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Transcript of Meeting of the Tolerance Reassessment Advisory Committee
April 27 & 28, 1999

ATTENDANCE LIST

John Ehrmann, Project Director, Meridian Institute
Peter Robertson, Acting Deputy Administrator, EPA
Richard Rominger, Deputy Secretary, USDA
Daniel Botts, Director, Environmental and Pest Management Florida Fruit and Vegetable Association
Jim Czub, National Corn Growers Association
Wally Ewart, Northwest Horticultural Council
William Lovelady Chairman, National Cotton Council
Brad Luckey, Owner-Operator Luckey Farms
Jose Amador, Texas Agriculture Research & Extension Center in Weslaco, Texas
Greg Krissek, Assistant Secretary of the Kansas Department of Agriculture
Steve Balling, Del Monte Food
Mark Greenwood, Ropes and Gray.
Kay Holcombe, Policy Directions
Jon Jessen, President, Gowan Company
Tobi Jones, California Department of Pesticide Regulation
Robert Keifer, Chemical Specialties Manufacturers Association
Mike Kashtak, Center for Food Safety and Applied Nutrition, FDA
Mike Linker, North Carolina State University
Charles Mellinger, Glades Crop Care, Florida
Elin Miller, Global Vice President, Dow Chemical Company
Mark Miller, American Academy of Pediatrics
Nancy Rachman, Director, Global Regulatory Affairs, American Cyanamid
Bill Spencer, Citrus Farmer, President, Associated Citrus Packers American Farm Bureau Federation
Robin Spitko, Plant Pathologist, New England Fruit Consultants
Mark Trostle, Texas Department of Agriculture, Representing the Association of American Pest Control Officials
Jay Vroom, President, American Crop Protection Association
Mark Whalon, Pesticide Research Center Michigan State University
Dave Whitacre, Novartis
George Wichterman, Lee County Mosquito Control District
Margaret Wittenberg, National Communications Team Leader Whole Food Market
Anne Lindsay, Office of Pesticide Programs
Marcia Mulkey, Office of Pesticide Programs
Stephen Johnson, Acting Deputy Assistant Administrator, EPA
Jim Aidala, Associate Assistant Administrator, OPP, EPA
Susan Wayland, Acting Assistant Administrator Preventative Pesticides and Toxic Substances, EPA
Keith Pitts, Special Assistant to the Deputy Secretary, USDA
Al Jennings, Office of Pest Management, USDA
Lois Rossi, Director, Special Review and Reregistation Division, OPP, EPA
Jack Housinger, EPA
Ed Zager, Associate Director of the Health Effects Division, EPA
Margaret Stasikowski, EPA
Margie Fehrenbach, Executive Assistant to Director, Office of Pesticide Programs, EPA
Susan Hazen, Deputy Director, Office of Pesticide Programs, EPA
Mike Metzger, Chemist Branch Chief, EPA
Felicia Fort, EPA
Catherine Eiden, Health Effects Division, Office of Pesticide Programs, EPA
Jack Arthur, Health Effects Division, Office of Pesticide Programs
Jess Rowland, Toxicologist, Health Effects Division, OPP
Barry O'Keefe, Special Review and Re-registration Division, Chemical Review Manager for Azinphos-Methyl
Therese Murtaugh, USDA
Wilfred Burr, Entomologist, USDA, Office of Pest Management Policy
Suzanne Deatheridge, USDA, Office of Pest Management Policy
Lora Lee Schroeder, Representative, Region Four
Richard Avcoin, Pest Management Regulatory Agency of Health Canada
Teung Chin, USDA, Office of Pest Management Policy
Sarah Walen, Meridian
Steve Galfon, Director of the Office of Science Coordination and Policy, EPA
Bill Jordan, Office of Pesticide Programs
Kevin Keaney, Worker Protection and Applicator Certification Training, EPA
Antonio Bravo, Special Assistant to Pesticides, EPA
Jeff Kempter, EPA
Carol Peterson, Policy and Regulatory Services Branch
Brad Shurdit, House Agricultural Committee
Terri Nintemann, Senate Agricultural Committee
Neysa Call, Congressman George Brown's Office
Kathy Monk, Branch Chief, Special Review and Registration
Dave Jones, Environmental Fate and Effects Division
Neil Anderson, Biologist, Biological and Economic Analysis Division, EPA
Tom Kiely, Economist, Biological and Economic Analysis Division, EPA
Rich Dumas, Special Review and Registration, EPA
John Cady, President, National Food Processors Association
Linda Abbott, Office of Risk Assessment and Cost Benefit Analysis
Bob Epstein, Secretary Science Advisor

PROCEEDINGS

MR. EHRMANN: Welcome to the -- what I believe is the sixth meeting of the Tolerance Reassessment Advisory Committee of EPA and USDA, which is a subcommittee of the NASEP committee at EPA.

And what I want to do first is go around and have folks introduce themselves. And we have a lot of people at the table, as well as at the back tables.

And I want to take the time also to introduce the folks at the back tables, because you're going to be hearing from a number of them throughout the course of this agenda as -- and in presentations and also they're here as resource folks, so I think it's important to recognize everyone.

And we also have some -- some friends from the Hill here, I want to make sure they get a chance to introduce themselves. So we'll go first around the inner table and then around the two outer tables.

And then I will turn it over to our co-chairs for some opening comments. And let me start the introductions with Dr. Amador and we'll work our way around.

MR. AMADOR: Good morning. My name is Jose Amador and the Director with Texas A & M Research and Extension Center at Weslaco.

MR. BALLING: Steve Balling, Del Monte Food.

MR. BOTTS: Dan Botts, Florida Fruit and Vegetable Association.

MR. CZUB: Jim Czub, National Corn Growers Association, a grower from upstate New York.

MR. KRISSEK: I apologize for the alphabetical order. I was Allie Devine. I am Greg Krissek, I'm the assistant secretary of the Kansas Department of Agricultural for Allie.

MR. EHRMANN: Welcome.

MR. EWART: I'm Wally Ewart with the Northwest Horticultural Council.

MR. GREENWOOD: Mark Greenwood, Ropes and Gray.

MS. HOLCOMBE: Kay Holcombe, Policy Directions.

MR. JESSEN: Jon Jessen, Gowan Company.

MS. JONES: Tobi Jones, California Department of Pesticide Regulation.

MR. KEIFER: Robert Keifer, Chemical Specialties Manufacturers Association.

MR. KASHTAK: Mike Kashtak, Center for Food Safety and Applied Nutrition, FDA.

MR. LINKER: Mike Linker, North Carolina State University.

MR. LOVELADY: Bill Lovelady, I'm a cotton grower from Texas and I represent the National Cotton Counsel.

MR. LUCKEY: Good morning. Brad Luckey, I'm a farmer from the Imperial Valley in southeastern California.

MR. MELLINGER: Charles Mellinger, Glades Crop Care, Florida.

MS. MILLER: Elin Miller, the Dow Chemical Company.

MR. MILLER: Mark Miller, American Academy of Pediatrics.

MS. RACHMAN: Nancy Rachman, American Cyanamid.

MR. SPENCER: Bill Spencer, I'm a citrus grower from Yuma, Arizona and I represent American Farm Bureau Federation.

MS. SPITKO: Robin Spitko, I'm an independent crop consultant from New England, representing the National Alliance of Independent Crop Consultants.

MR. TROSTLE: I'm Mark Trostle with the Texas Department of Agriculture, representing the Association of American Pest Control Officials, which is all the state lead agencies.

MR. VROOM: I'm Jay Vroom, President of the American Crop Protection Association.

MR. WHALON: Mark Whalon, Michigan State University.

MR. WHITACRE: Dave Whitacre, Novartis.

MR. WICHTERMAN: George Wichterman with the Lee County Mosquito Control District in Fort Myers, Florida.

MS. WITTENBERG: Margaret Wittenberg, Whole Food Market.

MS. LINDSAY: Anne Lindsay, Office of Pesticide Programs.

MS. MULKEY: Marcia Mulkey, Office of Pesticide Programs.

MR. JOHNSON: Steve Johnson, EPA.

MR. AIDALA: Jim Aidala, EPA.

MS. WAYLAND: Susan Wayland, I am the Acting Assistant Administer for Preventative Pesticides and Toxic Substances at EPA.

MR. ROBERTSON: I'm Peter Robertson, Acting Deputy Administrator at EPA.

MR. EHRMANN: I'm John Ehrmann, Meridian Institute.

MR. ROMINGER: Rich Rominger, Deputy Secretary, USDA.

MR. PITTS: Keith Pitts, USDA.

MR. JENNINGS: Al Jennings, USDA.

MS. ROSSI: Lois Rossi, EPA.

MR. HOUSINGER: Jack Housinger (phonetic,) EPA.

MR. ZAGER: Ed Zager, EPA.

MS. STASIKOWSKI: Margaret Stasikowski, EPA.

MR. EHRMANN: Margie, why don't we start with you.

MS. FEHRENBACH: Margie Fehrenbach.

MS. HAZEN: Susan Hazen, EPA.

MR. METZGER: Mike Metzger, EPA.

MS. FORT: Felicia Fort, EPA.

MR. EHRMANN: It would be helpful if the EPA folks could tell us -- just give us a sense of what part of EPA you work in, just so people can get a --

MS. EIDEN: Catherine Eiden, the Health Effects Division in the Office of Pesticide Programs at EPA.

MR. ARTHUR: Jack Arthur (phonetic,) Health Effects Division, Office of Pesticide Programs.

MR. ROWLAND: Jess Rowland, Toxicologist, Health Effects Division, OPP.

MR. O'KEEFE: Barry O'Keefe, Special Review and Reregistration Division, Chemical Review Manager for azinphos-methyl.

MS. MURTAUGH: Therese Murtaugh, USDA.

MR. BURR: Wilfred Burr (phonetic,) USDA, Office of Pest Management Policy.

MS. DEATHERIDGE: Same office. Suzanne Deatheridge, USDA.

MS. SCHROEDER: Lora Lee Schroeder, representing region four and former TRAC member.

MR. AVCOIN: I'm Richard Avcoin with the Pest Management Regulatory Agency of Health Canada.

MR. CHIN: Teung Chin, USDA Office of Pest Management Policy.

MS. WALEN: Sarah Walen, Meridian.

MR. GALSON: Steve Galson, I'm the Director of the Office of Science Coordination and Policy at EPA.

MR. JORDAN: I'm Bill Jordan, I work on science policies in the Office of Pesticide Programs.

MR. KEANEY: Kevin Keaney, with Worker Protection and Applicator Certification Training at EPA.

MR. BRAVO: Antonio Bravo (phonetic,) Special Assistant to Pesticides, EPA.

MR. KEMPTER: Jeff Kempter, I work on science policy issues, EPA.

MS. PETERSON: Carol Peterson (phonetic,) Policy and Regulatory Services Branch.

MR. SHURDIT: Brad Shurdit, House Agricultural Committee.

MS. NINTEMANN: Terri Nintemann, Senate Agricultural Committee.

MS. CALL: Neysa Call, Congressman George Brown's Office.

MR. EHRMANN: Great. Did we miss anybody? Let me turn it over to Mr. Rominger with some opening comments.

MR. ROMINGER: Thank you, John. Well, good morning everyone. And I want to thank all of you for coming to our sixth TRAC meeting.

And we look forward to updating you on the Administration's ongoing efforts to implement the Food Quality Protection Act.

I also look forward to hearing your thoughts on the progress that we've made to date, as well as your guidance on future actions being considered by USDA and EPA as we shift into the risk management phase for some of the organophosphate chemicals currently in the final stages of interagency review.

Peter, I also want to welcome you onboard as the esteemed co-chair of the TRAC. As a long-termer here, I was initially planning to regale you with tales about how Fred and I struggled through our first TRAC meeting and how fortunate you were to inherit a -- the mantel of co-chair under some relatively calm circumstances.

But unfortunately, some recent events have resulted in some refinements to my own preliminary risk assessment under the assessment of TRAC.

In all seriousness though, I do welcome you aboard, and want to emphasize to the Advisory Committee how much I value the working relationship that you and I have developed over the past several months.

