity to participate in more or less a pre-work group meeting to tee up the issues from their understanding rather than having it presented to us almost as a fait accompli at the end. And it allows us to have more ownership of the process and the agenda.
I don't know how far ahead of time the agendas finally get set up, and I recognize that's a planning issue and some other things, but quite frankly it's frustrating to get a two inch thick package of material over Christmas holidays at a time when you're trying to take the accumulated leave that you're going to lose if you don't take it because you've been attending TRAC meetings and other things, to have to review prior to the meeting to come in.
It would be a lot better if we could have it more or less teed up a more focused framed discussion on those issues, and quite frankly, I think it's up to the agency to -- with recommendations from us as a committee, to set the agenda on what's important to you. Because that's what our job is is to provide recommendation on policy and direction as I understand it from the original charter of PPDC.
As process issues go, having been involved on some of the work groups and spent a lot of times in making inordinate amount of comments at meetings other than this one, I'm a little concerned that we never get feedback on what we've presented.
That goes to Jose's comment earlier as far as, all right, we've had two hours of discussion on this issue and other than what we read in Pesticide Toxic Chemicals newsletters, their impression of what went on at PPDC, we don't get a lot of feedback back on how the interaction really plays out in the policy arena and the rest of the stuff. I'd like to see some way of being sure that that type of feedback was produced.
And the last thing, you asked about USDA role in PPDC. I think as far as the PPDC original charter, the role of USDA and FDA has been at the appropriate level prior to now. If PPDC is intended to replace the older much larger agenda that was put into place at TRAC, then I think there needs to be an increased role by both agencies as it moves forward. Now, depending on how that process works out, it -- that would change my opinion of how those two roles should work.
MS. MULKEY: Thank you. Shelly?
SHELLY: From my discussions with Ralph and with Marion and others, there's been a feeling that farm worker concerns have been underrepresented in terms of the agenda topics at the PPDC, and that's the reason that they have felt -- and I share this feeling -- that there should be a work group to present two or three different reports on major issues of concern. I think Nelson has certainly identified a very important one which is the implementation of the Worker Protection Standard, how has that gone, how has that been enforced, that kind of issue.
But I also think that on the registration side, the farm worker health concerns have not been adequately addressed and there are big policy concerns that we would like to raise. Then there are the, you know, the what isn't happening for farm worker's side, right to know and other issues that we would like to see.
So, I would hope that a farm worker work group got constituted that could, you know, have as I say maybe some time on more than one PPDC meeting to tee up different issues and make some recommendations.
MS. MULKEY: How do you feel about this idea that some floated about sort of putting that issue together with the issue about the incident reporting, adverse effects reporting, which is obviously not limited to farm workers, and with poison center and maybe company, you know, feedback from their responsiveness? Do you think it would lose the focus if you added that to the rubric or do you like the idea of sort of taking on that set of issues all at once?
SHELLY: Well, I think that in terms of the registration side, that could be a very important piece of it. What data there is, what is the inadequacy of the data, what could we do to enhance the usefulness of the data for registration purposes, I think that all would be very helpful. But I do think that there's a separate set of things about the Worker Protection Standard itself. You know, how are -- are these practices enough, are they being implemented, are these things being enforced. And that cannot be subsumed by this other discussion.
MS. MULKEY: Okay. Thank you. Phil?
MR. BENEDICT: Yeah. I'd support having work groups dealing with topics that come out of this forum. I think the inerts actually is probably ripe, based on what happened yesterday, for a work group to try to solve or come up with some solutions to settle those labeling questions.
I'd like to touch on the FDA and USDA, and I'd like to throw into this hat, I guess, or ring, OECA (phonetic) as well. You know, from a state perspective we run a pesticide program and it's usually put together. We come to Washington and we got an Office of Pesticide Programs which has some responsibilities and then there's some far off office somewhere else. We get all of these enforcement and compliance issues, and in my mind, they never quite come together.
I think it's important that you bring all of the players to the table on pesticide issues. I really think it's appropriate the Office of Pesticide Programs do that. It's really your program, and I view OECA as serving your program to some degree, but yet, they still can have their own agenda, so to speak.
I think you need to bring the other components that impact on pesticides, especially the compliance and enforcement issues to this table. I suspect you'll invite them. I guess I would encourage you to try to get somebody here, because I think in the long run if we're going to settle the pesticide issues, we're going to settle it with a whole program not with just aspects of the program. The whole program has to work together.
