SPEAKERS CONTENTS INSERTS
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REVIEW THE ENVIRONMENTAL PROTECTION AGENCY'S PROPOSED RULE ON PLANT PESTICIDES
SUBCOMMITTEE ON RISK MANAGEMENT, RESEARCH, AND SPECIALTY CROPS
SUBCOMMITTEE ON DEPARTMENT OPERATIONS, OVERSIGHT, NUTRITION, AND FORESTRY
COMMITTEE ON AGRICULTURE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
MARCH 24, 1999
Serial No. 10610
Page 2 PREV PAGE TOP OF DOCPrinted for the use of the Committee on Agriculture
COMMITTEE ON AGRICULTURE
LARRY COMBEST, Texas, Chairman
BILL BARRETT, Nebraska,
JOHN A. BOEHNER, Ohio
THOMAS W. EWING, Illinois
BOB GOODLATTE, Virginia
RICHARD W. POMBO, California
CHARLES T. CANADY, Florida
NICK SMITH, Michigan
TERRY EVERETT, Alabama
FRANK D. LUCAS, Oklahoma
HELEN CHENOWETH, Idaho
JOHN N. HOSTETTLER, Indiana
SAXBY CHAMBLISS, Georgia
RAY LaHOOD, Illinois
JERRY MORAN, Kansas
BOB SCHAFFER, Colorado
JOHN R. THUNE, South Dakota
WILLIAM L. JENKINS, Tennessee
JOHN COOKSEY, Louisiana
Page 3 PREV PAGE TOP OF DOCKEN CALVERT, California
GIL GUTKNECHT, Minnesota
BOB RILEY, Alabama
GREG WALDEN, Oregon
MICHAEL K. SIMPSON, Idaho
DOUG OSE, California
ROBIN HAYES, North Carolina
ERNIE FLETCHER, Kentucky
CHARLES W. STENHOLM, Texas,
Ranking Minority Member
GEORGE E. BROWN, Jr., California
GARY A. CONDIT, California
COLLIN C. PETERSON, Minnesota
CALVIN M. DOOLEY, California
EVA M. CLAYTON, North Carolina
DAVID MINGE, Minnesota
EARL F. HILLIARD, Alabama
EARL POMEROY, North Dakota
TIM HOLDEN, Pennsylvania
SANFORD D. BISHOP, Jr., Georgia
BENNIE G. THOMPSON, Mississippi
JOHN ELIAS BALDACCI, Maine
MARION BERRY, Arkansas
VIRGIL H. GOODE, Jr., Virginia
Page 4 PREV PAGE TOP OF DOCMIKE McINTYRE, North Carolina
DEBBIE STABENOW, Michigan
BOB ETHERIDGE, North Carolina
CHRISTOPHER JOHN, Louisiana
LEONARD L. BOSWELL, Iowa
DAVID D. PHELPS, Illinois
KEN LUCAS, Kentucky
MIKE THOMPSON, California
BARON P. HILL, Indiana
WILLIAM E. O'CONNER, JR., Staff Director
LANCE KOTSCHWAR, Chief Counsel
STEPHEN HATERIUS, Minority Staff Director
KEITH WILLIAMS, Communications Director
Subcommittee on Risk Management, Research, and Specialty Crops
THOMAS W. EWING, Illinois, Chairman
BILL BARRETT, Nebraska,
NICK SMITH, Michigan
TERRY EVERETT, Alabama
FRANK D. LUCAS, Oklahoma
SAXBY CHAMBLISS, Georgia
Page 5 PREV PAGE TOP OF DOCRAY LaHOOD, Illinois
JERRY MORAN, Kansas
JOHN R. THUNE, South Dakota
WILLIAM L. JENKINS, Tennessee
GIL GUTKNECHT, Minnesota
BOB RILEY, Alabama
GREG WALDEN, Oregon
MICHAEL K. SIMPSON, Idaho
DOUG OSE, California
ROBIN HAYES, North Carolina
ERNIE FLETCHER, Kentucky
GARY A. CONDIT, California,
Ranking Minority Member
GEORGE E. BROWN, Jr. California
CALVIN M. DOOLEY, California
EARL F. HILLIARD, Alabama
EARL POMEROY, North Dakota
SANFORD D. BISHOP, Jr., Georgia
JOHN ELIAS BALDACCI, Maine
VIRGIL H. GOODE, Jr., Virginia
MIKE McINTYRE, North Carolina
DEBBIE STABENOW, Michigan
BOB ETHERIDGE, North Carolina
CHRISTOPHER JOHN, Louisiana
Page 6 PREV PAGE TOP OF DOCLEONARD L. BOSWELL, Iowa
KEN LUCAS, Kentucky
MIKE THOMPSON, California
Subcommittee on Department Operations, Oversight, Nutrition, and Forestry
BOB GOODLATTE, Virginia, Chairman
THOMAS W. EWING, Illinois,
RICHARD W. POMBO, California
CHARLES T. CANADY, Florida
JOHN N. HOSTETTLER, Indiana
SAXBY CHAMBLISS, Georgia
RAY LaHOOD, Illinois
JERRY MORAN, Kansas
JOHN COOKSEY, Louisiana
GREG WALDEN, Oregon
EVA M. CLAYTON, North Carolina,
Ranking Minority Member
MARION BERRY, Arkansas
BENNIE G. THOMPSON, Mississippi
VIRGIL H. GOODE, Jr., Virginia
DAVID D. PHELPS, Illinois
BARON P. HILL, Indiana
Page 7 PREV PAGE TOP OF DOCMIKE THOMPSON, California
GEORGE E. BROWN, Jr. California
DAVID MINGE, Minnesota
C O N T E N T S
Brown, Hon. George E. Jr., a Representative in Congress from the State of California, prepared statement
Clayton, Hon. Eva M., a Representative in Congress from the State of North Carolina, prepared statement
Ewing, Hon. Thomas W., a Representative in Congress from the State of Illinois, opening statement
Goodlatte, Hon. Bob, a Representative in Congress from the State of Virginia, prepared statement
Stabenow, Hon. Debbie, a Representative in Congress from the State of Michigan, prepared statement
Aidala, James V., Associate Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances, Environmental Protection Agency
Submitted memorandum of August 28, 1997
Cook, R. James, on behalf of 11 professional scientific societies, and the Institute for Food Technology
Page 8 PREV PAGE TOP OF DOCPrepared statement
''Appropriate Oversight for Plants With Inherited Traits for Resistance to Pests'', a report from 11 professional scientific societies
Kelman, Arthur, on behalf of the Council for Agricultural Science and Technology
Issue Paper No. 10, ''The Proposed EPA Plant Pesticide Rule''
Panetta, Joseph, vice-president, regulatory and environmental affairs, Mycogen Corp., on behalf of American Crop Protection Association and Biotechnology Industry Organization
''A Comparison of Perspectives on Key Issues Concerning EPA's Proposed Plant Pesticide Regulations''
American Seed Trade Association, statement
Proposed rule, Federal Register, November 23, 1994
USDA Biotechnology Council, letter of February 23, 1995 to the EPA
The Committee on Agriculture submitted additional questions to the Environmental Protection Agency. The Agency did not respond in time for printing.
REVIEW THE ENVIRONMENTAL PROTECTION AGENCY'S PROPOSED RULE ON PLANT PESTICIDES
WEDNESDAY, MARCH 24, 1999
House of Representatives, Subcommittee on Risk Management, Research, and Specialty Crops, joint with the Subcommittee on Department Operations, Oversight, Nutrition and Forestry, Committee on Agriculture,
Page 9 PREV PAGE TOP OF DOCWashington, DC.
The subcommittees met, pursuant to call, at 10:30 a.m., in room 1300, Longworth House Office Building, Hon. Thomas W. Ewing (chairman of the Subcommittee on Risk Management, Research, and Specialty Crops) presiding.
Present from the Subcommittee on Risk Management, Research, and Specialty Crops: Barrett, Smith, Everett, Lucas of Oklahoma, Chambliss, Moran, Thune, Gutknecht, Riley, Walden, Simpson, Ose, Hayes, Fletcher, Condit, Brown, Goode, McIntyre, Stabenow, Etheridge, Boswell, Lucas of Kentucky, Thompson of California.
Present from the Subcommittee on Department Operations, Oversight, Nutrition, and Forestry: Goodlatte, Ewing Hostettler, Chambliss, Moran, Cooksey, Walden, Clayton, Berry, Goode, Phelps, Thompson of California, and Brown.
Staff present: John Goldberg, Stacy Carey, Kevin Kramp, Ryan Weston, Callista Bisek, Wanda Worsham, clerk; Brad Sharduy, Danelle Farmer, and Russell Middleton.
OPENING STATEMENT OF HON. THOMAS W. EWING, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS
Mr. EWING. The subcommittees will come to order.
Welcome to all of you. The Risk Management Subcommittee is holding this hearing today to review the Environmental Protection Agency's proposed rule regulating plant pesticides.
The Risk Management Subcommittee held a biotechnology hearing 3 weeks ago. At that hearing, we learned about the importance of biotechnology to production agriculture, the global market, and to international trade.
Biotechnology allows producers to use safer controls and less chemical applications. The benefit of growing biotech products is twofold: environmental impact to farming is reduced, and, two, less applications of chemicals allows producers to reduce their production cost.
Page 10 PREV PAGE TOP OF DOC After only three seasons biotech products account for more than 50 percent of soybeans and cotton plantings and 40 percent of corn plantings. The importance of U.S. biotechnology reaches beyond production agriculture to the international trade arena.
United States Special Trade Representative Peter Scher has stated that there are few other issues which pose a greater challenge to the future of U.S. agricultural trade and demand than biotechnology. It holds the future of U.S. agriculture for meeting exploding global food demands.
The USTR also noted that biotechnology is more than just a regulatory process. It is about the fundamental challenge facing U.S. agriculture.
While it is necessary to have a regulatory process in place to assure the health and safety of consumers and the environment, we must assure that regulatory excesses does not suffocate this industry.
Today we have joined with the Department Operations Subcommittee to review a regulation proposed 4 years ago by the Environmental Protection Agency that would, in their own words, create a new regulation. This regulation creates a new class of pesticides called plant pesticides. That would then be subject to FIFRA.
Included in this new class of pesticides are substances that plants themselves produce to protect against pests and disease, along with the genetic material used to produce them.
This new regulation which is in its final stages has large implications for the U.S. biotech sector. If the regulation is flawed, the implications on U.S. biotechnology are very likely to be negative.
We heard at our previous hearing that our current biotechnology regulatory process is working to safeguard the public and the environment. Testimony was received stating that the current system of EPA, USDA, and FDA regulation is fully adequate now and for the future.
Page 11 PREV PAGE TOP OF DOC Ladies and gentlemen, I do not believe we can afford to take a chance on such an important industry to production agriculture. This is why two House subcommittees, accounting for 44 members of the entire 51-member committee, are taking the time to review this regulation today. We hope to explore a number of issues this morning.
The first being a very basic question: is defining plants that are bred to defend themselves as pesticides and then subjecting them to FIFRA an appropriate regulatory approach for the agricultural biotechnology industry?
Two, if so, why are there differing opinions within the scientific community regarding the validity of this regulation?
Three, we would also like to explore any potential benefits this regulation may provide to the industry.
And, finally, is this regulation ready to be issued as a final rule this year?
Mr. Goodlatte is not here at this time, however, if there are any statements for the record that Members would like to submit, they may be inserted at this point in the record.
[The prepared statements of Members follow:]
PREPARED STATEMENT OF HON. BOB GOODLATTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF VIRGINIA
I would like to welcome everyone to this joint hearing of the Department Operations, Oversight, Nutrition, and Forestry and the Risk Management, Research, and Specialty Crops Subcommittees. Chairman Ewing and I decided to convene this hearing to learn more about the Environmental Protection Agency's proposed rule to regulate genetically engineered plants.
The plant pesticide rule has peaked the interest of our respective subcommittees for very different reasons. Chairman Ewing's subcommittee has jurisdiction over biotech issues and is concerned about its regulation. My subcommittee has jurisdiction over the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). This is the statute from which EPA is deriving its authority to regulate pesticides. It is the convergence of these two distinct issue areas that has grabbed our attention and causes some concern.
Page 12 PREV PAGE TOP OF DOC We all recognize EPA's authority to regulate those products whether chemical, biochemical or microbial, intended for sale and distribution that control or prevent pests. It is my understanding, however, that plant biotech varieties that have made it to market have been de-regulated by USDA, in implicit stamp of approval from the U.S. Department of Agriculture and the same thing EPA wants to do. I am interested to learn today why the USDA's review of these plant varieties hasn't been good enough, or why EPA thinks they would do a better job.
I understand that this is an evolving science and what might be considered safe today might cause unknown challenges tomorrow. No one is challenging that sound, scientific review is appropriate. In fact, scientific monitoring will probably enhance our knowledge and spur future advancements. It doesn't take much clairvoyant power, however, to foresee a regulatory choking of a promising technological tool for our farmers. An inefficient, burdensome regulatory process can retard innovation rather than stimulate growth. Regulatory oversight must be embedded in providing a safer product not mere bureaucracy. Today's exemptions could be tomorrow's regulatory targets and many of those supporting this proposed rule will be sitting at that same table asking for us to intervene on their behalf.
As we have seen all too often recently, there is great disagreement between the interests in this industry and the EPA on what constitutes sound science. If the registrants thought they were shooting at a moving target while working in the context of the Food Quality Protection Act implementation, imagine the frustration of a popular genetically engineered seed whose exemption from this proposed rule was revoked just in time for planting season.
In that same vein, we have heard quite a bit about the cost of tests to gather the data EPA requires for approval of a traditional pesticide under FIFRA. I am concerned that the requirements to prove qualifications for exemptions will hit similar price stratospheres, narrowing the competition, increasing prices to the farmer and chilling further innovation. Excessive prices will likely be paid in order to get ''new'' exemptions for novel chemistries introduced.
Page 13 PREV PAGE TOP OF DOC I look forward to hearing the witnesses' testimony today. We have assembled uniquely qualified witnesses that will provide insight into challenges and needs presented by the proposed plant pesticide rule.
PREPARED STATEMENT OF HON. GEORGE E. BROWN, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Chairman, thank you for holding these hearings today as one of a set of hearings to update our understanding of commercial biotechnology developments in agriculture. In the 1980's when I was chair of the Research Subcommittee of this committee, we conducted a series of oversight hearings on biotechnology regulation, so there is a rich tradition for this inquiry.