For me, that sense of value and respect extends to each person that we've asked to contribute to this committee.

Each of us has an important perspective to offer to the TRAC, and ultimately to the larger effort, to ensure that the Food Quality Protection Act is fully and appropriately implemented. And that suffers in the absence of any one segment or even any individual.

The decision of the environmental and public health community members to resign from the TRAC is very disappointing to Peter and to me and to our agencies.

USDA and EPA are fully committed to getting the most out of this process, to better inform and shape our implementation of the FQPA.

We also want to make it abundantly clear that our responsibilities in implementing this law extend beyond the TRAC, and that -- and that USDA and EPA will make every possible effort to solicit a broad range of advice to fully inform our decisions.

In turn, each of you should know that your views and voices are not limited to your participation on the TRAC.

Peter and I both look forward to working with each of you today, tomorrow and well into the future through this forum and others.

Recently in Chicago, we had a gathering of our Land Grant University partners, the pesticide coordinators from those universities. And I think there were about 90 of them there, is that right, Al?

We got together to talk about the work that -- that they are doing in helping us on the crop profiles, and on the risk assessments, and the increasing involvement they'll have as we develop mitigation and risk management strategies.

So we had a good three-day session with all of them there, going through some examples of what we've accomplished so far and -- and how we expect to be partnering with them in getting the additional information and activities as we move to continue to implement FQPA.

So we wanted to make sure that our Land Grant partners were full engaged, and I think they are, and will be of tremendous value as we move forward with implementation.

Before we go any further with the meeting, I want to make some brief observations about where I think we are in the organophosphate review process.

First, EPA has to date formally delivered 10 organophosphate risk assessments through USDA. We've completed our review of four, and have returned them to EPA.

And within the next few days, we'll complete two additional reviews and submit our formal comments to the Agency, bringing our total to six completed reviews.

The two agencies recently met on a seventh chemical, azinphos-methyl, and we've collectively agreed to work intensively over the next few weeks to bring that interagency review to closure.

Some lessons learned on my part from this subset of the organophosphate class of chemicals are number one, that these risk assessments are quite complex and in some instances daunting.

USDA has truly gained a greater appreciation for the very difficult work that many people at EPA undertake on a daily basis.

EPA and USDA are jointly making every effort to ensure that risk assessments are made on the best available data.

USDA is confident that the data that we're collecting is being used by the Agency, and that USDA data is generally being collected in a manner and format that is useful to EPA.

Number three, the refined data have had a significant impact in changing the preliminary risk assessments for dietary exposure on individual chemicals.

And four, many agricultural uses appear to contribute little or nothing to the individual risk cup. Conversely, major contributions to the risk cup for some chemicals seems to concentrate on a few commodities.

And number five, even in the event that an individual chemical falls within its reference dose, the cumulative risk assessment will have an impact on some commodities.

So recognizing this, USDA and EPA want to engage some selected commodities on mitigation and transition strategies now, in order to avoid any risk of future market disruption.

And finally number six, worker risks are a consistent issue across the entire class of organophosphates, and will provide some interesting challenges to all the impacted parties.

USDA's gained a lot of knowledge and insight from our new working relationship with EPA. And on the basis of this information, we're now in a better position to understand and even anticipate the needs of both EPA and the grower community.

So USDA is accepting its new role in this process and is making long-term budgetary and immediate resource allocation decisions to support the implementation of FQPA, particularly as risk mitigation needs arise from the regulatory process.

So I look forward to hearing your thoughts about how the Department can continue to be an effective partner in this evolving process. Thank you. Peter?

MR. ROBERTSON: Rich, thank you very much. And good morning to all of you. I'm very grateful for you continued willingness to commit to this process, and for just showing up. I didn't know how much a measure of success just showing up would be until this morning.

Rich, let me say to you how grateful I am, both for your warm welcome and for your willingness to -- to work with me, counsel me and tutor me over these last several months.

I've appreciated your personal help and the help of everyone at USDA, as I've tried to come up this steep learning curve over the last several months.

This is a critical time for EPA, for USDA, and for the agricultural community as we move into the implementation of the Food Quality Protection Act.

We've got a full agenda ahead of us. We've gotten to this point because of the commitment of everyone around this table and around this room. But we'll need your continued full support if we're going to move ahead in this process.

FQPA, the enactment of FQPA, and now the implementation of FQPA, is one of the most significant accomplishments of the Clinton Administration.

EPA and USDA are working extremely hard together to ensure that the statute is fully implemented in a timely manner to achieve greater food safety for U.S. consumers, particularly infants and children.

As I said, I very much enjoyed my working relationship with Deputy Secretary Rominger and everyone at the Department of Agriculture. I think we have a closer relationship between our two agencies than has ever existed before, certainly in this arena.

As you know, we've had some resignations -- or I guess we'll experience some resignations from the TRAC this morning, stemming from differences over an acceptable time frame for regulatory or transitional issues.

I deeply regret these resignations, because I'm certain that they do not help our shared goal of protecting the health of the American people.

TRAC is charged with ensuring that EPA's implementation of FQPA be transparent, inclusive, based on sound science, and that it provide a reasonable transition for agriculture. These charges are easy enough to enumerate, but they are by no means easy to carry out.

Nonetheless, the Clinton Administration is absolutely committed to implementing FQPA's important protections on schedule as the law requires.

Making sure that EPA's risk reduction actions are based on sound science, is the most important step that all of us can take to guarantee that FQPA's promise of protection for our children and the American public is actually fulfilled.

Let me clarify a few things about the differences in opinion that led to the resignations, specifically some things about which there were no difference of opinion.

There was no disagreement about the fact that organophosphates pose health risks. There was no disagreement that significant reductions in use will be required.

EPA also wishes that this process could move faster. But let there be no mistake, we're on schedule for assessing risks and for taking risk reduction actions beginning in August as the law prescribes.

In the meantime, we're calling on the manufacturers of OPs to work with us to reduce the significant risks these compounds pose in a sensible manner.

We also will continue to work with the farm community to ensure that it is able to provide the American public with an abundant, affordable, healthy and safe food supply.

I think the accomplishments of TRAC so far have been truly outstanding, and that's one of the reasons that I'm so disappointed by the resignations that we witnessed this morning.

We've made a fundamental change in the way that this Agency approaches pesticide regulation. The goals of transparency and inclusiveness have never been better annunciated or accomplished than they have been in this process.

The presence of all of you who are here today, I think signals the progress that we've made. We've really changed the way that pesticide decisions are made in our Agency.

We have, for what is for all practical purposes, a new process for review of the organophosphates. I think that new process -- we hope to talk with you further over these last TRAC meetings about ways we can improve that process. But we hope that it will continue to serve us as we reassess other groups of chemicals.

Another goal was to ensure the use of sound science. We forged a strong partnership with USDA, which will help us to ensure the use of the best available agricultural data.

Cooperative efforts with the Land Grant universities has increased the quality of our information.

Working with all of the stakeholders, we're continuing to improve the database that we're using in making our decisions.

We have enormous challenges yet before us, and we need your help in facing and meeting those challenges. We need to build on the progress we've made so far on the difficult issues of organophosphates.

We need to work to ensure continued protection for public health and stability for U.S. agriculture. We want to work to improve our transparency.

We've made enormous success so far in that arena, I believe. But in particular areas, for example, worker protection, I think our efforts could continue to improve transparency.

Finally, we will at all times and under all circumstances work as hard as we can to support and encourage extensive stakeholder involvement by all parties.

We will continue to work for a reasonable transition for agriculture, as we continue the tolerance reassessment and risk mitigation efforts.

We will work hard with our partners at the Department of Agriculture and with all of you to reduce the risks that the American public faces, and we will minimize disruptions for growers while providing these strong protections.

It is my hope that during these final TRAC meetings, we can focus primarily on formulating ways to gain everyone's input on practical, feasible and affordable risk mitigation measures.

Again, my thanks to all of you for your continued willingness to help us do our job of protecting public health in the environment, while continuing to provide a strong agricultural community for our County. Thank you.

MR. EHRMANN: Thanks both of you very much. And let me just say a few words about the agenda for today, and then we'll get at it.

The -- this morning we're going to, after a very brief summary of what took place at the work group a few weeks ago, hear a report on the current status of the organophosphate pilot process.

And this will be an update of exactly where the various organophosphates are in the process, the various time lines for public review, comment, et cetera. And there will be an opportunity for questions and answers about that.

This afternoon we're going to have an opportunity to hear from a number of you with some initial presentations on some thoughts that folks have collected about that pilot process. So I want to keep the discussion this morning to be more of a clarification kind of discussion.

When we get to that afternoon part of the agenda at 1:30, where we'll hear from various perspectives, will be more of the time where we can have a qualitative kind of evaluative discussion about the pilot process.

And specifically get your recommendations about how you would like to see that process going forward that -- that Peter and Rich referred to in their comments.

So that will be -- the 10:30 item will be the update and status of the pilot process. After a break then we'll hear a prototype briefing on azinphos-methyl.

For those who were at the work group meeting a few weeks ago, this briefing will include a review of the current dietary risk assessment which will have some updated numbers from what you saw a few weeks ago.

Plus there will be briefing, as the agenda indicates, on other aspects of that assessment of azinphos related to drinking water, worker risk, eco risk, et cetera. So it will be a -- a fuller presentation than what we reviewed at the worker meeting a couple of weeks ago.

Then as I mentioned, after lunch we'll have the opportunity for an interactive discussion about the current status of the pilot process in the azinphos review.

And again, looking for advice and guidance to the Department and the Agency for how you believe they should go forward as it relates to that kind of process.

After an afternoon break, we're going to hear a -- a discussion on worker-risk issues. This will be a -- basically a generic presentation.

So not focusing on any particular organophosphate, but what is the approach and methodologies that are being used to evaluate worker risk.

This is an issue that the TRAC has not spent any indepth time on, but obviously it's come up throughout the course of these discussions. And that will be the -- an opportunity to hear from the Agency and the Department about their work in that arena and discuss those issues.

Then at 4:30, for members of the public who are here, we will have a public comment period between 4:30 and 5:00.

And I would encourage you -- request that you sign up outside if you're interested in making public comments, so that we can calibrate our timing. And I'll make sure we allow adequate time for those folks who do wish to make public comment in that period.

Tomorrow's agenda will start with a brief overview of the nine science policies, which again will be updated from the information you received at the briefings a few months ago.

Mark Whalon has kindly agreed to make a presentation regarding various transition activities in Michigan.

This kind of complements a couple of presentations that we had at the work group meeting, one by Sarah Lynch from World Wildlife Fund one by Jan Relford from Gerber on their transition work.

And Mark unfortunately wasn't able to be at that meeting, so he's kind enough to make this presentation tomorrow morning. And I know that will be very helpful.

And then we'll go into a more general discussion of transition strategies led by USDA right before we adjourn tomorrow.

And we will end the session with a discussion and any advice you have to the Department or the Agency about the -- the next TRAC meeting in terms of both content and timing. And again, there will be an opportunity for public comment tomorrow in that session.

So we will, as I indicated, work through the agenda as we have in previous meetings, trying to keep as close as we can to these time lines, but be flexible if we need to adjust things. And I'll try to keep you posted on how I see the timing affecting the overall flow of the agenda.

Also, as always, we have a lot of people here. I'd ask that you use your name teats on end, or give me a clear signal when you want to speak.

I'll try to blend together the desire of people to follow each other's comments, as well as keep everybody in the que, which is a balancing act.

But I think sometimes it's helpful to be able to let folks kind of cut in line and respond to somebody else.

But I also want to make sure everybody gets their chance to comment, so I'll do my best to blend those priorities together as we go through the agenda.

Let me just say a word about the work group meeting that was held on April 8th and 9th, and a number of you did attend that meeting. Which was I think a very helpful opportunity to kind of get warmed up on some of these issues, since there hadn't been any organized TRAC meetings for a while.

And I'm not going to go into detail on what was covered in that work group meeting, because we're going to hear some of that at this meeting, in addition to the new information that I commented on a few minutes ago.

