SPEAKERS CONTENTS INSERTS
Page 1 TOP OF DOCREVIEW THE IMPLEMENTATION OF THE FOOD QUALITY PROTECTION ACT
THURSDAY, APRIL 22, 1999
House of Representatives,
Subcommittee on Department Operations,
Oversight, Nutrition, and Forestry,
Committee on Agriculture,
The subcommittee met, pursuant to notice, at 10:32 a.m., in room 1301, Longworth House Office Building, Hon. Bob Goodlatte, (chairman of the subcommittee) presiding.
Present: Representatives Pombo, Chambliss, LaHood, Moran, Walden, Clayton, Goode, Berry, Phelps, Hill, and Stenholm [ex officio].
Staff present: John Goldberg, Kevin Kamp, Brad Shurdut, Callista Bisek, Wanda Worsham, clerk; and Danelle Farmer.
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, Oversight, Nutrition, and Forestry 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 FQPA. This hearing continues the aggressive oversight of FQPA implementation this subcommittee started in the 105th Congress on June 25 of last year, and initiates what I am sure will be intensified efforts by this subcommittee in the 106th Congress.
Page 2 PREV PAGE TOP OF DOC By way of background, the process of regulating the use of pesticides was dramatically changed when Congress passed the Food Quality Protection Act in August 1996. The FQPA amended the Federal Insecticide, Fungicide, and Rodenticide, FIFRA, and the Federal Food, Drug and Cosmetic Act by significantly modifying the criteria for assessing and issuing pesticide tolerances. The process by which the FQPA amendments are implemented is of real interest to this subcommittee because it has the potential of bringing major changes to our system of food protection, disease control, and other public health programs. If not properly implemented, we could see a significant negative impact on overall nutrition, especially for children. Likewise, random and unjustified revocation of pesticide tolerances will wreak havoc in rural America as food production shifts to foreign countries.
I have called this hearing today at the request of Congressman Stenholm and Congresswoman Clayton, the ranking members of the full committee and this subcommittee, respectively. The frustration of this committee is bipartisan. 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.
For instance, we will hear today about the tolerance review of a specific ''OP,'' so I only reference it now, but it dramatically proves why we are so concerned by EPA's inability to establish a consistent process. Many stakeholders have told me that they are willing and able to submit accurate and actual data. EPA, however, either refuses to accept these data or refuses to tell the stakeholders what data they need.
If these complaints sound familiar, they are. They were a focus of the hearing last June. The only difference is now we have proof. In this hearing I hope to learn where EPA and USDA are in the implementation process. If there is a process, I hope the administration witnesses can assure this committee that it is fair and responsible.
Page 3 PREV PAGE TOP OF DOC In the interest of disclosure, I will not consider a process responsible if it doesn't take into account unintended consequences or potential negative impacts that could be avoided. This subcommittee is committed to science-based, accessible, predictable, and transparent regulatory process that assures public health and safety. Anything less violates the letter and spirit of the FQPA. It also puts our Government in the position of damaging the highly respectable position of American agriculture, both nationally and internationally, something that this subcommittee will not tolerate.
I look forward to hearing the witnesses' testimony today. We have assembled uniquely qualified witnesses that will provide insight into FQPA implementation.
At this time, I would like to recognize the ranking member of the subcommittee, 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.
I want to thank you for holding this hearing and think this is certainly an appropriate hearing, because we do have oversight over this important issue. More importantly, the implementation of the FQPA is so important, not only to the well-being economically of the agriculture industry, but also to the safety of food for children and consumers.
We are also interested to make sure that, as we approach this important issue, we are not suggesting by any means in calling this hearing or asking profound questions that the protection of public health is not a priority. There is no abrogation as to the priority of this. The protection of public healthparticularly of our consumers and our childrenis a priority. But that is not to suggest that, as we approach this worthy public policy, we should do it without having our decision based on reasonable, sound science. That science should be available. It should be reasonable. It should be understood.
Page 4 PREV PAGE TOP OF DOC Also, there are principles articulated in the memorandum that the Vice President had offered to both the agencies responsible for this. Those principles need to be adhered to. I want to just serve warning that I intend to be engaged with the agencies to make sure that not only the science is sound, it is the best and it is reasonable; the transparency is there; that we have a transitional period, and, indeed, that we do reach to make sure that the other participants in this whole implementation are trying to identify not only the pesticides, but new registrants, as we go forward in that.
The whole issue about having the opportunity for transitional period is a concern of mine. I hope that the witnesses will illuminate their particular agencies on that. The issue of having sufficient resources for the implementation and the registration of these new pesticides is another concern.
All in all, I think we have made some progress. I want to acknowledge that. But, indeed, there are opportunities for the TRAC Committee that has been meeting. I noted in some of the testimony that it has been meeting now for a year. You have had at least seven meetings. There are a number of issues still remaining, and I hope that this committee will be engaged with that.
Mr. Chairman, again, thank you for holding the hearing.
[The prepared statement of Mrs. Clayton follows:]
PREPARED STATEMENT OF HON. EVA M. CLAYTON, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NORTH CAROLINA
Mr. Chairman, I would like to thank you for holding this hearing today. It is appropriate that this subcommittee conduct oversight because implementation of the Food Quality Protection Act has a significant impact on agriculture.
I am looking forward to hearing from the witnesses and appreciate the diverse point of views represented. Although I am disappointed that members of the environmental community declined to participate today. Their views on this subject are very important. I would also like to thank the chairman for the bipartisan manner in which this hearing has been handled.
Page 5 PREV PAGE TOP OF DOC As you know the FQPA passed overwhelmingly in 1996 with the support of environmentalists, growers, chemical companies, and food industry groups. If implemented correctly, FQPA can protect human health without jeopardizing agriculture and rural America in the process. Without question, public health is a priority. Safer food is good for the consumers and farmers.
But, we must ensure that EPA bases their decisions on sound science. EPA and USDA must also work to ensure that there is clear and understandable process for tolerance reassessment. Stakeholders must be involved in this process and EPA and USDA must continue to work together. All of these principles were laid out by Vice President Gore in his memorandum to EPA and USDA one year ago this month. I intend to work with the agencies to ensure that they adhere to these principles.
I am pleased with the progress that has been made over the last year but there are still issues that need to be addressed. One area of concern is whether or not EPA has all of the data they need for their decision making process. FQPA requires EPA for the first time to consider non-dietary risks (water and residential) as well as dietary risks. EPA should use complete and actual data instead of using default assumptions that unfairly portray risk.
Additionally, the issue of a reasonable transition for agriculture needs to be adequately addressed. I hope that the Tolerance Reassessment Advisory Committee (TRAC) will address this issue more thoroughly in the upcoming meetings and that both EPA and USDA will continue to solicit stakeholder input.
Finally, I would like to be assured that adequate resources are devoted to registration of new, safer, and more environmentally friendly products. EPA should make registration of this type of chemical a priority.
We must also ensure that USDA is adequately funded. USDA's role in implementation of the FQPA is imperative to the success of
Page 6 PREV PAGE TOP OF DOCthis law.
Again, thank you Mr. Chairman for holding this hearing today.
Mr. GOODLATTE. Thank you, Mrs. Clayton.
It is now my pleasure to recognize the ranking member of the full committee, someone who is very interested in this issue and also involved in requesting that we hold a hearing, Congressman Stenholm.
OPENING STATEMENT OF HON. CHARLES W. STENHOLM, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS
Mr. STENHOLM. Thank you, Mr. Chairman. Thank you for holding this oversight hearing today on the implementation of FQPA.
This law is critical to agriculture. I think it is very appropriate that we review FQPA implementation on AG/Earth Day. Now, while some folks have asked why we are holding a hearing now, I think the answer is simple. It has been nearly a year since the last oversight hearing was held. It has been about a year, or a little over a year, since Vice President Gore made some significant instructions to EPA and USDA, when he suggested in all of these decisions that sound science should be used. Most of us agreed to that.
He suggested that we have transparency; that everyone interested in the process be allowed, permitted, and encouraged to participate, and that the decisionmaking process should be transparent, so that all parties would see what is going on; reasonable transition for agriculture, and recognizing that sometimes decisions are made that can have a very devastating effect on production agriculture, and that transition time needs to be utilized where public health is not imminently in danger.
With regard to consultation with the public and other agencieswe observed at that time that it was sort of amazing that we would have to have the Vice President of the United States instruct two agencies of the Government of the United States to work together. But, that has happened. There have been some very positive actions have happened since then, as evidenced by some of the criticisms now being made.
Page 7 PREV PAGE TOP OF DOC It has been a year since the TRAC Committee began its work. These are the reasons for this hearing today. The August deadline for EPA to reassess one-third of all tolerances is rapidly approaching. The appropriation bills which fund EPA and USDA's work on FQPA will be considered fairly soon. Legislation to amend FQPA has been introduced. EPA has begun making decisions on the nine key science policies they released for notice and comment. EPA and USDA have begun to work on risk assessment for organophosphates. We continue to receive numerous phone calls and visits from concerned growers, industry folks, and consumer representatives.
For all of these reasons, I welcome this opportunity to get an FQPA update before the next full TRAC meeting next week, April 27 and 28. It is very important that we continue to exercise our oversight authority on this important issue. I greatly appreciate Mr. Goodlatte holding at least one more hearing on FQPA implementation this summer.
As you all know, there is still a lot more work to be done to ensure that FQPA is implemented in a fair, reasonable and workable manner, and that all decisions are driven by sound science. I believe the TRAC has been a valuable tool, and I commend the interested groups for trying to work through all these difficult issues.
I would also like to commend both USDA and EPA for their commitment to this issue. While I do believe we are better off today than we were a year ago, there are still several issues that concern me. First, USDA's role is critical to the successful implementation of this law. For the first time, USDA is reviewing the risk assessments before they are finalized. Unfortunately, they are seriously underfunded and understaffed in this area. I intend to work with the appropriators as we look at USDA funding for Fiscal Year 2000. I will also ask that USDA make this a priority and utilize all available resources for these purposes.
Second, I am pleased that EPA has put key science policies out for notice and comment. However, I am greatly concerned that decisions on products might be made before these science policies are finalized. As a farmer in real life, common sense tells me you don't make decisions until you have all of the information. The FQPA gives EPA the authority to make time-limited tolerances on products. But it is important to keep in mind that passage of FQPA did not make registered chemicals unsafe overnight. Prior to FQPA, chemicals still had to go through a rigorous approval process.
Page 8 PREV PAGE TOP OF DOC I am also concerned with EPA's public release of preliminary risk assessments over the Internet. While I have no problem with the public release of this information once it can be supported by sound science, I do have concerns with the release of information based on worst-case assumptions instead of actual data. There is no justification for needlessly scaring people with misinformation, when there are several groups just waiting for the opportunity to do just that.
The bottom line is this: The FQPA can be implemented in such a way that it works. By the same token, it can also be implemented in such a way it won't work. We must all work together to ensure proper implementation of this law. As long as sound science is driving the process, everybody wins.
I am pleased that so many different points of view will be presented here today. However, I am very disappointed that we will not hear from some in the environmental community. Two environmental groups were invited, one of which called and asked to testify. Regrettably, both turned down the invitation. While we may not always agree on FQPA implementation, I hope these groups will want to participate in the process in the future. I hope that those of you will want to do more than just run cute little ads in The Washington Post the day before a hearing of this nature. This is what upsets most of us in the production agriculture community. Those of you out there who have an agenda which you believe is more important than sound science developed at EPA and USDA, might come up with very cute little ads. You have every right to do that. I respect your right to do that. You did it to me all through last September and October. But it did not work, because most of the folks I represent are like most of the folks in this room, today and in this town: They understand that, if we pursue your theories, we will not have the most abundant food supply, the best quality, the safest food supply, at the lowest cost to the consumers.
Let me say that I, along with several other Members of Congress, were depicted as dogs. I'd proudly wear that label, ''blue dog.'' My photo was placed over the body of a Dalmatian I thought was somewhat appropriate, seeing as how I was working with those who were willing to work with me to try to put some fires out in this endeavor, in order that we might have a positive result and not a negative result.
Page 9 PREV PAGE TOP OF DOC It is interesting that those with opposing views were depicted in this ad as chewing on our ankles because they didn't have the opportunity to testify at the FQPA hearing last year, Mr. Chairman. Last year, they were chewing on you and criticizing you for not allowing them to testify. This year we made sure they would have a voice. Two different environmental groups were invited to be here today. Both turned you down, Mr. Chairman, even after one of them had contacted the committee last week with a request that they be allowed to participate.
Now I understand that this is not necessarily the perfect process from any of our points of view. But I still hope that the environmental community will decide they want to work with you, Mr. Chairman, and with this committee.
I want to thank and express my appreciation to those who have worked hard through the TRAC process. It is harder to stay and work through these difficult issues than to get up and walk away when the going gets tough, as one environmental group did.
I hope that those representing different points of view today will contribute to the beginnings of an even more successful implementation of FQPA.
I should note in closing, Mr. Chairman, that the USDA Deputy Secretary, Richard Rominger, and Acting EPA Deputy Administrator, Peter Robertson, were unable to be here because of AG/Earth Day. They will, however, do a briefing for the full House Agriculture Committee on April 30.
Finally, I would like to extend a special welcome to Mr. Donnie Dippel, the assistant commissioner for pesticide programs for the Texas Department of Agriculture, and I look forward to hearing from all of the witnesses.
Thank you, Mr. Chairman, and let me take this opportunity again to express my appreciation to you and your staff for your cooperation, assistance, and leadership in putting together this hearing today. Mr. GOODLATTE. Thank you, Mr. Stenholm. Let me just say that you are one dog I want to have in this fight. [Laughter.]
Page 10 PREV PAGE TOP OF DOC Mr. STENHOLM. We may no longer be a Dalmatian or a blue dog; we may be a pit bull or a Doberman.
Mr. GOODLATTE. I will take it. We have another Member of Congress who is vitally interested in this issue who represents a major agriculture protection area in the San Joaquin Valley of California. We are glad to have Mr. Pombo's statement as well.
OPENING STATEMENT OF RICHARD W. POMBO, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA
Mr. POMBO. Thank you, Mr. Chairman. I want to join my colleagues in thanking you and the ranking member for holding this hearing. After that statement from the ranking member of the full committee, Mr. Stenholm, I don't have an awful lot to say. I think I will just say that I agree wholeheartedly with his sentiments and concerns over this legislation.
Over the past year, I have become increasingly more concerned about the implementation of what, I believed at the time, was a good low. I still believe that it, basically, was a good law. But like a lot of other things that we do here in Washington and that the bureaucracy does, we kind of messed it up. I think that, as you look at the implementation of this law, there is concern for all of us.
I have spent the better part of the past year working with outside groups and trying to find out exactly what is wrong and what is right with the current implementation; the way that it is working; the concerns that have been raised, and intend on introducing legislation next week that I believe will take a sound science approach to solving this problem.
I think we all have concerns. That is why the legislation was passed to begin with. That is why we tried to do something about the law at the time. But when we look at the implementation, I think that it scares all of us. I think that if we have sound science and if we have a good process in place, we can live with the results. My greatest concern is that is not where we are ending up.
Page 11 PREV PAGE TOP OF DOC I encourage all of you to take a look at the legislation that we are going to introduce next week, as well as other legislation that has been introduced already. I think that, as you look at that and try to figure out what the best way to solve this problem is, I believe that we can come to a consensus and move legislation that we can all be very confident in the results. Thank you, Mr. Chairman.
Mr. GOODLATTE. Thank you, Mr. Pombo. Does any other member have an opening statement they would like to make? Mr. Walden.
OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF OREGON
Mr. WALDEN. Thank you, Mr. Chairman. Thank you for holding this hearing and giving me the opportunity to comment on the implementation of the Food Quality Protection Act by the EPA and USDA. My district, the Second Congresional District of Oregon, is home to a wide variety of crops, from pears and apples in the Hood River and Rogue Valleys; to potatoes and onions in Malhuer County; mint in central Oregon, and wheat and barley in the Columbia Basin.
Growers in my district are concerned about how Government is going to make the decisions that affect their very livelihoods, as much as the growers from around the country are. Right now, there is very little margin for error. As I travel my district, I hear firsthand from my constituents about the Government regulations that affect their lives. One of their greatest concerns is the possibility of losing the very tools they need to combat pests and disease, tools that make a difference as they try to make a living growing the crops that feed us.
Some of the questions I have been asked on the subject of implementation of FQPA are similar to those I am hearing from my colleagues from around the country. Will the pesticide review process be based on sound sciencepredictable, transparent, and expedient? Will growers and other stakeholders be a viable part of the process? Is EPA following the original intent of FQPA as passed by Congress? Will there be room in the risk cup for pesticides used for minor crops? Will the loss of access to products further impact the ability of growers to compete in today's marketplace?
Page 12 PREV PAGE TOP OF DOC These questions are serious. Their answers will have a significant impact on the people whom I represent. So, as we review efforts to ensure the safety of our food supply, we need to make sure that the growers are not put at competitive disadvantage.
I look forward to today's testimony from my colleague, Representative Doc Hastings, because our districts are very similar. Our constituents share a lot of the same thoughts and concerns. I welcome the opportunity to hear from the administration about the progress they have made in implementing FQPA, and where they are going in the months ahead. I look forward to hearing from the grower and industry groups today, to get their input on the implementation of FQPA and its impacts on their ability to grow their crops and make a decent living.
Obviously, we all want a very safe food supply and we want the ability to grow that supply, as well. Mr. Chairman, I appreciate your subcommittee holding this hearing on this very critical matter. I look forward to working with you and members of the committee on this issue of great importance. Thank you.
Mr. GOODLATTE. Thank you, Mr. Walden.
Mr. Phelps, do you have a statement you want to make?
OPENING STATEMENT OF HON. DAVID D. PHELPS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS
Mr. PHELPS. Thank you, Mr. Chairman. Just to thank you for hosting this hearing. I am still learning. I am a new member. I am a blue puppy and still trying to cut my teeth and get my eyes open. We just appreciate the sensitivity to the science being verified in these matters. I come from a heavy agricultural district in Illinois. Thank you for the opportunity.
Mr. GOODLATTE. I thank you.
Page 13 PREV PAGE TOP OF DOC At this time, it is my pleasure to welcome our first witness, the Honorable Doc Hastings, a Congressman from the Fourth Congressional District of Washington. I want to welcome you and let you know that your written statement will be made a part of the record. We would be pleased to receive your testimony. Thanks for joining us.
STATEMENT OF HON. DOC HASTINGS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF WASHINGTON
Mr. HASTINGS. Mr. Chairman and members of the subcommittee, I want to begin by thanking you for this opportunity to testify on the implementation of the Food Quality Protection Act as it is being administered by the EPA and the USDA. I want to say that I wholeheartedly want to associate myself with remarks by my colleague and ranking member of the Agriculture Committee from Texas, Mr. Stenholm. Thank you for that.
There are, frankly, very few issues which have provoked more sustained interest and concern in my district than the implementation of this act. For those of you that have not had the opportunity to visit central Washington and my districtseveral of you have from outside my area; Mr. Walden's district is right across the Columbia River from my districtwe are one of the most productive and diverse agricultural areas in the country.
Let me give you a couple of examples. Washington State leads the Nation in the production of these crops: apples, pears, hops, mint, peas, lentils, grapesincluding wine grapesand asparagus. That is just a few of the crops that we have and we lead the Nation in that. In addition, we are a very large producer of wheat, potatoes, cherries, and alfalfa. This diversity creates a problem, because minor crops, frankly, face the greatest difficulty in finding replacement chemicals when the use of current pesticides are lost. I don't know there is any other area of the country, with the possible exception of the Central ValleyI will say that in deference to my friend from Californiathat will be impacted more by the implementation of the Food Quality Protection Act than in central Washington.
Page 14 PREV PAGE TOP OF DOC In response to the concerns of growers in my district, I invited the former EPA Assistant Administrator for Pesticides, Dr. Lynn Goldman, to join me for a public hearing last May in Yakima, in my district. I think it was the first outside public hearing by anybody in regard to FQPA. The comments that we heard from those that were thereand there were about 500 people attending that meetingwere clear and consistent. They were clear and consistent with the principles that were outlined in the April 1998 memo from the administration that the agencies must use sound science; must have a transparent process; must ensure reasonable transition periods, and must consult with other agencies before decisions are made.
Making radical changes to pesticide policies, especially without scientific justification, would, frankly, potentially devastate our agriculture industry, and, as a result, drive many farmers out of business. Of these principles, my constituents are most insistentas has been mentioned here several timesthat the EPA use sound science.
Mr. Chairman, I supported the Food Quality Protection Act of 1996 because I believe that the replacement of the zero-risk Delaney clause with risk standards based on sound science would be good, not only for our farmers, but for consumers. Standards that are not based on sound data, however, threaten our Nation's agricultural producers, and, frankly, may result in even more risks to our children and other at-risk consumers if food imports increase.
That is why I was very pleased to join with my colleagues from Illinois, Mr. LaHood and Mr. Blunt, in sponsoring H.R. 1334, the FQPA Implementation Act of 1999. This bill would ensure that sound data is the basis for consistent implementation of the Food Quality Protection Act. It directs the EPA to consider additional data, including outside data, and the public interest before suspending the use of any pesticide. A requirement to ''call in'' additional data before modifying a tolerance will ensure that these critical decisions are made on the basis and reliable science, rather than on mere assumptions. The information is available and the EPA should use if the Food Quality Protection Act is to be implemented successfully.
Page 15 PREV PAGE TOP OF DOC House Resolution 1334 also calls for a study of the international trade impacts of the Food Quality Protection Act. We must keep in mindsometimes we lose sight of thisthat our producers are competing in an international marketplace. Federal regulations that raise costs and decrease productivity only serve to increase the chance that U.S. farmers, the ones that follow the rules, could lose their international competitiveness, and that the imports of foods grown with pesticides banned in this country, but not in other countries, will increase.
In addition to the review of existing pesticide registrations, the growers of my district are concerned about the Food Quality Protection Act's impact on new registrations. The crops that I mentioned earlier are, by and large, minor crops. They are the ones that are most impacted by this. Because the EPA is devoting so much effort to review the process, the waiting period for new registrations and growers' dependence on emergency exemptions, frankly, has increased.
H.R. 1334 would provide the EPA Administrator with authority to grant emergency tolerances so long as the incremental exposure does not pose any significant risk. I believe that this is a reasonable approach, and I encourage the committee to consider the issue of emergency exceptions in its oversight of the Food Quality Protection Act.
Mr. Chairman, the Food Quality Protection Act is good law, as I mentioned earlier. It balances the need to ensure food safety with the need to give our farmers the tools to produce the food that we eat. Sound science is a point on which these interests are balanced. We must ensure that both the EPA and the USDA honor this principle.
I also want to commend the committee for holding this hearing. I look forward to working with you to ensure that the FQPA is properly implemented so that our farmers will have the access to the tools that they need to keep their fruits and vegetables safe, abundant, and affordable for everybody.
Page 16 PREV PAGE TOP OF DOC With that, Mr. Chairman, I want to thank you for the opportunity to appear before you. If you have any questions I will be more than happy to try to respond.
Mr. GOODLATTE. Thank you, Congressman Hastings. I fully agree with your observations on this issue. We thank you for your contribution. I know that Mr. Pombo's eyebrows were raised when you said you produced more wine grapes than any other State. But as long as it is based on sound science, we are willing to accept. [Laughter.]
Mr. HASTINGS. What I said, for clarification hereI don't want to get into a shouting matchI said we lead in production of grapes, including wine grapes, which is a growing industry. I am not going to suggest that we grow more wine grapes than California, although I would argue about maybe the quality of our wine. [Laughter.]
Mr. GOODLATTE. We are getting away from scientific evidence here. We do thank you for your observations on this issue. We are very pleased to have you join us today. Thank you again.
We would now like to invite our second panel to the table. We have with us Mr. Keith Pitts, the Special Assistant to the Deputy Secretary of the United States Department of Agriculture, who is accompanied by Al Jennings, Director of Pest Management Policy, also with the USDA. We also are joined by Mr. James Aidala, who is the Associate Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances with the Environmental Protection Agency; who is accompanied by Steve Johnson, Deputy Director of Office of Pesticide Programs with EPA.
Mr. LAHOOD. Mr. Chairman?
Mr. GOODLATTE. Before we do that, I had promised Mr. LaHood that he would have the opportunity to give his opening statement. He will do that at this time.
OPENING STATEMENT OF HON. RAY LAHOOD, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS
Page 17 PREV PAGE TOP OF DOC Mr. LAHOOD. I am sorry to be an interloper on this, but I had to go over to the Transportation Committee and vote on a very important bill. I wanted to read my statement, because I have taken a great deal of interest in this issue to the extent that I have introduced a bill which Congressman Hastings alluded to. I, too, want to thank you for holding this very important hearing.
I, too, have heard from a lot of growers in my district on this issue. When I summarize what they are saying about FQPA implementation, it is clear that they are still afraid they are going to lose pest control products they depend on, as a result of the new law, particularly as we begin the growing season. They are uncertain as to the process of having alternatives available under FQPA and concerned about being able to maintain the high quality of U.S. crops in the field, in transit, and in storage.
When FQPA was enacted, Congress never intended, nor expected, FQPA to result in the threat of disruption to U.S. agriculture. Many in my district are convinced that EPA was proceeding with unilateral cancellations of some pesticides, which would harm the production of certain crops on millions of acres of U.S. cropland. Consequently, I have introduced H.R. 1334, and I would ask any of you on the committee to take a look at it and become co-sponsors. It is a good bill.
The FQPA Implementation Act clarifies FQPA and opens the process to the public even further. The bill requires the EPA Administrator to consider additional data before revoking or modifying a tolerance to determine if adherence to the deadlines is in the public interest and to publish its conclusions in the Federal Register. The bill gives new authority to the EPA Administrator to grant expedited section 18 exemptions if exposures will not pose any significant risk.
Additionally, the bill requires both the Secretary of Agriculture and the EPA Administrator to detail to Congress financial resources it may need for proper FQPA implementation. The report should include an assumption that new appropriations will not be available from Congress.
Page 18 PREV PAGE TOP OF DOC Finally, the bill requires the Secretary of Agriculture, in cooperation with the EPA Administrator and the U.S. Trade Representative, continuously monitor the competitive strength of U.S. agricultural commodity sectors in the international marketplace.
Pesticide law has always been a very large and complex issue. In my opinion, its complexities involve highly technical, scientific issues such as toxicology or risk assessment issues. The new FQPA definition of a safe tolerance for food residue continues that longstanding foundation of sound science by requiring aggregating only when there is reliable information on other exposures, such as drinking water and residential exposures.
I encourage all of the members of the committee to look at my bill. I think it sends a strong message to the EPA that we are serious about this. In the event that the bill would not pass, it does, I believe, get a good debate going, obviously today. It also sends a message that we are serious here about requiring EPA to do what is right: to use sound science; get off the dime; make some of these decisions, and make them in a way that is palatable to sound science and agricultural industry.
Again, Mr. Goodlatte, thank you, and also, to both Mr. Stenholm and Mrs. Clayton for requesting this hearing. This is an important issue in agriculture country. We are hurting in agriculture country. We don't need any more hold-ups. Thank you very much, Mr. Chairman.
Mr. GOODLATTE. Your timing is impeccable.
Mr. LAHOOD. Thank you.
Mr. GOODLATTE. Thank you, Mr. LaHood, for those comments. What I think we ought to do is go ahead and start the testimony. We may have to take a break here for some votes. But if we can get started, I think it will be very helpful. So, at this time, Mr. Pitts, we welcome you, and your testimony will be made a part of the record. We would very much like to have your oral statement.
Page 19 PREV PAGE TOP OF DOCSTATEMENT OF KEITH PITTS, SPECIAL ASSISTANT TO THE DEPUTY SECRETARY, ACCOMPANIED BY AL JENNINGS, DIRECTOR, PEST MANAGEMENT POLICY, AND HAROLD COBLE, IPM COORDINATOR, U.S. DEPARTMENT OF AGRICULTURE
Mr. PITTS. Thank you. We will go ahead and submit our written statement for the record. I will be brief.
First of all, I want to thank you for having us here today. The Deputy does send his regrets. We have all been on the road quite a bit, meeting with land grants this past week, specifically working on FQPA implementation. He just rolled in from Chicago and is busy with Earth Day assignments that he has gotten for today.
I do have Dr. Harold Coble with me, who is the Department's IPM Coordinator, and Dr. Al Jennings, who is the Director of our Office of Pest Management Policy. They will be available for questions, as well.
I have broken our oral statement down to basically three sets of issues: the process we are engaged with with EPA; the kind of data we are collecting and how it is being used, and where we are with transition and mitigation strategies in the even FQPA implementation does present some unacceptable risks.
Since the formation of TRAC, we have been pretty much meeting with EPA on a daily basis. The law has certainly presented us all with a lot of challenges. I think the working relationship is a good, solid one. Historically, I think the Department in the past had a tendency to collect a lot of pertinent pesticide use data and pesticide residue data, often without consulting with EPA. Many times our approach was to plod on, set our data on a stump in the woods, and hope that EPA would come by and pick it up.
We are way beyond that these days. EPA is very much involved in talking with us about the kind of data they need. Our programming is now able to work quickly on its feet and adjust as needed. That goes for our NASS data, which is collecting a lot of the pesticide use the pesticide data program aat AMS, which is doing a lot of the residue data collection, and we do have the new Office of Pest Management Policy, which is a retooled and revamped NAPIAP program. We felt like it was not appropriate for FQPA implementation. We also do have ARS collecting important national food consumption survey data. We have finished one round of data collection that was specifically targeted toward FQPA. I think that we are seeing a significant and positive impact of that data with the risk assessments process at EPA so far. We are looking forward to continuing that working relationship.
Page 20 PREV PAGE TOP OF DOC As far as the process goes, working daily on TRAC-related issues, the science policies papers are being developed. We are developing these concurrently with EPA. We review all of them before they go out.
At this point in time, of the 38 OPs, 10 of them have been sent over to the Department. We have completed our review of four of them and sent them back to EPA. I anticipate here, soon, we will have technical briefings associated with those particular OPs. Those four, none of them are major food use OPs, but they did have some issues related to worker exposure and ecological toxicity issues that we are working on with EPA now. We have two more that we anticipate having done in the next couple of days.
We do have a major food use OP over at the Department now that we have been trading a lot of information back and forth with the Department on. That is Guthion or azinphosmethyl. Again, it has been quite a challenge trying to work with probabilistic software and making sure we have all the data we need in place. As we have gone through the software runs, we have been able to define data that has been pertinent to the process. I think that you will be hearing some today about the impact the working relationship that we have generated with EPA has had on going from the preliminary risk assessment on azinphosmethyl to where we are today.
As far as process, when the OPs come over to the Department, we have the headquarters team, led by Al Jennings and Therese Murtaugh, his Deputy, review it. We also have top-level scientists from ARS, CSRAS, NASS, PDP, or Office of Risk Assessment and APAS as part of the technical review team. We will do an initial review of the risk assessment and get comments back to EPA as they come in. If we see a particular area where we don't have the expertise around the table at the headquartersif it is a commodity-specific issuewe have identified people in the land grant and Extension and ARS research systems that we farm those risk assessments out to. It has worked well. I think we are getting a lot of information. As far as if and when we do see a risk related to an OP, we are also asking land grant and Extension scientists to help work with us on mitigation transition strategies.
Page 21 PREV PAGE TOP OF DOC One thing that the Department has undertaken, as we have seen the OPs that have come through, is that even in the event that an individual OP may be within its referenced dose, we are thinking about cumulative now. We know there is still a lot of science and work that needs to be resolved about how to do a cumulative risk assessment, so we are not surprised and not having any unintended consequences in the further implementation.
The Department is stepping up its efforts and steering resources toward the development of transition strategies. That said, the programs we are going to use for transition are our Pest Management Alternatives Program. We have a new program developed we call Crops At Risk, which currently in our budget. And a third program, which is the Risk Avoidance and Mitigation Program. We will be happy to talk about those more. Harold Coble is here and helped us develop this program. We think it is a very key part of this entire package that we trying to pull together.