But the development of biotechnology in this country has a rich tradition as well, one of open public debate at each difficult stage of this sector's growth. At the Asilomar Conference in 1972, scientists called for a moratorium on recombinant DNA (rDNA) research until we could better understand the implications of this powerful area of science. After much public debate, we established the recombinant DNA advisory committee (RAC) at the National Institutes of Health to approve every rDNA research application. We also included non-scientists on that committee to insure public trust and confidence. Over time with increasing knowledge, we were able to exempt whole types of research from the purview of the committee. And over time, the public confidence in the technology and in the Government's ability to avoid risks grew with our positive experience.
In 1980, the Supreme Court ruled that bioengineered life forms could be patented, setting off another round of public debate that rose and ebbed. In the early 1980's, biotechnology was on the verge of commercialization, and companies were seeking permission to test bioengineered organisms in the field. The debate on moving biotechnology outside of the lab grew and resulted in field testing protocols and eventually in the Coordinated Framework for Biotechnology in 1986. Many argued at that time that the move to establish unique regulatory approaches to bioengineered products was
Page 14 PREV PAGE TOP OF DOCa simplistic overreaction and overly broad.
I would note that the push for clear regulation of biotechnology products came from both the environmental community and the business community. For the business community, there was a need to show investors how orderly commerce would be conducted and how a product would reach market. Without this Coordinated Framework, the biotechnology industry would likely have starved for cash.
In more recent times, we have seen a reoccurrence of this cycle of debate, broad concern, broad regulatory sweep, and narrowing concern and regulationas we gain more knowledge about the new phase we have entered. This is the case with the issue before the subcommittee today.
The public needs to have confidence in the products being marketed, and beyond actual risk, it needs to be assured that any perceived risk has been faithfully examined as well. Companies seeking to raise capital and move a product need a clearly defined pathway to market. Companies seeking to sell into increasingly uncertain international markets need the ''EPA good housekeeping seal of approval'' that is a pesticide registration from the U.S. Government.
Those who seek to take issue with this proposed rule have forgotten the tradition of biotechnology development in this country. They can argue that many of these products are the same as natural products, and they are right. I am sure they are trying to argue this same point in the EC and Brazil, and elsewhere in regions of the globe that are boycotting genetically modified organisms (GMO's), areas that do not have the same level of confidence in biotechnology products and their regulation.
The irony of this situation is inescapable: one reason we are so far ahead of the rest of the world is because we have taken the time for full public debate and regulation. Over time, the regulatory scope, and the scope of the debate, has narrowed as we have gained confidence in our ability to understand the newest threshold of discovery in biotechnology.
Page 15 PREV PAGE TOP OF DOC I for one am not ready to turn my back on this tradition.
PREPARED STATEMENT OF HON. EVA M. CLAYTON, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NORTH CAROLINA
I appreciate your holding this joint hearing today to review the Environmental Protection Agency's proposed plant pesticide rule.
First let me extend a special welcome to Dr. Arthur Kelman, from North Carolina State University. Dr. Kelman is the Emeritus Reynolds Professor of Plant Pathology and he will be testifying on behalf of the Council for Agricultural Science and Technology. I would like to welcome all of the distinguished witnesses and thank you for being here today. I look forward to your testimony.
I appreciate the opportunity this hearing provides for us to review the Environmental Protection Agency's proposed rule on plant pesticides.
On November 23, 1994, the EPA published a proposed policy and rule that would define plant pesticides as substances that plants produce to protect themselves against pests and disease, and subject these substances to regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In response to the proposed policy and rule a report entitled ''Appropriate Oversight for Plants with Inherited Traits for Resistance to Pests'' was issued jointly by 11 scientific societies representing 80,000 members.
On October 19, 1998, the Council for Agricultural Science and Technology (CAST) released an issue paper on the EPA proposed policy and rule plant pesticides. The CAST Issue Paper concurs with the findings in the scientific societies' report, concluding that: ''Federal regulatory proposals should be guided by policies that encourage research and its application, resist unduly burdensome regulations, and also minimize public anxieties about hypothetical hazards. The EPA proposed rule fails to meet any of these desirable objectives.''
Under the proposed rule, EPA would designate all substances responsible for pest resistance in plants as plant pesticides to be regulated under FIFRA. In an effort to capture only those plant pesticides that are incorporated into the plant using recombinant DNA technology, EPA would exempt from the requirement for a tolerance those pest resistance substances, and the genes necessary for the production of those pest resistance substances, and the genes necessary for the production of those substances, that evolved naturally or were transferred to the plant by traditional plant breeding methods.
Page 16 PREV PAGE TOP OF DOC As described in the report, the mainstream scientific community regards EPA's approach to the regulations of pest resistance in plants to be scientifically indefensible. All plants possess traits by which they resist pests and diseases. The use of pest resistant crop varieties, developed through plant breeding, has long been a safe and effective cornerstone of crop protection. EPA's proposed rule would send a message to the public that virtually all crops contain pesticides; this would erode public confidence in our food supply while doing little to actually enhance food safety.
By EPA's own estimates, the cost of each plant pesticide registration would range from $60,000 to $1 million for a single gene transformation. These significant regulatory burdens would have stifling effects on research, agricultural trade, consumer perceptions of safety, and the ability of publicly funded institutions and small companies to use DNA technology to develop pest-resistant plants. This would also effectively preclude significant use of this important technology to develop pest resistance in crops grown on limited acreages, because the seed markets for individual varieties do not justify that level of additional development cost.
The safety and environmental impact of biotechnology is already well regulated by the Food and Drug Administration and the U.S. Department of Agriculture. Furthermore, the National Academy of Sciences and the World Health Organization have endorsed the development of the new plant varieties through biotechnology and have determined that there is no increased risk in the use of biotechnology as compared to conventional methods of breeding. The proposed policy and rule do not focus on the risk of the product, but on the process; this is directly inconsistent with Federal policy on the regulation of biotechnology as articulated by the Office of Science and Technology Policy 57 Federal Register 6753 (1992).
Thank you, Mr. Chairman.
PREPARED STATEMENT OF HON. DEBBIE STABENOW, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN
Page 17 PREV PAGE TOP OF DOC I appreciate today's opportunity to hear from both the Environmental Protection Agency and the scientific community about the proposed rule on plant pesticides. It is my hope that today's hearing is just the beginning of the dialogue between these groups and the Agriculture Committee on this important biotechnology issue.
The incredible advances that have already been made in biotechnology have vastly improved the quality and the yield of many of our Nation's agricultural commodities. This is only the tip of the iceberg. The researchers at the land grant in my district, Michigan State University, and at ground-breaking biotechnology companies in Michigan such as MBI and Neogen, tell me that the entire face of agriculture will be changed in the next decade. As a result, our Nation and the world will benefit from a safe and plentiful food supply.
Congress and agricultural regulators such as the U.S. Department of the Agriculture and the EPA must approach the field of biotechnology with caution. Each new regulation or law that we consider at the end of this decade and into the 21st century will set a precedent for generations to come. We must explore every possible outcome and try our best to base our decisions on sound science so that our laws and regulations do not create unintended consequences.
At issue today is the EPA's proposed rule on plant pesticides. The EPA proposes that plants which are engineered to be resistant to various pests should be registered with them as a pesticide. Specifically, the gene that expresses the resistance will be deemed a pesticide. There is some concern in the scientific community that EPA is over-stepping their regulatory authority and that their rule is not consistent with scientific principles. I am encouraged that both the EPA and the scientific community are here today to discuss this issue and hope that this hearing is the beginning of an effort to develop a consensus on this critical issue for agriculture.
Mr. EWING. Due to the time constraints, we will be operating under the 5-minute rule and the Chair will ask that witnesses help us meet time constraints by summarizing oral testimony as quickly as possible. We would like to give Members adequate opportunity to ask questions. I would like to thank today's witnesses for their time and effort, and we look forward to your testimony. Your entire written statements will be placed into the record.
Page 18 PREV PAGE TOP OF DOC The Chair would also like to ask Mr. Aidala to remain available throughout the hearing to comment on issues that may arise later in the proceedings.
Our first witness is Mr. James V. Aidala, Associate Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances, Environmental Protection Agency, and he is accompanied by Dr. Janet L. Andersen, Director of Biopesticides and Pollution Prevention Division, Office of Pesticide Programs, EPA, and Dr. Elizabeth Milewski, Special Assistant for Biotechnology, Office of Science Coordination and Policy, Office of Prevention, Pesticides, and Toxic Substances at the EPA.
Mr. Aidala, we welcome you. Thank you that you are here today.
We would mention for the record that we have rules about getting testimony up here for the benefit of all Members, and your testimony from your agency did not arrive until late yesterday afternoon, which makes it very difficult for the staff and for other Members to review that material before such an important hearing, and I would hope that we could improve that process with your agency.
Mr. AIDALA. So do I, Mr. Chairman.
Mr. EWING. Thank you.
STATEMENT OF JAMES V. AIDALA, ASSOCIATE ASSISTANT ADMINISTRATOR, OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES, ENVIRONMENTAL PROTECTION AGENCY
Mr. AIDALA. Well, thank you, Mr. Chairman, and with your permission, I will give a few brief remarks now and then submit my formal statement for the record.
I will not repeat the names. You have already introduced us. Let me just say that we are from the office responsible for drafting the rules on biotechnology and plant pesticides from EPA.
Page 19 PREV PAGE TOP OF DOC We welcome the opportunity to appear before you this morning to discuss the EPA role in an approach to reviewing new products of biotechnology. Now, before discussing the particulars of the 1994 proposed rule, I would like to outline a few fundamental principles upon which the rule is based.
First of all, we believe that biotechnology, echoing some of the statements the chairman made, holds tremendous promise for agricultural producers, consumers, and the environment.
We also believe that public acceptance of these products both here and abroad in our export markets depends on a clear and transparent regulatory process based on sound science and open to public scrutiny.
Second, we strongly support the 1986 coordinated framework on biotechnology, which laid out the Federal Government's approach to regulating the products of biotechnology.
Third, consistent with this framework, our regulations, we believe, should be based on the nature of the product, not on the process used to make it.
Fourth, the plant pesticides are included in the broad definition of pesticide under FIFRA, which refers to any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest. That is the definition of pesticide in the statute in FIFRA.
And, lastly, regulatory decisions must be based on sound science and the best available expert advice. We will continue to seek the advice and counsel of independent scientific experts, including peer review of important science issues by the FIFRA scientific advisory panel.
Now, these fundamental principles served as a starting point for the development of the rule that we issued as a proposal in 1994. At the same time, we recognize that these same principles have not been fully transparent in our communications about the proposal. Now, this communication may be one of the reasons the proposal has generated significant concerns, particularly among some members of the scientific community.
Page 20 PREV PAGE TOP OF DOC We have been working very hard to address the concerns raised both in terms of the official comment period and also in reports received by the agency. We believe we have made significant progress in the last few months to help clear up some of the confusion about the proposal, and that we have, in fact, reached agreement on a number of the most important issues.
I am sure we are going to be talking more about that in the hearing, but let me briefly outline some of the areas where we believe we have reached some consensus.
First of all, for example, concerns have been raised about the term its, plant pesticides, used in the proposal. This term is used to differentiate these kinds of substances produced compared to other types of pesticides we regulate.
There has been a lot of expression of concern or a preference now. You will read in the other testimony about a term called ''plant expressed protectants.'' As a result of that concern, we are willing to publish a Federal Register notice to seek public comment on the appropriate terminology, including taking comment on whether or not we should call these materials this new term, ''plant expressed protectant.''
Second, issues have been raised about the scope of products that we would regulate, especially the kind of exemptions from the 1994 rule. We understand that representatives of the industry and the scientific community have agreed, contingent upon that name change, that four categories of products should be exempt from review and that a fifth category of exemptions might be debated further.
Basically that is the real principle that we started with in the proposal, trying to establish categories of exemptions that would not be subject to further EPA review, and we do intend to make as part of our final rule the proposed exemptions that include the ones, again, that have been agreed to by many different parties and, again, have been indicated to us in comments, both the formal comment period and other conversations we have had with various stakeholders.
Page 21 PREV PAGE TOP OF DOC The fifth suggested category from this consensus process in some other quarters is not included in our proposal, but it may certainly warrant merit and further discussion, and we will continue to work with the research community to explore those issues.
In general, in addition to all of those exemptions that have been talked about in the proposed rule, we also think that additional exemptions may be appropriate, and towards that end, we are working with the Department of Agriculture to develop an expedited process for further exemptions.
We intend to propose this expedited process at the same time that this rule becomes final, if not before.
Finally, concerns have been raised that EPA is not addressing issues raised in the report by members of 11 scientific societies. I would like to personally assure both the chairman and every member of both subcommittees, of all the members of the full committee that we will, in fact, address all of the issues raised in that report, and they will be specifically addressed in the final rule. They will be part of the discussion on the comments received on the proposal.
And further, if there are still scientific issues that remain unresolved, we will work with members of the research community to assure that those concerns are addressed in an open and transparent process, for example, by consultation with the FIFRA Scientific Advisory Panel.
And as I stated earlier, we believe that there has been significant consensus reached on these important issues that have gone a long way towards clarifying earlier miscommunication and misperceptions about the proposed rule. The dialog has been very helpful to all parties. It has helped us better understand the concerns of the broader community of interest that may be affected by the regulatory process, and it has helped them who have not traditionally interacted with EPA to better understand our regulatory process.
Page 22 PREV PAGE TOP OF DOC We do believe that finalizing this rule would help add clarity and regulatory certainty to the process of regulating these important products. Regulatory certainty is critical to everyone who has an interest in developing and commercializing the products, including growers.
Finalizing the rule will allow EPA to establish written guidelines on the regulatory process and the data requirements that will help create a predictable and consistent road map for commercializing new products.
Basically, a transparent, regulatory process based on sound science and open to public scrutiny is fundamentally critical to the public acceptance of these products, both here and in the world marketplace. With the rapid adoption of this technology, as the chairman indicated, wide public acceptance of these products here in the United States is due, we believe, in part, to the public confidence in the regulatory process.
Finalizing these rules and thereby carrying through with the commitments to a scientifically sound and transparent regulatory process is an important and key element in helping maintain that public trust.
Let me close on talking about the trade issue, which again is very important to everyone, but especially members of this committee. Obviously, Mr. Chairman, there have been difficulties that U.S. growers have had in gaining access for our products in critical international markets, and that is a deep concern both of you and to the American farmers.
EPA staff have worked closely both with Department of Agriculture, Department of State, as well as the U.S. Trade Representative's Office in trying to insure that we get this much needed market access. We believe that finalizing a clear, science based, domestic regulatory process will only bolster our ability to demonstrate without question the safety of these products.