But for those who weren't there, that meeting -- basically we did hear a -- a status update at that point about the organophosphate pilot process and the numbers of reviews and where pieces were. And again, we'll hear an update on that presentation today.

We did have a -- a dietary risk assessment presentation on azinphos-methyl. But again, it didn't include the other parts of that assessment, which we will hear today.

But I think it was of -- I think widely seen by folks who were at that meeting as -- as the best and clearest presentation of the risk assessment process that the TRAC had had.

And I know that the staff both appreciated that feedback, and has tried to incorporate that in the presentations that you're going to hear today. So I think that was a very helpful run through on that overview.

And it also, I think, gave, as Rich and Peter mentioned, a sense of the kind of refinements that are taking place as these risk assessments move forward and the coordination between USDA and EPA.

In the afternoon of that work group meeting, we had a dry run, technical briefing on bensalane. Which again I think was a very clear and helpful presentation, and gave the group a sense of the way that these technical briefings are going to be structured.

Again, just to remind everybody, at the end of the risk assessment refinement process the plan is to have a technical briefing which would invite stakeholders to participate.

Where the Agency and the Department would present their -- their review in that final form, to allow an opportunity for everybody to get the same information at the same time as the process moves into the risk management side of the overall process that the TRAC has -- has helped the Department and the Agency lay out.

So that was a -- kind of prototype of that technical briefing. And I think some very helpful feedback came back in terms of the way that briefing was structured, and how those might be done going forward.

Then as I mentioned, we had a presentation from -- from Jan Relford from Gerber and Sarah Lynch from World Wildlife on the work that they've been doing in the area of transition.

And we'll try to reprise some of that and summarize some of that for you in the context, along with Mark's presentation tomorrow, so we can use that as input to that overall transition discussion that we'll have tomorrow. But those presentations were very helpful.

We had a brief update on the science policies, and then we had a very good discussion about the organophosphate and initial discussion on the pilot process. And that's really what I think seeded our request to have some of the folks at this meeting give us a more indepth feedback on the pilot process.

So that the Department and the Agency can really move forward in making the decisions they need to make about how that process is going to operate in the future in terms of stakeholder involvement, transparency, public review, et cetera.

So I think the work group meeting gave us a good opportunity to determine what would best be on the agenda for this meeting, and appreciate those who attended and participated in that context.

Are there any questions about either that meeting or the agenda for the next day and a half before we move to the first agenda item on today's schedule?

Okay. Then let me turn it over to Lois and Al, who are going to provide the update on the status of the pilot process.

MS. ROSSI: I'm going to discuss the pilot process, and then Al is going to finish the presentation with some points on the pilot process that USDA is directly involved with.

What we're going to do this morning is present the six stages of the pilot process and some comments that hopefully will be the source of your discussion this afternoon.

What you have in your packet is a paper related to this presentation called, "Organophosphate Pilot Process Discussion." There's a cover page.

This paper actually takes a couple of papers that have been developed for this TRAC as we've developed phases one through three and then four through six, and it presents them all in one. So this -- this is basically the TRAC pilot process all in one paper.

And the second sheet of paper gives you on both sides the status of the OPs that are being considered in the pilot process and which phase they're in.

So starting with phase one, which is considered -- or called the registrant "error only" review phase.

What it is designed to do is give registrants an opportunity to identify errors in the preliminary health -- human health and ecological risk assessment for a given OP. EPA has also shared this preliminary risk assessment with USDA.

The Agency has received the comment that 30 days is too short a time to review some of the lengthy risk assessments. However, this is just one of several comment periods in the whole process that people do have a chance to comment on.

The Agency has received more than just error comments during this phase, sometimes we receive data. We've also received analysis of the assessments.

We have been able to review the comments that are directed to errors that are error comments -- truly error comments.

And have been able to make those corrections, or note in the assessment that's put in the docket. We've noted any changes we've made or addressed these changes.

So we have been able in this phase one, we have been able to deal with the comments received and move the process along to the next phase.

And we are -- we are only actually aware of one instance where the preliminary assessments have had any impact -- real-world impact.

Phase two is an EPA phase. We've also started thinking of these phases as -- is -- as registrant activity, EPA activity, intergovernmental activity.

Phase two, again, is the EPA phase. And as I said, that we -- that it is the 30-day phase. We have been able to stick to that schedule for the most part, and have been able to address the comments.

Again, I'd like to note that this phase, as well as phase three, has resulted in the generation and submission of a lot of data on a fairly rapid time frame. So it has been valuable in that the Agency has received quite a bit of data.

Phase three is a public comment period, the -- the first public comment period in the process. And it is a second opportunity actually for registrant involvement, and it is the first opportunity for the public.

At that time, EPA releases the preliminary risk assessments for the public review and comment and opens a docket and places them in the docket, as well as the Internet.

I think docket and internet have almost become synonymous these days. But we have been posting them on the internet, and they are available in a public docket.

The majority of comments that we have received in this 60-day comment period have been from the manufacturers of the chemicals, the registrants.

Comments from other stakeholders or general pubic, have in some cases been generic to all the OPs, and a few are chemical specific.

We have addressed this phase and as we go into the next public comment phase, we will be addressing the comments.

MR. EHRMANN: Thank you.

MS. ROSSI: We will -- we will be addressing the generic comments as well as the chemical-specific comments as we go into phase five.

Okay. The next phase, phase four, which is the one most of our chemicals are in right now, we have 27 chemicals that we're currently working on phase four.

It begins at the close of the 60-day public comment period, and it gives the Agency up to 90 days to revise the risk assessments based on the public comments.

In drafting the revised assessments, the Agency, together with USDA, has discussed and implemented several revisions to the risk assessments.

I'd like to just briefly touch on those. They were presented to the work group, and some of them were presented at the TRAC update. Many of them were presented to the TRAC work group meeting three weeks ago.

But I'd like to just highlight some of these changes that we've made in revising the risk assessments.

First of all, we developed a methodology to use composite PDP data to estimate single servings in probabilistic risk assessments.

We've used the best data available to get the most realistic exposure estimates to predict risk. We are determining the risk contributors of these assessments.

These have been referred to as drivers, risk contributors. The analysis has been referred to as sensitivity analysis.

When anyone hears these words, they all refer to looking at the risk assessments to see what is going on in them.

You can look at -- you look at the underlying assumptions and you can see if a risk is being driven by a particular commodity, or even a food form within that commodity. Is it the consumption data, is it -- are the residue levels driving the risk, contributing to the risk.

We've tried various runs with our model, with our dietary probabilistic assessment model to see if we used zeros instead of non-detects, what the impact of that would be. We've also run these assessments at various level -- levels, percentiles, 99, 99.5, 99.9.

Those are many of the refinements that we've made to our thinking process and our analysis as we're going through these revised risk assessments -- going through the process of revising these risk assessments.

With regard to worker risk, we've received some data and we are continuing to get data from the Agricultural Reentry Task Force, which was formed in response to a DCI, the Agency issued to get worker -- better worker reentry data.

Back in 1995 we issued that DCI. And these are being used in the assessment as they are received by the Agency.

In an effort to make clear to the public the data and the assumptions used in the risk assessment, we have developed standard formats, overviews, and an even briefer summary cover sheet. Those were presented to the work group when we did our dry run of the bensulide last time.

The assumptions that go into the assessment are laid out, including the risk and the data and other factors that have impacted the assessment of risk.

Again, the purpose of the overview was to help communicate to the public how we develop the risk assessments, and the Agency's findings in a shorter, more easily understood way.

As referred to this morning, these assessments are very complex and very lengthy. And these overviews and summaries are an attempt by the Agency and the Department to make clearer what goes into these assessments, to allow for a better public comment and understanding of public comment, and ultimately to aid in the risk management process and decision.

Once the revised assessment and overview are completed, EPA then sends the entire package to USDA for intergovernmental review.

And as was said this morning, there are 10 currently that the Department has received at this time and that we are working. We have 17 more yet to deliver.

USDA will focus their assessment on the assessments, utilization of use and usage data, the assumptions used, as well as possible strategies and options for managing the risk.

Their review team will include their Land Grant University employees, and I was going to tell a little more about that in a minute.

We will also consult with the Department of Health and Human Services when an OP has public health uses. And their role will be similar to USDA's.

We have sent -- one OP currently is with DHHS. And we have actually received comments on that OP since the work group meeting.

USDA and DHHS need time to do a proper review of the OP documents. And originally when this process was designed, that time was not provided for. The intergovernmental review does take time beyond the 90 days.

Let me just say at this point that the 90 days that was allotted to this phase, in some cases the Agency has found this time is adequate.

And in other cases, it's found that it's needed more than the 90 days, particularly when a lot of the comments have been new data being submitted.

So while we have aggressively worked with this 90-day time period and in most cases have been able to get the majority of the revised risk assessment completed in the 90 days, it -- it does become a little difficult depending upon new data and the extent of the comments received, but mostly the new data.

We -- with USDA, we have agreed upon another amendment to the time frame of this process. We have allowed -- we need to allow USDA and HHS time to review these documents.

And if it generally takes us 90 days -- while we turn over the revised assessment to the Department or the -- or HHS as soon as we complete it, if it does take us 90 days, then USDA -- we have come to an agreement with them that depending upon the complexity, which mostly is a function of the number of uses that are -- that a chemical is registered for, we would determine whether a two-week, a four-week or a six-week time period would be adequate for the Department.

So if it's -- in the case of -- of a fairly straight forward chemical with one use and -- and we have had one like that, the Department has turned that around very rapidly. And that was like less than two weeks. Some of the more complicated ones are more like four weeks and six weeks.

So we can look at this phase as going from 90 days to a minimum of like 120, because the Agency would need some time to look at the Department's comments, address them, and agree with the Department on how we are going to address the comments, to possibly 180 days in the case of where you have six weeks of USDA review time.

By the end of the review process, USDA will then send their comments to the Agency and we will incorporate these comments and discuss them with USDA. And we've had many discussions just on the ones that we've sent over so far.

At the last TRAC work group meeting we announced a slight amendment to the -- even that delivery, in that we directly hand over to Al and his team the assessments once the Agency is ready to send them. And we meet and sort of do a debriefing.

Because by the time the Agency has finished with these assessments, we've certainly spent a lot of time and Al thought it would be a good use of our time and his time to share that information with him.

And we have done that since the last work group meeting. We've already done that once and probably will do it again in the next two weeks.

The next step in the process would be after the USDA, HHS review. EPA would announce the date of a public meeting, and we call that a technical briefing.

We will post a -- a notice in the Federal Register to publicize the meeting, as well as other traditional ways that the Agency has used to announce meetings. And we'll give it a two-week announcement.

At the work group it was suggested that at the time we post the announcement that we also post the summary, so that -- in that it would be a good way for people to decide if they need to come to the technical briefing or not. Because the two-page summary just briefly summarizes the uses and highlights concerns, and that was suggested.

Again, the purpose of this briefing would be yet another opportunity to go through the risk assessment and explain the assumptions behind the assessment.

It would give interested stakeholders an opportunity to become more informed about the major points in the assessment, such as the risk contributors and drivers and the data that was used, and describe how public comment has affected the assessment. In addition, USDA could bring to this meeting ideas on possible risk management strategies and options.

The public would be given an opportunity at that point in time to ask clarifying questions about the refined risk assessment.

And again, all meeting minutes, as the case with all meetings in this process, would be placed in the public docket.

It was also suggested at the work group meeting that -- the focus of these technical briefings. Because some of them, if you go through every aspect of the assessment that's presented in these documents, it could be a fairly long presentation.

And the -- and the work group suggested that we focus on the areas of concern, that is the areas that are most likely to need risk management.

(END OF TAPE)

After the technical briefing, we would open a public docket and post on the internet the risk assessment for a 60-day public participation period, in which the -- the public and -- and stakeholders would be invited to submit risk management proposals on the risks that have been identified in the assessment as needing management and mitigation.

During this time we also view it as a time where we would be conducting meetings with registrants, with growers, both USDA and EPA.

And again, all these meetings would be docketed. And it would be a time to discuss strategy for the risk management of the chemical.

