SPEAKERS CONTENTS INSERTS
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IMPLEMENTATION OF THE FOOD QUALITY PROTECTION ACT
THURSDAY, JUNE 25, 1998
House of Representatives,
Subcommittee on Department Operations,
Nutrition, and Foreign Agriculture,
Committee on Agriculture
Washington, DC.
The subcommittee met, pursuant to notice, at 9:15 a.m., in room 1300, Longworth House Office Building, Hon. Bob Goodlatte (chairman of the subcommittee) presiding.
Present: Representatives Ewing, Canady, Smith of Michigan, LaHood, Thune, Clayton, Berry, Brown of California, Bishop, and Stenholm [ex officio].
Also present: Representative Dooley.
Staff present: Pete Thomson, legislative director; Kevin Kramp, subcommittee staff director; John Goldberg, professional staff; Keith Menchey, science fellow; Wanda Worsham, clerk; Stephen Haterius, minority staff director; Danelle Farmer, and Russell Middleton.
OPENING STATEMENT OF HON. BOB GOODLATTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF VIRGINIA
Mr. GOODLATTE. Good morning. This hearing of the Subcommittee on Department Operations, Nutrition, and Foreign Agriculture to review the implementation of the Food Quality Protection Act is now called to order.
The purpose of this hearing is to receive testimony and written statements reviewing the implementation of the Food Quality Protection Act that passed unanimously in July 1996. FQPA amended the Federal Insecticide, Fungicide, and Rodenticide Act, FIFRA, and the Federal Food, Drug, and Cosmetic Act.
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The Food Quality Protection Act repealed the unworkable and unscientific Delaney clause which mandated zero-tolerance for most pesticides and replaced it with a new, scientifically-based safety ''standard reasonable certainty'' of no harm. This standard provides a clear mechanism for the U.S. Environmental Protection Agency to institute workable protections for infants and children, establish parameters for comprehensive risk assessments, ensure uniformity of safety standards, maintain producer access to essential crop protection compounds, and, most importantly, ensure consumers will continue to enjoy the most abundant, safe, wholesome and affordable food supply in the world.
If implemented in a rational, scientifically-justified manner, FQPA will be a very good law. Unfortunately, the perception is that EPA's agenda for FQPA implementation is neither rational nor scientific. As a result of the leaking of internal EPA documents, there has been particular anxiety within the agricultural community that EPA has predetermined the cancellation of entire classes of chemicals before the mechanisms for making such a decision have ever been established.
I have called this hearing today because EPA's refusal to base decisions on the best available scientific evidence and their unwillingness to call for additional, reliable data to meet new requirements is intolerable. EPA's risk assessments are not adequately portraying the best available data, as required by the law. Instead, the agency insists on using default assumptions regarding pesticide use, as well as associated risks. Many stakeholders have told me that they are willing and able to submit accurate and actual data. The EPA, however, either refuses to accept these data or refuses to tell the stakeholders what data they need.
EPA has told us recently that the new law has thrown so many new responsibilities at them and they need time to promulgate new protocols. This is quite a different tune than the EPA was singing two years ago. In discussions over the yet-to-be-passed bill, EPA told both the committees of jurisdiction—the House Agriculture Committee and the House Commerce Committee—that the Food Quality Protection Act merely codified their current tolerances review practices. Yet, here we are, a growing season away from the first tolerance review hurdle with absolutely no guidance from the agency on how they have made decisions or how they plan on making decisions.
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Our frustration grows each time we hear farmers describing the economic ruin they will face if the EPA continues with their current implementation of the FQPA. While some may ignore the farmers and ranchers of this country and push aside their pleas because they fear retaliation from environmental extremists, I stand here to tell you that our producers are the first and best stewards of our land. Their family's survival depends on productive land and safe food and drinking water. Why on earth would they be willing to endanger that?
It's not only our constituents from rural America that are standing up and screaming. Editorial pages are all too frequently balking at EPA's current implementation procedures or lack thereof. Take, for example, a Wall Street Journal editorial entitled, ''Will the EPA Make America Safe for Cockroaches?'' The editorial asks how harmful pesticides are to humans. The answer is in the same editorial—the average human adult would need to eat 875 pounds of broccoli every day for the rest of his or her life to approach the levels that caused problems in the rodents. And, let me say, as for myself, I'm with former President Bush when it comes to broccoli. [Laughter.]
Other published reports detail frustrated scientists leaving the agency rather than suffer through the morale-bruising management style the agency employs against those that question dubious scientific methodologies or, as some have described, the inclination of high ranking officials in the agency to make ideological decisions, then require the science to be modified to justify the political approach. Without objection, I will enter these reports in the record at this time.
[The information appears at the conclusion of the hearing.]
Mr. GOODLATTE. Are there safety concerns? Absolutely. Are we defending the status quo? Absolutely not. If there are products or uses which, based on reliable data, do not meet the standard of reasonable certainty of no harm, they should come off the market. We authorized the EPA to force chemical manufacturers to provide additional data proving the safety of their products. If the data demonstrates a measurable risk to infants and children, we authorized the agency to use an additional margin of safety. Congress encouraged the EPA through the Food Quality Protection Act to find newer, better and more accurate ways to review the tolerances of agricultural chemicals. We did not authorize them to implement a chemophobic agenda and jeopardize the availability of food to our children.
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What we can't tolerate is EPA abuse of authority. We can't tolerate the EPA using authorities they don't know how to use. Until the EPA can publish protocols for using these new authorities that are granted them in the FQPA, they should not use them.
The Food Quality Protection Act requires a third of all tolerances be reviewed by next August. Nowhere does the law say that the EPA has to apply all of their new authorities when reviewing the tolerances. In fact, it says just the opposite. It says that tolerance decisions have to be made on the best available data. It doesn't say to guess what the data might be, or to estimate what the data must be to arrive at predetermined decisions.
I welcome our witnesses to the table with. Normally, I do so with optimistic expectations. Today, however, I welcome our witnesses from the administration expecting to get firm commitments on several questions that the agency has been noticeably vague about to date.
I now welcome and recognize the Ranking Democrat on the committee, Mrs. Clayton from North Carolina.
OPENING STATEMENT OF HON. EVA M. CLAYTON, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NORTH CAROLINA
Mrs. CLAYTON. Thank you, Mr. Chairman. Thank you for calling this meeting.
It is, indeed, an unfortunate act. The Food Quality Protection Act of 1996 is the most significant pesticides and food safety act that we have had in recent years. In fact, to come to that point took many years and a lot of struggle and a lot of compromise, give-and-take. The implementation hasn't been as any would have expected and it certainly hasn't been at the level that this Member expected.
But, I would be the first to remind all of my colleagues that, indeed, the expectation that the implementation should be without any stumbling blocks is not realistic in the significance of this bill. Having said that, the bill sets out standards and expectations and it says the goal is for protection of our children and protection of our food quality in the production and to allow for the compromise of what now is used world-wide science—it used to be the best science, but whatever that means—that we would have decisions based on scientific data, rather than impulses or rhetoric or assumptions that are not substantiated by the evidence.
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And that means that evidence should be, indeed, forthcoming. It also means that it should be received with integrity. So, the process has to be put in place and that process has to have the integrity of everybody in the States. Certainly, the producers but also the consumers who buy the food and who expect that the food they have and the chemicals that are input on there are, indeed, safe and that the American public is protected.
It also involves those who produce the pesticides—they have a stake in that—children, of course, public health, and environments. All of us are better off when, indeed, all of us can have our views represented and have the understanding that no one sector has the upper hand.
And, the process is ill-served to have the company against the environmentalist, or the environmentalist against the consumer, the producer made as if he doesn't care or the producers don't care about the environment.
I concur with the chairman; most farmers I know are good stewards of the land; they love the land, they depend on the land, and it's illogical to assume that they would want to abuse God's gift to the land. But, nevertheless, there are inputs, indeed, that have been found to be more strenuous than any of us knew. And, it does compel us to look at all the data, to look at all of the implications, so, this is an important exercise. I don't take it lightly. So, it's not—I welcome this hearing. I don't look with expectation of finding the rhetoric to be unreasonable. I expect that we will have the presentation of the administration candid.
There are some questions that you need to answer. Obviously, the question is, why haven't we proceeded faster, given the time—1996. It is now 1998 and almost July. I understand there is a procedure. At least an advisory committee of some 52 persons, representing all the sectors and places, now met twice. There isn't a reassessment that must be made. The August date that the chairman spoke up does suggest that one-third of the tolerance of certain chemicals must be in place. So, there are some critical deadlines that suggest that very valuable time has escaped and that we haven't used it wisely.
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Likewise, I think that compels the administration to have the same sort amount of time and transition for the—I think they call—the industry calls the—registrants—that's a new word, I have to remember that—the registrants to put forth the scientific data.
Again, I welcome the witness and look forward to their testimony. Mr. Chairman, I ask unanimous consent to put my full statement into the record later.
Mr. GOODLATTE. Without objection, so ordered, and we thank you.
Members may include their prepared statements for the record, if they have any, within the next 10 days.
At this time, it's my pleasure to recognize the ranking member for the full committee, Mr. Stenholm of Texas.
OPENING STATEMENT OF HON. CHARLES W. STENHOLM, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS
Mr. STENHOLM. Thank you, Mr. Chairman for holding this hearing today. And let me start by welcoming Deputy Secretary Rominger and Deputy Administrator Hansen. Thank you for being here and for your demonstrated commitment to this issue. While much more remains to be done, your joint efforts are greatly appreciated.
We're blessed in this country to have the most abundant, most affordable, safest food supply for our consumers of any other country in the world. And there's no question that public health is a high priority and that all of us want to ensure that our food supply is safe. For these reasons, the FQPA was overwhelmingly passed in 1996 with the support of a broad spectrum of interests, including environmentalists, chemical companies, growers, and food industry groups.
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As with any legislation of this magnitude, however, there has been troubles in its implementation. The FQPA requires the Environmental Protection Agency to look for the first time at dietary risks and non-dietary water and residential risk. Organophosphates, OPs, and carbamates are the first class of chemicals to go through this tolerance assessment or reassessment. This group makes up 70 percent of all insecticides and affects all crops. Unfortunately, instead of a reliable, coherent process for registrations resulting in safer technology, the FQPA has caused considerable confusion and alarm.
The EPA has failed, thus far, to identify a process for completing these reassessments and has not, until very recently, openly communicated with the affected groups. As a result, growers are facing a great deal of uncertainty and are understandably frustrated.
As you know, earlier this year, the Vice President issued a memorandum to EPA and the United States Department of Agriculture directing them to follow four simple principles in the implementation of FQPA. No. 1, base decisions on the best science and data that are available; No. 2, ensure that decisions are transparent to affected constituencies; No. 3, provide a reasonable transition for agriculture—the EPA and USDA should work together to address transition challenges, as Agriculture looks to newer pest management strategies. And, No. 4, consult with the public and other agencies concerned with FQPA implementation.
Since the Vice President issued his directive, we have had some time to review any progress. As a result of the memorandum, the Tolerance Reassessment Advisory Committee has been formed for stakeholders to consider implementation issues and has already held two sessions. In addition, there has been increased communication between EPA, USDA, and stakeholders.
While I appreciate these changes, I still have several important concerns which I hope will be addressed today. For instance, we know we do not have complete, reliable data for all OPs for non-dietary risk. But, as I understand it, EPA has not and is not planning to utilize the authority given to them in FQPA to request additional data in order to base their decision on the most complete set of facts available. I would look forward to addressing this and other important issues with EPA today, and as we move through the implementation process.
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Let me be clear. I support the concepts in the Vice President's memorandum. Unless they are carried out by EPA and USDA, however, they are just words on paper. I intend to measure all issues against the four principles in the Vice President's memorandum in order to ensure that they are adhered to.
Finally, while I am looking forward to hearing from the witnesses assembled today, I regret that we will not be hearing from all the interested parties. If we are going to resolve the differences on this or any other issue, we must put aside our differences and rhetoric and work together. The recently passed Agriculture Research bill certainly illustrates the importance of working as a coalition toward a common goal.
Again, I thank you, Mr. Chairman, for holding this hearing. I look forward to hearing from the witnesses and, at this time, I would ask unanimous consent to submit copies of two petitions for the record. The first is a petition for rulemaking to develop policies and procedures for implementing the FQPA, a coalition of 21 associations representing a broad range of growers, food processors, and pesticide manufacturers. State agricultural agencies filed this petition with the EPA.
The second petition, Mr. Chairman, is for rulemaking to implement FQPA provisions regarding section 18 of FIFRA. Another coalition of 19 agricultural agencies and associations filed this petition.
Mr. GOODLATTE. Without objection, they will be made part of the record.
[The information appears at the conclusion of the hearing.]
Mr. STENHOLM. Thank you, Mr. Chairman.
Mr. GOODLATTE. And I thank the gentleman for his remarks.
At this time, because Mr. Hansen, in particular, is under a very tight schedule, we'll ask that other members submit their opening statements for the record.
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[The prepared statements of Members follow:]
PREPARED STATEMENT OF HON. ROBERT F. (BOB) SMITH
I want to thank the chairman of the subcommittee, Mr. Goodlatte for holding this hearing.
Mr. Chairman, in the interest of time, my remarks will be brief.
Mr. Chairman, since coming back to Congress, I have made elimination of trade barriers one of my main priorities. Unfortunately, every time I think we may be on the verge of a breakthrough with our friends from around the globe, I find that our main adversary is irresponsible regulation within our own country.
With all due respect to my friend from my home State, Fred Hansen, every time I turn around, the EPA is doing something else to force American farmers—I'm talking about family farmers—out of business.
Just within the last 2 years, I have seen EPA impose on working farm families unnecessarily harsh standards for air quality that were based on politics, not science. Next came an effort from Kyoto, Japan to attempt to force America to sign onto a global treaty whose sole purpose, it seems, was to eliminate agriculture.
While we have been waiting for the EPA to submit a legislative proposal—a proposal that the President himself promised—to allow American farmers the same opportunities to use methyl bromide as farmers around the world; instead EPA chose to try to eliminate the livestock industry in this country with their so-called clean water action plan.
Mr. Chairman, the Food Quality Protection Act is a very good law. It provides the EPA with many new tools for evaluating pesticides under the condition that their decisions be based on reliable data—not assumptions.
Unfortunately, it seems that EPA is on track to reject the need to explain what they're doing and how they're doing it to the public, as well as rejecting the opportunity to ask for the scientific data necessary to implement the authorities Congress has granted them.
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On top of all this, after 23 months, all that we have to show for Congress's efforts to improve pesticide regulation is an unreasonable slowdown of the process to bring new, safer, more efficacious products to market. This is completely unacceptable.
I look forward to reviewing the testimony from today's hearing. Thank you Mr. Chairman.
"The Official Committee record contains additional material here."
Mr. GOODLATTE. At this time, welcome our first panel.
The Honorable Richard Rominger, Deputy Secretary of the U.S. Department of Agriculture, and Mr. Fred Hansen, Deputy Administrator of the U.S. Environmental Protection Agency.
I would like to welcome all of you and tell you that your written statements will be made a part of the record and we'd be pleased to receive your testimony at this point.
Mr. Rominger.
STATEMENT OF RICHARD ROMINGER, DEPUTY SECRETARY, U.S. DEPARTMENT OF AGRICULTURE
Mr. ROMINGER. Thank you, Mr. Chairman, members of the committee. I'm pleased to be here this morning to discuss with you the EPA's implementation of the Food Quality Protection Act.
Fred and I appreciate the opportunity to discuss the FQPA with the committee. We're also interested in your views on how we can implement the Food Quality Protection Act in a way that continues the broad-based support that existed for this law at enactment.
We've heard the four principles of the administration for implementing the FQPA that were set forth on April 8, 1998 by the Vice President in his memorandum to Secretary Glickman and Administrator Browner. But, I would like to just mention them again.
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No. 1 was ensuring that decisions are based on the best science and data available. And, No. 2, ensuring that the decisions and positions of the U.S. Department of Agriculture and the EPA are transparent to the affected constituencies. And, No. 3, ensuring a reasonable transition for producers of at-risk commodities. And, No. 4, establishing an effective means of consultation with groups interested in the implementation of the FQPA.
To meet these objectives and to ensure full public participation in the implementation of the FQPA, the Vice President, Secretary Glickman, and Administrator Browner have instructed Fred and me to chair a Tolerance Reassessment Advisory Committee that will advise the administration on how best to proceed with fulfilling the requirement of the law. The TRAC has met twice and, after an admittedly rough start almost a month ago, the group working together has decided to make some adjustment to the process and to its agenda.
And, while we may not reach consensus on some of the difficult issues, both Fred and I are optimistic that the advisory group will provide valuable and concrete advice on the processes we can use to ensure broad and reasoned comments from all affected by the changes the FQPA makes.
I do think this is the view and the desired outcome of the majority of the TRAC membership. We look forward to continuing our work with EPA, the Department of Health and Human Services, and the membership of the TRAC to review, to discuss, and to define policy and procedural options that are available for the administration to exercise in achieving the requirements of the FQPA.
Clearly, the law, with its emphasis on standards that protect children, poses some new challenges and opportunities for U.S. agriculture and for USDA. We're prepared to meet these challenges. I'm pleased that the law provides an enhanced role for USDA to represent the agriculture sector in the regulatory process and to provide EPA with reliable, real-world data to better inform the regulatory process.
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Working with EPA and the agricultural community, USDA has already made changes to data collection and data support programs, like our Pesticide Data Program, the National Food Consumption Survey, and the National Agricultural Statistics Service Pesticide Use Surveys. In general, the changes to these programs enhance the size, scope, and value of our databases. Specifically, we want to ensure that the data collected are relevant both to the risk assessment tools used by EPA and to policy considerations for USDA, agricultural producers, EPA, and HHS. We also want to guarantee that data are reliable and can be recognized by all stakeholders as reflective of real-world conditions for pesticide use and pesticide exposure.
This year, also working with EPA, the grower community and the Congress, USDA established the new Office of Pest Management Policy to guide the Department's implementation of FQPA and coordinate the Department's pest management programs and policies. The Director of the Office of Pest Management Policy answers directly to and carries the authority of the Office of the Deputy Secretary of Agriculture.
The OPMP will coordinate closely with EPA, grower groups, and the State land-grant university system to develop and provide important crop-specific information that will be key to supporting growers and demonstrating critical pest control needs for commodities, as well as for supporting regulatory decisions at EPA and programming decisions at USDA.
In particular, the OPMP will be instrumental in developing important mitigation plans, such as lowering label rates or increasing pre-harvest spray intervals for EPA's consideration as alternatives to eliminating important uses for regulated pesticides. The Office of Pest Management Policy will also be responsible for working with growers and the EPA to develop transition strategies for commodities affected when a pesticide use must be eliminated. The research needs of growers of at-risk crops with certain crop-pest profiles that require mitigation and transition strategies will be addressed under the Department's Pest Management Alternatives Program. Program managers will consult closely with the OPMP in establishing program priorities.
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Also, managers of the Interregional Research Project No. 4, better known as the IR–4 Program, which develop important field trial data to support new and important minor crop tolerance petitions have implemented a new priority setting process to ensure at-risk, minor crops have efficacious pest management alternatives before regulatory decisions are made that halt the use of existing pesticides. The program managers are working closely with growers, registrants, and EPA to register new and safer alternatives for minor crops.
The law also provides an opportunity for USDA, growers, and EPA to review and, as necessary, refocus the USDA research agenda to meet producer needs that may derive from FQPA regulatory decisions. The Vice President specifically asked the Secretary and the Administrator to review their respective operating plans and budgets to expedite new product approvals and expand integrated pest management strategies. Review and reassessment of the research and education agenda is an on-going process. The administration is committed to using the FQPA implementation process and the TRAC to assist us in developing a solid and responsive research and outreach agenda to support U.S. growers and the agriculture industry.
The Department, with your support and that of the grower community, the White House, and EPA, has implemented many reforms over the past year to implement FQPA. The President's fiscal year 1999 budget submitted to Congress in February sets forth an estimate of what the Department would need to meet its responsibilities to the grower community and to EPA under FQPA.
Unfortunately, after several months of working with Congress, EPA, and U.S. growers to develop a FQPA implementation strategy and budget, we're concerned that important parts of the implementation budget are in jeopardy.
As our appropriations bill stands now, among other setbacks, the Office of Pest Management Policy will either be eliminated or, at the best, will be unable to develop crop specific mitigation or transition strategies.
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The Pesticide Data Program will be unable to initiate a Pesticide Residue Monitoring Program for drinking water to address aggregate exposure requirements of FQPA. We'll be unable to support an important Acute Dietary Exposure Program and, more than likely, we'll have to negatively impact program capability by ending its long-time financial support for some State sampling operations and laboratory facilities. The Pest Management Alternatives Program will be only partially effective in meeting the needs of the most at-risk crop-pest combinations and program managers will not have the benefit of the crop-specific profiles that were to be completed by the Office of Pest Management Policy and our land-grant university partners.
The Department will not be able to develop large-scale area-wide implementation projects and the National Agricultural Statistics Service will be unable to initiate a new survey of pesticide use practices in the nursery crop and greenhouse industry, and NASS will be seriously limited in its efforts to enhance existing commodity pesticide use surveys. Planned data refinements and programs, such as these, could be the difference between retaining or losing a pest management tool for some commodities.
Finally, the President has signed the Agricultural Research, Extension, and Education Reform Act of 1998 which will provide an additional $120 million per year for the Initiative for Future Agriculture and Food Systems and $30 million per year, more or less, for research under the Fund for Rural America, both of which can and will be used to enhance the Department's overall FQPA implementation strategy. However, we are very concerned about constraints being placed on these programs in the pending appropriations bills.
In general, the pending House and Senate appropriations bills could severely limit any further, meaningful participation by USDA in the FQPA implementation process that could translate into unfortunate and decidedly avoidable impacts on some agricultural producers, particularly minor crop farmers. Certainly, these are problems the Department wishes to avoid and we're committed to working with Congress to resolve these programmatic issues.
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Mr. Chairman, in closing, let me say that the law provides many opportunities for USDA, EPA, HHS, and all participants in the agricultural sector of the economy to further develop constructive, working relationships. I believe the FQPA implementation policy we've described here will ensure American consumers, including children, continue to have a safe and abundant food supply produced by a strong and competitive U.S. agricultural industry. Ultimately, a law and a process that allows and requires the Government to confirm clearly, unequivocally, and confidently the safety of the pest management tools used by our growers is important and valuable to all of us.
Mr. Chairman, that concludes my statement. Thank you.
[The prepared statement of Mr. Rominger appears at the conclusion of the hearing.]
Mr. GOODLATTE. Thank you.
Mr. Hansen, welcome.
STATEMENT OF FRED HANSEN, DEPUTY ADMINISTRATOR, U.S. ENVIRONMENTAL PROTECTION AGENCY
Mr. HANSEN. Thank you, Mr. Chairman, and good morning to you and the members of the committee. I am pleased to be able to be here. I will be brief in my opening statement. I thank you, Mr. Chairman, for having the written statement entered as a part of the record.
As has been referenced previously, we are all very pleased with, obviously, the unprecedented example of cooperation that was reflected in the enactment of the Food Quality Protection Act. As has been commented on already, the Vice President directed in April of this year EPA and USDA—Secretary Glickman and Administrator Browner—to ensure that implementation of the Food Quality Protection Act follows four guiding principles. Mr. Stenholm mentioned this.
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I want to be able to stress them as well. The first is to ensure that our pesticide and food safety regulatory decisions are grounded in the best available science. Second, that the regulatory processes must be transparent and predictable. Third, that we must ease the transition to new pest management strategies for affected pesticide users. And, finally, to consult with the diverse stakeholders whose opinions and experience are essential to the successful implementation of the act.
And I want to ensure you that Administrator Browner and I are fully committed to these principles and are working diligently to deliver the enhanced public health protection, especially for children, envisioned by the Clinton administration and this Congress while maintaining a safe, affordable, and abundant food supply.
Let me provide some highlights of our activities in each of these areas. Sound science. At the core of the new law are several basic concepts: Risks are to be examined in an integrated or aggregated fashion; cumulative risk among chemicals that act in a common way must be considered; and protection must be provided where special sensitivities exist, particularly for infants and children.
Two, transparency. As you know, Deputy Secretary Rominger and I co-chair a new Federal advisory committee, the Tolerance Reassessment Advisory Committee. This advisory committee is working to advise EPA and USDA on ways to assure that our science policies, our risk assessments of individual pesticides, and our processes for decisionmaking are all as transparent as possible.