We do have a budget up here that has added $34 million to our FQPA implementation plan. It has almost doubled out budget. We think it is really important for the Department to go to work with Congress and realize those funds, so that we can be the kind of players we want to be in this effort.
[The prepared statement of Mr. Pitts appears at the conclusion of the hearing.]
Mr. GOODLATTE. Thank you, Mr. Pitts.
Mr. Aidala, if you will forgive us, we have to go vote. I also apologize for butchering your name. Am I pronouncing it right, now?
Mr. AIDALA. You are. If that is the biggest problem we have this morning, I will take that as personal victory. [Laughter.]
Mr. GOODLATTE. We are already making progress and the subcommittee will stand in recess.
Page 22 PREV PAGE TOP OF DOC [Recess.]
Mr. GOODLATTE. The subcommittee will come back to order.
At this time it is our pleasure to welcome, again, Mr. James Aidala. We are ready for your testimony.
STATEMENT OF JAMES V. AIDALA, ASSOCIATE ASSISTANT ADMINISTRATOR, OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES, ACCOMPANIED BY STEVE JOHNSON, DEPUTY DIRECTOR OF OFFICE OF PESTICIDE PROGRAMS, ENVIRONMENTAL PROTECTION AGENCY
Mr. AIDALA. Thank you, Mr. Chairman. I am also, as you mentioned earlier, accompanied by Mr. Steve Johnson, also from our office at EPA.
Good morning, and thank you for the invitation to appear here today to discuss EPA's implementation of the Food Quality Protection Act. Obviously, now, I will just make a few brief remarks and then submit my full testimony for the record.
It has been about a year since EPA and USDA last testified before the committee and I am happy to have this opportunity to fill you in on the progress that we have made. Much has changed in the last year. When we were last here, the TRAC process was just beginning and there were many questions and concerns from all sides about how EPA would be implementing FQPA. There were questions about whether EPA would be able to get the information needed to make sound decisions; whether or not we would be able to apply FQPA new standards in a manner that would be fully protective of public health, especially for infants and children, while maintaining the abundant food supply that American consumers have come to expect; whether we would be able to keep making decisions on new chemical uses at historically high rates; whether or not we would be able to meet the ambitious time table for tolerance reassessment; whether EPA would precipitously cancel important uses of organophosphate pesticides without adequate information, and whether or not we would be able to carry out these duties in way that is fully transparent and accountable to public scrutiny and based on sound science.
Page 23 PREV PAGE TOP OF DOC Mr. Chairman, I believe that these concerns were understandable then and now. FQPA created significant new challenges for all of us and came at a time of great uncertainty within agriculture. The increasing importance of world markets; pressures on commodity prices, and growing consumer awareness of food safety issues in general, all contribute to that uncertainty. We recognize that how FQPA is implemented can have important consequences for growers and consumers, alike.
This morning I am happy to be here today to report on what we are doing and that, if you will, we are on track. In partnership with our colleagues at the Department of Agriculture and with the advice and assistance from growers, registrants, scientists from the academic community and the environmental community, we have put in place procedures and systems that are allowing us to meet the important goals of the statute. We are making decisions based on sound science and reliable data, and we would like to talk about that. We have established an unprecedented level of cooperation and partnership with the USDA. We are bringing new technology to the market at historically high levels. We have established a routine and predictable process for review of organophosphates. We are on target to meet the FQPA tolerance assessment schedule. We are doing all of this in a manner that is open and transparent to all of our diverse stakeholders.
One of the key elements of the implementation process has been the advice that we have gotten from the Tolerance Reassessment Advisory Committee, the ''TRAC.'' The TRAC was established by EPA and USDA to help us find a more effective way for the public to participate in development of the tolerance assessment and risk management processes and has been enormously helpful.
The TRAC process has resulted in two particularly important new developments. First, EPA and USDA have put in place a new pilot process for refining their organophosphate pesticide risk assessments and develop reasonable risk mitigation approaches and transition strategies. This process provides for public input at each critical step, so that all interested parties can clearly understand what information our assessments are based on and have the opportunity to provide new data that can help to further refine our analyses. We believe this pilot has been extremely useful in opening up the risk assessment process. Perhaps even more importantly, it is bringing in substantial amounts of new information. The data and information provided by USDA, growers, and registrants has greatly assisted in making better regulatory assessments.
Page 24 PREV PAGE TOP OF DOC The second area that the TRAC has been particularly useful in is developing a framework for addressing key science policy issues raised by FQPA. To date, papers covering seven of the nine original science policy areas and one other related issue have been released for public comment. As proposed at the TRAC, we have been applying these science policies in our risk assessments at the same time they are being refined through scientific preview and public comment. We expect to have virtually all of the science policies finalized before organophosphate risk management decisions are completed.
Another area that is critical to successful FQPA implementation is our ability to meet the growers' needs for new pest management tools. I would like you to look at this chart on my left to illustrate that point.
We do continue to place a high priority on bringing new and safer technologies to the marketplace. And as the chart shows, our review of new chemicalsthese are our approvals of new active ingredient registrationsis at historic levels. Obviously, you can tell a little bit of a dip right after FQPA enactment, but, again, we are back up to historically high levels compared to a 3-year moving baseline in the 1970's, 1980's, and through the 1990's.
Typically, for example, in that earlier period we saw no more than about 15 or 16 new active ingredients. Now we are the high 20's, which is an historically high average. This is not only a comment on our work, but also the innovation and investments that the industry has made.
One last point, Mr. Chairman, I am very pleased to report that we are on schedule to meet the deadline for reassessing the first third of the tolerances. That is the other chart on my right.
Page 25 PREV PAGE TOP OF DOC As this chart shows, we expect to meet the August 1999 deadline, with about two-thirds of the reassessments coming from the highest priority group, group 1. As in my written testimony also, the requirement is for us to review 3,210 tolerances. We expect that by August 3, the deadline in the statute, we will have over 2,000-plus tolerances from the group 1 category reviewed; approximately 600 from group 2 and 700 from group 3. Add that up; we expect to have at least 3,300 tolerances reassessed by the August 3 deadline. This would meet the deadline.
Taken together, I believe the record shows we have put in place the systems and procedures necessary to achieve FQPA public health goals in a predictable and transparent way, based on sound science and reliable data. We will continue to build on this strong foundation and work in close partnership with USDA and with input from our stakeholders to address the critical challenges that we all face.
One last comment, Mr. Chairman, in your opening statement you said that we need to FQPA implementation based onI think I took the notes here''science-based, predictable and transparent.'' Other members added the concept we would also agree with that growers and other constituencies need to be part of that process. My last comment is, we couldn't agree more.
[The prepared statement of Mr. Aidala appears at the conclusion of the hearing.]
Mr. GOODLATTE. Thank you very much. Mr. Aidala, this first question is for you. The Food Quality Protection Act was a very difficult bill to craft and pass. It involved the cooperation of farmers, industry, consumers, and environmentalists. Everyone wants safer, better products on the market. That takes alternatives to what is currently available. If chemical products are taken off the market without effective and economical replacements, farmers suffer because there are no viable tools to protect their crop.
Consumers also suffer because there is a shortage of agricultural products to buy at the marketplace, and what is available is of lower quality and costs a great deal more. In fact, I think someone here today who will be testifying later has an example of that.
Page 26 PREV PAGE TOP OF DOC Mr. AIDALA. We brought props that weren't perishable.
Mr. GOODLATTE. That is right. Can you tell me how many applications for new, conventional, active-ingredient pesticides are pending now?
Mr. AIDALA. I will turn to Mr. Johnson, here, in a second. Altogether pending, I think we have usually about a 2- to 3-year supply, if you will. Obviously, what we do is go through an assessment. We get literally over a 120-plus studies to review. Obviously, you can't do all those overnight. We sort of queue them up and put them through stages. The results you see on this chart are the final decisions we see on a per-year basis. But let me ask Mr. Johnson about the exact backlog.
Mr. JOHNSON. Well, Mr. Chairman, we have at the present time approximately 50 conventional chemicals and 20 biopesticides; therefore, a total of approximately 70 new active ingredients in the registration queue.
Mr. AIDALA. And again, that is about a 2- or 3-year kind of rolling number of applications that we move through the system.
Mr. GOODLATTE. Is it true that you asked the industry to hold off on submitting more new applications?
Mr. AIDALA. We have asked and createdsomewhat to help with the predictability on their end and our management of the workloadwe have what we call a priority scheme. I think that is what you are referring to. There we have said that, given the resources we have available, we will work downgiven your list of prioritiesto a certain level. Beyond that point, we have then suggested that submitting more applicationswe won't be able to get to them. So, it is not really a particular value to be submitting them. The short answer, I think, relatively, yes.
We understand, from the industry, there are more applications that would be submitted if we did have the resources.
Page 27 PREV PAGE TOP OF DOC Mr. GOODLATTE. Well, is that a good policy to pursue at a time where we are effectively, with this new law, transforming our efforts to deal with pesticides? We want to bring new products onto the market as quickly as possible. Shouldn't you be up here asking for more resources to expand your ability to process more applications in a shorter order?
Mr. AIDALA. Two points, Mr. Chairman. One is, we are asking for more money. I will have Mr. Johnson give the exact numbers, but we are asking for an increase this year of $4.5 million in the President's budget for registration activities. No. 2, in order to meet some of what you are asking aboutthe availability of replacements under FQPA that might take away a tool that a grower currently haswe have also insisted that one of those priorities in the priority scheme I mentioned will be granted for alternatives that may be jeopardized by FQPA; specifically, for example, organophosphate alternatives.
I am not trying to prejudge the outcome of any particular assessment, but in order to have those new transition alternatives available.
Mr. GOODLATTE. Wouldn't it be a good idea to encourage folks to bring in new products and get them before the EPA, and with that information in hand, determine what kind of additional resources you need to process the larger volume, so that we can process as many safer pesticides as quickly as possible?
Mr. AIDALA. I generally agree with that statement. One of the things that we have asked with the industryand you might want to ask ACPA, who is one of your witnesses lateris to have a survey of what are the applications that they currently do have in hand, would have in handeven projecting out into the future to help manage this workload. We are also engaged in a discussion with them about what we call a ''fee-for-service'' scheme. That, given budgetary limitations, there may be a scheme similar to the one at FDA to pay for pharmaceutical approvals that. With some combination of public and fee-for-service funding from the industry, we could increase that output.
Page 28 PREV PAGE TOP OF DOC Mr. GOODLATTE. What is your typical number, your average number of applications you process in a year?
Mr. AIDALA. Again, there are two ways that we do that to meet the needs of growers. One is the chart that we had up about the approvals of new, active ingredients. Again, that is in the neighborhood of the high 20's. Twenty-five to 30 is the range of new active ingredients a year.
The other thing that is very important, especially for minor crop growers, are the number of new uses. Again, this was an arena that did take a hitto be blunt about itright after FQPA's enactment. Let me give you an example from this current fiscal year.
Our budget calls for approving 90 new uses. This is where a company already has their first approval. Almost always that is for a major crop like corn, wheat, cotton, rice and soybeans. Then the minor crops follow. This year, we had projected to approve 90 new uses for the entire fiscal year. Already, up to this point in the fiscal yearwe still have some time to gowe are at 107.
Mr. GOODLATTE. What is the average review time for a conventional pesticide?
Mr. AIDALA. For new active ingredients, in the neighborhood of about 40 months.
Mr. GOODLATTE. How long for safer pesticides?
Mr. AIDALA. Safer pesticides are more in the range of half that time, or less, 18 to 20 months.
Mr. GOODLATTE. And what about biological pesticides?
Mr. AIDALA. Biologicals can be as short as 3 or 4 months; typically, more in the neighborhood of a year.
Mr. GOODLATTE. My time has expired on this round. At this time I am pleased to recognize the gentle woman from North Carolina.
Page 29 PREV PAGE TOP OF DOC Mrs. CLAYTON. Thank you, Mr. Chairman. Also, I just wanted to note the acknowledgment of the agreement of everyone in terms of the principles that we are trying to do. There doesn't seem to be a disagreement in terms of the very principle and I want to acknowledge that.
So I gather that the point of confusion, or disagreement or tension, is in how we interpret implementation, speed, and understanding. To that understanding requirement, on my part, my understanding is that, when we amended FIFRA, it provided that both the risks and the benefit of public health pesticides must be considered when the EPA made tolerance review. Is that correct?
Mr. AIDALA. Under FIFRA is the cost-benefit balancing statute. The food and drug amendment has resulted in a limited role for benefit considerations under very prescribed circumstances. In general, though, there is a balancing question that you always have when you make these kinds of decisions.
Mrs. CLAYTON. Limited means limited in application or limited in the products you would apply that to?
Mr. AIDALA. Specifically, under the Food and Drug Act, which is amended by the FQPA, the limitations on the benefit considerations are somewhat narrow and confined to a certain arena of some risk questions. In general, regardless of that sort of precise legal and technical formulation, you always ask yourself, in terms of that balancing of concerns you have, the strength of the evidence and the impact on not just growers, but the public in generaleverything from the public health to the price of food.
Mrs. CLAYTON. How do you plan, as an agency, using the public health pesticide, even in that limited way, in weighing the risks that might also be associated with the aggregate use of pesticides on food for public health?
Mr. AIDALA. In terms of public health, that does have some additional considerations under the FIFRA provisions that were added as part of FQPA. Obviously, again, it is a balancing test. In the strict public health application, for example, mosquito control, if you have a material that helps prevent malaria versus the tradeoff what the potential risks are, that is something that you need to address. So, we are engaged with the Department of Health and Human Services, specifically, similar to what we are engaged with for, say, grower concerns on an agricultural commodity with the Department of Agriculture, on exactly trying to assess those impacts and the potential needs of that community.
Page 30 PREV PAGE TOP OF DOC Mrs. CLAYTON. Is that plan developed, or is that a process allowing the plan to be developed?
Mr. AIDALA. It is both. We do have some material that we are jointly working with Health and Human ServicesI believe a Memorandum of Understandingof how we will approach the kinds of questions you are talking about.
Mrs. CLAYTON. Have you had an example to do that yet?
Mr. AIDALA. Some of the first assessments that we have completed, at this point in the assessments, we have some of the organophosphates are used for mosquito control, for example; those are the ones that we are using to be the engine that drives this ''How are we going to cooperate? How are we going to get the information we need out of all kinds of sources of the public as well as Health and Human Services?''
Mrs. CLAYTON. So you have an example where you actually had a process where you evaluated it?
Mr. AIDALA. We are in the beginning stages of that process on a couple of the OPs. Do you want to talk about which ones they are?
Mr. JOHNSON. We have shared the risk assessments. The ones that have been shared with the Department of Agriculture we have also shared with the Department of Health and Human Services. In fact, we have just received their first set of comments on the risk assessments, both to refine the risk assessments on the data they have available, as well as to better characterize what the benefits are and what kinds of issues we need to work together to solve with regard to the public health pesticides. So we are very much in that process.
Mr. PITTS. Can I just add one thing, too?
Mrs. CLAYTON. Yes.
Mr. PITTS. We do have one OP that fits in that category now that both HHS and USDA and AFAS are reviewing. It does have public health applications. It is a process that we are working through right now.
Page 31 PREV PAGE TOP OF DOC Mrs. CLAYTON. Is there a written plan based on that process between USDA, EPA, and Health and Human Services?
Mr. PITTS. I would not say. We have the MOUs between the agencies. Also, just following a lot of the processes laid out in the law as far as sharing lists of pertinent public health pesticides, we do have something that derives from the law.
Mr. AIDALA. The last page of my written testimony, Congresswoman, also the generic process for the both the public input and input byusually it is the Department of Agriculture, but not solelyfor example, HHS.
Mrs. CLAYTON. Thank you. Let me move to another area just to put the contrast between the tensions. The producers of pesticides, as well as the users, obviously, want to make sure that as they are required to implement that they have viable substitutes as quickly as possible. On the other hand, the environmentalists, who feel that the fast-moving pace may be that you are putting on the market a not-safe pesticide. Can you give a balance of the time that is in place now to assure both sides that what you have, indeed, ensures the process to be sufficient in terms of time? At the same time, obviously, the expediency for producers who need to find an alternative or substituteobviously, these are different time pressures, schemes. Both will acknowledge the other has a right. They aren't different in understanding that time costs money. On the other hand, it is not unreasonable to understand that due process and due diligence and erring on the side of caution takes more time. Can the length of time you have in place, can you just share for us, in a few minutes, that that process meets both of those goals?
Mr. AIDALA. Absolutely. We are committed to the proper implementation of the statute: protecting public health; making sure it meets the standard of both FIFRA and the Food and Drug Act. The timelines I mentioned to Mr. Goodlatte in his question, for example, 40 months on average for a new conventional pesticide; 20 months for a new, so-called safer pesticide. The reason we are able to compress that time is not only because of the sort of initial profile that the safer materials represent to us, but because we grant them a priority, there is, in effect, no queuing time. We are the first to admit that, if everyone at EPA dropped everything and worked on the petition that came in today, it could move through the system more rapidly. But, obviously, we have, as mentioned, 50-plus applications at any given time on top of our additional elements of our workload and the scope of our work.
Page 32 PREV PAGE TOP OF DOC The fee-for-service scheme that is currently under discussion with the industry would basically accelerate that turnaround time, not by compromising, in any way, the health and safety and environmental protections that our laws call us to implement, but basically the goal would be eliminate altogether the queuing times. So, one part of the assessment is done, but when it goes to the next stage in the review, it has to wait in line again. If you take out all those queuing times, fully reviewing it as we do now to assure public health, you end up with a much different timeframe expectation. We would see less time. We could have both goals: quicker turnaround with full protection and implementation of what the statutes require us to do.
Mrs. CLAYTON. Thank you, Mr. Chairman. My time has expired.
Mr. POMBO [presiding]. Mr. LaHood.
Mr. LAHOOD. Mr. Aidala, do you think there is a need for the kind of legislation that I have introduced or do you think you folks are pretty much on track on trying to implement FQPA? I am curious to know what your perception is of what we are trying to accomplish up here. Could you comment on that?
Mr. AIDALA. Sure. At this time we would not see a need for amendments. I have looked at your bill. There are other drafts floating around, and these ideas, if you will, are not new altogether. I think the central issue that you are concerned about, as well as we are, is whether or not the Agency has adequate information to act. If you don't have the adequate information, make sure you get it before you act. So much is at stake. Many members spoke passionately about that need. We entirely agree with that.
Obviously, there may be some disagreements about, ''Well, you say you have enough, but there might some additional data.'' Again, that is a very viable point and one that you people can disagree with. But at the core notion of ''make sure you have the information before you act''that is one of our principles. How else do you do sound science? How else do you have all the goals that we have set already, both in the Vice President's memo and many members spoke of it in their opening statements. Though, at this time, I think that we are doing what the goals of that proposal are about. Obviously, there might be some people who disagree and we would want to sit down and talk about that.
Page 33 PREV PAGE TOP OF DOC Mr. LAHOOD. What about the timeliness issue? Part of the reason I introduced my legislation is the issue that you just addressed, but also the timeliness part. There are farmers and growers of fruits and vegetables that believe that things have not been done in a very timely fashion. That is one of things that we have tried to address in our legislation. I wonder what you think about that.
Mr. AIDALA. There, again, it is similar to an issue I think, especially the time element has come across in the section 18 emergency exemption approval process, where if the current requirements are such we have to do a full-blown tolerance assessmentother witnesses speak about this in their testimonydoes it take too long and too much time and is, in effect, unpredictable or too lengthy, so that growers that have pest control needs are going to answer in a timely way? There, again, I would say that the impact of FQPA, initially after enactment, did see significant delays or increases in the review time. We have levels of review time that are less than they have ever been in the history of the section 18 process.
So, again, there is a question of exactly what. There may have been an initial problem, but exactly what is the concern now in terms of timeliness or allocation of resources to get the job done?
Mr. LAHOOD. Did that really come about as a result of the letter that you got from the Vice President? Has timeliness, in terms of your review, increased as a result of that, or just because you have been able to hire more staff?
Mr. AIDALA. Well, both of those things. For example, Congress, in its generosity, right after enactment gave us $15 million more. On a base, at that time, of somewhere in the neighborhood of $90 million, that is a significant increase. We appreciate that. It was a wise investment and is something that, given the way the Government, civil service, and all that works, you give us a check today, it takes a fair amount of time to get those people in place, get them trained and all that. That is one of the reasons you saw the review time slip and then get better. Now we are able to say we are back, and in fact, better than we have been.
Page 34 PREV PAGE TOP OF DOC The other point is we made a conscious priority to continue new active ingredient reviews, as well as section 18 priorities. They are called emergency exemptions for a reason. It is an emergency. We need to review those in a very timely way.
Mr. LAHOOD. Do you hear from farmers and growers from around the country about the delays in the implementation of this, and the delays in the reviews, and whether you are using sound science?
Mr. AIDALA. Of course we have. You have heard both from your own constituents and from other places. As Congressman Hastings said, our Assistant Administrator went out to his district. I have been to other districts. A head of the Pesticide Program, for example, just met with the Farm Bureau Task on FQPA, just a few days ago in Chicago. We always want to have further outreach. We are welcome to hear any other recommendations of any other things we need to do. We have heard these complaints and have attempted to respond to them.
Mr. LAHOOD. Thank you.
Mr. POMBO. Mr. Stenholm.
Mr. STENHOLM. Part of the problem is that over the years EPA has not had a lot of credibility with the agricultural community. That is part of the problem. That is Mr. LaHood's line of questioning and it is shared by producers all over the country in the past. I think that most folks that have listened to your testimony today understand that there has been a change. It is a visible change. I guess my question to you is, what have you learned this last year, Mr. Aidala, in your association with the USDA? What knowledge have you learned in this association that was not, perhaps, present before this year.
Mr. AIDALA. I would ask Mr. Pitts to comment because I think it might be more the other way. As people learn more about the EPA process and understand it, they can help us more, both literally and efficiently as a department, in the kinds of information they are giving to us. Or, as Keith had mentioned his statement, in the past there was an assessment and it wasn't clear what happened to it. Now, there is much more formalized ways that we use it. That, especially, is something that came out of the TRAC.
Page 35 PREV PAGE TOP OF DOC In light of the Vice President's memo, and I know yourself, Mr. Berry, and other members of the committee were very interested and pivotal in seeking some of that counsel and guidance directed from the Vice President. What that has done, as we have gone through the TRAC process, is two important things. We have laid that process so that all can play. There are many stakeholders in this process. Whether or not they put ads in newspapers and other kinds of things, as you know it is a big country. That is everything from environmentalists, producers, companies, and academics. What we have attempted to do is lay out a processthere is a literal description of it in very short form at the end of my written testimonyin order to make it regularized, transparent, and predictable, some of the goals yourself and others raised this morning. That is the single biggest achievement.
At the same time, it also has helped us just to get input, as Mr. LaHood just asked. These are folks from all over the country, all kinds of stakeholders saying what they think of it, with skepticism. One of the comments, reading today's written testimony compared to earlier testimony, I made a note to myself. I think there was sort of a large dose of cynical pessimism a year ago, and now, I think, it is at least cautious skepticism. I do think that is an improvement.
Mr. STENHOLM. That is progress.
Mr. AIDALA. And we need to move it to cautious optimism. That is our goal, among other things.
Mr. STENHOLM. Well, Mr. Pitts, would you comment for me from the USDA's standpoint?
Mr. PITTS. I think, for us, it has just been a real eye-opener on what EPA has to deal with. We really have imposed ourselvesbeen invited into a process, I should emphasize thatthat was, in the past, really closed to us and also a lot of growers. It had traditionally been a working relationship between registrants and EPA. A lot of us just did not see what happened. That includes growers, except in the cases were a registrant may have actively pursued bringing an end. But USDA really did hold this whole regulatory process at arm's length. I think that was really unfortunate. I think the one thing that we have learned is that we go on and we have a couple of data points that we feel like need to be run through a risk assessment and think it can be dropped in and the answer spit out in 5 minutes. What we are realizing is that you are dealing with a process where, if you change even number, it is sometimes taking days just to get an answer out of the software just because of the amount of data points you are using. The tremendous amount of work that they have to do over there has been an eye-opener for us.
Page 36 PREV PAGE TOP OF DOC I think as far as the Department, it has really been apparent to me that early on in this process, historically, we just really have not done a good job incorporating regulatory pressures and anticipating them in our research programming. I think that is something we are trying to catch up on now. I think that is why you are seeing the budget that we are sending up. What I want to make sure of is, when the door closes behind me, being a local appointee, that we are not resting on our laurels and are not trying to move things forward as far as the research agenda. We have spent a lot of time in the last year-and-a-half outside of DC working with RARS, land grant and Extension folks to make them aware of the FQPA, as well as commodity groups. I think that with that awareness we are going to do a better job in the future.
Mr. STENHOLM. Mr. Aidala, upon incorporating actual data into risk assessment, risk levels have been dramatically reduced. Doesn't this suggest that there is a tremendous value to using real data in these assessments as opposed to unrealistic default assumptions?
Mr. AIDALA. Absolutely. Real data is always a very helpful thing to have. Data trumps assumption. Science trumps speculation. We would agree to that. Sometimes the problem we have is that we have to use the best available information. I also think there has been a concern by many constituencies in this whole arena about the level of reasonableness, orI forget the adjective that you usedunreasonable assumptions. We have to use some assumptions as we go through some of these analyses in order to, at least, get an initial view. Often, what we dowhether you want to call them unreasonable or overly conservative, or simply conservativewe often find out clearly to then not have to do any further work. It saves us time and money, the registrants and the growers.
If you grow a commodityfor example, cottona cotton crop has often not gotten a heavy dietary presence, compared to, say, a fresh fruit or vegetable. Obviously, that may mean when we do these preliminary assessments, that some of the grower groups that might otherwise be involved know that we don't have a stake in this particular one. You might as we go on further in accumulative. But right now, that tells something that we need to know. That is the spirit in which we use a lot of these models and assumptionscall them preliminary assessmentsin order to make that initial priority list or agenda. It does come at some cost.
Page 37 PREV PAGE TOP OF DOC We need to then be, and I think we have been, properly placing those in context. We are open to any feedback. These are preliminary and could change, but here is what we know now.
Mr. POMBO. Mr. Moran.
Mr. MORAN. No questions.
Mr. POMBO. Mr. Goode.
Mr. GOODE. I would like to ask Mr. Aidala just a question or two. I was not here when the Food Quality Protection Act was passed. In testing pesticides, do you use EPA employees, mainly, or do you contract out?
Mr. AIDALA. The data that we have to assess a pesticide for decision to approve or not comes from the company. They have to conduct according to what we call ''good laboratory practices,'' which is a sort of formalized protocol, which lays out what they have to do and how, and how long to keep the data. The data, itself, is generated by the company.
Mr. GOODE. So, it is all in-house?
Mr. AIDALA. It is not our house. It is company-generated.
Mr. GOODE. I can't understand why it takes, if you don't do any testing yourself, 40 months to do your analysis.
Mr. AIDALA. Mr. Johnson, in an earlier life, was in charge of the registration division, so I think may have some unique insights on this and will ask him to respond to that.
Mr. JOHNSON. Mr. Goode, for a typical food-use pesticide, a company will develop approximately 120 different types of studies that try to assess what the human health and environmental fate of the chemical are. Just taking one of those studies, for example, a chronic study to look at whether it may cause cancer, there are over 500,000 data points in just that one study. Of course, what our charge is is to do an independent evaluation of those 120 studies; then to a combine what does that whole picture look like, both for human health assessment as well as the environment. That process takes a long time.
Page 38 PREV PAGE TOP OF DOC Based upon my experience in industry and my experience at EPA, frankly, takes about the same amount of time for toxicologists, if you will, at EPA as in industry. As Mr. Aidala pointed out, the 40 months to review a new chemical also has quite a bit of queuing time where the application is waiting for the scientist to sit down and review.
The last comment is, we use a combination of both scientists within the Agency, and for those functions that are not inherently Government functions, we actually contract out independent review. We use both those sources to try to accelerate our review, while maintaining sound science.
Mr. GOODE. Thank you, Mr. Chairman.
Mr. POMBO. I would like to followup on a question that Mr. Stenholm was asking. I believe you said that in your initial assessment that you do make some assumptions, at the beginning. I think what concerns a lot of people is that those assumptions then find their way into the process. You proceed with your analysis of a particular chemical with those assumptions being in place. Are you telling us that you don't do that now?
Mr. AIDALA. We use assumptions. For example, there is one assumptiona model, if you willwhen we assume that, in the kind of study that Mr. Johnson just referred to, whether or not it causes cancer in the animals and what is the proper way to extrapolate its potential human risks. That is a model and an assumption: when we dose animals to see whether or not they cause cancer, that tells us something about potential for human health risk.
The bigger controversies come when there are either broader, sort of call it less-well-refined assumptions or models; also, where it is not clear, exactly, how they were built and have they been previewed and all those other appropriate questions. One of the goals that we have had all the time, but emphasized by the Vice President's memo emphasizing part of the TRAC process, is transparency: understanding what were are doing, why, when and then, shall we say in a later assessment, ''Did you still keep this? Did you change that? Shouldn't you change that?'' Or, ''I want to argue about that.'' That is all part of the transparency process.
Page 39 PREV PAGE TOP OF DOC In general, and then in particular, what the TRAC did is lay out nine science policies in some sub-issue, kind of getting specifically at that. How are you going to assess residential exposure, water exposure and other examples?
Mr. POMBO. But that, in taking your nine science policies, and I have them in front of me, a lot of the assumptions that you make in coming up with your answers to each of these different science policies are based upon models or assumptions that I think are questionableor, a lot of people believe are questionableas to whether or not they are giving you accurate data.
Mr. AIDALA. The model themselves are based on science. They are peer reviewed in almost all cases. Or they are subject to peer review if they are still under development. They are based on the actual data that is input into them. Again, I think there is a distinction between using them, and, shall we say, people understanding when they are used. There may be some disagreement about their appropriateness to use them. Obviously, in general, the first cut is when we do these sort of broader, if you will, more conservative models. Then we go to further refinements.
The testimony of other witnesses, for example, will cite some of these specific examples. We agree with you in terms of that process. When you go from using the broader assumptions down to the more narrow specifics, supplemented by either more refined estimates, additional data from the Department, the growers and the companies, that is how you then improve your assessment.
Mr. POMBO. Let me ask you about one, specifically: the interpreting no residues detected from exposure assessments. If you are assessing a particular crop or a particular chemical on a crop and there is not residue detected, does that go down on the book as a zero, or does it go just below the detection amount?
Mr. AIDALA. Neither one. What we have as a policy, and this is one of the policies subject to notice and comment and getting some public input on, is whether or not zero is really zero. When is it? When should it be? I current policy, for example, would be to say that at least in our initial assessments that we will have half the level of detectionnot right belowbut half the level of detection. There is some statistical justification for that given that if you don't detect it, you don't know exactly what the number might be.
Page 40 PREV PAGE TOP OF DOC Mr. POMBO. Is that number then subjected to the 10-fold?
Mr. AIDALA. No. That would just be simply the number that you put into your risk assessment.
Mr. POMBO. But when it goes into the risk cup; when you add up all these different exposures, it has a 10-fold safety factor at the end. So it is times by 10, is it not?
Mr. AIDALA. For example, if there were a number of non-detects in an assessment, we would do an analysis assuming half the level of detection. If that was the only question at hand: full data set; fully valid data; no increased sensitivity in the animal studies, and so and so forth, the FQPA safety would be removed. It would not be added because it is unfound.
At the same time, let us say that the case being brought before the decision makers indicated that, for example, ''Gee this appears to have an overly full risk cup, but it is never found on any food in the FDA samples or the USDA PDP.'' Would that concern us? Would we start asking more questions? Absolutely. It is what we called and is referred to in our testimony, and, I believe, in Mr. Pitt's statement, a sensitivity analysisif you will, a common sense test.