And -- and then the last phase, which is phase six of the process. Phase six, which we have not had experience with at this point.

We're getting ready to have experience with phase five on four of our chemicals, which would be the first step in the formal regulatory decision process, and that would be an EPA with USDA phase.

That pretty much concludes my thoughts. We -- we are hoping that the discussion this afternoon will comment on the various phases as we determine to move this process out of the pilot into just a process for the review of chemicals in the tolerance reassessment program. So with that, I'll turn it over to Allen.

MR. JENNINGS: Well, as usual, we've divided up the work here so that Lois has to do most of it. You can find in your package, staff paper 36, which is just a one-pager, kind of outlining the -- the USDA review process in short bullet form. But I will talk a little bit about that and expand some of the bullets.

So far the experience I think has been very positive. We've had a good exchange of thoughts and data on the first 10 -- actually, we've only probably gotten our teeth into about eight of them.

But of the first ones that have come over, I think we've learned a lot from each other, lessons that will apply to the future risk assessments as they come through the door, how to do it better.

I think as Lois mentioned, we're -- recently experimented with getting a detailed briefing from Lois and her people, and that helped a great deal to get us oriented and will save time down the road as we go through the review process.

I guess the other thing to focus on with -- with our review process is that we are not engaging heavily in toxicology.

The USDA review is directed more towards the exposure part of the equation, looking at the data generated by USDA, pesticide-data-program-type data, the consumption survey information, as well as the ag statistics pesticide-use information, to ensure ourselves that the risk assessment accurately captures our information, and the analysis is something we can agree with, and finding any additions or corrections or gaps that -- that may be there.

It's also caused us to think about those data programs in the planning mode, what do we need to do in the future.

As we're seeing how they're applied in risk assessments, it helps us look forward and ask what we can do to gather information that will be of more value to EPA in the future.

So as I said, we're learning a lot in this process. And I think some of it will help, again, in the future as we get better at doing this process.

Well, once the risk assessment arrives in my office, we create our team. And our team really is a combination of USDA headquarters, as well as our Land Grant partners, the state -- out in the states, the state universities.

Within headquarters, I've already mentioned a couple of those, The National Ag Statistical Service. Our Office of Risk Assessment and Cost Benefit Analysis, who have expertise in Monte Carlo analysis are part of the team.

The Ag Marketing Service, these are the people who collect the -- the data in the pesticide data program.

The Ag Research Service, I already mentioned them, for the food consumption. But we also have scientific crop production experts, both at Beltsville, which is in the area, as well as research facilities across the country. So we identify those.

Animal Plant Health Inspection Service, Teung Chin, who is on detail from my office, represents APHIS. And they are particularly useful in looking at public health issues, as well as other invasive species-type control -- use patterns for these chemicals.

So I've probably missed somebody. But I think the message is that the USDA headquarters' team really is broad based and incorporates the -- the agencies within the Department to -- who have expertise in a role in pest management.

Our outside team at the Land Grant depends on our review internally. The use pattern is where is the chemical used, where is it important, what are the risk drivers.

So we will then contact -- through out network of pesticide impact assessment people, contact the appropriate expert, get them to agree to do the review in a reasonable time, ship it out and ask them for a response by a date certain.

As with most things, there's still some kinks in that process. These are not directly under our control, they are our partners, and they, like everyone else, have too much to do. So we are imposing on them to do something extra. And the timing isn't always something that is not as good as we'd like, but we're working on that.

Again, as I mentioned, the Land Grant review -- reviewers work with my team. Once their comments are in, we assemble everything in -- in my office. Therese Murtaugh does the bulk of that work. And then we will then ship our comments over to EPA.

Now, during this process, when we find issues, questions, concerns, we don't wait until everything is in. We will sit down with Lois and her folks and go over any issues that we've identified.

So again, we're trying to be more proactive, rather than looking at this as a huge block of time in which we're not communicating.

Any issues that are identified, we do communicate. And that I think is helping accelerate the process.

I think that's primarily what I wanted to cover. I guess the other thing -- the important feature of the team that we're putting together -- this is not a team that is here just for review and then it goes away and never looks at the chemical again.

I'm looking at this as building a group of expertise to engage later on in the risk mitigation or the risk management phase, as well as when needed to lead the transition strategy process when we do need to move to alternative pest management strategies.

The team we're putting together now and the depth of expertise that they're gaining from familiarity with the risk assessments, will help down the road in -- in both of those processes. And I think those are the main points. So both Lois and I will entertain questions.

MR. EHRMANN: And again, let's keep the questions in this portion to clarification or, you know, initial observations.

And this afternoon, we'll come back and have a more indepth conversation about how you might want to advise modifying this process for future work. Bill Lovelady?

MR. LOVELADY: Thank you, John. I have a question for Lois, and also one for Al. But before I do, I -- I had the opportunity to attend the hearing -- the oversight hearing last week.

And -- and I was hoping I could say this and get the floor before Jim came back in, because I certainly wouldn't want him to get a big head. But he -- he received some very, very good comments.

And I'm not saying this for EP or -- EPA or USDA's benefit, but for the benefit of the other members of this TRAC who were not there.

But Charlie Stenholm (phonetic) was extremely complimentary about the progress that had been made in the TRAC.

And I think it's important that everybody understand that there are members of Congress who are very happy with progress that is being made.

And -- and I say that because -- because we all know that there are people who have walked out of this committee because they say no progress is being made or not sufficient progress is being made.

So I just want everyone to know that -- that there are some who think that -- that good, positive progress has been made.

So now to -- after editorializing, I will get to my two questions. Lois, I just would like a clarification.

You said during the errors-only corrections that you received comments beyond just error correction. Could you kind of clarify how those comments are handled?

MS. ROSSI: Those comments are handled when we do the revised -- when we take the comments from phase two, I guess -- three.

They were -- they are just looked at with -- with the other comments that we get during the 60-day public comment period, if they're not --

MR. LOVELADY: So they --

MS. ROSSI: -- if they're not errors. If they're --

MR. LOVELADY: You don't -- you don't note it or anything? You just kind of roll them over into the next --

MS. ROSSI: Right.

MR. LOVELADY: -- phase?

MS. ROSSI: Right. I mean, we start start looking at them and they --

MR. LOVELADY: Okay.

MS. ROSSI: -- they give you a head start on what you might receive in phase three. Because lots of times they're submitted again in phase three. But we don't -- we don't respond at that time.

FEMALE SPEAKER: You do put them in the docket?

MS. ROSSI: We do put them into --

FEMALE SPEAKER: They do go into --

MS. ROSSI: -- the docket.

FEMALE SPEAKER: -- the docket?

MS. ROSSI: Yes.

MR. LOVELADY: Okay. And -- and -- and Al, now that you have had a chance to -- to see some of these and you have returned, what, four of them I believe you said, is -- is the time adequate to do -- in view of the complexity of -- of some of this data, is -- is the time adequate for USDA to do that?

And does the information come in a format that's usable? And do you have any suggestions of how things should change after having done four of them?

MR. JENNINGS: As Lois mentioned, the time is somewhat variable. We try to shoot for two weeks on the easy ones.

And those are generally just a headquarters' review, where we feel we don't really need to involve the Land Grants.

And it can go out to six weeks on the more complicated ones. So, yes, I think it is adequate and I'm sure we can negotiate longer if we really needed.

The one area we have had a lot of trouble with is in worker risk assessments, and that's partly I think because we haven't had this long history of the TRAC process with a lot of papers and a lot of discussion. Our Land Grant reviewers have been very puzzled by some of them.

And I think Lois and I have talked about the need to do a workshop with our Land Grant partners, or at least some of them, to go through the process and get a better understanding of how that works and what data are used in that process. So that's been I think our major concern.

MR. EHRMANN: Okay. Brad?

MR. LUCKEY: I think my comments are kind of the same as -- as Bill's. Looking at specifically phase four and then phase six.

And you allow yourselves 90 days, and I'm assuming those are calendar days, which equate back to only 60 work days.

And I'm wondering -- and Lois you did mention that sometimes you do get into a time crunch. Since this is a pilot process, how -- how concrete are these time lines? Can you extend them in order to be more comfortable with the information as you're collecting it?

And I guess Allen it would be the same question to you, in that you're looking at -- at -- at 60 calendar days, which is only 40 work days. Is that enough time and -- or is it too big a burden on the staff to try and get through this? And do we need to allow more time?

MS. ROSSI: The phase four where we revise the risk assessments. Well, at the work group I answered this question also.

I think it's a -- I think 90 days is probably a good target to shoot for. It -- it really depends on what your -- it really depends on the new data.

If you get new data that we are trying to review and that will make a difference in the risk assessment, that is what ends up taking the more time.

For the most part, I think the Agency has been able to get the bulk of the work done within the 90 days. So I think it's a reasonable time length to shoot for.

And what I think has taken a little longer, but I do think we're getting much better at this, is understanding what the risk assessment says after it's been completed, and looking at the drivers and looking at the sensitivity.

And again on these early ones, we've been developing process, developing thinking, developing methodology, as well as doing production.

And any time you're trying to do all of those three things with production, it's difficult and it takes a long -- a long time.

A lot of that routine thinking that we've -- the routine questions that we've been asking along with USDA in the assessments, we're getting pretty good at asking these questions and figuring out what it is. And so I think it will go smoother.

Again, also, I think some of the preliminary assessments that you'll see in these ones -- these 10 remaining ones where we have an issue of preliminary assessments, I think they will be of a higher quality than the earlier preliminary assessments, which again affects how much of a revised assessment you have to do in phase four.

So I think 90 days is a good one to shoot for. And I think it will be attainable as we continue to go through the process. But it has been -- it has been difficult in some of these early ones.

MR. EHRMANN: Al?

MR. JENNINGS: Brad, as I understand your question, it's near the same -- same as Bill's, is the time enough? Or did I miss that?

MR. LUCKEY: Basically, yes. Is there enough time?

MR. JENNINGS: Again, I think so. I'm counting on learning a lot. I'm also hoping on some increased resources.

I think as this process has gone on, you've seen new faces back here. I am bringing in people like Teung Chin on detail from other agencies to help with the process.

And again, Lois and I talk fairly routinely. And if we're having a problem, I'm sure we can get a few extra days to get our work finished.

These deadlines are things that we are shooting for. We recognize a need to bring reviews to conclusion, but they're not drop dead dates.

MR. LUCKEY: Thank you.

MR. EHRMANN: Steve Balling?

MR. BALLING: Lois, I'm curious about the sensitivity analysis for risk drivers. Any general conclusions from those? What -- is it the zeros? Is it specific high-risk crops?

MS. ROSSI: It -- it really varies. I mean, it -- depending upon the chemical, it -- it varies. Whether it's -- whether it's a crop, whether it's -- whether the zeros make a difference.

We've -- we've seen in each of the chemicals that we've done so far -- I mean, we've seen different things affect each one of them, residue values.

We look at the consumption data. We haven't really seen outrageous consumption, you know, like eating -- some commodity, you know, eight -- eight or 10 helpings of something. We haven't really seen that.

In some cases the endpoint might be the driver if the exposure and the residue levels are -- so we've seen various things.

It's -- it's not always the same commodity. And it also differs what's driving the risk, depending upon what subpopulation you're looking at.

So -- and it's even gotten into the food form of the commodity, which we're able to do.

You're actually able to go in and look at the -- at what food form it is. And in the case -- in some cases it's the food form, it's not the rock commodity.

MR. BALLING: Well, the reason I ask is in -- in the context of trying to be most efficient in collection of data, if --

MS. ROSSI: Um-hum.

MR. BALLING: -- if we go through what EPA has asked for over the last two and a half years, it's pretty much the kitchen sink. That data is very difficult to get, it's very expensive.

And in the context of trying to refine -- and as we go through these pilot processes, that seems the most appropriate thing. In the process of trying to refine that, how can we better provide what you really need?

MS. ROSSI: Ed, do you want to --

MR. ZAGER: Yeah. The USDA's Pesticide Data Program has been focusing on the top consumption foods -- top consumption foods mostly for children, and we found the data extremely useful.