MS. MULKEY: I think we'd be interested to know whether others think that's a good idea.
MR. ELWORTH: I hear two different things. One is an interest in hearing people make informational presentations so to provide a forum for what's happening and things like that. I look at that as a separate issue from the deliberations of a dialogue committee on specific policy issues that you face and to the extent that you might want recommendations.
I'm neutral on the number or whether we have work groups or not. My at least participation in work groups was sort of interesting, I was glad to do what I could, but not an ennobling experience.
I would recommend that you use the same rule of logic for both agenda items and for work groups, and that is that the purpose of it and its relevance to the agency, that you be able to clearly state that to at least the Office of Pesticide Programs. Secondly, that you identify the specific questions you want to ask, and third that you identify what the output of the discussion is going to be.
MS. MULKEY: Um-hum.
MR. ELWORTH: In all three of those areas, there was an enormous variation across work groups, and especially in our Ecological Standards Work Group, we argued about what the purpose of the work group was, what questions we were supposed to answer, and what, in fact, the report was supposed to look like. So -- and I think you ought to apply that same rule both to agenda items at least for discussion and for work groups.
If you have to have some informational sessions, here's what's happening like we did at the beginning of this, that's fine. But I would want to focus the majority of our time on cuing up issues for discussion.
MS. MULKEY: Well, I think I've heard some -- two themes closely interrelated. One is that we need to really move to a way of using this to identify policy issues and to solicit advice in enough of a structured way that we can make some use of it. Whether that's through some work group approach or consensus building approach or just your taking turns telling us what you think in answer to the questions, that it be structured enough that that's what we're getting is advice. I think I'm hearing that.
I think I'm also hearing that you'd like some feedback about what we do with your advice. Not clear in, you know, exactly how, when, what. Somebody had a very specific proposal. But at a minimum, you'd like it to be a genuine loop here. And I think we can work with those two suggestions. I think they are not inconsistent with the resource issue, because if we're truly seeking advice on things we need help on and if we're making some use of it, then presumably it is our work and not in any way a distraction from it.
So, that might sort of cover that loop, too. We have -- somebody has an editorial opinion on that idea.
I think that we can take our two final members of the public and then have about five minutes for anything that our leadership wants to lead us to.
FEMALE SPEAKER: Marcia, just one last thing. This has been a much better meeting than our last meeting and I want to congratulate the staff and thank you for all the hard work you put into it.
MS. MULKEY: Well, thank you. It's always good to get -- I like the fact that although there was some positive feedback, that most of you were really energized about how to get it even better. I always regard that as a good sign. If people, you know, are focused on improvements, that generally means that they've bought into something in a meaningful way.
Ken, we'll take your -- (inaudible).
MR. ROSENBAUM: Could we ask unanimous consent to adopt the report of the Eco Standards Group? I mean, is that -- I don't want that to fall between the cracks.
MS. MULKEY: Do people feel -- I had assumed that people didn't feel comfortable that that was teed up for that. We understand that it's important not to let that drift. I wanted to reassure people that that work has not gone unconsidered. Without having waited for you to -- a lot of the work of that group is informing our work every day. But perhaps we can try to find some way to do that before we meet again. I think your sense of not wanting it to hang out there is also true in the internal.
But I just don't feel it would be fair to the membership to ask them to vote on something when we didn't give any hint that we were going to ask that. Though I understand the impotence behind that.
FEMALE SPEAKER: Marcia, we can probably send out a letter to the committee.
MS. MULKEY: We'll try to do it by letter.
FEMALE SPEAKER: Because -- (inaudible) -- copy of the report. We can send something out.
MS. MULKEY: Okay.
MR. ROSENBAUM: Is there objection?
MALE SPEAKER: Yeah.
MALE SPEAKER: Yes.
MALE SPEAKER: Yeah. Let me object for this, purely a process reason. This is not a majority vote, it's a consensus process, and so that doesn't provide a consensus opportunity. That's my only concern. That voting isn't the same as consensus.
MR. ROSENBAUM: Well, I wasn't asking for a vote, I was asking for unanimous consent and so that's why I wanted to know --
MALE SPEAKER: I didn't understand who was objecting --
MALE SPEAKER: (Inaudible) -- the hot wire the night before.
