Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.
Pesticide Program Dialogue Committee
March 18-19, 1997
Ramada Hotel, Old Town
Jim Aidala, Associate Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances, EPA
We appreciate everyone's attendance at the third Pesticide Program Dialogue Committee (PPDC) meeting. Welcome to new members -- Dr. Marion Moses of the Pesticide Education Center in California, Carolyn Bergholz substituting for Gordon Hassing of Proctor and Gamble, Jim Kutzman of EPA Region 4 substituting for Stanley Meiburg, and Keith Pitts, EPA Liaison at USDA.
Today we are very proud to release advance copies of the FQPA Implementation Plan, which lays out the framework for some of the things we have to do and have done already under the new law. Following the overview in this public session, we also are offering a Press Briefing.
Our achievements during the past six months have been reached along with the regular, ongoing work of the Pesticide Program, which also is undergoing a reorganization and flattening, with new managers and a staff selection process. A fact sheet that details our accomplishments during the past six months and a press release are available here today.
Obviously the work of this committee is very important. It is even more important now since the Food Safety Advisory Committee established under the new law has expired. This Pesticide Program Dialogue Committee is where FQPA implementation work will continue; it's a forum for getting information from you, and to discuss the ongoing activities of the regulatory program.
AGENDA AND MEETING OBJECTIVES
Dan Barolo, Director, Office of Pesticide Programs (OPP), EPA
This begins the process of truly using the Pesticide Program Dialogue Committee as an aid in implementing the FQPA. We want to use the next day and a half to see how well the mini work groups that have started have advanced, and to get ideas and recommendations about how better to accomplish the type of interim work that's needed to show progress. We are not going to proceed as quickly as we'd like through three or four meetings of the full Committee during the year. We also recognize the need to get background materials to this group farther in advance, and we recognize that many groups outside of this room want to be involved. We ask you to consider whether the mini work groups are the best way to proceed.
This group represents disparate views, and it's absolutely essential to be mutually supportive and constructive in our comments. This is an opportunity to advance the program. We have the most advanced and complicated program in EPA, and we need to obtain our stakeholders' interests and ideas. We want to get the full breadth of points of view, take all views into account, and make sure we are delivering the intent as well as the reality of the statute.
A lot is going on in OPP, and we want to discuss FQPA progress within that context. This morning's agenda includes an overview of the FQPA Implementation Plan, and later a discussion about the GPRA and measurement indicators. This afternoon, you will hear a report from the Minor Uses work group, and an overview of the Scientific Advisory Panel topics to be covered in their meeting which starts tomorrow. In the morning, we'll cover automated labels, and a special prize will be given to all the Dialogue Committee members. The Right to Know work group will discuss the consumer brochure that's required by the new law. A quick overview of ecological protection will follow. Then, since this Committee dies at the end of the fiscal year, a discussion of the FACA process will complete our session.
The folder in front of you contains the following pieces: the FQPA Implementation Plan, fact sheet, and press release; GPRA objectives and subobjectives for measuring broad progress in the pesticide program (a draft); a background paper on Communications/Right to Know; FACA explanatory documents; and an interim report from the Spray Drift Task Force.
Work groups can get together during breaks or lunch. We will find a mechanism in the future, via conference calls or other means, to make their work easier. This meeting is the kick-off for the work groups to assist with delivery of the new statute.
OVERVIEW OF PESTICIDE REGULATION (PR) NOTICE 97-1
Steve Johnson, Director, Registration Division, OPP
I will discuss why we developed PR Notice 97-1, its major components, and how it's working.
First, why we developed this PR Notice. When the new law was passed, there were a number of questions. New areas had to be addressed. People asked how we were going to implement the new provisions. They also wondered what interim decision logic we would use to make decisions while the science issues were being sorted out. A unanimous message to the Agency was, "We urge you to put together some sort of guidance to companies on how to proceed in setting tolerances and navigating other provisions of the FQPA."
So we developed PR Notice 97-1.
- It describes our interim approach to risk management decisions, a.k.a. the risk cup. It describes what this is, and our approach.
- It provides guidance on the content and format for tolerance packages. It explains what aspects the Agency would love to have information on, such as common mechanism of action, aggregate exposure, indoor and outdoor exposure through nonfood uses, etc. It lays out the issues on the Agency's mind, and lets companies and others know what we expect for setting tolerances.
- It explains what types of submissions we are accepting including section 18's, time limited tolerances, reduced risk pesticides, biologicals, priority actions such as minor uses, and reregistration information. We have identified three groups of compounds that are our tolerance reassessment priorities: the organophosphates (OP's), carbamates, and B2carcinogens.
- It gives a preview of coming attractions -- our next PR notice on minor uses, which are to receive priority attention; how we are going to address the safer policy; and, how we are going to sort out priorities as we open the door to the next group of registration actions.
- How is the PR Notice working? What types of submissions are we receiving? From our standpoint, the submissions have been very good. Companies are doing a good job of pulling together information on very short notice. In some areas, like common mechanism and aggregate exposure, companies are trying to provide good information but it's weak because EPA hasn't provided much guidance. The SAP meeting this week should help. But, all in all, the applications we are receiving are making legitimate attempts to meet the requirements of the FQPA for establishing tolerances. As the science policy issues are further addressed and refined, we may update this guidance.
Question: The PR Notice suggests there will be another round of prioritization. Is the universe only the conventional chemicals?
Response: Yes. Prioritization under this PR Notice only applies to conventional chemicals. New Divisions in OPP will be looking at the biopesticides and the antimicrobials. For the rest of the conventional chemicals, we must have a system for prioritizing. We have a law that says we'll give special consideration to minor uses and to safer pesticides/reduced risk. Other Agency commitments dictate that we give special consideration to alternatives to methyl bromide. Under NAFTA agreements, when we are aware of trade irritants, we must make those a priority. The problem is that we have multiple "number 1" priorities, and must figure out how to address all of them. That's what the second PR Notice, which we'll discuss this afternoon, will address.
Question: Are the registrants' five priorities on a separate track from the safer pesticides track?
Response: So far, we've asked companies to make their safer pesticides one of their five priorities. As we've moved through the priority system, it makes EPA more accountable in its decision making, and brings a governor to the system for companies, where previously different internal divisions didn't communicate with each other. Now they agree on what's most important to get registered.
Dan Barolo: Since the beginning of the year, we've registered 12 new biopesticides and 8 new chemical pesticides, 2 of which are safer. So 14 out of 20 are in the safer/biopesticides category, and this looks like the trend.
Question: When is the revised scheduling for REDs coming out?
Lois Rossi: We have a tentative schedule for FY-97, with mostly B2 carcinogens this year, and OP's and carbamates in FY-98 and FY-99. The reregistration program will carry out tolerance reassessment.
Dan: At the June PPDC meeting, tolerance reassessment will be featured in our discussion.
Question: Will all B2's have REDs this year?
Lois: Some will have REDs this year, and some will carry over into next fiscal year.
Question: To what extent did FQPA require EPA to go back over analyses that already had been completed for REDs?
Lois: FQPA required looking at the factors of common mode, aggregate risk, and risks to children. That's the only extra work that had to be done in those RED chapters.
Question: How many priorities can the same chemical have?
Response: It's not just one chemical/one use. Prioritizing is at the active ingredient (AI) level, generally, unless the AI has many uses.
Question: How many of the newly registered biopesticides are genetically engineered?
Janet Andersen: Two, one is a crop and one's a micro-organism. The fact sheet in your packet lists these on the back.
Question: Speaking for the consumer products industry, there's a great deal of confusion and uncertainty about how PR Notice 97-1 applies to nonfood uses. It's clear for new active ingredients, but for actions around end uses, it's confusing. How much information do you want?
Steve: Call us and get answers case by case. Give us a list of the types of actions that are at issue.
Dan: Besides new AI's and major uses, many routine registration actions also are getting done. Almost 1,000 amendment decisions have been made in the program during the past six months.
OVERVIEW OF THE FQPA IMPLEMENTATION PLAN
Anne Lindsay, Director, Field and External Affairs Division, OPP
FQPA's major changes:
- It amends the two major pesticide laws in the U.S. at once;
- It provides for a comprehensive, integrated approach to risk assessment and risk management with increased protection for infants and children;
- It recognizes the need for continuous updating and reinvention of regulation to remain credible.
- FQPA did not explicitly provide a phase-in period for all the major changes it entails. So both EPA and the regulated community and stakeholders are busy trying to figure out how to make all the necessary policy, resource, and infrastructure changes needed to implement the law while decisions still have to be made. Thus, this is a year of transition.
The Implementation Plan that we have released this morning is our first focused attempt to show you where we are going, what we are going to be doing, and when and how we are going to be doing it. The plan shows where we are building on/making departures from the past. It doesn't cover everything that will have to be done. We will be issuing updates as we proceed. But it does include all the statutory mandates and it shows what needs to be done during the coming year.
Five guiding principles are articulated:
1 - Sound science
2 - Health-based approach
3 - Safer, more effective pest control methods
4 - Openness
5 - Accountability
We've talked about these principles a lot. Use them to evaluate the plan and our activities, and where we are not living up to them or could do better, let us know.
Several major elements include:
Risk management tools
Communications/right to know
The most significant things are:
- Extra Ten-fold Safety Factor - We are following the SAP's advice in this area. We intend to continue using our best scientific judgment and applying it to all relevant, available data. We'll apply a safety factor when the data are not complete, or are not reliable for assessing pre- and post-natal toxicity for infants and children, or if the data show effects of concern. The size of the safety factor will vary. In our section 18 and related tolerance decisions, for example, we have been using different safety factors based on the quality of the data base and what it shows.
Every tolerance now and in the future will have specific findings regarding infants and children, so it will be easier to look at our decisions and understand the basis for our judgments.
- Aggregate Exposure - New exposure models will have to be developed. Meanwhile, EPA will use an interim approach, as Steve Johnson discussed earlier. We think our approach is good because it's flexible and it allows us to use more data as it becomes available. We'll be presenting our approach to the SAP tomorrow, and look forward to their advice and recommendations.
We issued a DCI in 1995 for outdoor residential exposure data, which is due at the end of this year. When this data is available, it will allow us to begin to develop much more specific exposure profiles for both professional applicators and homeowners--for adults as well as children and adolescents--and to build a data base. This will allow us to refine our assessments in the residential area.
- Common Mechanism of Toxicity - This is one of the big proposals we are bringing to the SAP this week. We are proposing guidance that will help define the term for us all; it will describe data necessary and possible ways of grouping. The guidance we are proposing should be considered in the context of the case study we are presenting.
We will further refine these proposals. In June, we will present to the SAP proposals on how to combine exposures and quantify risk when we believe common mechanism may be pertinent.
We have entered into a cooperative agreement with the International Life Sciences Institute to organize a work group on common mechanisms, using the organophosphates (OP's) as a case study. This work group will be meeting from March to September, culminating in a workshop in September. Later in the fall, we'll present a process for evaluating cumulative exposure of OP's that have common mechanisms of toxicity to the SAP, and in January '98 comprehensive, cumulative risk assessment for selected groups of OP's. This is a tall order not only for Agency staff but for all of you.