In closing, let me assure you that EPA recognizes the potential benefits the products created through modern biotechnology can bring to U.S. agriculture. We believe that consumer acceptance will be key to the ultimate success of the products, and the consumer acceptance is strongly influenced by confidence that regulatory agencies will insure their safety.
Page 23 PREV PAGE TOP OF DOC EPA believes that our actions will contribute to the long-term viability of agricultural products created using modern biotechnology by insuring public health and environmental safety.
I would be happy to answer any questions the committee may have at this time.
[The prepared statement of Mr. Aidala appears at the conclusion of the hearing.]
Mr. EWING. Thank you very much.
In my statement, I indicated that EPA, USDA, and FDA had all had regulatory authority in this area. Has that system been working pretty well?
Mr. AIDALA. Mr. Chairman, we think so. The market acceptance alone, you mentioned numbers of the widespread adoption by our growers in the marketplace.
We also have really carefully attempted to stick with the coordinated framework from the 1986 deliberations among the Federal agencies.
And lastly, it is not just an exercise that happened some years ago. For example, we meet biweekly as the three agencies to coordinate our functions to make sure we do not have duplicative data requirements, share information, and basically to achieve some of the efficiencies, if you will, that we intended from the original 1986 framework.
Mr. EWING. How do you anticipate the issuance of this new rule would change the mixture there of regulatory control in the biotech industry?
Mr. AIDALA. I am not sure it will at all. It is not intended to per se. The rule is really intended to clarify our scope and especially to clarify exemptions from needing any EPA review. It is not adding more EPA review per se. It is, in fact, trying to say who does not need to worry about any EPA review.
In terms of the framework and how we interact with the other agencies, it does not change any of that kind of scope or jurisdiction per se. USDA will still do what they do, FDA what they do, and EPA is doing what they are good at.
Page 24 PREV PAGE TOP OF DOC Mr. EWING. Can you reiterate the categories of exemptions?
Mr. AIDALA. The three or four exemptions? Let me ask Dr. Milewski just to quickly tick those off.
Mr. MILEWSKI. OK. The three categories of exemptions. The first category are those plant pesticides that are moved between plants that are sexually compatible, those types of plants that would naturally exchange genetic material, for example, through the passage of pollen from one plant to another.
The second category of exemptions are those types of exemptions that plant pesticides that would act by primarily affecting the plant. For example, the hairs on the leaf of a plant might be longer. There might be a thicker wax cuticle on the leaf so that the insect cannot penetrate to get at the interior of the leaf. So those types of things would be exempted.
Also included in that category are something that is important to scientists, which is called hypersensitive response, and this is essentially a response that when a disease organism lands upon a leaf, for example, and begins to attack, the plant closes off that part of the leaf, essentially kills a part of itself to get rid of the pest. So that would also be exempted.
And the third category of exemptions are those that are plant pesticides based on viral coat proteins, and viruses are something that we are all fairly familiar with. They cause colds in us. In plants they cause diseases, such as wilting. The code protein is what protects the virus from environmental effects, and if you take the genetic material from the virus and insert it into the genetic material of the plant, the mechanisms that we do not quite understand, it protects the plant from infection by that virus.
It is almost akin to a vaccination that a human might receive against a disease.
Those are the three categories.
Page 25 PREV PAGE TOP OF DOC Mr. EWING. It is obvious that it is very technical and not easily understood. Part of the justification though of this rule is to create a regulation to exempt certain products.
Why does a new regulation need to be considered for this purpose?
Mr. AIDALA. The fundamental starting point here is that these materials, plant pesticides or plant expressed protectants, are pesticides under the statute. So the fundamental starting point is that without an exemption or registration, you'd be in violation of the law.
So what we have done certainly in this effort is trying to articulate those people, that list of activities Dr. Milewski talked about, that do not need to be subject to EPA review because, again, without a registration or the exemption from needing a registration, you would be in violation of the law if you tried to sell these products.
And so fundamentally that is why we have tried to articulate those kinds of things that we think that a priori just are so safe. It is not that you need to apply for an exemption. You just are exemption. You do not need to deal with EPA at all.
Mr. EWING. Does the EPA currently exercise exemptive authority for biological control agents?
Mr. AIDALA. In 1982, we did have a regulation that said that certain kinds of biological agents are exempt from FIFRA because we thought USDA could do a better job, does do a better job. Parasitic wasps is one example, I think, that you may be referring to.
This is basically a further articulation in light of biotechnology and some of the concerns that may be relevant in terms of this new technology to try and articulate, again, where the various lines of jurisdiction should be between the agencies.
Mr. EWING. So you are saying that current authority is not sufficient?
Page 26 PREV PAGE TOP OF DOC Mr. AIDALA. Current authority is sufficient actually, we think. Again, this is an articulation to make it clearer for people to have that sort of call it regulatory certainty of either if you are regulated where you need to go, and especially in terms of this rule, who is not subject to regulation so you do not need to worry about, in this case, you do not need to worry about EPA.
Mr. EWING. Thank you.
My time is up, and I want to inform the committee that the Chair will recognize the chairman and the ranking member first, and then we will call on all Members at the time that they came into the room.
So, Mrs. Clayton.
Mrs. CLAYTON. Thank you, Mr. Chairman.
And referring to those persons from the EPA who are here to try to help us understand this kind of complicated process, and I also want to acknowledge Dr. Kelman from the State of North Carolina who will be up later.
I am assuming that the basis for which we are concerned is that both farmers and the industry that have responsibility of following the law have found that the implementation of it has been difficult, and there has been an evolution of that implementation that has now caused, I guess, the scientific world in some instances to question how this has developed.
In a very practical sense for me as a legislator, how it comes to me is that the farmers perceive that they are being over burdened with regulations that they support in principle, but in the implementation it puts a great burden on them. Their production or their crops, they say, are at peril.
Of course, none of them will ever say they do not want to protect the safety of food because they realize that the public perception and the reality of having safe food is the very backbone of their industry.
Page 27 PREV PAGE TOP OF DOC So I come to this with the assumption that farmers want to purchase in a reasonable way, and I also come to this hearing with the assumption that I want to do everything in power to make sure that we have safe food, and environmental concerns are the premise of my very being. I think this is God's creation. We ought to do everything to make sure it is perfect.
But there is a point to be said, as we define this in such minute terms, that it makes it difficult to achieve all of those principles, and I am not assigning any bad motives to anyone. I just want to tell you it becomes very difficult in trying to do that.
I have some questions here, believe it or not. One is in terms of your appropriate oversight plan, that the 11 scientific societies responding, and I guess they represent some 80 members, they are casting now doubt as to your moving in this direction.
I understand that you are going to answer that by having some further regulations, but would you explain that to me?
Mr. AIDALA. Sure.
Mrs. CLAYTON. Either the exemption plan that speaks to their concerns or to their concerns that this has moved a little too far to the extreme?
Mr. AIDALA. Again, we take some responsibility for that. We think there has been a lot of miscommunication on our part or lack of communication on our part because many of the concerns are raised in that. It is called the 11 societies' report that you are referring to.
Mrs. CLAYTON. Right.
Mr. AIDALA. It raises a number of excellent issues, and in some sense internally we sometimes are in a quandary just because we agree with many of the points. Many of the things that are being asked for are things that we agree with and are in the proposal and are currently envisioned as being in the final.
Again, it is one of the reasons why, as I mentioned before also, in the past few months I think we have come a long way in clarifying some of those areas of potential disagreement and coming to a large measure, not entirely; science is a tricky thing, and it is very hard to get everybody to agree on everything, but on a whole lot of things compared to some relatively recent earlier time, you could pick a variety of different time periods, and as a result we think we have made a lot of headway, if you will, on talking to the scientific community.
Page 28 PREV PAGE TOP OF DOC And underneath that is something else you talked about in terms of what is the net payoff for the farmers. Right now the things in this rule are not so much the kinds of things that would ensnare farmers in any particular regulatory net as much as the sort of promise of this technology. Is the promise of this technology somehow hindered or burdened or less available as a result of whether it be our activities or, I think, any regulatory agency would be of concern to the members here?
And we agree with that. We think this technology is a win-win situation both in terms of the environment and also for the growers. It will lead to better and higher productivity, and for example, one study that we received from one of the registrants, you know, for example, a million pounds of insecticides are not used on cotton because of the engineered cotton that is being grown in this country in one season, things like that.
We see this as having tremendous promise and tremendous potential, and we do not want our regulations to be in the way of achieving that potential. That is one reason for this particular exercise. We have tried to articulate who does not need to be worried, involved with, is not subject to EPA review.
Mrs. CLAYTON. I also have from my colleague, Mr. Pomeroy, who asked me to ask two questions.
Mr. Chairman, if I would like to submit for the record two questions from Mr. Pomeroy to the Administrator for his answer.
Mr. AIDALA. We would be happy to respond.
Mrs. CLAYTON. Oh, good. My last question is: How is the pesticide produced through biotechnology different from those produced through conventional plant breeding?
Mr. AIDALA. They are not, and that is the basis of our approach. For example, one of the most common bioengineered crops today is a crop entered that Bt expressed in the cells of the plant. Obviously if that Bt protein is the same as a farmer might spray on the outside of the plant, we make no distinction in our system between the two.
Page 29 PREV PAGE TOP OF DOC Mrs. CLAYTON. I just want to make a confession. Part of my background is I had a minor/major in genetics, and this is completely foreign to me, and I am trying to understand. So I am trying to understand how biotech and this goes, but thank you for your being here and your answer. I am trying to understand this as best I can.
Mr. AIDALA. We would be happy to come up and even spend more time and revigorate your genetics degree in any way that we can.
Mrs. CLAYTON. It is probably antiquated because this is far beyond my pay grade I can tell you.
Mr. EWING. I think Mrs. Clayton was very close to something there in what is the difference. Could you repeat that answer again?
I mean if the plants do it naturally or if they don't do it naturally, what is the difference?
Mr. AIDALA. In terms of whether or not the pesticide is expressed internal or sprayed over the top, as the term is used, we would still be interested in knowing whether that pesticidal substance has potential impact on health and the environment and would review it.
The basis of, again, how we are trying to decide who may be involved in terms of needing some EPA review and who is not, and again, this rule is mostly about who does not, it pertains to two things. One is the pesticidal substance, if it is in fact a pesticide that is subject to our regulation, but who can we let go, and then I think underneath your question, Mr. Chairman, is whether or not it is a natural pesticide or somehow a synthetic and does that make a difference.
And the answer is basically it does not make a difference. We would want to see whether or not that is something that we need to examine, again, for its potential health and environmental effects.
Page 30 PREV PAGE TOP OF DOC Again, in the jargon of the coordinated framework of 1986, the principle is do not regulate the process; regulate the product. It does not matter if it is bioengineered or God given or whatever you want to call it. We should look at it in terms of its potential impact because of the product.
Mr. EWING. Mr. Smith.
Mr. SMITH. Are you looking at the consequences of disease or potential human health damage from lack of use of pesticides?
Mr. AIDALA. Not directly in terms of the rule. It may be something that we would examine. For example, we register a number of public health pesticides that prevent health problems, and that is something we consider in terms of our larger regulatory scheme.
Mr. SMITH. No, no. I mean I am talking about maybe akin to potato blight or some of the scabs or some of the apple fire blight that have been recognized as potentially dangerous to human health. Is there some balance? Who is doing some of the policy balancing of deciding what is in the long term going to be best for our human health in terms of the apparent aggressive effort to do away with some of the organophosphates and some of the other pesticides that may have some cumulative damage?
But as we rule that we cannot use those pesticides anymore, maybe we are faced with anything from the potato scab/blight type of human health problem to a lack of fresh fruits and vegetables.
Mr. AIDALA. We worry about that. I mean, it is part of our job under the various statutes that we have.
In terms of directly tied to this technology, as what I said before about some of the promise of this technology, this technology has tremendous promise for replacing certain pesticides, conventional pesticides, if you will, that may present problems. I am not saying they all do or which ones, but just in general.
Page 31 PREV PAGE TOP OF DOC For example, given the kinds of acreages that are now planted in Bt crops alone is a tremendous benefit because Bt is such an excellent pesticide in terms of not only control, but also in terms of its lack of environmental impact.
Mr. SMITH. Do you have papers or reports that you can provide to this committee analyzing the consequences of doing away with some of these pesticides in your rule?
Mr. AIDALA. Again, this rule really would not have that kind of impact, but the larger question, we will try and see what we have and get back to you on that. We would be happy to supply that to you.
Mr. SMITH. If you try and see what you have, that is saying that you are not aware of anything?
Mr. AIDALA. Off the top of my head, no, in terms of that specific formulation of the question. Do we look at sort of are the replacements what would happen if, and those kinds of analyses? We do that usually on a case specific situation. Whether we have sort of an overview over all documents, I mean, again, off the top of my head I am not sure.
Mr. SMITH. And here again, who makes those kind of policy evaluations? Is it sort of left up to you go as fast as you can, and if Congress and the people think you are going too fast, they are going to raise hell someplace out there and slow you down? Is that how it works?
Mr. AIDALA. Were it to be so. Again, it is the kind of thing that we do worry about, and for example, in terms of replacement products, you mentioned the organophosphates, for example. That would be one of the most critical, critical elements of any decision we would face, is whether or not there are adequate substitutes available, whether they be bioengineered or other conventionals, or something else that is coming down in the queue from a company.
Page 32 PREV PAGE TOP OF DOC And I will give you one example. Not trying to prejudge the situation overall on that particular class of compounds, the organophosphates, anything which is a replacement for that gets a priority in our system. We are able to turn those around in terms of the approval process much more rapidly than we would otherwise because we do not want to leave growers without a pest control tool.
Mr. SMITH. OK, and another policy decision that is someplace in EPA and somebody just look at, and that is the provisions in FIFRA that allow exemption from your oversight, and you talked and Dr. Milewski talked about some of the biological or natural occurring pesticides that might be exempt. How about the provision in the law that says if it is adequately supervised and administered in some other way, that it would also be exempt?
Mr. AIDALA. Well, again, I think that was underneath one of the chairman's questions, the proposal in 1982 that said things like parasitic wasps or other sort of whole plants and things. That is regulated by USDA because even though they may be some kind of pesticide under some definition, USDA is better able and does a better job.
One point in terms of the current, we will reaffirm those exemptions from the 1982 regulation in the current rule, but overall we agree with that statement, and underneath that is the coordinated framework set in 1986 between the three agencies, FDA, EPA, and USDA, and we still respect that.
Mr. SMITH. Can you help me understand what part and what section of the FIFRA law directs you to move ahead with these kind of safeguards and investigations and prohibitions?