We also have another policy that we have issued for comment. For example, if we have no expectation of finite residues, which is sort of the term of art, should we then not have it be subject to meeting a tolerance at all? I don't know Keith if you wanted to add anything?
Mr. PITTS. I wanted to use an example of what we are doing with sensitivity analyses on zero-detects that we are finding. We have run the risk assessment at the old policy, which is half the limit of detection to see what happens with the risk cup. Then we drop all the uses out, but have no detects and see if it changes the risk cup, as well.
Page 41 PREV PAGE TOP OF DOC Mr. AIDALA. Right.
Mr. PITTS. So, we do it at half. Then we do it at absolute zero. If it doesn't change, we understand that it doesn't really have an effect. But if it did change by running those two sensitivity analyses, we would have a lot of discussion about what it means.
Mr. AIDALA. It is common sense. You are making a good point.
Mr. POMBO. That is what I question, the common sense in the whole thing. I just picked out one of your nine. I think I could make the same argument on seven out of the nine, or six out the nine, that the same kind of question comes into play in terms of what the final data tells you.
You know the drinking water standards that you use. What you happen to have in one particular part of the country; how that gets extrapolated across the entire country and gets included in the entire risk cup for a particular chemical, I think, gives you a very, very, very safe outcome. But at the same time, I question whether or not the data that you are basing the outcome on is accurate.
Mr. AIDALA. Well, you are basically on the right track, Congressman. If it is safe, even using that very crude assumptionone number for the entire countrythen that is helpful to know. Then we don't have to ask further questions. We can go on other kinds of work. As we have said, there is a backlog of work at any given time. At the same time, too, the company does not have to spend more money trying to further articulate exactly what the numbers might be in different parts of the country. That is the first consideration.
The second consideration is, would you just use that one number and then stop and say, ''Oh, my goodness, we have a problem. We need to deny approval, or do what ever?'' The answer is no. What we would do in those cases is ask, given thisin the jargonvery conservative model, this very safe assessment, does that make sense? One issue that came up, for example, in a particular decision facing us last year was whether or not a material might get into water. In general, it might as a profile from some of our models. But where is it really used? It is used in Texas or west Texas where it doesn't rain much, sometimes. Don't want to get into that issue with the drought recently, but does that make sense? Is it going to get into ground water in west Texas? Well, not if it doesn't rain or given the historic rain patters, if you want to call it that, compared to what the rain might be in New England. This is, again, a common sense test that you thenwe call it ''peeling back''peel back the decision and say, ''What is really going on here?'' Because it doesn't rain much in west Texas.
Page 42 PREV PAGE TOP OF DOC Mr. POMBO. My time has expired. Well, I do have a lot of questions about the assessment that you are doing and the factors that you come up with your final decision on. As I have tried to walk myself through this over the past several months, it just raises more questions and concerns on my part. In having had the opportunity to talk to some of the folks that work at EPA and are working on this issue, they also see some need for doing it a little bit different way that what we are doing and coming out with a better idea.
I don't necessarily blame EPA and USDA for all of this. I think Congress has to have the courage, if there is something wrong, to change the law and not just to keep blaming EPA and USDA for it. That is why I think that there may be a need to go forward with amendments. Mr. Stenholm, did you have any further questions?
Mr. STENHOLM. Yes. Just one question and then a comment. Along the lines of the last questioning in talking about sensitivity analysis, I understand from your testimony that EPA will meet and most likely surpass the requirement of FQPA to reassess one-third of the tolerances by, or before, August 1999. Will all the science policies be completed prior to the August deadline?
Mr. AIDALA. Again, I think we have a schedule for the science policies that is part of the attachment to the testimony. What you will see is that the milestones include, certainly out for public comment, whether or not the final policies will be published in whatever time frame. Will all of them be published by August 3 of this year and finalized? The answer is no. Notwithstanding that, we do planthis is this chart over here to my rightwe still have enough information about enough tolerances that need to be reassessed that we will meet the deadline.
Not all tolerance decisions facing us are keyed to an ongoing science policy that is still subject to some possible change.
Mr. STENHOLM. Will you have all the decisions on the OPs and carbonates completed by the August deadline?
Page 43 PREV PAGE TOP OF DOC Mr. AIDALA. No, we won't.
Mr. STENHOLM. Then the obvious question: How can you make final decisions on any compounds until you have the science policies?
Mr. AIDALA. Because a lot of decisions that we face are not ensnared in some of the ongoing science policies. Let me give you one example. In some cases there may be reassessments completed because, notwithstanding some of the things Mr. Pombo mentioned about an overly conservative assumption, it meets the test. If it meets the test, it can be reassessed, even though we might further refine that reassessment or change that policy underneath and making it a less conservative model as we improve it.
Another time might be where, in some cases, the registrant has decided for a number of reasonseconomic reasons and other thingsto drop all those tolerances. That counts in our accounting system as a reassessed tolerance. There are a number of kinds of things that we do. When we look at a section 18 emergency exemption, it was a chemical that was first approved before FQPA, we have to do some type of FQPA-type analysis. That will help us decide what we think of that chemical. It might not, again, ensnaredif you willby some of those science policies that are ongoing.
With PDP data that we are getting from the Department, we can make a clear conclusion. One issue that is at controversy is that 99-percent level, is that overly conservative? Is it reliable? What if the analysis tells us that even at a lower level we have enough information to make a decision? That is where we are making those decisions.
Mr. STENHOLM. Mr. Chairman, my comment is this: I have been sitting at this dais now for 20 years listening many times to EPA and USDA discussing the issues before us. This has been one of the most refreshing discussionstestimonies, answers to questions, the targeted questions, Mr. LaHood's bill and the specific questions that he asked, and your answersthis has been one of the most refreshing to me. To me, this indicates we are making progress, but you have stated over and over, we have a long way to go. There are many stakeholders. When we start talking about interpretation of science, I know that any opinion is going to have different scientific interpretations.
Page 44 PREV PAGE TOP OF DOC Ultimately, you have to get a consensus. I believe we are now moving toward consensus science instead of opinionated science, which has been the problem of EPA in the past and which earned you the bad reputation in growers' circles. This is refreshing. Again, what we have always asked for is transparency; allowing all of the stakeholders to participate; recognizing that the protection of the safety of the food is utmost and primary; but, also, asking those who take different opinions to realize that there is a risk in eliminating pesticides.
There are increased costs; the lack of availability of fruits and vegetables, which is a risk of doing what some would ask you to do on a regular basis. There is a risk there. That needs to be debated in transparent and open hearings. I acknowledge that. I also want to repeat, lest I be misunderstood by my comments regarding the ''dog'' advertisement, I respect the rights of that group, to run an ad. They criticize me for my support for many in the agricultural community for the positions that I take. Criticisim is a valid right of any citizen, but you should identify who you are.
I don't think it is fair to criticize me for doing what I openly do, unless you are prepared to be subject to the same criticisim. Aren't we blessed to live in a country that has the most abundant food supply; the best quality of food; the safest food supply at the lowest cost to our people of any other country in the world? I challenge those who don't accept that to an open debate.
Again, Mr. Chairman, I commend you for this hearing. I am hopeful about the cooperation that we have seen between USDA and EPA and the participation by all of the groups. We can resolve this, administratively. If it takes legislation, Mr. LaHood, I will be among the first to co-sponsor your bill.
But, right now, I thank you for being here. I think we are headed in the right direction. We keep moving forward.
Mr. POMBO. Thank you, Mr. Stenholm.
Page 45 PREV PAGE TOP OF DOC Mr. AIDALA. I would also to any member, myself, members of our staffI am sure speaking for the Department, alsobe happy to come down and sit with yourselves or your staff, whatever it takes to walk through these things. Even if you do have some points of disagreement, at least to better understand it. This is a very technical-based subject. It is very difficult to understand.
FIFRA is one of the shortest statutes. The Food and Drug Act provisions are not very long, either. But it has a huge impact and it is science-based and very tricky. We would fully admit that. We would be happy to sit down and do, sort of, a mini TRAC presentation for any member and any staff.
Mr. POMBO. Mrs. Clayton, you have a follow-up question?
Mrs. CLAYTON. I did, but since he has made an offer to come and walk me through it, I think I will just walk through it. But I want to express, also, my appreciation of the working attitude and cooperation of trying to bring both the needs of a continuous need for public health and safety for food and for consumers and children and others. I was impressed at one of the one potential effects from your exposure. So I wanted to make sure that we had all the concerns there.
Also, we as an agriculture committee should be perceived and understood by everybody that we want to be environmentalists; we want to have health. I don't see it as either/or; I think it is both. We are trying to find out how agriculture, growers and producers can make a good living and continue to produce food. But also, they respect the necessity of always having a goal of a safer product. In the end, if their products are not safe they suffer.
I want to thank you.
Mr. POMBO. Thank you. Mr. LaHood.
Mr. LAHOOD. I just wanted to followup on something that Mr. Stenholm said. In a way I agree with what he said about the fact that I think this has been enlightening. I think we are making a little bit of progress. I would say that has come only becauseand you probably don't agree with thiswhat the Vice President did last yearas a result of that fact that I had a resolution that had over 80 co-sponsors last year that took his language, the Vice President's language, in the letter that he sent to you folks. And the fact that we have had an outcry from people in agriculture country. I think the progress has come at a cost of scaring the hell out of people in agriculture to the extent that they have come to us and said, ''Hey, we are worried about what is happening or what is not happening.''
Page 46 PREV PAGE TOP OF DOC I hope that you will continue your initiatives. I hope you will continue to make progress. We can move ahead with some of the work that you are doing now. I think it comes as a result of the fact people in agriculture country were really worried about the fact that they were not going to be able to the things they have been able to do in the past. The bill was not being implemented in a way that they thought it would be implemented. It took the Vice President's office. It took legislative activity up here.
I am going to accept your invitation. At some point in the next couple of months, I would like to have a status report on where we are. I think you, alsoI know this is probably not part of your job. I am going to be able to go back and tell people that I represent that I think we are beginning to make some progress.
In some way, shape, or form, I think you have an obligation to do that, too. Perhaps you do that to people who send you letters or call you or whatever. I guarantee the message that you have conveyed here today is not out in the hinterlands around the country. It simply is not. People are scared to death out there, just as we are beginning the planting season in the of the country that I come from. Thank you very much.
Mr. POMBO. I did have further questions. I will submit those to you in writing, if you could answer those.
Mr. AIDALA. I will be happy to do that, Congressman.
Mr. POMBO. I would appreciate it.
Mr. STENHOLM. Mr. Chairman, I would assume that goes for all Members and any additional questions we might submit for the record.
Mr. POMBO. I will ask the panel. I am sure there are additional questions. I know that Mrs. Clayton has additional questions, as well. Those will be submitted to you in writing. If you could answer those in a timely manner, we will hold the committee hearing open in order for you to do that. I will caution you that we will not hold it open that long. If we don't get answers, I will send Mr. Stenholm down there and he get them. [Laughter.]
Page 47 PREV PAGE TOP OF DOC But we would like you to answer those. I understand that Mr. Johnson is going to stay, if we have additional questions with the other panels. I would request the USDA, as well, have someone stay in case there are questions that deal with you.
Having said that, I will dismiss this panel. Thank you very much for your testimony and for the answers you gave to our questions.
I would like to call up our third panel: Mr. William Lovelady, Mr. Herbert S. Karst, Mr. Dean Kleckner, and Mr. Doug Wilson.
Thank you all for joining us. I think you all are probably familiar with the time limit. We have a 5-minute time limit for your oral testimony. The lights in front of you are similar to a traffic light. Green means ''go,'' yellow means ''hurry up,'' red means ''stop.'' If you could try to stick to that 5-minutes as closely as possible, we would appreciate it. Your entire written testimonies will be included in the record.
Having said that, Mr. Lovelady, if you are ready, you can begin.
STATEMENT OF WILLIAM LOVELADY, FORMER PRESIDENT, NATIONAL COTTON COUNCIL
Mr. LOVELADY. Thank you, Mr. Chairman, for you interest and your leadership in this issue and for the opportunity for me to speak on behalf of the National Cotton Council.
My name is Bill Lovelady. I am a cotton farmer from Tornillo, TXthat is near El Paso. I am also a former president of the National Cotton Council and I represent cotton's interest on the Tolerance Reassessment Advisory Committee.
As a farmer, I am proud that American agriculture produces the most abundant, the highest quality and the safest food and fiber supplies in the world. To maintain this production, there are tools that we need to protect our crops from the ravages of insects, diseases, and weeds. Analyses indicate that if cotton farmers lost the use of organophosphate compounds, economic losses would totally approximately $7.2 billion per year. This estimate does not include the use of other necessary compounds.
Page 48 PREV PAGE TOP OF DOC Mr. Chairman, I testified before the subcommittee last year during a hearing on this very same subject. There have been some positive developments over the past 10 months, but there are still quite a few concerns. It is a absolutely critical, that FQPA be implemented with the use of sound science. In fact, the statutory language of FQPA requires EPA to use solid, reliable data in its tolerance reassessment. However, in the absence of good data, EPA often relies on conservative default assumptions, such as assuming 100 percent of a crop is treated at maximum rates. These assumptions grossly exaggerate risk.
An example of the problems involved with such assumptions and one which, I am sure, you will hear a lot about today is the case of azinphosmethyl, or the brand name Guthion. At the initial phase of its assessment, EPA's default assumptions led it to overestimate the risk involved with the use of Guthion by 95 times. Such a discrepancy in risk assessment clearly illustrates why it is critical that EPA use data which reflect real-life situations.
EPA can only use sound scientific data, if it has such data in hand. The Agency must inform the agricultural community and the registrants of data it is lacking. The agricultural community is very willing to provide necessary data. The National Cotton Council is currently working with the EPA on data regarding the feeding of waste products from ginning operations. We discovered that EPA's initial assumptions over estimated the amount of gin trash that is in the diets of beef and dairy cattle by 7 to 20 times.
The TRAC has been a useful means for producers to participate in FQPA implementation and to voice their concerns. The TRAC has met on five different occasions. Its sixth meeting is scheduled for the end of this month. I encourage that this committee, or a similar forum, be continued at least until the time that EPA has established a well-defined methodology for reassessing existing tolerances and establishing tolerances for new products.
During the TRAC meetings, EPA decided upon nine science issues, which it believes are important for FQPA implementation. The position of the agency on these issues is being published in the Federal Register for public comment over a period of time. We support this type of public participation. On the other hand, the final completion of the science policy issues is not scheduled until the first part of next year. In the meantime, EPA will be making tolerance decisions for the August 3 deadline before it has all of the science policy issues resolved.
Page 49 PREV PAGE TOP OF DOC The TRAC meetings have also resulted in an increased role for USDA in FQPA implementation. We fully support a higher level of USDA participation, especially with the planning for transition strategies. USDA is currently reviewing EPA's revised risk assessment for organophosphates. The Department is utilizing the expertise of the land grant universities for further review and input. We support this approach, providing that USDA is using land grant faculty who are familiar with the respective crop and their protectants.
We are concerned, however, that over time that use of university resources could place a burden on that system. We also support USDA's Pesticide Data Program and National Agricultural Statistics Service for the data that they are generating.
EPA has funneled much of its time and resources into the reassessments of the existing tolerances under FQPA. We do not want EPA's other responsibilities, such as section 18s and registrations of new active ingredients, to suffer. EPA is interpreting FQPA to say that a full-blown FQPA tolerance must be determined to issue a section 18. EPA should adopt an incremental risk approach for evaluating and approving section 18 requests.
The National Cotton Council is also concerned that the implementation of FQPA has detracted from the registration of new crop protection products. Farmers need a variety of products for resistance management, for specific pest problems, and potentially, to replace organophosphate uses.
Mr. Chairman, as I have said, there have been some positive developments in FQPA implementation, but there are still some concerns. The National Cotton Council looks forward to working with your subcommittee on these issues. Thank you again, for this opportunity to speak to you.
[The prepared statement of Mr. Lovelady appears at the conclusion of the hearing.]
Mr. POMBO. Thank you.
Page 50 PREV PAGE TOP OF DOC Mr. Karst.
STATEMENT OF HERBERT S. KARST, PRESIDENT, MONTANA BARLEY GROWERS
Mr. KARST. Thank you. I am Herb Karst. I am a wheat, barley, and canola farmer from northern Montana. I also serve as president of the National Barley Growers Association. It is a pleasure to appear before the committee today.
We have submitted our written testimony. In light of the repetition in some of that testimony to other comments, I would like briefly summarize and make some oral points.
I think that out crop, maybe more than any other crop, is in dire trouble. Those of you that saw the planting reports for this year will notice that barley acres in the United States are projected to be down 17 percent in this coming year. That is a huge decrease in one year. That decrease can be directly attributed to insect and disease problems in the Red River Valley in Washington, and the economic pressure that we are receiving across the border from Canada. By contrast, that same Canadian production is often treated with chemicals that have not been approved yet in this country.
Faced with those two facts, we are in dire straits in my industry, in barley. We have some specific concerns, and, also, a couple of specific ideas that we can see that could help our industry. First of all, we are a niche. We are not classified under the minor-use crops, under the Food Quality Protection Act. We have over 300,000 acres. We have about 6 million acres of barley. Because we are one of the smaller of the major crops and a lower-value crop, we often are not on that priority list. If fact, we are never on that priority list for section 3 registrations. That puts us in a very difficult niche between the major crops and the minor crops in getting chemicals approved.
I listened with interest at EPA talking about a program, the sharing of costs between the private companies to expedite the registration. However, that for a small crop, could only make those chemical products more expensive as those costs are passed on to our producers. So, I caution that approach, as well. But I do think we have to make sure that EPA understands the niche that lower-acreage crops are in.
Page 51 PREV PAGE TOP OF DOC We need section 18s that are timely. Under section 18s I think that it was just mentioned, the incremental risks. I think the one fact that gets overlooked on section 18: these are often for insect pests. These insect pests often attack very rapidly and spread very rapidly. One day, you might have a 1 acre infestation, and the next day 10 acres, and the next day 100 acres. Incremental risks and judging the total use of that pesticide in an emergency situation should be a factor in allowing an emergency use. So, we support Congressman LaHood's proposal in his bill that he is proposing.
We also see that using residual requirements from similar grain cropsfor instance from wheat to barleytransfer of those residual data could serve to expedite the registrations for crops like barley. They are grown in the same areas. They are grown under the same agronomic conditions and the same type of uses. We see that where the science supports that transfer of residual data, residual data can be transferred to a limited-acreage crop.
I want to say a few words, also, about the new harmonization procedure. That is something that we have not touched on today. For our crop, that is very important. The harmonization that we see starting to take place in with Canada and Mexico, where we can use residual data from these countries and come up with joint registration of chemicals. We do, however, support taking that one step further. We are in a situation where nearly all of the major chemicals we use are higher-priced in this country than they are in Canada. The chemical companies will tell us that is because, possibly, the higher cost of registration. That is not necessarily the case. But whatever the case is, part of the difference is just the change in the dollar values. We need to go to NAFTA labeling of products so they can be purchased and used cross-border, if indeed we are going to importing the food products from Canada and Mexico, the we have to be able to compete with input costs that our competitorsin my case only 2 miles north of meare using. We support that harmonization process. We hope that it's work is indeed done by the 2002 deadline.
Page 52 PREV PAGE TOP OF DOC The last thing I would like to mention is that during the reassessment process, it was pointed out earlier, the section 18s were slowed down. We would like to cooperate with EPA in making sure that they have the resources necessary to continue to shorten those times for the full registrations, as well as the section 18 registrations. We would like to support them in any way they can make more resources available, if need be.
With that, thank you for letting me appear before the committee this morning.
[The prepared statement of Mr. Karst appears at the conclusion of the hearing.]
Mr. POMBO. Thank you.
STATEMENT OF DEAN KLECKNER, PRESIDENT, AMERICAN FARM BUREAU
Mr. KLECKNER. Thank you, Mr. Chairman. Thank you for holding this hearing. I am Dean Kleckner. I am the elected president of the American Farm Bureau. I am a corn, soybean, and hog farmer in north central Iowa. Hopefully, we will be planting corn later this week.
Like everybody else, or almost everybody else, Farm Bureau supported passage of FQPA in 1996. Today, as we approach the third year anniversary, how the act is being implemented is causing great concern. We are now being told that farmers must mitigate risk for many critical pesticide tools, some of which have been used safely for more than 40 years. This could mean outright cancellation of some uses and dramatically alter uses of some others.
The organophosphates represent the single, most important class of insecticides used in the United States and are the target of EPA. Others will follow. This will only increases farmers and Farm Bureau's anxiety and concern. For the farm economic crisis, now is not the time for increased regulation and costs for farmers. This issue, FQPA, has become Farm Bureau's highest concern. It is our No. 1 priority issue last year and again this year.
Page 53 PREV PAGE TOP OF DOC These concerns gave rise to an unprecedented coalition effort. Last summer, Farm Bureau, American Crop Protection Association, National Food Processors, commodity groups, pest management organizations and over 50 others, known as the Implementation Work Group, ''IWG'', completed and released the FQPA Road Map Project. The Road Map, we believe, is consistent with Vice President Gore's Memorandum on the implementation of FQPA. Both call for sound science, transparency, transition in the process and stakeholder involvement.
Since release of the Road Map, we have worked with EPA and USDA and remain very concerned for the future of agriculture, as implementation efforts proceed.
Our concerns: First is sound science. Before the FQPA the focus was on food. After FQPA, the focus is still on food, but additional exposures must now be considered, like drinking water and residential exposures. These provisions seem to make sense. What doesn't make sense are the unrealistic default assumptions EPA is using when data are absent or incomplete. If we look hard at this, it becomes clear that those types of assumptions have very little resemblance to real world exposure, and that actual data lowers risk considerably. The charts you have been looking at just proves that: 10,000 down to 100 percentfor heaven's sakewhen you go from assumptions to real data. It is unbelievable.
Farm Bureau has filed a petition with EPA calling for the use of the data call-in provision that was in the law. I want to submit a copy of this petition to the subcommittee. Another area of great concern to us is a so-called ''cumulative approach.'' If this provision is implemented using defaults, the result could be the unnecessary cancellation of entire classes of chemicals and the loss of critical crop protection tools for growers.
Another issue is transparency. We trusted that the implementation process for FQPA would be open, transparent and follow established administrative procedures. It has not. Vice President Gore's memo shed light on this subject. EPA then began to act upon the memo by forming the Tolerance Reassessment Advisory Committee, or ''TRAC.'' Bill Lovelady serves the TRAC. Out of the TRAC, EPA began to establish sets of science policies for public comment. However, nearly a year after the Vice President's memo, and only several months from an August deadline, only 1 out of the 20-plus policy papers has been re-released to the public, and it is not yet final. How can the Agency be making fair pesticide risk assessments at the same time they are still seeking public comment for most parts of that same process.
Page 54 PREV PAGE TOP OF DOC Just because FQPA was passed in 1996, did not instantly make all existing pesticides unsafe. It simply created a new standard with new requirements. EPA must take the needed time to figure out how to implement these new requirements before they rush to make regulatory decisions based on default assumptions.
A third issue is availability of safe crop protection materials for us farmers. New registrations for new, effective and economical crop protection products have not accelerated. They told us that they would. They have slowed.
The fourth issue is international trade. The Farm Bureau has been a long-time supporter of freer and more open trade. Pesticide residue testing at the border is not adequate to catch produce entering the United States that has been produced using a pesticide restricted or eliminated due to FQPA. So while the FQPA potentially regulates farming practices in our country in an attempt to improve food safety and the diets of childrenlaudable; it does then provide a competitive advantage to foreign growers who still can use these tools. It is hard to see how this will improve food safety and provide stronger safeguards for infants and children.
Now a very important issue: the need for legislation. The legislation will not be a rewrite of FQPA. We support legislation that will refine and build upon the process for pesticide reassessment in just two ways. First, by requiring the use of sound science in place of default; and second, by creating transition time for agriculture, the EPA and the USDA.
We don't believe that by passing the FQPA, Congress intended for the EPA and USDA to make hasty decisions based on theoretical risks. Instead, we believe and agree with Congress that sound science and a fair process is a foundation of this law. These themes are consistent with the Road Map and with the Vice President's memo.
In conclusion, our society derives significant benefit from the safe use of pesticides. There is a lot of good news out there for the American food consumer on today, Earth Dayor on any other daythe supply of food is bountiful; quality is unparalleled; variety is ever-expanding; prices are reasonable; the U.S. system, frankly, is unrivalled anywhere in the world. I have been in 62 countries of the world in my travels. The United States has the best food, the most variety and the lowest price. Our quality of life and health, in this country, are evidence of what I have just said. Our hope is that FQPA will allow us to build on these successes rather than turning our back on them. Thank you, Mr. Chairman.
Page 55 PREV PAGE TOP OF DOC [The prepared statement of Mr. Kleckner appears at the conclusion of the hearing.]
Mr. POMBO. Thank you.
STATEMENT OF DOUG WILSON, PRESIDENT, ILLINOIS CORN GROWERS
Mr. WILSON. Thank you. My name is Doug Wilson. I am a farmer in north central Illinois. I raise corn, soybeans, high oil corn, and hybrid seed corn. Had it not been for a generous rain this past week I would have appeared more nervous, because my planter would be sitting still while my neighbors were back home planting corn.
I am president of the Illinois Corn Growers' Association. I am former National Corn Growers' director. I am also president of the Illinois Council on Best Management Practices.
Farmers need a variety of crop protection products to be successful in their farming operations. These products allow for a healthier crop, providing a higher yield, due to protection from pests. NCGA supported the Food Quality Protection Act when it was passed in 1996, and remain committed to the law. We agree with the fundamental goals of the law, including safeguards for children and the establishment of a uniform public health standard. We feel that review of pesticides using reliable data, as stipulated by the law, will ensure public health. However, farmers remain concerned about the lack of a defined process for the implementation of FQPA.
NCGA would like to thank the members of this committee for your continued oversight on FQPA implementation. Corn growers are very encouraged by the role of USDA in FQPA and the implementation process. However, USDA needs to be prepared to handle its increased role in the risk assessment review, which we believe is their key role. We support all necessary resources for this process to continue.
Page 56 PREV PAGE TOP OF DOC We also appreciate the EPA's working on making several of their science policy papers available for public review, and the work that has taken place at the Agency as a result of TRAC. However, we remain concerned about how EPA is using its resources. The Agency has not allocated sufficient funds to ensure that new product registration will continue in a timely manner.
Natural methods of pest control that have worked in the past do not always remain effective. One of the most common control methods employed is a traditional corn/soybean rotation. This is to limit the western corn root worm and other pest pressures. Unfortunately, in areas of Illinois and Indiana and other places throughout the country, we are seeing the western corn root worm beetle adapting and laying eggs in soybean fields instead corn fields so the eggs hatch in rotated corn fields the following spring. This is already happening in Congressman Ewing's 15th Congressional District, where I live, and to an even greater degree in Indiana.
Without effective crop protection products to control the root worm, yields will be cut by 25 percent and the remaining plants will not stand nearly as well and could result in additional losses. In addition, crop protection products are often used in concert with conservation tillage to preserve the soil.
Corn growers have a great deal at stake during the entire reassessment process under FQPA. The policies developed now will set the stage for future actions and reassessments. EPA must have a clearly-defined process in place prior to making assessment decisions under FQPA. NCGA and the Illinois Corn Growers Association have been working very closely with Representative LaHood on this issue. Representative LaHood's bill, H.R. 1334 will assure consideration of sound science before suspending the use of a pesticide and will consider overall public interest before taking such action. Corn growers feel that Representative LaHood's bill is right on target because it addresses implementation of FQPA. FQPA can work if it is implemented correctly.
Page 57 PREV PAGE TOP OF DOC If corn growers are not provided sufficient options for crop protection, U.S. corn production will be at a competitive disadvantage. The FAIR Act allows me to flexibility to grow crops that make sense for my land in terms of conservation, production, and economics. One of the basic precepts of the FAIR Act was the balance sheet: reduced farm program payments offset by more flexible programs and other efforts such as tax reform, increased export assistance, and regulatory relief.
The manner in which FQPA is being implemented is inconsistent with that balance sheet concept. Mr. Chairman, members of the committee, I encourage you to keep that balance sheet in mind as you exercise your oversight authority in this process.
Mr. Chairman, I would like to thank you for holding the oversight hearings 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 impacts of this law on production agriculture are taken fully into account. Thank you.
[The prepared statement of Mr. Wilson appears at the conclusion of the hearing.]
Mr. POMBO. Thank you. Mr. LaHood.
Mr. LAHOOD. Mr. Kleckner, have you looked at the legislation that I have introduced? Has your organization?
Mr. KLECKNER. Yes, Mr. LaHood. I have not looked at it personally, but the organization has looked at it.
Mr. LAHOOD. Do you see some need for that legislation?
Mr. KLECKNER. Yes. There is need for legislation. I am aware that you have introduced a bill. I believe there is going to be another bill introduced very quickly. We hope, I am hoping and I am also believing, probably, there will be a lot of similarity and cooperation between people on the two bills. Maybe there will even be more than the two, in the end, that want to fix what is wrong.
Page 58 PREV PAGE TOP OF DOC As my staff has mentioned to me, on your bill there are a number of good things in it. We want a broadly-based bill.
Mr. LAHOOD. What is your reaction to what was said here earlier by the EPA in terms of what they have been doing? I know you were sitting in the audience during that question-and-answer period and during that testimony.
Mr. KLECKNER. Well, Mr. LaHood, sometimes I was nodding my head, and sometimes I was kind of shaking my head. I don't want to be really super-critical of EPA. I think, in this last year, since the TRAC committee, someone saidmaybe it might have been Mr. Stenholm or Mr. Pombosomeone said that you have kind of been forced into doing something. Maybe, Mr. LaHood, you made that statement. That is probably right, but they have made some progress, it seems. They are working with us. USDA is working closely with EPA.
I have got a lot of questions, yet, about how they are doing things. We believe don't guess, use real data. I think one of the witnesses said something about some kind of level of sensitivity, I think he said, that they had to use when data wasn't available. I don't want to misquote him. I thought that what that reminded me of was an out-of-body experience. That is what, regrettably, popped into my mind. If you don't have real data, I think the FQPA law says get it. Use data call-in. Get at it; don't guess. I really question if they can meet the August 3 deadline, because of lack of data. I am sure Congress put those three deadlines for good and valid reasons. But really, the law is asking, I believe, EPA to do things they can't do. There has been no methodology.
The food side, yes, they have the methodology. But when you start bringing in all the rest of the things that the law says that they have to bring in, it does not appear to usor to me, I should saythat they know how to do. They are feeling their way as they need to. My gut feel is that to meet the August 3 deadline for a number of these chemicals, they are going to still have to do a lot of guessing. Frankly, I see some bad things coming out if they don't have data and make the default assumptions.
Page 59 PREV PAGE TOP OF DOC Mr. LAHOOD. When you leave here today, are you going to be any more reassured that EPA is on track with implementing this the way some of us believe? I will tell you the reason I am asking these questions. You represent an organization that represents, probably, the largest number of people that I represent. One of the reason I got involved in this issue a year or so ago is because a lot of farmers in my district, and a lot of people that Mr. Wilson represents, came to me and said, ''This is not being done correctly.'' I wonder if you are going to leave here today reassured by what was said by the folks at EPA, particularly in response to Mr. Stenholm's comments and what my comments were.
Mr. KLECKNER. Well, I guess I wish I could say that I am leaving here more reassured. I don't think farmers want to be an enemy of EPA. They are an agency that is there and we have to work with them. But I guess, when all is said and done, am I more reassured? The answer would be, no, I am not. I think oversight hearing like this; things that have some out from all of you today; your questions were on target. You have skepticism and concern, and so do I.
Mr. LAHOOD. Mr. Wilson, what is your feeling about what has been said earlier by the EPA and what they are doing, and the progress that they have indicated they believe they are making in trying to meet deadlines and using sound science, and so forth?