The advisory committee has been asked to focus on the reassessment of tolerances for organophosphate pesticides. But, their advice will assist both EPA and USDA not only with that group of chemicals but with tolerance reassessments as a whole. Some of the other issues that the committee is addressing include ways to increase the pace of decisionmaking, to provide growers with newer and safer pesticides and new uses of registered pesticides, strategies for reducing risk to acceptable levels while retaining pesticides of the highest public value, and identifying opportunities for reasonable transition mechanisms.
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The advisory committee is not only assisting EPA and USDA in building a framework for implementation, it is helping forge that partnership of all parties that is necessary for successful implementation of the act. Once this framework is further refined, EPA will—through notice and comment—make it available for broader public review. It is important to note that, in the interim, EPA will continue to use sound science and the processes we have already established to make decisions on new chemicals, on applications for emergency exemptions, and to continue the reassessment of older chemicals.
Third, transition. It is likely that FQPA's new standards may result in modification or cancellation of some currently existing pesticide registrations. EPA wants stakeholders to be able to anticipate and plan for our actions and to have access to new pest management tools where they are needed. We need to balance the reassessment of tolerances to achieve the important health protections called for by the act with the introduction of new products and pest control methods to help ensure that a broad range of alternatives are available.
In the past few years, EPA has accelerated its efforts to provide better, safer choices for pesticide users. EPA has registered 45 new pesticide active ingredients which meet the new act's requirements. Since the law passed, we have also approved approximately 650 emergency exemption requests. This year, we have significantly reduced the time needed to review these requests.
I'm also pleased to announce that the Administrator and I are allocating additional funds during this fiscal year to the Pesticide Registration Program which will allow them, over the next two years, to complete the review of additional new active ingredients.
As I've mentioned earlier, one of the key issues is consultation. The advisory committee and other processes are absolutely key to that end.
In conclusion, the Food Quality Protection Act is an extremely important public health protection statute. It provides for a consistent health-based standard that will provide greater protection for consumers, particularly infants and children. It provides consumers with more information so that they can make more informed choices about what they feed their families.
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I believe that the United States has the safest, most affordable, and most abundant food supply in the world and that that status should be further enhanced by the FQPA. There is every reason that FQPA's standards can be met while maintaining the tools that growers need. And this is what the administration is committed to. Thank you.
[The prepared statement of Mr. Hansen appears at the conclusion of the hearing.]
Mr. GOODLATTE. Thank you, Mr. Hansen.
As I stated earlier, during drafting discussions of the Food Quality Protection Act the Environmental Protection Agency assured us that the language eventually adopted was simply a codification of the EPA's tolerance review practices. Was the FQPA a codification of EPA tolerance review practices, Mr. Hansen.
Mr. HANSEN. Mr. Chairman, the Food Quality Protection Act provided not only an opportunity to be able to codify a number of the provisions on activities that we were currently applying—some in limited areas, others in a broader area—the Food Quality Protection Act made consistent and constant the special protections that are provided for infants and children and does that in a consistent way. We are in the process of implementing that.
Mr. GOODLATTE. Is that a yes, then?
Mr. HANSEN. There are certain parts of our implementation, Mr. Chairman, that did not always—did not fully implement all elements of what now the Food Quality Protection Act requires and we believe that that is an appropriate part of how the act should be implemented now.
Mr. GOODLATTE. OK. Well, to the extent that you're saying part of it is yes, why have we had to have four Federal advisory committees and two tolerance review advisory committee with two more to come with no published notices, rules, or guidelines to date?
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Mr. HANSEN. Mr. Chairman, as I think all of you are well aware, the Food Quality Protection Act provides for significant new changes in several areas and let me be clear. It provides for a clearly expressed additional protection for children. It provides for looking at non-residential and residential exposures along with drinking water exposures, beyond the typical, or beyond the more traditional, places where our analyses had previously been provided for under law in terms of the dietary exposure.
In all of those areas, we have been in the process of putting together a very transparent effort to ensure that all parties know what we are doing. I don't think that the agency has been able to accomplish that as well as, certainly, many stakeholders believe we should be doing. That is why Rich Rominger and I are chairing this advisory committee, to be able to bring even more transparency to those efforts.
Mr. GOODLATTE. Mr. Hansen, to the extent, your answer is no, then. The Administrative Procedures Act requires regulations to be published. We're 22 months into this law now. Why has nothing been published regarding FQPA implementation?
Mr. HANSEN. Mr. Chairman, we have published a number of elements of our processes that we would be using to be able to implement FQPA. Some of those are able to be done under notice and comment without requiring full rulemaking. Others we have done through publishing full information within the Federal Register, having very open processes in other places. We believe that what is the——
Mr. GOODLATTE. But no implementing regulations have been published, is that correct?
Mr. HANSEN. In terms of the advisory committee, we are expecting to be able to focus on exactly how best to be able to accomplish that very set of issues. Is it through notice and comment, is it through formal rulemaking? We are expecting—and they have already made tentative recommendations in those areas.
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Mr. GOODLATTE. Anyone concerned about how they are going to be able to proceed—whether it's an agricultural producer, an environmental group, a consumer—anybody concerned about how the future use of these compounds is going to be used has, at this point in time, nothing published regarding the EPA's proposed regulations upon which they can rely as the deadline for the implementation of it looms before us, is that correct?
Mr. HANSEN. Mr. Chairman, I do not believe that is correct. I believe that there are a number of places where it has been published in terms of both our schedule, our processes, and others. What we are committed to, as an administration, is to make that even more transparent, to be able to, in fact—as the Vice President has directed—to be able to provide more opportunities not only for stakeholder involvement in our decisionmaking process and the development of that framework but also to ensure that all elements of it are transparent.
Mr. GOODLATTE. Let me ask you about a letter that was signed by 45 members of the House Agriculture Committee. I think we only have about 48 or 49, so that's a pretty substantial bipartisan letter sent to the EPA on July 16 that emphasized the importance of using the data call-in authority to make sound scientific decisions. Dr. Goldman responded that the EPA had all the necessary data. Do you believe that the EPA has sufficient reliable data to complete sound aggregate tolerance reassessments?
Mr. HANSEN. Mr. Chairman, I believe that we have substantial amounts of information in a number of different categories and we, in fact, need to be able to have more information. We provide that information or receive that information in a number of ways——
Mr. GOODLATTE. So, are you contradicting Dr. Goldman when she said she had all of the necessary data?
Mr. HANSEN. No, Mr. Chairman. I believe that what Dr. Goldman was saying—what certainly I am saying—is that we have substantial amounts of data to be able to make decisions. We always welcome and want to have more ability, more information to be able to make more refined decisions and that that process is one that oftentimes is between the agency and the chemical manufacturer to be able to provide additional data.
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The data call-in that you referenced earlier is a broad approach to be able to address across a broad class of either chemicals or chemical manufacturers a level of information that would be applicable in all cases. In some settings, that is very appropriate. In others, however, we believe that it's been important to be able to have that additional information, come around that chemical-specific setting, and we have asked for that in numerous settings and will continue to do so.
Mr. GOODLATTE. In a document that the EPA published on January 31, 1997, PR Notice 97–1, the EPA states that in addition to dietary exposure, such sources as drinking water, residential and lawn care use need to be considered. For most pesticides, EPA has insufficient information on specific exposures through these routes. My question to you is, how do you propose to do cumulative risk assessments when you do not even have the information to do aggregate risk?
Mr. HANSEN. Mr. Chairman, certainly in areas of dietary exposure, the agency has the most robust information available—over many, many years, information supplied by chemical manufacturers, by other surveys, what the U.S. Department of Agriculture has done in terms of exposure—that information is available. Certainly, we recognize that it is less robust in terms of the availability of information in terms of both residential and in drinking water.
However, because a number of the pesticides that have gone through registration processes are used for in-home purposes, over the years substantial data has been developed on exposure to, particularly both the home applicator as well as the residents with particular emphasis on children. There are data that are in those areas and certainly we need more. A part of one of our earlier data call-ins was, in fact, the outdoor residential turf exposure task force which is an area of being able to look across a whole series of exposure pathways coming principally from lawn care application and how that might expose individuals and children. That work is on-going, it has already been—parts of it has already been supplied to us, and we are making use of that. Their report certainly, as I understand it—because this is an industry-led effort—is still a number of months if not years away from being completed but we're still making use of the data that are available today.
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Mr. GOODLATTE. Mr. Hansen, at the TRAC meeting earlier this week, the EPA distributed preliminary analyses of the organophosphates. These analyses clearly showed that the more real-life data is used, the less risk is associated with the pesticides. Isn't it then incumbent upon the EPA to obtain as much real-life data as possible in order to make the most accurate appraisal?
Mr. HANSEN. Mr. Chairman, the answer is absolutely. We want to be able to deal with actual risk, not with phantom risk, and we want to be able to reduce that level of risk when it is real. That is able to be accomplished by having more information. The charts that you're referring to, I think, referenced the fact of using what is referred to as the Monte Carlo analysis. It's a more refined way to be able to estimate what kind of exposure than what the previous approach had been. We think that there ought to be continuous refinement of our efforts to be able to have more and better information, absolutely.
Mr. GOODLATTE. Well, several companies have been willing to provide the EPA with real-life data that could assist in making more accurate risk assessments. However, the EPA has not been willing to promise any confidentiality of the data. Some of the data is proprietary and the companies feel that their data may be twisted by certain extremists. Producers are also reluctant to provide usage data for fear that unintentional misuse may be penalized. If the EPA needs such information to make the most accurate decisions, why have you not allowed some protection for the suppliers of the data?
Mr. HANSEN. Mr. Chairman, I'm not aware of the specifics that you are referencing. Certainly, the direction that the Administrator and I have given is that we want to be able to have access to the most and the best reliable information. We certainly are very sensitive to the issues of confidential business information and yet, we also want to make sure that all parties do have as much access to information as the law requires. I'd be happy to get back to you for the record on the specifics of the question you raised. I'm just not familiar with that specific question.
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Mr. GOODLATTE. We'll direct those specifics to you and we would appreciate if you would respond to the committee with any specific reasons why you would not make it easy to obtain that data that we think—and, I understand from your statement, you think—would be most useful to you in making reliable assessments.
At this time, I recognize the gentlewoman from North Carolina.
Mrs. CLAYTON. Thank you, Mr. Chairman.
Mr. Rominger, could you just review again the role of USDA in this process of implementation? You said—you used the word, you had an ''enhanced'' role and I wanted to know if your enhanced role meant that you were in a position to request and to provide the needed data as it was called for.
Mr. ROMINGER. Yes, I'd be happy to answer that question. The law calls for USDA to provide information and data to EPA so that they can make more accurate risk assessments, using actual pesticide use information—from growers. We also have enhanced our Pesticide Data Program that collects residue information. USDA also has modified our NAS surveys that collect pesticide use information. ARS also collected food consumption information so we know what consumers are eating which helps to refine EPA's risk assessment.
Through the act, we are required provide such information, and data, based on actual farm practices. For example, we can get information on how many times a farmer uses a chemical, rather than assuming that every farmer uses the maximum rate. Those kind of data will be very valuable for assisting EPA in making accurate risk assessments.
Mrs. CLAYTON. So, if the allegation is that this process is, in the absence of information, making faulty assumptions, I am assuming your enhanced role in providing the empirical data from the utilization actually of pesticide would negate that.
Mr. ROMINGER. Yes, we believe that's the case; that the actual data will show that the exposure is not as much as if the EPA uses default assumptions.
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Mrs. CLAYTON. OK. Obviously, the EPA has come under a lot of scrutiny and you know, Mr. Hansen, based on some of the questions the chairman has made, one, basically, largely that you are ignoring the existing data. And I just want to know—his question was, do you have sufficient data? The criticism that I'm hearing is that if you have it, are you ignoring it? Or you have the authority to call-in science data and you're not doing that. USDA is there within an enhanced role, providing the data. How do you answer your critics when they say largely you're ignoring the data that's already available either, I gather, now through USDA or through your own research that you've done over multiple years you said?
Mr. HANSEN. Congresswoman Clayton, from our standpoint, we believe that all data, if it is scientifically valid—obviously, that's important—is critical to our evaluation and that it will, in fact, be evaluated. If there are any examples of data that meet the standards of scientific reliability and are not being utilized, it is against the policy that I, that Administrator Browner, that Dr. Goldman has set as a direction. We'll be happy to see if there are any particular problems.
In terms of the work with the USDA, I think that one of the things that Rich Rominger and I have committed to that I think is going to be one of the more promising long-term elements of coming out of the Food Quality Protection Act is a new and effective working relationship between USDA and EPA.
Certainly, EPA must rely upon information on exposure of the population to pesticide residues. The market-basket surveys, the food consumption evaluations at USDA are absolutely critical to our ability to do that. They need to be up-to-date, they need to be as robust as necessary for us to be able to evaluate and I believe that that is what's coming forward and we think that that will provide even more opportunities to make better and more accurate risk assessments and, therefore, provide both the public health protections and, at the same time, to ensure that the growers and the chemical manufacturers are not unduly hurt by decisions.
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Mrs. CLAYTON. Well, part of my concern, as I said in my opening statement, is that people have faith and integrity in the process and part of that is to have some concurrence that the data or the standards by which you say are certified either is gotten to by joint effort and I gather there is some arbitrator in that process of saying, what is true scientific data. Who determines that? EPA or do you do it collectively through your new committee or how is that determined?
Mr. HANSEN. Mr. Chairman, Mrs. Clayton, we find that obviously we want to be able to have as much input into that process as possible. USDA plays a role in that, certainly, the chemical manufacturer who is supplying much of that information will supply it as well, growers, a whole series of people, depending upon the type of information. But, ultimately, the decision that must be made, as provided for in statute, is a decision by the U.S. EPA.
Mrs. CLAYTON. And that is known to everyone, what those standards are?
Mr. HANSEN. Again, the issue that we think is so very important that the TRAC is focusing on, our efforts are focusing on, is to make that completely transparent so that all parties to the process understand both why we have made a decision, on what basis we've made a decision, and what that decision is.
Mrs. CLAYTON. My time is almost over. Let me ask you one final question. Part of the transparency, obviously, is based on perception and understanding and, if you're trying to get that clarity that's, you know, indisputable, you've seen that well-written regulations—though there may not be a requirement for a formal rulemaking and I'm surprised that there would not be—but it would seem that if you wanted to achieve the goal of transparency and integrity of process that it would enhance that process if there were well-written procedures, standards that—if you are the ultimate arbitrator of that, that they are articulated and everyone, all the stakeholders, know what standards of science and reassessment—so they would know by what they will be governed, then, what the standards for reassessments are and that would give people, I think, greater faith in the process.
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Mr. HANSEN. The answer is absolutely. The TRAC that, in fact, just discussed this on both Monday and Tuesday, reemphasized—as they would say—in plain English exactly what the processes are, a process—for that to be able to be published, to have notice and comment, to be able to take in all different viewpoints, we believe that that is a very effective way to be able to accomplish that.
It, obviously, also addresses what the President and the Vice President have directed all agencies to address in terms of plain English in all of our communications.
Mrs. CLAYTON. Is there some date set for the publication of that?
Mr. HANSEN. The advisory committee is still discussing the specifics of the issue but we have proposed, and they are evaluating, to be able to have over the next number of months, being completed by January or February of next year, the major—what are called generic—risk approaches that we are taking in plain English, exactly what our decision logic for approaching those issues are, how that would be in taking notice and comment on all of those in this period.
The advisory committee is still evaluating that. It appears that that is what they will be recommending to us. We think it makes a lot of sense and we have committed to doing that in a full transparent process.
Mr. ROMINGER. Mrs. Clayton, if I could add to that, we agree that we want these regulations in plain English so that our growers and others can understand them. And we think that we are going to get such products from this advisory committee. We expect this TRAC process to provide some good recommendations on how EPA and USDA should proceed. And, in fact, we at USDA asked EPA to withhold publishing anything until we complete this TRAC process. The TRAC schedule is to be completed by the end of July so we should have some recommendations then on how the EPA should proceed.
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Mrs. CLAYTON. A final question. A final, final question:
Will you, therefore, make adjustments in the requirements, then, since you're taking longer than you had proposed? Because there were to be some guidelines published for the new tolerance by the end of August so if you're coming at the end of July and there's some expectation that some of these pesticides and fertilizers would be expiring—or either some new tolerance set—someone has to make some transitional adjustment for the registrants to make their guidelines.
I'll end with that.
Mr. GOODLATTE. Thank you, Mrs. Clayton.
The gentleman from Illinois, Mr. LaHood.
Mr. LAHOOD. Thank you, Mr. Chairman. Thank you for holding this hearing. I have a statement that I'd like inserted in the record and I have three points that I want to make from the statement that will be inserted in the record.
And these three points are three concerns that I have received an enormous amount of mail from my constituents about. And they fall into the area of farmers and growers being afraid that they're going to lose pest control products they depend on as a result of the new law. They're concerned about the uncertainty as to the process of having alternatives available under FQPA and they're concerned about being able to maintain the high quality of U.S. crops in the field in transit and in storage.
I don't believe we'd be having this hearing today and I don't believe we'd be at the process today if it hadn't been for some of the leadership demonstrated by Mr. Stenholm in arranging the meeting where, then, a subsequent letter came from the Vice President outlining what we're talking about here today.
I've put that into the form of a Sense of the Congress resolution which I have bipartisan support on and, if after this hearing in a subsequent amount of time, I don't feel that the EPA and USDA is making progress. I intend to take the language in my sense-of-Congress resolution and to put it in the form of a bill and I believe I would have an enormous amount of support on both sides of the aisle.
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I've talked to the chairman about this and I've been told to restrain myself, to be patient, that there are things that are going to be happening. Mr. Stenholm has told me that, the chairman of the full committee has told me that, people in the industry have told me that. But, I can tell you that farmers are very concerned about the EPA and I believe that you need to make an awful lot more progress.
Let me just go to a question because I know we're very limited on time here. And I want to insert into the record three articles; one that appeared in the Washington Times that was written by I think an employee of the EPA, an editorial that was in the Washington Times, and an EPA microbiologist—and I don't know if you've seen these or not, Mr. Hansen, but I'm going to put them in the record.
And, at some point, I would appreciate a response from you, responding to what these people are saying because in reality, what they're saying is that previously, up until today, the EPA is on very shaky ground in implementing what we believe has been a very good law.
One of the issues I want to raise is the issue of the zero-tolerance and let me just read this so that I can get it correctly. ''When the EPA detects no residues on crops, it assumes that residues are there but not being detected. EPA, then, assumes that the residue level is one-half of the level at which detection is possible.'' And I have the results of a study of a particular chemical on a variety of agricultural products.
And I have a chart here that I'd also like to insert into the record which, I don't know if you've seen this or not, it has anticipated residues and then it actually has the actual study that disputes the anticipated.
So, I guess my question is, really, if imported food products show not-detectable residues at the port of entry, how does EPA know what pesticides were used on them? And, the claim that EPA regulations enforcement are based on poor science and that policy is decided upon and then the science adjusted accordingly. We need to have a regulatory agency that is respected for its good science and that is trusted by the public and that is trusted by the international community.
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This chart that I'm going to insert into the record, these articles, I think, lay great claim to the fact that there is not a great deal of trust, particularly out in the countryside in the agriculture community about this issue. And if you can respond to any of those issues, I'd appreciate it.
Mr. HANSEN. Thank you. Mr. Chairman, Congressman LaHood, let me just pick out several of them and you tell me if I've responded to the right ones.
We will be happy, first, to be able to respond on the record to the specifics of the articles and editorials. Let me touch upon two issues. First, in terms of the importation of foods, we believe that there must be an absolute level playing field; that the standards that apply to any other country in terms of importation must be as protective, in terms of the final product that is arriving on American's tables, must be as protective and that we will do all we can to ensure that that is achieved and consider that to be tremendously important.
No. 2, you had raised in a number of different ways the issue of the so-called ''no detect.'' How do we evaluate that? And this has been an issue that the advisory committee has focussed on, as well. Let me just for a quick moment be able to address the element that is included here. Normally, when one looks at a set of data that talk about what residues are left on a food product, there are some that will show above the detect levels in a typical fashion. There are other places where it doesn't detect below—or isn't shown as a detect.
But, the quantification—the equipment that's used, cannot show that. If one thinks of it as being a normal distribution of data that are typical in this kind of a setting, then the fact that there are some things that are below the level of detect doesn't mean that there aren't residues—it just means that they are not there, not showing up on that test method. And the question is then, how best to treat that?
However, there are other settings in which the type of chemical that's being used is maybe applied very early on, is done in a way that will not, in fact, find its way to the food source. In those settings, we use what is called a reasonable certainty of no finite residues—it's a provision within our requirements—that the detect level is not anything but zero and we use that accordingly.
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That is generally used in the areas of milk and meat and has been more limitedly used in other places. One of the things we expect the advisory committee to do is to help us address that very issue of what's shorthand referred to ''no detect.''
Mr. LAHOOD. If the residues of a pesticide are not detected on any food people actually eat, might EPA's analysis say that the product can pose an unacceptable risk?
Mr. HANSEN. I'm not sure what the hypothetical is. I'd want to be able to look at it in more detail. The issue, though, I think that is implicit in your question—and let me be explicit about it—is that if there is a methodology or equipment to be able to detect residue that is not as effective as it could be, what we are concerned about is, are there real risks that people are facing? And we will look at a number of different ways to be able to evaluate that because, obviously, what is most important here is to be able to ensure that the public health—particularly infant and children health—is properly protected. But, I don't think there's any one answer to the question you just posed.
Mr. LAHOOD. Let me just say one more thing. How far into the future—can you give us some kind of a date certain, when you think you'll be coming back to us with some good information about what your committee is going to be doing and working on because it's taken an awful long time to get to this point. Again, I say what I said before—I don't think you'd even be to this point if it hadn't been for the initiative taken by the Vice President, Mr. Stenholm in really clarifying—so, you haven't come very far.
What I want to know, so I can go back and tell the farmers in my district and people who are concerned about this, how far into the future is it going to take before we have some good information from you folks?
Mr. HANSEN. The work of the advisory committee is to be completed by the end of July. We will then have what we believe to be very important recommendations available from that and will make that available to the broader public as well. I would urge you to be able to not only contact us directly on any specific question but to be able to talk to any of the other members of the advisory committee in whom you have confidence to see that their assessment is the same as mine. I believe it is, and that is a confidence that we're making real progress on the advisory committee and that we are really bringing stakeholders together on these important issues.
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Mr. LAHOOD. Thank you for your indulgence, Mr. Chairman.
Mr. ROMINGER. Mr. Chairman, if I could add to the discussion of this no-detect issue?
Mr. GOODLATTE. Yes.
Mr. ROMINGER. It is a concern to us and to the administration because I do think that it could have trade implications and that's why we've asked the advisory committee to give us some advice on this.
Using the one-half limit of detection when there is no detection, could result in the total risk for that chemical being to the extent that EPA would be forced to take it off the market in the United States. Whereas, our foreign competitor could continue to use that same product and it would not be detected on the imported product. So, it would result in an unlevel playing field. So, that's why we've asked for the advisory committee to give us some advice and why EPA is rethinking that process on how they assume that a non detect must be one-half the limit of detection.
Mr. GOODLATTE. The gentleman from Texas, Mr. Stenholm.
Mr. STENHOLM. Thank you, Mr. Chairman. I want to briefly follow up on Mr. LaHood's question. I'm not a scientist; I'm a farmer from west Texas. It's going to be very difficult to explain to most of my friends and neighbors why zero is not zero.
If we can't find a satisfactory answer to why zero is not zero, we could really do some harm in trade matters, just as Deputy Secretary Rominger has discussed. I hope that as the advisory committee continues to ponder on this we will, in fact, come up with a better satisfactory answer as to why zero is not zero.
I want to ask one set of questions to both of you regarding the four points in order to make sure that we are talking about the same definitions of the four points. I am also submitting two questions for Mr. Berry who had to go to another committee. When we talk about basing decisions on the best science and data that are available, he wanted me to ask you how you define science? And, No. 2, how do you justify continued use of modules and assumptions over scientific data?
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Mr. Hansen, would you start? And then, I would like Mr. Rominger to define science? How do we justify using models when we do have scientific data?
Mr. HANSEN. Mr. Stenholm, first I think that it's important—although it's certainly broader than just this issue—but to be able to focus on two elements of what is referred to generally under science. And the first is the processes we use, the methodologies, the other analytical tools that we use. We believe that what good science means, in that case, is if those approaches have been, in fact, peer-reviewed by independent scientists to be able to make judgements about whether or not they are appropriate and effective in how they are being used. And we are committed as an agency to be able to use peer-reviewed science in all of those types of settings, absolutely.