Mr. AIDALA. The fundamental starting point, I think, underneath this rule is the definition of pesticide in the law that says that these products are subject to FIFRA regulation. This is not an extension of our authority or even call it an interpretation, but rather in terms of usually the terms used, it is the plain reading of the statute.
Page 33 PREV PAGE TOP OF DOC And I think some of the other witnesses you will hear from later, you know, have some testimony about that point or have an appendage to some of their testimony talking about that.
Mr. SMITH. Maybe I have got time for one last question. What is your timetable? What is your proposed timetable?
Mr. AIDALA. What we would like to do is have this rule finished, as indicated in the opening statements, by the end of the year. Obviously we are making a lot of progress, we think, in the past few months on getting more consensus among various communities out there, and obviously though if we need to do some more thinking, do some more things, we could do that, but right now we think it is on track to be done by the end of the year.
Mr. SMITH. The rule is done, and the implementation would be? Any flexibility on the implementation?
Mr. AIDALA. Well, certainly we would always want to try and be as flexible as we could, but again, in terms of this rule, it is a number of who does not need to be involved with EPA, and we think that will just sort of set a lot of minds at ease.
And further from that the job will not be done. After that, the day after we issue this rule, it is not like we are never going to listen to these kinds of issues again. We already have some ideas and have some discussions with USDA and other people, for example, on how to continue granting more exemptions or how to modify even what we proposed and might make final now because it's an ongoing arena.
Science is always changing, and we certainly acknowledge that.
Mr. SMITH. And, Mr. Chairman, thank you.
I did not know you knew that I thought the meeting started at 10 o'clock, and so I was here at 10, in terms of the time people come in and the order of their ability to ask questions. Thank you, Mr. Chairman.
Page 34 PREV PAGE TOP OF DOC Mr. EWING. Yes. Let the record show that Representative Smith was here at 10. [Laughter.]
Mr. EWING. Mr. Brown.
Mr. BROWN. Mr. Chairman, I observe that if every member of the committee present were to take their 5 minutes, we would not have enough time to complete the witnesses. So I am going to waive my right to questions at this time.
Mr. EWING. Mr. Etheridge.
Mr. ETHERIDGE. Thank you, Mr. Chairman. I will be very brief, and I will not take all of my time.
Let me thank you for holding this hearing because it is important and for the folks who are here testifying, and hopefully we will get to the second panel.
As my colleague from North Carolina did, also I would like to extend a welcome to Dr. Kelman, who not only is from North Carolina, but happens to be from my district, and we are pleased to have him here today.
One very quick question, if I may. What I have been able to read on this issue, and I will try not to cover the ground that has already been. I remember back when the biotech stuff started in really North Carolina back in the early 1980's, and we were moving along this road.
My question to you is there is pretty good tension on both sides of the issue, of the regulatory piece on one side and the production, and the issue on the other side of the pathologists and others who are doing the work, and my question to you is, very briefly, as we move along this, do you see us getting to a point where we can bring these together and have a reasonable resolution of the problem, provide production, provide protection, and equally important, that we can sell our product?
Because if we get ahead with the material before we get approval, we have got problems in the world market, or are we at a point where we have to back up, scrap it and start over, not the whole thing, but the whole issue of EPA?
Page 35 PREV PAGE TOP OF DOC Mr. AIDALA. We hope so in terms of bringing all of those disparate parties and disparate goals together. I would like to think that given the, again, market acceptance already in incredibly faster time frames than envisioned just even 5 years ago when we first registered the first of these materials, it is a phenomenal success rate.
In fact, right now, to the extent that there is a problem or a potential roadblock, it is more in the market acceptance, not in this country so much, as in some of our foreign markets, and again, that is one reason why we think having the regulatory system as it is with the three agencies and the coordinated framework seem to be working and working pretty well, in our opinion.
And so we think we have done that. We think this rule can only hopefully clarify certain things, provide regulatory certainty to the innovators and the regulated community, to the regulated industry, to people to know, again, what they do need to do, what they do not need to do, and only foster further innovation and development of the industry.
Mr. ETHERIDGE. Thank you.
Mr. EWING. Mr. Hostettler.
Mr. HOSTETTLER. Thank you, Mr. Chairman. Thank you for holding this hearing, and I have some pretty basic questions about this whole process.
With regard to the exemptions, the exemptions speak in your testimony and to what was mentioned earlier regarding what I would refer to as naturally occurring, but what are referred to several times in here as, say, inherited past defense traits, and you made a comment earlier about bioengineered or God given substances, obviously.
Do we know of any what I would call naturally occurring or what may be referred to here as inherited past defense traits; do we know of any of those that would be in conflict with the proposed rule?
Mr. AIDALA. In conflict with the proposed rule? I thought where you were going there, Congressman, was whether or not any of the sort of naturally occurring things might be a problem.
Page 36 PREV PAGE TOP OF DOC Mr. HOSTETTLER. Well, the reason I ask is because they are specifically exempted, and I would assume that since there are specific exemptions for what I would call naturally occurring, then there may be some naturally occurring substances that would not be exempted.
Mr. AIDALA. Again, we are regulating not the process, but the product. Whether it is naturally occurring or bioengineered, if it is a pesticidal substance, it is a pesticide under FIFRA.
In this case, what can be sometimes confusing is one of the categories of exemptions is cross-breeding potatoes has been done for a long time to create a new potato variety. Even though technically it might be a pesticide under the law, or has been since the 1947 law, it is exempt, and it, again, is something that we never bothered with at all in terms of traditional breeding until the promise of biotechnology was upon us in the mid1980's and now in the 1990's, in terms of EPA's articulation, know, who is in and who is out kind of articulation, in order to clarify those rules for everybody.
So traditional breeding may have resulted in a naturally occurring thing may be a pesticide. It may be something we need to examine, but in terms of traditional crops breeding and things, that is exempt. That has not been subject to our review in the past. It is exempt under this proposal.
Mr. HOSTETTLER. And the reason I ask is because there is such specific exemptions regarding what we would traditionally refer to as, you know, food that was always ingested and that was never covered by any rule.
Mr. AIDALA. Sure.
Mr. HOSTETTLER. And there was never a problem before, but as a result of this rule
Mr. AIDALA. One of the suggestionsI am sorry.
Page 37 PREV PAGE TOP OF DOC Mr. HOSTETTLER. I was going to say and the mere presence of this rule will change all of that.
Mr. AIDALA. We do not think so, and it is not designed to do that, and we certainly hope not, and to the extent that it might, it is something that, you know, we would want to hear about and think about.
Again, just because it is naturally occurring does not mean it is absolutely safe. I mean some things can be dangerous, and it is something we would need to look at, but again, if there is that history of people are used to it, it is in the diet, what is the problem now? Why is EPA bothering with this?
One of the starting points for us is we do not want to. We are trying not to.
Mr. HOSTETTLER. OK. The second question is Congress and EPA has reacted in the past to known trouble spots in the industry. Do we know of any specific trouble spots at this point in the industry that would call on the need for such a rule? Is there a problem in the industry now that we are going to be addressing in a reactive manner by this rule?
Mr. AIDALA. You might want to also ask that question and you have got some industry folks coming in the next panel, but in reading their testimony and also my own conversations with those folks and my experience with them, this rule is an attempt to give them clarity and certainty, which any business person will tell you is helpful, even if they may disagree with some of the details.
Is it overly burdensome? That is often a question that is asked. The expense for registering one of these products if you are subject to registration, but again, remember the rule itself is mostly about who is not subject to our requirements, but MRV are relatively small compared to conventional pesticides.
And, again, it further helps the public credibility both in terms of market acceptance here and especially abroad, and so we do think we are addressing a problem, which is that lack of clarity and also to be able to go forward and then issue guidelines and sort of establish rules of the road even more certainly for people to then be able again to have the industry follows that.
Page 38 PREV PAGE TOP OF DOC Mr. HOSTETTLER. So let me get this straight. The problem that you are talking about is not necessarily with the product at this point. It is simply with the manufacturers, the producers creating this and being able to initially from the outset understand what EPA requires of them.
Mr. AIDALA. If I understand your question correctly, I think I agree. It is not like there is a big issue that came up where there is a problem of controversy, some exposure that caused health or environmental problems that is driving this. It is not that.
Mr. HOSTETTLER. Thank you very much.
Thank you, Mr. Chairman.
Mr. EWING. Mr. Berry.
Mr. BERRY. Thank you, Mr. Chairman, and I appreciate very much you holding these hearings.
The first question I would have is why is traditional breeding less of a need to be regulated than genetic engineering?
Mr. AIDALA. Two reasons. One is the rule makes no distinction between the two per se, but traditional breeding is basically, as other members have indicated and I think it may have been underneath your question, you know, long time of experience, you know, what problems have been found. Traditional plant breedings brought many benefits to agriculture.
Mr. BERRY. And the genetically engineered products have not?
Mr. AIDALA. They have tremendous promise, as we have indicated. The one thing that may be different is whether or not you are taking traits from, you know, different species that traditional breeding would never let you do and introducing that, you know, into a food product. You may have a question. That is not to say it is bad, but we do have a question, and we want to evaluate its safety to make sure it is OK.
So we are not saying it is bad or good, and again, we are certainly not doing it because of the process. It is not because it is bioengineered. It is because of the benefits of bioengineering, it lets us do new things that we have never been able to do before, introduce a pesticidal trait into a plant that previously was never able to do that.
Page 39 PREV PAGE TOP OF DOC Mr. BERRY. But if we could do that through traditional breeding, it would be OK? I mean, it would not be regulated?
Mr. AIDALA. Correct. We are trying to keep that distinction in place.
Mr. BERRY. The Director made a commitment to me over a year ago that she would have people from the agency come and explain the scientific reason for some of these things. We had one meeting. It did not amount to much, and I am still frustrated that that commitment had not been fulfilled, and I noticed that you made a commitment like that to Mrs. Clayton, and I would still very much like to see a scientific reason for these things rather than what I consider to be an opinion, and I think it would be very helpful to all of us on the committee and throughout the industry if we could see scientific reasons for these things rather than opinions.
Also, the Vice President made a commitment that we would use science in the process and follow science more closely than we do opinions, and I continue to be frustrated that EPA appears to use science when it is convenient and opinion when it is not.
But I would appreciate any help that you can give me on getting the information together that can help me justify some of these things that are being done.
Mr. AIDALA. I am happy to commit not only the agency in general, but myself personally, Mr. Berry, and you and I have had some of these conversations in the past. I would be happy to have any number more that you would like at any time. You know, you schedule is tougher than mine, I think, actually. So we can work that out.
Mr. BERRY. Well, I appreciate what you do for the agency and also for the agriculture industry in this country, and I look forward to working with you on that.
Mr. AIDALA. Thank you, Mr. Berry.
Mr. BERRY. Thank you, Mr. Chairman.
Page 40 PREV PAGE TOP OF DOC Mr. EWING. Thank you, Mr. Berry.
Dr. COOKSEY. Thank you, Mr. Chairman.
If I were to distill this entire conversation or your testimony down to one brief line, would it be correct to say that you are trying to justify the concept that RNA and DNA are pesticides, or is that an incorrect statement?
Mr. AIDALA. That is not how I would distill it. The distillation of the rule is that we are trying to articulate, you know, a number of exemptions in light of this, you know, new technology that has to do with DNA and whatnot.
Underneath your question, I think sometimes are we intending to regulate all of DNA? I mean, I have DNA, you have DNA, everything has DNA, and the answer is no. What we are trying to do is say that, and again, it is sort of process neutral in that the promise of bioengineering lets us do different things with DNA that we could never do before.
We can take scorpion venom from scorpions and put them into other species that, you know, traditional breeding could never do, could never have even conceptually have hoped to get, and so we are not trying to regulate the DNA per se, but the DNA results in some products that we want to review, you know, for health and safety reasons.
Dr. COOKSEY. Well, I am sure that you are aware that there is the public perception, and in particular, the perception among those that are involved in the use of these chemicals, chemicals that have been used in the past as pesticides, that the EPA oftentimes came in with questionable scientific data or sound sciences, as the words are used up here, and now that the industry, through research, development, innovation, has come up with some products that would lessen the need for these pesticides, these chemicals in the traditional sense of the word, well, then we look up, and here is the EPA as if, you know, the EPA has raised its head again and involved itself in an area that maybe it is not justified in.
Page 41 PREV PAGE TOP OF DOC My friend, Mr. Berry, is a pharmacist and, of course, is trained in the scientific method, and I have a similar background, but we get the feeling that a lot of times the people that are throwing out these messages and bringing up these issues are people that have a law degree and do not really even know what science is and certainly do not understand the scientific method, and there is a lot of litigation that is created.
And I make no apologies to my friends in the legal profession, but that is just a fact of life. So that is our concern, our overriding concern.
I have great hopes for the future of these bioengineered products. Right now in Great Britain, there is a lot of bad information being put out, and they have pictures on the front page of the paper of these monsters that are being created by bioengineering, genetic bioengineering, and also they are predicting it could even happen to people. Well, we do not need that in this country.
Mr. AIDALA. I absolutely agree with that.
Dr. COOKSEY. I would say that I have a lot of confidence in Dr. Goldman. She is trained in the scientific method and is a physician, is a pediatrician, and she knows the effects of these chemicals, but we just do not want you to get in the way of progress, and yet we understand your responsibilities.
Thank you, Mr. Chairman.
Mr. AIDALA. I appreciate all of those comments. If I may just respond in general that we basically agree with that, again, with the promise of this technology and, again, what we are mostly trying to talk about is not inserting ourselves newly into an arena where we have not before, but rather articulating, in effect, in terms of this rule, articulating where we are not involved and we do not want to be, do not need to be.
Because given the definition, it is not like sort of attitudinal about wanting to be. We are not, and we should not be.
Page 42 PREV PAGE TOP OF DOC Dr. COOKSEY. Good. Thank you.
Thank you, Mr. Chairman.
Mr. EWING. Mr. Phelps.
Mr. BOSWELL. I do not have any questions, Mr. Chairman, but I will take this second to say, again, we have had a conflict in scheduling with the other committee, and it makes it hard, but I know you are doing good work. I appreciate it, and I have great confidence in you.
Mr. EWING. We are glad you are here. Thank you.
Mr. GUTKNECHT. Thank you, Mr. Chairman.
I am going to pursue this line of comments and questions that Mr. Berry started, and that is it just strikes us, and I think Dr. Cooksey made the point as well, that this is one more example of what I believe is one of the unwritten rules of Washington, and that is no good deed goes unpunished.