Mr. WILSON. Well, I have to say that I have been very encouraged by the comments of the committee today. I think you are taking this very seriously. As of the farmers that I represent, as well, this is very good to hear. I think where I will focus is USDA's role in this, as far as their working as an equal player. I think that it is very important in a secondary review, if you want to use it that way, or as a working partner.
EPA, unfortunately, has not always seemed real receptive to information and questions that we have raised for them. Whenever you start talking about assumptions for my farm, it becomes very personal for me. I will go home. I will hop on the tractor when the field dries out. I will be the first level of potential exposure. I want a safe product. There are also other factors to be considered. There is the economics. There is the quality of our crops. We are paid, in many cases, by the quality of the crop we can raise.
Page 60 PREV PAGE TOP OF DOC In my case with hybrid seed production, you are taking an acre of corn that can be literally worth thousands of dollars and there is no more of that seed available. We need a variety of crop protection tools to be available to us. We can't overuse any particular thing. We can not take it too lightly, at all, what is going on.
I hope that EPA is serious in what they are doing. I will probably also remain somewhat skeptical as this progresses.
Mr. LAHOOD. If we are going to have a second round I will come back. Thank you.
Mr. POMBO. Mrs. Clayton.
Mrs. CLAYTON. Mr. LaHood has started a thought process that I am tempted to continue, but I guess I will restrain myself. Other than to make this observation, there is the old saying that ''the proof is in the pudding.'' Maybe, farmers, you were expecting a little too much. I am reassured that they are moving in the right direction. But I think they are back in the fields and they want to see that what we say and what EPA says is indeed reality. I am hopeful that when you see what they have said and what they do, that you perhaps have some of the same assurance that we have in that area.
I was going to askMr. Kleckner, you mentioned on the tradeI wanted to ask you, what procedures do we have now? Who is the wheat farmer near Canada?
Mr. KLECKNER. This man [pointing].
Mrs. CLAYTON. Mr. Karst. I am sorry, yes. You wanted some harmonization of the inputs between your neighboring competitors. You are having to buy inputs to meet Federal standards that are higher and you are competing with the farmers in Canada, who apparently have a process that is less expensive. The question I have is are there procedures in place now, in terms of the environmental issues, that measure the same chemical science input as well as the cost? For instance, are you assured that what you are having to do also meets the same standards that the Canadian farmers have to, if we buy the same products that you are growing? Does our trade policy protect you or give you assurance that you are not having to do a higher standard? Apparently, you know that you are being required to pay more money.
Page 61 PREV PAGE TOP OF DOC Mr. KARST. Well, there are about three questions. First of all, I will say that as a result of some of the northern States' Governors' actions last year in questioning the safety of some of the imported products from Canada, talks were held between the United States and Canada, not just at the executive level, but also with their environmental agency there, the PRMA and our EPA. As a result of a December agreement, there is an ongoing set of consultations with Canada at this time to increase the harmonization of the registration process and eliminate the duplication.
Certainly I applaud this process. I don't know if necessarily the process is more expense in this country or not. I don't want to take judgment on that. However, I do know that for the major crops that I grow there are five chemicals available in Canada for use on barley that aren't available in the United States, at this point. There are 10 on wheat that are available in Canada that aren't available in the United States. There are 14 on canola that are available in Canada that are not available in the United States.
We are making progress on that issue. But those three products are continuing to be imported across the border, right past my front door. Just yesterday, on the way to the airport, I passed six trucks containing 20,000 bushels, almost, of Canadian grain being importedusing these same products that we are still prohibited from use.
The last part of the question was on pricing and paying more. I think that that will only fully come about when we see a joint NAFTA labeling process, at least between the United States and Canada, and hopefully between the United States, Canada and Mexico, to make it economically viable for producers, as myself, to lower our input costs in competition with same producers 2 miles north of my farm.
Mrs. CLAYTON. Thank you. Thank you, Mr. Chairman.
Mr. POMBO. Mr. Stenholm.
Mr. STENHOLM. I know that everybody realizes this, but we need to repeat it now: When legislation is offered to make corrections, this committee has a very small amount of jurisdiction. This legislation would go to the Commerce Committee, as a result of the FQPA. It is certainly my hope that we can take the current law, with appropriate administrative corrections and, working the TRAC committee and various groups, have achieved the same desired result. It seems that might be a little easier.
Page 62 PREV PAGE TOP OF DOC Mr. Lovelady, in your testimony you talk about the burden that is being placed on our land grant institutions and perhaps that we should find some way to compensate them for it. I would rephrase that a little bit and suggest that our land grant institutions and all others who are concerned about this matter might look at ways in which we might reprioritize and make sure that we do have the adequate resources to develop the sound science and give you and the farm groups represented here the kind of back-up that we need. I think that is one of the answers that has avoided us in the past. We now have a very good opportunity at our disposal.
You also suggest that since the TRAC committee is on a phase out, we need to continue the process. Do the rest of you agree with that suggestion?
Mr. KLECKNER. Mr. Stenholm, we agree, the TRAC has been a great success. I compliment you and Congressman Berry on your efforts with Vice President Gore to get that memo to get all that going. The Vice President gets all the credit, as he should, but I know that you two did an awful lot to get him to move on it. I think he was not aware of the problem.
TRAC has been a success. There is going to be another meeting next week. I think one more is scheduled later this year. I would just urge this committee to do what you can do to keep TRAC in existenceI was going to say on track. But I think if they are in existence, they will keep exerting the common sense that was lacking before TRAC was formed. That is really what we talking about is common sense, good science, and good judgment. We farmers will live with that. None of us want to use anything that is harmful to consumers, here or anywhere in the world. I have been accused of being anti-organic. I am not. I will show you an organic tomato. I showed a couple of your earlier. This was bought last night at a major Washington, DC supermarket chain. The whole box was like this. A big sticker on it said, ''organically grown.''
Now, let me say that I have a son that grows. He bought a farm a year ago that was organic. He grew organic soybeans last year. He intends to keep it organic. I am completely in support of that. I am not anti-organic. There is nothing wrong with this tomato. In fact, I am going to eat it if I ever get a chance to. [Laughter.]
Page 63 PREV PAGE TOP OF DOC I will just cut away the blemishes and it will be very good. I don't think it will be any better than tomatoes that look better and were grown with chemicals. It cost more. These were $2.49 a pound. This was a 90 cent tomato. You don't feed many poor kids in the inner-city with 90 cent tomato. My point is we need crop protection chemicals. We use them wisely; we use them well. We will not feed the 6 billion people in the world today and the 9 or 10 or 11 billion that will be here in 40 or 50 years, if present trends continue. We will not feed them organically.
Mr. Stenholm, that is the long answer for ''Do we support TRAC?'' Yes. [Laughter.]
Mr. STENHOLM. You are getting like us politicians; you can go on and on because I couldn't agree more. I am hoping you are going to share that tomato with us. We have missed lunch, too.
Mr. Lovelady, you also pointed out in your testimony something that Mr. Aidala also made reference to. He did it a little differently talking about how it doesn't rain much in west Texas, therefore the rules shouldn't be the same in all regions of the country. Everybody at the table agrees. You also pointed out gin trash and other things. I really think the communication between EPA and USDA is going to be tremendously helpful with the decisionmaking process, as more people understand, what is involved in cotton production in your case and barley, wheat, corn production, and all of the other commodities.
Along the same line, this is more of a statement for each of you in your organizations to consider in an effort to be helpful to this committee. When we start talking about resources, we are operating under very tight budgets. In fact, if we are looking at the budget that passed here last week, we have big troubles maintaining what we have, much less increasing.
Therefore, I think your suggestion was good, I just framed it differently. I think that we really have to ask ourselves, through our Land Grant institutions, one of the questions I constantly phrase to EPA and USDA. Since EPA seems to have more money for this purpose that USDA, could there possibly be some cost sharing? The resources that we are allocating to EPA, could they reallocate those or suggest to the Budget Committee and the appropriators that some of these resources be reallocated in order to get more bang for the taxpayer buck? It is something that we really ought to think about, and not worry about turf.
Page 64 PREV PAGE TOP OF DOC That is the problem that we have with Mr. LaHood's bill. It doesn't come to us, solely, in jurisdiction. We have to work through the other committee to get this done. These are just some observations. I commend you on your testimony. I appreciate your willingness to be part of this.
I think the indication of some kind of an ongoing, constant and consistent TRAC could be one of the most invaluable tools to be used by EPA and USDA as they do that which all agree needs to be done. We question how it is being done and whether it is being done most efficiently, and whether it is going to get done in time for producers to continue to produce. That is a legitimate question.
Mr. LOVELADY. May I make a comment about that?
Mr. STENHOLM. Go ahead.
Mr. LOVELADY. I think it is pretty evident that we need to have some sort of advisory mechanism ongoing at least until we get all of these science policy issues resolved. If we are going to go to another level, to something permanent or semipermanent, I think EPA would be well-advised to streamline the process.
The TRAC is 50-some odd members. That is a very unwieldy group. I think that, at times, it makes it conducive to demagoguery. I would like to see the TRAC be more of advisory nature. And I would like to see the Agency use it more and receive it more as an advisory mechanism and not spend quite as much time on constant updates. I think that it is necessary that we have a mechanism, but I would like to see it streamlined so that we can get more into an advisory mode.
Mr. STENHOLM. Mr. Chairman, if I might just comment? These kinds of suggestions coming from those of you who have been there is going to be invaluable to EPA, USDA and this committee, for deciding the rhetorical answer to the question that I asked a moment ago. I thank you for that comment.
Page 65 PREV PAGE TOP OF DOC Mr. POMBO. Mr. Lovelady, I would like to get back to the science, if we can. There is something that you said in your testimony about 100 percent of the crop being treated at the maximum rate. Can you elaborate some on that statement?
Mr. LOVELADY. That is just an example of what an overly conservative assumption would be. That was not specifically directed at any one thing. That is what happens sometimes when they do not have the information of the percent of crop treated or the rate that is commonly used. They will fall back, sometimes, with 100 percent of the crop used and at maximum rates.
Mr. POMBO. When they don't have the actual data?
Mr. LOVELADY. When they don't have the actual information. There are very few products that are applied on 100 percent of a crop at the maximum level. There may be some of those, but I am not aware of them. None of those things come across my farm. But, yet, that is the way that some assumptions are made.
Mr. POMBO. Let me ask you this: Do you believe that the law requires EPA to make those assumptions?
Mr. LOVELADY. I am going to have to confess that I have not read the entire law. But it is my impression that the law states that they are to use data call-ins and other mechanisms to get the information when it is lacking.
I know in our particular case in cotton, we are in the process of developing coast-to-coast use and usage data sheets on all the organophosphates. So the information is being generated out there. To use these ultra-conservative assumptions, I don't think are in anyone's interest. I think that the law certainly gives them the authority, and I think they are supposed to use data call-ins and other mechanisms when they can.
Mr. POMBO. Mr. Kleckner, as the president of Farm Bureau, I know you represent all of American agriculture. Obviously, I am very aware of some of the impacts this is having on California and some of the decisions that farmers are making right now based upon what may or may not happen in the next few months. One thing that did surprise me, I recently had a group from Massachusetts that came into my office. They were cranberry growers. Because of their concerns over regulations and the concerns of the industry over regulation either current or proposed; they told me that the cranberry industry, which is historically an American industry, the new plantings that are being put in are not being put into the United States. They are being put in in Canada. Their fear is that that entire industry will ultimately abandon the United States because of self-inflicted woundsthings that we are doing ourselves versus what the rest of the world is doing.
Page 66 PREV PAGE TOP OF DOC Can you give me some idea of how prevalent that is within American agriculture today and what you foresee in the future?
Mr. KLECKNER. Well, Mr. Chairman, that is an excellent question. I hear it all over the country. I hear it more in the fruit and vegetable areas than I hear in the corn and soybean areas. It is all over. Farmers are frightened to death. Many of them that have the wherewithal, particularly if they live close to the border and can do it easier, are saying, ''If my country is not going to let produce here, I am going to go somewhere I can.'' I hear a lot in Arizona, Texas, southern California, some along the Canadian border. I hadn't heard the cranberry story, but I am not at all surprised.
There is kind of a pessimistic feeling among farmers that we are getting the job done to us for no good reason. I repeat what I said a little bit ago. We don't want to use these crop protection tools if science says they are unsafe. But use actual data and use good science that is peer reviewed. If they are unsafe, they ought not be used here or anywhere else.
Mr. POMBO. I will tell you what my real fear is. My fear is not that my family or my neighbors are going to move to Canada or Mexico to produce. My fear is that the major processors pick up and move because it is not only cheaper for them to pack or can in another country, it is also cheaper to produce the product in another country. If the major processors move out of this country, whether it is into Mexico or Indonesia or China or wherever it is, if our laws allow them to use products that are not allowed in this country and to ship the finished food products into this country, we are giving them the incentive. As a CEO of a major processing company, you would have the responsibility to your stockholders to pick up and move. That is the message that we are sending to American agriculture, today.
It is, I believe, a major concern that we are going to lose a huge number of these minor crops in the country that are going to be shipped offshore. We are, right now, giving those companies the incentive to move.
Page 67 PREV PAGE TOP OF DOC Mr. KLECKNER. Mr. Chairman, how FQPA is implemented in the next few years, I think, will determine whether or not what you said is going to happen or not. I think we are that close to having it happen.
Mr. POMBO. Well, I know you and your organization have been working with me and others on legislation. I believe you are right. I believe that that will be the straw that breaks the camel's back. I can see, with that crops that are produced in my region, the production of those crops being shipped offshore. Because the finished product, other than a niche market of fresh fruits and vegetables, the finished product can come back in without any restrictions. It is a major concern.
I have heard you guys say that you are concerned and you are worried. I know that my guys at home are. I will say what I said earlier that I can't blame EPA and USDA and the bureaucrats for all of this. Part of the problem is we passed the law that allowed them to do this. We have to have the courage and the strength to pass an amendment to that law that fixes the problems that are out there. One of the only ways that is going to happen is that we have the support of you and that you inform the Members of Congress how necessary that it. That is the only way that is going to happen.
Mr. LaHood, I know you had a followup? Did you have any questions?
Mr. LAHOOD. I have some questions I want to submit for the record.
Mr. POMBO. I am going to go ahead and wrap up this panel, but there will be further questions that will be submitted. I know that a number of members do have questions that they will submit. I will tell you the same thing, if you are submitted specific questions, if you can answer those as quickly as possible for the committee hearing it would be appreciated. Thank you. I dismiss this panel.
I would like to call up the final panel.
Page 68 PREV PAGE TOP OF DOC Thank you for joining us. I know that you have heard the description of the testimony time limits. I think you were all in the room. Your entire statements will be included in the record. If you could limit your oral testimony to 5 minutes, it would be appreciated by the committee.
Mr. Vroom, if you are ready, you can begin.
STATEMENT OF JAY J. VROOM, PRESIDENT, AMERICAN CROP PROTECTION ASSOCIATION
Mr. VROOM. Thank you, Mr. Pombo. I am pleased to be here as a representative of the registrant community. I am president of the American Crop Protection Association. Along with Mr. Lovelady, who was on the previous panel, I am one of 52 members of the TRAC that has been alluded to a number of times. He and I are the only two TRAC members who are appearing here today as witnesses.
I wanted to take an opportunity, at the outset, to indicate that I share Mr. Stenholm's disappointment that those representatives of the environmental community, particularly several members of the TRAC who, I understand, were approached by the committee to appear here today have not been able to. In fact, I talked to one of those individuals late yesterday afternoon to inquire as to the rationale. I understand that her reason for not being here in particular. That notwithstanding, I agree that it is unfortunate that their views are not being expressed here, nor or they able to answer your questions.
I would also observe that the world is watching how we do FQPA. The law is fundamentally a good law, as many of you have said. I believe the registrant community and ACPA would agree with that. It sets out some new higher standards for pesticides to have to meet in order to be deemed to be safe. It advances those standards in a way that the rest of the world is probably prepared, in part, to follow in terms of standard. But we also have to be careful about the implementation and the impact on farmers.
Page 69 PREV PAGE TOP OF DOC The fact of the matter is that it is very, very likely that the playing field for our farm customers, of my industry, and the constituents of this committee in America can suffer substantially. One point that was alluded to earlier in the discussion was the sensitivity of analysis; whether zero counts as zero in applying the new standard, and coming up with applying FQPA to limiting, in new ways, the ways American farmers can use products. While at the same time, if that happens and the access to oftentimes older and less expensive pesticide products is diminished or eliminated, it may still be possible for farmers in Mexico or Argentina or anywhere else in the world who are growing produce for this very rich market might be able to use products that get eliminated or reduced in use for the access to American farmers. That is a very real economic concern that, I think, we share along with the growers that have been here already.
I wanted to talk a little bit about FQPA and the context of the evaluation of old products. The azinphosmethyl organophosphate example has been referenced. I have appended a table to my written testimony. We have posters here for the committee to see and the audience, as well, that is straight from the Tolerance Reassessment Committee Workgroup meeting 2 weeks ago. It was created and shared by EPA with all of us at that meeting. It shows how, at the beginning, in the preliminary risk assessment evaluation of this particular example organophosphate product, EPA estimated using default assumptions and that included assuming that 100 percent of the crops by EPA currently for use by this particular OP would be treated at the maximum number of times per growing season. The last application would be as close to harvest as the existing label allowed, and et cetera. For infants less than 1 year of age, the risk cupthe allowable amount of risk, was exceeded under the FQPA standard by a factor of 100, 10,000 percent of the risk cup.
But after they got around to getting refinement thinking in place internally at EPA, that percentage dropped to 3.3, or 330 percent of the risk cup. Then after they turned it over to USDA for their review and evaluation, and got more realistic data into the risk assessment equation, it is 105 percent of the risk cup. So you can see that USDA's input is vital. But the first cu, that 10,000 percent estimate, was published by the EPA in the Internet as part of the transparency endeavor.
Page 70 PREV PAGE TOP OF DOC Now, another one of our member company's products that was also in that initial Internet posting suffered by way of a Latin American customer that produces bananas cancelling the contract for their product, because they immediately thought the product was in trouble with EPA evaluation. Those are real impacts.
The other thing that I wanted to mention is that the reference that many of you members of the committee have made to new product registration. I wanted to further expound on the record and the information that Mr. Johnson and Mr. Aidala shared with the committee about the number of products in the queue. They indicated that about 70 products, 50 conventional and 20-or-so biological products, that are currently in the queue. Of course, as they also elucidated in response to Mr. Pombo's question, they have prevented us from submitting additional applications for new products because their queue is filled up. They have also applied a lot of arbitrary priorities. We believe, as an industry, the priorities that have been set by EPA to sort of screen or limit the applications and the products that will be first considered for approval and market access, are driven by political considerations instead of the market.
There are at least six priority systems. They are overlapping. They are confusing, and in many cases, conflicting. When you add up our survey you count, including those that are already pending, 107 new active ingredients. I would be happy to submit for the record a copy of the survey we have done of our members of the additional new active ingredients that they will have ready for application if the doors are opened at EPA for review. Our members tell us that they have sunk in excess of $160 million into each new active ingredient that gains registration approval in this country in recent years. But if you take a small, conservative estimate of that, we have something in excess of $10 billion-worth of new technology-sunk cost waiting for pending EPA approval.
I think Mr. Hill has a background as a financial analyst, so maybe he could do the present value computation on that. But those aren't dollars that really are coming out of my industry's pocket. Those are farmer dollars that have been reinvested. It is half a billion dollars a year in present value cost at a 5 percent interest level. That is a cost to American agriculture that is very real that needs to be attended to, as well.
Page 71 PREV PAGE TOP OF DOC I thank you very much for the opportunity to be here and I look forward to responding to your questions.
[The prepared statement of Mr. Vroom appears at the conclusion of the hearing.]
Mr. POMBO. Ms. Smith.
STATEMENT OF FRANCES B. SMITH, EXECUTIVE DIRECTOR, CONSUMER ALERT
Ms. SMITH. Good afternoon. I am Frances Smith, executive director of Consumer Alert. Consumer Alert is the founder and Coordinator of the National Consumer Coalition, which is an ongoing coalition of 27 non-profits that together represent about 4 million consumers. Consumer Alert was founded in 1977. It is a national non-partisan, non-profit consumer group with individual members in all 50 States.
Our organization's mission is to assess public policy proposals for their effects on consumers; promote the importance of sound science and sound economic data to underlie public policy decisions; and to provide consumer educational material on topical issues. Our funding comes from dues-paying members, as well as individual foundation and corporate donors.
We are very pleased to have this opportunity to present the view of Consumer Alert for the subcommittee on these important matters relating to implementation of the Food Quality Protection Act. This is a really crucial time, as many witnesses indicated, for regulatory agencies' decision making on how to interpret FQPA. The intent of the act, clearly, was to correct some of the biases of food safety law relating to risk issues. Unfortunately, the criteria FQPA sets for pesticides could exacerbate these biases if the focus shifts to a standard that considers only risks on one side.
We feel it is critical for policy makers to hear the views of consumers and stakeholders. In our testimony, we emphasize the critical need to adopt a risk versus risk framework for evaluating pesticides and food safety issues. Risk versus risk looks at the risk of innovation, in this case the use of certain pesticides, and evaluates it against the risk of stagnation. That is the risk that may arise from further restrictions or bans on those pesticides.
Page 72 PREV PAGE TOP OF DOC I will explain that a bit further, because I think it is an extremely important concept. In taking action to address a concernto protect consumers from a riskregulators can fall into the trap of not looking at the very real risks that may arise from their own action. I will refer to these as the ''unintended consequences.'' I think some participants have already referred in general to those. Policies intended to protect the public from one risk, might increase risk in another area, leading to overall higher risks to the individual.
In discussing some of the unintended consequences, I would like first to share a true example of those. In 1995, there was a scare about pesticide residues on blueberries in Connecticut. It was widely reported in the media. Prominent toxicologists at the university received many calls from concerned consumers and told them there was only a minuscule risk of any problems. However, one woman caller followed up with a question. She said, ''You don't understand, professor. I am pregnant. Should I have an abortion?''
Again, these are some of the tragic unintended consequences that can result from an excessive focus on small risks, without consideration of how this information is perceived by the public. I will look at some of the less dramatic, but nonetheless, very important unintended consequences that could occur.
With severe restrictions, or bans, on pesticides the retail prices of many fruits and vegetables can rise significantly. We heard that about the 90 cent tomato. That would be pretty indicative, I think. Families, especially the poor, may not be able to purchase an adequate amount of produce for their families' diet. The restriction, or ban, for certain pesticides for non-food use should also be evaluated from a broad public health perspective, especially the effects on the poor.
Inner-city minorities currently have the lowest dietary intake of fruits and vegetables. Higher prices for produce could hurt them the most. The Council for Agricultural Science and Technology reported that the average U.S. family spends only about 10 percent of their disposable income on food. However, 30 million peoplethose with lower incomesspend at least 60 percent of their income on food. Those people have limited means. Any increase in the price of fruits and vegetables could impose a serious economic cost.
Page 73 PREV PAGE TOP OF DOC The science is very clear on the health benefits of a diet rich in fresh fruits and vegetables in lowering the risk of cancer and other diseases. These health benefits, weighed against the risk of pesticide residues, have been the subject of major scientific studies. In a 1997 report, a panel from the American Cancer Society and the Canadian National Cancer Institute concluded that the benefits of a diet rich in fresh fruits and vegetables far outweighs the minimal risks associated with pesticide residues. In its assessment the panel concluded, ''It is not aware of any definitive evidence to suggest that synthetic pesticides contribute significantly to overall cancer mortality.''
Those panels' conclusions reinforce results from earlier studies, such as the National Research Council's National Academy of Sciences 1996 report, which also found no significant evidence of increased risk of cancer due to pesticide residues in food. It also supported the earlier findings on the health benefits of fruit and vegetable consumption.
In one of those studies, the 1997 studyI will go quickly through that because this is a very important pointthe public's perception of risk took an important place. The panel pointed to the unintended consequences if public health policies are decided based on risk perception, rather than on scientific risk assessment. Their report urged greater efforts to present hazards and benefits in a balanced way to the public. I will quote from that. ''It is most important that we find the ways to put hazards into perspective for the public to provide a credible source of factual information to encourage a thoughtful and balanced assessment of both risks and benefits.''
It warned about the public's tendency to be more concerned about potential hazards imposed by someone else, than by hazards that are in control of the individual. That approach, ''may raise concerns that are not appropriate to the level of risk, and also may have the undesirable effect of diverting public attention from areas that present significant public health risks and that are modifiable by individual choice.''
Page 74 PREV PAGE TOP OF DOC Some public concern arose recently as a result of the February 1999 Consumers Union Report on Pesticides and the broad media coverage that got. That report prompted prominent toxicologists to take the unusual action of strongly criticizing it publicly. The Society of Toxicologists, in a letter to EPA Administrator, Carol Browner, said, ''The CU report's conclusions concerning the dangers of pesticides in food are not credible and are unnecessarily alarmist.'' That society is the largest professional association of toxicologists in the world.
Consumer Alert would also caution policy makers that FQPA, as EPA is currently implementing it, provides perverse incentives to manufacturers who will be forced to make choices on which chemicals and which uses of specific products they will continue to support. They may be forced to cut many minor uses, including vegetable crops, ornamentals and many public health uses. Such actions will cause many fruits and vegetables to become more expensive, place U.S. farmers at an economic disadvantage, and put the public at risk from preventable diseases.
Public health uses of pesticides, such as those used to control mosquitoes, ticks and other disease-carrying insects, are among some of the lower-volume uses of pesticides. Most public health applications do not generate enough use volume to justify the decision to retain those products if the risk cup is exceeded. These critical public health uses of many pesticides may be at risk themselves, as manufacturers may face the unenviable task of removing from the market uses of the product that benefit public health. Policy makers should carefully assess the public health risks of applying the new criteria to disease-controlling pesticides.
In conclusion, we strongly encourage policy makers to focus attention on unintended consequences of their actions in regard to pesticides.: The potential harm to people, especially families and the poor, that could result from a focus on risk in a vacuum. Risks have to be evaluated with full recognition of the their benefits and unintended consequences. The potential danger of pesticide residues on fruits and vegetables and on public health uses is infinitely small compared to the many benefits they provide.
Page 75 PREV PAGE TOP OF DOC Thank you. I apologize for going over time.
[The prepared statement of Ms. Smith appears at the conclusion of the hearing.]
Mr. GOODLATTE [presiding]. Thank you, Ms. Smith.
Mr. Dippel, welcome.
STATEMENT OF DONNIE DIPPEL, ASSISTANT COMMISSIONER FOR PESTICIDE PROGRAMS, TEXAS DEPARTMENT OF AGRICULTURE
Mr. DIPPEL. Thank you, Mr. Chairman and committee members. I am Donnie Dippel, assistant commissioner for pesticide programs, Texas Department of Agriculture.
Commissioner Susan Combs is sorry that she could not be here today, but I appreciate the opportunity to testify on behalf of the Texas Department of Agriculture to express my continued interest and concern regarding EPA's implementation of the Food Quality Protection Act.
No one argues with the intent of FQPA. However, the problems have arisen, occasionally, through the implementation. When the agencies responsible for pesticide regulation do not have clear regulatory guidance regarding issues such as risk assessments, uncertainty factors and emergency uses, it is very difficult to fulfill our responsibilities to the people we are in charge of protecting or the farmers and ranchers we strive to support. The changing needs for supporting data, differing acceptable risk criteria and changing environmental fate requirements demonstrate how important it is that the Agriculture Committee continues to provide this kind of oversight and insist that EPA provide clear specific data to States regarding what is required for crop protection product to be approved.
Today, I would first like to outline the Texas Department of Agriculture's commitment to ensure that the implementation of the new pesticide laws is based on real risk, sound science and continued availability of necessary crop protection products. Second, I will outline our experienced, good and bad, with the EPA's application of the FQPA. Finally, I want to suggest policy guidance that will help as States strive to meet the safety standards set by FQPA.
Page 76 PREV PAGE TOP OF DOC Commissioner Combs is committed to ensure FQPA implementation that is reasonable and rational. She became a member of the National Association of State Departments of Agriculture's Committee on Pesticide Regulations, which recently approved a very strong statement regarding EPA's implementation of the law. I respectfully submit a copy of that policy to the record.
TDA has committed staff resources to efforts such as TRAC to ensure that EPA clearly understands the State's need in order to responsibly administer the new law. The Commissioner continues to demonstrate the importance of this issue through our continued participation in these efforts. As you heard earlier about the problems we had with gin trash in 1997, and getting carbofuran approved last year, EPA planned to deny the requests because groundwater problems with carbofuran in New York. We went to the Texas National Resource Conservation Commission for our data on carbofuran detection. There were none in groundwater or surface water from the use of carbofuran on cotton. The only detects were for use on rice.
This raises the issue on EPA not accepting data from the States. EPA must use data from State sources instead of seeking a worst-case scenario in another State. Data must be relevant to the geographic area where pesticides will be applied. The States have the largest stake in making sure pesticides do not harm the groundwater, surface water or any other aspect of the environment. We are the ones who must answer to consumers, producers, and our State legislatures.
But despite these continued issues, I would like to commend EPA for the improvement we have seen in working with us to make the section 18 process more manageable this last year. The EPA staff has provided timely answers regarding emergency restrictions to Texas growers. The quick turnaround of agency decisions has been extremely helpful in our efforts to fulfill our responsibilities as a State pesticide regulatory agency.
Commissioner Combs wants me to convey her support for efforts made by this subcommittee, TRAC, and the industry's Implementation Working Group to help provide more clarity.
Page 77 PREV PAGE TOP OF DOC Finally, I want to provide a few suggestions on policy development that will help the Texas Department of Agriculture in our efforts to apply the new safety standard. We need specific rules developed through the rulemaking process regarding key FQPA issues. As regulators, if we know what the benchmark is on dietary, residential, and non-occupational exposure; how the additional safety factors will be applied, and how the non-detectable levels will be treated, we will do a better job providing EPA with the data and scientific information it needs to make registration decisions.
I cannot stress strongly enough the importance of the United States Department of Agriculture's Pesticide Data Program. PDP significantly upgrades the statistical reliability and the extent of information available for the assessment of risk posed by pesticide residues.
Once again, thank you for this opportunity to provide input regarding FQPA implementation. The Texas Department of Agriculture stands ready to continue this information exchange through the Committee, the rule making process, EPA and other organizations such as NASDA. Thank you.
[The prepared statement of Mr. Dippel appears at the conclusion of the hearing.]
Mr. GOODLATTE. Thank you, Mr. Dippel. I apologize to those that I was not able to hear testify earlier. We are marking up the bankruptcy reform legislation in the Judiciary Committee. I had to be over there for some votes.
One of the things that concerns me is some of the inconsistencies in the data that was reported and what has later been found to be the case with regard to some of these risk assessments. I know Mr. Johnson and Mr. Pitts are still with us. If you all could come back to the table, we have room for you there. I would like to ask you about a couple of things, if I may.
Page 78 PREV PAGE TOP OF DOC Specifically, what I am concerned about is the chart that is still up on both sides of the room with regard to azinphosmethyl analysis. I note that the preliminary assessment for infants less than a year showed that the risk estimate was 10,000 percent above the allowed amount, originally. That, apparently, was put up on the Internet. The current assessment, after it has been to the EPA or into the USDA where it came down considerably and then sent out to some scientific analysis outside, is that it is in compliance. Would you care to comment on that, Mr. Johnson?
Mr. JOHNSON. Yes, Mr. Chairman. As Mr. Aidala noted, the process that the agency uses for conducting a risk assessment starts with what is entitled here on the chart a ''preliminary analysis,'' or a ''Tier 1'' analysis, where we use conservative assumptions, including 100 percent crop treated and those kinds of things. We do that for three reasons. One, it is a screening tool. Second is that it helps us to identify where there is a major issue, if there are any of concern. Third, it helps conserve our resources, as well as companies', growers', and other resources.