Endocrine Disruptors - We now have established the Endocrine Disruptors Screening and Testing Advisory Committee (EDSTAC), which had its first full meeting in December 1996 and will provide recommendations by March 1998. Those will be presented to SAB and SAP, as well as NAS, in time to implement the program in 1999 and report back to Congress in 2000.
Tolerance Reassessment - We plan to use the reregistration process, first and foremost, to accomplish tolerance reassessment. When the reregistration program is completed in the year 2002, the registration renewal program will complete the remaining tolerance reassessments. We are on track with issuing a schedule in August 1997, and as we issue REDs, we'll be looking at chemicals sharing common mechanisms of toxicity. Restructuring the reregistration process is necessary so we can look at chemicals in appropriate groups.
Availability - An FR Notice announcing the availability of the FQPA Implementation Plan is being published today, but we encourage you to use the Home Page on the Internet. See:
Question: Non-agricultural users fear that the risk cup will be used up by agricultural users.
Response: It's premature to suggest that uses will start dropping out for any sector. We'll consider all types of uses in an overall approach. It's too soon to know how this will play out; however, extreme ends/scenarios are not likely. The law is creating opportunities for new coalitions--new friends--and it's not too early to talk to registrants, expressing interest in certain uses and offering to help support them.
Home/garden/lawn uses are those that are weakest for us in terms of having adequate exposure data. We're looking at OPs, carbamates, and B2's, so link these together. We do have a DCI for turf that will help, but more information in this area will be useful.
Comment: The minor crop community would make the same argument in reverse. Their concern is that since there is relatively weak data on lawn and garden exposure, the allocation of risk for those uses will push minor uses out. Everyone feels they will be the group most adversely affected. Also, hopes EPA will balance guiding principle #3 (Promoting Safer, Effective Pest Control Methods) against some other things going on here. Look at IPM in terms of the complicated trade-offs that have to take place.
Question: Regarding IPM and minor crops, we're looking at the loss of some valuable compounds. What's the time frame between when a decision is made on the registration/tolerance for a specific chemical and when the tolerance is revoked? It's a transition issue--what's the time during which a crop/pest problem can be fixed?
Response: It all depends. There are no hard and fast rules; no express phase-in period. EPA's objective is to give as much information and "heads up" as possible, and to allow time for alternatives to get through the pipeline, if possible.
Question: EPA works within statutory constraints. But public health tends to go beyond that. Consider urban, lawn, indoor/outdoor use. It's good that EPA is doing aggregate risk assessment, but what about mixtures? Is this going to be registrant based, or based on particular products? What does EPA mean since we say we are getting into public health? If EPA is going to do this, we must do it right. Are mixture exposures also being looked at?
Response: EPA's goal is to look at what the person in the home is exposed to. In setting tolerances, EPA will evaluate that chemical against others with which it may share a common mechanism. This expands beyond active ingredients to inerts, too, for groups of chemicals that can be evaluated together. Cumulative risk policy will consider exposure to multiple chemicals/mixtures in a number of settings that transcend the food safety setting.
EPA also is looking at inerts as part of product reregistration; looking at the combination of ingredients in end use products. However, the Agency is not really "there" yet, to look at mixtures across the board in all settings. We don't really know how to consider all these things together.
Question: Regarding the Antimicrobials Division, it's important to look at the process and how to streamline. Work in a consultative way. At the next meeting, could we look at what's happening in the Antimicrobials Division?
TRADE PRESS BRIEFING
EPA is announcing release of the FQPA Implementation Plan. This is our best and first shot at how we are going to address the scientific provisions, etc., of the new law.
Question: How have the additional FQPA requirements affected the number of tolerances issued since August 1996?
Response: EPA has issued 20 to 30 new tolerances since August. Three temporary tolerances have been issued for section 18's. Tolerance reassessment will be where we really see the effects, however. EPA must reassess 9,000+ tolerances in 10 years, or 900+ per year, compared to the 250 to 300 tolerances per year that we usually review. FQPA triples the workload and adds more considerations. On the positive side, EPA is receiving better, more complete applications as a result of the FQPA. The lack of transition time, however, puts pressure on all involved.
Question: Does EPA expect Congressional oversight hearings this year?
Response: There could be, though we've received no formal call for hearings at this time. We keep in touch with the oversight committees informally.
Question: What kinds of new data is EPA seeing, and what is your wish list?
Response: Acute dietary risk data; data that's organized and clear, and that explicitly addresses new areas covered by the FQPA.
Question: What's the status of EPA's new right to know responsibilities?
Response: We have a year and a half to develop a new consumer brochure; a PPDC mini work group is addressing both the content and distribution forms/formats (including EPA's Home Page).
Question: Dietary risk data in DRES is 20 years old. Is EPA updating it?
Response: We are using more recent data, and USDA has requested funding to update the consumption data. The push is to add sampling of kids so we can do more adequate analysis.
REPORT AND DISCUSSION FROM WORK GROUP ON GPRA/MEASUREMENT INDICATORS
Iantha Gilmore, Program Management & Support Division; and
Al Jennings, Director, and Sherry Sterling, Associate Director, Biological & Economic Analysis Division, OPP
The Government Performance and Results Act (GPRA) Work Group is an example of group involvement in our regulatory processes.
This is a statutory requirement. Part of what we are doing is driven by EPA's "goals project." The handout is now out for wider review. We have a work group consisting of seven people, and would like to get a good discussion of the issues in this meeting.
Background and Overview of OPP's Process - The GPRA was enacted by Congress in August 1993. It's intended to hold government agencies accountable for use of public resources by setting goals and objectives, measuring their performance, and reporting on accomplishments. The specific requirements are, by September 30, 1997, to have a Strategic Plan which covers our mission, goals, and objectives, and provides a statement on how we'll achieve our goals and objectives. Also by September 30, an annual Performance Plan must be completed which speaks to performance measures and links them to our goals. In the year 2000, we have to complete a Performance Report. But the focus right now is on development of the Strategic Plan with goals, objectives, sub-objectives, and performance measures by September 30.
GPRA moves us in the direction of measuring results and progress in terms of environmental outcomes rather than the more traditional counts of things like numbers of registration actions, labels approved, etc.. We are looking for environmental results. At our last PPDC meeting, Al Jennings said, "EPA's ultimate measure of success is to improve human and environmental health." We have problems coming up with outcome-based performance measures. In many cases, we don't have the tools to develop those measures. But we're still moving toward developing them. In so doing, we need help from our partners both outside and inside the federal government to develop goals, objectives, and performance measures that are meaningful and useful.
EPA has begun a process to guide or manage the process of developing goals. We must make sure we are involving our partners in the regions and states, and outside the federal government. And that's why we are soliciting your help today. The Agency work groups have set forth specific criteria that we have to follow. We've handed out draft objectives that you have in front of you, and invite your comments.
The next step is to take these objectives and link them to our budget, and to explain to the rest of the Agency why these things are important.
Discussion of the Four Goals:
Polly Hoppin, World Wildlife Fund
Goal #1 (Agency Goal 3): "All foods Americans produce or consume will continue to be safe for all people to eat."
(See objectives and sub-objectives in the handout.)
Even though these goals are simplistic and somewhat imperfect, they can be useful in driving change and improved public accountability and transparency. There's always a trade-off between being able to measure something at the aggregate level vs. measuring in a more accurate way at the field level. Ask yourself, will these measures be helpful in indicating general trends in the positive direction?
Note that the word "continue" seems ambiguous in this goal as stated and could be omitted.
There's lots of evolving science, and follow up work is needed. Would like to see a sub-objective added on endocrine disruption: "By 1998, set additional measurable goals on endocrine disruption as needed, based on the work of groups looking into this now."
Also, IPM needs to be mentioned here as a quantitative goal. Need to be able to show how IPM positively impacts risk if we are to secure future funding. So add a sub-objective that says, "By the year 2005, there will be an increase of x% of crop acres managed under biointensive or ecologically based IPM."
Comment: The objectives need some baseline numbers to make the reductions discussed meaningful.
Comment: All of the objectives are too one-dimensional. They measure risk reduction without taking into account things that make America a good place to live, like termite control and mosquito control. How to incorporate these ideas eludes me, but it's important to consider this.
Comment: Some of the goals seem too modest, for example, "50% reduction in use of carcinogens." Overall, the document has a lot of good objectives, however.
Comment: We've fallen into the problem of reduced use vs. reduced risk again. The goal of our regulatory system is to reduce risk, not use. We don't have good baseline information, or a good way of measuring use, and there's probably little value in trying to measure it. Focus instead on ways to measure overall risk and to obtain risk reduction.
Comment: Surprised that the GPRA project is being run by the goals project. We all buy into the goal of safe food for all Americans, but the majority of food-borne risk to humans is outside the purview of EPA. Also, concerned that EPA is including activities that are required by law in its objectives statements, such as objective 2. The Goals 2005 document is not necessarily the place to start.
Comment: If a purpose is to get away from bean counting, be sure we are not just counting different beans. Are there new things we can be measuring now? Give some thought to developing new types of measurements.
Comment: Note that this is not use reduction, it's hazard reduction. Granted, we are not taking into account exposure. But we are taking into account issues of carcinogenicity and neurotoxicity. This is oversimplifying, but the trend is in the right direction. Don't throw the baby out with the bathwater by arguing over the imperfections of these goals.
Goal #2 (Agency Goal 4): "Ensure that Communities, Work Places, and Ecosystems are Safe from Pollution"
Comment: What jumps out is that some of the sub-objectives are incredibly modest, such as #1, reducing the number of acute poisonings by 50%. Also #8, finding alternatives to methyl bromide, seems to be behind the curve.
Comment: How do you measure sub-objective #1, the number of workers with adverse health effects caused by acute poisonings, and how accurate is reporting on this now? Also, #4, reducing use of pesticides that can leach to ground water, poses an interesting measurement problem. If you can restrict use of these pesticides, you can achieve the same public health goal as by reducing use. Regarding #5, what about chronic toxicity, bioaccumulation, and other fish and wildlife issues? In #9, in addition to endangered species, should we also be thinking about protecting pollinators or migratory birds? What's the role of the states? There are some enforcement issues lurking in these, too. Should you have a goal regarding increased compliance with labels, as well as increased public education?
Comment: In goal #2, why didn't you tie this to State Management Plans? In general, the states need to be brought into this process more as stakeholders if the process is going to be successful.
Comment: There's a problem here with setting goals and objectives that EPA really has no control over. For example, sub-objective #2, "The quantity of biopesticides used for agriculture will double from 1995 levels." EPA has control over the registration of biopesticides. The Agency could control their use by removing all other pesticides, but that's probably not your goal. Define clearly how you are going to achieve some of these goals. EPA controls registrations and reregistrations. Be easy on yourself.
Comment: Looks like EPA is trying to change the way agriculture operates. That's not part of the Agency's mandate. It's difficult to see how some of these things will change by definition. Also, it's not clear that EPA has the resources to do any or all of these things.
Comment: Would like to see an objective added regarding the MOU between EPA and USDA to trigger USDA-funded research on nonchemical and other alternative pesticides. This might prod some useful action. Endocrine disruptors is omitted here, again. Also, re: #7 on the Pesticide Environmental Stewardship Project, EPA's original commitment to measurable goals was abandoned when PESP was established. Mechanisms of accountability as part of PESP would enhance its credibility in the environmental community. Suggest adding public accountability to this sub-objective.