And many of the research companies have gone out there and tried to come up with new innovations and technologies, and as Dr. Cooksey said, and then once they have done something that they believe is good and, frankly, by your own admission you say is good, we are creating once again a $50 solution to what may be a $5 problem.
I think that is the general feeling of the members of this committee. I think that is the general feeling of the folks in the research industry.
I want to come back, and I was reading through the testimony of R. James Cook, who is going to testify later, and he is representing a consortium of 11 scientific societies, and I would like to hear your response to some of the things that he says because they are pretty tough statements.
Page 43 PREV PAGE TOP OF DOC He said, and I will quote, ''I would add that I am greatly disappointed that EPA was dismissive of our concerns and refused to even solicit public comment on our report.''
Later they say in his testimony, ''Therefore, the scientific societies are unanimously opposed to the term 'plant pesticide' as scientifically indefensible,'' and he closes that paragraph by saying that they met in Washington on March 16, ''. . . and we respectfully submit that the term 'plant pesticide' should be replaced.''
I guess the only question I have for you is, first of all, were you invited to that meeting March 16?
Mr. AIDALA. No, we were not.
Mr. GUTKNECHT. If you had been invited, would you have participated?
Mr. AIDALA. I believe so. We had a separate session with some of those folks the next day or the day after. I mean, so it was all part of a larger plan.
Mr. GUTKNECHT. Well, I understand some of your concerns, and frankly, I mean, we all share this concern about plant safety and food quality and food safety, but I really do feel that we have got to find some kind of middle ground here so that we do not continue to pursue that no good deed goes unpunished kind of a strategy.
And, frankly, I think ultimately you mentioned that the only down side to this is that farmers and ultimately consumers may have to wait longer for some of this technology. That is only half true. The other thing is that it will drive dramatically up the cost of those new technologies.
We have seen this with the FDA, for example. A new drug in the United States can cost upwards of $250 million just to get through the FDA maze. Now, some of that certainly is justified, but when we compare what is happening in the United States to the process that goes on in Europe, it is not justified.
Page 44 PREV PAGE TOP OF DOC And, again, all we really want is some middle ground and some common sense, and we are willing to work with you, but I think we want a commitment from the EPA that you are going to work in good faith with the scientists and the research community.
That is all I have. Thank you.
Mr. AIDALA. You have that commitment, Congressman, and in particular, like I stated in my opening statement, you have our commitment that every one of those comments in that 11 societies report will be addressed in the final rule, number one.
And, number two, that does not mean those conversations are over. You know, there are other issues that will come up, do come up, and we need to continue that dialog, and we are also very sensitive to the same kind of issues you talked about about the burden and regulatory cost and all of those kind of things. They were all, you know, points well taken.
The ironic twist on this is that compared to the European system for drugs, we are the ones that are approving and actually adopting, you know, use of these products in the agricultural arena compared to the European system. I do not think anybody would trade our system for the European system currently at least for the biotech agricultural area, but your point is still well taken.
Mr. EWING. Mr. Condit.
Mr. CONDIT. Thank you, Mr. Chairman.
Once again I would like to also add my thanks for holding this hearing to you.
I do have a couple of questions, and I apologize. We do have a conflict in scheduling here, and if you have repeated some of this, just refer that to me, and I will look in the record.
I understand that EPA had to look at what impact the Food Quality Protection Act had with this proposed rule. My question centers around why there is such a pressing need to finalize this rule when it has been some time, I think 5 years now, and because so much time has already passed between the time that a rule was proposed in 1994 and the present time, can you sort of clarify for me what your reasons for not reproposing the rule with the modifications and the requests by the industry and scientific societies have made; why you have not just reproposed the rule based on their suggestions?
Page 45 PREV PAGE TOP OF DOC Mr. AIDALA. One reason it has taken this long is that we have done various reproposals in the past. That does not mean we cannot do any more in the future in some absolutely sense, but we have attempted to do that in the past on a number of different occasions.
First we extended the comment period because this is such a complex subject. We then did repropose in terms of one component of the puzzle, the inert ingredients, so-called, and then FQPA happened, if you will, and we had to repropose that for FQPA.
So that is part of the reasons for the delay up to now. In terms of the general question of why not, you know, why does it need to be finalized now, we have basically three main points.
One is, again, we think that finalizing the rule will help and make clear regulatory certainty and regulatory requirements for the affected industry. That is something that we feel would not just be a benefit to us obviously in terms of clarifying our scope and reach, but also for those people that do have to deal with us to have a better understanding and go further.
Second, we also would emphasize when this rule becomes final, exemptions from EPA requirements become final. So currently one of the exemption categories within the scientific jargon world is these kind of materials being based on viral coat proteins. You and I probably don't know exactly what that means. We have folks that do, but the bottom line is when these rules are final, if you're engaging in that arena of this kind of research, you are now exempt.
Currently you have to come to us and get a registration. So there is an element of regulatory relief that these exemptions will grant, and the longer we do not make these final is the longer we do not have that regulatory relief being granted to the industry.
And lastly, we also think that we have some a long way just in the past few months on achieving consensus or at least having more than a frank dialog, but a real coming to terms on a number of the issues that are behind some of the previous controversies.
Page 46 PREV PAGE TOP OF DOC Again, are they all resolved? No. Is there perfect agreement among all stakeholders? No, usually is not, but we have come a long way.
So those are the three reasons why we think we would like to see the rule go final, you know, sooner than later.
Mr. CONDIT. Well, maybe the exemption that you just brought up is one that would fall under this category that I am going to ask, but will you let me know how are the requests of the industry and the scientific society different from what is proposed in the rule?
Mr. AIDALA. They made a number of points, and I would be happy to get back to you on the record because it is kind of extensive. These are somewhat long reports, and we can provide that to you and the other members of the committee.
They make a number of points. In large measure we agree with many of the points. One of the previous
Mr. CONDIT. Do you disagree with any of their points?
Mr. AIDALA. We do disagree with some. That is correct.
Mr. CONDIT. Well, why don't we just take those? What do you disagree with them on?
Mr. AIDALA. Well, partly in terms of those points. Partly we disagree with some of the characterizations, for example, a claim that we are trying to regulate plants, where we are not. Re are regulating the pesticides in plants. We have no intention nor desire to regulate whole plants. That is the USDA part.
That is part of the miscommunications we have not been able until relatively recently to articulate to some of those observers and have them come to a better understanding of what we are doing and trying to do and why. That is just one example.
Mr. CONDIT. That is it?
Page 47 PREV PAGE TOP OF DOC Mr. AIDALA. No, there are a number of other differences.
Elizabeth, do you want to?
Mr. CONDIT. Yes, go ahead. The green light is on. So go ahead.
Mr. AIDALA. Or Janet, either one. All right. Janet, go ahead.
Ms. ANDERSEN. Well, some of the differences that have been proposed is one is that they are looking at an exemption for things which would come from any plant, animal, or microbial kingdom, that you could move those traits into a plant without any regulation, and we think that there is certain some merit in it overall, but that there are categories in there, which do actually have the potential to pose risk, and we think that we ought to look at them.
We regulate some of those now when they are outside the plant, and we think that those should also be regulated if they are these plant pesticide substances.
Mr. CONDIT. Anything else? Any other differences?
Ms. ANDERSEN. I think we are in great agreement in most of it. The term ''plant pesticides,'' we are willing to change it. We have expressed that several times. So we really are generally in agreement with what they have proposed, except that we think there is some misrepresentation or miscommunication in what it is that we are not regulating plants, that we do not need every variety to be approved by EPA, but just the plant pesticidal substances themselves.
So I think clarification is what is really needed the most.
Mr. CONDIT. Thank you, Dr. Andersen.
The reason I press that a little bit, we have the scientific panel coming up later, and I would hope that they will focus a little bit on what you have just said, the differences and the disagreements, and maybe we can be helpful in resolving those.
Thank you, Mr. Chairman.
Page 48 PREV PAGE TOP OF DOC Mr. EWING. Thank you, Mr. Condit. That is a very good line of questioning.
And our witnesses here I hope will be here for that panel and possibly you can give us a written report on the differences and how you come down on those with the panel. It would be very helpful.
Mr. AIDALA. Happy to provide that.
Mr. EWING. Mr. Simpson.
Mr. SIMPSON. Thank you, Mr. Chairman.
I am sure I did not understand your testimony just a minute ago or a few minutes ago. So Just to clarify it for me, when you were answering Mr. Berry's question, did I understand it that if a plant resistance was created by genetic engineering and that substance or that plant may fall under the rules and regulations by EPA if it is not under one of the exempt areas, but if that same plant, that resistance was created by a traditional breeding, that it would not fall under the EPA?
Mr. AIDALA. The distinction trying to be made is this: that a plant pesticide, however derived, by traditional breeding or by bioengineering, is technically a pesticide under the law, but everything by traditional breeding would be exempt because one of the exemptions, as Dr. Milewski indicated before, was what is in the science world called the sexually compatible plants.
So, again, taking a trait from one potato to another potato, it would be exempt, is exempt, even though it might be technically a pesticide, you know, under some definition.
In particular, for example, let me talk about one example. In potato leaves, there is a chemical expressed that could cause birth defects. People do not eat potato leaves. It is not a problem. FDA, no one worries about that per se.
Page 49 PREV PAGE TOP OF DOC If you took that trait though, and it is there because it has some pesticidal effect on potato pests, and put that into spinach, people do eat spinach leaves. You would want to at least look at that and make sure it is not, you know, going to be a problem in whether or not it causes any health or safety or environmental concerns.
So, again, it is not trying to regulate the process. It is not because it is bioengineered per se, but it is only because bioengineering makes it possible that you might need to come under the reach of EPA review.
Mr. SIMPSON. Thank you.
Mr. EWING. Mr. Chambliss.
Mr. CHAMBLISS. Thank you, Mr. Chairman.
I am one of those simple minded lawyers that Dr. Cooksey had reference to that does not understand much about genes, except that I know I have got two children. I guess genes has got something to do with that.
But let me tell you what I do understand and what bothers me. I know that Bt cotton produces as good a quality of bole of cotton as the non-Bt cotton. I know that research, like research that was done to develop Bt cotton, was designed to not only produce a higher quality product, but to lower the cost of production for our farmers, to help their bottom line, and in times when we are striving to lower the cost of production, particularly in light off the fact that we have got lower commodity prices across the board today than we have had in probably about 30 or 40 years, we need to do everything that we can to insure that that cost of production continues to be driven down.
And when I see what is going on with Bt cotton and other things like we are doing at Tifton Experiment Station of the University of Georgia on tomato spotted wilt virus and other things to try to insure that when our folks plant a seed in the ground that they are going to have to use as little pesticide as possible, I am bothered by the fact that they now are having their cost of production increased because of the fact that we have got another layer of bureaucracy and regulation that they are having to jump through to get those seeds on the market.
Page 50 PREV PAGE TOP OF DOC Chairman Ewing had a previous hearing, an agriculture biotechnology hearing earlier this month where Under Secretary Schumacher testified to two things that were, I think, particularly notable.
First of all, he said that all evidence demonstrates that biotechnology is as safe as traditional breeding methods.
The second thing he said was that a continued commitment to research by the United States is of the greatest importance to insure that advancements continue to be made in biotechnology.
And while we are from a USDA perspective extolling the attributes of biotechnology, we are told that this additional layer of regulation and bureaucracy that our researchers are having to jump through is just creating an additional burden, and I wonder if you could explain to us the risk assessment process that justifies the EPA decision to apply FIFRA regulation to these so-called self-producing plant pesticides.
Mr. AIDALA. Well, again, fundamentally it starts with the definition of pesticide under the statute, which means that functionally as a result
Mr. CHAMBLISS. Well, I understand that. You have already said that, and I do not mean to interrupt you.
Mr. AIDALA. Well, no.
Mr. CHAMBLISS. But I am curious about your cost-benefit analysis that you have gone through.
Mr. AIDALA. Two or three things. One is that we are worried about two particular things. One is not to overly burden the industry, but at the same time give it some kind of reasonable review for the things that are not exempt. I assume that that is the universe that you are talking about, in part, here. If they are not exempt, how can we minimize those burdens, not be duplicative, not get in the way of other agencies if they have looked at it or if they are doing an OK job, and the previous question was affirmatively if they are doing an adequate job, why do we need to be involved at all.
Page 51 PREV PAGE TOP OF DOC We would agree with all of those statements. Again, following that framework set up in 1986, we are trying to divide the duties among those three agencies, SUDA, FDA, EPA. This is not an attempt to sort of add new duties or burdens outside of that framework. It is an articulation of what that means as we see this technology actually coming to us and to the farm and would share basically all of the same points you made.
At the same time, in terms of the cost of all of this, quote, unquote, because that is a very legitimate question that comes up, the cost of what the kinds of questions that we will be asking, to answer the kinds of questions we would be asking and requiring are relatively small compared to conventional pesticides.
Does that mean they are absolutely small or does it mean it still could not have an impact? Of course, we would always be curious about that and worried about that and, for example, allow ourselves to grant waivers if someone comes in with an idea that technically it is a pesticide, but we need to do this for our regulations, but it is unnecessary, or you know, you have already answered that question in another way slightly differently, and we are sensitive to exactly the kind of issues that you raised because of, again, the potential promise of this technology.
I think that responds at least in part to your question, and I am happy to followup if there is other.
Mr. CHAMBLISS. Well, I still want to get a little more specific on whether or not you have found that there is a cost benefit in the requiring of these additional regulations for these cell producing plant pesticides.
Mr. AIDALA. I do not think we have done a formal cost-benefit analysis. For example, if EPA did not regulate this at all, what would be the cost versus, you know, what will be the benefit of that versus the cost of actually doing the regulations.
We do have some estimates of the cost of the regulatory requirements if you are subject to them, and again, remember this rule that we are talking about mostly this morning is people who will not be subject to our requirements, but some people will be because they will not be qualifying for the exemption.
Page 52 PREV PAGE TOP OF DOC We do have that kind of analysis and can provide that to yourself and to the committee.
Mr. CHAMBLISS. If you will, how about giving me a written response on that?
Mr. AIDALA. Sure. I would be happy to.
Mr. CHAMBLISS. I would be curious what your numbers look like.
Thank you, Mr. Chairman.
Mr. EWING. Mr. Lucas.
Mr. LUCAS of Oklahoma. Thank you, Mr. Chairman, and I appreciate you also for calling this hearing.
I cannot think of an issue of greater importance to agriculture, not only the producers out there, but those consumers around the world because we have a tradition of providing the highest quality food and fiber at the lowest quality rate, and we have done more in this Nation to raise our own standard of living and those of our fellow citizens around the world than to work in those areas.