What I mean by that is it enables us to screen, and in this case it showed that it looked as if based upon the preliminary risk assessment that there was a dietary problem. I should note that for many cases for chemicals and even a number of the organophosphates that we have reviewed, when we have done this, the preliminary assessment or the tiered assessment, this level has actually showed it is okay. So there is no need to go any further. There is no need to get any additional data. There is no need to do any additional assessment.
In this case, it showed there was a problem, or appeared to be a problem. When we released this information, we so noted with many, many caveats to say the preliminary nature and in fact we knew that there were data available to refine. So, we began the refinement process which then led to the assessment being sent to the Department of Agriculture. Since this was the first dietary risk issue that we facing, or potentially facing, we decided to go ahead and send what we had over to the Department to begin the discussions; begin the dialog; begin the understanding. In that process we found that there was some additional data that, in fact, we possession of that would cause us to revise the risk assessment even further. That is what represented the current risk assessment.
Page 79 PREV PAGE TOP OF DOC Mr. GOODLATTE. How would your initial preliminary assessment be 10,000 percent, which by my calculations is 100 times what is the accepted value and 100 times what the final analysis turned out to be. How could you be that far off?
Mr. JOHNSON. Based upon the data that we are using, the data that was used in the preliminary assessment said that this product is registered on approximately 50 crops. What we said is the pesticide label for each one of those says what the maximum application rate of the pesticide is as an example. In the first of the preliminary assessments, we used what the maximum label rate said.
Now, as it has been pointed out, we all know that frequently that is not the case of what actually happens in agriculture. We then gather that information, working with the Department to focus on refining that assessment. So, it is in one way not a surprise to any of us who have been in this business that the preliminary assessment seen at those high numbers and the current assessment being at the low numbers.
Mr. GOODLATTE. Can you understand why people would be concerned that you put this information on the Internet where those who might not understand the technical work that is being done would be alarmed? That is 100 times more than the allowed risk.
Mr. JOHNSON. Yes, Mr. Chairman, very concerned. Two points. One is all of this information is subject to the Freedom of Information Act and releasable. In fact, we received FOIA requests for a great deal of this kind of information and we are obligated to release that. That is number one. Number two is, as I did mention, we were so concerned; we worked with the Department to make sure that we not only caveated this information of the preliminary nature, both in what was put up on the Internet as well as, certainly, in any public statements. We are aware of the situation that Mr. Vroom mentioned of the one banana product. But of all the other 28 assessments, we are not aware of any other market disruptions.
Mr. GOODLATTE. I am very concerned. The crops that this particular product is used on includes apples. I recall, long before I ever got to Congress, a very serious scare that took place from a very bad misuse of information that was exceedingly costly to that industry that is well-established in the Shenandoah Valley, in my district, also in Washington State, Mr. Hastings district and many other places around the country. Here we have something thatthankfullyhas not, because we have made it clear what the truth is. But it could have easily been blown out of proportion by members of the news media, or anybody else, who did not understand the technical application of what you were doing and why you would put it up. Certainly, if you have got to comply with the law and respond to a Freedom of Information Act request, I can understand that. But why would you put it up and essentially advertise it, knowing that you have got a long way to go before you ever have any kind of degree of certainty about the science that you have applied?
Page 80 PREV PAGE TOP OF DOC Mr. JOHNSON. As part of the TRAC process, we did discuss what are the methodologies, or the vehicles, or the opportunities for sharing information. And while certainly not a consensus opinionin fact there were dissenting opinions, as you can well imagineit was recognized that the Internet is the vehicle of information of today.
Mr. GOODLATTE. But you know, Mr. Johnson, the Internet is also vehicle of misinformation. I caution anybody who reads things on the Internet that there is a whole host of things on there that may not be accurate and may not be true. One of the challenges that we face as a society is to make sure that people act responsibly when they put things on the Internet. Some people put stuff up there they deliberate know to be false. That is certainly not the case here. But others put stuff up on the Internet that they know to be true and it gets misused in different ways. In this case, you have something you are uncertain about. Why broadcast it to the world at that point?
Mr. PITTS. I just want to add that these were a lot of discussion that we had between the two agencies before we went down this path. It is something that was mindful in the developing this policy of transparency. We were also responding to a situation where we knew that something was going to go out FOIA-able. Someone else would characterize the risk. So we felt like it was really important for us to get out what we had.
With every preliminary risk assessment that did go out, USDA and EPA worked jointly on the statement that accompanied those risk assessments about what was really going on here; that it is preliminary; this is why we are not taking any action, because there is a substantial amount of new data and data that we are currently collecting that we know is going to impact the outcome of this number.
So, it was not an easy decision. It was one that we did make jointly. It is one that we did consult with the TRAC on. We certainly did not have consensus, but we did make people aware that it was a path that we were going to take.
Page 81 PREV PAGE TOP OF DOC Mr. GOODLATTE. Thank you. Mr. Vroom, would you like to comment on the implications of this publication of information that is preliminary in nature on the Internet?
Mr. VROOM. Well, we still have reservations about it. I believe that you make some very valid points, Mr. Chairman, in that there is a difference between release under a FOIA request to one party, versus the Government posting something on its own Internet site.
One of the considerations, I will mention this even though probably does not support my position, the point was made by EPA at this time when we were debating this in TRAC that wouldn't it be better for the Government and EPA, in particular, to post thisto distribute this, at leastand have some element of control over it, as opposed to having it be apt to more likely to be abused and contorted by those who were requesting information and getting it privately through a FOIA request. That certainly has some validity.
I think there is probably a compromise position. One of the things that we have been arguing for in the TRAC deliberations since this time is that we should learn some lessons from the pilot, of which this a part of the pilot, preliminary risk assessment disclosure process before it becomes made permanent. We think that there are some ways to take a different look and perhaps further refine, before posting on the Internet, some of this kinds of information.
Mr. GOODLATTE. Thank you.
Mr. JOHNSON. Mr. Chairman?
Mr. GOODLATTE. Yes.
Mr. JOHNSON. May I also add to what Mr. Vroom said? This is a pilot process that we have been collectively working through and, I would say, designed by the TRAC. I think that there are a number of lessons learned about the process. In fact, this pilot process is one of the subjects at the upcoming meeting, next week, to look at: what have we learned; what are areas for improvement, and what things do we need to do differently, not only as we look for the remainder of these organophosphates, but as we look to the whole process of tolerance reassessment. So, we really look forward to, I'm sure, an engaging discussion with the TRAC members to sort through this and some other of those issues.
Page 82 PREV PAGE TOP OF DOC Mr. GOODLATTE. Thank you, Mr. Johnson. Mr. Stenholm.
Mr. STENHOLM. That was going to be my suggestion to the TRAC committee, that you might revisit that in light of the Chairman's questioning. Let me also make an observation on the outlawing apples. We didn't have a TRAC committee there. I suspect that one of the reasons why there was no adverse utilization of this particular information is that those who might have been tempted to use it would have immediately had their hand called by a lot of folks saying this is preliminary. It also demonstrates the dangers in using preliminary data based on anything other than good, sound, scientific bases. I think that is what that chart proves.
It is reassuring to me that this is an ongoing experiment. Perhaps it can be further refined to where we will not have the kind of negative results that the chairman talks about. Mr. Dippel, as a State regulator, I was glad to see in your comments that you, too, acknowledge there have been some improvements in the past year dealing with section 18, specifically. Would you care to comment a little further on that? Specifically, is how is the relationship between the Texas Department of Agriculture and EPA and USDA in carrying-out the responsibilities associated with FQPA?
Mr. DIPPEL. Like I mentioned in my testimony, the process has greatly improved this last year. We are having very good conversations with EPA. We are being able to talk through some of the things. In the past, we had some problems with them using data that was not from Texas. We were getting data from New York and Virginia. We have been able to show them that we do have good data in Texas and that we can support the things we do.
We take section 18 as a very important part of our job. We have a very good staff that looks at these. We do not want to harm any of the environment. We want to make sure that we do a good job. The one concern that we have is our repeat section 18s. We do have a lot of repeat section 18s that we feel that these products could be registered. Products that we have been doing for 3 or 4 years on cotton are registered on food crops, already. They could be registered on cotton. We also have several other repeats that would save us a lot of work and would save EPA a lot of work if they would just move and register these products.
Page 83 PREV PAGE TOP OF DOC Mr. STENHOLM. Let me stop you right there and ask Mr. Johnson to comment on that particular aspect, to see where we may be making some improvement.
Mr. JOHNSON. Actually, two comments Mr. Stenholm. First is we do have an excellent working relationship with your Department. Donnie and I have worked together, although my hair reflects more years than his, quite a few years. We do have an excellent working relationship.
Second is that, as Donnie mentioned, the carbofuran situation was faced with a section 18. We saw the importance for cotton in the State. We the data that we had in hand we would have said ''no.'' We went to the State and said, ''This is what it looks like. Do you have any information?'' They provided us with information. In fact, the section 18 was granted, both last year and this. So, we certainly recognize the importance of the section 18s. We also recognize the importance of information. When we have it and can get it, we certainly use it to inform the decision.
Lastly on the section 18 process is that Mr. Dippel has raised some important comments about the repeat section 18s. The average 18s are repeated between somewhere between 3 to 4 years before a registration is actually issued. That comes from a whole host of reasons. One of the things that we have been working our State colleagues to try to sort through are what are some improvements in the section 18 program that can actually speed up both the section 18 program, as well as deal with some of these situations with repeats.
We expect, within the coming weeks, to issue a new, proposed regulation for section 18s, that embodied in the preamble are a number of suggestions of ways to improve the section 18 process, including this notion of the recurring, multiple-year section 18. We look forward to a public comment process and working with our State partners to see how we can improve that section 18 program.
Mr. STENHOLM. You mention, Mr. Dippel, that Commissioner Combs is a member of a new committee as part of the State's Department of Agriculture. Is this an entity that is being structured in a way that might be a helpful addendum to the TRAC system, as far as EPA and USDA is concerned? Taking into consideration the 50 State Departments of Agriculture, and with the duplication that occurs, without coordination between our agencies, is there a new focus along this line?
Page 84 PREV PAGE TOP OF DOC Mr. JOHNSON. I am not aware of the specifics of a new committee within the National Association of State Departments of Agriculture, but we have had some excellent working relationships with that organization and our State partners. I was aware that there have some focused discussion on ways to improve in the implementation of the Food Quality Protection Act and look forward to working with them.
Mr. PITTS. I would just add that Allie Devine is on the TRAC. She is Commissioner for Kansas and last year she ran the Pesticides Subcommittee for NASDA. I think that Steve and Al Jennings both went down and participated before that committee. There is a lot of discussion back and forth and some commitments to share data. This is certainly the case of California where we are actively using their databases in risk assessments like these, and we are doing that more with other States, as well.
Mr. STENHOLM. There is a Committee on Pesticide Regulations, which is what I was remembering you had referred to, that just approved a very strong statement regarding EPA. I assume you have received it? That is the cooperation that you are talking about.
Mr. DIPPEL. Yes, sir.
Mr. STENHOLM. I think that is very helpful. Ms. Smith, I found your risk versus risk framework very fascinating. I totally agree with your assessment. I hope more people, particularly those who report the matters that are before the committee today, will pay particular attention to your observations there.
Also, out of curiosity, who are you representing?
Ms. SMITH. Consumer Alert is a national consumer group. We have founded and coordinate what is called the National Consumer Coalition, which has 27 non-profit members.
Mr. STENHOLM. Did you list those in your testimony?
Page 85 PREV PAGE TOP OF DOC Ms. SMITH. I did not, sir.
Mr. STENHOLM. I would appreciate, very much, if you would list those groups you are representing here today. I think it would be helpful for the record.
Ms. SMITH. I certainly will do that.
[The information follows:]
NATIONAL CONSUMER COALITION
MEMBERSHIP QUALIFICATIONS AND APPLICATION
Organizations, rather than individuals, can join the NCC if they meet the following three criteria:
Organization is a non-profit organization that is not a single-issue organization;
Organization is a 501(c)(3) or 501(c)(4)organization;
Organization subscribes to the principles of the National Consumer Coalition, as evidenced by an authorized person with the organization signing and submitting the membership application.
Member organizations may join any of the NCC subgroups. Non-members may be admitted to membership in the subgroup if they meet the first two criteria outlined above. (This provision recognizes the fact that some organizations do not allow office membership in coalitions.) The NCC does not participate in lobbying activities.
NCC MEMBERS 1999
60 Plus Association, Frontiers of Freedom, The Advancement of Sound Science Coalition Americans for Tax Reform, Association of Concerned Taxpayers, Atlas Economic Research Foundation, Capital Research Center, Center for the New West, Citizens for a Constructive Tomorrow Citizens Against Government Waste, Citizens for a Sound Economy, Competitive Enterprise Institute, Consumer Alert, Defenders of Property Rights, Foundation for American Liberty, Alexis de Tocqueville Institution Fund for a New Generation, Heartland Institute, National Center for Policy Analysis National Center for Public Policy Research Pacific Research Institute, Political Economy Research Center, Public Interest Institute, Seniors Coalition, Small Business Survival Committee, This Nation, United Seniors Coalition, Women for Tax Reform.
Page 86 PREV PAGE TOP OF DOC The members of the National Consumer Coalition (NCC) do hereby endorse the following principles for a society of free and responsible consumers:
A market economy benefits consumers by expanding consumer choice and competition and fostering innovation, which lowers costs and improves consumer health and safety.
Individual consumers have different values and varying needs in the marketplace and shop for goods and services based on those, such as quality level, price, service, and convenience.
Informed consumers are better off making their own decisions in the marketplace and holding responsibility for those decisions.
Consumers exert clout in the marketplace by their decisions to buy or not to buy and to choose where to spend their money.
Government policies that restrict consumer choice and stifle competition harm consumers by substituting policymakers'values for individual values and raising the costs of goods and services to consumers.
Mr. STENHOLM. I don't have any other questions at this time. I thank each and every one of you for being here and for your contribution to this effort. I know, based on your testimony, that you intend to continue to participate in the process. Mr. Johnson, Mr. Pitts and those they represent have left a positive tone to the hearing today.
Mr. Chairman, I commend you for holding the hearing and for the follow-up hearing that you have planned for later this year in order that your subcommittee might provide the proper oversight, transparency and sunshine on this question. I want to participate with you, and I commend you for doing so.
Mr. GOODLATTE. I think the gentleman for his comments. I have a few more questions, so we will do another round.
Page 87 PREV PAGE TOP OF DOC Ms. Smith, I, too, am interested in seeing the list of your member organizations. I am always interested in learning of consumer groups that are interested in getting the whole picture rather than focusing on a narrow aspect of something. I think that is exactly what you are advocating: take all the risks into account before you make a decision about what is in the best interest of consumers. I have a specific example of that.
I know that there has been some new research from the University of California, Davis, Medical Center that demonstrates that apples contain substances that may help combat the effects of bad cholesterol and fight heart disease. This represents just the recent, in a number of studies, that tout the health benefits associated with fruits and vegetables. Could recent articles suggesting that children are being over exposed to pesticides in fruits and vegetables negatively impact a child's eating habits, either from the child's own impression or from parents steering them away from some of these benefits?
Ms. SMITH. From parent's impressions, certainly. Some studies have shown, including some surveys from the University of California, Davisthat consumers do fear pesticide residues on food, more than they necessarily should, when compared to scientists, and so forth. It could cause people to avoid feeding their children properly because of perceived risks of that. That is one of our major concerns, over all, that families may look at that and look at some reports, or on the Internet and reach preliminary conclusions.
Mr. STENHOLM. Mr. Chairman, would you yield on that?
Mr. GOODLATTE. I would.
Mr. STENHOLM. Just this week I saw research that eating one egg per day has no adverse effect on cholesterol under a new study. How many times have folks suggested we should not eat eggs. This is a perfect example of the two charts. When you take preliminary information and have that broadcast as being absolute, solid, sound science you get different reactions. I doubt we will ever improve on a good, solid, balanced diet.
Page 88 PREV PAGE TOP OF DOC Mr. GOODLATTE. Absolutely. Point well taken. Ms. Smith, do you agree with the findings of the Consumer's Union in similar reports?
Ms. SMITH. No. As I pointed out in my testimony, we looked at the reaction of a group of scientists, the Society of Toxicologists, to that report. We looked at the report ourselves, but I am not an epidemiologist or a toxicologist. I thought that when an organization as prestigious in the field as the Society of Toxicology took the very unusual step of condemning the report for its unscientific basis and writing a letter, that is very unusual in the scientific community. They are busy doing research. They don't, generally, have time to get involved in public policy issues as we do here.
Also, among some of our science advisors, Dr. Bruce Ames and Dr. Lois Gold are people with whom Consumer Alert works with in asking their counsel on some science issues related to pesticides. From our assessment, we thought that the study was very over-blown, alarming, and misleading to the public.
Mr. GOODLATTE. Thank you. Let me ask you this. In your estimate, do the benefits of a rich diet in fruits and vegetables outweigh potential risks that are known, that are truly determined by reputable, scientific organizations? In other words, we don't want to ignore risks that may occur with misuse of any kind of pesticide, or any naturally occurring substance. But those that are known to us and proven by scientific evidence, do those outweigh the benefits of having a good, balanced diet, as Congressman Stenholm notedwhich, in my opinion would clearly include fruits and vegetables? At least that is what I have told my kids for 15 years.
Ms. SMITH. Well, the two reports, I cited in my full testimony. It was a study that appeared in the journal Cancer. It was a joint Canadian-American institute study. A panel reached the conclusion that the benefits of eating a diet rich in fresh fruits and vegetables far outweighed the minuscule risk of pesticide residues. There are some risks, but the benefits far outweighed the risks. As did the 1996 National Research Council's report on carcinogens and anti-carcinogens in the diet.
Page 89 PREV PAGE TOP OF DOC I keep repeating myself, but they keep doing these studies over and over again and reaching the same conclusions. A diet rich in fruits and vegetables is one of the best preventatives against cancer and other diseases. Those benefits far outweigh the minor risks of pesticide residues on food.
Mr. GOODLATTE. Maybe we need to have a risk assessment of bad reports, as well as a risk assessment on pesticides. [Laughter.]
Mr. Dippel, many States and growers have suggested that they have been beset by serial cancellation of minor crop uses, fungicides in particular, after EPA and registrants go behind close doors. Have minor crop interests had an opportunity to weigh-in when these discussions are taking place?
Mr. DIPPEL. I think they have. They have been able to talk about it with the groups. The minor use are a very big concern. I think a lot of the concern is still coming on what is going to the organophosphates in the near future.
Mr. GOODLATTE. To what extent are the products that are currently undergoing review, organophosphates as you have mentioned, used for pest eradication programs?
Mr. DIPPEL. Malathion for the boll weevil and also, I am sure, for the Medfly.
Mr. GOODLATTE. How important are these products to managing a successful program?
Mr. DIPPEL. They are very important. We have got to have it to be successful in the boll weevil program in Texas.
Mr. GOODLATTE. Have you experienced any problems with the timely granting of section 18 emergency exemptions?
Mr. DIPPEL. It has improved a lot in the last year. We have been able to work very closely with EPA and they have been using our data in the last year. We really had no complaints about the time that they have taken to issue the section 18s.
Page 90 PREV PAGE TOP OF DOC Mr. GOODLATTE. Mr. Vroom, I understand that during the TRAC meeting when these data were presented, several additional data needs were discussed. Has the regulated community been told which process they will use to request additional data to fill identified data gaps?
Mr. VROOM. We have, as a general community, been given some additional indications through the publication of the science policy papers. However, there still remains a significant number of unknowns out there that, very likely, could turn the ultimate fate of a number of these chemicals individually and most certainly, as the Agency moves on with additional public input to refine and implement the common mechanism of toxicity cumulative risk assessment provisions of FQPA that all of those unknowns take on an even greater or more profound potential weight.
So, some answers ''yes,'' but there are still a huge number of unknowns.
Mr. GOODLATTE. Mr. Johnson, do you have anything that you would like to say about that?
Mr. JOHNSON. I think that as Mr. Vroom has characterized, we do have a great deal of information that we are going through and doing preliminary and refining assessments. In the event that we need additional information, there are a variety of mechanisms and tools, including the formal data call-in, that we will avail ourselves if we need that kind of information.
Mr. GOODLATTE. Is there a reason why you haven't used the data calling authority, to date, very much?
Mr. JOHNSON. For in the case of dietary, we believe we have sufficient information to make decisions. As we sort through other issues of drinking water and residential exposure, we have a continuum of information from a little to a lot. We are already aware of this because we have already issued data call-ins, for example, for residential turf grass. We are waiting for that information to come in, which should be coming in in the next year or soactually, in the next few months.
Page 91 PREV PAGE TOP OF DOC Again, as we move forward and do our refinements, if we find that there is a need then we will do a data call-in.
Mr. GOODLATTE. You are sitting next to an example where it might have been better to have had more data available earlier.
Mr. JOHNSON. It is true, Mr. Chairman. For example, in this case if we took the approach that we should just issue a data call-in, there were 50 commodities. So that means that we would go to the company and ask to generate data on 50 commodities, including drinking water and other things. Which, in fact, as you can see from the chart, there are four that are really driving the assessment.
We believe that it would be inappropriate, for a variety of reasonsscientifically and economically, to rush to do a data call-in without having gone through the assessment of the information that we have. This is a prime example of, ''Should we have gone out and issued a data call-in for 50 commodities?'' I don't think we should have. In the case of these four commodities will additional information help? Science, as such, has been around the Agency long enough that additional science is always helpful.
Mr. GOODLATTE. But the law requires you to use the best available data.
Mr. JOHNSON. And we use the best available data. Yes, sir.
Mr. PITTS. For example, with these four commodities, that is four that land grant and extension systems will be taking a closer look at.
Mr. GOODLATTE. Well, maybe Mr. Vroom wants to comment on this. My observation from practicing law for many years is that when you have to make a tough decision, you afford everybody who is involved and going to be affected by the decision an opportunity to make their case and submit data that may be helpful to the Agency and would, certainly, support their position. I think the law intends you to do that and to use it liberally. Mr. Vroom.
Page 92 PREV PAGE TOP OF DOC Mr. VROOM. I would agree. I think Mr. Johnson also makes an important point that we could be also taken to an extreme in the other direction and maliciously required to comply with an over-interpretation of what we are talking about here. This would, in effect, penalize agriculture because the economics would not support a malicious sort of data call-in request, either. Some balance and logic and good judgment is appropriate. I think that the partnership between USDA and EPA over the last year has brought a lot of that kind of focus to bear. It really is virtually brand new in the last year. We really commend USDA's involvement and the land grant system's involvement in helping bring forward this kind of information that is really reflected in the balancing of risk assessment that the azinphosmethyl chart illustrates here.
There is still areas, once again, in terms of toxicology and specific areas of exposure where a more targeted announcement of data call-in authority and search for information earlier would be welcome. We need to continue to work to seek those sorts of narrow, targeted kinds of data call-in opportunities that will help head off these kinds of problems and misunderstandings of the future.
Mr. GOODLATTE. Thank you. Well, those are all the questions I have. Mr. Stenholm, have I prompted any more? Nope. Mr. Vroom?
Mr. VROOM. Since our colleagues from USDA and EPA are here at the table, I wonder if it might be an opportune time to raise another question that relates the registration of new products and new uses and gets at alleviating some of the backlog of section 18s.
We have talked a bit about, when Mr. Aidala was here at the table earlier, the backlog of new product/new use registration decisions, and the fact that the Agency showed the chart earlier that indicated that there is a rebound and a return to something closer to historic levels of productivity on new product and new use registration decisions. But it has come to our attention and Administrator Browner, in this fiscal year, because of the budget that Congress approved and appropriations that are coming, EPA arbitrarily cut across the board certain funds that were available, in particular for registration contract work. Because we have not see that impact yet, does not mean contracts that are due to expire later in this fiscal year may not be renewed with outside contract reviewers. We may, in fact, be hitting a wall here of zeroing out a lot of the activity and new product/new use registration decision making represented on the chart EPA shared earlier. Maybe Mr. Johnson could shed some light on that.
Page 93 PREV PAGE TOP OF DOC Mr. GOODLATTE. Mr. Johnson.
Mr. JOHNSON. Mr. Chairman, yes, indeed. This year, because of the impacts across the Agency, there was in fact across the board cuts. It was not only affected in the pesticide program registration, but also re-registration, pesticide environmental stewardship program and our voluntary IPM program. So, it was across the board.
Administrator Browner, certainly, recognizes the need and the value of accelerating, particularly, the reduced risks for Safer. We are now working to see what we can do to address that, yet, this year.
Mr. GOODLATTE. Thank you. Mr. Pitts.
Mr. PITTS. I was just going to add that one thing we were talking about doing this summer is working on a joint budget for FQPA implementation between the two agencies. Both Secretary Glickman and Administrator Browner have identified FQPA implementation as a Department priority in our 2001 budget cycleI think most people are aware that we are working on those now at the agency level.
Mr. GOODLATTE. Thank you. I want to thank both of you, particularly for staying and addressing these additional concerns that I and Mr. Stenholm have. I want to thank the other panelists, as well. I think this has been a very informative hearing. I do believe we are making some progress. I want to thank the agencies for that work and for the future work that you will continue to do to make sure that we get a safe food supply, assured by the responsible use good quality products that allow us to have an inexpensive and high-quality food supply. Thank you all very much.
I will ask unanimous consent, and with Mr. Stenholm's consent I will have it, 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?
Page 94 PREV PAGE TOP OF DOC Mr. STENHOLM. Reserving the right to object. [Laughter.]
Mr. GOODLATTE. The gentleman will state his reservations.
Mr. STENHOLM. But I shall not object at this time. I will use this time to make an observation. At our next hearing, it would be very helpful for this committee if we would have a representative panel, giving an opportunity for panelists to ask each other questions.
Along that line, I look forward to working with you Mr. Chairman, regarding the prioritization of these issues. When we get to the agriculture appropriation bill or the EPA appropriation bill, should have something to say about the prioritization of what gets cut and what needs to be increased for need for U.S. agriculture.
Mr. GOODLATTE. Well, I wholeheartedly agree. I guess we will have to give Chairman Hyde the credit for the composition of this panel, since he is the one who called me away to votes earlier.
Mr. STENHOLM. I withdraw my objection. [Laughter.]
Mr. GOODLATTE. There being no objection, it is so ordered. This hearing of the Subcommittee on Department of Operations, Oversight, Nutrition, and Forestry is adjourned.
[Whereupon, at 2:30 p.m., the subcommittee was adjourned, subject to the call of the Chair.]
[Material submitted for inclusion in the record follows:]
Statement of James V. Aidala and Keith Pitts
Good morning Mr. Chairman and members of the subcommittee. We are pleased to appear before you today to discuss the Environmental Protection Agency's (EPA) and the U.S. Department of Agriculture's (USDA) implementation of the Food Quality Protection Act (FQPA). Since last June, when former EPA Deputy Administrator Fred Hansen and USDA Deputy Secretary Rominger appeared before you, we have made many important decisions. Mr. Peter Robertson has joined us as Acting Deputy Administrator to work side-by-side with Deputy Secretary Rominger. In our follow-up remarks this morning, we hope to provide you and your subcommittee with a brief summary of where we stand at the moment in implementing FQPA, and our future plans. Since the passage of FQPA, and especially in the past ten months, significant progress has been made in strengthening public health protections.
Page 95 PREV PAGE TOP OF DOC Today is Earth Day. While communities around the country are planting trees, collecting roadside trash, and learning the importance of recycling, we are reminded of the significance of this piece of legislation. FQPA was enacted to provide greater food safety, especially for infants and children, and all of us are fully committed to achieving the protections embodied in FQPA.
Earth Day also allows us to recognize that farmers play a significant role in our economy and in environmental protection. The administration realizes that we need to meet the mandates of FQPA in a manner that provides assurance to our farmers that they will continue to have the critical tools they need to grow our food. Mr. Chairman, both EPA and USDA are committed to the principle that safer food does not need to come at the expense of American agriculture. We believe we can strengthen environmental protection while maintaining agricultural growth. This is essential for the successful implementation of FQPA.
One year ago this month, Vice President Gore asked both EPA and USDA to employ four guiding principles to serve as the cornerstones of our efforts to implement FQPA. First, we should ensure that our pesticide and food safety regulatory decisions are grounded in the best available science. Second, our regulatory process must be transparent and predictable, so that consumers can continue to have full confidence in the safety of our food supply, and pesticide producers and users can depend on a consistent process. Third, the Agency and the Department must work together to provide a reasonable transition for growers to newer, reduced risk pesticides and pest control practices. And fourth, we must continue to reach out and open the process for participation by all interested parties whose opinions and experiences are proving to be exceedingly valuable. Since FQPA's enactment, EPA and USDA have developed new policies, created new programs, and established new proceduresall firmly rooted in these fundamental principles.
In August 1996, EPA was presented with a new food safety law. We knew we would have to work more closely with industry, growers and the environmental community to meet the challenges outlined in FQPA. We are indebted to the members of the Food Safety Advisory Committee and the Tolerance Reassessment Advisory Committee (TRAC) who helped us devise a process for developing complex science policies, and design an effective pilot program for refining risk assessments for the organophosphate pesticides, both founded on unprecedented stakeholder participation. The TRAC was established by EPA and USDA in May 1998, and has met five times since then. Two Working Groups were also established, and they have met a total of ten times. This morning we would like to describe for you how we are implementing the recommendations of the TRAC and highlight some of the outcomes and accomplishments.
Page 96 PREV PAGE TOP OF DOC Key Science Policies As FQPA was immediately effective, the Agency needed to put into place procedures that allowed for early decision-making, both in setting new tolerances for emergency exemptions and new registrations and in tolerance reassessments. The Food Safety Advisory Committee, established after FQPA was enacted into law, assisted EPA in developing an initial decision logic to ensure that the Agency could continue to make decisions while important science policies were being developed.
Last October, EPA and USDA announced a framework for addressing nine key science policy issues, based on work done with the TRAC. As part of the framework, EPA published a schedule for releasing for public comment draft documents on each of these science policy areas. To date, 11 papers out of 19, covering seven of the nine science policy areas, have been released for public comment. The Agency has also identified four additional related policy papers not on the original list, one of which has been released for comment. This paper focused on anticipated residue data for the organophosphates. A complete list of the science polices and their current schedule for public notice and comment is attached in Table 1. The nine issues include:
applying the FQPA 10-fold safety factor
using ''Monte Carlo'' analyses for dietary exposure assessment
interpreting ''no residues detected'' for exposure assessments
estimating dietary exposure
factoring in drinking water exposure
assessing residential exposure
aggregating exposures from all non-occupational sources
conducting cumulative risk assessment for organophosphates (OP) or other pesticides with a common mechanism of toxicity
selecting appropriate toxicity endpoints for risk assessments of organophosphate pesticides.
Page 97 PREV PAGE TOP OF DOC As proposed to the TRAC, the Agency has been applying the science policies, as appropriate, in making regulatory decisions for both new tolerance decisions and for tolerance reassessments at the same time the policies are being refined through peer review and public comment. Our approach is fully and clearly set forth in each of the science policy papers published. We are utilizing our interim science polices in our risk assessments with the full knowledge that, as these policies are further refined, some of our decisions may need to be revisited. EPA currently expects to have virtually all of its science policies finalized before organophosphate risk management decisions are completed.
The OP Pilot Process To implement FQPA effectively and fairly, a well-defined and clearly communicated process must be followed. Because of intense interest in and the potential impacts of the tolerance reassessment process for the organophosphate pesticides, EPA and USDA turned to the TRAC to provide advice on possible regulatory approaches to reassessing the organophosphate pesticidesone that is both consistent and predictable. The TRAC was asked to help find a more effective way for the public to participate at critical junctures in the development of OP risk assessment and risk management decisions.
As a result of the TRAC discussions, EPA and USDA have set forth a pilot process for the organophosphate pesticides, complete with self-imposed deadlines for releasing the preliminary risk assessments, further refining the risk assessments, and providing for public participation on risk mitigation measures and practical transition strategies. The six phases are as follows (a more comprehensive description of each of the phases can be found in table 2):
Phase 1: EPA completes the preliminary risk assessment and sends it to the registrant and USDA for review.