And we've been able also to translate the data from those commodities to other commodities. So if you -- if you work in coordination with USDA, that's going to be very helpful.

Not to duplicate what USDA is doing. USDA is mostly focusing on rock commodities, but maybe to fill some gaps.

MR. BALLING: Just to follow up. Al, have you found these crop assessments that USDA's been developing with the Land Grants valuable?

MR. JENNINGS: The crop profiles, yeah. They are, in my mind, not tools for risk assessments. So much as tools for risk mitigation, risk management and probably transition strategies down the line.

But they have been very helpful in identifying which Land Grants need to be involved in the process, helping to identify the risk drivers, and have had many other uses that are not directly related to the review process.

So they are a wealth of information. But in my mind, they are a starting point on a lot of other things yet to come.

MR. EHRMANN: Okay. Jay?

MR. VROOM: My question goes to the volume of public comment input, and I guess that it would come in phases two, three -- I'm sorry, three, four and five, with opportunity for written comments in three and five. And some public input in the technical briefings during phase four.

And I've heard some grower groups in particular indicate that they feel real frustrated at that earliest public comment point.

That because of -- of the inaccuracies and the fact that they know that their comments will be more applicable and targeted nearer the end.

Have you seen a difference in the volume and -- and applicability relevance and robustness of the public comment?

And is there anything that we can learn from the -- the variations across those three points of public comment input that could help sharpen this process, both what you've experienced so far in the pilot, and then maybe can you compare it to other public comment experiences that predated FQPA even?

MS. ROSSI: Well, we've only -- first of all, we've only had experience with phase three. I mean, we haven't -- we haven't put a -- a revised assessment in the docket. I mean, that will happen very soon, but we've only -- we've only had that experience.

One thing, you know, that could be raised is for these preliminary assessments where we don't do overviews and summaries, which we have done in preparation for the phase five, is something that could be considered.

Again, I think that the quality of the preliminary risk assessments that you'll begin to see for these ones that will be entering phase three over the course of the next few months, will be much better.

Because they're incorporating, you know, a lot of the thinking and a lot of the practices that we're doing for the revised assessments.

We're incorporating them into these ones that are preliminary, we don't have a separate set of directions for the preliminary and -- and the revised.

So I think you'll start seeing that the preliminary will be better. And -- and the complexity I think may be an overview, and a summary might -- might help there.

MR. EHRMANN: Let me suggest we take the cards that are up. And then we'll -- we'll move toward our break. Bill?

MR. SPENCER: Until I got involved in the TRAC process, first meeting last May, I thought Monte Carlo was the third riskiest place in the world to gamble with your money after number one being my citrus farm and number two Las Vegas.

But I noticed with a little bit of interest when Lois was talking about risk assessments, I believe you said, Lois, that you were running the Monte Carlo -- Monte Carlo analysis at 99, 99.5 and 99.9.

MS. ROSSI: Um-hum.

MR. SPENCER: And I think when we went to the work group two meeting on the 7th and 8th, you had just that day released science policy paper number 11 where you -- where you are starting to at least put it out for public comment, choosing a percentile of acute dietary exposure as a threshold of regulatory concern.

And I guess my question is, if the Agency is already doing something other than 99.9, in the form of 99 and 99.5, are you also running these risk assessments at 95, which is the way that you used to do them, and 97.5, which was the way that our friends across the ocean do them?

MS. ROSSI: You can -- I mean, I mentioned 99. I mean, you can run them at -- at just about any percentile.

The printout will give you 95, 97, 99, so you can look and see what happens as you -- as you go through the different percentiles. So you don't have to just run it for 99.9, you get -- get all those percentiles --

MR. SPENCER: So --

MS. ROSSI: -- in a run.

MR. SPENCER: As a follow-up, is the Agency using that data?

MS. ROSSI: Well, we're using it to -- in -- in sort of sensitivity analysis to see what -- what is happening as you go from 97.5 to 98 to 99 to 99.9.

And it -- what it -- what it -- what it directs your attention is -- is it -- once you see what's going on, it directs your attention to go into the data and see what's going on.

What -- what residue levels are causing the change from -- in this percentile or this small increment in going from 97.5 to 98, or 99 to 99.5.

It directs your questions, it directs -- peeling back what's behind this.

Then you've got to look at the consumption and see if there is a routine or -- or a reasonable consumption or a very high consumption.

And -- so that's how it's used in -- in -- in your thinking. And ultimately that leads to the points that would have to be risk managed. Do you want to say anything about that?

MR. EHRMANN: Any more on that, Al?

MR. JENNINGS: As I mentioned at the work group, I think it's a question of how do you interpret the output of the model, and 99.9 and other points are -- are just one.

Lois, I think, mentioned that other sensitivity analyses are going on. For example, does it matter whether you have zeros or the limit of detection or the limit of quantification. In those cases where it doesn't matter, that's one less thing to worry about.

So I think the sensitivity analyses that are going on try to narrow down to the real risk and risk management issues we have to spend our time and effort on.

MR. EHRMANN; Okay, Bill. Robert?

MR. KEIFER: At the last work group meeting we -- there was some discussion on public health uses. And you mentioned out of the 10 chemicals in the intergovernmental review, that one of them is currently public health use at HHS.

And I wanted to know if you can give a little bit more information on that use, and also how the process with Health and Human Services is going?

MR. EHRMANN: Lois?

MS. ROSSI: There -- actually, there were two. It was -- and the two specific chemicals were temephos and fenthion. And they're both -- the use is mosquito control. That -- that's being looked at.

We have talked to the HHS people, and we are planning in the near future to also have a meeting.

The problem with them is they're in -- they're down in Atlanta, so we need to do a little bit more creative coordination than just hopping a cab over to the Department.

They have provided comments on fenthion, which we're currently looking at. And once we look at them, we -- that's when we'd like to go down and talk to them about that.

And fenthion, I don't think we received that --we have -- we received them on both. So we're in the process of looking at them. And we really need to engage them in a dialogue like we have with -- with USDA.

MR. EHRMANN: Okay. Tobi?

MS. JONES: Lois, I know you've received funding to develop a National Residue Database. But I don't see -- and I'll just say in the fenthion draft risk assessment -- risk assessment group, I don't see any indication that any of the state data from residue monitoring programs managed by the state has incorporated that.

Do you see some time in the future when you'll work through some of the issues on -- and most of those samples are composite samples, when you will be able to use some of those data in the future, in addition to PDP and other -- I'm sorry --

MS. ROSSI: PDP?

MS. JONES: -- PPD and other sources?

MS. ROSSI: PDP. I mean, as far as the composite, the answer is yes. I mean, we do have a methodology that we presented in considerable detail at the work group meeting on how we can use the composite data to estimate single serving. Ed, the role of the state?

MR. ZAGER: Yeah. For acute analysis, we'll have to look at the numbers and the quality of the data received from various states.

And the way I understand it, the plan is to incorporate over state and to the National Pesticide Residue Database, and I think that's being done.

MR. EHRMANN: Okay. Dan?

MR. BOTTS: At the risk of getting in a fairly lengthy discussion, which knowing it's break time, we'll save most of the discussion until after lunch.

Lois, I appreciate the fact that there's been a major change in the numbers relative to the risk assessment.

But just in your general impression, how much of that change in the risk assessment has been the result of -- of new information versus changes in the process and the model and the way you look at things and utilizing existing information that was already at the Agency, prior to publication of even the first preliminary risk assessment?

I mean, looking at -- and the reason I ask, just looking at the first one that we've had a discussion on, a lot of the base information that was used to refine the risk numbers already existed, either through PDP or some place else. The problem was the process wasn't in place, the issues weren't there.

And having said that, is it going to be reflected in the new preliminary risk assessments that we will have a much more focused document to respond to, as compared to the first ones out of the box back in August and September, which is really the model that we've looked at as far as how to respond, at least in this process? And the next question's for Al. But I'd like to get some kind of --

MS. ROSSI: You've got a --

MR. BOTTS: -- response to that first.

MS. ROSSI: -- few comments in your question -- in your -- or a few questions in your comments, or something like that.

The answer to the last part of your -- your comment, yeah. Like -- like I said, we are not going -- we don't have two sets of directions, oh, we do this thing for preliminary and we do this for revised.

I mean, as we make these changes in the revised as far as the process goes and use the PDP and whatever, we're going to incorporate those in the preliminary.

So I do think you'll see in these remaining 10, as well as other assessments that currently are for non-OPs that aren't in this process, you'll see that kind of process being used in those. So I do think the preliminaries will be better. You had another question about the data?

MR. BOTTS: Well, a big point has been made of all the new data that was submitted --

MS. ROSSI: Right.

MR. BOTTS: -- that had to be looked at as a result of preliminary risk assessment. That's -- and that's just not my impression of --

MS. ROSSI: Right.

MR. BOTTS: -- what's actually happened.

MS. ROSSI: Right.

MR. BOTTS: There's been a new way of looking at data that may have already been there, rather than absolutely new information that's been submitted. And it's just a feeling for --

MS. ROSSI: Yeah.

MR. BOTTS: -- for how --

MS. ROSSI: I think --

MR. BOTTS: -- the relationship --

MS. ROSSI: I --

MR. BOTTS: -- between those two points.

MS. ROSSI: I think the difference is that new -- the new data has mostly related to the toxicology side of the whole equation.

Whereas, utilizing the data on hand and -- and just looking at it differently and developing methods to use it the best way has mostly happened on the exposure side. So that's kind of how the mix has played out. I mean --

MR. BOTTS: Yeah. I think your answer drives to the reason I asked the question. Because the exposure side is the stuff that we in the user --

MS. ROSSI: Right.

MR. BOTTS: -- community --

MS. ROSSI: Right.

MR. BOTTS: -- can deal with.

MS. ROSSI: Right.

MR. BOTTS: If it's a tox side, that's not something that we in the user community are really going to be --

MS. ROSSI: Right.

MR. BOTTS: -- the experts on. And would hope that there would be a lot of dialogue with the registrants or other people who have expertise with their own chemistry to drive that toxicology question.

The other question that's for Al, and listening to the discussion from this point forward, especially in the technical briefings that come forward, it's -- this is a little bit of change from some discussion that we had before that it was -- at one it was USDA bringing risk mitigation proposals together.

And what you just said, it was probably going to be USDA at that technical briefing that comes forward with risk mitigation.

What are the plans within USDA to open up that process to make the mitigation process development as transparent as how the Agency's done with the exposure and some of the other information processes?

MR. EHRMANN: Let me ask Al to -- let's have a brief response here. I think that's really in a way the topic for tomorrow's discussion on transition, more than evaluating the pilot process.

But let's -- let's -- let him respond here, and then I think we'll get more time on it when we get to that part of the agenda. We can do it either place, but just in respecting the time. But go ahead, Al.

MR. JENNINGS: Well, then I'll brief that. I think it's a joint effort with EPA, and the briefings I think are the starting point.

And I envision some follow-up -- I would say a lot of follow-up in some cases, involving all stakeholders. And we can talk more about it tomorrow.

One of the things we are thinking about is some kind of a list server page where we can get into transition and mitigation and -- so we don't have to have meetings in Washington back to back for the next five years. But a way of dealing with this that will involve you and the internet hopefully.

MR. EHRMANN: Let's make sure we come back again to that either this afternoon or --

MR. BOTTS: We'll talk a little bit about it this afternoon --

MR. EHRMANN: Yeah.

MR. BOTTS: -- I'm sure.

MR. EHRMANN: Yeah. But if I remember right, you'll have a shot at another bite at the apple, so to speak, this afternoon.

MR. BOTTS: That is right.

MR. EHRMANN: Let's go ahead and take a 15-minute break and we'll come back and pick up with the discussion on azinphos.

(BRIEF RECESS)

MR. EHRMANN: Briefing on azinphos-methyl. And again, at the work group meeting a few weeks ago we had a first run through this just on the dietary portion.

What you're about to hear is going to be some additional information on the dietary side, as well as the current state of affairs as it relates to other aspects of the overall assessment.

So this is some -- some new information, and I want to turn to -- to Lois to initiate this part of the agenda. Lois?