The second area is the data that are actually coming forward to us, that are available to use to be able to analyze everything from exposure to the issue of hazards or risks. Oftentimes, much of that information is being brought forward by the actual chemical manufacturer, the registrant. Some of it comes from the USDA on the exposure side. We believe that all of that must be evaluated to be able to be determined that it is good science. But that is a process that our scientists—within EPA and USDA—work through to be able to evaluate to make sure that it's sound science and, in that process, when those come together, that we are absolutely committed to be able to use and continually improve that scientific base.
Mr. STENHOLM. Mr. Rominger.
Mr. ROMINGER. Yes, Mr. Stenholm, we think that our science starts with the scientists that we have at our USDA and the Agriculture Research Service and our partners in the land-grant universities. And we agree that the science is developed by those scientists must be able to withstand peer-review. We do gather that kind of rigorous scientific information and then we pass that information along to EPA. So, we believe that we are developing sound science for use in making decisions to support FQPA implementation.
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Mr. STENHOLM. In light of that, then, give me your definition of transparency. What do we mean when we say we're going to be transparent in our decisionmaking process?
Mr. HANSEN. Should we go in the same order if we do——
Mr. STENHOLM. We will go in reverse order. Mr. Rominger take this.
Mr. ROMINGER. Yes, to me transparency and the decisionmaking process means that I or anyone else—I consider myself a farmer—so I could understand what the process is, how the decisions were made, what science was used, what the decision process was, and be able to understand the decision, as well. That's what transparency means to me.
Mr. HANSEN. I would just say ditto to that. I think that's absolutely the case.
Mr. STENHOLM. I think it would be very, very helpful if we could get to that definition of transparency, and I believe that's the direction we're moving and I concur to that.
When we say a reasonable transition for agriculture, when we have chemicals that are not an imminent hazard but are of such a nature that with full scientific data, with transparency, there is an agreement that we need to move away from that. What does transitionary time mean, Mr. Hansen, as far as your definition is concerned?
Mr. HANSEN. For me, it contains a number of elements, Mr. Stenholm. No. 1 is that we must have new and safer pesticides. We must have a process that provides for alternatives to whatever we're moving away from to be able to move toward something. No. 2 we need to be able to better understand where the priority uses are. Generally speaking, I don't think any of us think that there are going to be, you know, in a particular pesticide use, no uses whatsoever. Rather, if the risks are as determined by the sound science higher than what is the protection standard provided in the law, than one needs to be able to mitigate those risks.
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How do we find where the highest uses are? Maybe where there are no alternatives for a particular crop, or where minor use——
Mr. STENHOLM. What if there is no alternative at the time for the particular compound in question? How do we treat that in transparency?
Mr. HANSEN. Well, one of the things that we think is very important and that the grower community has been particularly vocal in the advisory committee about is they want to be a part of that decisionmaking process. They want to be able to have input, to be able to tell us that, pull it, we don't have any choices for this crop, maybe that other crop over that does have alternatives, why not—if there are going to be mitigation measures, why aren't we going to preserve this use rather than that?
And we think, from EPA, that that is exactly the way this law ought to be implemented. We can't do that ourselves. We have got to be relying upon USDA to a very large degree to be able to help us how to be able to implement that in a very reasonable fashion.
Mr. STENHOLM. Regarding the fourth point, how do you define consultation with the public and other agencies?
Mr. HANSEN. Consultation for us is, again, involving stakeholders, such as the advisory committee that we have currently operating. The fact that we have 52 people at the table means there are lots of people who are very interested in this and more would like, I think, to probably serve.
But, it doesn't just stop at that advisory committee or our science advisory panel or our reviews that are done in other existing panels. It also means that we have a full—as we are proposing on some of the elements that are coming forward—to be able to have full notice and comment opportunities so that all parties may, in fact, both review and comment on and that we evaluate those comments before taking final action. A whole series of different approaches is that effort. It is one that I think needs constant vigilance to make sure we're doing as much outreach and, in my view, is almost impossible to ever err on the side of doing too much.
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Mr. ROMINGER. I would just add that we have committed to the growers and other stakeholders that this consultation process doesn't end when this advisory committee, this TRAC committee, is finished. This is going to be an on-going process. We want to make sure that they continue to be involved as we move forward with implementation of the act and on down the line for the next number of years.
Mr. STENHOLM. Thank you, Mr. Chairman. I would refer all committee memebers to the points Mr. Rominger made concerning some of the budget decisions that had to be made regarding our agriculture appropriations bill. I hope that this committee will look into the concerns that Mr. Rominger expressed as to whether or not we are going to have the tools required to do the necessary oversight.
Mr. GOODLATTE. I thank the gentleman for his insight and his efficiency in the questions that he propounded to the panel.
The next member is the Congressman from Michigan, Mr. Smith.
Mr. SMITH of Michigan. Mr. Chairman, there's a long line outside of people waiting to get into this room who wish they could be here to hear this testimony. The potential damage to American agriculture is significant, depending on what EPA does in implementing FQPA.
I just want to ask you a question, Mr. Hansen. If EPA were given evidence that implementation of your rules would result in 50 percent loss of fruit and vegetable production in this country thus increasing imports from other countries, would that make any difference in the implementation of these rules?
Mr. HANSEN. Mr. Smith, my apologies. We are absolutely committed as an administration and as the Environmental Protection Agency that the very important, abundant, healthiest food supply that's available in America and the provisions of the Food Quality Protection Act can and must and will go hand in hand in that we believe that the ability to be able to improve the safety of our food supply—and to keep it as abundant and healthy as it is——
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Mr. SMITH of Michigan. I appreciate those good words. So, is your answer, yes? You would delay the implementation of those rules if it was going to result in the loss of 50 percent of our fruit and vegetable production in this country?
Mr. HANSEN. Mr. Smith, I don't feel I can respond to it—that hypothetical—because I don't feel that we're ever going to face that issue. I believe that we can, in fact, and will implement the law in a way——
Mr. SMITH of Michigan. I'm very concerned right now the profits of those farmers and producers are not great enough that they can afford to apply other pesticides with much less effectiveness. Nor can they afford increased operating costs. If implemented poorly, FQPA would take away their profits of doing business, it has the potential of losing our specialty crop production in this country.
And, it seems to me, that a closely connected question would be in as much as we're only examining 3 percent of the fruits and vegetables that are now coming into this country in imports, would we simply—would there be—would you assume that other countries would be allowed to use the pesticides that are going to be ruled out by your implementation of FQPA?
Mr. HANSEN. Again, Mr. Smith, the issue that you raise is one that, as an earlier response that both Rich and I provided, that we have, one, asked the advisory committee to be able to assist us in looking at the foreign production of food for importation in this country. My commitment is—and I know it is Deputy Secretary Rominger's as well—that we absolutely must have a level playing field.
Mr. SMITH of Michigan. Does that mean you wouldn't implement the rules unless you were satisfied there was a level playing field?
Mr. HANSEN. I believe that we can accomplish that by addressing specifically the issue of what happens in other countries to ensure that that food supply is not only being able to meet the requirements but is safe for Americans to eat.
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Mr. SMITH of Michigan. But, you realize in talking about budgetary concerns, we're only inspecting 3 percent of the fruits and vegetables that come in now. And so that is a tremendous challenge to follow up on what you say you believe is going to happen.
On a budgetary issue, let me ask you another question. After we passed FQPA, this Congress appropriated another—an additional $30 million to implement what we intended to be used for expanding your ability to investigate and register new pesticides that might be substitutes.
My understanding is this hasn't been done and I've heard the budget for the new registration has been reduced and I understand that you're somewhat responsible for that budget. Is there going to be a restoration for the section 3 money? Don't you believe this is important to expand the efforts of EPA to register new products and make that quicker and easier so that we can look at the possibility of substitutes for the organophosphates and the carbamates and the B–2 residues?
Mr. HANSEN. Mr. Smith, the answer is absolutely it is very, very important. And in my opening statement, I indicated that Administrator Browner and I are, in fact, shifting additional resources into the new registrations for safer pesticides because we believe that it needs additional resources to be able to even speed up more its work. I couldn't agree with you more.
Mr. SMITH of Michigan. Well, I would just suggest to you that it was my understanding and the understanding of a lot of the other members of Congress that we put that additional $30 million for that purpose and I hope you will move ahead with it.
How many years does it take for the development and registration of a new pesticide?
Mr. HANSEN. I need to be double-sure on this. For a traditional chemical, about 30 months. For the safer pesticide, because we have streamlined that process, about 17 months.
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Mr. SMITH of Michigan. I understand we have, Mr. Chairman, over 250 petitions now pending so it's something that I think you should really move ahead on.
Mr. HANSEN. Absolutely.
Mr. GOODLATTE. I thank the gentleman for his questions and for his long support for holding these hearings.
Mr. ROMINGER. Mr. Chairman, could I add something on the potential loss of agricultural production?
Mr. GOODLATTE. Yes, Mr. Rominger.
Mr. ROMINGER. What we're doing at USDA to try and address that issue is doing crop-specific profiles; in other words, we're looking at each crop and what pesticides are used on it, what pests there are there, so that we can make that part of the process of determining which uses would be curtailed and which won't. So, I think we do need to meet the standards of the law but I think that we have these tools where we can put the crop that has no alternatives—make that one at a criteria for that kind of use being retained. So, we're looking to the crop profiles to provide those consumers and we hope we'll have the budget to be able to do as many of those as are needed.
Mr. GOODLATTE. Thank you.
The gentleman from Arkansas, Mr. Berry.
Mr. BERRY. Thank you, Mr. Chairman. I also want to thank you for holding this hearing.
You know, what I've heard this morning, particularly, Mr. Hansen, from EPA is very reassuring but I have to tell you after my—and I think you and I talked about this when we visited earlier—after my experience last summer where USDA and EPA and FDA attempted to destroy thousands of producers and their families and their family farms in my congressional district, the congressional district that I represent.
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And they used false information to do that, gave no indication that there was any interest whatsoever in acknowledging the fact that they had used false information after the GAO report made this very clear that that had happened. You'll have to understand my skepticism about all of these things actually taking place.
So, having said that, you've got a new herbicide that's pending approval. As best as we're able to determine, there is no indication whatsoever of any risk to human health. But, you're using a modeling technique to determine that this chemical might be phytotoxic. And yet, the good science indicates that there is no problem whatsoever. But, there's no indication of the part of EPA that they are willing to use the available science, the collected data, or let the company collect more to verify the safety of this product in that particular area. Can you explain why that is the case and do you intend to continue to do things like that?
Mr. HANSEN. Mr. Berry, I'm not familiar with the specific chemical that you're referring to. I'd be happy to look into it and get back to you. That one I don't have personal knowledge on.
Mr. BERRY. But the general principle—do you intend to continue to do things like that or do you intend to use good science and let it have precedence over supposition and assumption and models?
Mr. HANSEN. We believe and are fully committed—the Administrator and I—to sound science, sound peer-reviewed science, based on reliable data, reliable information as the fundamental of all activities within EPA, obviously, absolutely the case within the pesticide area.
Mr. BERRY. Yes, sir. I understand and I've heard that over and over again and continue to hear it. I want some indication from you that it's going to really happen.
Mr. HANSEN. The Administrator and I are doing to the best of our abilities—and I think that is a very high level of ability—to be able to ensure that that actually does happen in all elements.
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I don't want to kid anybody, though. Oftentimes—or at least at some times—there are disagreements among legitimate scientists about particular effects. But, I don't think that's what you're really getting at. You're getting at, are we ignoring facts, are we ignoring sound science, and my view is that we should never do that and I will be happy to look into the specifics of the chemical that you'd raised.
Mr. BERRY. Thank you, Mr. Chairman.
Mr. GOODLATTE. Thank you.
The gentleman from Illinois, Mr. Ewing.
Mr. EWING. Thank you, Mr. Chairman, for holding this and, gentlemen, thank you for being here.
I hope that what's going on around here resonates with both of you today. I think it does. I mean, people standing in the halls to get into an agriculture hearing is not very common. There is a lot of concern, Mr. Hansen, and I think I hope that you take that concern back. And, some of the answers, you know, I'm confused. Yes, we have the data; no, we don't have the data. It's really going in a big circle and we always bring up what's important for infants and children and it is important and we do care.
We also care they have a good diet and they have a good food supply and it's very important that we have the farmer's ability to do that. And, I would just say that there probably is some leeway in implementing one-third of the chemicals in the first three years of this act and maybe your agency should look at that.
I also think that you could do a better use of time-limited tolerance data call-in authority. These are the complaints I'm getting that you can't—that you're not working with the chemical producers and the farmers in using and allowing this to happen. You know, we wanted a new bill to get rid of the Delaney clause. We might have been better off with the Delaney clause than the implementation we're getting today.
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There's a lot of seriousness in this committee room today and in this Congress about what your agency is doing and I hope that message gets downtown. I don't think the President would have had the Rose Garden ceremony and announced the four elements if he wasn't concerned also about it.
First question: the Food Quality Protection Act states that a tolerance for a pesticide residue may be considered safe when the administrator has determined that there is reasonable certainty that no harm will result from the aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposure and all other exposures—and the important words—for which there is reliable information. How does the EPA interpret the language ''exposure for which there is reliable information?''
Mr. HANSEN. Mr. Ewing, we believe that the other exposures must be based on reliable information. We do that in our analysis of specific chemicals, as we evaluate each of those elements. A part of the work that the Tolerance Reassessment Advisory Committee that both Rich and I are chairing is in fact, to advise us on some of the elements of exactly how we look at those non-food risks—that is, in particular, what is referred to as the residential, non-occupational, and drinking water.
Mr. EWING. Doesn't this language imply that the EPA's aggregate risk assessment may be limited to dietary exposure if reliable data for water and residential exposure is absent?
Mr. HANSEN. We believe that we evaluate all sorts of information—different data coming from the U.S. Geological Survey, for example, on drinking water supplies from around the country, certainly the new Safe Drinking Water Act that was passed at about the same time as the Food Quality Protection Act—provides substantial——
Mr. EWING. The answer, then, is no.
Mr. HANSEN. We find that there is substantial——
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Mr. EWING. I think you'd have to come back with—that answer is no, you are going to use other things, whether they might be considered reliable by somebody on this side.
Mr. HANSEN. We believe that there is reliable information and we will be using reliable information.
Mr. EWING. Well, we'll have to watch and that's our responsibility in oversight to see that that is happening.
Mrs. CLAYTON. Mr. Chairman, would you yield on that question?
Mr. EWING. Very quickly.
Mrs. CLAYTON. If he doesn't have reliable data, do they put it in the assumption that Mr. Berry was talking about? In the absence of reliable information assuming——
Mr. EWING. I'm told they do and I think that's one of the problems. Maybe Mr. Hansen would like to answer that.
Mr. HANSEN. What we do and certainly the advisory committee has, I think, found lots—feels that there are lots of very good reasons for it. We use a weight-of-evidence approach; that is, we look at all the information that is available. And, to be able to, as scientists—and these are career employees who have been with the agency for many years across many administrations—that are, in fact, using that, getting together in a peer process to be able to evaluate the information and then to be able to make a recommendation on how it should be treated.
They are using weight-of-evidence, not trying to be able to say that only one factor, if it says this, has to be interpreted in this fashion. But, rather, to be able to look at the broad range of that information and I think that's something that we all think is the very appropriate way; that is, scientists making scientific judgements.
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Mr. EWING. But, the law says, use the best available data and I don't think you can just pull it out of the air and say that's the best available data. And, my time is up. We have one gentleman on the other side who hasn't had the opportunity to question. So, I'm going to quit but I would reiterate the seriousness with which we take this matter and I hope that message goes downtown to your agency.
Mr. HANSEN. I hear it very loud and clear.
Mr. GOODLATTE. Thank you, Mr. Ewing.
The gentleman from California, Mr. Brown.
Mr. BROWN. Thank you, Mr. Chairman.
I appreciate your calling this hearing and the fact that you have the patience and the tolerance to sit through them. I sometimes feel that I spent the best years of my life conducting FIFRA hearings during the 1970's. [Laughter.]
Mr. BROWN. Of course, let me just ask unanimous consent to insert an opening statement in the record.
[The prepared statement of Mr. Brown follows:]
STATEMENT OF HON. GEORGE E. BROWN, JR.
The honeymoon is over. Two years after we passed the amendments to the pesticide laws interest groups are expressing their concerns about how EPA will proceed with the implementation of the law. Passage of the Food Quality Protection Act initiated substantial changes to our food safety laws, a number of which were long overdue and which had been recommended by various scientific advisory groups: An explicit consideration of the potential risks to infants and children; direction to examine all sources of potential pesticide exposure in setting safety standards, and the consideration of the cumulative risk associated with exposure to pesticides that have a common toxicological mechanism. These are not simple changes in policy or practice. It is understandable that there will be anxiety over the implications these policy changes will have on pesticides currently in use.
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Before I provide some of my own observations on the current situation, I would like to commend the EPA and USDA for organizing the on-going discussions on FQPA implementation. I know of few instances where all interested parties have been invited to sit at public meetings to provide such direct input to the policy-making process.
I would like to go through some of the concerns that we have all been hearing over the past few months and examine them in the context of my years of experience in dealing with pesticide issues as a member of this committee and as the former chairman of this subcommittee. As I see it, few of the concerns being raised are new ones. Industry, pesticide users, and public interest groups have always been concerned about their ability to understand and to influence EPA's decision-making on pesticides. All of these groups have questioned the sufficiency of EPA's models, data, and risk assessment methods. Industry and pesticide users are concerned that EPA is too quick to point to potential problems with pesticide chemicals and may move too quickly to cancel or suspend their use. Public interest groups have felt the Agency moves too slowly and looks at risk too narrowly. Growers have concern about how the cancellation or increased use restriction of a pesticide impacts them and whether they will have adequate pest control tools to substitute for the lost pesticide. What is new here? Nothing.
This law has tightened the health and safety standards that pesticides must meet to remain in use. It should come as no surprise then, that more cancellation and suspension decisions will be made and that they will be as controversial under the FQPA as they were prior to its adoption. I suspect that many of the pesticides that will be considered for cancellation under these amendments would also have received the same consideration as they moved into special review or through the re-registration process under the old law: we have simply accelerated the process. We have known for years that some of these pesticides were associated with health and environmental problems.
The Agency has an obligation to make these difficult decisions. The Department of Agriculture has an obligation to anticipate which decisions will impact producers and to have some viable alternatives available for producers to use. These obligations have also not changed with the passage of the FQPA.
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I recognize a period of transition is inevitable with the passage of any new statutory requirements. The need for a transition should not become an excuse for paralysis in decision-making at the Agency. Many decisions the Agency needs to make are long overdue and should not be deferred indefinitely while we develop perfect scientific information or a consensus of all interested groups. That day will never arrive.
In fact this day is already 26 years overdue. When Congress passed the modern pesticide regulatory statute, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), in 1972, we required EPA to review all existing pesticides within 3 years and bring them up to the new standards. In 1976, we saw that this deadline was not met and moved it ahead to 1978. In 1978, we removed any mention of a deadline and told EPA to review pesticides as rapidly as possible. When that didn't produce sufficient results, we changed the law again in 1988 to provide for accelerated re-registration of all pesticides by the end of this year. All of this shows that the FPQA process is not sudden or all that new. It simply restates 26 years of Congressional intent.
The administration and the Congress promised the public a science-based, food safety law that would ensure that safe pesticide products would be used in our homes, workplaces, and to grow our food. We said we could accomplish this without hampering our farmers' ability to grow the products we all need and enjoy. We should not be so afraid of change that we cannot make good on these promises and move ahead to further improve the safety of our food supply and the health of our environment. We should not get caught in the trap that has immobilized progress on this issue for the last 26 years.
Mr. BROWN. Let me recite, briefly, some historical data. FIFRA was passed in 1972 and it required EPA to review all existing pesticides within 3 years, and to bring them up to new standards. When we saw that wasn't working in 1976, we moved the deadline ahead to 1978. When that didn't happen, we told EPA to move as quick as possible but didn't set a deadline. When that didn't help remove the backlog, we changed the law again in 1988 and proceeded to make whatever progress that we could. All this shows is that the FQPA process is not sudden or new; it merely restates 26 years of Congressional intent.
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As far as the Department of Agriculture is concerned, I have here an October 1976 memo, proposing to undertake a program for managing and coordinating USDA activities related to impact assessment of pesticides, in which it says the Department of Agriculture has responsibilities for contributing to the EPA decisionmaking process on pesticide regulation and that adequate data and objective interpretation is required to meet these responsibilities.
We're still saying that, aren't we? We apparently—in fact, one of the questions that I was going to ask each of you is whether we've made any progress in the last 26 years and I'm sure you will say that we've made a great deal of progress.
I want to make a very brief comment about the zero-tolerance thing or the presumption that if you don't detect something, that it's still there. That happens to be based on science because there is, in science, a principle called the Heisenberg Uncertainty Principle which says you can't measure anything precisely and that includes finding that it doesn't exist. That is not an absolute statement; it depends upon the accuracy of the measuring instrument.
If you were to take a yardstick and go out and measure the dimensions of your yard, for example, if you were a scientist you would say the dimensions are such-and-such plus or minus 1 or 2 inches because of the built-in uncertainty in measuring with a yardstick. They do that even with atomic clocks out at the Bureau of Standards. They say, it's accurate to within one-millionth of a second, plus or minus a millionth of a second. It's never precisely or absolutely accurate and this is also true in spades when it comes to measuring pesticides or any other chemicals in food or anything else.
Now, I want to raise this very briefly—the question that I indicated that I would like to raise. And that is, as far as Mr. Rominger is concerned, you've been working on this for a large number of years, not since 1976, but it seems almost that long. And you have been trying to get the Research Education Extension and other Department programs to anticipate problems caused by the loss of pesticides—in other words, to prepare alternatives when the inevitable pesticide cancellation came about.
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Are you having success with that? Are you doing a better job of focusing the Department's resources to help the farmers in that way or are you still handicapped by the lack of funding which you've commented on and which others have commented on and which is very regrettable? What do you see as the situation at the present time?
Mr. ROMINGER. I think we have made some progress. We are developing these crop-specific profiles that I talked about. But, it's also true that we can do better and FQPA asked us to do more, to get more information, and to be able to develop information for these at-risk chemicals and the crops that they are used on. So, we are making some headway but there's a lot more that we need to do. And, as a matter of fact, I did start working on pesticides in 1977 when I went in as director of the California Department of Food and Agriculture.
Mr. BROWN. I remember that day very well. [Laughter.]
You did a great job.
Now, the act itself, in section 305(a), says that the Secretary of Agriculture, in cooperation with the Administrator of EPA, shall prepare a report to Congress, evaluating the current status and potential improvements in Federal pesticide use information gathering activities. And, it sets forth the nature of the report and says that you have a year to present it. Has that report been prepared and submitted, Mr. Rominger?
Mr. ROMINGER. It's my understanding that we did send something up in conjunction with the IPM report that we sent to the Congress.
Mr. BROWN. You did send something up?
Mr. ROMINGER. Right.
Mr. BROWN. Did it include an analysis of options to increase the effectiveness of national pesticide use information collection, including cost, burdens placed on agricultural producers, and so forth? Was it a report just saying that you haven't completed the work and you'll do it later?
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Mr. ROMINGER. I think it did not include all that. It was more of a laying out the program of how we will be able to accomplish improvement to our various pesticide-related data collection program.
Mr. BROWN. Well, I would ask, if I have a minute left, the same question of Mr. Hansen. Do you have in place some processes to govern what should happen when you withdraw pesticides? Are you working with the Department of Agriculture developing alternatives which can ease the burden on the farmers as well as protect the public health and safety?
Mr. HANSEN. Mr. Brown, the answer is absolutely. We think that is one of our highest priorities, both to be able to find new and safer pesticides as well as to be able to work with the U.S. Department of Agriculture and others to be able to identify—during any transition—how to be able to protect those essential uses, those only no-other-choice uses and the answer is absolutely. We think that's very important.
Mr. BROWN. Well, in my question, I asked for a specification of the particular mechanisms but let me submit that question to you in writing, since my time has expired, and you can answer in further detail, if you will.
Mr. HANSEN. Mr. Brown, I might just add quickly, though, that that is one of the specific questions that Rich and I have asked the advisory committee to be able to assist us on because we think that the opportunity to be able to involve growers as well as many others in that process is absolutely essential. And, obviously, we have lots of growers on the advisory committee.
Mr. BROWN. Well, as you can sense, I'm sure, many members of this committee—and I point to Mr. LaHood who is normally a very patient man. He's beginning to get impatient with the process here and I'm even more patient, I've waited 26 years, and I'm still not too impatient. But, we would like to see progress in this area.