Phase 2: EPA addresses the comments it has received and amends the document.
Phase 3: EPA releases the preliminary risk assessment for public notice and comment.
Page 98 PREV PAGE TOP OF DOC Phase 4: EPA addresses the comments received and refines the risk assessment. The refined risk assessment is shared with USDA for review.
Phase 5: The refined risk assessment document is released for public notice and comment. If warranted, EPA solicits the submission of risk management proposals.
Phase 6: USDA and EPA work together to develop risk management strategies which will serve as the basis of EPA's risk management decision.
Recently, EPA and USDA met with a Working Group of the TRAC and identified the objectives and activities of phase 4 and phase 5. The fundamental principles of these two phases are: (1) intergovernmental review of the refined risk assessment, (2) presentation of the findings in a clear and understandable way to affected stakeholders and the public, (3) public participation in risk mitigation approaches, and (4) USDA and EPA collaboration in designing an appropriate and acceptable method to lower the risk to an acceptable level.
Thus far, 27 organophosphate pesticides have made it to phase 4, refining the risk assessments. Ten OPs have been sent to USDA, and the Department has completed its review of the revised risk assessments for four of them. The Department relies on experts from a number of internal offices for its review, and often consults with experts from Land Grant Universities and Extension Service as well. USDA's review, led by the Office of Pest Management Policy (OPMP), focuses on how EPA utilizes the data provided by USDA, such as use and usage data, pesticide residue data, and food consumption data, as well as the assumptions used by EPA and on possible strategies for managing the risk. Our recent experience with this process is that data and information provided by USDA has greatly assisted in the refinement of OP risk assessments.
EPA and USDA believe that the pilot process has served as a useful model to provide greater transparency and to encourage greater public understanding and participation. In addition, this novel approach has definitely delivered positive resultsthe public's ideas and input have been extremely useful. We are pleased to see that, in many instances, the new notice and comment process is resulting in the submission of additional health and environmental effects data, use data, and other relevant information which EPA is using to refine the risk assessments. The bottom line is that this pilot process has improved timeliness and quality of the data submitted to the Agency, and required a higher degree of discipline of all parties, particularly the two government agencies present here today.
Page 99 PREV PAGE TOP OF DOC Reassessing the OPs While not all individual organophosphate tolerances will be reassessed by the first deadline, we are making significant progress with this group of chemicals. So far, over three hundred organophosphate tolerances have been reassessed through tolerance revocation actions resulting from voluntary cancellations by the registrants of nine of the chemicals. Preliminary risk assessments for 10 OPs are now being prepared and are scheduled to begin Phase 1 this spring. Two OPs are in Phase 2; none are in Phase 3; and 27 OPs are in Phase 4. We expect that the tolerance reassessment for all the organophosphate pesticides will be completed in the year 2000.
''A Reasonable Transition for Agriculture'' FQPA set new standards for pesticide use in food and feed crop production, and both agencies recognize that how the law is implemented may have important and far reaching consequences. We are particularly conscious of the potential impacts on minor crop growers and integrated pest management programs. USDA and EPA will continue to work with growers and registrants to focus attention and resources on those situations where limited crop protection alternatives exist.
FQPA reinforced our commitment to bring new and safer technologies to the marketplace. To be sure that pesticide users have access to a range of safer pest control tools, EPA is assigning priority to and expediting the review of reduced risk pesticides which might be used as alternatives to riskier pesticideswith special emphasis on organophosphate alternatives. Of 27 new pesticide active ingredients registered in fiscal year 1998, 14 were done as a result of expedited review.
Both EPA and USDA also are focusing on reducing the risks of existing pesticides in a manner that accommodates growers' needs. Many existing pesticides will almost certainly be found to meet the new standard. However, when the risk of a pesticide is above the safety standard set by law, EPA must take regulatory action to manage the risk. EPA has identified a range of regulatory approaches for achieving risk management. This includes a number of options from amending the product label (a lower application rate, longer pre-harvest interval, or decreased number of seasonal applications may be enough to bring the risk down to acceptable levels) to the elimination of some agricultural and non-agricultural uses. We all agree, the most appropriate approach is dependent upon the level of risk.
Page 100 PREV PAGE TOP OF DOC Through the course of our growing experience with risk assessments, the data used, and the analytical factors, USDA and EPA have come to realize that, in some cases, a limited subset of commodities may be the most significant contributors to the total risk. EPA, in its risk assessments, will attempt to identify those crops/uses that contribute most to the risk, so that both the government and the growers can work together to devise effective and sensible solutions.
USDA is taking the lead role, in cooperation with EPA, in developing transition strategies for growers. USDA's strategy is, regardless of whether there are pending regulatory pressures, it is prudent for USDA to begin to work with growers and processors of the commodities that are anticipated to be major risk contributors and to proactively research and develop additional pest management tools, and for EPA to aggressively pursue the registration of promising new pest management tools. This approach will focus early attention on finding sound and effective approaches for mitigating risks and also serve to facilitate the transition process by minimizing any negative impacts on growers as the regulatory decision-making process proceeds.
Earlier this month, USDA presented transition considerations to one of the TRAC Working Groups and received some valuable input from the TRAC membership and EPA. On the basis of this discussion, USDA's Office of Pest Management Policy will begin to engage willing commodity groups, crop consultants, and food processors in establishing a foundation for constructing and implementing broad-based, commodity-specific transition plans. With the resulting information from this process, and Congressional support for USDA's proposed fiscal year 2000 FQPA implementation budget, USDA believes that U.S. agriculture will be insured with aggressive and reliable pest management strategies and a new research and implementation infrastructure that stays far ahead of the always evolving pesticide regulatory process. Furthermore, the remaining TRAC meetings will focus on formulating ways to gain grower input on practical, feasible, and affordable mitigation measures.
Page 101 PREV PAGE TOP OF DOC In today's competitive global market, The administration is also very concerned about ensuring a level playing field for domestic growers. All food sold in this country, whether grown domestically or elsewhere, will be subject to the same tolerance standards. Any imported produce containing residues above the tolerance level, or any food with quantifiable residues for a pesticide that does not have a U.S. tolerance or exemption from tolerance for that food, will be considered adulterated and subject to FDA's enforcement authorities. We are concerned that food coming into our ports meet our stringent standards. EPA and USDA are interested in finding new ways to address the issue of imported produce. Some possible options would include encouraging advancements in technology to improve the ability to detect minute residues; promoting increased monitoring by the government and the private sector, possibly including growers or distributors; or requiring some form of certification or testing on the production end to ensure that there is a U.S. tolerance established for the commodity and that residues are within that tolerance level. EPA will continue to work with USDA, the Food and Drug Administration, as well as with our major trading partners through the North American Free Trade Agreement (NAFTA) and other international forums to ensure all food consumed in the U.S. meets our standards.
Some of Our Accomplishments Although EPA faced an initial adjustment period, the Agency's pesticide program is now performing at historically high levels that reach or exceed pre-FQPA levels. The pace at which regulatory decisions are made, in all facets of the program, is impressive. For example, the antimicrobial division has virtually eliminated its backlog of pending actions; 83 new pesticides have been registered; the current review time for FIFRA Section 18 emergency exemption requests is the best in EPA's history; 63 Reregistration Eligibility Decision documents have been issued; and over two thousand existing tolerances have been reassessed.
EPA is pleased to report that it expects to meet the FQPA deadline of reassessing 33 percent of all food tolerances by August 1999. Although we are working hard to meet our risk- and hazard-based priorities, a number of pesticides which may pose high risk will not be reassessed in the first 33 percent given the complexities involved. As of January of this year, of the 9,728 tolerances subject to reassessment, EPA has reassessed 2,308 tolerances, of which 303 are for organophosphate pesticides. We expect to reassess approximately 1,000 more tolerances by August to surpass the 33 percent target. This ''first third'' will consist of reassessments from tolerance revocations, reregistrations, and registration actions.
Page 102 PREV PAGE TOP OF DOC EPA has also reassessed a number of non-OP priority pesticide tolerances including 220 tolerances of the carbamates, 50 tolerances of the organochlorine, 187 tolerances of pesticides which are probable (B1) human carcinogens, 105 tolerances of pesticides which are possible (B2) human carcinogens, and 145 tolerances for other, unquantified C carcinogens for a total of 437 tolerances altogether. Another class of high priority chemicals, identified as possible carcinogens, are the high hazard ''inerts.'' There are three such ingredients, formaldehyde, rhodamine B, and phenol, with a total of 24 associated tolerances. Formaldehyde, which has 22 of the 24 tolerances, is currently under review and should be reassessed by August 1999.
Resource Needs The new statute has significantly redirected, and added to, our programs' priorities and responsibilities. With the development and implementation of new policies, procedures, and outreach projects, resource needs to support these new activities are growing. For this reason, additional funding is important for ensuring smooth implementation of FQPA.
Both Administrator Browner and Secretary Glickman have identified implementation of FQPA as one of their top priorities. For EPA, the Agency is seeking increased funding that will be dedicated to accelerate registration of new pesticides, including reduced risk and biopesticides. USDA is devoting significant effort and is requesting additional funding in its fiscal year 2000 budget to help grower groups develop strategies that will result in reduced risk but still ensure adequate pest control.
An important part of achieving the administration's goals in implementing FQPA as laid out in the Vice President's memo and the recommendations of the TRAC is winning Congressional support and approval of the President's Budget currently pending before Congress. The fiscal year 2000 budget provides targeted increases to FQPA and other high priority initiatives within overall legislated budget targets.
Page 103 PREV PAGE TOP OF DOC The Future FQPA implementation is proceeding significantly and efficiently. We now have a process in place through which we can successfully tackle all of the provisions of the law. While we know that there are still important issues that need to be resolved, we are confident that with continued broad stakeholder input, we will reach sound, open, and common-sense solutions. The FSAC and TRAC's contributions have been immeasurable. EPA and USDA will continue to seek broad stakeholder input and are exploring options, including use of the Pesticide Program dialog Committee and other forums, to provide stakeholder input on all pesticide issues.
Conclusion Throughout the implementation process of FQPA, it is important not to lose sight of the fact that agriculture in this country, and throughout the world, is constantly changing. Farmers, like all others in business, must keep pace to remain profitable. New technologies, global markets, fluctuating commodity prices, and government regulations affect not only the producer, but everyone who shops at a grocery store. FQPA presents EPA, USDA, and our many stakeholders with a unique and important opportunity to help farmers and other pesticide users move to safer pest control tools and methods while improving public health protection.
Meeting the FQPA mandates demands an effective multi-front effort to complete the many necessary tasks. While the last three years have been busy, the last ten months have been even busier. As you can see, much has happened since the last time EPA and USDA appeared before your subcommittee. Indeed, significant progress has been made to date, and we are proceeding at an expeditious rate. We have reaffirmed our commitment to using sound science in all our decisions so that they are reasonable and consistent; we are committed to transparency so that our process can be understood and followed by registrants, growers, the environmental community, and all interested people; we have begun the development of transition strategies so that growers have the tools necessary to respond to changing pest control needs; and we are and will continue to extensively consult with all stakeholders on any issue related to pesticides so that we can achieve a workable, open, and accountable regulatory process.
Page 104 PREV PAGE TOP OF DOC Thank you for the invitation to appear before your subcommittee this morning. We will be happy to answer any questions you may have.
"The Official Committee record contains additional material here."
Statement of Donnie Dippel
Mr. Chairman and committee members:
Commissioner Susan Combs is sorry she could not be here, but I appreciate the opportunity to testify on behalf of the Texas Department of Agriculture to express our continuing interest and concerns regarding the Environmental Protection Agency's implementation of the Food Quality Protection Act.
No one argues with the intent of FQPA; however, problems have arisen occasionally through implementation. When the agencies responsible for pesticide regulation do not have clear regulatory guidance regarding issues such as risk assessments, uncertainty factors, and emergency uses, it is very difficult to fulfill our responsibilities to the people we are charged with protecting or the farmers and ranchers we strive to support. The changing needs for supporting data, differing acceptable risk criteria, and changing environmental fate requirements demonstrate how important it is that the Agriculture Committee continues to provide oversight and insists that EPA provide clear, specific guidance to states regarding what is required for a crop protection product to be approved.
Today, I would first like to outline the Texas Department of Agriculture's commitment to ensuring that the implementation of the new pesticide laws is based on real risk, sound science, and continued availability of necessary crop protection products. Second, I will outline our experiences, both good and bad, with EPA's application of FQPA. Finally, I want to suggest policy guidance that will help as states strive to meet the new safety standards set by FQPA.
Page 105 PREV PAGE TOP OF DOC Commissioner Combs is committed to ensuring FQPA implementation that is reasonable and rational. She became a member of the National Association of State Departments of Agriculture's Committee on Pesticide Regulations, which recently approved a very strong statement regarding EPA's interpretation of the law. I respectfully submit a copy of that policy to the record.
Even prior to Commissioner Combs' administration, the Texas Department of Agriculture was committed to providing advice and input to EPA's application of FQPA. TDA has committed staff resources to efforts such as the Tolerance Reassessment Advisory Committee to ensure that EPA clearly understands what states need in order to responsibly administer the new law. The Commissioner continues to demonstrate the importance of this issue through our continued participation in these efforts and her commitment to ensuring that FQPA policy expertise is part of her new administration.
Though you have heard it before, I want to remind you of the ever-changing demands EPA made during the summer of 1997 relating to the request for an emergency specific exemption to use carbofuran. TDA invested extensive time and money to answer potential carbofuran residues in cotton gin trash. EPA alleged it was fed to cattle in Texas despite evidence that gin trash is seldom used as a source of feed for dairy cattle.
Last year, even after exhaustive preparatory work, EPA raised yet another issue regarding carbofuran that created extreme uncertainty for us, as the agency issuing the emergency exemption, and even more uncertainty for South Texas farmers who desperately needed the product. EPA planned to deny the request because of groundwater problems with carbofuran in New York. We went to the Texas Natural Resource Conservation Commission for data on carbofuran detections. There were none in groundwater or surface water from use of carbofuran on cotton. The only Texas detections were from the use of granular carbofuran on rice.
This raises the issue of EPA not accepting data from the states. EPA must use data from state sources instead of seeking a worst-case scenario in another state. Data must be relevant to the geographic area where the pesticide will be applied.
Page 106 PREV PAGE TOP OF DOC The states have the largest stake in making sure pesticides do not harm groundwater or surface water or any other aspect of the environment. We are the ones who must answer to consumers, producers and our state legislators.
But despite these continuing issues, I would like to commend EPA for the improvement we have seen in working with us to make the Section 18 process more manageable over the last couple of years. The EPA staff has provided timely answers regarding emergency registrations to Texas growers. The quick turnaround on agency decisions has been extremely helpful in our efforts to fulfill our responsibilities as the state's pesticide regulatory agency.
Many of these problems could be eliminated if alternative, reduced-risk pesticides were available. FQPA forced EPA to refocus its resources toward meeting the requirements of the act, specifically reassessing tolerances. As a result, states have had to ask for Section 18 exemptions which also require EPA resources.
Here are just a few examples of some reduced-risk pesticides that we believe should have been registered by now. We have obtained Section 18 emergency specific exemptions for Confirm on cotton for four years, Capture on grain sorghum for four years, Dual on spinach for 5 years and maleic hydrazide on rice for 3 years. Dual use on spinach is an IR4 project , and EPA has had this reliable and scientific data for two years yet the product is still not registered.
Commissioner Combs wants me to convey her support for the efforts made by this subcommittee, the TRAC, and the industry's Implementation Working Group to help provide more clarity.
Finally, I want to provide a few suggestions on policy development that will help the Texas Department of Agriculture in our efforts to apply the new safety standard. We need specific rules, developed through the rulemaking process, regarding key FQPA issues. As regulators, if we know what the benchmark is on dietary, residential, and non-occupational exposure, how the additional safety facts will be applied, and how non-detectable levels will be treated, we will do a better job of providing EPA with the data and scientific information it needs to make registration decisions.
Page 107 PREV PAGE TOP OF DOC I cannot stress strongly enough the importance of the United States Department of Agriculture's Pesticide Data Program. PDP significantly upgrades the statistical reliability and extent of information available for the assessment of risk posed by pesticide residues. The EPA should use the statistical reliability of this data on a broader scale so that it is applicable to agricultural commodities not specifically included in PDP. TDA has worked very hard to make sure that we have a qualified, competent staff of risk assessors who are able to provide the necessary information to EPA when we submit Section 18 packages. Good PDP data is crucial to our ability to do so.
Once again, thank you for this opportunity to provide input regarding FQPA implementation. The Texas Department of Agriculture stands ready to continue this information exchange through the Committee, the rulemaking process, EPA, and other organizations such as NASDA.
Statement of Dean Kleckner
Good morning, Mr. Chairman. I would like to thank you and the members of the subcommittee for holding this hearing. I am Dean Kleckner, a hog and soybean farmer from Rudd, IA, and I serve as the president of the American Farm Bureau Federation, the Nation's largest agricultural organization.
Like the members of this committee, all members of Congress, many of the agencies and organizations represented at this hearing today, Farm Bureau supported passage of the Food Quality Protection Act of 1996. Passage of the FQPA was viewed as the successful conclusion of a 15-year effort by the agricultural, food processing and crop protection community to modernize our food safety and pesticide laws. FQPA repealed the obsolete Delaney standard for food pesticide residues and replaced it with a new science and health-based standard. It established national uniformity for chemical residues and provided incentives and streamlined registrations for ''minor use'' farm chemicals, and gave the Environmental Protection Agency the ability to adapt and change as scientific developments and data warranted.
Page 108 PREV PAGE TOP OF DOC Our support for these provisions was tempered with serious concern that other provisions of FQPA could result in unjustified restriction of essential crop protection products if it was not carefully implemented. EPA assured Congress and others affected that implementation of the new law would cause little change in the availability of crop protection tools to farmers. Today, as we approach the three-year anniversary of FQPA's passage, how the act is being implemented is causing great concern across the country.
We are now being told that farmers must mitigate risk for many critical pesticide tools, some of which have been used safely for over 40 years. This could mean the outright cancellation of some uses and dramatically altered use patterns for others. How EPA implements provisions addressing cumulative risk, non-occupational exposure, or toxicity endpoint selection and other new requirements of the FQPA will dramatically affect how many crop uses will be lost or the extent of cost increases to farmers.
The organophosphate pesticides (OPs) represent the single most important class of insecticides used in U.S. agriculture and are the first of EPA's targets under FQPA. The OPs are critical to farmers because they represent about 50 percent of all insecticide treated acres and about 65 percent of the total pounds of insecticides applied in the United States. Of the roughly 350 million acres of farmland in the United States, OPs are used on roughly 10 percent of those acres.
This is only one class of crop protection chemistry at risk under FQPA. Others will follow with uncertain outcomes, which only increases Farm Bureau's anxiety and concern. The FQPA sets forth a number of new requirements that will result in major changes to existing regulatory policies and procedures involving a high degree of complexity. Practical implementation of these new requirements demands EPA have and use new scientific tools in addition to those that were available when the FQPA was enacted. EPA must have adequate time to properly evaluate and implement these new tools.
Page 109 PREV PAGE TOP OF DOC As you know, this implementation is happening in the middle of a farm economic crisis when farmers have little or no ability to absorb higher and higher regulatory costs. Market prices for some commodities do not reflect the cost of production. EPA's implementation of FQPA could drive costs even higher, making a bad situation even worse. As a result of all this, the FQPA has become Farm Bureau's highest priority issue.
In 1996, Farm Bureau members nationwide contacted their members of Congress urging passage of the FQPA. But they would never have done so knowing what they know now. Please consider the following:
Would farmers have asked for your support knowing that the FQPA could remove many of the crop protection tools we rely upon most?
Would farmers have asked for your support knowing that the FQPA could simultaneously eliminate these critical and widely used products while simultaneously slowing the registration process for newer pesticides that might serve as alternatives?
Would farmers have asked for your support knowing that the FQPA would provide greater incentives to register pesticides for minor uses on one hand, while at the same time leading EPA to target many critical and widely used minor uses?
Would farmers have asked for your support knowing that crop protection tools, many of which have been used safely for over 40 years, that were safe before August 3, 1996, would be in jeopardy?
Would farmers have asked for your support knowing that EPA would consider using the law to group and assess the risk of entire classes of pesticides as one pesticide?
The answer to each of these questions is no.
If the safety of our food supply was in question and deteriorating, or if the health risks for Americans from consuming food treated with crop protection tools were increasing, it would be understandable to take appropriate action to correct these problems. But that is not the case.
Page 110 PREV PAGE TOP OF DOC I testified before the Senate on May 5, 1996nearly 3 years agoto talk about these very same issues. Earlier that year the National Research Council released the report, ''Carcinogens and Anticarcinogens in the Human Diet.'' The report draws several conclusions which I raised then and will repeat now. Those conclusions include:
''Most naturally occurring minor dietary constituents occur at levels so low that any biologic effect, positive or negative, is unlikely. The synthetic chemicals in our diet are far less numerous than the natural and have been more thoroughly studied, monitored and regulated. Their potential biologic effect is lower.''
In other words, natural chemicals present in the foods we eat pose a greater health risk than synthetic substances. However, both natural and synthetic substances are present in our diets ''at levels so low that they are unlikely to pose an appreciable cancer risk. '' Those words are worth repeating in light of how the FQPA is being implemented today. If we could enumerate the health benefits Americans could expect to enjoy following EPA's current implementation track, it might be worth it. But we can 't. The fact is, our food is safe and forcing farmers to switch to other products will not change the health and welfare of Americans at all. We will demonstrate this point in greater detail in a few weeks. We have asked the Harvard Center for Risk Analysis to examine this issue in greater detail and we will provide to you the results from their study as soon as it is available.
The growing concern over EPA's implementation of FQPA gave rise to an unprecedented coalition effort. Last spring Farm Bureau, the American Crop Protection Association, National Food Processors Association, major and specialty commodity groups and over 50 other farm, food, manufacturing and pest management organizations, known as the Implementation Working Group (IWG), completed and released the FQPA ''Roadmap Project.'' The ''Road Map'' provides a comprehensive implementation proposal which is consistent with FQPA, serves the interests of consumers and is workable for the regulated community. It was and still is our hope that the ''Roadmap'' be viewed by EPA, the Agriculture Department and Congress as our constructive recommendations for workable, health and science-based implementation of FQPA. The ''Road Map,'' we also believe, is consistent with Vice-President Al Gore's ''memorandum'' on the implementation of the FQPA. Both called for the use of sound science before regulatory decisions, transparency in the process, and stakeholder involvement.
Page 111 PREV PAGE TOP OF DOC Since the release of the ''Road Map,'' we have worked with EPA and USDA in an effort to provide comments on the implementation process as appropriate. While we are encouraged in some aspects with the distance the agency and department have come over the last year, we remain very concerned overall for the future of agriculture as implementation efforts proceed. I would like to expand on several of our continuing specific major concerns.
The FQPA requires EPA to assess pesticide risks for ''anticipated dietary exposures and all other exposures for which there is reliable information.'' Before the FQPA, the focus was on food. After the FQPA, the focus is still on food, but additional exposures must now be considered. This includes exposure from drinking water and exposure from non-occupational or residential exposures, such as indoor exposures to termite or cockroach pesticides.
What doesn't make sense are the unrealistic, default assumptions EPA is using when data are absent or incomplete. It was our understanding that upon passage of FQPA better data for these new requirements would be obtained before regulatory decisions were made. Unfortunately, instead of asking for data from farmers, registrants and others, EPA is using these unrealistic default assumptions. One example of the unrealistic default assumption is that when the agency does not have real pesticide use information, it assumes that farmers use pesticides at maximum rates, on all acres, and apply products the maximum number of applications. In some cases, it is also assumed that consumers are exposed daily to the maximum dose of pesticides from a variety of exposures.
If we look hard at data that is available, it becomes clear that those types of assumptions have very little resemblance to real-world exposure. Also, it is becoming clear that when actual data is substituted for default assumptions, risk is lowered and lowered considerably. EPA proved this in their recent example of a risk assessment for Guthion (Azinphos-Methyl) which they briefed stakeholders on two weeks ago. Last summer EPA's preliminary assessment, using many defaults assumptions, showed risk at nearly 5,000 percent above acceptable risk for the general public, and 10,000 percent above acceptable risk for children. Recently, EPA incorporated more realistic data from several sources including the USDA. The result was that risk is now well below acceptable levels for the general population, at 68 percent, and at the safe margin for children at 105 percentagain, 5,000 down to 68, 10,000 down to 105, by using more realistic data.
Page 112 PREV PAGE TOP OF DOC This particular assessment underscores the need for continual and expanded EPA and USDA cooperative involvement in the process. Without this mutual partnership, we believe determining real-world exposure to pesticides would be nearly impossible to obtain.
With real-world data, we can replace these worst case assumptions, but it takes time and cooperation from EPA and USDA. Very simply, we are asking EPA to do what we feel FQPA calls for. As part of this hearing, Congress should clearly instruct EPA to use its data call in authority in order to obtain reliable information and to take the necessary time to collect and use this data. This requirement may need to be law. On this point, I am attaching a copy of a letter sent by myself and Jay Vroom, president of the American Crop Protection Association, to EPA urging the agency to utilize their authority under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to call in data from registrants to satisfy the many data needs associated with a sound implementation of FQPA.
On May 22, 1998, AFBF, as lead petitioner, filed a Petition for Rulemaking and Procedures for Implementing the Food Quality Protection Act of 1996. In that petition, we request EPA and USDA to issue formal regulations that will govern EPA's tolerances decisions. Such regulations will give notice to registrants of what data EPA will require with applications and the methodology that EPA will apply in making decisions. Notwithstanding statutory requirements, EPA has not yet issued a coherent implementation plan and continues to rely on ad hoc policies. Under its statutory mandate, EPA must collect and evaluate new scientific and technology data about many pesticides. Because we are concerned that EPA may bypass this process and revoke tolerances by reason of broad default assumptions, Farm Bureau and others filed this petition. To date EPA has not responded.
On June 19, 1998, AFBF and numerous agricultural and food trade associations petitioned EPA to issue regulations streamlining the approval process for Section 18 tolerances for pesticides used under emergency conditions. Such proposed regulations would accelerate the Section 18 tolerances review process, avoid disruptions of EPA's tolerances review schedule and allow EPA to concentrate its limited resources on full risk assessment for the small number of emergency permits. To date the EPA has not replied to this petition.
Page 113 PREV PAGE TOP OF DOC Finally, Farm Bureau and others have petitioned EPA to implement a key provision of FQPA, the data collection provision, codified in 8 408(f)(1) of the Food Drug and Cosmetic Act. The data collection provision would provide the agency with a way to make tolerances decisions based on reliable data rather than unsupported assumptions. Our petition in this regard was filed on October 21, 1998 and followed up on March 18, 1999. On March 30, 1999, EPA Acting Administrator, Susan Wayland, responded by stating, among other things, ''While we are always interested in new information that could help us refine our analyses, the Agency already has a wealth of reliable data upon which to evaluate these chemicals.'' The letter concludes by stating that Congress did not intend or require that the Agency rely on such (call in)data and, moreover, the Agency it has determined that it has sufficient data on which to base its tolerances decisions. Thus, the Agency continues to ignore its obligation under the statute.
Another area that concerns Farm Bureau greatly is the so-called ''cumulative approach.'' This provision in the law could require not only single pesticides to meet the new standards of FQPA individually, but could require a group of compounds, like the organophosphates, to be considered together and meet a standard previously allowed for just one chemical. The possible implementation of this single provision of the law underscores the need for the use of sound science and not the use of default assumptions. This cumulative approach could mean the unnecessary cancellation of entire classes of chemicals, and the loss of critical crop protection tools for growers.
We believe that the implementation process for the FQPA should be open, transparent and follow established administrative procedures for Federal rules and regulations. But EPA's implementation procedure has not followed normal administrative procedures for the rulemaking process.
Vice President Gore's April 8 memo has helped on this subject. It asked EPA and USDA to ''ensure that the decision and positions of the two agencies are transparent to affected constituencies. '' EPA then began to act upon this announcement by forming the Tolerance Reassessment Advisory Committee (TRAC) and out of the TRAC, EPA has begun to publish sets of science policies for public comment. Farm Bureau believes the TRAC process has been positive for agriculture in many important respects. We believe it is essential for all concerned that this process continue in an effort to ensure openness, input and accountability. I would like to thank all of you, especially Representative Stenholm and Representative Berry for your personal efforts opening this process.
Page 114 PREV PAGE TOP OF DOC The nine science polices, with over 20 sub-papers, began to be released last fall for public comment and continue today. We greatly appreciated this effort as it offered an understanding of the tolerance reassessment process. However, nearly a year after Vice President Gore's memorandum, and only several months away from an August deadline, only one out of the 20 plus policy papers has been re-released to the public, and it is not yet final. Furthermore, it is a guidance document, not a formal rule. The agency states that they have been operating under a ''pilot process '' for the last year as they review pesticides. But again, this process has not had the benefit of official public comment. We question how the agency can make fair pesticide risk assessments while at the same time seeking public comment for most parts of that same process?
We ask that the agency take the needed time to figure out how to implement these new requirements before they rush to make regulatory decisions based on default assumptions.
AVAILIBILITY OF SAFE PRODCUTS
We believe that EPA needs to fulfill its obligations under the law in prioritizing and accelerating the registrations of new, effective and economical crop protection products. These registrations have not accelerated, but have actually become slower. This means that essential crop protection products may be lost before new ones replace them, leaving farmers no tools to protect their crops.
We don't know what products are in the registration process at EPA nor do we know if these new products are truly replacements for uses that may be canceled. Plus, agriculture needs to know the effectiveness and cost of potential replacement products. If farmers need to use two or three new products to do the same job one pesticide does now, can they be considered a replacement? Farmers need to know the cost of new products. If new products cost much more than existing products and aren't effective, they really can't be considered replacements.
Page 115 PREV PAGE TOP OF DOCTRADE ISSUES
Fourth issue, international trade. Farm Bureau has long been a supporter of freer and more open trade. EPA's implementation of the FQPA may force the agricultural community to rethink its trade goals and objectives. Already, U.S. agriculture is more regulated than most countries. The disparity is particularly large between the United States and developing countries, our major agricultural trade competitors.
According to USDA, the United States is a net importer of fruits and vegetables. In 1997, U.S. imports of fruit and vegetables reached $10.1 billion, up 6 percent from 1996. Imports as a share of domestic consumption also continue to rise. Imported fresh fruit accounts for about 40 percent of total domestic consumption. Imported fresh vegetables account for about 14 percent of domestic consumption.
Mexico is the largest supplier of fruit and vegetable imports to the United States, accounting for about 50 percent of the total value in 1997. Mexico supplies about 60 percent of all fresh vegetable imports and 35 percent of the total value of fresh fruit imports.
Farmers in other countries will likely benefit and gain a competitive edge if U.S. growers lose the ability to use certain pesticides due to anecdotal information, default assumptions or invalid methodologies. Pesticide residue testing at the border is not adequate to catch produce entering the United States that has been produced using a pesticide restricted or eliminated due to the FQPA. Organophosphate and carbamate pesticides break down quickly through the action of sunlight and water into harmless by-products. Foreign growers, to prevent residues from being detected could merely increase their pre-harvest intervals to ensure that resides are not detected at the border.
So while the FQPA regulates farming practices in the United States in an attempt to improve food safety and the diets of children, it provides a competitive advantage to foreign growers who will be able to use tools U.S. growers won't be able to use. This will not improve food safety and provide stronger safeguards for infants and children. We are very concerned about the serious consequences for U.S. farmers if critical and economical crop protection tools are lost due to hasty implementation of FQPA.