Would like to see a sub-objective on migratory birds, ensuring compliance with the Migratory Bird Treaty Act. Reducing bird kills is a place where EPA could improve its impact.
Comment: The overall goal is one that all can support. But language below it could be read to mean that we are trying to eliminate all chemicals and pesticides. Qualify this very broad statement.
Goal #3 (Agency Goal 7): "Empowering People with Information and Education -- Expanding their Right to Know"
Comment: Sub-objective #1 is very hard to measure. Also, add something about improving labels.
Comment: Sub-objective #2 assumes the statute does not require EPA to enter formal agreements with food retailers in order to do the consumer brochure.
Dan Barolo: We are looking for ideas and mechanisms to implement the consumer brochure provision of the act, and are not planning to sign contracts. We need help reaching the food retailers and grocers, and in encouraging them to assist us.
Comment: Make sure brochures don't get published and sent, and then sit in the back of the grocery stores.
Comment: On the conference call last week, we discussed the brochure. Consider use of the Internet -- some people don't have access to it yet, but use is increasing. Also, use Internet to reach people who in turn can take it to end users. Bottom line is, get the information out to the consumer.
Goal #4 (Agency Goal 8): "Develop and Implement Innovative (Nontraditional) Approaches for Current and Future Environmental Problems"
Comment: Would like some elaboration on sub-objective #3. Is there a way to catch qualitative concerns that are difficult to address with quantitative measures? Points to a common concern throughout this goal-setting process. The danger is that if you focus on things you can measure, you may ignore things that are important but that you don't know how to measure well.
Comment: Add a sub-objective on supporting public and private efforts to measure pesticide risk reduction and adoption of IPM, and facilitate use of measurement tools in the marketplace.
Comment: Sub-objective #3 again is something the law requires EPA to do.
Thanks for this discussion. This forces you to deal with the practical issue of how to comply with GPRA. Enables you to help us shape performance measures. GPRA is a new law, a new requirement of government agencies. We have to look at outcomes, not outputs. And we have to measure these things. If we have an ideal measurement indicator, people will say, "Where is your baseline?" Some will say, "If you don't have it, forget it." Others will say, "If you don't have one, build it." This is your chance to tell us which measures are worth building. The measures are tied to the budget. If we don't set these measures well, we won't do well in the budget process. This is an opportunity to build the public rationale, to form the resource base for the future if we build a good case, a good foundation. View these as food for thought, at this point. It's unfortunate that this is being cast as tied to EPA's Goals Project. There is a link. But take this as a framework to build objectives that make sense to the Office of Pesticide Programs.
We really are interested in beginning to work with you now as work group members. Decide whether other groups should be added without making this group too large. This is the beginning of reaching out to stakeholders. Get back to us with specific written comments -- send them to Margie Fehrenbach by April 16. We have to have goals and objectives in place by September 1977 for the FY-99 budget.
Question: Any coordination with the non-point source program?
Response: Yes, our objectives have to integrate. We'll provide copies of other program offices' objectives that relate to our program, as soon as possible.
John McCarthy, American Crop Protection Association
Commends EPA for the good job on the FQPA Implementation Plan. It's a good start; it should be a living document, and will be. Emphasis on sound science while moving forward and making decisions in the interim is the way to go. He apologizes for a misstep on the part of ACPA, which put out a premature press release on February 21 saying something to the contrary. ACPA supports EPA requesting outside advice from the National Academy of Sciences and International Life Sciences Institute on common mechanism and other science issues.
On Section 18's, ACPA has concerns about the process that's being used to work through these. EPA's decisions have been timely, but the resources placed on this have been more than necessary and are being taken away from other important activities. For future section 18 requests, EPA should do a dietary risk assessment right away. If it indicates less than 1 or 2% incremental risk of dietary exposure, then make the decision in a heartbeat rather than looking at all the dietary exposures on the books. For example, the recent cranberry section 18 was a elegant job, excellent work. But all the uses add up to 1.65% of the RfD. Did EPA really need to expend so many resources on this?
Objectives and goal setting is an important process, but limit this to things that are under EPA's control. You don't have control over the marketplace. Keep your eye on the ball. Also, there's nothing wrong with focusing on your statutory mandates.
Bob Larkin, Rohm & Haas Company
One of the fears here is that we may get to the end of the road and, in a panic, throw minor uses and nonfood uses overboard. Would like to avoid situations where decisions are made in a short timeframe without input from commodity groups. Could there be a cooling off period for registrants to sit down with the commodity groups, and then come back in to EPA and present their recommendations on how to mitigate? That way, everyone would win.
Steve Bursall, Agricultural Commissioner of Imperial County, California
Measurement indicators do need a baseline. Also, it will take extra resources to implement these. Who will pay?
Is this Committee planning to go out in the real world? He hasn't seen a farmer among us. The farmer is the one who is going to feel the impact of our decisions. He invites all to come to Imperial County and meet the folks directly affected.
REALIGNMENT PLAN AND BUDGET UPDATE
I'd like to take this opportunity to talk about the Office of Pesticide Programs in the context of this thing called the Food Quality Protection Act. As important as it will be for all of us, our children, and our children's children, we have to find ways to use current resources, alignment, and realignment to put it in place. 1997 is a time in which a lot is happening that will enable us to effectively, meaningfully implement the provisions of the new statute. The FQPA is important, we take it seriously, and you are here to help us do that. But there's a context in which we are able to deliver its provisions, and I want to discuss FQPA in this broader perspective.
The new statute brings significant new responsibilities. Luckily, it also brought a supplemental budget -- $16 million in supplemental funds -- to implement its provisions in fiscal year 1997. It looks good that we will also get $16 million plus in fiscal year 1998 to sustain the pesticide program. The irony is that when we look back to a year ago, when we were shut down, with promotion freezes, etc., it's ironic to be in a position to have more resources than we can put into place, so soon. Also, the '97 money is two year money, something we have not had the luxury of in the past. We also received a $2 million bump-up in registration maintenance fees to support the reregistration program, so we will go from an annual receipt of roughly $14 million to $16 million for reregistration. Right now, we have the resources we need for 1997.
Where are we going to invest these monies in 1997? Partly toward hiring additional people. The Office of Pesticide Programs plans to hire 100 additional staff members this year. Spread the word that opportunities for employment exist within OPP. Positions range from toxicologists to chemists and environmental protection specialists... The hiring process is long and complicated--it will take three to six months to bring this many new people on board--and additional time will be required to train them. We look forward to the infusion of new, younger blood in the program, and are excited about the opportunity. But it adds to the pressures on managers in the program who must interview, recruit, hire, train, and equip new people.
We also have been going through a realignment during the last year and a half, which became official last Sunday, March 16. All the new acronyms and branch names will have to be learned. All the senior managers have been formally announced. We've also had to flatten our organization--remove one layer of supervision in our structure. The advantage is that over time this should streamline our approval processes (one less sign-off will be required). Disadvantages include, any time you make any change in any organization, there's a down time and a transition time while people learn to work in the new organizational environment. The Executive Order requires an 11-to-1 manager-to-staff ratio. We don't know where 11-to-1 came from, but we are literally now right in the middle of achieving this. Yesterday, 740 people got their staff reassignments in the new organization. Many got their first choices, others didn't. About 100+ people are migrating from one division to another. For some, this is viewed as a unique, challenging, about-time opportunity, while for others it's the end of the free world. We'll adjust, we'll respond, but you need to understand the context in which other changes are taking place.
The organizational changes include formation of a new Field and External Affairs Division; Anne Lindsay is the Director. Frank Sanders is the Director of the new Antimicrobial Division. All the other divisions are flattening.
On top of that, we have the traditional issue of being in two separate buildings, both separate from Waterside Mall. Many issues and problems are associated with this. So far, we have been unsuccessful in our attempts to find one building for all of OPP. This is the single thing that would bring greater efficiency to the pesticide program--to be housed in one building. Absent that, we face the issue of where to put 100 additional, new people. So besides the new law, new resources, and new hiring authority, we have space problems to deal with. This is not a plea for sympathy, it's a context into which you can put other things.
There is not a group of individuals who have a better work ethic than employees of the Office of Pesticide Programs. Most are there to do a good job. They are confounded by the issues and areas I just discussed. If you find someone in OPP who is doing a good job, pat him or her on the back or send them a short note. Pissing and moaning should be directed to me and the other managers in the program since that's what we're paid to do.
We don't know whether the stars aligned in a certain way to create all these things at the same time, or if it's the most unique opportunity anyone has ever had, but this is the reality of where we are at this point in time. Meanwhile, I can assure you that the workload is relentless.
Question: What kind of people is EPA looking for?
Response: We will provide a list of title vacancies tomorrow. A plethora, with a science focus. If you are aware of someone who could benefit from this opportunity, please pass the word on.
Question: Are any positions in the Regions?
Response: Our program has a relatively small regional component, but our field operations component will be supplemented.
Question: Are managers being shifted into other areas?
Response: Some are shifting, but most moves are within their areas of expertise.
Question: Does most of the $16 million go to salaries, and will EPA be able to sustain this in future years?
Response: Yes, $8 or $9 million is for salaries and benefits (pensions, etc., have to be added in). We hope to be able to sustain this in the future.
REPORT AND DISCUSSION FROM WORK GROUP ON MINOR USE/SECTION 18'S
Sandy Zavolta, Biological & Economic Analysis Division, and
Hoyt Jamerson, Registration Division, EPA Co-Leads
EPA has formed an external group with geographic diversity whose members cover all interests. (See handout listing work groups and members.) This work group is developing two mission statements, and list of short term and long term goals; then we will develop a plan with issues to tackle this year.
Status of Section 18 Decisions under FQPA, and the Section 18 Stakeholders Workshop
Rob Forrest, Registration Division, OPP
First, let me dispel the rumor that the Section 18 program has come to a halt. Here's what we actually have done since FQPA was enacted in August. We have received 200 submissions, and have made a total of 67 regulatory decisions:
- 61 were approvals (including 15 tolerances and 30 state requests);
- 5 requests were withdrawn; and
- 1 request was denied.
This leaves 133 pending decisions.
The 61 approvals break down like this:
- 27 section 18's were approved, and 12 tolerances are associated with them;
- 6 section 18's were approved, and 4 associated tolerance documents are still in preparation;
- 5 crisis exemptions are pending, and tolerance documents associated with them have been signed;
- 19 crisis exemptions are approved, and tolerance documents for them are pending;
- 4 section 18 requests for nonfood uses were issued.
- Regarding the approved section 18's for which tolerance documents are still pending, sometimes we have situations like this. The states cannot go crisis, and they have to apply the pesticide in several months. We approve the section 18 and track the harvest date to make sure we issue the tolerance before the commodity goes into commerce.
We also have 5 crises that are pending where we have approved the tolerance. In these cases, we know the emergency is valid and that we'll be able to establish the tolerance. The harvest is quickly approaching so we establish the tolerance and go back later and do the paperwork on the section 18.
Question: Now you have a process where you can separate setting the tolerance from approving the section 18, correct?
Response: As the section 18 request comes in, we look at whether or not it's an emergency, and at the same time we screen the request from a risk standpoint. To an extent, we have split the tolerance decision from the section 18 process. Lynn Goldman has sent the states guidance on this, to ensure that EPA gets a chance to look at the tolerance request every time, even for crisis exemptions.