Mr. HANSEN. I agree.
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Mr. GOODLATTE. Thank you, Mr. Brown.
We are also joined by the gentleman from California, Mr. Dooley, a member of the full committee. Mr. Dooley, do you have questions directed to Mr. Hansen with the EPA? He is under a tight schedule. You might want to address those to him first.
Mr. Hansen, do you have time to take his questions?
Mr. HANSEN. Absolutely, Mr. Chairman. I would be happy to stay another 10 or 15 minutes if you'd like, if that would help, your choice.
Mr. GOODLATTE. That would be great.
Go ahead, Mr. Dooley.
Mr. DOOLEY. Thank you, Mr. Goodlatte, for allowing me to participate.
First off, I just want to make sure that Mr. Hansen and Deputy Secretary Rominger know that many of us, if not all of us, really fully appreciate the difficult task that you've been charged to carry out and that it is difficult to try to move forward with a new process when we're asking you to use the best of science by still providing the adequate protection and eliminating risk to all consumers of food products.
What I'm most concerned about is, how do we maintain the integrity, the credibility and the confidence in this new process that we're incorporating? And I think some of the frustration that you're hearing today is reflective of somewhat of a lack of confidence, primarily from the agriculture sector, on whether or not we are, in fact, moving as rapidly toward the use of science and actual data that will ensure that we're making decisions that are reflective of actual uses of products.
That's where I'd like to spend just a little bit of time. As I understand it, EPA is currently using some default assumptions in large part because there is the lack of that science or that data. And, my question is, what is the process that's being put in place that is going to move us from some of the default assumptions, as well as some of the present modeling programs, that are currently being used? What is the timeline for transitioning it into hard data that can be provided?
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Mr. HANSEN. We believe very strongly, as I know you do as well as other members of this committee, that the more information, the more sound science that's on the table, the better decisions that can be made, the ability to be able to address real risks, rather than phantom risks, is had. We believe that that can be accomplished in a number of different ways.
Let me go back to the issue that you had raised—and I know that there's been lots of concern around the so-called default assumptions. I believe that to be a misnomer. What we really use are screening mechanisms. We end up using a methodology, for example, in the drinking water program—or in the drinking water risk analysis—so-called farm pond. It's one that's relatively controversial because it has been perceived to overstate what the concentration of a pesticide in drinking water supplies could be. That is used first as a screening mechanism. That is to be able to say, in a very quick fashion that saves the agency money and time, that saves the chemical manufacturer time and money to be able to say, if it passes that, it doesn't cause a level of risk there, than it can move ahead without additional concern.
We have applied that in a number of cases and half of the time we've applied it has resulted in no further work needing to be done because it doesn't fail that test. If it fails that test, it goes to another—the next tier of additional analysis so that it takes more time, it takes more information, more reliable data, to be able to evaluate. But, we move through that, then, to be able to then determine if, in fact, there really is a reason for risk concern.
So, it's really a misnomer to think of them as default; they're much more screening mechanisms so that we can quickly move through certain issues, decide whether more analysis needs to be done or whether it is so clear that it doesn't pose a risk, that we can move ahead.
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Mr. DOOLEY. Dr. Richards, I believe, from the Water Quality Laboratory—I've had the chance to read his testimony—addresses this issue where he contends that, you know, the farm pond—and I guess it's the GENEEC model that you're using—there does significantly overstate, you know, what the actual risk is and I understand where your rationalization is in terms that this is just a screening mechanism.
But, where we've had some extensive research done—in the case of even atrazine—where you can also use a modeling technique which would be using referenced chemicals—such as that—where it might be able to get to a more accurate level of exposure. Is EPA giving any consideration to incorporating something like this as a more accurate model?
Mr. HANSEN. Mr. Chairman, Mr. Dooley, I can't speak to the specific of that one. We'd be happy to get back on the record.
But, the answer in the broader context is absolutely; we want to be able to find additional ways, both in terms of methodology as well as in terms of the actual data, that will give us an ability to be able to more accurately get to real risk and make sure we address it.
On the ''farm pond,'' I might just mention that we believe that that is not the most effective—and, in fact, we'll be taking to our science advisory panel—our outside, independent, peer-review group in July, just this coming month—an alternative that we think will be at least a better screening mechanism that doesn't overstate the risk as I think we have thought that the farm pond method does.
Mr. DOOLEY. Can I just ask, Mr. Hansen, one more question? And that is, on this default mechanism where you're saying they're using that for screening, but on some of the organophosphates where under the pre-FQPA where, even if there was a zero residue—as I understand it—you still used one-half of an expectation?
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How does that in being consistent with some of your screening in terms of—because this is what is contributing—if you do this under the FQPA, we run the risk of filling up the risk cup almost immediately based on some default assumptions that were pre-FQPA.
Mr. HANSEN. This has come up in a couple of previous questions. Let me say it this way. If the line for detection is at—let's just say hypothetically—5 parts per million, and we find that there are, in the actual analysis, the actual data that are collected, that there are a number of times where we are showing on a particular analysis, that it's at 7 or 8 or 10. The question then becomes, if we find no residue at the detect level of 5 parts per million, should be assume that it really is—there is nothing there, and that is actually at zero? Should we consider that it's at 2.5, that is, one-half of the detect level, or really at 4.9 parts per million in this hypothetical?
Our process that we have used—what has, in fact—been peer-reviewed, scientifically-based and that is to be able to estimate that they would fall at an equal distribution between the detect level and zero. What I have also answered, however, is that we are committed to be able to look more broadly at what is referred to ''reasonable certainty of no finite residue;'' that is, to be able to say, if, in certain cases, it isn't going to end up in the food product—it's applied early enough in the growing season or various other elements—then we need to be able to look and are committed to be able to expand our look at when is zero actually zero.
Mr. ROMINGER. If I could add to that, our Pesticide Data Program would begin in fiscal year 1999 doing drinking water sampling so that we could get accurate information on whether or not there are any pesticide residues in drinking water, if we get the funds to do that. We would also begin residue sampling in meat, poultry, and eggs, if we have the funds to do that, so that we'll have the actual data.
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Mr. GOODLATTE. Mr. Hansen, the law calls for the EPA to reassess 33 percent of existing tolerances at the time of enactment, by August of next year. Do you interpret the law to allow you to make an interim decision based on available, reliable data followed by a final decision when more data are available?
Mr. HANSEN. Mr. Chairman, I'm being slow in answering only because I want to make sure I'm understanding the question. Are you asking whether or not to be able to meet the one-third provision by August 1999 that we could make a preliminary decision which would somehow be revised later?
Mr. GOODLATTE. That's what I'm asking.
Mr. HANSEN. I would want to be able to consult with counsel. I'm not sure we've thought of that as a way to be able to address that issue. We certainly have approached the issue of August of 1999, the first one-third. We have already reassessed almost half of the number required and feel confident that we can—using good sound science, stakeholder involvement, the transparency, other issues—to be able to achieve that end. I'd be happy to be able to find out—or to be able to research that—and have a response back for the record.
Mr. GOODLATTE. Well, considering the complexity of the issue and the need for more complete data, couldn't you meet this deadline and give the registrants time to generate additional information by granting a time-limited tolerance?
Mr. HANSEN. Mr. Chairman, we use time-limited tolerances in a number of different settings—when we find—whether it's under the provisions of section 18 emergency, where it certainly is time-limited or other approaches as a way to be able to address additional data. I'd be happy again, as I said, for the record to be able to look at the specific question you had posed.
Mr. GOODLATTE. Mr. Smith.
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Mr. SMITH of Michigan. How does EPA assess or deal with the possibility of reduced application rates or applying application of the pesticide, if you will, further out from harvest where there's going to be a significant reduction in residuals? How do you deal with either of those two in your determination?
Mr. HANSEN. We think those are two facts that are tremendously important in our assessment. If you add to that the third element—which is the percent of crop treated—those three elements are tremendously critical.
One of the issues that the Department of Agriculture assisted greatly in is when they're looking, in fact, at their analysis of pesticide residues, they're able to tell us really what ends up actually being in that food supply in the methods that are actually being used by farmers on their crops in the field, rather than necessarily what the maximums might be allowed for under the label restrictions. And our ability to evaluate that—possibly adjust labels where appropriate, other sorts of things—are a very important part of how any reassessment works and certainly is a part of how we make sure that this law is implemented in a way that does not adversely affect farmers, at the same time achieving the public health protection.
Mr. SMITH of Michigan. Maybe—if I could, Mr. Chairman—Secretary Rominger, that look-see as far as USDA is concerned of 75-day out applications in relation to its effectiveness and in relation to greater acceptability——
Mr. ROMINGER. Yes; and, in fact, the crop profiles that I mentioned earlier that we are developing go right to the heart of this because they will give us the information so that we can look at these kinds of ways to mitigate the risk that is being developed as a result of that pesticide. And, I think, we've got about 450 of these specific crop profiles in development underway now.
Mr. SMITH of Michigan. And would that also apply to organophosphates through the spectrum of however many pesticides incorporates organophosphates?
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Mr. ROMINGER. Yes; it would include organophosphates and it would give us the opportunity to look at each crop and say that this one has no alternative so it should get a higher priority for retaining uses of that particular pesticide, whether it's an OP or any other pesticide.
Mr. SMITH of Michigan. Thank you.
Mr. HANSEN. Mr. Chairman, one other quick thing I might add on; that is, one of the things that we hear oftentimes from growers—which is tremendously important information to us to get at in detail—is they oftentimes will say, we don't apply it as the label indicates, we really apply it further away from harvest, we don't apply it as many times as the label says or at necessarily the label rates—we need to have that information so that we can, in fact, make substantially better decisions because, obviously, that's a part of that actual risk rather than phantom risk that I've referenced before.
Mr. SMITH of Michigan. Thank you, Mr. Chairman.
Mr. GOODLATTE. Mrs. Clayton.
Mrs. CLAYTON. I have two questions. One you can answer and the other, write me back.
The first one is, I heard the utilization of the aggregate exposure assessment and the cumulative exposure assessment. Could you distinguish between the two?
Mr. HANSEN. Yes. The issue is that when one is talking about aggregate, one is looking across at not just the food exposure but also the exposure that a child might pick up by petting a pet that has had a flea control product applied, or rolling in the grass because of a herbicide used there, or what they might get from drinking water. Aggregate is to look at all of the exposure pathways, principally those three areas; food, residential nonoccupational, and the drinking water supply.
Cumulative is to be able to look more broadly across different substances that act in a cumulative way with one another, have a common mechanism of operation, and to be able to look at what those cumulative effects are.
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Mr. EWING [presiding]. Mr. Hansen, you've been very good to take our questions and I have made it to National Airport in 7 minutes but it's not a good idea. [Laughter.]
And, if you have an 11:30 plane, you probably ought to excuse yourself. I think there's somebody to replace you on the panel?
Mr. HANSEN. I think you're going to—we were going to stay as long as you needed and then we would go ahead and leave, and I think you have another panel——
Mr. EWING. Yes; so, you do have some additional time?
Mr. HANSEN. I have about another 5 or 10 minutes, if you would like.
Mr. EWING. All right, fine.
Mrs. CLAYTON. My only other question you can submit it in writing.
Mr. Rominger mentioned the prioritization that those specialty crops that would be affected by the new tolerance requirements and I gather that's in response to the requirement to submit to Congress an approach that you are equipping yourself to deal with this new requirement. Are you also developing a corresponding one? Are you working with his? Can we get that data as to how you are preparing yourself to either give new transitional times or new priorities to new types of exceptions in the law? How will that process affect what you will give as guidelines?
Mr. EWING. Mr. Hansen, if you will respond to that for the record later.
Mr. HANSEN. I'll be happy to. This is an area that we think is very, very important and we're working very closely with the Department of Agriculture.
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Mr. EWING. Mr. Thune.
Mr. THUNE. Thank you, Mr. Chairman.
The producers in the State of South Dakota have a lot of things to deal with: Adverse weather, for one; obviously, low prices right now; and unfair trading practices by foreign competitors. But, I would also add to that list a lot of times EPA. And, I'm not sure at times which is worse, actually. At least EPA is somewhat predictable, which is more than I can say about the weather.
But, we've got a number of these issues that keep cropping up and some serious questions about implementation of various policies and regulations and laws and so forth. And, I realize that USDA is sort of the agency that's had responsibility for protecting and promoting American farmers and I direct this question to Mr. Rominger. But, why did it require a directive from the White House to engage USDA in this process in the first place?
Mr. ROMINGER. Well, I don't think it did. We were involved before the directive from the Vice President but that certainly heightens the responsibility that USDA has in working with EPA to implement the act.
Mr. THUNE. What role would you see now for USDA in that implementation process? And, maybe that ground has been covered and I apologize if it has, I've been over at another hearing.
Mr. ROMINGER. Well, the law does direct and anticipate that USDA will develop additional data for EPA to use in doing their risk assessment. So, we have proposed increases in our Pesticide Data Program, in the NAS Surveys, in the IR–4 Program to develop data for the minor use materials as well as other programs. So, we are reformulating our current programs and hope to be able to augment those to provide good, reliable data to EPA so that they can use the actual real-world data in making the risk assessments so they don't have to use default.
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Mr. THUNE. Let me ask you this: what steps will USDA take to ensure that producers concerns are heard in this implementation process?
Mr. ROMINGER. I have been meeting with producers. Producers are involved in the advisory committee that Fred and I co-chair—and we have committed to producers and others that this process will continue after this advisory committee is completed, that we will continue to make sure that they have input into USDA and EPA as the process moves forward. So, we're committed to doing that.
Mr. THUNE. And Mr. Hansen, could I ask you the same question? I mean, obviously, from Mr. Rominger's answer you're working together on that. But, do you have anything to add to on that in terms of what you will do to hear producer concerns?
Mr. HANSEN. Let me just add a couple of additional items to it, although I echo everything that Rich mentioned. We have also set up a process by which Rich and I get together periodically to discuss specific issues. We have also established a Senior Policy Group, involving both senior people from EPA and USDA, to meet and work through specific detailed problem areas.
We believe that that relationship is one that is not a first, necessarily, by any means, in the relationship between USDA and EPA, but is one that we think we can strengthen dramatically and have, then, to be able to rely upon much of what USDA brings. That does not relieve us from our responsibilities to be about—to work directly with producers, but we think that that is also a very effective tool through Department of Agriculture to receive that input.
Mr. THUNE. Are you both familiar—I assume you are—aware of the ''road map implementing FQPA'' that's been prepared by a group of producers organizations known as the Implementation Working Group? And, like the White House, this group calls for sound science and transparency in implementation of FQPA, but also calls for balanced implementation.
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And, I guess what I would be curious to know is if, in fact, you're familiar with that and then, if so, are you committed to at least reviewing the report and making a determination as to whether the process for implementation outlined by that report could be adopted by EPA and USDA?
Mr. ROMINGER. We think that that report will provide valuable information as we go through this process. It will be something that's factored into the TRAC process—the advisory committee process that we're using. It'll make a valuable contribution there.
And, although I haven't read every word of it since I just got it a few days ago, both Fred and I met with them prior to the completion of their report and yes, we do think that it will be a valuable help in making sure we get the process right.
Mr. THUNE. Mr. Hansen, anything to add?
Mr. HANSEN. I would echo that and say that I think a number of the recommendations are things that the advisory committee has already been focused on and things that we're looking at. There are other areas that still need some more work. But, I think that's been a very positive contribution to the issues that are reflected in what the Vice President and others have committed to.
Mr. THUNE. Well, I guess all I would simply say is that I would hope that you would involve, obviously, the regulated community and the folks who have to adhere to and abide by these types of regulations and try and make a living in a business that's very difficult on the best days to make a living, who have a great deal at stake in this discussion.
And I would hope, again, that we continue to move in the direction of science and less in the direction of theory when it comes to implementing, particularly, this policy and legislation and I understand that you do have a plane to catch so I'll conclude with that and thank you.
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Thank you, Mr. Chairman.
Mr. EWING. Thank you, Mr. Thune.
Mr. Hansen, do you have drinking water exposure data for currently registered pesticides and, if you do, how was that data obtained?
Mr. HANSEN. Mr. Chairman, we have data, as I understand it, from a number of sources. The one that I think is the largest and most robust is the U.S. Geologic Survey. But, certainly there are other sources of data than that, oftentimes coming from the actual drinking water suppliers—either municipality or private entities.
Mr. EWING. And you touched on that earlier about the variability of the water being tested. How does the EPA consider this variability when they are working on regulations on a National basis?
Mr. HANSEN. Mr. Chairman, let me just ask for clarification. When you say variability, you——
Mr. EWING. Well, some water won't have any and some water will have a great deal, depending on the use of a chemical or a substance in a certain area.
Mr. HANSEN. Well, Mr. Chairman, we obviously must look at what's the issue at hand. Is it a surface water supply, which may well clean itself out in a relatively short period, if it's only one source that is a short-term? Or is it an on-going exposure?
No. 2, we must look at the food supply because it's in combination with the food supply that's important. Is the food supply one that is part of a National food supply that would indicate that it would be coming from anywhere in the country and that the exposures would be appropriate? Or, is it really more of a local food supply? Milk, for example, generally doesn't move outside of a regional area.
All those factors will be taken into account as we look at drinking water as well as the food supply, aside of the dietary exposure.
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Mr. EWING. Are those factors published somewhere?
Mr. HANSEN. Mr. Chairman, those have been a part of what has been traditionally how we've looked at a number of these issues over time. The U.S. Geologic Survey data are certainly available broadly——
Mr. EWING. No, but—I'm sorry to interrupt—but how you look at them and the criteria you use so the people you're regulating will know how it's being applied?
Mr. HANSEN. Just what I was going to get to. I knew your point would be that. And that is that in the advisory committee, they have made a tentative recommendation—they're still wanting to be able to work it through the full committee—of exactly how that should, in fact, be made fully transparent for all parties to be able to understand exactly what the methodology and the logic we use to walk through that. We are absolutely committed to make that fully available. We are looking at, in fact, the best way with the help of our advisory committee.
Mr. EWING. What residential exposure data does the EPA currently have?
Mr. HANSEN. Mr. Chairman, on the residential exposure, we actually have quite a bit more, because we have had to over many years—well, before the Food Quality Protection Act—register pesticides for home use, whether it be de-foggers that are used for inside the house, or lawn care, or termites, or—and the list goes on.
We have a substantial amount of information that most of the chemical manufacturers who have worked with us over the years know of full well. We believe that that needs, likewise, to be fully transparent, but it looks at a whole series of different elements—everything from the nature of the chemical, whether or not it volatizes quickly, does it have a half-life that's short, a whole series of other things, to issues of the actual exposure—how often does a child typically move, an infant move, hand to mouth, and, therefore, is potentially exposed by what they would touch? Those issues are there, certainly have been available; we're going to make them even more transparent.
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Mr. EWING. But you don't have all the residential exposure data that you might wish to have?
Mr. HANSEN. Certainly, Mr. Chairman, we think there's always in all these areas need for additional information. That information is coming forward in a number of different ways. Some of it, in fact, as a result of the data call-in that we did some time ago to be able to get more information.
Mr. EWING. Well, my final follow-up question is, why can't we use more data call-in authority to get this information?
Mr. HANSEN. Mr. Chairman, we believe the data call-in authority is a very important authority that's provided for within the law, and that it is appropriate when we're looking at across a broad class of chemicals and wanting to have certain information that applies in a broader fashion. We also ask for substantial additional information on a chemical-specific basis, as we work with a particular manufacturer.
Mr. EWING. You believe, then, that it's used wherever it's practical?
Mr. HANSEN. We are certainly—a part of what the advisory committee is going to be assisting us with is, is should we be using specific—the actual data call-in—authority even more broadly. And I'd like to await for the recommendations from that advisory committee.
Mr. EWING. Well, I appreciate that because it does appear to be something that the regulated would think would be very helpful in giving you meaningful information, along with the use of time-limited tolerances, which you've also discussed here today, and they seem very reasonable to many of us.
Mr. HANSEN. Mr. Chairman, I think Rich and I are both up against meeting that.
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Mr. EWING. And I'm ready to dismiss this panel.
Mr. HANSEN. If I could make one just quick comment, and I'm not sure if Rich wanted—the Chair, when he was here, in his opening statement, made reference to something that I think that has caused consternation in a number of quarters. And that is, a staff paper that was produced and then printed. It indicated that one possible approach would be to cancel all of the organophosphates.
I want to be able to make the record absolutely clear. There is no intent to cancel all organophosphates. The administrator and I oftentimes jokingly refer to the fact that if we could only review every document that was produced by any of the 17,000 EPA employees before it ever went out elsewhere, we'd be overwhelmed, No. 1, but that would never have gone. That is not an issue that has any review by management. It is not an issue that has the leadership of this agency ever having endorsed such an approach.
And I know that that's caused consternation and misinterpretation. I just want to be able to set the record absolutely crystal clear. That was never an issue that was being contemplated by Carol, by me, the other senior leadership of the agency.
Mr. EWING. And I think you can understand that any time a statement like that comes out an agency that has the power that the EPA has that it causes great concern.
Mr. HANSEN. I regret the fact that that was ever published. It was one individual staffer's thoughts about how to be able to approach it. And I think in a way that I don't take anything away from that staffer being able to express an opinion. But it did not reflect in any way the policy approaches of what I, the administrator, or other senior officials believe is the appropriate process.
Mr. EWING. Thank you. Before I dismiss the panel, I would like to notice that there are many concerns about the implementation of the FQPA. Mr. Hansen, Mr. Rominger, please know that this subcommittee will be watching very closely your agencies' implementation of this law. While not a focus of this hearing, the implementation of section 18 is a concern and will be the subject of future oversight activities.
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I would like to submit a series of questions concerning one specific section 18 issue that could have significant adverse impacts for growers throughout the Nation. Mr. Hansen, I would ask that you respond to those questions in writing to the committee in a timely manner.
Mr. HANSEN. Absolutely.
Mr. EWING. Thank you both for your time.
Mr. HANSEN. Thank you. Thank you, committee.
Mr. GOODLATTE [presiding]. We would now like to invite our second panel to the table. Ms. Jean-Mari Peltier, chief deputy director of the California Environmental Protection Agency, Department of Pesticide Regulation; Dr. Barbara Petersen, president of Novigen Sciences; Dr. Peter Richards, senior research scientist, Water Quality Laboratory, Heidelberg College; Dr. Robert Krieger, extension toxicologist, University of California, Riverside, CA.
Ladies and gentlemen, your statements will be made part of the record, and we welcome all of you, and we will be pleased to receive your testimony at this point.
Ms. Peltier.
STATEMENT OF JEAN-MARI PELTIER, CHIEF DEPUTY DIRECTOR, DEPARTMENT OF PESTICIDE REGULATION, CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY
Ms. PELTIER. Thank you very much. I appreciate the opportunity to appear before you this afternoon. I have prepared some written comments, which have been submitted for the record.
In addition to the prepared statement, I also am submitting for the record, a copy of a letter that the Department of Pesticide Regulation sent to Congressman Gary Condit earlier this year, that gave a more thorough outline of a number of issues with which we have concern in the implementation of the Food Quality Protection Act.
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I won't spend a lot of time going through all the details; I'd like to modify my remarks slightly to reflect some clarification of points that were raised earlier in the discussion today.
First of all, let me say that the Department of Pesticide Regulation has been actively involved and working with the Environmental Protection Agency through its implementation of Food Quality Protection Act, and has served on a number of advisory committees, including the Tolerance Assessment Advisory Committee and the Minor Crop Subcommittee of the Pesticide Program Dialogue Committee.
You've heard a lot today about transparency, but I think there are still two areas in which DPR is concerned that there has been a lack of real transparency in our dealings with Environmental Protection Agency, and in those two fundamental policy decisions there has been a lack of a full explanation. The first is why EPA isn't fully employing its data call-in capability, and is instead employing default assumptions. And I'll talk a little about some of those default assumptions.
And the second related point is clarification of the Agency's definition of a reasonable certainty of no harm. You heard some comments made about the section 18 process, and I would like to take some time and elucidate a bit further.
In the area of why they're not calling in data where I'd like to use an example the situation that we face right now in the tolerance reassessment of organophosphate insecticides. EPA is struggling, as is the Department of Pesticide Regulation, in the interpretation of the area of how to assess the risk of pesticides in the diet that work with a common mechanism of toxicity.