Page 116 PREV PAGE TOP OF DOCTHE NEED FOR LEGISLATION
The Guthion risk assessment is a perfect example of why we are now asking for legislation that specifically addresses the needs for an effective, science-based, fair implementation process that we understand and which creates a level playing field for all crop protection products. We urge your support for legislation that will refine and build upon the process for pesticide reassessment in two ways.
First, by requiring the use of sound science in place of default assumptions for the new provisions of the law. And second, by creating the much needed transition time for agriculture, EPA, USDA and other stakeholders, that the original law did not provide. We look forward to legislation that allows this transition time for the agriculture community and EPA to collect realworld data and for the agency to use it.
We don't believe that by passing the FQPA, Congress intended for the EPA and USDA to make hasty decisions based on theoretical risk. Instead, we believe and agree with Congress that
sound science and a fair process is the foundation of this law. These themes are concurrent with the ''Road Map'' that was released last summer and with the Vice President's memo to EPA and USDA. These issues must be addressed in order to address the legitimate concerns of growers across the country, and avoid serious economic impact on farmers.
Our society derives significant benefits from the safe and judicious use of pesticides.
Pesticides reduce the risks of crop failure and stabilize food production.
Pesticides increase yields and allow food to be produced on less land. Land that would otherwise be needed for food production can be devoted to wildlife habitat and other beneficial uses. Pesticides also allow environmentally fragile lands to be idled. Fewer farmed acres reduces the amount of water needed for irrigation.
Page 117 PREV PAGE TOP OF DOC Pesticides prevent soil erosion resulting from increased cultivation to control weeds.
Pesticides reduce farm costs. Reduced costs allow us to compete in world markets. Lower farm costs also translate to lower food costs, which encourage consumption of foods important to health.
Pesticides allow food to be grown domestically, rather than depending on imports where we have little to no control over food production methods.
Pesticides improve the quality and storability of food. Consumers can expect more perishability at the marketplace as a result of pest infestation and consumer rejection of products with poor appearance and quality if farmers are forced to arbitrarily reduce pesticide use. Consumers can expect poor quality foods if they are typically stored for long periods. High quality foods are essential for meeting export standards as well. Customer countries will reject U.S. products if they do not meet quality or phytosanitary standards.
Pesticides decrease farm labor requirements. History has shown that it is difficult to attract labor to agriculture due to the often difficult working conditions.
There is a lot of good news for the American food consumer. The supply of food is bountiful, quality is unparalleled, variety is ever-expanding and prices are reasonable. The American farmer/government/university food production system is unrivaled. Our quality of life and health provide sufficient evidence and argument to build upon our current system. Our hope is that the FQPA will allow us to build on these successes rather than turning our back on them.
In conclusion, FQPA implementation is now the top priority for the American Farm Bureau Federation and many other agricultural, crop protection, pest control and food manufacturing organizations. Thousands of personal contacts have been made with EPA, USDA and members of Congress expressing the need for fair implementation. We need to have an effective, science based, fair, implementation process that we understand, that will create a level playing field for all crop protection products.
Page 118 PREV PAGE TOP OF DOC Thank you for holding this important hearing and for your attention to our concerns.
Statement of Herb Karst
Thank you for the opportunity to appear before the Subcommittee this morning. My name is Herb Karst. I am a barley, wheat, and canola farmer from Sunburst, Montana, and president of the National Barley Growers Association (NBGA). NBGA represents barley producers in Minnesota, North Dakota, Montana, Idaho, Washington, Oregon, and Maryland, comprising the majority of U.S. barley production. NBGA is pleased to have this opportunity to testify on EPA's implementation of the Food Quality Protection Act (FQPA).
NBGA recognizes the difficult task facing EPA in implementing FQPA. While we appreciate the efforts of the Agency to fulfill diligently the reassessment process required by the law, we believe that the Administration should prioritize its FQPA implementing objectives in a way that ensures that America's farmers do not suffer unnecessarily from policies predominantly focusing on eliminating chemical options. Insufficient attention has been given to providing access to better chemical alternatives to the farmer.
EPA must allow key pesticides to be used on barley and other crops that EPA considers ''minor use'' crops, or the small farmers who grow them will suffer devastating losses, and consumers who purchase those products will face higher prices.
EPA must improve its process for granting emergency exemptions that allow key pesticides to be used on crops that will be unprotectedand likely lostwithout those pesticides. Presently, the review and approval process can be very slow due possibly to staffing demands of the FQPA reassessment process. This situation needs to be addressed immediately!
Page 119 PREV PAGE TOP OF DOC
EPA must speed up its process for approving registrations for alternative pesticides that farmers can use in place of the products that they traditionally have used. Many uses of the older pesticides are being canceled, or soon will be canceled, as a result of FQPA implementation. Farmers must have alternatives to protect their crops.
EPA must be more flexible in allowing residue data for one crop to be used to support the use of a pesticide on another crop, when the science supports such a use. Without this flexibility, growers, especially growers of minor use crops such as barley, are left without products to save their crops from loss or damage, while unnecessary, costly, and time-consuming data are produced.
EPA must make its regulatory requirements consistent with Canada's standards. American farmers simply cannot compete with crops grown in Canada, when Canadian farmers face fewer and less costly regulations. We believe that the NAFTA Technical Working Group on Pesticides (TWG) must quickly complete its work to provide harmonized registration options.
I will discuss each of these points in more detail.
EPA MUST ALLOW SPECIAL CONSIDERATION FOR MINOR CROPS AND LOWER ACREAGE CROPS LIKE BARLEY
EPA's implementation of FQPA has meant that fewer and fewer pesticides can be applied on lower acreage crops. EPA considers a ''minor use'' a use on crops grown on less than 300,000 acres. Barley, with an projected acreage of approximately 6 million acres, is not afforded special EPA allowances reserved for minor use crops, yet falls short in competition with the major crops for the limited registration priorities afforded each manufacturer. With the implementation of FQPA, farmers may lose the use of many pesticides traditionally used on these low acreage crops. These farmersmany of whom are small operationsface devastating crop losses as a result. Consumers of these products will find them unavailable, or available at much higher prices than they should be.
Page 120 PREV PAGE TOP OF DOC
The problem is a result of the FQPA requirement that EPA assess the total risk of all uses of certain pesticide products and determine the total risk it will allow for all those useswhat EPA calls the ''risk cup.'' Often, the major uses of a pesticide product ''fill'' the ''risk cup,'' and EPA will not allow any other uses, no matter how small. In other words, EPA believes that the total risks of the major uses are the maximum that it can allow. EPA will not allow additional uses on minor crops, such as barley. Growers of these minor crops then are left without important products that they need to protect their crops and face significant losses as a result.
Not only are growers losing products that they must have to survive, they are not getting new products to take their place. Registration of a low acreage use often lags several years behind registrations of major crops because pesticide producers can earn much more money with the major uses than they can with the minor uses. FQPA attempted to address this type of problem by providing incentives to encourage the minor uses. These incentives include providing flexibility in waiving certain data requirements, and requiring EPA to expedite its review of applications for minor uses. In enacting FQPA, Congress recognized how important minor uses are. Congress now should require EPA to make changes in its FQPA policy so that minor use and lower acreage crops are not lost.
We believe there are several ways that EPA can meet its FQPA requirements and still allow much needed minor uses. One important change that EPA could make is to use actual data, rather than data assumptions, as it now does, in assessing the risk of pesticide products. We believe that if EPA used actual data, its risk calculations would allow many more minor uses, because actual data would show much less risk than the default assumptions that EPA uses. EPA should actively seek out real data from real documented usage rates. Our growers and state commissions, state agriculture departments, and extension services could provide the sound scientific data needed to be accurate in such calculations.
Page 121 PREV PAGE TOP OF DOC
EPA MUST IMPROVE THE EMERGENCY EXEMPTION PROCESS
Barley growers and growers of other minor use crops often need emergency exemptionswhich the statute specifically allowsto save their crops from loss. These exemptions allow growers to use a pesticide on a crop, even though EPA did not register it for use on that crop. These exemptions have become more important to growers of barley and other minor use crops since FQPA was enacted, since, as I discussed, many products now are prohibited from use on these crops. EPA must continue to improve the emergency exemption process or farmers will lose crops needlessly.
The reasons that the emergency process is bogged down is that EPA will not grant an emergency exemption without first conducting a lengthy and costly assessment to determine whether the ''risk cup'' for that pesticide is already full. EPA believes it must conduct this assessment because FQPA requires EPA to establish pesticide residue limits or tolerances for emergency exemption uses. EPA believes it must assess the risks of all uses of the pesticide before it can decide what tolerances it will allow for the emergency use. It is impossible to complete this type of assessment on an emergency basis. What is hard to comprehend is why in repeat Section 18 requests the whole process could not be expedited by the recognition of the previous year's collection of data. Additionally, priority must be given to the lower acreage crops that have few options in crop protection products.
The emergency uses requested often involve very small numbers of acres of a specific crop. Thus any risk posed by the requested use would be insignificant. When an emergency use situation arisesfor example, the unexpected infestation of a crop with a pest and no pesticide registered for use on that crop to eliminate the pestgrowers must have these exemptions on an immediate basis or they will lose the crop. Growers cannot wait for the results of an assessment that is months or years long.
Page 122 PREV PAGE TOP OF DOC
One recent example of an emergency use situation affecting barley occurred when the Russian Wheat Aphid infested crops in Colorado. An emergency exemption was essential to allow small family farmers in central Colorado to provide a reliable domestic supply of barley, but unavailable because of EPA's interpretation for conducting emergency use risk assessments. NGBA applauds EPA's timely grant of an emergency exemption for the pesticide Warrior to be applied to barley crops in Colorado and Montana. We urge Congress and EPA to do whatever is necessary to assure that all such requests are handled as expeditiously.
We believe there is a solution to this problem. EPA should conduct an incremental risk assessment for each emergency exemption application, instead of conducting an assessment of whether the risk cup is ''full.'' This solution to the emergency exemption problem was proposed in June 1998 petition filed with EPA by the National Food Processors Association, and we believe it should be adopted immediately. We understand that EPA is considering rejecting an incremental risk assessment and will propose to employ the same process it uses currently. This would be a mistake.
We also support the provision in Representative LaHood's bill entitled FQPA Implementation Act of 1999 (H.R. 1334) that would amend FIFRA Section 18the emergency exemption provisionto state that ''EPA may issue such a tolerance or exemption associated with an emergency exemption without regard to other tolerances or exemptions for the pesticide chemical residue and before reassessing such tolerances or exemptions, if the Administrator determines that any incremental exposure that may result from the tolerance or exemption associated with the emergency exemption alone will not pose any significant dietary risk.''
Page 123 PREV PAGE TOP OF DOCEPA MUST APPROVE NEW PESTICIDES THAT CAN BE USED ON MINOR USE CROPS
I have discussed the dire situation barley and other minor use crop growers face with respect to the pesticide products they traditionally have used, products that may not be available in the future. We need new, safer, and more effective products or we will not be able to grow our crops. New products are not available as soon as they could be, however, because of lengthy delays in the EPA approval process. Staffing limitations mean that EPA limits the number of Section 3 applications that can be submitted by any one company. These delays must be eliminated so that crops with lower acreage are not sacrificed to those of greater economic return to companies.
Much of the delay in the approval process is the result of EPA's efforts to ensure that all FQPA requirements are met with respect to new products, by applying stringent default assumptions that have little basis in reality. As Representative LaHood's bill recognizes, however, if EPA makes decisions on how individual pesticides are approved before ''new policies are in place or before the needed data are available, they may be based on outdated and overly stringent policies, worst-case assumptions, or both.'' That bill further recognizes: ''These actions may be accompanied by adverse publicity that could lead to unwarranted concern and could effectively destroy the marketability of products that in fact are safe.''
When Congress passed FQPA, it placed a high priority on the registration of new, reduced risk pesticides. FQPA requires EPA to develop criteria for reduced risk pesticides and to expedite the review of registration applications that reasonably appear to meet those criteria. Congress now should ensure that EPA has the tools and incentive to register new products, especially products that can be used on minor crops, such as barley. Such action is essential to protect these crops from devastating and unnecessary losses.
Page 124 PREV PAGE TOP OF DOC
EPA MUST BE MORE FLEXIBLE IN ALLOWING RESIDUE DATA FROM ONE CROP TO SUPPORT REGISTRATION ON ANOTHER CROP
Pesticide registrants who try to obtain EPA approval of their products for use on barley, often face formidable residue data requirements for that use, even though they have data on other similar grain crops that would support it. EPA should be more flexible in allowing uses of a pesticide on one crop based on residue data for another crop, when the science supports doing so. Otherwise, those products cannot be used before unnecessary, costly, and time-consuming residue data are produced. Products then are unavailable to growers for many seasons, without any good reason.
EPA has spent much effort in developing policies to implement the new FQPA standard for tolerances. Under FQPA, EPA must determine whether tolerances are ''safe,'' which is defined as ''a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' These new policies must not ignore practical realities. If the science supports the use of already existing residue data for another crop, EPA should allow use on that crop. EPA regulations currently establish crop groupings that enable the establishment of tolerances for a group of crops based on residue data for certain crops that are representative of the group. Barley, for example, is in a crop grouping with other cereal grains such as corn, oats, rice, and wheat. EPA should ensure that this sensible approach is available readily by promoting greater use of crop groupings for tolerance-setting purposes.
Congress should require EPA to ensure that it makes the maximum use of already existing data before imposing costly and time-consuming data requirements. Needless residue data requirements can and do deprive growers of badly needed products for many years.
Page 125 PREV PAGE TOP OF DOC
U.S. PESTICIDE REGISTRATION REQUIREMENTS MUST BE HARMONIZED WITH CANADIAN REQUIREMENTS
Growers face unfair competition from Canadian growers, because U.S. and Canadian pesticide registration requirements are different. Only recently has the US begun to take advantage of work that Canada has already done in registering new pesticides for use on crops. Canadian growers have been able to protect their crops with new, cost-efficient products that were unavailable in the U.S. and thus produce bigger crops for less money than U.S. farmers. U.S. and Canadian standards must continue to be harmonized, so that U.S. growers are not an a disadvantage that they cannot overcome.
There are many examples of pesticides and herbicides that have been registered in Canada that are not labeled for use in the United States due to EPA's slow registration process. One product, Achieve, an inexpensive and effective wild oat herbicide used routinely in Canada, was only recently labeled for use in the United States.
Without this new competition, companies have been able to charge more for competing products in the U.S. One is Assert, a wild oat herbicide. At the end of 1998, Assert cost $14.75 per acre in the United States, but only $8.25 per acre in Canada. Another is Hoelen, also a wild oat herbicide. At the end of 1998, Hoelen cost $14.65 per acre in the United States, but only $8.12 per acre in Canada.
EPA has begun working with Canada and Mexico to coordinate scientific and regulatory decisions on pesticides through the NAFTA Technical Working Group on Pesticides (TWG). The NAFTA TWG's goal is to make work sharing the way of doing business among the United States, Canada, and Mexico by 2002. NBGA applauds the efforts of the TWG. The TWG must expedite its work to provide harmonized pesticide registration options.
Page 126 PREV PAGE TOP OF DOC
Congress should ensure that the inequities that U.S. growers now face in competing with their Canadian neighbors are eliminated. EPA should develop an efficient and streamlined system to exchange and share pesticide registration information with its North American neighbors and should actively help to create a North American system for pesticide registration.
On behalf of NBGA, I thank the Subcommittee for allowing me to appear today to discuss these very important issues.
Statement of William Lovelady
Thank you, Mr. Chairman, for your interest and leadership in this issue and for the opportunity for me to speak on behalf of the National Cotton Council (NCC). My name is Bill Lovelady. I am a cotton and pecan farmer from Tornillo, TX near El Paso. I am also a former president of the NCC and the NCC representative on the Tolerance Reassessment Advisory Committee (TRAC).
As a farmer, I am proud that American agriculture produces the most abundant, the highest quality, and the safest food and fiber supplies in the world. As farmers, we also take seriously our role as stewards of our land and natural resources. At the same time, there are tools that we need to protect our crops from the ravages of insects, diseases, and weeds. Analyses indicate that, if cotton farmers lost the uses of organophosphate compounds, economic losses would total approximately $7.2 billion per year. And, this estimate does not include the use of other necessary compounds.
Mr. Chairman, I testified before this subcommittee last year during a hearing on this same subject. At that time, there was a high level of anxiety among the agricultural community that Environmental Protection Agency's implementation of FQPA would unnecessarily result in the loss of some of our most valuable pest management tools. There have been some positive developments over the past ten months but there are still quite a few concerns. I would like to briefly mention those developments and concerns.
Page 127 PREV PAGE TOP OF DOC It is absolutely critical that FQPA be implemented with the use of sound science. In fact, the statutory language of FQPA requires EPA to use solid reliable data in its tolerance reassessments. However, in the absence of good date, EPA often relies on conservative default assumptions, such as assuming 100 percent of the crop is treated at maximum rates. These assumptions grossly exaggerate risk.
An example of the problems involved with such assumptions and one which I suppose you will hear a lot about today, is the case of azinphosmethyl or Guthion. This compound was first registered in 1959 and is now used on more than 50 food crops. Guthion is an important product used on cotton particularly in the southwest-growing region. At the TRAC Working Group meetings of April 8 and 9, EPA reviewed its tolerance reassessment of this product. At the initial phase of its, EPA's default assumptions led it to overestimate the risk involved with the use of Guthion by 95 times. Such a discrepancy in risk estimates clearly illustrates why it is critical that EPA uses data which reflect real life situations. The need for accurate assessments becomes even more critical when other sources of aggregate risk and cumulative risk are considered.
EPA can only use sound scientific data if it has such data in hand. The agency must inform the agricultural community and the registrants of data it is lacking. The agricultural community is very willing to provide necessary data. The NCC is currently working with EPA on data regarding the feeding of waste products from ginning operations. We discovered that EPA's initial assumptions overestimated the amount of gin trash that is in the diets of beef and dairy cattle by 7 to 20 times.
The TRAC has been a useful means for producers to participate in FQPA implementation and to voice their concerns. The TRAC has met on five different occasions. Its sixth meeting is scheduled for the end of this month. I encourage that this committee or a similar forum be continued at least until the time that EPA has established a well-defined methodology for reassessing existing tolerances and establishing tolerances for new products.
Page 128 PREV PAGE TOP OF DOC During the TRAC meetings, EPA decided upon nine science issues which it believes are important for FQPA implementation. The position of the agency on these issues is being published in the Federal Register for public comment over a period of time. We support this type of public participation. On the other hand, the final completion of these science issues is not scheduled until the first part of next year. In the meantime, EPA will be making tolerance decisions for the August 3 deadline before it has all the science issues resolved.
The TRAC meetings have also resulted in an increased role for USDA in FQPA implementation. We fully support a higher level of USDA participation especially with the planning for transition strategies. USDA is currently reviewing EPA's revised risk assessments for the organophosphates. The department is utilizing the expertise of the land grant universities for further review and input. We support this approach providing that USDA is using land grant faculty who are familiar with the respective crop and protectant. We are concerned, however, that, over time, the use of university resources could place a burden on the system. We realize that this committee is not responsible for funding these programs but we would encourage you to discuss with the appropriators a means to compensate the land grants for their services. We also support USDA's Pesticide Data Program and National Agricultural Statistics Service for the data they are generating.
EPA has funneled much of its time and resources into the reassessments of existing tolerances under FQPA standards. I have already stated the need to do such reassessment accurately. At the same time, we would not want EPA's other responsibilities, such as Section 18's and registrations of new active ingredients, to suffer.
Section 18 of FIFRA authorizes EPA to exempt a state or Federal agency from the provisions of FIFRA if EPA determines that emergency pest conditions exist. The fact that an emergency exits suggests that time is of the essence. However, EPA is interpreting FQPA to say that a full-blown FQPA tolerance must be determined to issue a Section 18. This is a time consuming process. There needs to be a better system to meet these emergency needs while still maintaining adequate safety standards. EPA should adopt an incremental risk approach to evaluating and approving Section 18 requests. This approach will take into account the limited time and area of usage.
Page 129 PREV PAGE TOP OF DOC The NCC is also concerned that the implementation of FQPA has detracted from the registration of new crop protection products. The number of new product registrations in fiscal year 1995 shows that EPA has a greater capacity to register new products. Growers need these newer tools. They are looking for safer products. They need a variety of products for resistance management, for specific pest problems, and, potentially, to replace organophosphate uses.
Mr. Chairman, as I have said, there have been some positive developments in FQPA implementation. But, there are still quite a few concerns. The NCC looks forward to working with your subcommittee on these issues.
Thank you, again, for this opportunity to speak.
Testimony of Jay J. Vroom
My name is Jay Vroom, and I am President of the American Crop Protection Association (ACPA).
Organized in 1933, ACPA is the not-for-profit trade organization representing the major manufacturers, formulators, and distributors of crop protection and pest control products, including bioengineered products with crop production and protection characteristics. ACPA member companies produce, sell, and distribute virtually all the active compounds used in crop protection chemicals registered for use in the United States.
I appreciate this opportunity to come before the subcommittee today to discuss the status of FQPA implementation from the vantage point of the registrant community. The process by which EPA implements the FQPA changes in pesticide regulation will determine the ultimate fate of many crop protection tools and will surely establish a reference point for implementation of future changes in pesticide law. To avoid unnecessary disruptions in pest control programs and for reasons of precedent, the implementation of FQPA must be balanced, reliable, and based on sound scientific principles.
Page 130 PREV PAGE TOP OF DOC Industry History. The crop protection industry has a long history of government regulation according to up-to-date, peer-reviewed scientific principles and reliable data and information. The basic toxicity studies that we conduct on pesticides are identical to those initially conducted on human drugs. In addition, we evaluate the fate and impact of our products in the environment, a proven process that is continuously being refined to better insure their safe use. When we actively supported repealing the Delaney provisions in FFDCA in conjunction with passage of FQPA, it was because we, along with the scientific community, recognized that the zero risk Delany standard for carcinogenicity was not based on accepted scientific principles.
FQPA Provisions. With the enactment of FQPA in 1996 our industry was aware that certain provisions of the law would be especially challenging, particularly in the time frames stipulated in the law for re-evaluating previously registered products according to the new standards and requirements. But we were somewhat comforted by the fact that Congress incorporated into FFDCA provisions from FIFRA that prescribe how EPA should update and publish the new data requirements for registering pesticides and how registrants should be given adequate time to collect the new data on old products and make it available to the Agency. We had seen this process work very well in the updating of product data bases as part of reregistration as mandated by the FIFRA 1988 amendments. In the intervening months since FQPA passed, we have petitioned and repeatedly urged the Agency to fully utilize these data updating provisions of the new law. To date, EPA has not responded to all of these petitions and has shown little indication that the use of these product specific data development provisions is a meaningful part of their implementation process.
Early EPA Decisions and IWG. Based on some of EPA's early decisions with respect to FQPA implementation, it appeared to the agricultural and user communities that many safe and effective pest management products essential to public health protection and agricultural production might be in jeopardy. Out of this concern, the Implementation Working Group (IWG) was formed.
Page 131 PREV PAGE TOP OF DOC The IWG is a coalition of farm, food, pest management, and manufacturing organizations that have joined together to address and respond to the requirements of the FQPA and to recommend a framework for its implementation. The IWG members are committed to the goals of FQPA, but we believe that it can and must be implemented in a fair and reasonable manner. IWG saw the need to develop a set of principles and recommendations to assist in building understanding, foster consensus, and address the evolving issues related to the implementation of FQPA.
To these ends, the IWG sponsored the ''Road Map'' project which laid out a set of guiding principles for implementing FQPA. Members of the IWG believe that the implementation of FQPA must be:
Based on sound science and reliable information;
Transparent with respect to process and decision making;
Balanced between protecting public health and the environment, while assuring an abundant, wholesome, and affordable food supply;
Workable with respect to allowing timely inputs, reasonable transition to new products where necessary, and minimal legal or functional disruptions.
IWG is actively engaged in commenting on the new science policies as they are published by EPA and looks forward to participating in the identification of new data requirements that these policies will likely create. ACPA is an active member of the IWG coalition.
TRAC. The TRAC process of stakeholder involvement was created out of recognition that greater transparency was needed in the FQPA implementation process. Through the TRAC process, many participants began to understand for the first time the complexity of the process of pesticide registration and regulation.
This process brought USDA's important role in FQPA implementation to the forefront, and their participation has allowed a better understanding of the potential impact of implementation decisions on agriculture.
Page 132 PREV PAGE TOP OF DOC In the spirit of transparency and cooperation, our industry agreed to a TRAC pilot process of publishing the most preliminary phases of individual product risk assessments. Though preliminary and incomplete, we envisioned this as a first step in helping non-registrants better understand the scientific foundation supporting the use of our products. By openly following the process of risk refinement from preliminary to final, we felt that the user community could better understand the valuable role they can play in providing information on actual product use practices. To accurately assess the exposures and therefore the risks of our products, it is necessary to use the most accurate use information that can be obtained.
For the most part, this pilot process has served a useful educational purpose. There have been abuses and misuses of the preliminary information that was made public. But the greater value of the process surfaced only 2 weeks ago in a TRAC Work Group session on the risk assessment refinement process. The information released by EPA at that meeting on a widely used organophosphate insecticide (Azinphos-methyl) provided an excellent example of why it is so important to only make risk determinations using the most accurate information.
The risk refinement of Azinphos-methyl is such a critical example of how this process can and should work when accurate information is used that I would like to briefly walk through it with you using a poster display of EPA's summary table, recently made public.
The Poster (See attached). Before we examine this table of information, let me set the stage for you.
Azinphos-methyl is an organophosphate insecticide registered by EPA to control a broad spectrum of insect pests on approximately 50 food crops.
This table addresses the acute or short term risk from food residues, not including water. Water exposures, if any, must still be added to the risk cup.
Risk estimates are expressed in terms of percent of Reference Dose (RfD)
Page 133 PREV PAGE TOP OF DOC 1. RfD is another term for risk cup, the allowable daily exposure to a product
2. The goal in the risk refinement process is to only allow uses that would result in exposure of no more than 100 percent of the RfD or 100 percent of the risk cup.
In this example, risk estimates are presented for dietary exposures to:
1.The general population, and
2.Infants less than 1 year of age
Of the 50 or so crops for which Azinphos-methyl is approved, the four crops shown here (apples, peaches, pears, and cherries) represent the greatest contribution to acute dietary risk, and for this reason are identified as the major contributors to risk.
With respect to the statistical precision of these assessments, EPA is attempting to carry these to the 99.9th percentile of the consuming population or population subgroup. We have a major concern when this level of statistical precision is applied to dietary risk calculations but is based on residue data and food consumption survey data where sample sizes would not support this level of precision.
Preliminary Assessment. This initial assessment represents a worst-case scenario of product use, namely:
1. 100 percent of crops treated
2. Field residues under maximum use conditions
Highest labeled rate
Highest number of applications allowed
Closest possible treatment prior to harvest
Use of field residue data for both single serving foods and blended foods
Page 134 PREV PAGE TOP OF DOC 3. USDA food consumption data from the late 1970's
Clearly, these conditions do not represent real world use or exposures, and they result in an exposure estimate to infants of 10,000 percent of the risk cup. Remember, 100 percent or less of the risk cup is our goal. As inaccurate as this initial assessment is, it was released in the TRAC pilot program for purposes of transparency and was both misunderstood and misused. At least one major foreign customer discontinued use of a pesticide based on a published preliminary worst-case assessment
Refining Risk Assessments. Refining the preliminary worst case risk assessments for a product is the critical part of a risk assessment process. It is data dependent, it involves groups other than registrants, many aspects of it are new, and it must be clearly defined and communicated by the Agency.
It requires accurate information on:
1. Percent of crop treated
2. Application rates typically used by growers
3. Number of applications typically used by growers
4. Food residue data at the point of consumption from USDA and FDA
5. More precise single serving residue data
6. More accurate USDA food consumption data for population subgroups. More precise statistical predictions of chance exposures from dietary sources (Monte Carlo)
Current Assessment. The table shows that the current assessment of Azinphos-methyl with some of the mentioned refinements places infant risk from dietary exposures right at 100 percent of the risk cup, which is our goal. Statistically, 105 percent and 100 percent are not distinguishable.
It is my understanding that additional residue data will be available in the coming months that will allow even further refinements of the exposure and resulting risk associated with Azinphos-methyl insecticide.
Page 135 PREV PAGE TOP OF DOC Again, USDA's role in providing more accurate use and residue data was critically important to this process. In that regard it would be helpful if USDA's reviewer comments were made available to the interested public. USDA's resources to continue this role should be thoroughly evaluated and enhanced where needed.
FIFRA Preemption. Before I conclude my remarks, I wish to mention a recent FIFRA development that is technically outside of FQPA per se, but may affect the uniform implementation of FQPA and other pesticide regulatory decisions.
Recent Developments. The United States Department of Justice (DOJ) has recently filed amicus curiae briefs on behalf of the United States Environmental Protection Agency, in support of the plaintiffs, in two FIFRA preemption cases: Etcheverry v. Tri-Ag Service, Inc. and Bayer Corp, which is awaiting hearing in the California State Supreme Court; and Hart v. Bayer Corp., which is awaiting hearing in the United States Fifth Circuit Court of Appeals. These amicus briefs argue that FIFRA does not preempt state law tort claims at all because, in the view of this administration, FIFRA preempts only direct regulatory commands, not indirect pressure resulting from tort liability. This is a profound departure from all previous positions taken by the U.S. Federal Government on questions relating to FIFRA label preemption.
Background. Every pesticide product sold or distributed in the United States must be granted a registration by the United States Environmental Protection Agency (EPA) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and must be accompanied by its own, nationally uniform, EPA-approved labeling. Labeling is the means by which EPA ensures that a pesticide product's manufacturer provides warnings and directions for use that are adequate to protect health and the environment.
Section 24(b) of FIFRA, entitled ''Uniformity,'' expressly prohibits states from imposing any requirements for pesticide labeling that are in addition to or different from those imposed by EPA under FIFRA. By mandating that each pesticide product be distributed with nationally uniform labeling regulated solely by EPA, Congress sought to ensure that a single Federal agency in possession of the necessary data, expertise, and experience would determine what warnings and other information should or should not appear on a pesticide's labeling.
Page 136 PREV PAGE TOP OF DOC State tort claims for failure to warn about alleged risks of using a pesticide imply that the warnings on the EPA-approved labeling accompanying the product are inadequate. FIFRA preemption prohibits juries from second-guessing EPA's pesticide labeling determinations and impose their own state law standards for ''adequate'' labeling. Without Federal preemption, juries would determine the content of labels without any increased benefit for anyone alleging injury from such pesticides. Indeed, aggrieved parties have the ability to seek legal recourse through design defect, manufacturing defect, breach of contract or breach of warranty litigation claims, separate and apart from this FIFRA label preemption avenue.
Implications of Preemption. Pesticides are sold nationwide, and lack of Federal preemption would lead to different state labels for each product, resulting in a barrier to interstate commerce. Also, product availability could diminish and/or prices could artificially increase in litigious states. Without FIFRA preemption ensuring a federally mandated label, state juries that lack scientific expertise on pesticides would, in effect, be making decisions about the labeling and subsequent use of pesticides.
The Department of Justice's amicus brief directly conflicts with the precedent set by over 200 other state and Federal FIFRA preemption cases. This profound change in direction by Federal policy makers has the potential of reducing the availability of crop protection products, especially for small markets (minor use products), because of the uncertainties and potential liabilities that would be attributed to the labels of the pesticide registrants. Potential loss of FIFRA preemption would serve to diminish farmer (and other pesticide user) confidence in the credibility of EPA's regulatory process and, in turn, consumer confidence in the safety of the food supply will take another assault from this potential loss.
A copy of a letter from Senator Lugar to Carol Browner on this matter is attached to this testimony.
In conclusion, I would like to say that we recognize that additional accurate information can either increase or decrease the exposure and risk associated with product uses. We must have the best information, and then we must go where the science takes us and deal with the results accordingly.