Steve Johnson: Our goal is to eliminate the gap in time between use of the pesticide and issuing the tolerance. And we don't ever want to be in a position where we approve the use and then have to deny the tolerance.
Dan Barolo: The statute requires a tolerance action for every section 18 decision. This won't go away. We need to find a more effective way to create the tolerance document, and to get the information we need more clearly and as cleanly as possible, in advance. The worst dilemma would be to wind up with adulterated food. Our goal is limit or eliminate the number of times that this [issuing the tolerance and approving the section 18 at two different times] has to be done.
Comment (FDA): It seems like EPA is taking a reasonable approach to dealing with a very difficult problem, and FDA doesn't have a problem with this. The trick is to make sure that the tolerance is in place by the time the food is ready to move in interstate commerce. As long as this happens, FDA is comfortable with EPA's approach.
Question: If EPA can use a gross filter first for risk, is it also possible to bypass a lot of the other routine work we do?
Dan: That's the dilemma right now. Say we use a screen and learn there's minimal risk or no problem at all. We have had to create boilerplate language to accommodate those cases. We would love to have the authority to put a one-liner in the Federal Register referring people to the Docket, or to reference previous section 18 decisions, rather than putting all the particulars into a unique FR document for every section 18 decision. This process takes time and costs money. Rarely do we get comments, so the purpose could be served by giving public notice. We are trying to streamline this.
Jim Aidala: If there's a chemical that contributes little to the risk cup, could it automatically be approved? Probably not. The section 18's tend to come in from several states, etc.
Comment: This has always been a program where EPA says it is doing analysis but they really don't. Now it seems that the Agency has incorporated this thinking into FQPA implementation by not preparing the documents until after the fact. PPDC needs to look at the indicators to see how the process really is working.
Response: We will provide samples of some recent section 18 decision documents for the Committee members' review.
The Section 18 Workshop in November 1996
Rob Forrest, Registration Division, OPP
We had good participation from states, growers, and manufacturers, and some from the public interest community. We discussed FQPA and tolerance setting, and got feedback and advice. We discussed issues of concern to stakeholders including:
- Delegating section 18 authority to the states;
- Allowing section 18's for safer pesticides, even if there are registered alternatives;
- Allowing section 18's for resistance management prior to the development of resistance; and
- Revising the criteria for emergencies, specifically re: significant economic loss.
- To briefly summarize the feedback we got from stakeholders:
- Re: delegating authority to the states, there was broad support for EPA to consider multi-year exemptions and tolerances. Stakeholders identified several criteria for these longer exemptions.
- Re: reduced risk, there was broad consensus that EPA should consider requests for pesticides with lower impacts on human health, even if there are registered alternatives available.
- Re: resistance management, again there was strong support for consideration of allowing section 18's where resistance to alternatives hasn't been documented but resistance can be expected.
- Re: revising criteria, participants were very anxious for EPA to revise its definition of "significant economic loss."
A report summarizing this conference is available and copies are out on the table. Also, NASDA and AAPCO convened their own work group to address these issues and their report was recently issued. For the most part, it supports the views we heard from participants at EPA's workshop.
As far as the Agency's position goes, our discussions are in the preliminary stages. But we want to push the envelope to achieve the most efficient way of doing business, giving the states a role in repeat section 18's, establishing criteria that have some promise, and streamlining the process, especially for repeat requests. Regarding reduced risk pesticides, an issue worth discussing is whether the section 18 process is the appropriate venue for considering reduced risk pesticides if other criteria are not met. Resistance management has possibilities; however, we need to make sure appropriate criteria are met. Regarding revising our criteria for "significant economic loss," stakeholders would prefer that EPA be more flexible in terms of criteria. The Agency is open to having a dialogue and looking at the data we consider for significant economic loss.
To address the other issues, EPA would have to amend its regulations, which we are not adverse to doing. The question is when we could begin. We have 133 pending submissions. By the end of this summer, we will receive an additional 200 to 250 submissions. We would like to focus on processing section 18's and establishing the necessary tolerances. We plan to advance these issues. To do so, we need to establish a regulatory work group, probably by early fall.
Question: How much does this program cost?
Response: There are 11 people involved full time, plus about 6 people providing science support, so about 20 people processed 470 section 18's last year (not counting all the policy issues and other associated things).
Tolerance Reassessment Process and Minor Uses
Dan Botts, Florida Fruit & Vegetable Association, and
Hoyt Jamerson, Registration Division, OPP
A topic that came up frequently at the Food Safety Advisory Committee meetings last year was, what do you do when the risk cup gets full? The concern is with the impact this may have on minor uses--these would be the ones most likely to be dropped by companies to reduce risk. At the last FSAC meeting, Deputy Administrator Fred Hansen charged the growers, pesticide industry, and food processors to look at this topic and come back with some proposals on how EPA could get better information for its risk assessments, and also how we could incorporate grower needs into the process of determining what stays and what goes on the label. So Dan Botts, Larry Elworth, Wally Ewart, and other people around the table here put considerable time into discussing this issue. If anyone has thoughts, now is the time to express them as EPA approaches tolerance reassessment for minor uses.
Here's an overview of the work that's been going on. An ad hoc umbrella group was assembled in mid-January comprised of the Minor Crop Farmer Alliance, National Food Processors Association, American Crop Protection Association, and the big five major commodity groups. The overall emphasis of this group was to look at process and implementation of FQPA, and look at things the grower/registrant/user community could bring to the table to make implementation of this law the soundest process possible given the existing criteria.
The three goals of this group were:
1. Efficiency - To determine common interests of the group and move forward in the most efficient manner possible;
2. To develop processes to provide EPA critical information currently lacking to meet FQPA standards; and
3. To improve communication and cooperation among the user community and registrant community as FQPA implementation takes place. Everyone recognizes that there is going to be pain all around as this process moves forward. We can work together as a group to minimize that pain, and to make sure no critical needs go lacking during this process. Critical needs must be identified as the process moves forward.
We have identified five issue areas where the user community and registrants can come together and work with the Agency to identify specific data needs or information that will move this process forward:
1. Develop pesticide use information and pest management needs information for pesticides undergoing tolerance reassessment. Look at the use and determine if there are ways to reduce the risk, and if not, identify any critical needs that won't be met if a pesticide use is lost. Co-Chairs of this group are Larry Elworth, Program for Strategic Pest Management, representing the user community and Janice MacFarland of Novartis representing the registrant community.
2. Develop a process to address nonfood, non-occupational exposure data needs. There is a task force looking at lawn care uses. This goes farther into interior uses, pet uses, etc.. Co-Chairs are Elin Miller of Dow Elanco and Fred Regelbrugge from the American Association of Nurserymen.
3. Develop mechanisms concerning involvement of the user community in the regulatory process. Not just at the end of a decision, but design an early warning mechanism for the user community to learn about uses that may be at risk two or three years down the road so we can start planning transition periods for those critical needs. I am the Co-Chair from the user community and Doug Nelson of the American Crop Protection Association is the Co-Chair from the registrant community.
4. For section 18's, come up with recommendations to reconcile the requirements of FIFRA for section 18 with the new FQPA requirements re: tolerance reassessment, and deal with the apparent inconsistencies in that process. Dr. Robert Larkin of Rohm & Haas is Co-Chair from the registrant side, and Dr. H.W. Ewart, Northwest Horticultural Council, is the Co-Chair representing the user community.
5. Develop mechanisms to use existing proprietary residue data that's in the hands of the food processing community and growers, and factor it into the exposure assessment. Hopefully, with existing residue data plus use information, we can put these two models together and come up with actual risk rather than theoretical risk that we don't feel adequately represents real world situations. The Co-Chairs are Rick Jarman, National Food Processors Association, and Dr. John McCarthy, American Crop Protection Association.
Summary of Recent Use Profile Discussions
Larry Elworth, Strategic Pest Management
We've been trying to make sure that as EPA makes decisions in the initial screening of tolerances, the exposure assessments are based on the best information possible. EPA puts together the initial profiles based on national usage patterns of specific active ingredients for specific uses. This is being done now for the organophosphates. EPA is willing to share these initial profiles with the grower and registrant communities, to verify the basic information and identify places where information is missing -- for example, information on crops used nationally but with regional differences in chemicals used, growing patterns, etc.. So we're working with universities and USDA to collect this type of information and get it back to the Agency.
The key here is that the Agency has to make some major decisions in a relatively short period of time. EPA would prefer to have better information rather than poor information on which to base its decisions. The grower community shares this same interest. We want to make sure that actual use information is folded into the process as early as possible. And regional differences are important to growers like those in south Florida, whose practices differ from national use patterns.
The larger issue we are facing is, once you identify risk, how you go about refining those exposure estimates, identifying mitigation measures, and determining which alternatives will or won't be efficacious in a situation. It's a long term problem only in terms of the next 3 to 4 years. It's not clear that the information needed to do these estimates will be available without significant additional effort.
Steve Johnson: When we come to the point where we have a risk issue and the risk cup is overflowing from a whole variety of uses, what kind of process are we going to put into place so that the people in this room can help us figure out what to do? What role can and should each interest group play?
Comment: When the cup is overflowing, what's the prospect for adding a new use that clearly adds no exposure?
Dan Barolo: There are as many opinions as there are people involved in these discussions. (Also, if anyone can come up with a better analogy than the "risk cup," please let us know.) If we get in a situation where there is no residue, no risk, no exposure, we may be able to approve that use, but only as we simultaneously address the full cup issue and try to find ways to reduce the overflowing risk.
Jim Aidala: There's a distinction between low and zero exposure. Also, EPA would attempt to have some sort of time-limited options. In any case, risk cups being full are a bad thing.
Question: How useful would existing proprietary residue data be, how much of it is out there, and can't EPA get a handle on it?
Penny Fenner-Crisp: Back when the NAS kids' study came out in 1993, one of the recommendations was that the Pesticide Residue Monitoring Database ought to be created. USDA, FDA, and EPA put together a work group to develop a structure for such a database. There's a format for reporting, input from FDA and people outside the government, etc.. We do know these data exist, we do use them in separate ways, but we haven't been able to join them into an integrated database so we can use the data most effectively. We hope some of the FQPA money can be spent to develop this type of database.
Question: Can't one of these groups address this problem?
Penny: The data is there, we just have no place to put it.
Comment: Industry has data that works for them but not necessarily for EPA. It's not fully quality controlled so it's more valuable for confirmation than for risk assessment.
Penny: As data were put into our database, they would be graded so we would know how to use them.
Question: What percent of total pesticide use is minor use?
Hoyt: FQPA defines minor uses as crops grown on less than 300,000 acres. There are only about 26 agricultural crops that are grown on more than 300,000 acres, so most fruits and vegetables we eat every day are minor uses. The act also recognizes minor uses of major crops, and nonagricultural uses of agricultural use pesticides.
Response: Better than 60% of the total volume of pesticides used in major crops also are minor uses. So most pesticide use is "minor use." Minor uses constitute a lot of the kid foods, and can result in high exposures.
Priority Review for Minor Uses and Other Registration Submissions
Peter Caulkins, Associate Director, Registration Division, OPP
EPA's next PR Notice will cover some critical issues and we invite you to comment. The Registration Division in OPP developed a priority system to handle registrant submissions because we have insufficient resources to do everything. It enables us to have greater accountability.