So I guess my question to our witness goes something like this. Having listened to your testimony today, it appears to me, it seems to me that you are saying that the scientific communities make some very excellent points and that you will address those points.
But it also seems to me that you will address those points after you issue the final rules. So I guess my question to you is that does not seem to be the way the order should proceed, that the issues that are here are of such great importance, the definitions you create and the actions you take impact not only the way these products will be produced, but the way our consumers and customers, both domestically and internationally, will react around the world for decades to come.
Now, why shouldn't these points be addressed before the final rules?
Page 53 PREV PAGE TOP OF DOC Mr. AIDALA. It is partly the context of administrative law that this takes place in. To the extent that some of those outsiders would want us to, quote, commit to doing blank, like we say we agree, but prove it. The proof will be in the final rule.
Obviously we are not just trying to say sort of blindly trust us and things. I think before all of that, before the rule really goes final, we need to continue to have those conversations.
It was asked about whether, you know, there had been separate meetings between the industry and the representatives of the scientific societies. Separately we met with those folks. Would we be willing to meet with those folks had we been invited or if they have another meeting? And we would welcome that opportunity to further explain and further say where we do have agreement and where there might be some points of disagreement.
I think you correctly talked in the front end of that about, you know, mostly we are finding ourselves in agreement, and that is a very good sign.
Does it mean that it absolutely has to go final tomorrow night? We have no such plan. There is no rush to judgment per se in that, but we do think that the clarifications that will come in making the rule final will benefit not just sort of in terms of addressing those specific questions, but again, regulatory certainty to the industry and also particularly, you know, if we delay the finalization of those exemptions, that regulatory benefit relief, if you will, is not granted to certain parts of the industry.
But we have no particular ''hell bent for leather,'' you know, rush to judgment kind of thing. It is one of the points earlier made by some other Members about it has been 5 years and counting. What is the rush now?
Mr. LUCAS of Oklahoma. I just know that for our society and this world as a whole to progress, we have to continue the march forward in ever increasing needs to provide that high quality food and fiber, and that is a long term perspective.
Page 54 PREV PAGE TOP OF DOC But I also know that some of the terms you use, such as plant pesticides, have tremendous meanings in the minds especially of those who do not have the necessary background to appreciate what all is involved, both domestically and in international trade.
So I would hope that we take appropriate steps very carefully and very thoroughly not to create unintended consequences that might be difficult to undo and might take decades to undo if unfortunately those circumstances were to work out.
Mr. AIDALA. We agree with that, and, for example, one thing we could do just in the testimony being received by the committee today, there is a suggestion about the name being changed. That is one of the issues that give some people some concern. That could be something that we could either, you know, do before the whole rule goes final or literally with it.
This is the first we have heard of this specific suggestion. We can envision that. We can even commit to that here in terms of making sure that happens before this rule goes final. Some of those kind of changes, you know, some of those are more easily able to be sort of call it committed to than others, and we would be happy to talk, you know, in terms of the other issues raised by not only the witnesses today, but also in the larger reports and address some of those.
Mr. LUCAS of Oklahoma. Thank you.
Mr. Chairman, I yield back the balance of my time.
Mr. EWING. Thank you.
Mr. OSE. Thank you, Mr. Chairman.
Let me make sure I understand this correctly. I am not a geneticist by training. This plant over here that has a certain characteristic that is a function of its genetic code, the consequence of which would be very useful if transferred to a second plant by genetic manipulation, and the point of this rule is to address the consequence in the second plant.
Page 55 PREV PAGE TOP OF DOC Mr. AIDALA. That is the question?
Mr. OSE. Well, I am asking: is that the point of the rule?
Mr. AIDALA. The point of the rule is to say when does EPA want to look at what you are doing. So, for example, if you are taking a trait from one species and putting it into another, a pesticidal trait and taking it and putting it into another species, that is something that we want to look at.
Most of the rule is talking about what we do not want to look at, we do not need to look at, you are not subject to. So, for example, if you are taking a trait from one variety of potatoes, and it might have taken literally 13 years to do by traditional breeding to get this trait from, you know, this one variety to another and now you can do it in, you know, a very short time, that is the kind of thing we want to articulate we are not concerned about. You do not need to worry about being subject to regulatory review.
However, if you are taking a trait from, again, the example I used before was from potato leaves and putting them in spinach, that might be something that we do want to examine as to whether or not there is a health and safety concern.
Mr. OSE. So as long as the trait exists in potatoes in that example, it would be exempt.
Mr. AIDALA. If your two hands are potatoes in that example, you do not bother with it.
Mr. OSE. If this is potatoes and this is spinach?
Mr. AIDALA. It might be.
Mr. OSE. But if it were just potatoes, you would not be looking at it. You would just say fine, but if you would transfer it to spinach, you say you want to look at it.
Mr. AIDALA. You might, correct.
Page 56 PREV PAGE TOP OF DOC Mr. OSE. I am suffering from some confusion as to why you would not look at it in potato. Since it is there, it is having an impact. It is in the environment, and then you are putting it in another spot geographically or genetically or whatever, and you are saying, well, yes, I do want to look at it. I do not understand that.
Mr. AIDALA. Dr. Andersen's division is the one that makes the parse these things when companies come in with both hands.
Mr. OSE. OK. You are going to be able to parse this for me?
Ms. ANDERSEN. I am going to try.
Mr. OSE. Oh, this is going to be good. OK.
Ms. ANDERSEN. If you are talking about potatoes, the part that we consume of potatoes is the tuber, and what we are talking about is a pesticidal substance to control an insect in the leaf.
Mr. OSE. Correct.
Ms. ANDERSEN. And if you move that pesticidal substance to spinach where we eat the leaves, we now have an exposure to people that we never had before, and we could potentially have some adverse effects. There are compounds in potato leaves that are known to be able to cause birth defects in humans. So that is the kind of thing that we think why we need to look at.
Most of what is now happening is actually moving traits from bacteria and viruses into plants. There you are moving tremendously different plants. These organisms are not very similar at all, and while we can find many of them that are very safe, we also believe that there are some that are probably not, and we need to be able to look at those and say this is one where we have risks and we do not think it is appropriate to expose people and the environment to those kinds of risks.
Mr. OSE. Is the USDA not doing that research at present?
Page 57 PREV PAGE TOP OF DOC Ms. ANDERSEN. The research?
Mr. OSE. That would say whether it is good or bad.
Ms. ANDERSEN. Most of the research in this is done by the companies who are using the product.
Mr. OSE. OK. Is the USDA not doing that review?
Ms. ANDERSEN. They are not doing that review. In my understanding, they are not doing that review. That is right. They do it at a small scale when it is small scale testing. They are looking at whether or not the plant that is produced, the spinach then, would be a pest in the environment, a pest for agriculture.
EPA looks at the pesticidal substance.
Mr. OSE. Is the Food and Drug Administration not doing that review?
Ms. ANDERSEN. It is EPA's responsibility when it is a pesticide to look at those substances. If it was a nonpesticidal substance, FDA would look at it.
Mr. AIDALA. This is what is laid out in the framework about the duties of the three agencies.
Mr. OSE. OK.
Mr. AIDALA. Between FDA, USDA, and EPA.
Mr. OSE. Well, let me make it as personal as I can then. If someone has diabetes and they receive insulin, I mean, that is an artificial, non-naturally occurring substance in that person. Does EPA have review of that?
Ms. ANDERSEN. It is not a pesticide. No.
Mr. OSE. Well, depending on whether you like the person or not, it might be a pesticide. [Laughter.]
Ms. ANDERSEN. Would you like USDA to respond at all?
Page 58 PREV PAGE TOP OF DOC Mr. OSE. Actually, I am sure the chairman will be allowing comments or questions for that purpose, and rather than use the time, I do not get the connection though. I will tell you I do not yet get the connection between how in one location of the environment a naturally occurring substance when transferred for the benefit of production in another section of the environment creates the need for review. I have not made that.
Mr. AIDALA. It may not. Our question is if you do certain things, do we want to review it. We may say I think where your instincts are going, which is this is so routine. The phrase we use often is there is no novel exposure. People are exposed to this all the time, whether it was in the example we have come to, potatoes, and it is now being expressed in spinach, and it is not one of these materials that could cause a problem, and those are the kinds of things we say we would agree with that and it should be either exempt or we do not need to come in for further EPA review.
The question is if it is a novel trait, we want to at least know about it and examine it to see whether or not what you are saying or your instincts, if you will, are correct.
Mr. OSE. I am not nearly as eloquent as some of the other Members up here. I happen to think you might have enough to do as it is, and I am going to be very careful about giving you more to do.
So, Mr. Chairman, I yield back.
Mr. AIDALA. We appreciate that part about not trying to give us more if we do not need to. We agree with that statement.
Mr. EWING. Well, one solution that comes to my mind readily is not to eat spinach. [Laughter.]
Mr. AIDALA. Are we adding that to the list of Mr. Bush's original broccoli formulation?
Page 59 PREV PAGE TOP OF DOC Mr. EWING. Something like that.
Mr. AIDALA. At some point, the Agriculture Committee may have a concern if you go too far.
Mr. EWING. I know I will never have any trouble from eating spinach because I never do. [Laughter.]
But would you give us, again, the wording of your authority for this type of action?
Mr. AIDALA. In my opening statement, I did quote the part of the statute. Let me find it quickly for you. ''That a pesticide is any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest,'' and that is straight out of the law.
Mr. EWING. Could that be a human being?
Mr. AIDALA. Well, again, sort of kidding aside, humans are not considered to be pests, I mean. So we are not attempting to do it directly.
Mr. EWING. But plant is not a pest either, unless it is a thistle or something like that.
Mr. AIDALA. But we are not regulating the pest. Say thistle, say a weed species that could be a problem. Again, that is the USDA question they asked under the framework. It is not something that we would be getting into. We are not attempting to regulate whole plants, if you will. We are regulating the pesticidal traits and any novel exposure, potential novel exposure, to pesticides in bioengineered plants.
Mr. EWING. I guess the thought that comes to my mind is that we could be creating a new Delaney clause here, where you have taken that wording, and I think probably the context of that, out of context as far as what the Congress meant when they passed it. Would you agree?
Page 60 PREV PAGE TOP OF DOC Mr. AIDALA. I would agree that we probably do not want to invent another Delaney clause. We do not think we are here, if that is, again, part of the question. We have no intent in doing that.
Part of what makes this arena difficult to understand even for us sometimes is the definition of pesticide is very broad and includes intent, and sometimes that causes us to try and finally figure out exactly, you know, what is in and what is out, but it is an overreaching, broad definition or not overreaching. It is a very broad definition.
Mr. EWING. Well, when was that statute passed?
Mr. AIDALA. We believe that was the 1947 definition of pesticide.
Mr. EWING. Did we have the type of biotechnology in existence in 1947?
Mr. AIDALA. Absolutely not.
Mr. EWING. So it would have been difficult for any member of Congress to have visualized your taking this clause and expanding it.
Mr. AIDALA. I would agree with that statement, and again, one of the things I would
Mr. EWING. Wouldn't you think that it would have been better for the administration to propose a new law to give you that authority as to expand one that was passed well before this type of technology existed?
Mr. AIDALA. I think the question for us is not expanding as much as how to apply the various statutes that we do have in place at USDA, at FDA, and at EPA, and apply it to this new technology.
Practice has shown that those countries that have attempted to write totally new laws seem to have bolluxed themselves up. That might be part of the European problem compared to other countries that take the existing laws that they had, and almost all of them are kind of, as you say, Mr. Chairman, written before the advent of this technology at all.
Page 61 PREV PAGE TOP OF DOC The proof at some level is in the actual marketplace acceptance and market dominance in some cases almost of some of these bioengineered products. It is conceivable that one could have a whole new, separate law that says this whole new arena of biotechnology in drugs, in food, in pesticides, what should be the omnibus legislation for that, and there have been various Members of Congress over the years, over the past 15 or so years, that have attempted to think about that, and I have some personal experience with some of those efforts, and it has always been felt that it just gets too complex, too hard, and it has just never happened.
But conceptually could it happen? Certainly.
Mr. EWING. Well, just because it is too hard, I do not think that anything in the law or the Constitution or anything we have ever done here gives you as a bureaucrat the right to come in and take over because it would be too hard to have a law written on that.
Your agency went through with this committee considerable gyrations over the tobacco issue to eventually have the Court say you had exceeded your power. Do you have any qualms that the courts may say the same thing here?
Mr. AIDALA. No, we do not on this issue. I am not as familiar obviously with the tobacco case as I am here obviously because this is the area of jurisdiction that we work on, but again, it is because of the plain reading of the statute and definition of pesticide that basically gives us the initial authority.
The question is how to apply that authority in some reasonable way to meet some of the goals that many Members have talked about.
Mr. EWING. I need to be corrected. It was FDA, but the same result.
I think the point that I am trying to get at here is I wonder if you have the authority to make this kind of a rule under a statute that was passed before there was any concept of this type of plant breeding.
Page 62 PREV PAGE TOP OF DOC Mr. AIDALA. We are confident that we have that authority.
Mr. EWING. What is your confidence built on?
Mr. AIDALA. Again, the sort of plain reading of the statute, that what the definition of pesticide is under the law, and again, this is part of the exercise that the agencies went through in 1986 when they said can we take these lawssome of the laws for USDA are, you know, even older than the laws we are talking about here, whether it be the 1947 FIFRA or the 1972 FIFRA or what have youand apply that to this universe of products and adequately regulate them.
And the 1986 framework did conclude that existing laws were appropriate and sufficient, and that is the framework we have been working off of as a government ever since. That is one reason, too, I think that the administrations, whether it be the Reagan, Bush, Clinton administration, has not seen fit to offer a whole new set of laws or a law to Congress to try and regulate this technology.
Mr. EWING. How do you feel the rest of the world looks at the process that we are going through here? How do our customers overseas look at this rulemaking?
Mr. AIDALA. I am not clear exactly what they may think of the precise elements, you know, of rulemaking per se, but one of the things that has come up is the sort of market acceptance of these products, and again, as I said in my opening statement, especially in the European market, some of our growers may face some problems.
Let me just read one part of some testimony that Stuart Eizenstat, Under Secretary of State, and obviously recently of the Trade Office, gave to the Senate very recently. Let me just read this to you. It was something I was going to add and I cut out of my opening statement in the interest of time.
''Facing these problems regarding biotechnology in so many areas underlies the need for a strong and consistent U.S. policy that insures the safety of these products domestically while at the same time reaffirming internationally the importance of using scientific principles, not politics, as the basis for permitting marketing of these foods.''