MS. ROSSI: Okay. We're going to describe and explain the complete risk assessment for azinphos this morning, and illustrate how the assessment has changed and evolved through the various phases of the TRAC pilot public participation process.

We're going to try to show how this particular chemical went through the different phases.

Before I get into the specifics, for those of you who were at the work group meeting, this might be a repeat.

But for everyone here, I would like to introduce the azinphos team that's been working on this chemical for the last X number of -- of months. They're mostly sitting behind me, so I'm going to get up here.

Starting with -- Barry O'Keefe is with the Special Review and Registration Division. He is the chemical review manager for azinphos. He has coordinated the entire review of this chemical, the first line of contact for all questions and issues, and will be responsible for leading the risk management phase of the chemical.

Jess Rowland from the Health Effects Division, the toxicologist on the chemical. Kathy Monk, with Special Review and Registration, the branch chief on the chemical.

Dave Jones from EFED, Environmental Fate and Effects Division, the agronomist and risk assessor for the water part.

And Mike Metzger, who presented at the work group meeting the probabilistic assessment and methodology, a chemist branch chief on the project.

At the table -- and first of all, over by the slides, Felicia Fort, who is going to do the slides for us this morning.

But who -- whose role in the assessment has been -- Felicia has done all the probabilistic runs on the deem model for us, and has done many, many, many, many runs for us.

Jack -- presenting today on the -- on -- will be Jack Arthur, he will present the worker risks. He's with the Health Effects Division.

Catherine Eiden is also with the Health Effects Division, she's the risk assessment coordinator for azinphos.

And lastly but not least, Rich Dumas is with Special Review and Registration, and he's going to present the -- he's a team leader on azinphos, and he's going to present the use profile.

Oh, I forgot two very important people. The use people from our -- our Biological and Economic Analysis Division, Neil Anderson, the biologist on the chemical. Stand up. And Tom Kiely, the economist.

I just wanted everyone in the TRAC to see who the team is behind -- the actual people behind all the paper and the assessments that we've done here today.

Okay. We're going to expand on the acute dietary case study that was done for the work group session two weeks ago, in that we're including a discussion of all the risks that we consider in a comprehensive assessment.

This assessment, I'd like to point out, is not just one that's being done for the OPs or for azinphos, but it's the one that we do normally in the registration review of every single chemical.

The assessment will -- will consider worker risk, ecological risk, as well as the dietary risk from food and drinking water.

For azinphos, we will not be representing the residential risk assessment because it doesn't have residential uses. If it did, we would.

We're again using azinphos as an example to build on the case study already presented to the work group, because azinphos illustrates many of the complex methodology and policy issues related to the OPs that we are going to face.

We happen to be facing it -- facing some of these issues with azinphos. But it is not alone, in that we will be facing many of these issue with the other OPs.

Also, azinphos is relatively far along in the pilot process. It was among the first group of OPs that are nearing the completion of phase four. It -- it started actually phase one back in last August.

Today's presentation is intended to be an example or prototype for the technical briefings that conclude phase four of the pilot process for the OPs.

The technical briefings will be public meetings jointly hosted by EPA and USDA or HHS, and are intended to share the refined risk assessment and initiate the discussion of risk management options.

As with the previous acute dietary case study, our goal is to show advances in methodologies and the many revisions that have been incorporated into these assessments.

We'll try to clarify where assumptions are used, where actual data are used and the sources of those data, and the uncertainties associated with these assessments.

Finally, we intend to focus the discussion on risks that appeared to be of concern, since these will be the focus of the next phase that azinphos will enter, phase five and phase six of the pilot process.

The azinphos-methyl -- the azinphos-methyl risk assessments considered both human health effects and ecological effects.

Among the potential effects on humans, we look at dietary exposure from food and drinking water on both an acute and chronic basis.

We also consider risk to agricultural workers before, during and after pesticide applications. Azinphos has no residential or public health uses, so those risk assessments were not performed.

It's important to note that exposure bystanders, including children, is possible from secondary exposure to azinphos, such as drift into residential areas and from clothing brought home by agricultural workers.

We currently do not have a method for quantifying these types of exposures, and they're not reflected in this assessment today.

In the ecological effects assessment we consider potential effects of pesticide use on birds, mammals, fish and other aquatic species. As well as the possible impacts on water resources, specifically drinking water.

Where is this chemical in the pilot process and how did it get to where it is today? That -- by the way, you have a copy of these slides in your packet to follow along. That slide presents the phases one through six. And it presents for the health effects and the ecological assessment, the dates which various completions in the review go.

You can see first of all that the health effects assessment is slightly ahead of the ecological assessment, and we'll -- and that will become obvious when we talk about the ecological assessment.

But it went through phase one, the health assessment, last July it was placed. The docket was the -- it went through the error/comment period.

The docket was opened in August. There were really no substantive errors identified in either assessment. The -- the ecological one entered phase one in -- in November, so there -- there is that lag.

The minor corrections to the ecological assessment included correcting typo's, clarifying a model input value, and reconciling a table to match the text. It was out of since there. There were no major changes made prior to the opening of the public docket in phase two.

The preliminary health assessment that was placed in the docket in August showed acute dietary risks of concern. And that assessment was based on a non-probabilistic model, referred to as the DRES system, D-R-E-S.

Use of mostly tolerance-level residues, except for blended commodities where we used field trial data; 100 percent crop treated, which was necessitated by the use of the non-probabilistic model to estimate acute dietary risk; and USDA consumption data from 1977 and 1978, which is the consumption data in that DRES model which was used at the time.

The preliminary human health assessment also indicated a concern for workers based mostly on surrogate data, and some chemical-specific data.

The preliminary ecological effects assessment indicated risk of concern for both aquatic species and terrestrial species. The concern for aquatic species is in part based on many incidents resulting from azinphos use.

During phase three, comments on the human health assessment were received from the registrant, public interest groups and growers. We received 31 comments, about half addressed azinphos specifically.

We also received a number of comments that dealt with issues that relate to all of the OPs, such as the nine policy issues and consistency among the assessments.

The registrant's major concern was that the Agency should incorporate data that is currently in development before moving forward. This outstanding data will be discussed further after the presentation on the risk assessments.

Growers commented on the importance of azinphos in agricultural, specifically in the integrated pest management programs and for crop/pest combinations for which there are few, if any, good alternatives, such as control of the codling moth in cherries, several pests in apples, and the import quarantine use for almonds.

Public interest groups question the removal of the 10X FQPA safety factor, and called for action based on the preliminary dietary assessment.

Along with comments, both growers, registrants provided additional data. Growers provided information on use practices that enabled us to verify percent crop treated, actual use practices, application rates and other use perimeters.

Registrants provided a Monte Carlo analysis, along with the residue data files that enabled us to do multiple runs with different inputs and assumptions.

The registrants also provided dermal exposure studies for cotton and apples. These are so-called, and we'll get into this term.

And hopefully by the end of the day we'll all be familiar with dislodgeable foliar residue data, which basically tells you how much of a chemical comes off a plant and gets on your skin as you're walking through treated areas.

That provide actual measurements of the amount of residue that workers could contact in the field during the course of harvesting and other post-application activities.

(END OF TAPE)

Even though some of these data were submitted after the close of the comment period, we have taken them into consideration and reviewed them and are -- they are accounted for in our revised assessment that we'll talk about today.

Phase four revisions to the assessment. The most dramatic changes to the preliminary reassessment -- or assessment resulted from refinements to the acute dietary risk assessment.

This was possible because the Monte Carlo submission with residue files that allowed us to do multiple runs, and sensitivity analysis projecting what-if scenarios.

However, it should be mentioned that EPA's development of the methodology for being able to use monitoring data from USDA's pesticide data program, PDP, in acute assessments, also had a big impact on the assessment.

For the worker assessment, the dermal exposure data that were submitted did not greatly change risk estimates for post-application exposure to azinphos.

However, azinphos specific data gathered under actual use conditions increased the level of confidence in these post-application risk assessments.

No changes were made to the chronic dietary risk assessment, the drinking water or some of the mixer/loader/applicator scenarios for the worker assessment.

In summary, we've made many changes to the preliminary assessment, which are reflected in the revised assessment, and which will affect other assessments.

As well in -- specifically developing a method for using the monitoring data for acute dietary assessments, developing the in-house Monte Carlo capabilities, our ability to perform sensitivity analysis to see which factor most influences the risk assessment or which piece of data, and incorporating new data as it comes in, particularly from the agricultural reentry task force.

The work that remains to be done focuses mainly on the ecological assessment, which is currently still in phase four, and we are working on that. The comment period didn't close that long ago.

So now it's getting into the specifics of azinphos, I've tried to show you how it's gone through phases one through four, and is about ready for phase five.

A little bit of regulatory history, in that we have been working on azinphos -- different aspects of the azinphos review for some time.

But the whole comprehensive one came up in the que, and the reregistration red review que about a year and a half ago.

A registration standard actually was issued for azinphos back in September of 1986. And then it is subject to the FIFRA-88 requirement, so it was in -- in the reregistration program once again.

We also worked with the State of Louisiana on -- with regard to their use of azinphos on sugarcane back in 1993, based on some large fish-kill incidents in Louisiana. And we worked with the registrant, the state, and the use of -- of azinphos on sugarcane became a prescriptive use only.

And it was -- and we increased buffer zones and -- on incidents monitoring program and this use we said would be definitely dealt with when -- at the time of reregistration.

Azinphos also was looked at along with the other OPs, a total of 28 chemicals, OPs and carbamates, and an acute worker risk strategy that we undertook in 1992, which was an analysis based largely on incident data from California, as well as from Poison Control Center data.

And recently over the last year, we've worked with the State of California on emergency regulations that they've undertaken regarding worker exposure, and particularly the post-application exposure involving extending the reentry intervals. And we'll get into that a little more in the presentation.

We've had a series of label changes on azinphos, in part because the California regulations, and in part because of the Agency's work with the registrants to implement some interim mitigation.

Which included some additional personal protective equipment and closed cabs, and the use of the closed mixing/loading systems for products.

The REI, the reentry intervals for various commodities have been extended to 14 in 30 days and 21 days, depending upon the commodity. And we'll talk a little bit about that later.

Right now, we -- I'd like to get started with the presentation with Rich Dumas, who'll go briefly through the use -- the uses that we're considering in the review.

Catherine Eiden will talk about the actual human health assessment, the dietary portion. And Jack Arthur will discuss the worker risk assessment. And then it will come back to me for the rest.

MR. DUMAS: Okay. Azinphos-methyl was first registered for food use in 1959. It is currently registered on about 50 foods.

The Agency typically gets its use information from USDA and some other sources. In some cases, we actually get registrant and grower-group information.

When we get this type of information, what we normally do is we compare it with our other information. Oftentimes it corresponds with the information. In fact, it even comes from the same sources.

However, when we do find inconsistencies, we look -- delve into it further to reconcile those differences.

In the case of azinphos-methyl, the comments that we receive were -- or the data that we receive were primarily from USDA.

For more information on sources -- sources of use data, how estimates are developed, and how the Agency uses these estimates in risk assessment, the Agency recently completed a draft paper on use information that will be available for public comment in the near future.

On average, 2,000,000 pounds of azinphos are used per year. Of that amount, over half is used on fruit trees, about 15 percent on nut crops, and about 20 percent on cotton.

Foods for which a high percent of the crop is treated include apples, pears, cherries, with at least 50 percent of the crop treated.

And in addition, blueberries, almonds, pistachios and cranberries have at least 25 percent of the crop treated.

Azinphos is used throughout the U.S., but is most widely used in California and the Pacific Northwest on tree crops and in the Delta States and in Texas on tree and cotton.

As you'll hear in our discussions this morning and this afternoon, use practices, that is application rates, application method and reentry, play an important role in our risk assessment.

To illustrate this type of information, I refer you to the table either in your handout or on the screen. What the table shows is the Agency's most current use information that can be incorporated into our risk assessments.

The crops that are used were primarily there, not to pick on any one crop, but it was just to show ones that were important for some reason, such as high-percent corp treated or a large volume of use.