We pioneered this concept in 1995. Each of our customers gets five top priorities; we schedule them and do the work.
The next round of priorities must reconcile the following. The FQPA identifies minor uses as a priority and says we must make registration decisions on them within one year. So the number one issue we are dealing with is how to marry up the priority set forth in the FQPA -- minor uses -- with our customers' top priorities.
A second major issue is that FQPA requires us to reassess tolerances in the next 10 years, starting with the riskiest chemicals first. We are developing a strategy, and will be doing the OP's and carbamates within the first three years. It's critical to have close coordination between reregistration, where tolerance reassessment will be spearheaded, and registration. We want to avoid the shifting sand syndrome, in which one division is limiting uses in view of a full risk cup while the other division is adding new ones. So the new PR notice will raise this to your attention, and note that OP and carbamate registration "priorities" are not likely to receive a final decision.
Another issue is methyl bromide alternatives. If you bring one in, it will not count against your top 5 priorities. Reduced risk candidates must be one of a company's top 5 priorities but does not have to be their #1 priority. EPA is sharing data reviews on these with Canada.
Minor uses, economic definitions, and criteria also are covered in this PR notice, as are trade irritants.
Question: Does trade irritant status work both ways, both going in and going out?
Dan Barolo: The only way it's going to work is if it works in all directions.
Question: What's the status of safer pesticides?
Response: Due to scheduling and resource allocation considerations, if a company brings in a safer pesticide, RD will make it one of the company's 5 priorities, even if the company did not do so. Yes, this raises equity questions, so let us know how you think we can handle it most fairly.
Question: Can non-traditional minor use registrants continue to hold priority status?
Steve Johnson: What should EPA do if one of the priorities coming in is for an OP? How should we link registration priorities with tolerance reassessment? [No responses.]
Dan Barolo: These are the kinds of practical issues we face, and we'll do our best to suggest an approach. Let us know your thoughts, ideas, and recommendations.
Options to EPA's Approach for Section 18 Tolerances
Wally Ewart, Northwest Horticultural Council
A subject that's important to the minor use community is section 18's. We're suggesting that EPA look toward a more efficient section 18 tolerance review process. As you know, FQPA requires the establishment of a tolerance for each section 18. There is general agreement among a variety of stakeholders that EPA should exercise its discretion in the process it utilizes to issue tolerances for section 18's.
Right now, EPA is using the same review process for the section 18 tolerance as for the section 3. We believe that EPA should look at the diminished exposure that results from a section 18 use. There is limited acreage, limited pounds of AI, and limited duration of the tolerance. Considering these factors, the theoretical risk is much lower and section 18 exemptions can be significantly overhauled and simplified.
The major change in the process is that EPA now requires a full risk assessment for tolerances for section 18's. This requires a great deal of time, time that could be better spent. We recommend that EPA recognize the limited exposure and risk associated with the majority of section 18 requests, and modify the review and approval process accordingly.
Specifically, EPA should:
- Correct exposure to recognize the maximum percentage of crop that can be treated under the exemption, and use this percentage to adjust the risk for the chemicals;
- Look at the time of the exposure, and amortize the risk over the appropriate timespan;
- Consider a default approval, such as 1% of the RfD.
This process might not result in approval of every section 18, but it would expedite the process for the vast majority.
Comment: We are concerned about section 18's because while they may be only 1% of dietary exposure, they represent 100% exposure to people who harvest those crops and who apply the pesticide. The fact is that 25% of the work force during harvest time is children. Is this taken into account?
Jim Aidala: Factors other than dietary risk have been and still are taken into account.
Penny Fenner-Crisp: For mixer/loader/applicator risk assessments, the smallest person considered is a female of childbearing age (not kids). This is an area where we should consider doing more.
Dan Barolo: Wants to make clear, however, that dietary risks are not the only ones looked at in considering a section 18.
Comment: If we open our door to imported produce, doesn't this raise a new problem? The availability of tools for domestic producers is adversely affected if the risk cup overflows.
Response: One of the reasons why the tolerance requirement was added for section 18's was concern about imported produce.
FDA: Resources for monitoring imports are down by about one half compared to 1990. Most produce gets on the market without a look by FDA. When FDA finds produce that's over tolerance, they have no idea where it came from, usually.
OVERVIEW OF THE SCIENTIFIC ADVISORY PANEL TOPICS
(To be discussed during the SAP meeting on March 19-20)
Margaret Stasikowski, Director, Health Effects Division, OPP
Both the National Academy of Sciences Report and the FQPA raised a number of critical science policy issues that we need to resolve and address in our risk assessments as these are the underpinnings for the risk management decisions that we need to make daily in the Office of Pesticide Programs.
We have been working to analyze these issues, develop short term and long term approaches, and identify research needs. A very important part of what we are doing is bringing the work we have done to the scrutiny of outside peer review. Tomorrow and Thursday, we are holding the second SAP meeting since passage of the FQPA, with the main focus on the progress we've been making in addressing these risk assessment issues.
To remind you, we covered these topics with the SAP in the fall:
- Use of the extra uncertainty factor to assess pre- and post-natal developmental and reproductive effects in infants and children;
- The requirement of an in utero carcinogenicity bioassay;
- Proposed changes to the developmental toxicity guidelines and the reproductive and fertility testing guidelines.
At the meeting tomorrow and Thursday, we're discussing a number of risk assessment issues directly or indirectly related to FQPA. Tomorrow morning, the first topic is the process we have developed for selection of toxicology endpoints. Our presentation will cover:
- Acute dietary risk assessment,
- Dermal and inhalation occupational and residential risk assessment,
- For occupational and residential risk assessment, short term, intermediate term, and long term effects assessment methods.
We will ask SAP to comment on: how valid is our overall approach?; our assumption that developmental effects can occur after a single dose of a pesticide; whether it's appropriate to use oral studies for hazard identification for dermal risk assessment; and whether it's appropriate to use the default assumption of 100% dermal absorption if there is no dermal absorption data available.
The second topic that we will discuss tomorrow morning with SAP is inhalation risk assessment and combining of margins of exposure. We'll ask the Panel about the appropriateness of the method that we've developed for deriving a route-specific margin of exposure, and method that we're using to combine the margins of exposure.
The third topic, after lunch, will be our methodology for conducting aggregate exposure assessments. We have made certain decisions on how to approach this, and we'll ask the SAP to comment on our decisions so far. Operating with limited information, especially for time limited tolerances and section 18 emergency exemptions, we are using default assumptions on the relative contribution of individual sources to a picture of total risk. We'll be asking SAP if there are other approaches we could be using in those cases.
On Thursday, we'll be discussing perhaps our thorniest issue, the issue of common mechanism of toxicity. We have done a lot of work, and are seeking SAP's comments on the reasonableness of what we have done, so far. We'll be proposing definitions for terms like mechanism of toxicity and common mechanism of toxicity, as two examples. We plan to use a number of different elements of evidence, and in making the decision about common mechanism of toxicity, we want to use a weight of evidence approach. We'll be discussing this with SAP and asking for comments. We'll also be presenting a case study using a group of pesticides and asking the SAP to comment on our conclusions.
A couple of additional topics we'll be discussing Thursday afternoon include visual system toxicity testing for organophosphates, and standard operating procedures for peer reviews.
For those who cannot attend the SAP meeting but are interested in getting a copy of the meeting summary, it will be available in about a month. This document will be available on the Internet on EPA's home page, and from the Pesticide Docket (telephone 703-308-5805). For information on future meetings, contact SAP Executive Secretary Larry Dorsey (telephone 703-305-5369).
Dan Barolo: We mailed the PPDC members copies of documents for the SAP meeting, and will send you the SAP meeting summary report when it is completed.
Question: Re: aggregate risk, you said it may not be appropriate to establish national drinking water exposure estimates. How do you plan to do this?
Answer: We plan to do region-specific risk assessments looking at areas of the country, like the corn belt.
Question: I do not understand the statement on page 3 of the Aggregate Exposure Assessment paper for the SAP.
Answer: We are asking the SAP to comment on the assumption that in one day, an individual is unlikely to receive a large exposure to a pesticide through food consumption and also through drinking water.
Question: How did EPA arrive at this assumption? Conceptually where is this going, and why would the SAP be qualified to comment on this issue? It's a factual issue, not necessarily a science issue. What can the SAP bring to this issue?
Penny Fenner-Crisp: They can bring to bear and inform the discussion from the general perspective of their understanding of probablistic evaluations. If there are over 400 food use chemicals, and more exceptions than not, then this assumption wouldn't hold up. But if you apply it to food use pesticides, in terms of probablistic evaluation, it might hold up as a generic assumption.
Dan Barolo: A core of people make up the SAP, but we can and do draw in others with expertise in particular areas. Someone will be there tomorrow who has expertise in this area and can address this issue.
Comment: Foods grown regionally are likely to be eaten in the region. You need to look at the specific agent and the food commodities on which it's used regionally, and then look at transport. Also consider seasonal consumption of different foods in an area.
Comment: This raises a red flag about process. It seems like EPA is leaving a major science decision to a few experts available tomorrow, as opposed to using its own data and analysis.
Dan: We don't have all the data every time on all the issues, but we do develop an issue as far as we can before going to the SAP. They tell us if we haven't done enough homework in an area yet, or if we can't make conclusions based on the information that we have so far.
Question: How would EPA like PPDC to be involved in these science questions?
Dan: PPDC is encouraged to give us views and input on science policy issues, but SAP has the lead in giving the Agency feedback and advice on science questions. If PPDC would like a more complete summary overview, we can get the SAP chairman to be on the agenda next time to discuss these science policy issues.
WRAP-UP OF DAY 1
1. We sincerely appreciate your time, energy, involvement, and expertise. There are always many opinions on any subject related to the pesticide program, and we look forward to hearing your opinions and then taking the next steps.
2. We appreciate competing pressures about timeframes for tomorrow's SAP meeting. We structured the agenda for this meeting so you can attend the SAP meeting tomorrow afternoon and Thursday.
3. Remember that you have a homework assignment. By April 16, provide comments on the GPRA objectives and sub-objectives. Your input will be in everyone's long-term interest.
4. Hold until tomorrow the follow up discussions on the work groups.
5. The next meeting will be June 25 and 26. [NOTE: Dates were changed later to June 24 and 25.] The 50th anniversary of FIFRA occurs then. We'll commemorate this event. Any specific ideas? Let us know.
6. Agenda items for the next meeting? Subject areas?
- Bring the SAP Chairman in for an overview;
- Tolerance reassessment program - where we are and where we are going;
- What OPP is doing about constituencies other than dietary exposure "victims";
- Home use/urban use/nonag use and children's exposures;
- Aggregate risk overview and resulting policy issues.
Question: When can we start the other PPDC work groups?
Dan: We want to meaningfully invest in these work groups but have many competing priorities right now. We want to get them going as soon as possible, however.
Suggestion: Schedule a half day of work group meetings during the next PPDC meeting. (Dan agrees.)
UPDATE ON OPP EFFORTS TO AUTOMATE LABELS
Linda Travers,Director, Information Resources & Services Division, OPP
Good morning. Here is your prize. Each of you gets a full set of pesticide labels approved since 1971, on CD-ROM. We're also passing along a cheat sheet on how to load it into your computer, and information on how to order additional copies from NTIS.