EPA's decision of how to define common mechanism of toxicity is going to lay the groundwork for its cumulative risk assessment on organophosphates, on carbamates, and on other similar materials that may have a common mechanism of toxicity. Because this is a relatively new area of law, the U.S. Environmental Protection Agency went to the International Life Sciences Institute, or ILSI, to try to see first how to define common mechanism of toxicity, and then secondarily, if there are logical ways to subgroup the organophosphate pesticides to narrow the focus of what that common mechanism of toxicity might be.
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The ILSI group tested a number of different hypotheses on how they might subgroup the organophosphates, and ultimately came to the decision—and this is an important point—there are insufficient data on which to make sub-groupings. They didn't say it's impossible or that they couldn't be further subdivided, but rather that there's insufficient data to do so.
U.S. EPA is now apparently using the report from ILSI as a basis for making a determination that OPs share a common mechanism of toxicity at a level of plasma cholinesterase inhibition. We believe that is essentially a default position of ILSI—a default position in the absence of data to further subgroup the organophosphate pesticides.
Why is this important? It's important because as EPA pursue the reassessment of tolerances on this class of materials, we believe that the OPs vary in their level of toxicity, they vary on the target organ and the toxic effect on that target organ, and we believe there's also important information on whether these materials are additive, whether they may be synergistic when in combination with each other, or whether there actually antagonistic.
By failing to gather additional data, we believe that EPA will be putting all of these uses in a single risk cup, which is going to greatly exaggerate risk. In the opinion of the Department of Pesticide Regulation, U.S. EPA shouldn't proceed with regulatory decisions based on cumulative toxicity of organophosphates until additional, relevant, meaningful subgroups are defined. EPA should instead rely on their data call-in authority to require additional studies of the registrants to delineate these subgroups.
When you take this issue a step further down the road, EPA also does not have a model on how to conduct cumulative risk assessments. And so we understand that they're calling ILSI to develop an approach to conduct these, but we have some real concerns about key issues on how they're going to define toxicity equivalants for organophosphates; the use of multiple default assumptions in a cumulative risk assessments, because you're just magnifying the level of certainty in your risk management decision.
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There was a lot of information earlier this morning about the development of additional data, particularly in the area of drinking water. DPR has had some real concerns in the application of the drinking water standards with regard to specific section 18's that the State of California has put forth. EPA has moved from an interim decision logic in which they allocated a set portion of the risk cap to exposure in water and residential exposure to instead taking a look at available data and using available models.
That's fine, except a lot of the available data is not particularly reliable, and the models have not been validated. I think that Mr. Hansen made the point that they are looking for validation of all these non-validated models, and yet these screening level reviews based on these models are ultimately being used for making final determinations on whether or not a section 18 is granted.
Let me finally say that included in the Condit letter is a discussion of the incremental risk approach for section 18's. The State of California believes that this is a valid alternative method for the agency to make a determination of a ''reasonable certainty of no harm.'' If a proposed use under a section 18 emergency exemption represents no more than 1 percent of the theoretical risk, we believe that that represents a reasonable certainty of no harm. Our scientists point out that that 1 percent of theoretical risk is well within the level of rounding when they're completing these risk assessments. And so certainly we think that you intended, through the Congress, of providing them that kind of flexibility.
One final point, and I'd be glad to come back to it through the question and answer session, I think that one of the areas that is not necessarily so obvious is that every day there are small policy decisions made that have a major impact on the way risk assessments are conducted.
Handling the zero detects is something that this committee has focused on—I think that's important. Using water as a point estimate—I think that was alluded to before. If you have one find in water, do you assume everybody in the United States is exposed at that level? We don't think so. The use of non-validated models. The issue of which percentile exposed individual you're going to use when taking a look at the risk assessments. That's a really critical point which is a policy decision that impacts the ability of the agency to issue tolerances for needed crop chemicals.
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Finally, let me just say, I appreciate the opportunity to speak before the committee, and I'd welcome the opportunity to answer any questions that you may have.
[The prepared statement of Ms. Peltier appears at the conclusion of the hearing.]
Mr. GOODLATTE. Thank you very much. Dr. Peterson, welcome.
STATEMENT OF BARBARA PETERSEN, PRESIDENT, NOVIGEN SCIENCES, INC.
Ms. PETERSEN. Thank you, Chairman. I'm Dr. Barbara Petersen, president of Novigen Sciences. We're a scientific consulting firm, located here in Washington. I'm a Ph.D. biochemist and have devoted 20 years of my career to food additive pesticide residue and food metabolism research. I'm currently a member of EPA's Science Advisory Board's Committee on Integrated Exposure Assessment—they use that term for aggregate.
Over the past 2 years, our committee has looked at a variety of methods that have been proposed by different groups within the Environmental Protection Agency to conduct both aggregate and cumulative assessments, and we've talked about what those two terms mean a little bit earlier, so I want go through that again.
Most of the methods that have been presented to our committee, while they have not been focused on pesticides, I think offer opportunities for methods that could be applied to pesticides. They have been used for other EPA mandated programs. The Office of Pesticides Programs' proposals for aggregate or cumulative methodology have not been brought to this EPA Science Advisory Board. And I do believe that that will be very helpful to the Office of Pesticides to have the opportunity for the in-depth review that that committee does.
It is clear from the methods that have been proposed to the SAB so far, that there are a variety of different ways for conducting exposure assessments and that those need to be looked at.
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Many of the components of FQPA highlight the need to consider additional factors in the evaluation of pesticide uses on food, including both the cumulative assessments and the aggregate. And while these factors have been noted, the methods for conducting such assessments are really in the very early stages of development. Not only are they not fully developed, but they've not been tested and they've not been validated. The appropriateness of one approach versus another approach is currently the subject of heated debate in a variety of scientific forums.
It's clear from the presentations that have been made to the Science Advisory Board, and also earlier this year, to the EPA Science Advisory Panel, that apparently small differences in assumptions regarding which data are used can make orders of magnitude difference in estimates of exposure and risk, and can lead you to make regulatory policy that is inappropriate.
Therefore, I believe that each assumption needs to be carefully examined to understand it's impact on the overall assessment. Where an assumption makes a significant difference in the outcome, the impact needs to be examined or alternatives.
The most appropriate assumptions will be those that are not only based on sound scientific principles, but which reflect the real world. Data assumptions must be relevant to both current agricultural and consumer practices. They should not be hypothetical worst situations, and should be based on really good data.
I think we've talked quite a bit about the LOQ this morning. And basically, what we're worrying about there is that by compounding worst case assumptions, you end up creating a completely artificial risk that doesn't exist if you had really looked at the data correctly.
Although there are a wealth of data about pesticides, including toxicity studies and food residue level, FQPA does require new information, and that information cannot be obtained with existing methodology. In spite of what you heard earlier, I believe that FQPA requires a great deal of creative design and thought to develop approaches that actually answer the questions that were posed.
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For example, FQPA requires the assessment of simultaneous intake of a number of a different pesticides in a single meal or even in a single food, or fruit or vegetable. This type of assessment will only be accurate if the residues are measured in foods as they are consumed. A market basket study can be used to generate this data, and although we have conducted market basket studies—FDA has done also market basket studies—all of our previous methods have been designed to predict long term intake.
We must now modify those designs to allow us to quantify residues in individual pieces of food, and to allow us to determine the presence of more than one pesticide in those foods. This raises a host of new statistical questions, everything from how do you sample when you're looking for a single food instead of a representative lot of a number of samples of food, as well as the analytical challenges of how do you analyze for multiple chemicals in a single piece of food. There are no existing guidelines for such studies. Rushing to collect such data without validation of the methods is very likely to generate faulty data that, in my opinion, will be worst than no data at all.
The scientific issues facing EPA in the implementation of FQPA are at the research stage, rather than regulatory policy implementation stage. I urge you to urge EPA to proceed as they have in other areas where the science has advanced or where new concerns have been raised. EPA should conduct a thorough and systematic evaluation of existing methodology to determine the most appropriate approach to generate the assessments. Once those methods have been identified, they must then be validated. All methods must be validated before they are used as the basis for any government regulatory policy.
I believe the existing data do provide sufficient information to assure you that there are no existing public health issues that require us to circumvent the standard regulatory procedures for generating data and assessing risk. FQPA identified new areas to be considered in evaluating the safety of pesticides. Now it's EPA's turn to develop and validate the methodology, and to propose guidelines and rules for not only the new data collection, but the assessment of that data.
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Wherever possible, those assessments should be based on data, not assumptions. Even if that requires a delay to permit the design of the correct study methods to answer the question and then the collection of pertinent data.
Thank you.
[The prepared statement of Ms. Petersen appears at the conclusion of the hearing.]
Mr. GOODLATTE. Thank you.
Dr. Richards, welcome.
STATEMENT OF PETER RICHARDS, SENIOR RESEARCH SCIENTIST, WATER QUALITY LABORATORY, HEIDELBERG COLLEGE
Mr. RICHARDS. Thank you, Mr. Chairman. Thank you for the opportunity to testify on the Food Quality Protection Act. My area of expertise is the drinking water side of things—or I should say perhaps, the water exposure pathway in general.
The Water Quality Laboratory has been involved with studies of the connection between agriculture and water quality for 30 years. I've been involved with that study for 20 years. For 15 years, we've been looking at pesticide concentrations in rivers going into Lake Erie and the other Great Lakes. And during that time we've looked at literally thousands of water samples, analyzing their pesticide concentrations. So we have a pretty good sense of what's going on, at least in our region.
I want to try to make three points and I want to try to be as brief as possible, because I know we're running behind. The first point that I want to make is that there is in fact a great deal of data out there about pesticide concentrations in surface waters and ground waters of the United States. And not only is there data, but there's sufficient understanding of that data that we can generalize and begin to understand what we should expect in places where we have not got data or parameters for which we don't have data. So the data has been turned into information which predicts reasonably well in other situations.
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We know, particularly that in rivers and streams, the concentrations are quite seasonal. And the high concentrations are limited to a period of 2 to 6 or 7 weeks following the application of the pesticide, and thereafter, concentrations are low and generally below detection limits. We also know that lakes and reservoirs have lower concentrations, particularly than in the rivers, and that ground water has the lowest and most stable concentrations of all, although a few occasional situations lead to high concentrations.
There's a lot of information that relates to the surface waters or the ground waters themselves, not the drinking water which is drawn from them. And it's important to realize that the process of treating the water for drinking water almost always leads to lower concentrations that are present in the raw water source. So if you have information about a raw water source, you know that that's sort of a worst case estimate of what's going to happen in the corresponding drinking water.
And we can say, at least from our own studies, that in 15 years, we've not seen a single case where one of the pesticides that we look at has exceeded a short-term or acute health advisory level. In 15 years, we've not seen a single case where on an annual average concentration basis, the concentration of a pesticide exceeds a long-term health advisory. So from our area where at least some of the compounds are used quite heavily, there's really not much of a case for being concerned about the compounds that have been looked as a source of possible human health risks, as they're interpreted in the current EPA guidelines.
What about pesticides we don't have any data for? I think we can reasonably extrapolate from the ones that we do we have information for, using comparison of properties like the half-life—how quickly it breaks down—the solubility in water, how strongly it's attached to the soil particles, and things of that sort, and fairly well predict what we should expect of compounds that we don't have data for or in places where they're not studied, based on the relative amounts of use.
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So we have ways of taking the knowledge that we already have and extrapolating it or extending it to situations where we don't have data. And I think it's really important that we do that.
The third thing that I want to emphasize is the danger of using models as a source of exposure information. Most modelers will tell you that you should never use a model to predict absolute concentrations. You should use models to choose between several scenarios in terms of which one might be better or worse than another one. But to use a model to predict an absolute concentration is very dangerous, particularly when you have not calibrated the model.
In the context of the risk assessment here, if you don't have data on the compound, you can't calibrate the model. And if you had data, you might not need the model in the first place. The model the EPA has used in this assessment procedure is known to over-predict pesticide concentrations by a factor of about 10 in situations where it's been tried out against compounds whose behavior is known.
Furthermore, the scenario they used the model in—this farm pond scenario—is extremely conservative; extremely protective. It involves so many assumptions that it probably leads to predictions of concentrations that are anywhere from 100 to 1,000 times what you'd actually expect in the kind of environments that would be used as drinking water supplies. On top of that, they take an extreme upper end of the distribution of concentrations from their model, and they use that as the reference concentration.
I am aware that this is done in the interest of trying to protect people's interests, trying to be very conservative and cautious about things, but it seems to me that it's so extreme and so conservative that it loses all touch with reality. And I'm actually quite happy to hear Mr. Hansen saying that they're thinking of moving away from this procedure toward other approaches.
I'm going to try to finish a little early. The bottom line is that there's a lot of data out there. It should be used; it should be used intelligently; it should be used to try to understand the behavior of compounds for which there is not data; and we should be very, very careful in applying models, particularly models which are inaccurate, and which are applied in unrealistic scenarios.
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Thank you very much.
[The prepared statement of Mr. Richards appears at the conclusion of the hearing.]
Mr. GOODLATTE. Thank you.
Dr. Krieger, we welcome you and welcome your testimony.
STATEMENT OF ROBERT I. KRIEGER, EXTENSION TOXICOLOGIST, UNIVERSITY OF CALIFORNIA
Mr. KRIEGER. Thank you, Mr. Chairman. I'm pleased to have an opportunity to discuss some of the non-occupational non-food/water issues with the committee this morning.
I'm an extension toxicologist at the University of California, Riverside, and I think my bio contains all those other things about how long I've been involved in the field and so on. This has actually been the only field that I've looked at for the last 30 years, I guess.
The question of human exposure has really been brought to the forefront by the utilization of the National Academy of Science risk assessment approach. And I'd like to glean some important points from my prepared comments, and hope that that might serve to represent at least a somewhat different perspective perhaps on some of the issues that we've been talking about.
First of all, I think it's very important to recognize that when we talk about chemical exposures, we're not talking about illnesses. And if each of you appreciate that, I guarantee you that the public that you're dealing with, do not.
And it's very important that we invest some time in helping the public understand that when we're talking about exposure, we're talking about amounts of chemicals that can be detected in our air, water, diet, untreated surfaces, and so on. That these are amounts of chemical that don't represent a threat to health. They are absorbed. They are metabolized. They're cleared in urine and feces, just like all the other chemicals that are in our diet.
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Most of the things that we're exposed to are not nutritive, and we're not getting that across to the public very well. And in the process, chemicals which are potentially hazardous are the subject of health concerns which are farther removed from reality than most of the models that we've been critical about this morning.
Responsible risk assessment clearly requires the best possible human exposure estimates. And with respect to the residential exposures of children and parents, the available information is limited in scope and does not imply excessive risk in any circumstances that I'm familiar with.
One of the things that we're failing to do in talking about transparency of the FQPA process, is to utilize other exposure information that could give us insight about what to expect from exposed children and parents. That information comes from the persons who harvest the crops with the same materials that we're talking about using indoors. We have, as carefully as possible, evaluated that situation in the fields, and found it safe. Now we're talking about 1/100 or 1/1,000 of those dosages, and ringing our hands about how to build a model. I think we're wasting a lot of time and the unscientific part of it is, we're not taking advantage of available data from the workplace.
I will quickly add that that was not part of my comments when I walked in this morning. We've got to look at a much broader database than is presently on the table. And the workplace can and does provide us that information about how continued pesticide exposures effect people, and in fact, we're having people work under conditions that had judged safe. Why do we put on a different hat when we talk about a residence? It makes no sense to me whatsoever.
The specific indoor residential issues relate to measurement, monitoring, and management. And very quickly, we have been engaged for a period of about 5 years to try to study the absorption of chemicals as people use them indoors. There are two very important findings that our studies have revealed so far.
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One is that the duration of exposure is longer than predicted by the models. That is, if we look at air levels or surface chemical levels, they decay with a time factor of hours. The residents' exposure continues over periods measured in days and weeks. So the hourly model isn't predicting what's happening.
Now more importantly, with respect to simple health issues, is that the levels are much lower than predicted. So you've got lower levels, but they're persisting longer than expected. And that implies a need for a different kind of model building than has gone so far.
The initial predictions were that we'd be looking at milligram chemical per kilogram body weight exposures in children and adults. It looks like those estimates are high by a factor of 100 or 1,000. We're really talking about micrograms instead of milligrams, and that's a big difference. Easily detected by available methodology, without resorting to non-detect assumptions or anything of the sort. The models have not predicted well what's really found.
I believe that this means more measurement is needed. And when measurements have been made of contemporary exposures under contemporary use conditions, the exposure levels are predictably low.
The second issue relates to the available models. And I'll just say that I use the term default a little differently than it was used earlier this morning. We default if we don't know something, and the default models must be replaced by a better understanding. The elements of better models exist within EPA research programs, but they have not been congealed into an unified and useful whole, in my opinion.
And finally, with respect to managing this risk issue, I think it's very important that we come clean with the American public. When we're talking about hazards of chemicals, that's what they can do in an excessive amount. When we're talking about risks, that's the likelihood that use is going to cause a problem. We're not making that distinction, and it must be made. Because when statements to describe higher risk and safer are used without any understanding of the reference point or what the basis of that statement is, people become confused and tend to view themselves as victims, rather than of the benefactors of important chemical technologies.
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Thank you very much.
[The prepared statement of Mr. Krieger appears at the conclusion of the hearing.]
Mr. GOODLATTE. Thank you. I am, without objection, going to defer my initial time here to the gentleman from Illinois, because he has to leave in just a few minutes.
Mr. EWING. Thank you, Mr. Chairman, and I appreciate that. This has been really a very interesting panel, and I'm very sorry I missed the first presenter's testimony. I have some questions that I would propound to all of you, and because of time, if you could just answer yes or no where possible, or as short as possible, we'll get through them.
First of all, when I listen to your testimony, I get the distinct feeling that we don't have a crisis in America under current procedures and endanger our children from chemical uses. Is that so, or am I being too broad in that? We'll start here.
Ms. PELTIER. It's been the position of the Department of Pesticide Regulation for years that we have the safest food supply any place in the world, and that we are doing a very good job of protecting all sensitive species, if you will, from exposure to agricultural chemicals.
Mr. EWING. Dr. Petersen.
Ms. PETERSEN. I would support that.
Mr. RICHARDS. I would say the risks from water are very low as we understand them at present.
Mr. EWING. Dr. Krieger.
Mr. KRIEGER. The exposures that we receive, whether in the in the workplace, which is the final aggregating activity, or in the home, to my knowledge, are well below toxic thresholds, low effect levels in rats, no effect levels in rats, and proposed reference doses.
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Mr. EWING. Is it not true that before any chemical can come on the market, it has to go through an extensive period of approval—I don't know if that approval is at the Federal level, or if some of it's at the State level—and that that has done a pretty good job of protecting the public?
Ms. PELTIER. That's correct. We in California have a Pesticide Regulatory Program that really parallels that of United States Environmental Protection Agency. After a material has been approved for use in Washington, if a registrant wants to sell that product in California, he has to submit data studies to the state for its evaluation as well.
Mr. EWING. Anyone else? Well, Dr. Petersen, I thought I maybe got in the tone of yours that you could see a great deal of damage maybe to the commercial side of agriculture, maybe to the available supply of food in America, by the implementation or the failure to implement this legislation we're talking about here in a proper manner. Is that so?
Ms. PETERSEN. What my concern is that we will end up regulating the wrong chemicals in the process. I believe firmly in doing a detailed exposure assessment and risk assessment. I think it's a very important part of approval of chemicals. But if you're using wrong assumptions, or you're generating data that leads you the wrong way, you can end up drawing the wrong conclusion. And we saw that this spring.
The Environmental Working Group published a report. In that report, they listed 10 foods that were the highest contributors to exposure, and on that list included popcorn. And we spent a lot of time, in my office, trying to understand why popcorn would be fingered as a dangerous food in this regard, when it had neither high residues, nor was it consumed in large amounts by children. And it turned out to be one of the assumptions that were used in doing the risk assessment, which on the surface appeared to be an assumption that wouldn't make much difference, but it hadn't been tested. And once you did test it, you realized that popcorn did not belong on any list of foods that you would be trying to take a regulatory action. So you would have come to totally the wrong conclusion, based on that assessment.
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Mr. EWING. So we could have some loss of chemicals that could be useful or even some of loss of foods that might be denied the public, that more thorough study would have allowed us to use?
Ms. PETERSEN. That's my opinion. I think there's time, and I think we should figure out how to do these studies and then do them correctly.
Mr. EWING. There's always a problem with delay, and that's a great Congressional reason often. When you don't know what else to do, delay it.
Ms. PELTIER. It's a default assumption. [Laughter.]
Mr. EWING. Yes.
Ms. PETERSEN. I'm not suggesting we delay; I'm suggesting we get started and do it right.
Mr. EWING. Well, I guess the question that I wanted to ask though was: wouldn't it be better in some cases to delay until we have our implementation down to a more workable science, than to push ahead without the necessary information?
Mr. PETERSEN. I would support that.
Mr. EWING. Do most of you agree with that?
Ms. PELTIER. We suggested in the case of consideration of organophosphates and whether or not they operate with a common mechanism of toxicity, that it makes sense to handle this in an iterative approach. To handle assessment of each of the individual organophosphates first and develop better methodologies for conducting a cumulative risk assessment.
Mr. EWING. Dr. Krieger, you talked about a database. Does America have the best database in the world, or do other countries—the European community, many of them are very into safe food, or Japan—are we behind, or are we even, or ahead?
Mr. KRIEGER. There's general concern in U.S., Canada, and Europe, as well as in Japan as you mentioned, for individual exposure issues. I don't think it's a question of being ahead or behind, but more being able to utilize the data that's available in those other venues to help us resolve our problems. The kind of studies that we're talking about are not easily performed and not cheap. I think behooves us to take advantage of the greatest possible experience in building a useful database for decision making.
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Mr. EWING. Thank you very much. Thank you, Mr. Chairman.
Mr. GOODLATTE. Thank you. The gentlewoman from North Carolina.
Mrs. CLAYTON. Mr. Ewing raised the question whether we have the best science and we are protected. I wondered, just to build on that, I'm assuming that you believe that we have—our children are protected, our food is protected, and the quality of food is protected, and consumers are protected in part, because we now have this law. Is that right?
Ms. PELTIER. I'm sorry, was that question directed to me?
Mrs. CLAYTON. Well, let me change it. Do you see a value in the law we now have—that the Food Quality Protection Act of 1996 is of value in protecting children, quality of food, and the environment?
Ms. PELTIER. Absolutely. In fact, the State of California supported many of the concepts that are embodied in this legislation. We think properly implemented, it's a very good law.
Mrs. CLAYTON. So you wouldn't be for delaying it; you would be for making sure the full intent and properly implemented is correct?
Ms. PELTIER. The question of delay is a difficult one, and I know that Mr. Hansen sort of dodged it as well. I think that maybe I'll do that too. [Laughter.]
Mrs. CLAYTON. It's always safe in dodging. [Laughter.]
Ms. PELTIER. I think that they are fighting with a couple of different things—one, getting through this mandate to review one-third of the tolerances within a specified time period. And still there are areas where this legislation is ahead of the science. It's ahead of the science in the determination of cumulative risk assessment, I would argue. And there are many other areas too, where we're really at the cutting edge. We haven't talked at all this morning about endocrine disruption, but that's an area where the science is still being defined. And I think that rather than a rush to judgement, I think that we need to go about this deliberatively.
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I would like to add one other point, if I could. There was a lot of talk this morning about the need to generate data in actual use practices, and the need to make a determination of critical uses in agriculture that ought to be preserved, and somehow that that's going to make a difference in the process. I do think it's important to underscore, the agency at this point is trying to develop a role for the grower community, for the user community, in this process.
But ultimately, the decisions that are made about what products remain on a label, what tolerances are revoked, really is between U.S. Environmental Protection Agency and the registrant. And so the importance of developing a meaningful role for USDA in this process, and having a way of weighing the relative impacts of their tolerance revocation decisions is going to be very, very important, I would imagine, to the members of this committee.
Mrs. CLAYTON. I think Mr. Rominger indicated they were setting some priority where certain commodities were going to share that with EPA, and hopefully that will speak to that issue in that area.
Dr. Krieger, I thought I detected a sense that there is an additional burden we have. And that is that is beyond our frustration, or the science frustration, or those who are the experts, is that the public had a certain level of anxiety and concern. And unless we educated them in the differences of tolerance or existing and expecting, where they weren't perceived to be the victim of either our predisposition, or our industry, or our vice, that we were going to lose a larger battle. Did I understand that correctly?
Mr. KRIEGER. I concur. I believe that we have more to lose than to gain, if we don't effectively communicate with the public. There is always going to be a most toxic something-or-other out there. If you stop using chemicals, then it will be tomatoes over some other kind of a vegetable that doesn't have as many alkaloids in it, or whatever you might want to develop.