Just to sort of look at the table, you'll see, like, percent crop treated. I think most of you are aware from how important that can be in our risk assessment.

The application rate and the number of applications actually -- as you'll see more in -- today, are important not only in our dietary risk assessment, but also in our occupational and ecological assessments.

And the reentry intervals in particular, you'll see when Jack talks about occupational risk, are very important.

And final point on this table is you'll notice a few NS's, and just -- we didn't put a footnote unfortunately on that. What that means is it's not specified on the label.

And sometimes instead of putting a maximum application rate and the maximum number of applications, we'll put a cap on the maximum that can be used per year.

And that affords a -- a grower community a little bit more flexibility on how they can use this to control their own pest problems.

To give you more information on how the Agency's azinphos assessment was done, I'll turn the presentation over to Cathy Eiden for the dietary and aggregate risk assessment, who will be followed by Jack Arthur on the occupation assessment.

MS. EIDEN: Good morning. It's a pleasure to be here. Is this on?

MS. ROSSI: Yeah.

MS. EIDEN: Okay. The human health risk assessment consists of several components. And I will be describing the dietary inclusive of food and drinking water, and then briefly the aggregate assessment.

Next slide, please? Some of you may be familiar with this particular equation, it's the risk equation, basically hazard times exposure, where exposure is a product of consumption times residue.

In this sense, we're talking about the consumption of food items, how much you eat of a particular item, how often you eat it. And then the residues of -- in this case, talking about azinphos-methyl, that may be on those food items.

Two basic dietary assessments were conducted for azinphos, an acute assessment which is meant to reflect one-day dietary exposures to azinphos-methyl and a chronic dietary assessment that is meant to reflect lifetime exposures to azinphos-methyl in a diet.

Let me just say one thing here on the chronic side, that assessment was completed fairly early in the process and the risk estimates based on that assessment were not of concern to us.

So most of my presentation will be focused on the acute dietary, which is also a reflection of the effort and time that we put into the acute dietary assessment for azinphos-methyl.

The next few slides will basically go over the toxic endpoints that were selected for azinphos that were used in this assessment.

I want to point out that these toxic endpoints are basically how we measure the hazard associated with the chemical, and these toxic endpoints are the fundamental basis of these risk assessments.

For the acute toxicity of azinphos-methyl, we used an acute neurotoxicity study in rats, and the endpoint or toxic effect selected as the basis of the risk assessment was cholinesterase inhibition in red blood cells, plasma and brain tissue.

Significant effects were seen at one milligram per kilogram body weight per day, and this was the lowest dose tested in this particular study, and for that reason, we established that -- that level, that dose as the lowest observed adverse effect level, the LOAEL.

Because the lowest dose tested had significant effects, we could not establish or determine a no-observed adverse effect level from this study.

And this particular endpoint then most accurately reflects what we would believe could be toxic effects experienced from exposure to azinphos in the diet over a one-day period.

Next slide? This slide captures the same information used in the chronic dietary assessment for azinphos-methyl. Some of you saw the acute assessment previously.

For the chronic assessment, we used the results of a one-year chronic feeding study in dogs. The toxic effect or endpoint selected was also cholinesterase inhibition, but in the red -- red blood cell only.

The level at which the cholinesterase inhibition was seen, was point seven milligram per kilogram body weight per day. This was established as the -- the LOAEL, the lowest observed adverse effect level.

And in this study, the next lowest dose tested, 0.15 milligram per kilogram body weight per day was established as the no observed adverse effect level, as we did not see any effects at that particular dose.

And again, this endpoint reflects what we believe would be potential toxic effect seen from long-term, lifetime-type exposures to azinphos-methyl in the diet.

Once we select the endpoints based on the toxicity data, we make a determination as to the uncertainty associated with those results.

And in the particular case for azinphos-methyl, we applied the following uncertainty factors. A 10X factor for interspecies variability, that has to do with extrapolating from the test species which was rats to humans.

A 10X factor for the interspecies variability, which has to do with sensitivity differences within individuals within a species, be it rats, dogs or humans.

And we applied an additional 3X factor to the acute dietary assessment only, to account for the lack of a NOAEL, no observed adverse effect level. We removed the FQPA safety factor for special sensitivity in infants and children.

The total uncertainty factor then applied to the acute dietary assessment for azinphos was 300X, and the total uncertainty factor applied to the chronic dietary assessment was 100X.

And this is a typical type of uncertainty analysis that's conducted on a daily basis in the Office of Pesticide Programs.

This information on endpoints and uncertainty factors is then used to basically calculate the reference doses for chemicals.

In the case of azinphos-methyl, the LOAEL value divided by the uncertainty factor results in the acute reference dose used as the basis of the acute dietary risk assessment, point zero, zero, three milligrams (.003) per kilogram body weight per day.

And the following equation shows you the -- how the chronic reference dose was calculated for the chronic dietary assessment, point zero, zero, one, five milligram (.0015) per kilogram body weight per day.

And these -- the reference dose then is used in a percentage form as a measure of risk. You can think of the reference dose as the exposure or dose which we do not want to exceed.

And we compare exposure calculated to that reference dose to develop our risk measure in the form of a percent of the reference dose.

An analysis was done regarding special sensitivity to infants and children for azinphos-methyl. The database was complete and of good quality, and a comprehensive review was made of that database. As well as a search of the open literature from 1969, looking for any articles that might be present from 1969 to the present that might describe any sensitive effects. And the basic conclusion of that effort was that for comparative cholinesterase inhibition between adults and their fetuses or offspring, there was no evidence of that.

And on that basis and some of the other points up there on the slide, the decision was made to remove the 10X factor.

There was also a determination not to require a developmental neurotoxicity study at this point for azinphos-methyl.

However, the Agency is considering a broader requirement for a DNT study for a broader class of compounds of which AZM would be included.

The other side of that risk assessment equation is exposure. And exposure is a function of consumption, foods you eat, how much you eat, and residues, in this case of AZM that might be present on those foods.

To include consumption in our assessments -- as you've heard, we use the USDA's continuing survey of food intake by individuals.

These particular assessments for azinphos-methyl used the most current data we had at the time that had been validated, that was the 1989 to 1991 data. And as soon as the 1994 to 1996 data are updated, we will be using that.

USDA will also be providing us some supplemental information on children's foods, and we expect that information in December of 1999.

Okay. If you're looking at your handout, this is slide 29, it's a -- out of sequence. The other part of the exposure equation then is the residues present.

We have several sources of data that we can go to, to use in our assessments on residue data. We can -- at a tier-one assessment, which is a preliminary assessment, very unrefined, almost really a screening-level-type of assessment, we use tolerance level residues, these are worst-case residues not expected at the point of consumption.

At the tier-two level, we can use field trial residues. These are high-end residue values, also not expected at the point of consumption, and more reflective of residues on the food item or crop at the farm gate.

At tier three when we're moving into our probabilistic assessment, we're turning to monitoring data and leaning heavily on USDA's pesticide data program data, as well as FDA's surveillance marketing data. And when we have it available, Market Basket data for specific food items.

And the point of this slide is that as we move through these tiered level of residue information, we're refining our risk estimates based on data that closer approximates actual residues at the point of consumption.

As I said earlier that our chronic dietary risk assessment's at a fairly unrefined level of analysis, using field trial level residues, resulted in risk estimates that were below our levels of concern.

Because of that, we stopped our analysis at that point. Any further refinement would have provided us with lower risk estimates, and we focused our attention on acute dietary assessments for azinphos.

But the results of the chronic dietary are presented on the next slide, for four subpopulations of interest.

The risk estimates are given as a percentage then of the chronic reference dose that was described earlier and the most exposed subgroup on this particular assessment was children one through six, where -- basically what that is telling you is that residues of azinphos-methyl in the diet were taking up 33 percent of the available exposure or dose -- chronic reference dose.

At this point I'd like to turn your attention back to the acute dietary assessment, because we did spend an awful lot of time on this.

The acute dietary assessment -- the first phase was a tier-one assessment using tolerance level residues, it was non-probabilistic, and we assumed that every crop on which azinphos is registered had a tolerance level residue.

The tier-three assessment that was a probabilistic assessment, then used monitoring data, and we incorporated information -- specific information on the percentage of a particular corp treated with AZM.

The monitoring data used again was USDA's PDP, that is statistically designed for these types of dietary assessment. It has important children's and infant's foods included in it. We also used FDA surveillance monitoring data when we did not have USDA's PDP data for a specific crop.

Visually, you can think of these two types of dietary risk assessments. The slide up there now is showing you the non-probabilistic assessment.

In that assessment, we use a range or distribution of consumption values taken from the CSFII, and we assume that a high end, in the case of azinphos, a tolerance-level residue is present on each piece of food eaten.

That results in a range of exposures -- dietary exposures that are very high end and unrealistic of what you might actually expect at the point of consumption.

The next slide shows you visually or graphically the probabilistic type of assessment. In this case we use the same distribution or range of values related to consumption; however, we use that along with a range or distribution of values on residues of AZM, and again, taken from our various sources of monitoring data.

The result of this assessment is a range of exposures to azinphos-methyl in the diet that -- are reflective of what you would actually expect at the point of consumption.

Not to beat this to death, but again, the types of residue data that we use relied extremely heavily on USDA's PDP program. We were able to use data for approximately 80 percent of the foods consumed in the assessment.

We also supplemented that PDP data with FDA surveillance monitoring data. Although I must say PDP data are the data of first choice when they are available.

As a third choice, in the absence of either FDA or USDA data, we will use field trial data. But acknowledging that they are high-end residues and less reflective of residues at the point of consumption.

We use processing data related to foods that are blended and processed, that might be cooking factors, saucing factors, dilution factors or concentration factors.

There is, I think, something in your handout that goes through the specific foods and how they were handled in the analysis as far as the data used for each of the different crops, and you can refer to that for specifics on that.

The results: Okay. For the acute dietary, this slide provides risk estimates as a percentage of the acute reference dose for four subpopulations of interest. And in the first column there under the 95th percentile, those were the results from our tier-one analysis, the screening level analysis with tolerance level residues, and assuming that 100 percent of the crop was treated with azinphos-methyl. And you can see why we moved to the tier-three assessment.

At the 99.9th percentile of exposure under a probabilistic assessment, the risk estimates change fairly remarkably.

And in the middle column there, that was the results of the assessment that we sent to the U.S. Department of Agriculture.

In the column to the far right then are the risk estimates at the 99.9th percentile of exposure based on a very refined risk assessment, using the most current information that we had. The most highly exposured subgroup as you can see, is children one through six.

I want to make one comment here that the results of these assessments are very sensitive to the toxic endpoint used.

In the case of the previous -- or the acute assessment, if we had used a chronic reference dose that was not rounded down to one significant figure, the risk estimate for that most exposed group, children one through six, would probably have been around 120 percent.

And I just point that out, again, to let you have some indication of how sensitive these dietary assessments are to the toxic endpoint selected and used. Did I say -- what did I say? It was the acute reference dose. All right.

This side is a continuation of the results that we've seen previously. However, it provides you with a look at the risk estimates, again, as a percentage of the acute reference dose at two different percentiles of exposure, the 99.9th on the far left and the 99th in the middle column.

The far right column is probably the most interesting. It shows you the percentile of exposure at which we reach 100 percent of the acute RfD, which would be -- you can think of as the -- as far as we might want to go.

At the 99.89th percentile of exposure, you're at 100 percent of the acute RfD for infants less than one year.

And at the 99.83 percentile of exposure, you are at 100 percent of the acute reference dose for children one through six.

The main differences between the assessment sent to USDA and the most recent assessment or the current assessment, are shown on this slide.

New percent crop treated data, use of single serving data on pears, and we used canning or saucing factor for canned fruits and the acute dietary assessment.

We also did an analysis to determine the -- the critical or the -- the major contributors to these risk estimates, specific crops.

And in the case of azinphos-methyl, the major contributors to the risk estimates were peaches, apples, pears and cherries.

Some of the minor crops, that is those crops that had very little affect on the risk estimates, included tomatoes, grapes, almonds, citrus and beans.