What we have here is all labels from 1971 through 1996. We plan to do a quarterly update -- we'll do three of those a year -- and then we'll update the whole set annually. This very basic version allows you to search by company, by product, and by date. It's very important for you to take these back, share them with people, and give us feedback and reactions. We also have fact sheets describing how to get copies. They are available by subscription from NTIS, at a very reasonable price compared to the microfiche approach.
At the next meeting, we'll try to have some demos set up. Think about what information you need, so we can better organize our information and get it out to you and others. We are putting emphasis now on enhancing our Web site. So watch the Web site and give us your comments.
Dan: These are simple images of existing labels. As time goes on, we want to be able to make the document more friendly, so you can go in and look by registration number, or trade name, or company, or active ingredient, to get to labels of most interest. Also, we're going to make copies available to each state and EPA Regional office. So updated versions of these will be available there, too.
Question: Can it be copied?
Question: Are we in the PPDC lifetime members?
Dan: We'll see how the budget holds out. We're sure that you will find label discrepancies, etc., and look forward to receiving those.
Anne Lindsay: If you have questions about the label, contact the Labeling Unit in FEAD's Policy and Regulatory Services Branch.
Question: Supplemental labels, 24(c)'s, etc.--are these included?
Response: We're not sure but we think that all labels are included.
Question: Does this contain full product labeling, or just what's on the container?
Response: It contains full labeling.
Question: EPA had talked about using a single date when labels had to be changed.
Response: Procedurally, we're heading in that direction. Rather than have label changes required throughout the year, we'd like to group many into one deadline at some point in the year. Of course, there are exceptions. If we uncover a risk, for example, and need to have labels changed more quickly, we'll require changes at any time.
Question: Is there a way to track beyond the Federal Register for section 18's? Could those be listed on the Internet? A list including the State, pest, crop site, and active ingredient is all that's needed.
Response: We've talked about starting to put those on the Internet.
Question: How are sales going? Can we get a report next time?
Response: We've already sold more CD's than we ever sold microfiche.
REPORT AND DISCUSSION FROM WORK GROUP ON RIGHT-TO-KNOW / COMMUNICATIONS
George Bonina, Information Resources & Services Division, and
Charles Franklin, Field & External Affairs Division, EPA Co-Leads
We see this as a great opportunity to seek stakeholder input potentially on a range of products, and particularly on the new communications tool that came out of the FQPA. In developing communications products, we want to make sure these are readable, understandable, balanced, and help us make more informed decisions.
The work group was formed to help us develop the right-to-know information that's required by the new law. We'll focus on this area since it's going to be a real challenge putting together something that's readable, understandable, and balanced; that will provide information that needs to get out to consumers; and that grocery stores will be willing to support us in distributing.
To review the mandates in the FQPA: By August of next year, EPA must publish with USDA and FDA information (not necessarily a brochure) that communicates several different content areas:
1 - Provides a discussion of the risks and benefits of pesticide residues in/on food purchased by consumers;
2 - Lists tolerances EPA has set based on benefits;
3 - Provides recommendations to consumers for reducing dietary exposure to pesticide chemical residues;
4 - Provides a list of foods that may be substituted for foods having benefit-based tolerances.
It's a pretty narrow set of requirements, coming out of the law.
Another interesting element of this is that EPA is to distribute this information to grocers for public display, but there's no requirement that the grocers display it. This puts more of an onus on us to develop something that's informative, and also to make sure it's something grocery stores are comfortable providing and are able to provide--considering the options they have for displaying the information.
It seems to be a narrow set of content areas, but within those areas there's a lot of room for discussion. What are the key messages that come out of this mandate? Are there any areas that don't show up but are integral areas of whatever products we put out? We want to hear your thoughts as we go into the early scoping phase of developing a draft. What do you see as key messages to be putting in?
Phil Benedict: For people to understand what this brochure is, they have to understand the process that gets us to the decision making point. People have to understand the risk assessment/risk management issues to get any benefit out of this.
Last night, Jose and I did our homework. We went to the local grocery store to see what was on the shelf. We picked up a variety of pamphlets. It's interesting to see what's in these pamphlets, and to see where they're at. The most effective thing we saw was not a pamphlet, but a chart showing the nutrition content of fruits and vegetables.
A grocery store brochure isn't very effective. It's only part of what's needed. This is an educational effort. Education is to tell them what you're going to tell them, tell them, and tell them what you told them, and a single brochure won't do it.
Jose Amador: Considering the poster over the vegetable section; that might be more efficient. Consider from the beginning that we have to do more than one brochure.
Question: Is it EPA's assumption that this brochure has to be published regardless of whether any benefits based tolerances have been established?
Comment: If the mandate of the statute was to do an educational effort, something much more intensive than a brochure would be necessary. The legislation didn't intend that EPA undertake an extensive educational effort, but just to get a set of information out there to consumers.
Jim Aidala: There's two issues. One, there's a requirement in the statute that can be read many ways. It evolved from some members who wanted a specific label on each food product which would have a benefits based tolerance. The upshot was that this evolved into a brochure or pamphlet, whatever. Also, other members were interested in better education of the public. Keep these two things separate.
Comment: Somehow, we need to gain the help of the grocery stores and others in distributing this information. Maybe the Extension Service, with its extensive network of agents, etc., can assist.
Comment: I argued yesterday against taking a laundry list approach -- trying to put everything out without thinking about what the purposes are. To make sure the effort is effective, it
makes sense to start narrow, but to think about what the purpose of providing the information is. Right to know means empowerment of consumers to do something with the information, in this case to use their purchasing power to reduce their dietary risk. Re: content, focus on the third bullet. Get input from grocers, the organic foods industry, and IPM producers. The retailer could link this information with foods in the grocery stores that are organically grown or IPM labeled, so the consumer gets the information and can do something with it. This committee should include retailers that are on the cutting edge of this type of effort.
Comment: A couple of messages could be included: what chemicals are being used, and what you can do to avoid them. At what point will we know what chemicals are out there?
Dan: We won't know until we finish tolerance reassessments during 1998 and 1999. In the first year, we are not likely to have many reassessed. Are you suggesting that we don't need a brochure if there are no benefits-based tolerances?
Comment: Maybe. We could spend a lot of time gnashing teeth over something we don't need to do, otherwise. Another point is that you could do a brochure on the risks and benefits of pesticides and what you can do to avoid those risks, but that's a different kind of message to focus on. If we're going to work on this project, we need to focus first on what the message is. People are not going to invest in distribution, etc., until they know what the message is going to be.
Comment: Origin of produce also is very important. Was that considered?
Response: Point of origin information was not part of this discussion.
Comment: There's lots of information we can and should give consumers besides benefits-based tolerances. The point should be to help people decide what to buy. Also, by giving people information about risk, you make things seem less risky.
Comment: In order for this to be even a remotely successful undertaking, we must get buy-in from the grocery industry. If the idea of this is to produce a document that's going to disparage the sale of fresh produce in the Giants and Safeways, or promote an agenda of IPM or organic gardening, I don't see the folks who need to buy in buying into this, and it's a horrible waste of the Agency's time. If we go forward with this, EPA must explain the process it goes through in making these determinations. In the past, the Agency has failed to communicate to the public the process used to regulate pesticide manufacture and use. The Agency must instill public confidence based on the elaborate and substantial efforts that it engages in, and that must be part of this message.
Comment: Different interests/ideas re: the message are represented here. A pamphlet written by NFPA will much different than one written by EWG.
Comment (FDA): This is an annual event. Don't be too ambitious. Start out with what's required; over time, gain from experience, broaden it out. Also, the target has to be the consumer -- go about it with them in mind. We should be trying to provide them with information that allows them to make intelligent choices about what's in the grocery store. Focus that way so we don't get bogged down in other issues.
Comment: Through its nutritional labeling program, FDA has a tremendous amount of experience in working with the grocery retailers that we could benefit from. Point of origin has been undertaken many times in the last eight years and always hits the same roadblock. Florida is the only state with a law in this area, and several bills are pending, so contact your Congressman -- Florida growers will appreciate your support.
Comment (FDA): We have in the audience today Dr. Robert Scarborough, the expert on FDA's nutritional labeling program. He is on the agenda later. This group should take advantage of his presence.
Charles Franklin: While we have a work group together, other groups also will be necessary to this effort -- see handout -- it lists other groups we are trying to bring in. If there are others you recommend, let us know.
Comment: Point of origin is a very complicated issue that involves customs, trade, and some other statutory authorities. Are there other measurable standards to determine what residues food contains? Keep the focus on science standards, not on where food comes from. Point of origin is not a proper indicator for health-based tolerances.
Comment: Point of origin probably is vital to this process at some level because there will be produce grown in some states and treated with some chemicals that will meet meet the letter of the law while the same produce from a different state will not. Florida uses certain chemicals on certain commodities while New Jersey uses something else, and consumers have a right to that information as well.
Comment: National/regional distribution of food is such that if you do a brochure on the area where food is from, it will have to change every month depending on the changing sources of food.
Comment: This brochure does not have to cover point of origin. But there are processes in place to address this and we should be aware of it.
Anne Lindsay: Because FQPA asks us to do aggregate exposure as part of tolerance assessment, and to look at both dietary and nondietary sources of exposure, if you were to give consumers information with which to make choices, would you include information on how to reduce nondietary sources of exposure as well as how to be a smarter consumer with regard to food? This would get into home and garden, household use of pesticides, and other sources of exposure. To me this is all connected and could be very useful, but it also may be more ambitious than what we want to do, to begin with. We would benefit from your thoughts on this, as well.
George Bonina: Re: process, our goal is provide a process where there's an opportunity for the subcommittee to participate with us and provide recommendations to the full committee. We are envisioning a process with two major drafts and lots of interaction with the committee in between. We've started having conference calls and will continue this for about another month to gain recommendations concerning the format, content, message, and distribution mechanisms; then we will do an initial draft and have discussion on it; give the work group members time to consult with their constituents and provide comments; meet to discuss and try to reach resolution on a first draft; and then do it again with a second draft. We also envision a public comment process probably around January 1998. We'll share those comments with the work group members so they can provide more comment to the full committee. After the full committee has an opportunity to meet and consider the comments, they will provide recommendations to EPA, and we will finalize the brochure, we hope in time to meet the statutory deadline for distribution. We recognize that we need to have to have a parallel process for distribution mechanisms, and invite your comment on that.
Charles Franklin: A couple of people have already commented on the challenge of working on distribution mechanisms while we are still scoping out the message. There may be value in working on the two aspects together so we involve grocers and retailers and get their buy in early on, so they help us think about what we can do.
Comment: Is this a brochure, for sure? A brochure may not be the best way to do this.
Dan: It has to be a brochure equivalent -- it can be whatever we want to call something, so a chart or folder can be a brochure.
Comment: So brochure doesn't mean brochure. Thinking about what Anne Lindsay has said, I'm happy to think about this, but I don't get the connection. How could we do this under the law, since there are no tolerances for other sources of exposure besides food?