Page 137 PREV PAGE TOP OF DOC The key message from the Azinphos-methyl example and my message today is that EPA must take the time to do these assessments right, and base them on the most accurate information possible. The key to that process is clear direction from EPA to the stakeholder community about the kind of data they need, how it should be gathered, and that stakeholders be given the time to provide that information.
Thank you Mr. Chairman for the opportunity to be here today.
Testimony of Frances B. Smith
We are pleased to have this opportunity to present the views of Consumer Alert before the subcommittee on matters relating to the implementation of the Food Quality Protection Act. I am Frances B. Smith, executive director of Consumer Alert.
Consumer Alert is the founder and coordinator of the National Consumer Coalition, an on-going coalition of 27 non-profit groups that together represent over 4 million consumers. Consumer Alert, founded in 1977, is a national non-partisan, non-profit consumer group with individual members in all 50 States.
The organization's mission is to assess public policy proposals for their effects on consumers, promote the importance of sound science and sound economic data to underlie public policy, and provide consumer educational materials on topical consumer concerns. Consumer Alert points to the consumer value of a market economy in increasing consumer choice and competition, which leads to lower prices and advances in technology that can improve health and safety. Our funding comes from dues-paying members, as well as individual, foundation, and corporate donors.
This is a crucial time for regulatory agencies' decision-making on how to interpret the Food Quality Protection Act (FQPA). This Act was prompted by a growing realization that the Delaney Clause was creating serious health risks by focusing solely on the minuscule risks while ignoring the far larger risks associated with lower availability and higher prices of health-enhancing consumer products. FQPA was intended to correct some of the biases of food safety law relating to risk issues. However, with the FQPA and the criteria it sets for pesticides, these biases could be exacerbated as the focus shifts to a standard that considers only risks.
Page 138 PREV PAGE TOP OF DOCRISK VS. RISK FRAMEWORK
We feel that it is critical for this subcommittee and the Federal regulatory agencies responsible for implementing the Act to hear the views of consumers. In our testimony, we ask the subcommittee to understand the risk vs. risk framework for evaluating pesticides and food safety issues. This is not the standard cost/benefit analysis, nor is it the traditional risk assessment approach. Instead, risk vs. risk looks at the risk of innovationin this case, the use of certain pesticidesand evaluates it against the risk of stagnationthat is, the risks that may arise from further restrictions or bans on those pesticides.
In taking action to address a concern, to ''protect'' consumers from a risk, regulators can fall into the trap of not looking at the very real risks that may arise from their actions; what will be referred to as the unintended consequences. It may be helpful to put this concept in question form: How does the pesticide risk for consumers compare to the risk of eating fewer fruits and vegetables because of misplaced fears or increased costs that result?
The appropriate evaluation of risk is important not only for decisions taken by each individual but also for public policy considerations, since policies intended to protect the public from one risk might lead to higher risk in another area. For example, a comparison can be made to delays in the approval of a drug or medical device. Although there might be risks in approving the drug, there are also risks that withholding the drug would result in people dying. These different risks have to be weighed against each other for public policy decisions.
If a minor risk for the public is portrayed out of context, so that the public misperceives it as a major risk, decision-makers could underestimate other unintended consequences. In such a case, a policy concentrating on only one risk without considering the trade-offs involved might turn out to do more harm than good for the public. We would like to point out some of the possible pitfalls that could arise from assessments of pesticide risk that fail to consider the risk vs. risk framework. We will focus on the unintended consequences that fall most heavily on consumers, children, and the poor.
Page 139 PREV PAGE TOP OF DOC I would first like to draw the Subcommittee's attention to a true story of those unintended consequences. In 1995, there was a scare about pesticide residues on blueberries in Connecticut that was widely reported in the media. A prominent toxicologist received many calls from concerned consumers and told them there was only a minuscule risk of any problems. One woman caller, however, followed up with a question: ''You don't understand, professor, I'm pregnant - should I get an abortion?'' An excessive focus on small risks without consideration of how this information is perceived by the public can have tragic unintended consequences.
With severe restrictions or bans on pesticides, the retail prices of many fruits and vegetables can rise significantly. Families, especially the poor, may not be able to purchase an adequate amount of produce for their families' healthy diet. Inner-city minorities currently have the lowest dietary intake of fruits and vegetables. Higher prices for produce could hurt them the most. The restriction or ban of certain pesticides for non-food use should also be evaluated from a broad public health perspective. In their June 1992 report, ''Pesticides: Minor Uses/Major Issues'', the Council for Agricultural Science and Technology (CAST) highlighted this injustice to the poor.
''The average U.S. family spends only about 10 percent of their disposable income on food. For these families, a substantial increase in the costs of fruits and vegetables would not be popular, but could be absorbed without great hardship. However, some 30 million of the U.S. population spend at least 60 percent of their disposable income on food. For those of limited means, a substantial increase in the price of fruits and vegetables would impose a further serious economic burden. As fruits and vegetables become less affordable, this segment of the population would consume less at a time when health experts recommend an increased consumption of fresh fruits and vegetables.'' (Chapter 4, Pesticide Loss Implications, p. 11, emphasis added).
About 80 percent of U.S. children and teenagers already FAIL to meet the daily requirements of produce recommended by the National Cancer Institute and the National Research Council. Numerous scientific studies have shown an association of a diet rich in fresh fruits and vegetables and a lowered risk of cancer and other diseases. A recent study by the distinguished biologists at the University of California at Berkeley, Drs. Bruce Ames and Lois Gold, noted that a high consumption of produce is ''associated with a lowered risk of degenerative diseases including cancer, cardiovascular disease, cataracts and brain dysfunction.''
Page 140 PREV PAGE TOP OF DOC In a 1997 consensus report, an Ad Hoc Panel from the American Cancer Society, in conjunction with the Canadian National Cancer Institute, concluded that the benefits of a diet rich in fresh fruits and vegetables far outweighs the minimal risks associated with pesticide residues. The report also echoed earlier findings that increased consumption of fruits and vegetables lowers the risk of developing cancer. In its assessment the panel concluded, ''...it is not aware of any definitive evidence to suggest that synthetic pesticides contribute significantly to overall cancer mortality.'' (Cancer, 1997; 80:2019)
The Ad Hoc Panel of experts reviewed several studies by government agencies and international scientists on the relationship between public exposure to pesticides and cancer. The panel focused especially on the general public's exposure to pesticides through residues in food and the use of pesticides in homes and gardens. It also looked at the existing regulations relating to pesticide use and discussed the beneficial effects of their use in agricultural production. One of the main goals of the review was to find out
whether the risk from synthetic pesticides was significant enough to justify a reallocation of resources and a shift in cancer prevention programs away from tobacco.
The report further stated that the panel ''...did not believe that any increased intake of pesticide residues associated with increased intake of fruits and vegetables poses any risk of cancer.'' The panel's review of surveys and monitoring programs revealed the majority of food is free of chemical pesticide residues, according to different Canadian and U.S. studies. Only a very small number (between 0.67 percent and 1.5 percent) of tested food in these studies contained residue levels above the allowed standards.
The report also mentioned that the level of residues at the time of consumption might even be much lower because of the washing, cooking and processing of food after the harvest. The residue levels could be reduced by as much as 14100 percent, according to a survey in the U.S. Thus, the panel said that it saw no need to tighten current regulations of pesticide use. It did suggest that further research should be done, since many factors in cancer development are still not well understood, for example, the effects on infants and children and agricultural workers.
Page 141 PREV PAGE TOP OF DOC In its assessment of the use of man-made pesticides in agriculture, the panel emphasized the positive role that pesticides play in the prevention of crop destruction, which enables farmers to provide the general public with more affordable produce than they could without these protective measures. Since the increased intake of fruits and vegetables is associated with a lower risk of cancer and other positive health effects, to guarantee an
extensive and inexpensive supply of a wide variety of produce provides a significant contribution to public health.
With its conclusions, the panel reinforces results from earlier studies, such as the National Research Council/National Academy of Science's 1996 report on ''Carcinogens and Anticarcinogens in the Human Diet,'' which also found no significant evidence of increased risk of cancer due to synthetic pesticide residues in food. It also supported the earlier findings on the health benefits of fruit and vegetable consumption, and the significance of a person's diet on his or her risk of developing cancer.
MISPERCEPTIONS OF RISK
Finally, the public's perception of risk took an important place in the 1997 study. The panel pointed out that risk is usually perceived in a different way depending on whether a person has influence over the decision to take it or not. A small involuntary risk might stir up much more anxiety among people than much higher risks people face voluntary, such as driving a car.
This phenomenon can lead to unintended consequences if public health policies are decided based on risk perception rather than on scientific risk assessment, the report noted. The panel recommended more efforts to present hazards and benefits in a balanced way to the general public. ''It is most important that we find the ways to put hazards into perspective for the public, to provide a credible source of factual information to encourage a thoughtful and balanced assessment of both risks and benefits. . .'' It warned about the public's tendency to be more concerned about potential hazards imposed by someone else than by hazards that are in the control of the individual, because that approach ''... may raise concerns that are not appropriate to the level of risk and also may have the undesirable effect of diverting public attention from areas that present significant public health risks and that are modifiable by individual choice.''
Page 142 PREV PAGE TOP OF DOC (Cancer, 1997; 80:2030). (A copy of the Cancer article is included as an attachment.)
RISKS OF PESTICIDE RESTRICTIONS FOR THE FOOD SUPPLY AND PUBLIC HEALTH
The use of pesticides to produce a healthy, abundant, and affordable food supply must be an important component of reassessment before considering the elimination or additional, significant restrictions on certain pesticides. It has been estimated that a 50 percent reduction in pesticide use would mean a 100 percent loss of peaches produced in Georgia and South Carolina, and a 100 percent loss of apples produced in Michigan. Less drastic reductions would dramatically reduce the yield and thus increase the cost of many fruits and vegetables.
Prominent toxicologists have recently weighed in on some of the problems with highly publicized reports relating to pesticides, specifically, they took issue with the February 1999 Consumers Union report on pesticides, saying that ''information obtained from flawed methodology misinforms the public on the risks of pesticide exposure.'' In a letter on March 8, 1999 to Carol Browner, the head of the Environmental Protection Agency, top elected officials of the Society of Toxicology said that ''the CU report's conclusions concerning the dangers of pesticides in food are not credible and are unnecessarily alarmist.'' The Society is the largest professional organization of toxicologists in the world.
The scientists called on Browner ''to reassure the American public that there is not cause for alarm, and that fruits and vegetables are important components of a healthy diet.'' The writers also expressed the organization's belief that sound science has to be an ''integral part of risk assessments and the regulatory actions based upon them,'' and offered the services of many of their members who are experts in pesticides and food safety to serve as resources for the EPA on such issues. Those signing the letter on behalf of the Society were SOT's president, Dr. Steven D. Cohen, vice president, Dr. Jay Goodman, vice- president elect, Dr. Daniel Acosta, Jr., and past president, Dr. R. Michael McClain. (A copy of the letter is included as an attachment.)
Page 143 PREV PAGE TOP OF DOCPERVERSE INCENTIVES
Equally important, as EPA is currently implementing it, FQPA provides perverse incentives to manufacturers who will be forced to make choices on which chemicals and which uses of specific products they will continue to support. They may be forced to cut many minor uses including vegetable crops, ornamentals, and many public health uses. Such actions will cause many fruits and vegetables to become more expensive, place US farmers at an economic disadvantage, and put the public at risk from preventable diseases.
Public Health uses of pesticides, such as those used to control mosquitoes, ticks and other disease-carrying insects, are among some of the lower volume uses of pesticides. Most public health applications do not generate enough use volume to justify the decision to retain these products if the risk cup is exceeded. These critical public health uses of many pesticides may be at risk, and manufacturers may face the unenviable task of removing from the market uses of a product that benefit the public health. Policy makers should carefully assess the public health effects - the risksof applying the new criteria to disease-controlling pesticides.
In conclusion, we strongly encourage the committee to focus attention on the unintended consequences of their actions in regard to pesticides: the potential harm to people, especially children and the poor, that could result from a focus on risk in a vacuum. Risks must be evaluated with full recognition of benefits and unintended consequences. The potential danger of pesticide residues on fruits and vegetables and in public health uses is infinitely small compared to the many benefits they provide in achieving a large supply of affordable produce and the health benefits that follow from that.
Testimony of Doug Wilson
Thank you. My name is Doug Wilson. I am a farmer in north central Illinois and I raise corn, soybeans, high oil corn, and hybrid seed corn. And had it not been for a generous rain last week, I would have appeared much more nervous today as my planter would have been sitting still while my neighbors were planting corn. I am president of the Illinois Corn Growers Association and am a former National Corn Growers director. One other involvement I would like to mention is being President of the Illinois Council on Best Management Practices (CBMP). Illinois CBMP is a board of agricultural organizations and businesses working to assist watersheds on water quality issues and sharing information with both agricultural and non-agricultural interests.
Page 144 PREV PAGE TOP OF DOC The NCGA represents more than 30,000 corn farmers in 48 States. Farmers need a variety of crop protection products to be successful in their farming operations. These products allow for a healthier crop, providing a higher yield due to protection from pests and weeds.
NCGA supported the Food Quality Protection Act (FQPA) when the law was passed in 1996, and we remain committed to the law. We agree with the fundamental goals of the law, including safeguards for children and the establishment of a uniform public health standard. We feel that review of pesticides using reliable data, as stipulated in the law, will ensure the public health. However, farmers remain concerned about the lack of a defined process for the implementation of FQPA.
In working to more clearly articulate our concerns regarding FQPA implementation, farmers, farm and food groups, pest management and manufacturing organizations formed the Implementation Working Group (IWG). The IWG's ''Framework for Implementing the FQPA'' or ''Road Map'' document provides a series of workable recommendations for implementing the law. This document represents the consensus of a variety of affected parties as to how we believe FQPA can be implemented fairly and effectively. Based on the provision of the Road Map, IWG has prepared comments during the open comment period of several of the science policy papers and will continue to do so.
NCGA is also involved in the FQPA Tolerance Reassessment Advisory Committee (TRAC) created by the EPA and USDA, with Jim Czub, a farmer and member of NCGA's Board of Directors, as a participant. We support the TRAC and look forward to continuing to participate in the process. However, we see this as just one step in the implementation process. This advisory committee does not replace the need for sufficient information to U.S. farmers from EPA and USDA on the implementation process and valid scientific data behind tolerance reassessment and registration decisions.
Page 145 PREV PAGE TOP OF DOC NCGA would like to thank the members of this committee for your continued oversight of the FQPA implementation. Corn growers are very encouraged by the role of USDA in the FQPA implementation process and the achievements that have been made over the last year. However, we remain concerned that the USDA does not have sufficient financial resources or staff to continue providing the needed support to farmers throughout the implementation process. NCGA and the Illinois Corn Growers Association have been working very closely with the University of Illinois in the various programs relating to FQPA. Primarily, our focus has been on the need for accurate information on pesticide use patterns. The University of Illinois has submitted a ''Corn Matrix Response'' to the EPA, using data generated for the corn crop profiles in the EPA's crop matrix format. Much more of this work needs to continue in various areas of the country on corn and other commodities. Land grant universities need to be actively engaged in this process.
USDA also needs to be prepared to handle its increased role in risk assessment review, which we believe is a key role of USDA during the implementation of FQPA. We support the necessary resources for this process to continue. Also, the new programs being developed by USDA to develop broader participation and programs and to assist in the collection of data and disseminate of information are very important.
We appreciate EPA's working on making several science policy papers available for public review and the work that has taken place in the agency as a result of the TRAC. However, there are still issues that need to be resolved. We remain concerned about how EPA is using its resources. While we understand the new requirements under FQPA substantially changed the way pesticides were regulated, the reassessment of existing tolerances cannot overshadow the importance of new product registration. The agency has not allocated sufficient funds to ensure that new product registration continues in a timely manner. Currently, the EPA expects 13 out of the 40 pending new product applications will be reviewed in fiscal year 1999. Thirty-three percent is not sufficient in light of the continued changes in agriculture.
Page 146 PREV PAGE TOP OF DOC When new products are made available to growers, their adoption is not immediate. These products must have sufficient time on the market for before growers know and understand their efficacy and application methods. The mere ''Washington'' identification of a product as a replacement for another product is not always sufficient. There are regional variances in application and efficacy that need to be taken into account, not just the fact that the products are labeled to eradicate the same pest.
New products need to be introduced to the market in timely fashion to allow an orderly transition. There is also an important economic impact to having new products available at the same time that existing products are being reassessed and that is simply the price of the products. The price of existing products is most likely less than new products, but the sheer fact that these products are on the market allows some measure of cost containment. This applies for both traditional crop protection tools and biotechnology products.
Another element dictating the need for a variety of crop protection tools and methods is pest resistance. The most common production method employed is the traditional corn/soybean rotation to limit the corn root worm and other pest pressures. Unfortunately, in areas of Illinois and Indiana, we are seeing a root worm that is beginning to adapt and lay eggs in soybean fields instead of corn fields so that eggs hatch into rotated corn fields the following spring. This is already happening in Congressman Ewing's 15th Congressional District, where I live, and in areas east and southeast of there. Without an effective crop protection product to control the root worm, yields could be cut by 25 percent and the remaining plants will not stand as well and could result in additional losses. As this adaptation continues to spread, the use of various crop protection products is even more critical to successful crop production. In regions with irrigated corn, crop rotation is often not an effective option and pesticides are even more vital for corn production. Use of these same crop protection products is also critical for seed corn production fields that will provide the seed for the following year's crop. In addition, crop protection products are often used in concert with conservation tillage to preserve the soil.
Page 147 PREV PAGE TOP OF DOC Farmers must contend with many factors, including choice of crop, seed technologies and products, soil, climate and rainfall, and historical weed and pest pressure in the field. The same elements influence my decisions on pre-emergent and post-emergent application of crop protection products. Growers seldom use the maximum amount of application or the maximum rates because of cost alone. Safety and optimum yield are considered at length before application of any pesticide.
Corn growers have a great deal at stake during the entire reassessment process under FQPA. The policies developed now will set the stage for future actions and reassessments. This is not just an organophosphate issue or a herbicide issue, but applies to all areas equally and should be regarded in such a manner. The reassessment decisions on the first third of products should not be made without sufficient data and a defined process in place. The EPA must have a clearly defined process in place prior to making reassessment decisions under FQPA. As a result of the TRAC meetings, the science policies that indicate EPA's actions are being made available for public comment. This process of public input must continue and these policies must be clearly defined and reviewed prior to final reassessment decisions by the agency. The clarification of these policies is necessary to define a process for the reassessment of all tolerances under FQPA.
Due to the large crop acreage of corn, NCGA is not only concerned about health effects portion of the reassessment decisions, but also about EPA's use of lower tier or unrefined data in determining environmental fate and ecotoxicology. As well, the information on actual pesticide use patterns and data must be taken into account when calculating these assessments. If the EPA calculates environmental risk assessments using unrefined or inaccurate data, unnecessary losses in crop protection products will result. It is vital that sound science, actual pesticide use patterns and accurate information on formulations and application methods be used in all areas of pesticide reassessment. Often with corn products, there is a great deal of scientific information regarding these products and most accurate and higher level of refined data must be used.
Page 148 PREV PAGE TOP OF DOC As changes are made in product availability and/or product use through the adoption of risk mitigation measures, growers must be given appropriate transition time. As with new product availability, any mitigation measures or alteration in farming practices must be given time for adoption. Changes cannot be expected immediately. Any mitigation measures that may require equipment changes, or similar significant changes in farming practices, but be weighted with significant economic concern and be provided sufficient transition time.
As a part of our effort to articulate some of our existing concerns with FQPA implementation, NCGA and the ICGA have been working very closely with Representative LaHood on this issue. We support H.R. 1334, the FQPA Implementation Act of 1999, and its goals of sound implementation of FQPA through the use of data when making decisions, sufficient public input during FQPA implementation and analysis of the resources and priorities of EPA and USDA. Another important provision in this legislation is an analysis of the competitive strength of U.S. agricultural commodity sectors in the international marketplace.
Congressman LaHood's bill will assure consideration of sound science before suspending the use of a pesticide and will consider the overall public interest before taking such action. Corn growers feel that Rep. LaHood's bill is right on target because it addresses ''implementation'' of FQPA. FQPA can work if it is implemented correctly.
If corn growers are not provided sufficient options for crop protection, U.S. corn production will be at a competitive disadvantage. U.S. corn growers rely upon the latest technologies for all aspects of our farm business, and we evaluate current and new technologies constantly to choose the best products for our operations. Currently, the United States leads the world in corn production. NCGA strongly supports the 1996 Federal Agricultural Improvement and Reform Act's shift from supply management farm programs to a market-oriented farm economy. The FAIR Act allows me the flexibility to grow crops that make sense for my land in terms of conservation, production and economics. But to make these decisions, we need to have a regulatory process that supports product choice based on sound science and realistic agronomic practices.
Page 149 PREV PAGE TOP OF DOC NCGA monitors the corn production of other countries, including our closest low cost competitor, Argentina. 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. The U.S. government must help assist the U.S. farmer to remain competitive in the world market and not restrict our competitiveness through unnecessary and unreasonable regulation.
Keeping farm input costs in check is essential if we are to remain competitive in both domestic and international markets. Current low corn prices and weak export demand drive home the importance of this issue. If corn farmers have reduced options for crop protection the prices of these products will undoubtedly rise. If prices become cost prohibitive, corn farmers will be limited in our ability to produce food for the world.
One of the basic precepts of the FAIR Act was the ''balance sheet''- reduced farm program payments offset by a more flexible farm program and other efforts such as tax reform, increased export assistance and regulatory relief. But the manner in which FQPA is being implemented is inconsistent with that balance sheet concept. Mr. Chairman, members of the Committee, I would encourage you to keep that balance sheet in mind as you exercise your oversight authority in this process.
Mr. Chairman, I want to 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 the impacts of this law on production agriculture are fully taken into account. We need transparency during the implementation of the law and the use of reliable information. We need to consider how this law effects agriculture, changes in farming practices, actual pesticide use and the need for new products. Provided that these things happen, we believe that FQPA can succeed in meeting the goals set by Congress.
Page 150 PREV PAGE TOP OF DOC
ANSWERS TO SUBMITTED QUESTIONS
Thank you for the opportunity to further respond and thank you for the earlier opportunity to testify before the subcommittee. The issues reguarding the best structure and system to ultilize FQPA are very important to agriculture. Following are the questions you submitted and my answers.
You mentioned the need to understand production agriculture as EPA implements FQPA. What specifically are your concerns?
The need for a variety of products and new product registration is very important for several reasons. I often must weigh the differences between application methods, or more specifically when I apply a crop protection tool, based on specific pest pressures and economic factorsthe potential damage to my crop and economic loss and the actual cost of application. Also the efficacy of a product is very important. Regional differences, soil types, and climate all play a role in my decision. Some products are not as effective in certain regions of the country due to the development of resistance to products. The actual cost of different products must be considered as well. Having a variety of choices not only let's me match the effectiveness of a product, but also allows me choices in how much I need to spend for treatment.
What do you think of the data collection and information USDA and EPA are undertaking?
It is vital that they have accurate information and do not use default assumptions. The use of default assumption over estimate the actual use of these products and do not provide for an accurate calculation of exposure and risk. It is unacceptable for the EPA to assume that their assumptions and data are the only correct choices, there are other sources that in some cases have better data and knowledge of products than EPA. EPA also has a tendancy to have tunnel vision and only look at one area at a time and not being able to look beyond to see the whole picture, I have seen this too many times and for the most part it causes unnecessary economic costs. We have been working to assist in data collection and want to ensure that this real life data is being used in both dietary and environmental risk assessments.
Page 151 PREV PAGE TOP OF DOC Can you give us an example of what you consider before you apply crop protection products? How would you gather the information used in your analysis of your specific crop needs?
There are a variety of concerns. First is treatment necessary? I am not interested in applying products if the threat to the crops is not beyond an economic threshold. Safety and economic factors are very important. Can I use an environmentally safe product that will be effective in relieving the specific pest pressures and be economically viable in relation to my cost of production. Consultation with neighbors, extension and crop consultant will provide me with some history in the efficacy of a certain product and the regional cultural practices. I want to make certain that the product has a proven track record prior and the infestation is serious to warrant the use of a specific crop protection tool.
Why have corn growers become involved in this process?
Farmers are facing a wide array of problems, the worst of which is economics. Having a variety of crop protection products that are effective, cost efficent, and environmentally safe is very important. If we limit our choices to only a few tools costs will be higher, pest resistance will come faster from overuse of only a few products, and likelyhood of a buildup of a particular product in the soil or water is more likely. Quite frankly I want someone looking over EPA's shoulder and making them accountable for the regulations they impose. The USDA must be an equal partner, TRAC should continue and the full picture of the effects of products from a postive and negative must be considered. The timeline for review of current and new products must be done in a timely manner considering all viable data. Corn Growers want to be fully engaged in any changes that may affect the availability of crop protection products and ensure that decisions are made using sound science and reliable informationbecause these decisions affect our livelihood.
Page 152 PREV PAGE TOP OF DOC
Statement of Alice A. Devine, Secretary, Kansas Department of Agriculture
I could not travel to Washington for the hearing this week, but would like to offer the following written comments. I have been serving on the Tolerance Reassessment Advisory Committee (TRAC) convened by EPA and USDA for the past year. Clearly, USDA and EPA have progressed significantly from the initial meetings almost a year ago. I believe there has been real progress made toward the goals established when TRAC was created. However, there are a number of issues that need addressed by USDA, EPA and perhaps, Congress. Below are some of the issues I hope Congress will discuss during your hearing.
Reregistration and FQPAEPA's reregistration process and FQPA's implementation must be open and public processes. The FQPA/TRAC process has been very helpful in revealing the activities of USDA and EPA. I believe it would be helpful for EPA to explain to Congress and the public the interrelation between these processes and their combined effects on the availability of pesticides. This issue has not been addressed by the TRAC because it is not within the perview of those discussions.
Water, Environment and Worker ProtectionThe current TRAC has focused on dietary exposure. Water, environmental (structural), and worker exposure merit similar review. The TRAC has not reviewed in detail the methodologies, data, and processes used by EPA to assess the risks associated from water and the environment. Clearly this is a significant portion of the analysis. I have requested that these issues be addressed during the final TRAC meeting. I believe it is important for the planning of transition strategies that these processes be as throughly reviewed as the dietary information. This is important to states planning water quality strategies as well. If a particular chemical is present in water and a major contributor to exposures through water, state regulators and users of the product need to know. This would allow use to be adjusted to avoid contamination.
Page 153 PREV PAGE TOP OF DOC The way worker protection standards are being integrated into this assessment process also is unclear. Worker protection issues have been raised at a number of our TRAC meetings and need clearer definition. Was it the intent of Congress to include worker protection standards as a component of the FQPA process? If so, USDA and EPA need to more clearly define the worker protection component and how it is integrated into the assessment process.
Imported ProductsIf producers in other countries are allowed to use pesticides not available in the U.S. because of FQPA, American producers will be on an uneven playing field. The public would also benefit greatly from a discussion of the effects of FQPA on imported products. U.S. producers must clearly understand the rules they are to follow and know their competitors worldwide are held to the same standards. Consumers expect imported products to meet the same requirements for food safety as U.S. products.
Role of USDAUSDA must substantially increase its role in the FQPA process and farmer groups must be included at each step. USDA has very few people working the issues associated with FQPA. It must gather data that has been ''field tested'' and reviewed by users and specialists in particular cropping practices. EPA's assessments will only be as good as the data used. It is my understanding that USDA is relying upon specialists within the land grant universities to review EPA assessments. While I am certain the reviewers are knowledgeable people, I am not certain they understand or choose to accept the critical role they are playing in this regulatory process. I would suggest that USDA create an in-house team of experts who have the experience and technical skills to carefully evaluate EPA data and aggressively search for expert input. USDA should then forward this information to EPA. USDA should not be a casual reviewer but a fully engaged entity which cross-checks EPA's work.
It also appears that producers, because of the complexity of the issues, are either consciously or unconsciously relying on registrants or university researchers to represent their interests. This concerns me because that is the role of neither the registrants nor the research community. I have continuously raised this issue to commodity organizations and USDA. I am hopeful that the processes will be very open and notice provided to all stakeholders when a product is being reviewed. The processes should also allow adequate time for information ''from the field'' to be offered. I would encourage Congress to direct USDA and EPA to actively seek information from persons who may or may not read the Federal Register on a daily basis but whom USDA and EPA believe to have an interest in or knowledge of the product under review.
Page 154 PREV PAGE TOP OF DOC What is the objective of the FQPA process? Does FQPA maintain a safe and wholesome food supply with realistic goals for pesticide use? There have been a number of presentations to the TRAC regarding organic or integrated pest management programs. While I believe these approaches to production of food have merit and are demanded by some consumers, I do not believe they are practical for mass food production today. Is there a goal for the reduction of pesticide use in this country? If so, what is it and was it discussed publicly? It was my understanding that the objective of FQPA was to assure the public a safe, wholesome food supply. Does safe and wholesome mean that no pesticides should be used? It would be helpful if producers and state regulators understood the true goals and objectives of Congress, USDA, and EPA so we can focus our efforts in those directions.
TimingCreate realistic time frames for further FQPA implementation. The TRAC process has clearly illustrated the complexity of the issues and the time necessary to resolve issues. I would encourage Congress to examine the progress made to date, and the number of issues outstanding in light of the deadlines established by law. I do not support unnecessary delay, but do support realistic time frames for completion of critical work.
Finally, I want to acknowledge the work of USDA and EPA to date. Real progress has been made but there are a number of unanswered questions. Hopefully, your hearing and the final TRAC meeting will address some of the issues. Thank you for your time and I hope these comments have been useful.
Statement of the Minor Crop Farmer Alliance
The Minor Crop Farmer Alliance (MCFA) was formed in November 1991 to address legislative and administrative policies to ensure the continued availability of safe crop protection tools for minor uses. MCFA has more than 130 organizations as members, representing all aspects of the agriculture sector, including the production, packaging, processing and shipment of agricultural products, including nursery stock, as well as public health sector.
Page 155 PREV PAGE TOP OF DOC MCFA appreciates the opportunity to offer its views regarding the implementation of the Food Quality Protection Act by both the U.S. Environmental Protection Agency and the U.S. Department of Agriculture. Since enactment of the FQPA there has been a strong concern on the part of users of pesticides that the future availability of these tools may be severely affected if the law was not properly interpreted and implemented. After all, pesticides have served a very valuable function in the production, storage and handling of foods and nursery stock, and the protection of public health. Elimination of these tools can have severe adverse consequences for consumers, farmers, processors and the general public.
MCFA has been supportive of various efforts to help assure a reasonable and balanced interpretation of the FQPA. These have included supporting the development of the FQPA Roadmap by the Implementation Working Group, supporting the issuance of the guidance to the agencies by Vice President Gore, participating in The Tolerance Reassessment Advisory Committee Process and commenting on various science policies and risk assessments being issued by EPA.
MCFA recognizes that FQPA implementation involves a process, much of which continues to be defined and developed. Based on the progress made to date in the initial stages of the implementation process, EPA appears to be incorporating many of the suggestions of the MCFA. That is not to suggest that all concerns have been addressed or that the process is complete and the outcome is satisfactory. We are a long way from the completion of the tolerance reassessment process. Critical issues and decisions remain to be determined. We will continue to work to help assure a reasonable implementation of the FQPA. We look forward to the support and oversight of the Committee in that effort.
The members of MCFA are prepared to deal with the decisions associated with FQPA to the extent such decisions are based upon sound science and reliable available data. We will continue to challenge the agencies to meet these standards in the implementation process. If such standards are not met we will be persistent and vocal in our criticism.
Page 156 PREV PAGE TOP OF DOC Again, we appreciate the subcommittee taking time out to review how the agencies are implementing FQPA. We are confident that such oversight is also appreciated by the agencies as an opportunity to further express publicly their plan for implementation of this important statute as well as their continued incorporation of advice by MCFA.
"The Official Committee record contains additional material here."