Page 63 PREV PAGE TOP OF DOC Again, I think in terms of in some regard, I cannot speak for other countries and their state of mind. If one is a proponent about technology, we are the envy. We have more market penetration. We have, again, over 40 percent of soybeans, for example, that are genetically modified, and so on and so forth.
I mean this technology is taking place here, and we are getting ahead of the game compared to a lot of other countries.
Mr. EWING. We want to stay ahead of the game, but I think that you are in interpretation of the statute, assuming what the Congress thought when they passed it. So I guess you should be able to read what the Europeans are thinking.
Are you willing to allow the comment period to be left open or to reopen it so that questions raised in this hearing can be answered to the satisfaction of this committee?
Mr. AIDALA. That is something that we can talk about. Again, in general, in terms of the comments that we have heard, especially by, say, in the scientific society's report and all of that, we feel our comments that have come up in the comment period that has closed, are we totally against ever opening the comment period and things? No. We are not sure exactly what the purpose may be served, and that is something we would be happy to talk about with yourself or other members of the committee.
Mr. EWING. I have indulged myself, and I want to allow any other member to ask a question. We will start with Mrs. Clayton.
Mrs. CLAYTON. I just want a clarification. The basis of your authority is the utilization of the word ''pesticide''; is that right? Am I correct? The basis of your authority in this area is starting from ''pesticide.''
Mr. AIDALA. Correct, is the definition of pesticide, correct.
Mrs. CLAYTON. Is there a difference between pesticides and pesticidal?
Page 64 PREV PAGE TOP OF DOC Mr. AIDALA. In terms of the pesticidal substance?
Mrs. CLAYTON. Right.
Mr. AIDALA. Pesticidal substance is a pesticide, if I am following correctly.
Mrs. CLAYTON. Well, if as a result of a gene's modification there is no toxic developed, would you still be engaged in regulating that as much?
Mr. AIDALA. No. Those kinds of situations would be things that either (a) maybe subject before to an exemption, or if it is not exempt, once we have found out, given your scenario that there is no concern, then it would be quickly going through our system. We would not be asking many questions, would not have many things required of it.
Mrs. CLAYTON. Well, how do you set that out in the rule? I gather you say this is going to be process neutral, right?
Mr. AIDALA. Correct.
Mrs. CLAYTON. Therefore, if you do not know it ahead of time whether this is going to be resistant, and use your potato scenario, you just automatically say you are not engaged; that Agriculture or FDA is engaged?
Mr. AIDALA. Well, that researcher in terms of having to deal with FIFRA would not have to deal with us and not have to deal with FIFRA. It would be exempt from the requirements for registration under our law.
I think in that scenario USDA would still need to be involved as soon as that went to some field testing as to whether or not under its authority, the Plant Pest Act, whether that could be a problem.
So they would have to go through USDA, but in a lot of these scenarios will not have to come to EPA at all.
Mrs. CLAYTON. The rulemaking period, commenting period, is open until when right now?
Page 65 PREV PAGE TOP OF DOC Mr. AIDALA. The comment period closed some time ago. In fact, it closed before the 11 societies' report was had. Another member asked about, in effect, why we did not reopen the comment period at that time.
The answer to that question is because when we examined the 11 societies report, all of the issues raised there were raised by other commenters during the comment period.
And, in fact, Mr. Chairman, if I could submit for the record literally an articulation of that, one of the comments that we see from the 11 societies' report and where they were already raised by other commenters when the comment period was open, and that is why we did not at that time open the comment period, but it might be helpful to the members of the committee if they see that comparison.
Mrs. CLAYTON. Those are the only questions I have, Mr. Chairman.
Mr. EWING. Mr. Brown.
Mr. BROWN. Mr. Chairman, I have become increasingly intrigued as I listened to this process, and I entered the hearing with a record of having tended to be protective of EPA and helpful of its processes as much as possible, and I have observed over many years that we enter into a new area like this with an effort being made to react in such a way as to, in effect, protect ourselves by over regulating sometimes and then gradually modifying it as we get more information and reducing the amount of regulation until we reach some optimum.
That may or may not be always true, but basically I think that we have done a good job in moving through this transition to a new era of technology, and I am concerned from what I have heard here that we may have what is basically a semantic problem, and in that case my view would be somewhat different.
You have testified that if we are dealing with a pesticide, it is appropriately within EPA's regulations, but if we are dealing with a pest, it is Agriculture's, and if it is something that involves food, it is FDA probably.
Page 66 PREV PAGE TOP OF DOC Now, I am concerned that we may have structured the wording here so as to conform to existing authorities, and the Congress made a conscious decision not to create new legislation to deal with this situation because the existing laws were fairly broad and with a certain amount of goodwill could be adapted to accommodate any apparent conflicts within the situation, and that is what you have been doing over the years.
Now, in this situation, the scientific community seems to have felt that you have misnamed these naturally occurring plant expressed protectants maybe from the standpoint of protecting jurisdictions rather than achieving any real effect.
In other words, you call these plant expressed protectants. Where they're done by genetic engineering, you call them pesticides and you regulate them. If you had decided to call them plant expressed protectants, you open the subject up to where the jurisdiction really should lie.
You do not now regulate plant expressed protectants when they are naturally occurring, do you?
Mr. AIDALA. I think we would interpret it as whatever you call the term, they are subject to FIFRA regulation. It is just the naturally occurring ones are things that we have never worried about in the past and would be exempt under the rule.
Mr. BROWN. You have never regulated them in the past. You assert an ability under the law to regulate them if you call them plant pesticides, even though they are identical to a naturally expressed plant protectant; is that correct?
Mr. AIDALA. Yes, I think I agree with that. In other words, whatever you call them, we think, you know, again, you would be subject to the FIFRA requirements, again, of needing either a registration or an exemption from registration.
Mr. BROWN. Whatever you call them, but all those which have existed in nature for, say, thousands of years that protect plants naturally occurring you have never even considered regulating them.
Page 67 PREV PAGE TOP OF DOC Mr. AIDALA. Correct.
Mr. BROWN. Well, that raises a real question with me as to whether you are seeking to expand your jurisdiction by just changing the name of the activity.
Mr. AIDALA. Well, actually we are, given the testimony that we see here today, and in the interest of the members of the Commission, we are happy to commit to change the name, which we do not think would change the basis of the regulation or our jurisdiction.
But we actually struggled internally with what to call it, knowing this was a controversy. Plant pesticide was done at the time for a number of different reasons. We are not at all wedded to the term. We literally had a
Mr. BROWN. I am not wedded to any terms either, but I note that one of the reports that we have from the next panel indicates that that is a major area of difference between them and EPA.
Mr. AIDALA. And that is one of the areas where we think we agree. We are happy to call it something different and put out a notice, officially take comment on it, and change the name. We do not see that as a problem.
Mr. BROWN. Well, my desire to protect EPA has diminished somewhat if I feel you are just dealing with semantic differences. I would not want you to be doing that, and I hope you will take another look at it, or if you had any evidence whatsoever that a naturally occurring plant expressed protectant does any harm or that its replication by genetic engineering did any harm, I might justify what you are doing, but lacking that evidence, and that is what you are supposed to find, is evidence of some deleterious effect from these genetically engineered activities; I do not think you should be reaching strictly on the basis of a semantic distinction.
Mr. AIDALA. I think I agree with that. I do not think we are trying to, but I would like to get back to you in writing on exactly where
Page 68 PREV PAGE TOP OF DOC Mr. BROWN. Without even trying you may have achieved it.
Thank you, Mr. Chairman.
Mr. EWING. Thank you, Mr. Brown.
Mr. EWING. I would ask then in closing that you consider opening the comment period for the three questions that we have made major points of here today. One, of course, is the term ''plant pesticides.''
Second is the proposed exemption to include suggestions that may have been made as a result of this hearing.
And finally, the burden resulting from the rule through a cost-benefit analysis. I think those would be very helpful.
And I think you can tell from this hearing that there is concern on this side of the table, not a partisan concern, but concern for agriculture, and we would like, if we have to have this rule and it is necessary, for that to be proven and then to move with a rule that does, indeed, benefit agriculture and society and not one that is bureaucratic in nature.
Mr. AIDALA. Mr. Chairman, I would agree with what you say and would just like to be able to come back to you and other members of the committee on whether or not the best way to serve those ends is by reopening.
I think, again, in the last literally number of weeks and months we have made significant progress on those points that you mentioned, as well as a number of others, and we would like to have the opportunity to talk with you and others about that and perhaps then consider whether or not we need to reopen.
But we can consider that, and we are happy to take that under consideration.
Page 69 PREV PAGE TOP OF DOC Mr. EWING. We will keep this dialog going, and there will be questions submitted by the Members and their staff.
Mr. AIDALA. We would be certainly happy to answer those, Mr. Chairman.
Mr. EWING. Mr. Phelps.
Mr. PHELPS. I had a question earlier on, and I know we are pretty far along and are ready to get out of here. So I apologize. Thanks for the opportunity.
Just in trying to review the materials because I came in late from other committees, too, in examination of the approaching of the final rulemaking process, I know EPA is working with other Federal agencies, USDA and others, to publish, I guess, or come to grips with an expedited exemption process, I understand.
Mr. AIDALA. Correct.
Mr. PHELPS. And you will publish those as soon as the final rule is made.
Mr. AIDALA. Along with it, and again conceivably even, you know, beforehand. The problem with doing that beforehand is that auxiliary exemption process is really tied to what is in the rule. So, again, it is one of the benefits of making the rule final, is then we can key off that to do this further consideration of further exemptions.
Mr. PHELPS. I see. I guess just one questions, and there are many concerns, but I do not even want to go into questions about it because I am still trying to be qualified to understand everything.
Who determines somewhere if the exemption can be made by regulation of any pesticide determined, some status, but who makes the final decision if a pesticide has already been, I guess, what I should say maybe adequately or under regulated or over regulated by one agency as opposed to another? Who makes that determination?
Page 70 PREV PAGE TOP OF DOC For example, do all of the agency heads get together and go down this list and say, ''I think this one is OK. We have done enough here. This one needs to be reviewed more''?
Does some one person sit in a room somewhere and say, ''Oh, this is enough''?
Mr. AIDALA. The three agencies meet regularly to sort of make sure that we are in sync. For example, the way a product would be introduced in the Congress is a researcher or a company getting a researcher's work is attempting, first, to do some field trials. For example, anything under 10 acres, you know, we have exempted that in another process, but USDA would want to know about that because it might be a plant pest, and under their authority in the Plant Pest Act they need to look at that.
That might provide data that that researcher or that company has. They would then give that to USDA. That may satisfy us in terms of our biweekly meetings. It may also tell us that it is something that we do not need to be concerned about.
If somebody was doing something they were not supposed to, you would be subject to violating the law, and you may or may not get caught ultimately, but there is not like one person on one day that sort of does it.
Mr. PHELPS. So there is a dialog between the three agencies?
Mr. AIDALA. Correct.
Mr. PHELPS. Or four or whatever.
Mr. AIDALA. Again, regularly, and again, it still is a
Mr. PHELPS. Are there minutes somewhere where you have, say, an actual vote as the agency going on record and saying this is adequate regulated; let's forget this one?
Mr. AIDALA. Janet may want to talk about the process, being more familiar with it.
Page 71 PREV PAGE TOP OF DOC Ms. ANDERSEN. I do not think there are minutes available. There are probably staff notes that they take.
Mr. PHELPS. OK.
Mr. AIDALA. That is not a kind of decision meeting where, OK, you have got this one and, USDA, you have got that one, but rather, given the way the evolution of this might happen, it is again first there will be some field trials beyond 10 acres, first field trials under 10 acres. That would be USDA, and then does EPA need to get involved and when? And then if it is a food issue or some kind, FDA might get involved, and again, that is attempting to implement the so-called coordinated framework.
Mr. PHELPS. But who is the guiding agency that determines how all of this should be done by one particular agency or another?
Mr. AIDALA. It depends on what part of the process where they are in, I guess is the most direct answer I can provide.
Mr. PHELPS. Thank you.
Thank you, Mr. Chairman.
Mr. EWING. Thank you, Mr. Phelps.
Mr. SMITH. Mr. Chairman.
Mr. EWING. Yes.
Mr. SMITH. I have one more question.
Mr. EWING. Yes, Mr. Smith.
Mr. SMITH. Do you think this would give you the authority to move into the supervision and oversight and regulation of biologically modified animals?
Mr. AIDALA. No.
Mr. SMITH. Why?
Mr. AIDALA. That would be USDA, under their authority, and that is the kind of thing they would worry about under the framework, as I understand it.
Page 72 PREV PAGE TOP OF DOC Mr. SMITH. Even if that biologically modified animal and, if you will, was controlling insects on that animal or otherwise keeping pests away from that animal that might affect the quality of the product?
Mr. AIDALA. I think if this example fits your question, a parasitic wasp that has been bioengineered to
Mr. SMITH. No. I just throw out that question because I am not sure that EPA should be the agency that should be getting into the depth of scientific evaluation and research of genetically modified animals or genetically modified plants, and I think this is a huge question, Mr. Chairman, that needs to be evaluated by Congress.
Mr. AIDALA. Fair enough, Congressman.
Mr. EWING. Thank you, Mr. Smith.
It has been a very good panel, and I appreciate your participation and your frank answers, and we will look forward to continuing the dialog.
Thank you for being here, and I hope that you can stay for the next panel.
Mr. AIDALA. We will be staying, Mr. Chairman.
Mr. EWING. I would like to have the next panel come forward to the table, and as we are changing I need to call on Mr. Smith of Michigan again.
Mr. SMITH. Mr. Chairman, thank you very much.
This relates to biotechnology pure agricultural products. Mr. Etheridge is, of course, is from North Carolina. I am from Michigan. North Carolina with Duke, and Michigan with Michigan State this Saturday, have a basketball semi-final playoff, and we are challenging each other, and the losing team, the member who is representing that losing team is, Mr. Etheridge, is I understand going to furnish each member of this committee, Mr. Chairman, with a biotechnology pure agricultural product, and I yield to Mr. Etheridge.
Mr. ETHERIDGE. Mr. Chairman, I appreciate Mr. Smith's challenge, but I would remind him that we expect it to come from Michigan. [Laughter.]
Page 73 PREV PAGE TOP OF DOC Mr. GOODLATTE. If the gentleman would yield, I look forward to having a fine Michigan product, too. [Laughter.]
Mr. EWING. Our second panel is made up of Mr. Joseph Panetta, vice-president, regulatory and environmental affairs of the Mycogen Corporation, on behalf of American Crop Protection Association and the Biotechnology Industry Organization; Dr. Arthur Kelman, Emeritus Reynolds Professor of Plant Pathology, North Carolina State University, Raleigh, NC, on behalf of the Council for Agricultural Science and Technology; and Dr. R. James Cook, Endowed Chair in Wheat Research, Department of Plant Pathology, Washington State University, Pullman, WA, on behalf of Eleven Professional Scientific Societies and Institute for Food Technology.