Anne Lindsay: If you are asking whether it would be possible for us to set tolerances in the homeowner sphere, I don't think the current law gives us the authority to do that. I was thinking more broadly of various educational methods to inform the homeowner. As a homeowner, I feel like my sources of information right now are relatively poor, and I can make choices about using pesticides inside and outdoors that directly affect the exposure I receive. My best sources are the plant store and grocery store, which makes me think that everything is fine since these products are on the shelf next to other familiar products. We might also think about some of the related labeling issues. I was looking at the education end rather than setting a standard for exposure because I think we have some mandate to do education.
Comment: I think the point is information. I'm an education-oriented person, but information is the basis of education. Frankly, I don't really want EPA educating me about pesticides. I wouldn't mind getting information, and I think we should stick with a strong right to know process. Give the information to the consumer as straight as we can, and then worry about whether they understand it. I'm very much against an educational approach that's not based on good hard scientific data or specific information about that product.
Comment (FDA): Maybe there's an opportunity for a broader collaboration between EPA and USDA and DHHS/FDA, in which the information EPA is required to disseminate is combined with other information from the sister departments on nutrition, etc.. It might be possible to get more bang for the taxpayer's dollar.
Dan Barolo: Most bureaucracies take something simple and make it complicated, quickly. My suggestion is to focus in the short term on meeting the obligation in the statute -- delivering a simple educational vehicle/brochure -- to an audience, with a relatively simple message. Meanwhile, we have to build on the concept of right to know by providing other educational materials. So, while satisfying the intent of the law with this brochure, we must take advantage of the experience and expertise surrounding this process so we can build other educational materials as time and resources allow, that support the fundamental premise of the program. We all feel a tremendous need to do a lot more in that area. So, separate the two things: focus on audience, message, and a simple vehicle. (Can we produce a draft of an alternative vehicle or two by the June meeting, for discussion?) As we proceed, continue to capture the Committee's resident experience in these areas.
Comment: I Agree. We're confusing two initiatives -- FQPA's requirement for something simple that meets the needs, vs. the Administration's initiative to do more right to know.
Dan: Off the top of our program, we are going to take dollars and invest them in educational/right to know activities. We want to make sure that message is not lost. It's not either/or, it's both.
Comment: While it might be nice to focus on a draft in June, it probably would be more useful to us if the other people who need to get involved have provided input, first. Get people from the distribution side involved, and then come in with a draft for the full committee to discuss.
Comment: The law doesn't require that EPA do tolerance reassessment before completing this brochure. For many pesticides on food and in water, the level of 1 in a million already is being exceeded. With requirements of the law assessing aggregate exposure and common mechanisms of exposure, there are many compounds with a weight of evidence assumption that they will be on this list. We don't think production of this brochure should be delayed by the reassessment process.
Comment: There's a factual question you are going to have to answer--What are you going to say about tolerances that exceed the standard in August 1998? Re: a general effort to educate the public, you can start with a message: "Here is the new law and what we're doing to implement it." That's probably a very different thing than this mandate is. They are two relatively different things. If you are not prepared to say something definitive in August 1998 about what chemicals exceed the standard, then the message that this requires is a pretty normal message, and it's not going to have a lot of punch no matter what you do. Maybe you need a clever PR person to draft three or four versions of this that we can look at in June. (We are going to be ready to look at that in June.) The question is then, what do you do about chemicals that exceed the standard, and how do you educate the public about what you're doing?
Comment: Focus first on meeting the requirements up on the screen. Also, bullets #1 and #3 are irrespective of where EPA stands in its tolerance reassessment effort, and are part of what Congress contemplated and consumers are interested in, so maybe you can focus on that first.
Dan: We need to advance information in the right to know area parallel with developing what the statute specifically requires.
Comment: We are lumping together right to know with public education with information about the pesticide program. Right to know doesn't mean information about what government programs are doing, it means information about how a product is produced, whether it be an industrial product or an agricultural product. We need to look at an educational vehicle as an opportunity for communicating information about how a product is produced, which consumers can then use effectively. Information about EPA's programs is a separate set of activities. I'd like to support your two-tiered approach because the narrower the message, the more likely it is to come through clearly to the consumer and allow them to do something concrete.
Comment: About the kind of information that should be included--for example, there is an assumption under a health-based standard that fruit is considered healthy if the residue on it will only result in one additional cancer death per million people. If that is the assumption, that should be in this brochure. It's a simple statement, quite understandable, that should be available to consumers. If fruit which is waxed has residue on it that is difficult to remove, that's one sentence with information that's valuable to know. I would hope people would not replace information like this with pap.
Dan: Thanks the group for their input.
FDA's NUTRITION LABEL INITIATIVE
Dr. Robert Scarborough, FDA
FDA's food label reform initiative started back in 1988. It would be hard to condense eight or nine years' experience into 10 minutes, so I will focus only on the format chosen by the panel and how we got to that point as a illustrative example of process.
FDA's initial attempts or activities were to set up a series of three meetings. First, public meetings were held in Washington, D.C., Chicago, Seattle, San Antonio, and Atlanta. At each meeting, we tried to get the food industry and consumers in the area to attend and discuss how food labeling could be improved. We allowed broad discussion on issues other than labeling, too. At the same time, "pathway B" meetings were held with our stakeholders -- the food processors, food retailers, and that was the genesis of this voluntary program. And with consumer interest groups, health interest groups, and some segments of the food industry with special problems such as the dietary supplements industry. By law, these are foods and have to be labeled as such, but they have special needs. Finally, FDA held a series of over 50 different Consumer Exchange meetings targeted with urban, rural, and many ethnic groups.
We tried to get from these three series of meetings ideas about how food labels should be improved, and what format should be used to present nutritional information on the label. Not surprisingly, every group had a different opinion about the best label format -- pie charts, bar graphs, adjectives instead of numbers, mixed presentation, etc. There was no clear signal from stakeholders on which was the best format to use, so we did a series of consumer tests across the country. These were done in two phases. First we did a series of focus groups. These were freewheeling discussions with small groups of people -- each test consisted of about 10-15 people -- discussing how they use the label, what they look for on the label, etc. From this, we could find out how consumers were using the label, but we also noted some misconceptions about food and labeling. Based on the focus groups, we did a mall intercept study. FDA created realistic-looking packages and on each container put a different label format. In a shopping setting, stalking someone in a grocery store, we asked them to look at these labels. We asked which label they preferred and why. The second part was a test requiring them to use the labels to compare foods and determine which one was higher in fat, lower in calories, etc. This way, we were able to get a reading on how the different label formats performed.
The disturbing results from that study were that the labels consumers said they preferred did not perform very well; and the labels that they didn't like scored well on performance tests. So FDA was faced with a decision at that point -- which way to go? It was a major discussion but, in the end, we decided to go with the label that performed rather than the label that was preferred. That's a label that puts the nutrient facts with the numbers, but also with a percentage value compared against a reference level so that all nutrients are on a 100% scale. Even though we were told that consumers could not deal with percentages, this turned out to be a way for the consumer to look at a label and tell if the food is low or high in sodium, fat, calories, vitamin C, etc., and it turned out to be the best performer.
The next step was to turn that label over to a graphic designer to get some ideas on how the label could be made most effective. Some things that came out of this phase are that the nutrition labeling is set off in a box, there is mandatory bolding on the label, different sections of the label are set off by mandatory bars, there's a type size requirement, and upper and lower case letters are required. This label was prescribed in our regulations that were published.
The food industry's first reaction was that it was over-prescriptive, that FDA had gone farther than its mandate allowed. That phase passed very quickly, and next there was a rush to implement the new labeling. So the industry took to it, and was very cooperative. They saw there was a competitive advantage to being the first in the market with the new labels.
What about consumers? FDA did a series of approval tests. The new label scores very high, with a 90% approval rate. FDA also has done tests asking consumers if they are using the label and how they use it. Use continues to grow. In finishing, there are some problems. Consumers fall into three distinct groups:
1 - A group that wants more information (15-20%); they suggest new information be added; they can't get enough.
2 - A group on the other end of the spectrum (15-20%) who couldn't care less. They want to know how much the product costs and what's in the package.
3 - The large group in the middle (about 60%) has some knowledge about nutrition; they are concerned, but confused in some ways. They are using the label more, but more education is required. They primarily use the label to avoid something and do not consider the overall nutrition profile -- for example, they look at fat content but forget about calories.
The Nutrition Labeling and Education Act established a "voluntary" program for retail of fresh fruit, vegetables and fish, that FDA regulates. More recently, USDA has adopted the same program for fresh cuts of meat. This says that a significant number of retailers must provide information on the top 20 selling fresh fruits, vegetables, and fish at the point of purchase. FDA must survey the retail industry every two years, and if they find that significant numbers of retailers are not complying, the voluntary program becomes mandatory. So there's some incentive for the retailer to display the poster. FDA just completed the third survey. It indicates that 70-75% of the retailers in the country do provide this information. The small, independent grocers tend not to provide this type of information, but if you weight the big stores, we think we are reaching a fair number of American consumers.
Wrap-Up of Right-to-Know/Communications Work Group Discussion
To wrap up, FDA's is one example of an experience we can benefit from. It's an opportunity to see what we can do to make the process go more efficiently and effectively.
Some of the things we'll be following up on include:
1 - To what extent should we be looking at benefits based tolerance aspects vs. the overall risk reduction messages as we get into early drafts of the brochure;
2 - To what extent should we focus on risks as opposed to the risk process we go through;
3 - How to empower consumers without alienating grocers and other organizations we need to have buy in from to get this information out;
4 - To what extent should point of origin issue be considered in this and other communications products;
5 - To what extent, in this project and others, should we look at food risk awareness vs. nonfood risk awareness.
It's good that this group, while focusing early on on the right to know brochure, is contributing other ideas as they come up that will help us identify what other products are needed. So all the discussion will help us have a more informed communications program.
Also, regarding the need for some follow up meetings, during the next couple of months, we'll continue to hold conference calls including other groups. We hope to have a pretty vibrant dialogue as development of the draft brochure progresses.
UPDATE ON ECOLOGICAL PROTECTION
Joe Merenda, Director, Environmental Fate and Effects Division, and Paul Mastradone, EFED, OPP
This morning, we would like to give you an update on the progress and status of the work we are doing toward probablistic risk assessment. Things are starting to gel fairly quickly toward a series of work shops and work groups. We are very anxious to have the PPDC engaged in this process and look forward to your input, particularly to help ensure that we have a broad balance of stakeholders in this activity.
As with many of the technical areas of risk assessment, there tends to be a somewhat narrow collection of government, industry, and academic scientists who speak the language and like to get together and discuss these things. But we realize that the end application of this is risk management decisions that affect everyone, and we want to make sure we don't end up with too narrow a focus.
Status of the Workshops
First a quick review of the acronyms involved:
- SAP - EPA's FIFRA Scientific Advisory Panel;
- SAP Response Team - EFED/OPP's internal team that's working on this;
- ACPA/ERAOWG - American Crop Protection Association's Ecological Risk Assessment and Oversight Working Group;
- PPDC - this body;
- SFIREG - State FIFRA Issues Research and Evaluation Group;
- WOK - Workshop Organizing Committee.
How we got to where we are today: Last summer, EFED presented two case studies to the SAP and asked them to comment on our ecological risk assessment processes. They suggested that what we did was acceptable but we could make some improvements, and they directed us toward more probabalistic risk assessment processes. EFED then condensed their report into about 25 pages and came up with some initial recommendations. One of these was moving formally toward probablistic risk assessment. At the same time, the ACPA industry contact came forward and presented a number of issues that they felt were at the forefront in the ecological area. These ideas paralleled the SAP's. This was the beginning of the workshop organizing committee (WOK). The WOK formed from the industry group and EPA's staff.