MS. MULKEY: I was picking up body English, which is part of my thinking that it was a little too abrupt. But we take your point about not wanting that to hang out there. We'll try a letter-based effort to see if people are comfortable with that, to keep that from being continuing unfinished business. It's definitely a fair point.
All right. Well, let's hear from, and ask them to honor our time constraints, Michael Surgan, we heard from him yesterday, but he did want to speak to the membership question, and David Miller who wants to speak about methyl bromide just to finish this on a totally new topic.
MR. SURGAN: Thank you. For the record, again, I'm Michael Surgan, I'm the chief scientist in the New York State Attorney General's Environmental Protection Bureau.
Several months ago the Attorney General wrote to EPA requesting that the New York State Attorney General be granted membership on the PPDC, and in that letter we outlined what we believed to be a unique mix of viewpoints, experience and qualifications that we had that were relevant to the charter of this committee and which we felt we could contribute to the dialogue.
Within the last week or two, EPA invited us to come to this meeting and to essentially make a presentation of that letter, make a presentation of that request to the committee and to EPA, and I'm pleased to see that there are still a great many committee members here, and that Susan Wayland and Jimmy Aidala are here also to hear our request.
During the last 12 to 15 years the New York State Attorney General's Office, now under the administration of the fourth Attorney General in that period, has sustained a commitment to promoting the reduction of risks associated with pest control. My presence here during the first week of newly elected Elliott Spitzer's administration, I think, is witness to the fact that there is a continued interest and commitment to this project.
And so, I'd like to take a few minutes to outline our activities and our accomplishments as a way of introducing the office beyond the discussion of inerts yesterday.
Over the years we've pursued a variety of civil and criminal cases that involved pesticides. These are in the realm of traditional law enforcement activities which I think don't need very much explanation. We've been involved in cases involving the improper use and disposal of pesticides, worker exposure, workplace exposure, and environmental contamination.
But perhaps what differentiates the New York State Attorney General from many other offices, civil offices across the country, is the way that the office has creatively and sometimes innovatively applied other laws, not necessarily environmental regulations, to the goal of reducing risk.
For more than a decade, we've been prosecuting cases involving deceptive advertising of pesticides and pest control services. In those prosecutions, we have relied primarily on New York State's General Business law rather than environmental regulations, and we've pursued a variety of claims about safety and environmental benefit which we felt were deceptive.
We've pursued those cases, many of them came as a result of our own investigation, but I have to say that we've gotten many that were referred to us and they're referred in about equal numbers by members of the environmental community and members of the commercial community who are seeking relief from unfair advertising practices of their competitors.
We've obtained settlements with large companies, large manufacturers and formulators, large applicators, some of who are represented in this room. It's not necessary for me to recite their names. But we have also obtained settlements from a very large number of small companies, mom and pop shops, not so much registrants with the mom and pop shops, but there have been one or two formulators and applicators.
In doing this, we feel that we're providing not only protection to the public from misinformation and from the actions they may take based on misinformation, but we're also providing a level playing field in commerce so that various companies, be they registrants or manufacturers or applicators, are competing fairly.
We have, in the last couple of years, gotten settlements with literally scores of small companies as a result of an initiative that we started in 1996, looking at Yellow Pages advertising for pest control services in New York State. And we have brought many, many companies -- just about 100 companies -- into compliance in New York State. This program has, I think, caught fire.
Very recently in Massachusetts, the Massachusetts AG did the same thing following us -- following our process of looking at the Yellow Pages, calling companies in for a meeting and asking them to voluntarily comply with appropriate advertising guidelines. I know that in other states in the nation, there are public interest groups which are now lobbying their Attorneys General to adopt this sort of program.
More recently, we've been looking at the Internet and mail order sales of pesticides to residents of New York State, and by the end of this month we'll be able -- we have already settled one, but by the end of this month, we will be settling eight more cases that involve illegal sales of either unregistered or restricted use pesticides to New Yorkers, and in almost every case, those sales were also accompanied by deceptive and illegal advertising claims.
I spoke yesterday about the Attorney General's petition to change EPA's practice as to inerts. This is not the first time that we've petitioned EPA. About a decade ago we were involved in a successful petition to increase the neurotoxicity and neurobehavioral effects testing that is applied to pesticides.
The Attorney General in New York has maintained a very long and complex public outreach program. We have served on federal, state and local advisory committees. We've put out a number of reports. I won't go into them because of time. And we frequently speak on public issues.