We also did an analysis to determine the effect of basically substituting zeros into the residue distribution for all samples for which non-detectable residues were reported, and that had very little -- significant impact on the results of the risk estimates.

And finally we're looking at percent crop treated data and how much of an effect those types of data have on the risk assessments.

Okay. So in summary then on the acute dietary assessment, we've developed methodology that allows us to use PDP and FDA data in our acute dietary risk assessments.

And this then included monitoring data in this assessment for approximately 80 percent of the foods included in the assessment, most -- included most or if not all of the major contributors to the risk estimates.

We used most current crop treated information, and we conducted the -- again, as I said, the sensitivity analysis to look at the different crops that would be driving the risk as -- as Lois referred to these crops before.

The sensitivity analysis is going on to look at the tail of the exposure distribution to see if there are any outliers as in people that eat 10 pounds of apples a day, or unusual amounts of food, or maybe very high-end residues that would be suspect.

At this point, I'd like to turn your attention away from food and talk about the drinking water assessment.

As you've heard, azinphos-methyl is widely used on a number of crops based on its use pattern and some of its environmental fate characteristics.

We determined that we needed to conduct drinking water assessment for azinphos-methyl, and the environmental fate data indicated it could get into the surface water and potentially into some limited sources of ground water.

Our available monitoring data do show that AZM gets into surface water. And we have had some sporadic results, detects, also in ground water.

We, however, relied on model estimates for the drinking water assessment. And we do expect some exposure to AZM in drinking water, and therefore some contribution to the risk. Concerns raised by this very preliminary assessment indicated the need for additional monitoring.

I don't know if you all are familiar with TRAC's science policy paper number five, but it does lay out how we estimate drinking water exposure for inclusion into the dietary risk assessments.

And as per that paper, generally we determine the exposure to food first and then concentrate on the drinking water.

In the case of azinphos-methyl, I will use the chronic assessment as an example. For the children's group one through six, remember the chronic percent of the RfD that was taken up was 33 percent. This is basically telling us that we have a 67 percent of that chronic reference dose left over.

And our drinking water assessment then included an estimate of the drinking water exposures based on model estimates that was determined to be less than the remaining 67 percent of the chronic RfD.

And based on this, again, screening level preliminary assessment, we determined that drinking water concerns -- the chronic exposure to azinphos-methyl in drinking water was not of concern.

And we base this conclusion on the health-protective nature of the model estimates used to estimate the drinking water exposure.

That is, we don't expect concentrations of AZM in actual drinking water to be as high as the estimates from our models.

Last slide is -- or last two slides, basic summary. The aggregate risk assessment is something as you know that we now conduct under FQPA.

We consider exposures not only through food, but in drinking water. And if there are any nonoccupational exposures such as lawns or golf courses or home uses, we consider that as well.

But azinphos-methyl having no nonoccupational registered uses, we only consider food and drinking water in the aggregate risk assessment for AZM.

And in the case of the acute assessment, we did not conduct an aggregate acute risk assessment because of the results of our risk estimates for acute exposure to AZM on the dietary side.

We did, however, as I have shown previously, do a preliminary screening-level-type assessment aggregate chronic risk assessment for AZM.

And that assessment indicated that the combined exposures to AZM in food based on a very refined assessment using monitoring data and exposures in drinking water based on model estimates, were not of concern.

At this point, I will turn the presentation over to Jack Arthur, and he will tell you about the occupational risk assessment.

MR. ARTHUR: Thank you very much. I'm pleased to discuss with you this morning the worker risk assessment.

This first -- this first slide simply shows you that there are actually a couple of different worker populations that we're covering in our assessment.

One of them are the handlers, and these are the professional applicators and farmers and growers who mix, load and apply pesticides.

And then the other group are the post-application workers, and these are the people who conduct activities in the field following pesticide application.

We assessed these two groups separately, because the kinds of data that we have for them and the approach that we use in assessing their -- their risks are different.

The next slide -- there are a number of factors that form the basis for our risk assessment for pesticide workers, and I've listed them here.

I'll briefly go through them, and remind you that later this afternoon there will be a discussion of our approach in general.

But the first factor I've listed is that formulation and application equipment have an impact on the exposure potential.

It makes a difference whether you're using liquid versus wetable powder, or using an airblast sprayer versus a groundboom sprayer.

And because of this fact, we assess all the different relevant combinations of formulation and application equipment for azinphos-methyl.

The next factor is unit exposure. It's an indicator of exposure potential in milligrams of active ingredient per pound of active ingredient handled. And this varies according to formulation and application equipment type.

The rate of application in pounds AI per acre, that's the normal one we have, is -- I guess the affect of that on exposure potential is pretty obvious.

And areas treated per day -- acres per day is the normal one we work with. And these values primarily vary, depending on the capabilities of the application equipment and formulation that you're using.

The toxicity endpoint is a toxic effect of primary concern for our pesticide assessment. And it's expressed as a dose to the test animal where this effect is actually not seen, and that's expressed as a no-observed adverse affect level in our assessment.

And the last factor I have listed are levels of protection. These include the use of protective clothing or PP -- PPE, personal protective equipment, which refers mostly to respirators and engineering controls which covers a variety actually of controls.

And we assess each exposure scenario with -- at a baseline, and then with varying levels of mitigation. So that in the end, we can see the effect and the need for these mitigation measures.

The next slide is where we bring all of these factors together in our handler-risk calculation. We're just talking about the handlers now, and I'll talk about the post-application workers in a moment.

The dose -- exposure dose is the unit exposure times the application rate times the acres per day times the dermal absorption factor if you need one.

For the acute effects for azinphos-methyl, we did not use one because we had a 21-day dermal toxicity test -- animal toxicity test that we use directly in our calculation. And those factors are divided by body weight to give a milligram per kilogram per day exposure dose.

Now, our risk expression is known as the margin of exposure, which is the ratio of the no-observed adverse effect level in the animal study to the potential human exposure dosage.

We do this calculation for each of the exposure scenarios that we identify for the azinphos-methyl handlers, and we usually want this to be at least 100 or above.

Next slide? Now, for the next two or three slides I've simply listed the 14 exposure scenarios that we came up with for azinphos-methyl. You can see that they're organized by mixing and loading liquids first, and then mixing and loading wetable powders. And then under each of these, we've listed the type of application equipment that matched with this formulation. And in the italics below each major grouping are the maximum mitigation measures that we figured in our assessment. We also did these, as I indicated before, at the baseline exposure and with just personal protective equipment and clothing.

Also you'll notice that we -- for each of these scenarios, we've chosen a couple of important representative crops. And we used their application rates in the exposure calculations for each of those -- for each scenario.

The next slide is just more of the 14 scenarios that we've identified. And then the next slide is likewise.

Getting right to the results of our assessment. The results for our short and intermediate term handler risks.

Out of the 14 handler scenarios, one has an MOE above 100 when considering the short and intermediate term exposure.

I'd like to move on now to the post-application worker population. There are a couple of major factors that -- upon which we base our risk assessment for post-application workers. One is the dislodgeable folia residues, which have been mentioned a couple of times earlier on today.

And simply put -- I think it was put simply before, I'll do it again. It's the amount of the residue on foliage that workers can contact.

And then the transfer coefficient is an indicator of the amount of the pesticide residue that workers actually contact. It's a bit more complicated than that, but -- simply put, that gives you an understanding.

And these factors come together in the formula that you see below, to give us a dose again for the workers. It's a dislodgeable foliar residue number times the transfer coefficient times an eight-hour day divided by the body weight.

And then we again use the -- we use the acute NOEL -- acute affect NOEL divided by that dose to give us our MOE.

And by looking at MOEs on various days' post-application, we can determine what reentry interval there should be.

And in your note there you see that the reentry interval is that period of time during -- following application, during which the worker cannot enter the field.

The next slide we've included to show that -- for this assessment for azinphos, we were fortunate because the registrants had supplied data on dislodgeable foliar residues.

And also we had real data for transfer coefficients, at least for the orchard crops and citrus crops.

And many times we don't have this data and we have to rely entirely on our standard default assumptions.

Some of those were included in this assessment. But for -- for orchard crops and citrus crops, we had some good transfer coefficients.

And now the next slide shows the results of the post-application risk assessment. And using our data and methodology, we found that the risk assessments for reentry workers for azinphos post some concerns, especially based on the current application rates and REIs that are on the labels.

Many of those reentry intervals have been established at two days, except for the stone and pome fruits and nut crops, which are at 14 days, and grapes are at 21 days, and citrus are at 30 days.

The table below shows you some of the results. We didn't take it all the way out as far as it would go. But we show for the major crops that we had assessed, what the MOEs were at the day that -- the day indicates when the dislodgeable foliar residue amount was recorded, and then at what application rate.

And then finally we do have some incidents information available from the California Pesticide Illness Surveillance Program and the American Association of Poison Control Centers.

That information showed cases of illnesses among mixers, loaders, applicators, reentry workers and from spray drift. The effects that were seen were systemic skin, eye and respiratory effects.

I would like to say that these results had not driven our risk assessment, but they served to inform and reinforce some of our concerns. That ends my presentation.

MS. ROSSI: Okay. In conclusion about the worker risk, it -- it should be pointed out that worker risks are regulated under FIFRA. As opposed to the tolerance and dietary, which is under and FQPA. And so the worker risk would require a -- a FIFRA risk benefit balance.

And -- and it's just important to keep that in mind as we're going through these assessments that now I'm not only -- crossed lots of endpoints and lots of roots, but now they're also across two different laws.

In wrapping up this assessment, I want to spend a couple of minutes on the ecological assessment, and then conclude with some of the outstanding issues the -- the issues the Agency is facing with this particular chemical.

But some of them are going to be for all the chemicals, as well as any additional data that we know of that's out there that possibly could impact the assessment.

With regard to the ecological assessment, this is preliminary. We're currently in the midst of phase four for the ecological assessment. As I pointed out earlier, it's -- it's lagging now.

So I'm just going to really touch on the highlights of what we know is kind of going on. But it is by no means a revised risk assessment at this point.

Comment period closed in March. We received comments from registrants and grower groups. And the registrants' comments focused mainly on fate and water issues. Grower groups focused on the application methods considered.

The aquatic risks seem to be of greatest concern at this point. The concern is -- is based mainly on runoff and drift, and is supported by incidents.

There have been many reported incidents relative to other chemicals for azinphos. They have involved large numbers of fish.

And approximately 50 percent of the incidents in OPP's database for ecological incidents are associated with azinphos.

It should be noted that many of the reported incidents were associated with the sugarcane use, which we have worked with the states on.

And initially many of the incidents were related to the initiation of the boll weevil eradication program, which also has been modified.

So you need to keep those in mind and we need to keep those in mind as we're -- as we're reviewing these incidents.

Estimated risk to birds and small mammals appear to be high. And there are some incident reports that support those conclusions.

(END OF TAPE)

I think the next slide -- but the overall status of our risk assessments -- once again, at this point, we do not have a -- we do not have a concern with the chronic dietary risk.

For the acute dietary risks, there are some subpopulations of concern at the 99.9 percentile, even with use of PDP and FDA monitoring data.

Also, the acute dietary risk does not include the contribution from drinking water. And under FQPA, we would have to take that into consideration in the aggregate.

It is based on a probabilistic model. And we have used methodology to be able to use PDP with regard to the occupational and handler risk assessment. For most handler exposure scenarios considered, we do not have margins of exposure approaching 100, even with the maximum personal protective clothing and engineering controls. When we combined mixer, loaders and applicators, all scenarios have margins of exposure below 100.

With regard to the occupational post-application exposure, again, for the currently labeled reentry intervals, we do have MOEs that are less than 100.

We have used recently submitted data from the Agricultural Reentry Task Force. We have basically used the best data that we have currently -- that currently is with the Agency.

While the eco is preliminary, it does begin to show, you know, risks that we will have to address for particularly aquatic and to some extent terrestrial.

With regard to additional data, we are aware of additional data being generated out there. And we have incorporated a couple of the things even since -- within the last month, refinements to the percent crop treated that we received from USDA and working with their sources and growers.

We used in our dietary assessment the US