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Chemical exposures are with us, and we're not doing a very good job of talking about that to the public. Otherwise, they wouldn't be concerned about the residue in the water. A statistically-valid number, but I don't know how many thousand samples were mentioned that have been measured, and no toxicity. But how many people are buying bottled water in the United States to avoid pesticides or other chemicals?
Mrs. CLAYTON. We all have it up here.
Mr. KRIEGER. Yes. If you're buying it because you like the flavor of that water, that's one thing. But if you're buying it to avoid pesticide residue, you're misled. And we mislead a lot.
Mrs. CLAYTON. Well, the whole issue of clarity is also part of perception. And the clarity to the scientist is one thing; clarity to the public, and the integrity and confidence of the public is based on the consumer buying it for the same reason many more consumers are buying organic materials.
So I think—I don't know whose role that would be—you're from the Extension Service—I looked through your bio—and it seemed like you have defined the role that we need. We've just passed the research—agricultural research bill—which perhaps will give us an opportunity to use this science and be able to communicate in an open way where our consumers would appreciate having the best food, the best air, the best water, based on what is in fact the truth. Because what we hear is so oftentimes the fear of what they were told by their officials have not been the truth. And wherein those are just exceptions, rather than the rule, we have to find a way of gaining the confidence of the public that are environment is safe.
The environment issues are very high in the public. Very, very high. In spite of all the science, they still have a great fear that they do not have clean air, they do not have clean water, and feeling sometime that maybe the inspection of their quality of their food, or salmonella, or whatever, is not in their interest. So we have to find a way to reinforce what we do have—is celebrate that, but also to give them some confidence based on the actual facts, rather than—somehow we have lost that battle. So I share that with you.
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Mr. KRIEGER. Thank you. I think that the process or the idea of aggregating hazards and developing a risk assessment is something that the public does understand. And that is a concept that is very positive within the FQPA package.
Mr. GOODLATTE. Thank you, Mrs. Clayton. Ms. Peltier, can you explain in layman's terms for me what you mean by multiple conservative default assumptions and what problems these might pose.
Ms. PELTIER. Probably not, but I'll try. I'm a non-scientist also sitting here on a science panel, so I'm a little intimidated. I'm trying to think if I can come up with a good analogy.
I think Dr. Krieger pointed to the fact that some of the information that we have about residential models adds an additional factor of 10 to the theoretical risk. And I think there was another discussion by Dr. Richards that in the exposure of water, that that adds another 10. And to that, you add the initial assumptions made during the risk assessment process, that if a study is submitted, and it's an animal study, U.S. EPA adds a factor of 10 to account for the fact that humans act differently than rodents. Well, some do and another factor of 10 to account for the differences between various subspecies—children versus the elderly versus others.
And so in that particular scenario that you have where you had something where you said, here's the no observable effect level, the NOEL; to that you added a 10, and another 10, and another 10, and another 10, to come up with a level that you think is going to represent a ''reasonable certainty of no harm.''
Imagine you're going to stack up in this one cup that you've already filled with four orders of magnitude additional safety, you're going to add a number of other materials with those same levels. So that the level of actual risk is maybe down here lower than what I have at the bottom of my cup, but the cup is filled and overflowing on the basis of additional default assumptions that have been added to it.
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I hope that makes it a little bit clearer.
Mr. GOODLATTE. Are you saying that the EPA lacks the methodology to make risk assessments, or that they know how to do it, but lack the necessary data?
Ms. PELTIER. I think what I'm saying is that EPA is depending on additional conservative default assumptions, and that when put together, particularly as they go through the first step of aggregating exposures, and then to the ultimate next step of accumulating those exposures from other pesticides, is going to greatly over-exaggerate risk.
Mr. GOODLATTE. You mentioned the incremental risk assessment proposal. Can you explain how this would make the section 18 program more efficient?
Ms. PELTIER. Yes, the State of California has had an ongoing working agreement with U.S. Environmental Protection Agency to allow us to conduct tolerance assessment work for them on those section 18's that we submit. So we have a pretty good idea of the resource needs to do this full tolerance assessment. We have found that it takes as many as 40 man days to go through this kind of tolerance assessment that they believe is required in order to support a temporary tolerance under section 18.
In contrast, the other proposal that we have put forth would say that you would look at the proposed use and make a determination if it represents less than 1 percent of the theoretical risk, whether that is risk based on whatever the applicable toxicological end point is. If it's an acute risk, it would have a margin of exposure of greater than 10,000, for those who play with those numbers. It represents less than 1 percent of the reference dose and a chronic risk, rather than the typical, traditional 1 times 10 to the minus 6—it would be 1 times 10 to the minus 8. Long way of saying that the scientist would be given an ability to do a shorthand version of a calculation of the proposed risk.
Our toxicologists have indicated that they believe that this is a sound methodology, and importantly, it takes about 1 man-day, compared to 40 man-days, to do that kind of a risk assessment. And I think that's a pertinent point, given that the pipeline of new pesticides registered has pretty well dried up through EPA. We had a presentation made to the PPDC that indicated that there were—in a given set of time—there were a total of five tolerances granted, one of which was for an imported product, not even for domestically produced.
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So, we've had as a situation all of the resources of the agency in tolerance assessment are geared toward section 18's, and we can't believe it was the intent of Congress to re-order the priorities of EPA and its tolerance reassessment every time a State, like California, submits an application for an emergency registration.
Mr. GOODLATTE. Thank you. Mr. Bishop, do you want to ask questions at this time? We recognize you for 5 minutes.
Mr. BISHOP. Thank you very much. Let me thank the panel for coming and thank you for your contribution. I have a question for Dr. Krieger. You've extensively used organophosphate insecticides in your human exposure studies. Why did you choose those particular chemicals?
Mr. KRIEGER. Thank you. The organophosphates have been used as models in our work basically because they are widely used under normal conditions, they have moderate toxicity, and the amounts of exposure that people get are well below toxic levels. And we've been interested in the pathways that can move chemicals around a residential environment, and they have been useful for that purpose. We've not conducted a risk assessment using them as a model for human exposure.
Mr. BISHOP. Are you familiar with pesticide illness data that's associated with a residential and commercial indoor use of organophosphate insecticides, and what is the relationship to the exposures that you're now studying?
Mr. KRIEGER. The exposures that I referred to in my previous comments are low and measured in micrograms per kilogram body weight. The kinds of illness reports that we've had—and these go back to the time that I worked with the California Department of Food and Agriculture, now Cal EPA were a series of reports in the late 1980s. It was quite clear that based on the short time interval between a person entering a treated room and the nature of the effects, that the responses were to the bad odor of the chemicals, rather than to organophosphate toxicity as we presently view it.
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This has some very important implications for establishing no effect levels. The levels of concern are the ones resulting from uptake and systemic toxicity, as the chemical moves through the exposed person's system. The odor response—it's a real response—but it would have a very different no effect level than would say the systemic toxicity, with perhaps one exception in that early data. The reported illnesses should be ascribed to odor, rather than to systemic toxicity. In all cases, the toxicity was associated with misuse.
Mr. BISHOP. Thank you. Can you clarify or can the difference between hazard and risk be clarified for those of who are laymen during the discussions of pesticide regulatory policy and the FQPA?
Mr. KRIEGER. I think it's very important to separate hazard and risk. Perhaps the easiest way is to think that the hazard represents everything bad that a chemical could do, irrespective of how much. Risk represents the possibility that an effect could be observed based on the amount of exposure that occurs during normal use.
So most chemicals have a list of hazards associated with them, but most of those hazards aren't seen in people in that are exposed primarily because the levels of exposure are very much less than those necessary to show the hazards. Too often, we present the chemical and list of hazards, and then go on to describe how it's present in the food, water, or air, without indicating that the hazards apply only to high dose.
So in general discussions, hazard must be followed with some indication of the amount of exposure.
Mr. BISHOP. OK. Dr. Krieger, once you have a monitoring process for residential exposures to a pesticide, how will you decide if that exposure that you're monitoring is harmful to adults or to children? And what is the toxic end point that EPA is using for residential exposures to organophosphate and carbamate insecticides?
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Mr. KRIEGER. I think the most generally applied standards are the no adverse effect levels with an additional uncertainty factor of 10 for interspecies variability, and another additional person-to-person factor of 10 to get down to the level that would represent a reference dose. The pathway for developing chronic reference doses is much more clear than the pathway for developing acute ones. And I'm not well informed about how the acute ones will be developed.
Mr. BISHOP. Thank you. Dr. Richards, do you drink bottled water?
Mr. RICHARDS. I don't know what's in this [pitcher] but normally I don't.
Mr. BISHOP. Do you have a filter on your home water supply?
Mr. RICHARDS. No, I don't.
Mr. BISHOP. So you generally feel that most of our water is consumption safe?
Mr. RICHARDS. I do.
Mr. BISHOP. That's all I have, Mr. Goodlatte. Thank you.
Mr. GOODLATTE. I thank the gentleman. I think his last question gets right to the point.
Dr. Petersen, you mentioned that the use of accurate assumptions is vitally important. You said, ''small differences in assumptions regarding which data are used can make orders of magnitude differences in estimates of exposure and risk.'' Would you please provide some further explanation on that statement and provide some examples, if you possibly can.
Ms. PETERSEN. Sure, I mentioned already the example with the popcorn, which was I believe a difference of almost 10,000 than what you would have calculated as the exposure, not as the risk. It made a difference in what in your estimated exposure was.
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But I think it's also critical when you look at both the food consumption data and residue data that you're looking at data that a representative of the food that's consumed and the amounts that are consumed. And one of our problems in doing risk assessments, particularly with the methods that are being suggested by EPA right now, at least informally, is that the underlying data that we have may not be completely representative. There are outliers in that data and we've not developed the methods for moving that.
So, for example, we do have in our database for food and water consumption, an individual who consumed about 9 liters of water—a couple of gallons of water—in a day, and that was a young child I believe. Same thing for individual foods. We have high quantities of consumption. We're not underestimating the exposure in any situation, and in a number of places, we can be overestimating by, as I said, by several orders of magnitude.
Mr. GOODLATTE. We always seem to hear that when doing sampling of dietary intakes we come across the kid who consumes 50 pounds of broccoli. In your opinion, how should this data be handled?
Ms. PETERSEN. I think the data need to be—I'll call it cleaned up—but adjusted so that it really is representative. And we need to acknowledge that those extremes are most likely errors in the data. I'm not discounting that there are people who eat extreme amounts, and we do have those people in the data set, and we do keep them. But I think we also have to be reasonable about what's not only plausible, but what represents a representative diet as well.
Mr. KRIEGER. I'm glad to know I'm going to be kept in the database. [Laughter.]
Ms. PELTIER. Per unit body weight. [Laughter.]
Mr. GOODLATTE. Dr. Richards, in what situations might you expect to find concentrations of pesticides in drinking water supplies which would exceed health advisory levels or standard? What kind of field uses and under what weather conditions?
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Mr. RICHARDS. I think probably the best single predictor for having a good chance of exceeding the health advisory would be the word small. It would be a small stream as opposed to a big river, it would be a small pond or a small reservoir as opposed to a large body of water, like the Great Lakes. It would be almost certainly a private rural well as opposed to a well-maintained municipal well. It's—particularly in the case of a standing body of water like reservoir—an awful lot of it depends also on what's the land use in the watershed. If it's all agriculture, it's more likely to have a problem than if it's all forest. And also, if the amount of water that's going into the reservoir in a year is virtually all used up by the water supply, then there's very little opportunity for dilution and averaging out over time.
But primarily small systems in which the land use is particularly unfavorable for the pesticide of interest.
Mr. GOODLATTE. And what about weather conditions?
Mr. RICHARDS. It really depends to a large extent on what kind of a water supply you're talking about. Weather conditions aren't going to have that much of an impact on ground water, except over a long period of time. But certainly, if you have a particularly bad year in terms of a lot of rainfall coming at the wrong time, you could very well wind up with a situation where in some surface water settings, you'd have an annual average which is much higher than typical—maybe by a factor of two or three. So weather can play a role, but it's probably not quite as important as this factor of size.
Mr. GOODLATTE. And help me out with another terminology here. What are the health implications if a drinking water source exceeds a lifetime health advisory level?
Mr. RICHARDS. Lifetime health advisory levels are set with the intent that they be protective that—they don't have legal bearing as a maximum contaminant level does—but they're calculated so that the presumption is that consuming water at that concentration for a lifetime is going to have no adverse effect. So the implications of being at or slightly above that level is that it's time to start thinking about doing something to lower the exposures by altering the water supply. But it's not a matter of panic. The important point is that the health advisory level is not a level of health affect, but simply a level of warning that it's time to maintain the protection, and it's a substantial level of protection.
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Mr. GOODLATTE. Thank you. Dr. Krieger, during the TRAC meetings this week, the EPA handed out several bar graphs depicting several preliminary analyses of 40 organophosphates. One chart showed acute and chronic effects. I have understood that cholinesterase inhibition is in acute toxicity. Are there other chronic concerns also? Am I pronouncing that?
Mr. KRIEGER. You got the enzyme right. It's difficult when dealing with the organophosphates to develop a chronic concern. Generally speaking, it's a short term, high-level exposure that gives an inhibition of the enzyme cholinesterase that you're referring to. One of the limitations of available data is that our standards for cholinesterase are usually developed with a longer term exposure. And part of the difficulty in the data that you may be referring to is the fact that it's difficult to use a 1 month exposure to set a short-term limit. Without knowing a little bit more about the data, I wouldn't want to comment further on that point.
Mr. GOODLATTE. Dr. Krieger, we've heard about some methodologies being used by the EPA that concern us. One involved a jazzercize routine. Are you familiar with that?
Mr. KRIEGER. I developed it.
Mr. GOODLATTE. Tell us about it. [Laughter.]
Mr. KRIEGER. The method that's used—and it's part of the ongoing exposure studies—is to measure the transfer from a treated surface to a person. The misuse of it that you refer to rightly, is that it's been extrapolated from a 20 minute experimental period to 24 hours. And that would be a good example of an assumption—or a default—that is very misleading. In fact, in two 20-minute periods, you can pretty well approximate a person's 1-day exposure in a treated room, and that's subsequent work to published studies. That method is valuable for studying transfer, but it is not valid for measuring day-to-day exposure at this time. The procedures have been misapplied and used to estimate day-to-day exposure using invalid assumptions.
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Mr. GOODLATTE. Could you explain that to us in a little more detail? What's the intent of—how do you do this procedure and what is the intent?
Mr. KRIEGER. The persons in the study—and we've used from 5 to 40 in a single study—will enter a treated room wearing a cotton suit. The persons will go through a standardized set of activities.
Mr. GOODLATTE. When you say treated room, how is it treated?
Mr. KRIEGER. A room that may be treated crack and crevice; it may be fogged or area sprayed, whatever the pesticide application procedure.
Mr. GOODLATTE. It has some chemicals in the room.
Mr. KRIEGER. It has been treated. The studies have been approved by human subjects' review committees, I should add.
During the course of this set of exercises that take 20 minutes, the people have maximum contact with the floor, and that's the scientific part. Because we now can come back a year later, or this case, 10 years later, use the same chemical, and get about the same amount of transfer. And that's the use to which the method is being productively put.
But the unfortunate issue is that if you take the data from those people—you measure the amount on their feet, on the suit, and on gloves—if you just take that raw data and try to extrapolate from the 20-minute exercise period to let's say a 16-hour day, to estimate daily exposure, you'll get a number that will be 100 to 1,000 or more than what real exposure is.
Using people, one group wearing suits and the other group wearing bathing suits, which had 75 percent skin exposure, we've recently calibrated that model now. That work is presently under review for publication in the scientific literature. The model shows pretty well that the transfer is representative and that a 20-minute period closely represents the amount of transfer that occurs from a treated surface to a person in a course of a full day under normanl conditions.
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And it looks like exposure can be adjusted so that you could use suits, instead of having to do biological monitoring study every time you need to and evaluate a chemical. A biological monitoring study requires us to have people under study and collect urine for varying periods of time. With a suit, it's over in 20 minutes, we take the suits back to the lab, and if you had a whole bunch of money, you could have results at the end of a week. Or if you had half as much money, you'd take 2 weeks.
That methodology was developed at the Department of Food and Agriculture, refined at California EPA, and is used by us fairly extensively in our exposure work.
Mr. GOODLATTE. But that has been misused by the EPA to attempt to calculate what a person's average daily exposure would be?
Mr. KRIEGER. Anyone who would try to calculate average daily exposure from that suit would be very much misled.
Mr. GOODLATTE. And is that what has been done with this mechanism?
Mr. KRIEGER. Not to my knowledge—if they've done that, that would be a big surprise to me. But not an overwhelming shock, I guess. [Laughter.]
Mr. GOODLATTE. Thank you. Ms. Peltier, the law calls for EPA to reassess 33 percent of its existing tolerances at the time enactment by August of next year. Do you interpret the law to allow an interim decision based on available, reliable data, followed by a final decision when more data are available?
Ms. PELTIER. We do, and actually, initially I think that U.S. EPA had that position. I know that there was a presentation made to the Pesticide Program Dialogue Committee, I believe last summer, that outlined in particular what they were going to do in evaluation of organophosphate pesticides for which they had not yet developed a method for going through the cumulative risk assessment. And at that point in time, we were told that each of those individual risk assessments are going to be done individually, and then a cumulative assessment done as the methodology had been developed.
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Mr. GOODLATTE. Good. Thank you very much. Anybody else have any questions?
I want to thank all of you for your participation, and your valuable evidence. This is very useful to us in trying to determine whether or not the EPA is following reasonable procedures in their effort to comply with this law. And we will dismiss this panel and welcome our third panel.
We would like to invite our third panel to the table. Dr. Mark Whalon, Council for Agricultural Science and Technology; Mr. Ken Evans, American Farm Bureau Federation; Mr. Daniel Shreckhise, vice president of Shreckhise Nurseries and a constituent of mine; Mr. Bill Lovelady with the National Cotton Council; Mr. Mike Randall, chairman, South Dakota Corn Growers Association; Mr. Leonard Gianessi, senior research associate, National Center for Food and Agricultural Policy.
Gentlemen, your written statements will be made part of the record. And we would be pleased to receive your testimony at this point for the purpose of introducing our first witness. I would like to recognize the gentleman from Michigan, Mr. Smith, who has, as I indicated earlier, been a strong advocate of holding these hearings for quite some time now. The gentleman from Michigan.
Mr. SMITH of Michigan. Mr. Chairman, thank you very much.
I'm proud to welcome Dr. Mark Whalon, director of our Pesticide Research Center at Michigan State University to the committee. Dr. Whalon is an internationally recognized expert in IPM resistance management and pesticides alternatives in fruit and vegetable production. He served in an advisory capacity to both the Environmental Protection Agency and USDA, as well as a consultant to both industry and international governments. Dr. Whalon's currently supervising the transition of the Pesticide Research Center at Michigan State University into an integrated crop management center. We've given it a new name: The Center for Integrated Plant Systems. And Dr. Whalon also is a member of the Joint USDA-EPA Tolerance Review Advisory Committee, which is working with EPA on FQPA implementation.
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Dr. Whalon, welcome. I look forward to your testimony.
STATEMENT OF MARK WHALON, COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY
Mr. WHALON. Thank you, Congressman Smith, and Mr. Chairman. I appreciate the invitation to present testimony before the subcommittee, and I am testifying on behalf of the Council for Agricultural Science and Technology, CAST, which is located in Ames, IA. It's a nonprofit organization composed of 36 different scientific societies and many other members. Its mission is to identify food and fiber, environmental and other agricultural issues and to interpret these and relate the scientific research and other information for legislators, regulators, and the media. I'm chairing currently a task force of scientists presently preparing a CAST report, the title of that is ''Impact of EPA Implementation of the Food Quality Protection Act.''
First, let me say that CAST is supportive of the broad principles encompassed in FQPA, including, No. 1, greater protection for the most at-risk portions of our society, when appropriate; second, consideration of whether groups of pesticides have a common mode of action; and third, consideration of the aggregate exposure of pesticides in diet, drinking water, and nonoccupational exposures.
However, we are concerned that the manner and the time in which these changes may be implemented will significantly alter agriculture's ability to control insects, mites, nematodes, and disease problems. Our concern specifically focuses on unintended consequences and potentially negative impacts on IPM programs, resistance management, minor crops, the perception of safety in the food supply, and the competitiveness of U.S. agriculture. We also have questions regarding the public resources available to facilitate the implementation of alternative pest controls after FQPA has its impact.
One of the principal dangers of FQPA is that it would remove critical insecticide tools like organophosphates, carbamates, some herbicides and B–2 fungicides before replacement chemistries and IPM systems and alternatives are in place. In some agricultural applications and in mosquito control, tick control, cockroach control programs these consequences will result in drastic impacts on our ability to protect the public and to produce safe food.
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To address these concerns, the EPA should adapt a rulemaking accommodation and allow for situations through time limited tolerances and emergency exemptions that allow the development of alternative IPM systems. In addition, more registrant, commodity and public support should be directed to IPM programs, to pesticide alternatives, and resistance management strategies so that we can deal with the impact of FQPA. The potential for shifts in agricultural production and processing, from FQPA implementation clearly exists.
The elimination of key pesticides or classes of pesticides could trigger international impacts, similar to the shifts that could occur domestically and regionally. Especially troublesome, particularly because of the expanded free trade and limited monitoring resources is the prospect that foreign producers could continue to use pesticides that U.S. producers could no longer use under the FQPA.
The elimination of FQPA targeted pesticides should be predicated on the ability of viable pest management alternatives. There are two views of what pesticide alternatives are. In the first, alternatives are essentially viewed as products that can be directly substituted for FQPA targeted tools. However, many of these tools have significant problems themselves because they may cause secondary pest outbreaks. They may impact non-target organisms, or they may lead to other damaging environmental effects. In other words, the risk of unintended consequences may outweigh the risk under FQPA. I advocate, therefore, a risk-risk analysis to compensate for this.
A second class of alternatives include biological controls. Biological control alternatives are very important now and will increase in importance in the future. But in general, they are only partially effective alone, and or they require significant additional resources to implement. At the same time that USDA and FDA are being directed to, by initiatives from the administration and Congress, to increase food safety standards, most of the FQPA targeted pesticides are critical for reducing pest contamination, adulteration and putrefaction of food and fiber.
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To illustrate this dilemma, we estimate that each percentage reduction of a pest or contaminant beyond or below the 95 percent level requires two to 10 times more pesticide use.
Another significant point is that all production systems must address this same relationship, whether they are a pesticide calendar spray program and an integrated pest management program or an organic program.
In the absence of residue data, the EPA will use default assumptions for risk assessment, which assume that each pesticide or group of pesticides is used at maximum rate, at maximum frequency, and up to the legally defined last day of treatment. These default assumptions significantly overestimate actual residues in most instances. Therefore, the EPA should grant time-limited tolerances, as I mentioned before, and should issue data call-ins where residue data are not available so that these levels could be established in fact instead of supposition.
The principal point is that agriculture and human health protection must have the tools and the systems to manage pests to ensure a healthy nation.
In summary, without a balanced risk-risk analysis and time-sensitive approach to FQPA implementation, significant unintended consequences to U.S. agriculture and to human health pest management could result.
Thank you.
[The prepared statement of Mr. Whalon appears at the conclusion of the hearing.]
Mr. GOODLATTE. Thank you.
Mr. Evans.
STATEMENT OF KEN EVANS, AMERICAN FARM BUREAU FEDERATION
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Mr. EVANS. I was going to say good morning, but I guess that's long gone. [Laughter.]
Frankly, I'd rather be back on my tractor or in my pickup in Yuma, AZ, than here today, but I am here and I am here representing myself as a citrus and alfalfa, wheat, cotton grower. But I'm also here representing the American Farm Bureau and the Arizona Farm Bureau. We are the nation's largest farm organization with some 4.8 million members. And, as I sat here today listening to this group, first I take great pleasure in seeing the interest and the in-depth questions which the group has asked. You have my written testimony before you, and I'd like to divert from that just momentarily, with the chairman's permission, to tell a story from my background.
Mr. GOODLATTE. Go ahead.
Mr. EVANS. June 12, 1964 was a very long time ago, but it was very vivid in my mind. It was a hot, sultry day in Yuma, and as the temperature about 8 o'clock drifted slowly below 118 degrees, I was about to doze off in my big easy chair when a sudden noise disturbed my evening. That sound was screeching pheasant, and as I heard the noise, I bolted out the backdoor with my shotgun in hand. By this point, I had this procedure down to an absolute science. As the son of a migrant farm worker in order to raise the money to go to school and buy clothing, I had started an FFA project by raising pheasants and the land owner had allowed me to build some pens between the rows of citrus trees. So the pens were about 10 feet wide and some 300 feet long. By this point, I had ten of those pens, and, to my astonishment, as I stumbled out that evening, shotgun in hand, the coyote had gotten into one of my best brood hen runs—pheasant runs.