Where we hope to go: The WOK plans to hold an initial workshop early this summer. From that workshop, we plan to create two groups, an Aquatic Work Group and a Terrestrial Work Group. These groups will be tasked with coming up with a process and tools to implement probablistic risk assessment in the ecological area. These groups will produce work group reports that will go to a summarizing workshop about a year from now. From that, we will gather comments and develop a presentation for the SAP. Also, some new tools are needed, as well as validation of the prediction tools that we hope to develop.
One of the important parts of this is to get participation across the academic area, the industry area, consumer area, the affected parties. What we have in mind is the initial workshop early this summer, probably in D.C. area, with general discussions about what is probablistic modeling, how far we think we can go, etc. From this, the two work groups will begin to meet at least once and probably several times a month, for six to 10 months, to develop a process and tools that will allow us to do probablistic environmental risk assessments. Meanwhile, in September, we have a consultation with the SAP set up. We'll go forward with an in-progress report to see if they think we are appropriately addressing the issues raised in the previous SAP report. We will continue to make reports to the PPDC and to SFIREG. We welcome input, ideas, participation in this process. We may need to change, update, and come in with some new tools.
By November, we hope to go to scientific, engineering, and statistical societies, to present papers, and have symposia on the work in progress, trying to get input on how we can improve these models. Farther down the road, the work group reports will come out, and we'll have a closing workshop to obtain comments from experts in the area and other interested parties. Finally, we will go to the SAP with these new probablistic tools and processes, and following the SAP's review, put them into regular use in our assessment processes.
Remember that we need to develop some new tools and tests that better fit the new processes, and we will need to do some field validation tests to see if these predictive tools are doing the job we hope they will do.
Question: We are not terribly interested in the process, but what are the new tools you are trying to develop?
Response: We assume that the tools will be a computer modeling process. However, we open this up broadly because we may have to change some of the things we have assumed and used in the past. We are looking at our entire risk assessment process, not just tacking a new tool on the end.
We hope to be able to give an idea of the numbers of populations that might be affected, the certainty of populations will be affected, move into ecosystem areas, and predictive tools of this nature. We have a contractor doing a literature review to see where the world is in the area of prob risk assessment in the eco area.
Lynn Goldman: The extent to which we are able to quantify and predict the risk at different levels of exposure in the environment strengthens our ability to take action. The reverse is also true: if our data are not easily quantifiable, it's hard to know what to do to manage the risk. So this really is an effort to provide science tools that will help us make decisions to protect aquatic and terrestrial species and ecosystems. We know this is important for pesticides but the tools we are using today are very crude.
Question: So this will replace the mesocosm studies?
Response: We need to go back to field work, and mesocosm studies are not entirely ruled out. Look at them as a validation tool.
Question: In the past, pesticides have not been regulated because of ecological impacts but for other reasons, and there remain on the market a number of pesticides that when used properly still result in large scale ecological damage. My hope is that these tools will enable you to take action on that basis. How do you anticipate that the current focus on FQPA requirements will affect the ecological picture?
Lynn: FQPA has required us to do some internal redirection in other areas, but not in the ecological risk assessment area. Also, some of the FQPA consequences will end up providing ecological benefits. For example, common mechanism of action is important not only for residues in food, but also for residues in aquatic ecosystems, for birds, etc.
Question: Is there any possibility of risk transfer, that tolerance reductions in some pesticides might lead to greater use of other pesticides that pose risks to wildlife but don't pose human dietary concerns?
Answer: Theoretically it's possible. It's a reason to want to be able to understand and quantify the risk. To the extent that we can actually measure the risk, we are less likely to transfer it because we don't understand what the consequences are. That's why we need this focus on sharpening our ability to describe and quantify these risks.
Dan: Hopefully, it's an improved assessment tool as well as certainty tool that will allow us to feel more comfortable and confident in making more aggressive ecological risk assessment decisions. Also, we have added this topic to the agenda because we recognize that FQPA has dominated discussion in the past, and we want to make sure we don't lose sight of the fact that we have an eco protection responsibility, as well.
Joe: There is also some synergy between some of the work we are doing under FQPA and work we need to do to support more reliable eco risk assessments, particularly in the area of estimating surface water concentrations. We have used models in the past and they are rather simplified. We need to expand them to have a better approach for estimating human dietary exposure through drinking water, and those same tools will be useful in estimating impacts on the aquatic environment. We hope similar tools will be developed for the terrestrial environment.
Question: Re: separation of development v.s. implementation, this is a useful undertaking, however, on the implementation side, will these new tools be more resource intensive than the existing models?
Response: It's a mixed response. We put resources where they are required. For example, we now have a vast amount of information on spray drift from the Spray Drift Task Force. EPA's ORD is working on putting this information into models that can be validated, and then can be used to replace some of the case-by-case field data that were required. However, we need a large investment to assemble a body of data to validate the models.
Our first priority is to identify existing tools we can apply, and only where there are not existing tools to meet the need do we anticipate developing new ones. We realize there is a lot in existence from other bodies that we can incorporate much sooner.
Comment: Encourages EPA to reach out to the applied ecologists, land managers, people in the Park Service, etc.. There is a tendency to get so involved in quantifying things that you don't talk to people who have real qualitative experience and can give you some real insights.
PPDC COMMITTEE PROCEDURAL ISSUES, FACA REQUIREMENTS, AND NEXT STEPS
Margie Fehrenbach, Special Assistant to the Office Director, OPP
The PPDC charter expires on September 14, 1997. To renew it, we must receive EPA's approval at the Deputy Administrator level and have a consultation with the General Services Administration.
We plan to review the current membership, and announce in the Federal Register that will consider new members. All who are interested will be asked to reply to Dan Barolo. We have a list of people and organizations who have expressed interest in joining the PPDC over the last year and a half. They can apply again if they wish to, but we have maintained that information.
We want a membership that's balanced with respect to points of view expressed and functions performed, a diverse cross-section of those who are directly affected by pesticides, and who are interested and able to serve on the Committee. We will also seek geographical diversity.
We left copies of the charter, current list of members, and advisory committee act on the table and you have
We plan to advertise in the FR within the next two months so we can begin the selection process in July and complete it by September.
We are not asking everybody to leave. There is a lot of desire to have stability. At the same time, it would be good to have some turnover, and we know there is a lot of interest outside of this room. Earlier rather than later, it would be helpful to know if you are interested in leaving in September so we can keep that in mind and recruit people to cover your area of interest.
Question: Is there a limit as far as number of terms?
Response: FACA doesn't really address terms specifically. Everyone serves at the pleasure of the Administrator with the advice of the Assistant Administrator.
Dan: People are appointed for two years. In the middle of the second year, it makes sense to offer rotational opportunities so there is some overlap.
Question: Any thoughts on the final size you want the PPDC to be?
Dan: We need to have it be a manageable size. The present number is 24 counting Margie and me. So the 20 to 25 range supplemented by work group members is generally what we had in mind. There will be further communication on this.
STATUS OF THE PPDC WORK GROUPS
You all have volunteered to participate on the eight work groups we have identified. To date, we have gotten three of these work groups off the ground. It is our intention, sooner rather than later, to engage the other work groups. One possibility is to set aside time for the work groups to meet and work at the June PPDC meeting.
We also have seen a great deal of interest on the part of others to participate on these subgroups. If anyone in the general audience has an interest in being on one of the work groups, we need to receive a short note from you to that effect. FACA requires us to go through the committee to receive this advice and counsel. So, even though a work group might have a non-FACA member or two on it, they have to come back through the subgroup and this committee for us to consider their formal advice and counsel.
If you know of an organization that could assist us, please let us know. Our general commitment is to get started on the other work groups as soon as possible, and certainly to have a working session at the June meeting.
Lynn Goldman, Assistant Administrator, OPPTS, EPA
This is an exciting week for us. We have not only this meeting, but also the SAP meeting at which two very important topics for FQPA will be discussed, the common mechanism and aggregate risk issues. I'm sorry I wasn't able to be here for most of this meeting, but I will catch up. It's especially important that you be involved at this critical time, as we are implementing the new statute. It's been an exciting process, but also a very challenging process. We have a lot of choices to make about how we move forward, the priorities to set in our work. We have new resources but need to focus these on the most important needs first. Even with new FTEs and dollars, we can't do everything at once; we have to phase in our implementation efforts. So your ideas about priorities and your sense about where we should be headed, not only in the longer term but in the short term as well, is very important and potentially can make a big difference in how we protect children, farm workers, and ecosystems, and hold to other commitments in the statute with respect to minor uses, antimicrobials, and reduced risk pesticides. It's a challenge.
You also have a critical role in keeping our feet to the fire on implementation. With a big program like this one, we make some decisions about how to proceed, but we need to have that push and encouragement from the outside to get to actual implementation. Keep us honest, and take an activist approach to committee membership. Make sure the issues you are concerned about are being raised here, and that we provide a forum for those issues to be fully discussed and resolved. Use this as an opportunity to bring your set of issues to the table.
I remember an experience from years past, preparing for a meeting with OPP about pesticides. One thing that stands out in my mind is how much material had to be delivered from the program to us in order for us to begin to have a discussion. We spent hours reviewing the Rainbow Report and schedules... There is a tremendous amount of information involved in being able to look at this program. Don't get bogged down in the minutia -- it's important, but in the bigger picture, you bring concerns to us that are also important. Make sure we are addressing those concerns, as well as involving you in day to day details which can, after all, determine whether or not we meet our goals.
I appreciate your involvement.
Question: What are the kinds of products you are looking for from the individual work groups?
Dan: We have to do a better job of getting you the background papers in advance, and in highlighting the policy issues. This will help you and all of us in the longer run.
Lynn: If we are not asking the questions you think we should be asking, that also is fair game.
Question: Asking again, is this going to be about food only? What about non-agricultural/non-food use exposure? Where is the Agency going on children's/household exposure?
Lynn: This is an extremely important area, and one where it would be useful for this group to hold our feet to the fire as an agency. We have had a plan in place since 1989 to improve our tools for residential and other non-food exposures. Work has been underway at EPA ORD's Exposure Assessment Laboratory, and those efforts have not yielded new guidelines as quickly as we wanted. It is an important issue, and one where encouragement from the advisory committee would be very helpful.
Question: Is there a document about what has been done?
Response: Yes, a planning document.
Question: Another big picture issue we might want to look at is benefits assessment. In the context of IPM alternatives, what do some of the benefits assessments look like, for example, for carbofuran? What improvements over time have improved the depth of that analysis?
Response: We have use profiles -- NAPIAP has helped -- we would be happy to share.
Lynn: We could work with you on framing a benefits assessment issue for a future meeting so we could present the issue in a useful fashion. I think it's a good idea.
Question: As you decide which work groups to queue up, start the one on tolerance reassessment since we are going to focus on that next time. Also, please produce the materials you are going to use earlier and test drive them with a few members of the group to make sure they are understandable.
Question (Lynn): How useful is the Implementation Plan, and should we use this as a framework for future activities and discussion?
Response: Useful; continue to use it.