The Attorney General -- there was a question before. The Attorney General has frequently put his -- or recently put his money where his mouth is or perhaps more accurately put other people's money where his mouth is, again, creatively applying legal settlements. When we obtained monies as a result of a charity's fraud settlement, that money was given to a breast cancer group in New York State, which held a statewide series of forums talking about reducing the risks of pesticides and the concerns of pesticide involvement in health effects.
When we settled an anti-trust on price fixing of pesticides that money went to farm worker safety training to promoting integrated pest management in agriculture in New York and in a fund to promote education on pesticide-free agriculture in New York in the grade schools.
By virtue of his involvement in a wide diversity of issues, by virtue of a history of aggressive and creative application of state and federal laws and by virtue of the fact that he can apply the expertise of both scientists and lawyers to these matters, and New York is unique in that having an independent assigned staff, I think that the New York State Attorney General is unique amongst his colleagues and I'm here to represent Attorney General Spitzer's request that he be appointed to the committee.
MS. MULKEY: Okay. And if there's anything you didn't get to, you can submit it and it will be in the record.
All right. David? I'm sorry, I do need to ask you to keep it as short as you possibly can.
MR. MILLER: I'm David Miller. I'm the owner of an independent fumigation company called Fumigation Service and Supply out of Indianapolis.
And 1999 begins the first step reduction for the phase-out of methyl bromide, a very important product. You all have been talking about agricultural products that have been grown or harvested. What our company does is protect those products after they've been stored and as it goes into a finished food before you go out and buy it from a grocery store.
Methyl bromide has been a wonderful product for that, but we understand in the next few years we have to come up with alternatives to methyl bromide to be able to phase out that product.
One of the viable alternatives to methyl bromide has been phosphene. Recently, an RED was issued on phosphene which will distract and slow down the process of looking for viable alternatives for methyl bromide. I think the purpose, you know, here today is that these people that are looking for alternatives aren't going to be the Monsantos and they're not going to be the large buyers of the world. They're going to be individuals who are companies like ourselves who find an idea, try to tweak an existing label, make it a little bit better to the use that we need to replace methyl bromide.
And what I'm asking for from EPA today and also USDA is that maybe any time something comes before you that is methyl bromide alternative related, we would hope that you would give it your full attention, expedite it and give it a good priority. And if you could do that, I would appreciate it. Thank you.
MS. MULKEY: Methyl bromide alternatives are a high priority in our registration scheme.
MALE SPEAKER: They're the highest priority actually in our paper.
MS. MULKEY: Um-hum. Well, I -- I have very little by way of closure other than to say we will follow up on many of your suggestions, including your process suggestions and hopefully you will see evidence of that in the mailings you receive from us.
And I want to turn it over to Susan and Jim for any concluding remarks, having first extended my heartfelt thanks for all the hard work you did with and for us in the last long day and a half.
MS. WAYLAND: Thank you, Marcia. Thank you, everyone. I think I want to close the way I began, by thanking all of you for your time, your energy, your ideas. I can't emphasize enough how important this is to the agency. My sense is that the committee is really moving in the right direction. We are doing a lot more dialogue and a lot less talking heads. And even though we heard some very good ideas about how to focus it better, how to improve on it, I think clearly we are moving in the right direction and I want to make sure that we continue that way.
I want to talk a little bit about the future direction of the committee. I think I'll talk with Marcia and the staff after we get back and perhaps get another idea paper out to you which will synthesize the ideas that we heard this afternoon and come up with a proposal that you all can react to.
Let me just close by pledging, certainly on behalf of Jim and me, but I think all of EPA and
probably USDA and FDA as well, to keep the lines of communication open, both in this forum and other forums that we have with you. And thank you so much for your participation.
MS. MULKEY: Give yourselves a hand.
MR. AIDALA: My only closing comment is this is the first snow we've had in two years. Those of you who haven't seen Washington drivers in snow will have the dreadful experience of getting home or getting to the airports. That's it for me.
(The meeting was concluded.)
CERTIFICATE OF TRANSCRIPTIONIST
I, Connie Leonatti, do hereby certify that the foregoing transcription was reduced to typewriting via audiotapes provided to me; that I am neither counsel for, related to, nor employed by any of the parties to the action in which these proceedings were transcribed; that I am not a relative or employee of any attorney or counsel employed by the parties hereto, nor financially or otherwise interested in the outcome of the action.
CONNIE LEONATTI Transcriptionist