The project had proven pretty successful through the years, but the primary problem I'd run into at least from the physical standpoint was the resident coyotes liked the taste of my pheasants almost as much as my customers did. What made this particular summer eve unique wasn't that a coyote was after my birds. It was that it was Charlie. For almost 6 weeks now, a particularly Wiley and vicious coyote had been after my birds, stealing my prized pheasants. In fact, his uncanny ability at surviving all of our attempts at trying to repel him and trap him and scare him away had earned him that nickname of Charlie. He had dodged every attempt at poisoning, at repelling, at trapping, at shooting, and everything that we could do. Interestingly enough, as I approached I saw a grey figure in the corner of the pen, so I immediately fired. He began to run through the brush that I had put in the pen to protect the birds from one another. I fired again. I raced through the brush as best I could seeing his body here and there. Peering through the dark and with the flash of the flashlight, I would fire again. I loaded the shotgun a second time and emptied it a second time as I chased the coyote through the pen.
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As I approached his grey, limp body at the end of the 300 foot run, I was elated. My initial reaction was no more getting up at 3 o'clock in the morning to nurse maimed birds to health, no more worry about loss of income. I'd finally solved my major problem with this pheasant enterprise. And then suddenly, I got this gut-wrenching feeling right down in the middle of my stomach, the kind you get when you see flashing red lights in your rear view mirrors, your speedometer drops below 95. As I turned and retraced my steps through the pen, my worst fears were realized. You see I found that old Charlie had killed one pheasant and mauled two others. I'd killed 35 and wounded 61. In the intervening years, I have thought about that a whole lot, and as we're here and as I've sat and listened to both the agency and your experts today, I wonder if we're not in the process of killing the pheasants in trying to get rid of that pest. I wonder if our priorities are really where they ought to be. You know, as we've listened to this group today, as the members of your committee spoke earlier this morning, we all had high expectation and hopes when the Food Quality Protection Act was passed just two short years ago. Unfortunately, for many of us, we feel like our trust in the agency, when we were given assurances that they would apply the rules fairly and base them on sound science have been betrayed.
We viewed passage of that act, as many of you did, as the culmination of a 15-year odyssey for many of us coming back here working to try to eliminate the Delaney clause. We presumed that it was going to have all the positive effects that we were promised. It was going to be science-based, health-based. There were going to be considerations of pesticide benefits. We were going to see a streamlined registration for high valued, the so-called minor use crops that are so prevalent in my area. Our support was tempered with concern over provisions that were contained in the Food Quality Protection Act, but both you, as members of this committee that were there at the time, and EPA assured us that those concerns were unfounded and that we would be able to have a better program in the future.
Specifically, we were assured that a reasonable certainty of no harm standard would be based on health and science. And, as the chairman has appropriately pointed out with the preceding panel, that's not the case. We were assured that, along with you, risk assessments for food exposure would be based on best available, reliable information, just as the law required. And obviously, it's not. When data were absent, we were told that—or if it were incomplete—we were told that better data would be obtained before decisions were made. That's not happening.
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EPA is currently making unrealistic worst case assumptions for their regulatory decisions. To make matters worse, EPA has not defined the data needs that they have nor have they requested data from registrants or from farmers which could help fill those data gaps and reduce the number of conservative risk assessments—erroneous ones that the chairman has talked about. We, like you, trusted that the implementation process would be open and transparent. It hasn't been. We've heard today a lot about an advisory committee that was appointed. Mr. Chairman, I would suggest to you there's a whole lot of difference between listening and lecturing. And I'm not so sure that the advisory committee is advising as opposed to being advised.
We were thrilled to be told that EPA would fulfill its obligations under the law to prioritize and accelerate registrations of new, effective, economical crop protection products, something that hadn't been happening. And as you're aware, and as Mr. Smith pointed out earlier, that's not happening. We're not getting new registrations.
EPA has ignored its responsibility to facilitate those registrations, particularly on the minor crops, which aren't very minor in my area. They're the high value crops.
Last, the ag community and members of Congress were repeatedly reassured by EPA that FQPA as merely a codification of the law that existed at the time. Perhaps this is our greatest source of and sense of betrayal. Our concerns have been outlined by the earlier speakers today. They're in my written testimony.
I would close by saying that, Mr. Chairman, the actions that have been talked about here today are well intentioned. We don't question the intent of those involved. We do, however, question the outcome. We have many farmers who are at-risk. I farm in an area right across from the Mexican border. Sixty-seven percent of the farmers in my county have now gone into Mexico and developed satellite operations just in case. I hope that just in case doesn't happen.
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Thank you for this opportunity to address you.
[The prepared statement of Mr. Evans appears at the conclusion of the hearing.]
Mr. GOODLATTE. Thank you, Mr. Evans.
I'm particularly pleased to welcome Mr. Daniel Shreckhise of Shreckhise Nurseries in Grottoes, VA. He has a beautiful facility there between Grottoes and Weirs Cave that I enjoy driving by and seeing. And I welcome you today, and glad you could make the short trip up the Shenandoah Valley to join us.
STATEMENT OF DANIEL SHRECKHISE, VICE PRESIDENT, SHRECKHISE NURSERIES
Mr. SHRECKHISE. Mr. Chairman and members of the subcommittee, thank you for the opportunity to share my concerns as a nursery farmer regarding the implementation of the Food Quality Protection Act.
I'm not accustomed to sitting in meetings like this during the day. And after being here today, I have a deeper appreciation for you and your tolerance level. [Laughter.]
Shreckhise Nurseries is a wholesale nursery operation located in the central Shenandoah Valley of Virginia, within the bounds of August and Rockingham counties. We produce woody trees and shrubs, field-grown and in containers, for garden center and landscape customers in the mid-Atlantic region.
My comments also reflect the concerns of the American Nursery and Landscape Association, our national trade association. ANLA represents 2,700 growers, landscape firms, retain garden centers, and the 16,000 additional family farm and small business members of State and regional nursery and landscape associations.
According to USDA, the nursery and greenhouse industry is the fastest growing segment of American agriculture. Over the last 25 years, our industry's crop value, as a percentage of all agricultural crops, has increased from 4.1 percent to 11 percent. Our industry ranks as the third largest plant crop behind corn and soybeans, yet ahead of wheat, cotton, and tobacco.
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In Virginia, we rank as the No. 2 plant crop. The Virginia Department of Agriculture and Consumer Services conservatively estimated the value of Virginia's nursery industry at $155.3 million in 1996. As with other types of crop agriculture, the growth and success of my business depends on my ability to effectively manage insects, diseases, and weeds. In fact, our industry faces some unique challenges in this area.
First, consumers expect high quality, pest-free plants and flowers. A pest infestation can quickly ruin a crop, with no recourse for the grower.
Second, Federal and State agencies regulate nursery plant shipments to minimize the spread of harmful plant pests like the imported fire ant and gypsy moth. In most cases, regulations require that plants are virtually free of plant pests. In quarantine situations, absolute freedom from pests is mandated. The material and labor cost of making pesticide applications, regulatory requirements associated with worker protection, and stewardship goals are driving nursery and greenhouse growers to effectively pursue integrated pest management programs. Tactics we use in IPM programs include selection of pest resistant varieties, cultural controls, and judicious use of pesticides. We're trying to use the generalist products with the shortest re-entry intervals possible.
Still, many of the pesticides being reviewed first under FQPA are critically important tools. They are used in IPM programs to manage the resistance or to clean up a problem only when other tactics fail. Sometimes their use is mandated to meet a specific plant pest quarantine requirement.
You may wonder why our industry is concerned and watching carefully how EPA implements the Food Quality Protection Act. We are not growing bearing edible food crops, and so we are not affected directly by dietary tolerances. Yet, we are a textbook example of a minor use crop. The high cost of testing, registering, and marketing pesticides for our industry, plus the perceived liability for any damage of our high value crops, deter many pesticide companies from labeling products for our use. Often new pesticide products are registered last or never for uses like ours.
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Our industry strongly supported the Minor Use Regulatory Relief and Incentives in the FQPA, but now we are wondering if the potential benefits of the minor use amendments will really happen, with all the focus on tolerance reassessment.
EPA officials have stated to growers to non-food crops that industries like ours will not be directly affected by FQPA implementation. Based on past experience with other regulations, we are not so sure. If EPA uses unrealistic, worst case assumptions in the risk assessment process and overblown estimates of real risk force many food, home, and landscape uses off a given pesticide label, product registrations may not be kept for only a few uses such as ours.
Also, formulators and distributors maintain many nursery and greenhouse use labels. If the risk cup is overflowing for a pesticide or a group of pesticides considered together, what is the likelihood that distributors and formulators servicing our industry will be able to stay in the game?
Mr. Chairman, EPA must implement FQPA in the manner in which we believe Congress intended. The following specific issues must be addressed as EPA proceeds with the implementation process:
First, the agency must use some good science and reliable world information. For other uses other than food uses, we understand that the law clearly requires EPA to use reliable information. If such information doesn't exist now, the agency should compel the development and submission of such information.
In the interim, EPA should not use unrealistic and unreliable assumptions in its decision making process. The implementation process must allow for information to be collected rather than using worst case assumptions that overestimate risk.
Second, growers and other users must have a seat at the table and input into the process early enough to refine actual use and usage information, recommend measures that will reduce theoretical risks to an acceptable level, and prepare, where necessary, for an orderly transition to other tools or practices.
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Third, there should be no surprises. EPA's decision making process must be clear and understandable to those who will be affected. This may mean that the approaches to some of the most controversial or complex issues should be published for public review and comment.
Finally, many of the pesticides scheduled first for review have important and food and non-food uses. An abundant and safe food supply is in the public's interest. Also, many non-food uses offer both producers and the general public many benefits. All uses affected by the FQPA tolerance reassessment process should be considered on equal footing and with equal opportunity for information collection and risk reduction strategies where needed. New product registrations and new uses of existing products must be handled efficiently as well.
A coalition of farm, food, pest management and manufacturing organizations, known as the FQPA Implementation Working Group, has developed a roadmap document that offers a framework for fair and reasonable implementation of the law. This roadmap offers a great opportunity for discussion of key implementation issues with EPA.
We hope that in a decade or so, we will agree that FQPA was achieved—achieved what was intended: Confidence in a safe, wholesome, and abundant food supply in a way that is fair and least disruptive to U.S. growers and other pesticide users. This will only happen if implementation proceeds with clear and understandable processes using reliable and available information, and with ample opportunity for user involvement.
Mr. Chairman, thank you for this opportunity to express my thoughts, and those of my industry, on food quality protection implementation.
[The prepared statement of Shreckhise appears at the conclusion of the hearing.]
Mr. GOODLATTE. And thank you.
Mr. Lovelady, welcome.
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STATEMENT OF BILL LOVELADY, NATIONAL COTTON COUNCIL
Mr. LOVELADY. Thank you, Mr. Chairman, and thank you for calling this hearing on this very important item. Thank you for the opportunity to present my testimony. I have presented written testimony, and I will give an abbreviated oral version today.
My name is Bill Lovelady, and I'm chairman of the board of the National Cotton Council. And I'm a cotton producer, and I'm a pecan farmer in Tornillo, TX, near El Paso. I'm currently serving as the Nation Cotton Council's representative on the TRAC. Cotton has perhaps been the commodity that most affected by EPA's implementation of the Food Quality Protection Act.
Agency actions have alarmed cotton producers and have seriously challenged their confidence in the agency's pesticide registration process. In February of 1997, cotton belt states filed emergency exemption applications for use of carbofuran for aphid control in cotton. Though the product manufacturers submitted a full section 3 application 24 months earlier, in March 1995, the agency had not yet acted on it. After numerous requests from the agency for more information and more refined risk assessments from the registrant and several meetings with cotton producer representatives, EPA denied section 18's in July of that year. Beyond the critical timing problem this caused, the mechanism for making the decisions was and still is confusing.
Carbofuran was deemed to be unsafe of a 20-year-old database of residues in drinking water and because of a newly applied and incorrect, overly conservative margin of safety. As best we understand, the detections of concern in drinking water occurred before 1980, in the northeast, far from the Cotton Belt. And it was for a different formulation of carbofuran that was currently being applied in cotton.
While the registrant was setting the record straight on the water issue, EPA then surprisingly denied the petition based on a need to set a residue tolerance on gin trash, which is a cotton processing byproduct. Using the drinking water database, the carbofuran risk cup was exceeding, and FQPA, according to agency attorneys, will not allow a new tolerance to be set. Well, we objected to this new requirement since tolerances existed for cotton, food, and feed products—cotton seed, cotton seed meal and hulls.
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Further, the States offered to include a gin trash feeding restriction as part of the section 18 label. None of the attempts to address this concern were acceptable to the agency. And as mentioned earlier, Texas and Oklahoma finally had not choice but to use FIFRA State authority to allow use of this critical product. The State actions averted a near disaster aphid problem in Texas and Oklahoma last year.
Unfortunately, the concern over the agency's decision making was not alleviated this year. Though the agency issued the emergency use for Texas in mid April and other States subsequently, an unnecessary restriction related to the soil type added to the last minute on the initial label that would have disallowed the use on about 95 percent of the cotton acreage.
Equally troubling was the manner in which the tolerance extension decision for a herbicide, bromoxynil, used on genetically modified cotton seed called BXN was handled by the agency. With the advent of BXN, which is a bromoxynil tolerant plant, producers are able to use post-emergence herbicides sprayed over the top of cotton plants, rather than more traditional strategies of directed chemical applications, cultivation, and hand hoeing. The most concerning aspect of the decision to deny the tolerance extension late last year was the change in EPA policy that it represented. In the denial letters sent to cotton farmers and the product manufacturer on December 24, 1997, incidentally, Merry Christmas, Dr. Lynn Goldman indicated that she could not make an FQPA safety finding of reasonable certainty of no harm, because the need to apply the additional ten-fold safety factor allowed by law. However, in extending the temporary tolerance seven months earlier, the agency outlined why the additional 10X safety factor was not necessary.
Although the tolerance has been reestablished, as a result of additional data being revised subsequent to the denial and revised risk assessment, it cost the company that produces BXN's cotton seed at least $5 million. And it caused great uncertainty for cotton farmers, for cotton seed processors, and for State regulators.
The cotton producers are very concerned that such confusing and inconsistent application of the statute will lead to unnecessary loss of crop protection tools. As others will outline in their testimony, loss of the products could have dire economic and public benefit consequences.
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For instance, the product crucial to the Beltwide Boll Weevil eradications programs is the OP insecticide malathion. If we lose it, it would cripple our efforts to eliminate a pest that came close to ending cotton production in the southeastern part of the United States. In the States of Georgia, South Carolina, North Carolina, and Florida, cotton production has increased drastically since the weevil has been eradicated. And as a result, total insecticide use has been reduced from 50 to 80 percent. And rural economies have been revitalized.
With the other serious financial and economic problems that are facing our industry at the present, we simply cannot lose the ability to eradicate the boll weevil, and to do so would export a significant part of a $50 billion industry.
I'd like to just briefly mention the roadmap that was mentioned before me. After our experience last year, the Cotton Council became active with the National Food Processors, the Minor Crop Farmer Alliance, American Protection Association, and others through the implementation of a working group to make recommendations to EPA and USDA regarding FQPA implementation. This working group is a broad coalition of farm, food manufacturing, and pest management organizations. And last week this roadmap was released and I would like to submit a copy of this roadmap for our record.
Mr. GOODLATTE. Without objection.
[The information appears at the conclusion of the hearing.]
Mr. LOVELADY. Thank you.
The roadmap is a consensus document which demonstrates a widespread desire in the user community to work constructively to ensure the regulatory process of administrating FQPA inadequately protected. It's consistent with the statute and it allows domestic producers to continue to provide and affordable supply of food and fiber and other agricultural products. We also knowledge the attention this matter was given by the Vice President in his April directive.
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Congressman Berry and Congressman Stenholm both deserve a lion's share of credit for focusing the administration's attention on this critical issue.
Finally, we believe whatever regulatory policy related to critical issues, such as aggregate risk assessment and application of the additional 10X safety factor EPA adopts, it must be vetted through a formal notice and comment policy process. Transparency in this form is critical before confidence is restored in the process.
Thank you very much for this opportunity to present this testimony.
[The prepared statement of Mr. Lovelady appears at the conclusion of the hearing.]
Mr. GOODLATTE. Thank you. For the purpose of introducing our next witness, I would like to yield to the gentleman from South Dakota.
Mr. THUNE. I thank the chairman for yielding, and want to welcome to our panel today a gentleman from home State, who serves as the chairman of the South Dakota corn growers and is also vice chairman of the National Corn Growers Association's Public Policy Action Team. He has appeared in front of our Ag committee in the past, does an outstanding job of representing the people—corn producers in South Dakota, as well as having his own farm operation near Dell Rapids. So we look very much forward to hearing from Mr. Mike Randall.
STATEMENT OF MIKE RANDALL, CHAIRMAN, SOUTH DAKOTA CORN GROWERS ASSOCIATION
Mr. RANDALL. Mr. Thune, thank you. Mr. Goodlatte, it's an honor to be here. My name is Mike Randall. I farm near Dell Rapids, and I also am involved in South Dakota Corn Growers, as Mr. Thune mentioned, and the National Corn Growers. It's great to be here. Also representing the American Soybean Association today as I share my thoughts.
The National Corn Growers Association supported the Food Quality Protection Act when the law was passed in 1996. And we remain committed to that law. NCGA does, however, remain concerned about the manner in which the Environmental Protection Agency and the United States Department of Agriculture are implementing the FQPA. We are very concerned about EPA's failure to register new products in a timely manner, and the lack of transparency in the implementation process and the virtual embargo of new registrations are the cause of our concerns.
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To more clearly articulate our concerns, farmers, farm and food groups, pest management and manufacturing organizations formed the Implementation Working Group, IWG. NCGA is a primary sponsor of IWG's framework for implementing the FQPA or the roadmap, which has already been referred to. This document provides a series of workable recommendations for implementing the laws and represents the consensus of a variety of affected parties as to how we believe the FQPA can be implemented fairly and effectively.
We believe that the EPA simply needs to follow our roadmap to achieve implementation success. When using various crops protection measures, farmers take into account many different elements including choice of crop, seed technologies and products, soil, climate, rainfall, historical weed and pest pressure in the field.
These same elements influence my decisions on pre-emergent and post-emergent application of crop protection tools. The application of any pesticide is done with great analysis of each aspect of these elements for optimum crop yield and most importantly cost. Growers seldom apply the maximum application dose at the maximum application rate for the sheer factor of cost.
Corn growers are the largest users of organophosphates in the agricultural community. According to Mr. Leonard Gianessi's data, 68 percent of the corn acres treated with pesticides are treated with OPs. Let me make myself clear. We are not only concerned about the reassessment of OPs, we must have a roadmap to implementation that is transparent, reliable, and repeatable.
What type of process is being defined now that will carry over to the reassessment of the remaining two-thirds of products after 1999? The need for a clearly defined tolerance reassessment process reaches far beyond the reassessment of organophosphates, carbamates, and pyrethroids. It is essential to define this process for the public to understand the criteria used to assess risk and how reassessment decisions are reached.
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EPA must use accurate scientific data, not unreasonable default assumptions for decisions during tolerance reassessment. We want to ensure that the EPA is cognizant of current production practices and modern farming methods regarding use of these chemicals as their decisions are being made. Do not let these products be lost for failure to recognize realities of production agriculture.
As the August 1999 deadline approaches for the reassessment of the first third of the products under the FQPA, NCGA is very alarmed that corn growers are failing to see the registration of new products for corn that meet the new scientific requirements of the law. NCGA is concerned that adequate resource allocation within EPA is not being given to the registration of new products during the implementation of the FQPA. Given competitive, equally efficacious crop protection products, farmers like myself will always chose the safer product.
If corn growers are not provided sufficient options for crop protection, U.S. corn production will be at a competitive disadvantage. In 1996, the NCGA supported the Federal Agricultural Improvement and Reform Act.
Mr. GOODLATTE. Mr. Randall, let me ask you to suspend for just a moment. Unfortunately, we have some votes pending on the floor that we have about seven minutes to go cast, and so Mr. Thune and I are going to have to do that. So the committee will stand in recess. We'll pick up in the middle of your testimony when we come back, and we'll give you full opportunity to complete it. There are four votes, as I understand it, so we may be a little while. It probably will be at least 20 or 30 minutes before we get back here. So the committee will stand in recess.
[Recess.]
Mr. GOODLATTE. The committee will come to order and Mr. Randall will resume in mid-sentence.
Mr. RANDALL. Does that mean I get to start back over on the green light, or am I on the red one?
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Mr. GOODLATTE. We're going to give you time to finish, in fairness to you.
Mr. RANDALL. Very good. If corn growers are not provided sufficient options for corn production, United States corn production will be at a competitive disadvantage. In 1996, the NCGA supported the Federal Agricultural Improvement and Reform Act to transition from supply management farm programs to a market-created farm economy.
The FAIR Act allows me the flexibility to grow crops that make conservation, production, and economic sense for my land. To do so, the United States farmer needs to have the regulatory process to support an environment of product choice based on sound science and realistic agronomic practices.
If other countries can produce and transport corn at lower costs than the United States, we have the potential to lose our export markets and may suffer domestic market disruption.
Mr. Chairman, I thank you for holding this oversight hearing today and providing this forum for agriculture to voice our concerns over the implementation of the Food Quality Protection Act. NCGA will continue to work with EPA and USDA and through public forums to ensure that the impacts of this law on production agriculture are fully realized.
We believe that the IWG has developed a very balanced and workable implementation document in the road map and would urge the EPA to seriously consider following the recommendations in this document.
With transparency during the implementation of the law, use of reliable information, and taking into account how this law impacts agriculture, alterations in farming practices, actual pesticide use, and the need for new products, FQPA will meet the goals set by Congress.
Just as a little addendum, I guess I would just like to mention that about 48 hours ago right now, I was out in the township in which I reside with about 23 other farmers, and our local extension service had pulled us together because the grasshopper population was getting rather dominant in certain areas in South Dakota. And needless to say, it is to the point where we have to do something about it.
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Right now, we have those tools available to us. If the economic threshold is there and we determine that we need to do something, the tools are there for us to do something about it. And I would just hope that we will continue to have that option when necessary in the future.
Thank you.
[The prepared statement of Mr. Randall appears at the conclusion of the hearing.]
Mr. GOODLATTE. Thank you, Mr. Randall.
Mr. Gianessi, welcome.
STATEMENT OF LEONARD GIANESSI, SENIOR RESEARCH ASSOCIATE, NATIONAL CENTER FOR FOOD AND AGRICULTURAL POLICY
Mr. GIANESSI. Thank you, Mr. Chairman. My name is Leonard Gianessi. I am a senior research associate at the National Center for Food and Ag Policy, a small non-profit research group here in Washington.
For the past 18 months, I have been working on a project funded by EPA and the Department of Agriculture to collect information on how organophosphate insecticides are used in the United States. You have heard a lot about the OPs today. They are the first set of pesticides to feel the full brunt of FQPA.
We worked with 43 commodity organizations around the country collecting information and their views on the uses of these compounds. What I would like to do is summarize what we learned from those organizations, and I would also like to react a little bit to what I have heard from other witnesses today.
First, many commodity groups are concerned that they have no alternatives or very inadequate alternatives to current usage of organophosphates, and if the EPA were to ban these chemicals that they would suffer some serious yield losses because of their inability to control insects.
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Peanut growers in Virginia, North Carolina; Texas citrus producers; Maine and Michigan blueberry growers; cherry growers in Michigan; just about every crop grown in the United States has a key use of one of these compounds that would be sorely missed.
Second, many commodity groups reported that although effective alternatives—we've heard a lot about how alternatives exist for many of these products—the use of the alternatives might not be desirable because they would negatively affect integrated pest management programs. And I think Dr. Whalon has referred to this problem. Right now, we are managing some pests biologically in concert with the organophosphates. Sure, there might be alternatives to the OPs, but they would negatively affect, they would kill the beneficial organisms.
Third, several groups reported that the OPs are the only compounds that they have that give them effective control of mycotoxins in foods. Peanut growers, pistachio growers, almond growers all use organophosphates to control the insects that spread aflatoxin. And as a result, they are very concerned that if they were to lose those compounds, they might lose control of that mycotoxin.
Finally, many commodity groups are concerned that indeed new products might be registered. We have heard discussion today about how EPA will register new, safer alternatives. One of the concerns is that the new product will cost more, a lot more than the currently used organophosphates.
The OPs are used on about 50 million acres in the United States. Many of the new products might cost between $10 and $20 more per acre for farmers to use. We are talking about an increased aggregate cost of maybe between $500 million and $1 billion a year in terms of increased expenditures for insecticides. That is a significant regulatory action.
And you know what? There may not be alternatives developed for many organophosphate uses. There are about 500 uses of these compounds. They are used on 70 different crops. It is very complicated to do research and find effective alternatives. We heard today from the Department of Agriculture that they are just beginning to identify the research areas that they want to go into looking for alternatives. No assurances can be made at this point that effective alternatives will be found for any of the current uses.
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EPA has decided to fast-track registrations of alternatives to OPs. This isn't the first time the agency has had this kind of strategy. Back in 1989, the Agency indicated that they wanted to fast-track alternatives for rice water weevil control. It took nine years to find a replacement for that particular pest. Now we are looking at 500 different uses and 70 different crops.
We heard reference today to the IR–4 program and how the IR–4 program would get this responsibility of finding registrations for minor use crops. What wasn't mentioned in the testimony is that there has been almost a complete shutdown of the activities of the IR–4 program because of FQPA uncertainties.
In a normal year, that program comes in with about 100 or 150 full registrations approved by EPA. Last year, they got one. They got one registration approved for a minor use crop because of FQPA uncertainties on all the other petitions that were submitted.
EPA has not proposed to cancel any uses of organophosphates, although the Agency earlier this week released some preliminary risk calculations that showed that there may be excessive dietary risk for some of these compounds.
And Federal officials have warned growers that some organophosphate uses will have to be cancelled. And I think we heard Mr. Hansen here today repeat that. No one knows how many. No one knows which uses will be kept or would have to be cancelled.
We heard today this idea that EPA and the Department of Agriculture and commodity groups will work together to preserve the vital uses. But as Jean-Mari Paltier pointed out, it is going to be the final decision of ag chemical manufacturers as to which uses they keep or drop.
And the idea that the ag chemical industry would keep the vital uses, keep their plants operating to meet these uses, as you heard from the nursery industry today, that may simply be a pipe dream. It may no longer be economically viable for agricultural chemical companies to make these products for vital uses in the United States if FQPA takes away most of the market for their products.
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And this has already happened. One organophosphate has already been voluntarily cancelled, and as a result, mint growers and other specialty crop growers in the Willamette Valley of Oregon have been left with no alternatives. Potato growers in Pennsylvania have no alternative to control a serious pest. How was this allowed to happen if the needs of agriculture are going to be taken care of under FQPA?
All the grower organizations that we work with were very forthcoming with information. They want to work with the Agency. I think it is certainly everyone's hope that EPA will be able to collect enough information to make realistic risk-benefit estimates for these products.
[The statement of Mr. Gianessi appears at the conclusion of the hearing.]
Mr. GOODLATTE. Thank you, Mr. Gianessi.
The gentleman from Michigan, Mr. Smith.
Mr. SMITH of Michigan. Mr. Chairman, first, let me thank all of this panel for your patience and endurance in what is a normal day for most of us in Congress, jumping from one thing to another. Dr. Whalon, it was interesting in your testimony, you say that many organic minor crops are produced with pesticides and with most of, with a lot of people in this country thinking that somehow the organic developed food is somehow more wholesome, more safe, I thought it was very interesting that you related the fact that there's a lot of, there's a greater pesticide burden sometimes in the organically produced food and I would, maybe you would consider giving us some examples of what you mean.
Mr. WHALON. Thank you. In different cropping areas, because of environmental conditions and pest pressures and even pest complexity in terms of the number of species that are there, the number of generations they have, and the number of imported pests that occur in a particular region, there are different regional and even local pest pressures and situations. In the case of organic production, I think that there's a general perception in the American public that organics do not use pesticides. This is not true. Organic production uses pesticides and in the humid northeast and southeast, organic production uses much more pesticide than conventional production systems. Hundreds of pounds more than does something like biointensive integrated pest management. So for a specific example, we could turn to apple production in the northeast where hundreds and hundreds of pounds of sulfur and lime and copper are used to control fungi and bacteria in apple production and pounds and pounds of fish oil and emulsion products and natural pesticides are used. These toxicants have effects on humans as well, I mean, some of these toxicants are fairly dangerous. And yet, I think the perception is a false one that pesticides aren't used on organics, they are at high rates.
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Mr. SMITH of Michigan. Thank you. I'll ask you the same question I asked the gentleman from EPA and that is that the fruit and vegetable imports from foreign countries have increased by 38 percent since I think the late 1980's or early 1990's. With FDA only inspecting 3 percent, what do you see is the prospects for increased imports and the danger of FQPA unauthorized pesticides being used on more and more of those fruits and vegetables and horticultural goods that we import?
Mr. WHALON. Well I think that it's really true that we can mitigate organophosphate residues on a lot of products today, through extending the PHI or the pre-harvest interval, through decreasing the frequency and the rate of use, through using alternate row spraying techniques or spot spraying using precision agriculture, using row or border spraying strategies, we can very much reduce, at times, the input of organophosphates into agriculture. In addition, to these examples, there are techniques that could be used in processing. All of these by the way increase the risk of damage to the crop, and also increase the cost at times. Also in the processing side of things we can sometimes use chlorine or ozone or other kinds of enzyme washes to remove residues from treated crops, and in so doing we can produce no or very, very, very low residues, even undetectable residues on produce. The problem with FQPA is that we may not have a chance to do that. FQPA could cause the loss of OPs before farmers, the farm community, the research community and the processing community could mitigate residues in which case they would be banned here in the United States but those same products could be used overseas. In other words, in New Zealand one could produce apples with OPs and remove the residues and export them to the United States, thus allowing them to use a very significant tool to fight pests, whereas American farmers would have their hands tied and not be able to use those compounds.
Mr. SMITH of Michigan. And just maybe a last question, you emphasized that organophosphates and the carbamate and the other B2 residues could be substantially or completely mitigated how?
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Mr. WHALON. Well, they can be mitigated through changing use patterns. We already know and have data, for example on several crops in Michigan that one could use these compounds in a different way earlier in the season, not later in the season. The problem that occurs, though, is that many growers don't necessarily want to use these kinds of pesticides, but they're forced to. They're forced to by quality standards and by state mandated standards, and by processor enforced standards for quality. And we have no other tools that can deliver that same level of quality today. So growers are caught in a pincer movement, really. On the one hand there are legal requirements for quality, on the other hand, there are no tools available, what are they going to do, so in those situations there are no alternatives.
Mr. SMITH of Michigan. Mr. Chairman, my red light's on. Well, I think maybe a couple more, any other comments from any of the other panelists in this area?
Mr. LOVELADY. I would like to make a comment about, you all heard about zero detect, how when there is a zero detect of these residues that they go back to half of the detectable level. But one thing that has not been mentioned here is that when FDA checks the residue on that 3 percent of those imports, zero does mean zero to them. Now that may sound like a small item, but that is definitely a competitive disadvantage to the American producer, because zero detect doesn't always mean zero for us, but it always does for those products coming in to the United States.
Mr. SMITH of Michigan. Has Texas or Purdue or Michigan or anybody else done studies in terms of, I mean certainly our economic departments or somebody in the industry knows the margin of profit and how vulnerable a less effective pesticide might be in terms of whether that farmer can stay in business, or if they weren't able to use organophosphates, how many farmers would go out of business, how many apple orchards would go out of business in Michigan if EPA decided next year that you couldn't use organophosphates?
Mr. WHALON. I'll take a first crack at it, and then Len, maybe you could mop up. I'll just give you an example from peaches because it's on the top of my head. The use of organophosphates in production of peaches in Michigan costs about $68 a year to get complete control of lepidopterous pests and several other pests in peaches. When we go to a biointensive integrated pest management program which includes pheromones and growth regulators, including some of the new compounds that EPA is fast tracking through for registration, when we go to that kind of production system, we are looking at about $160 an acre for the same production quality and the same control.
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We've also done experiments with biological control. The cost of using biological control is about $300. However, we can't meet the quality standards and we lose about 28 percent of the crop annually using the biological control approach. So you can see a very dramatic economic cost increase, and generally in the past, OP and other chemical use in apple production in Michigan's been about 17 percent of the overall cost of production. As we look at these other systems costs, it could reach up into 30, 35, 40 percent of the cost of production and make growing crops in Michigan unprofitable.
Mr. SMITH of Michigan. Mr. Gianessi.
Mr. GIANESSI. Yes; thank you. What we've found is that there are very few studies that look at the loss of all of the compounds in a particular class. Generally, the way regulation had proceeded in the past was to look at one chemical at a time and now growers face the possibility of losing all the chemicals in a certain class. I have an attachment to my testimony today where I do review a couple of studies that the Department of Agriculture released in the last several years for asparagus and cranberries. The Department of Agriculture released a study that said that the loss of a key organophosphate would result in the total collapse of the California and Washington asparagus industry. For cranberries, if you look at all the organophosphates that are used in cranberries, they've referred to the remaining insecticides not as effective. At least half of the crop would be lost to direct pests alone in the first year in east coast beds.
So there haven't been enough studies for as many crops as we'd like, but certainly the couple of studies that have been done indicate the importance of these compounds for horticultural crops. And I think you'll see more studies like that.
Mr. SMITH of Michigan. One last question, and it probably shows my ignorance in the area, but it seems like organophosphates as a component in a lot of these pesticides has lasted a long time. With pest resistance to the different biological pesticide control, what are the implications of FQPA in terms of insecticide or resistance that build up to these other new pesticides?
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Mr. WHALON. Again, I think I could address that because I chaired an international organization for pest resistance management and I have worked in resistance management for many years. It appears to me that as we remove tools like broad spectrum organophosphates, carbamates, B2 fungicides—as we remove these broad spectrum compounds that can control many different pests—and move into an era where we've got specific compounds that have less mitigating effect on the environment, perhaps. These compounds are at greater risk for resistance because there are fewer compounds available, fewer tools available, and organisms can mount up more of their evolutionary ability or capacity to develop resistance.
We've seen this happen in various production systems. For example, potatoes in Michigan and on Long Island this past season, or this current growing season, where organophosphates were completely eliminated by one of these new or better compounds that is more specific. We see resistance growing very rapidly in Colorado potato beetle. And in fact this year on Long Island there is in some fields, crop failure as a result or at least control failure as a result of resistance development in just 3 years to one of these new compounds.
Mr. SMITH of Michigan. Mr. Chairman, thank you, and I'm going to ask to be excused to attend my 2 o'clock meeting. [Laughter.]
Mr. GOODLATTE. The gentleman is excused and we'll be happy to write him a note too, if he needs it. [Laughter.]
Mr. Shreckhise, how many different plants do you grow at your nursery?
Mr. SHRECKHISE. On our production facility we're growing about 250 different varieties of plants.
Mr. GOODLATTE. And how many different pesticides do you utilize in that——
Mr. SHRECKHISE. Presently we're using about 20 different pesticides. In an operation like ours that's not unusual, but in a larger operation—we're relatively small—in a larger operation you could expect that to be doubled, with larger varieties of plants being grown, a larger number of varieties.
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Mr. GOODLATTE. And what's involved in transitioning to a new pesticide or pest management strategy when one's knocked out?
Mr. SHRECKHISE. Well, it's hard to start with a new pesticide on your entire crop, because you run the risk of not being able to have the control that you're looking for so therefore you try to use new chemicals on a limited basis at first and expand that over a couple of seasons of growth to see how that chemical's responding for you. We wouldn't want to go completely to a new pesticide at one time, because you could always risk crop failure with that, as were being referred to on Long Island right now.
Mr. GOODLATTE. And what kind of transition time would be required?
Mr. SHRECKHISE. Most of the time we see new chemicals being available for the major row crops long before they're available for the nursery industry because of the amount of that chemical we may use. So oftentimes it's going to be several years before a chemical that's available for other agriculture crops to become available for use in the nursery and greenhouse industry. And then it goes back to what I was mentioning earlier, it takes us several seasons of testing to determine whether that product is satisfactory.
Mr. GOODLATTE. And you mentioned quarantines for plant pests. Are there any special problems or concerns of pesticide use for certification purposes?
Mr. SHRECKHISE. Well, for our products to be certified for transportation from State to State, they have to be certified relatively free of pests. In quarantine situations—and I'm real fortunate in the area where I am because we're not really faced with quarantine situations—but if you look at the nursery growers from North Carolina south into Texas, especially with the fire ant, those products have to be certified pest free, not relatively pest free, but pest free, and oftentimes the State agencies specify certain chemicals to be used. And if these chemicals are lost, if these pesticides are lost, then it's going to take probably several years for new pesticides to be tested to be able to be certified, that these plants can be certified as being pest free.
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Mr. GOODLATTE. Mr. Lovelady, in your view, what is the usefulness of the EPA/USDA tolerance reassessment advisory committee, and what should be the outcome?
Mr. LOVELADY. Well, I would hope the outcome would be that they would take our recommendations, but the TRAC, I think it's been a good exercise, and it has been invaluable in focusing attention on the problems that the EPA has had with implementing the FQPA. But I would hasten to add that nothing is going to take the place of a good formal process that allows plenty of opportunity for public review, comment and review. And I would hope that the major portions of the roadmap will be implemented and would be considered in the implementation. I think that that will be invaluable. It does provide for plenty of transparency for good science. It's balanced and it's workable. I would hope that the major points of that roadmap would be included in the implementation.
Mr. GOODLATTE. Getting to the specific problem that cotton growers have experienced, how were farmers notified that Furadan was canceled?
Mr. LOVELADY. Well, Furadan received a section 18 and then they were notified on Christmas that they just didn't renew it. We since have received a section 18, but it took a long time to get it.
Mr. GOODLATTE. Can you give us an idea in months when they were notified?
Mr. LOVELADY. When was it? Yes, it was 5 months. The States applied for this emergency provision and it was 5 months after that, it was well into the season when they were told.
Mr. GOODLATTE. How did it affect planting decisions?
Mr. LOVELADY. Furadan, or carbofuran, is a very important followup on boll weevil eradication and because you can get a secondary pest, the aphid is a secondary pest, as a result of that, and carbofuran is the only thing that really adequately controls it; something that the farmers can afford as far as price and efficacy. So, if you had an opportunity to plant some alternative crop in those areas, you probably would consider that rather than planting the cotton, because you wouldn't know whether you were going to be able to take care of that secondary pest. It creates terrific quality problems with your product.
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Mr. GOODLATTE. In your testimony on carbofuran you mentioned that the drinking water data exceeded the risk cup. Where did they get this information?
Mr. LOVELADY. Well, that came from the northeastern part of the United States, and it didn't have anything to do with the cotton belt. And we were even told by members of the agency that that was not a consideration, but since the risk cup was already full, even though it didn't apply to us, they couldn't issue a new tolerance.
Mr. GOODLATTE. Potomac cotton, is that one?
Mr. LOVELADY. I think it was even further north than the Potomac. We're not very far from the Potomac with cotton production now.
Mr. GOODLATTE. Were you surprised that the agency attorneys didn't set a new tolerance?
Mr. LOVELADY. I don't know whether I would say surprised is the word I'd use, but we had good science and we even had tolerances for some of these products for cotton seed and cotton hulls and meal, and yet we were not allowed to use it on this. It seemed kind of contradictory, but I don't know whether I would use surprised as the word, the whole process was very confusing and we were sort of used to having the rules changed in the middle of the process.
Mr. GOODLATTE. Thank you. Mr. Randall, did the agency ask for the roadmap or is this a proactive measure taken by the user community to try to inject themselves into the pesticide registration process?
Mr. RANDALL. My assumption is that it would be proactive.
[Mr. Randall responded further for the record:]
The road map was a proactive measure taken by the agriculture groups I mentioned earlier to prove a solution to what we felt was flawed implementation of FQPA. The document provides recommendations on implementation and provides scientific and legal papers supporting those recommendations.
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Mr. GOODLATTE. When are your planting decisions made?
Mr. RANDALL. My planting decisions? Oh, several of them will be made yet this fall, especially in terms variety. In terms of herbicide decisions and insecticide decisions, probably after the first of the year, January. Some of them are not made until a bit later.
Mr. GOODLATTE. We've heard quite a bit today about the need for agriculture transition. If a tolerance for a common pesticide were revoked, how far in advance would you need to know?
Mr. RANDALL. I think it would depend on how many alternatives I have.
Mr. GOODLATTE. What if there were no alternatives?
Mr. RANDALL. I'd need some advance warning, needless to say. One of the things that I was just thinking as Dr. Whalon was commenting a little bit earlier. One of the things that we do with corn and especially in terms of insecticide is simply rotating, and we are fortunate enough to have enough where we can rotate. I can rotate and probably not have to use that one until maybe, even what, 4 years down the road, and still be comfortable with all the choices that I have at this point.
Mr. GOODLATTE. Has the EPA ever asked you or your organization for actual usage data?
Mr. RANDALL. Personally, I'm not, I can't say that they've asked me personally. I don't believe so.
[Mr. Randall responded further for the record:]
No, the EPA has recently given NCGA the data that they have on corn regarding OP use and usage and we are in the process of reviewing this material and would welcome any material we [sic] could provide. The material that EPA provided to NCGA was specifically requested by the association.
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Mr. GOODLATTE. You or the organization? To your knowledge? Mr. Gianessi, you've mentioned that you've submitted to EPA data regarding usage patterns for individual organophosphates on specific crops. Is this data nationwide or region specific?
Mr. GIANESSI. The commodity organizations represented particular states where a crop is grown, and so it was usually state specific information.
Mr. GOODLATTE. How will this data help the agency more effectively carry out tolerance reassessments?
Mr. GIANESSI. Well, we designed our information sheets based on what the agency said it needed. For example, pre-harvest intervals, when is the pesticide normally applied before the crop is harvested, is the pesticide applied 10 days before or 60 days before? It makes a difference in your risk calculations; if you assume it's 10 days before, you get more residue. So we ask the commodity organizations to tell us what the normal pre-harvest interval is, and that would be a piece of information that EPA could use to refine its risk calculations. We also ask them how many acres are treated, is it 100 percent of the acres or 3 percent, and so we got those kinds of pieces of information as well.
Mr. GOODLATTE. Considering all of its components, does the EPA currently have enough reliable data to conduct scientifically sound aggregate risk assessment?
Mr. GIANESSI. Well, the area that I work in, the pesticide use information area, my conclusion is yes, that there is between what the Department of Agriculture has done over the past 5 or 6 years, what the State of California has done with a full reporting service, and if the agency needs a good estimate for a crop, there are commodity specialists around the country that can provide that information as expert opinions. It's better than assuming 100 percent of the crop is treated. So in my area, yes, I think there is enough use data so that they don't have to use this 100 percent assumption.
Mr. GOODLATTE. In a worst-case scenario, let's imagine that all or most of the organophosphates were canceled. What would be the impact on U.S. agriculture?
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Mr. GIANESSI. It depends on the timing, right now the uses that we're looking at, there are very few alternatives to step in. If there is a transition phase, and let's say if that transition phase is 5 to 6 years, I think many of the groups will find alternatives, they will cost more. I think if you had to quantify it as I tried to do today it would be at least $1 billion for increased expenditures, if you will.
Mr. GOODLATTE. How would that affect our global competitiveness?
Mr. GIANESSI. Well, that's what happens when you look at that $10 or $20 per acre, for a pea and lentil grower, let's say in the Northwest, that just takes him right out of the export market, for example. That's the difference I think for many crops in terms of their profit margin.
Mr. GOODLATTE. There are some, particularly in the sustainable community who claim that there are alternatives for OPs. How do you respond to that claim?
Mr. GIANESSI. Well what we'd like to see is, we'd like to see each one of the 500 uses listed with what those alternatives are. I think it behooves those analysts to send that kind of information over to EPA. And they haven't done it yet. We have not seen, you know, for each one of those 500 uses what the supposed alternatives are, how much they cost, what are the efficacy, so that scientists around the country with land grant universities could review that. We just haven't seen it, we've just heard, as you say, blanket statements that these alternatives exist but they haven't done the work.
Mr. GOODLATTE. Thank you. Dr. Whalon, what research has or is being conducted to solve problems associated with IPM pesticide alternatives and resistance management?
Mr. WHALON. Well, I think that there's a lot of work going on in the land grant universities and in various USDA/RAS labs and in other agencies. I also think growers themselves are doing things on farm to solve problems. In the area of integrated pest management, integrated pest management is a complex integration of different strategies to manage pests below economic injury levels without having an impact on the environment, or as low as possible.
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Integrated pest management takes a lot of input. At a time when we've had static or declining resources in the land grant universities to support extension and to support research budgets, we're asked to step up to the plate and provide all kinds of alternatives. Although we may be able to do that in some large scale crops like corn and soybeans, in the minor crop arena there's a dearth of qualified individuals to develop IPM programs across the board. And then if you step into the green industries, and the nursery crops and things like that, it's even more scarce there. So relative to resistance management, there's a lot of interest in the area of BT resistance management as it relates to transgenic plants and recent resources available there. But generally, across the board, resistance management is an area that's very underfunded and very complex to deliver. So as I look at the overall area in terms of alternatives we've developed databases at Michigan State on minor crops for alternatives and I can show you that there aren't, in many cases, alternatives to the OPs. Not that we couldn't get them in time.
Mr. GOODLATTE. Have you done any studies or do you know of any studies that have compared the EPA's default assumptions for pesticide residues with real life residue data?
Mr. WHALON. Yes; we've looked at some of those situations in our fruit crops, especially.
Mr. GOODLATTE. How do those two methods compare?
Mr. WHALON. The residues that are actually on fruit crops in Michigan are about 10- to 20-fold, at least under default measures. Sometimes as much as 100 or even 1,000-fold under.
Mr. GOODLATTE. So real life is real life, huh? It's very, very different than some of the assumptions that are being made by the EPA?
Mr. WHALON. That's correct.
Mr. GOODLATTE. And you mentioned that the EPA should grant time limited tolerances, would you explain why you believe such tolerances should be granted and how you would envision such a system working?
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Mr. WHALON. Well, the reason I think that time limited tolerances are really important is that we need to give agriculture a chance to transition. Part of the problem with FQPA is that it seems like EPA has interpreted the statute to read that they need to make decisions, and those decisions for organophosphates and carbamates need to be done by August 3, 1999. That's not enough time to transition, that's not enough time even to get alternatives tested. Not enough time for growers to adapt. So a time limited tolerance would allow growers to transition, would allow the land grant universities and the USDA to develop alternatives and get them in place. I think that it's, time limited tolerance are going to need to be adjusted almost on a crop by crop, region by region basis, because the pest pressures and the circumstances of production vary clear across this country. Apple production in Maine is not apple production in Washington. The pests are different, the pesticides are different, the circumstances are different. So we're going to have to be a little more tailored if we want to address the true biology of this system, the true circumstances of the system.
Mr. GOODLATTE. Thank you. I want to thank all of you for helping to bring the real world to Washington, DC. [Laughter.]
I think that's badly needed, and your testimony today has been very valuable in setting the record straight in terms of what is needed from the Environmental Protection Agency regarding the implementation of this legislation which we were very, very excited about when we passed it a couple of years ago, and we want to be excited about it again, because it definitely was long overdue and replaced an antiquated law, but the proof is in the pudding, as they say, and here the proof is in what the EPA produces in terms of helping to assure that we can continue to have the safest food supply in the world at the most reasonable cost anywhere in the world. And the, I think, closing point to be made is that while we are all very, very concerned that no one, children or anybody be exposed to chemicals that are likely to cause them harm, we are equally concerned about making sure that we do not expose children to malnutrition, to the inability to get to an adequate source of food supply, which is the ultimate result of our moving away from using safe pesticides in agricultural production. If we do that, we will have a disaster on our hands worldwide of inordinate proportions and that, in my opinion, is the greatest environmental risk that we face. So I thank you all for your contribution and for your work in production agriculture.
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The Chair would seek unanimous consent to allow the record of today's hearing to remain open for 10 days to receive additional material and supplementary written responses from witnesses to any question posed by a member of the panel. Without objection it is so ordered. This hearing of the Department of Operations, Nutrition, and Foreign Agriculture Subcommittee is adjourned.
[Whereupon, at 2:50 p.m., the subcommittee adjourned subject to the call of the Chair.]
[Material submitted for inclusion in the record follows:]