We will start with you, Mr. Panetta.
STATEMENT OF JOSEPH PANETTA, VICE-PRESIDENT, REGULATORY AND ENVIRONMENTAL AFFAIRS, MYCOGEN CORPORATION, ON BEHALF OF AMERICAN CROP PROTECTION ASSOCIATION AND BIOTECHNOLOGY INDUSTRY ORGANIZATION
Mr. PANETTA. Thank you, Mr. Chairman.
It is a pleasure to be here today before this committee on behalf of the American Crop Protection Association and the Biotechnology Industry Organization to talk to you about the continued implementation of the coordinated framework for biotechnology and its application to plant pesticides, which I will refer to as plant expressed protectants.
It is also a pleasure to be on this panel with two very highly esteemed research scientists. I am neither a scientist nor a lawyer. So I am not sure where that places me on the pecking order, but I am very pleased to be here today to testify before this committee.
My written records are entered into the record. I am going to try to summarize somewhat here, as Mr. Aidala has spoken about the coordinated framework and its impact on the regulation of plant expressed protectants.
Page 74 PREV PAGE TOP OF DOC Before I start, I want to address a question raised by Mr. Smith concerning the reduction of the use of chemical pesticides through the application of biotechnology. I think from our industry perspective, what we are looking at in developing biotechnology products is the opportunity to give farmers more tools, to give farmers alternatives, and to provide better means of controlling pests than the means that we have today.
This is not an exercise in reducing chemical pesticide use, and we believe that the two have complementary applications in agriculture.
Just in summary as far as the coordinated framework goes, we in the industry believe that collectively the early efforts to establish a coordinated framework and the 1986 work that was undertaken have successfully resulted in our ability to introduce biotechnology products into food and agriculture, and as well as the health care arena, that have provided tremendous benefits for American consumers and for farmers, both small and large alike.
The regulatory policies that were established under the coordinated framework gave the three lead agencies, USDA, FDA, and EPA, through the history that had been developed back in 1976, through early conferences that were held on biotechnology to develop a coordinated framework for regulatory oversight of biotechnology products. It encompassed all potential products for regulation.
We believe at that time that there was consideration given to the regulation of plant expressed protectants under the coordinated framework, and also that sound science would be the driver for the regulatory process.
It is important to recognize that the effort to develop the coordinated framework insured that the biotechnology process would not be what would be regulated. Rather, it would be the end products of that process, and as the regulatory process has been developed over the last 12 years, our industry has been a strong advocate for the design of specific regulatory programs that continue to be based on sound science and with sufficient flexibility that requirements are commensurate with the potential risk of the product.
Page 75 PREV PAGE TOP OF DOC So I think it is fair to say that we agree with the statement that regulatory review should be designed to minimize regulatory burdens while assuring protection of public health and welfare, and we recognize that this is an evolving science, and that products that are thought of as potentially being risky today may well in 10 years not be looked at as being as risky as they are today.
We believe that the policies and the procedures that were established by EPA in the proposed rule directly address the regulatory responsibilities for commercialization of these plants containing novel pest resistance traits. Through the use of biotechnology, crops can be developed by the direct transfer of disease and insect resistance traits with an improved degree of precision relative to traditional plant breeding, and as a practical matter, the rule would not change the manner in which the agency has been regulating these products since the approval of the first experimental use permit in 1992 and the first registrations that were issued in 1995, nor would this rule affect the important roles that are played by USDA and FDA with respect to the introduction of enhanced food crops.
Research in this important area would not be regulated by the rule, but would be continued to be subjected to a requirement for an experimental use permit once field testing reaches a prescribed level.
We believe that the rule would accomplish two very critical objectives. First, the rule would provide certainty for everyone with an interest in the development and commercialization of new plant and seed varieties, including growers and fruit processors. This regulatory certainty is a key element, as we discussed earlier, for public acceptance of any regulatory framework.
There must be a clear path regarding data requirements and submissions so that products can flow smoothly from research to commercialization. Because of the vast environmental and public health benefits that biotechnology has to offer, regulatory certainty is critical.
Page 76 PREV PAGE TOP OF DOC The second major benefit of the rule related to the issuance of exemptions from certain requirements of FIFRA and the Food and Drug Act. I won't go into the specifics here, as I believe that Mr. Aidala has adequately summarized the proposal for exemptions, and to a large degree, we have endorsed that proposal for exemptions.
I would only add that we believe that those categories for exemptions might be expanded to include some consideration of the movement of substances that are pesticidal between kingdoms of plant, animal, and microbe, but also add that we believe that the EPA should modernize the experimental use permit provisions of the rule so that potentially we could test on greater than 10 acres to conduct research.
Another benefit of the rule is that it would allow the EPA to issue guidelines for testing and data requirements to more adequately clarify the types of tests that would be needed to support the registrations of these products.
We met last week with the 11 scientific societies. I am pleased to tell you that we believe that this meeting brought about a fundamental agreement between the industry and the scientific societies both with respect to the issue of nomenclature and with respect to the issue of the scope of the proposed rule, and we intend to continue to meet with the scientific societies and continue those discussions and to move forward in greater agreement.
I think in summary I would like to say that the industry and the scientific societies agree fundamentally that the rule must be science based, and it must be product focused.
Because of the importance to the plant biotechnology industry of having a final rule supported by the scientific community and issued by the EPA at the earliest possible time, we propose that the agency immediately make the report of the 11 scientific societies available for comment.
We also propose that the agency would open up specific parts of the rule for comment, not the entire rule, but those areas that were mentioned earlier.
Page 77 PREV PAGE TOP OF DOC Finally, EPA should move expeditiously to make whatever changes are needed based on the comments received and issue the rule in final form.
Mr. Chairman, we would like to commend you and the members of the subcommittee for the leadership role that you have played in examining the appropriateness of the proposed rule and in facilitating the development of a consensus between industry and the scientific communities.
We would also like to commend you for your recognition of biotechnology and agriculture. This framework for regulation of biotechnology products here in the U.S. continues to set the gold standard around the world, and it is well respected.
When one considers the situation in Europe, the inertia that currently exists as a result of the lack of a consistent and transparent regulatory process for crops produced through biotechnology, it becomes exceedingly clear that we here must set the example.
We look forward to working with the EPA as it increases regulatory certainty and makes important improvements to the existing process for regulation of plant expressed protectants.
And I would be pleased to answer your questions at any time.
[The prepared statement of Mr. Panetta appears at the conclusion of the hearing.]
Mr. EWING. Thank you very much, Mr. Panetta.
Dr. Arthur Kelman.
STATEMENT OF ARTHUR KELMAN, EMERITUS REYNOLDS PROFESSOR OF PLANT PATHOLOGY, NORTH CAROLINA STATE UNIVERSITY, ON BEHALF OF THE COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY
Mr. KELMAN. Thank you, Mr. Chairman.
Page 78 PREV PAGE TOP OF DOC I wish to commend you for the perceptive statements that you made at the outset, which I think define some of the key problems that we have been addressing, and also thank the committee even though most of them are not here because in the kinds of questions that were raised, it was very reassuring in the sense that make moot many of the things that I had planned to present.
I think it is best that I not try to cover the material that should already be in your hands that represents a report of a panel of scientists for CAST, and so those documents should be in your hand, as is also true for my own personal background and the statements that I had prepared to make.
I would like to address two key issues as briefly as I can, and I think I cannot avoid making a personal reference to my own background, separate from the fact that I worked as a scientist both at North Carolina State and the University of Wisconsin at Madison for most of my career, dedicating my research to avoid the use of pesticides.
And it is ironic that at this point in time that the massive effort of all colleagues who were dedicated to the use of disease resistance as a primary mechanism which has made it possible in great measure for the enormous success of the agricultural enterprise in this country.
And it is also important to note that this process was self-regulated. It was regulated by the ethical concerns of the plant breeders, pathologists, and other crop related people who were dedicated to be sure that the products were safe before any regulations were put into place.
So the record of low risk, high safety that characterized this enormous effort to enhance crop production and quality, I think, is unprecedented anywhere that I can think of.
Now, everyone agrees that regulations that really work are those that have a scientific, solid basis. It is a concept and a principle that I think is very essential, that there is a scientific consensus that the guiding principle has to be not the way in which the breeding was done, but what are the products involved.
Page 79 PREV PAGE TOP OF DOC Now, I think although I want to commend Mr. Aidala on the statements that indicate a commitment by EPA to this guiding principle, but the fact remains that drawing that fine line is still not exactly clear.
The legal aspects of this indicate that regulations should be directed to compounds, specific substances that interfere with the growth or development of plant parasitic or insects in plants. That is based on the assumption that there is a substance.
The truth is, as I think my colleague Jim Cook will attest to, is the fact that a high percentage of the resistance characteristics in plants do not result in a known substance at all, and furthermore, it is important to noteand this is one of the good aspects about breeding for disease resistancethat in those cases where a pesticide has been determined or a pesticidal substance or inhibitory compound, that these compounds produced in plants are biodegradable. We never hear any mention of this, but the advantage of using these naturally produced substances is the fact that they disappear and are degraded because the natural world uses everything. There is no unemployment, and all waste becomes food.
So I think that is a very important concept.
And finally, I hope that the promise that Mr. Aidala made will be fulfilled in terms of the change in the use of pesticide because it is of great concern to all of us that this dedicated effort is ending up by the objectives that we have had being called pesticidal and the products of this effort become pesticidal plants.
[The prepared statement of Mr. Kelman appears at the conclusion of the hearing.]
Mr. EWING. Thank you for that testimony.
And our third witness, Dr. R. James Cook.
Page 80 PREV PAGE TOP OF DOCSTATEMENT OF R. JAMES COOK, ENDOWED CHAIR IN WHEAT RESEARCH, DEPARTMENT OF PLANT PATHOLOGY, WASHINGTON STATE UNIVERSITY, ON BEHALF OF ELEVEN PROFESSIONAL SCIENTIFIC SOCIETIES AND INSTITUTE FOR FOOD TECHNOLOGY
Mr. COOK. Thank you, Mr. Chairman, and I certainly appreciate the opportunity to speak before you and these committees today on the proposed plant pesticide rule.
And I also would like to commend the leadership of these two committees for convening this hearing and focusing attention on this fundamental issue that is so important to agriculture.
My testimony has been made a part of the record. I am here on behalf of 11 scientific societies that produced the report, which is also part of this record. So I would just like to summarize in the interest of time on three major points, which happen to coincide, Mr. Chairman, with the three points that you pointed out were pretty much capturing the essence of the capturing, which are the definition of the term ''plant pesticide'' or what we want to call the inherited traits in plants for disease and pest resistance.
No 2, the scope of this rule.
And No. 3 is what is appropriate in terms of a cost-benefit analysis.
Now, first of all, on the concept of or the definition of plant pesticide, if there was among the many concerns that the scientific societies have had for this proposed rule, the one issue that united us was that the substances that plants make for their own defense, however they are expressed, will henceforth be proclaimed as plant pesticides.
We did not believe that the 1947 definition of pesticide was intended to include the inherited traits in plants for pest resistance.
Page 81 PREV PAGE TOP OF DOC Now, we understand, as EPA has repeatedly proclaimed through all of the various communications, that many of these traits will be exempted, but that misses our point, which we do not believe that the hairs on a plant or the thicker skin on a plant, if it has been selected for and intended for pest control makes those hairs on a plant pesticides. We just do not believe that that is an appropriate use of the term.
Now, we are concerned for various reasons, including the alarmist side of this term ''plant pesticide,'' and we think it only adds confusion to where there is already confusion within the American consumers and our foreign customers over the safety of plant biotechnology.
But even beyond this, we would not accept scientifically that the defense mechanisms in plants can be so simply described as due to specific substances that themselves can be extracted out and tested in various ways for their safety because, in fact, defense can involve hundreds of proteins, coordinately expressed as the plant first recognizes the pathogen and then turns on a series of defense mechanisms, and there is just no scientific way by which to describe this under the term of pesticidal plant or plant pesticide or pesticidal substance.
And as had already been pointed out, we participated on March 16 with the industry and CAST representation and have agreed that the term ''plant expressed protectant'' would at least be more acceptable, but that brings me to the second point, which is: what is appropriately covered underneath this rule?
And, by the way, when we talk about changing the term that comes down then to even changing how we describe this rule. If we continue to call it the plant pesticide rule, then we will continue to be dealing with this term which is unacceptable.
Now, as to what comes under the scope, my second point, which scientific societies as a follow-up to our report submitted a list of what we believe are whole classes of defense mechanisms that should be considered outside of the scope of this rule, and of course, the morphological structure, such as hairs and thicker skin on the leaf, would be considered within that, but there are others which I have described in my written testimony.
Page 82 PREV PAGE TOP OF DOC Now, within this list of, in fact, we call it a decision guide, and it is a simple procedure, and admittedly, it can be expanded on in many different ways, but within this list we have five categories or classes of defense mechanisms that we believe are outside the scope of this rule.
But within that there is the sixth category, a very focused, very sharply defined category that we would concur would be within the scope of this rule, and that would include what we always hear: what about scorpion toxin? What would spider venom?
Well, we do not know who is doing this in terms of actually transferring those kind of traits, but if that was done, surely all of us as members of society would expect somebody to mind the store and it would appropriately fit under this rule.
And so as a scientific community, we have got this sixth category which is, as I say, a very sharply defined, very focused category of including the Bt that has been discussed this morning, but the other categories, the other classes, five of them, we would consider outside of the scope of this rule.
And, in fact, we have been doing plant breeding for most of this century, moving traits into plants for rust resistance, for resistance to verticillium wilt in tomato, for corn leaf blight, and for many other diseases, and just to call those pesticides but say they are exempt is not satisfactory. We do not even believe they should be called pesticides in the first place.
Finally, Mr. Chairman, with respect to this whole matter of cost, the burden of regulation, where we do agree that there are substances that are of a character to be considered a pesticide when expressed in the plant and might, therefore, require some review, testing, and so forth, we would like to see a means by which to monitor the benefits of this as opposed to the risks.
And here we are concerned about all of the minor uses. We have some 200 crops grown in this country. About 10 of them occupy 90 percent of the acreage. The other 190 occupy about 10 percent of the acreage. That does not make them unimportant. It includes things like tomatoes and peppers, and in fact, even within the major crops, it takes about 300 cultivars to grow the U.S. wheat crop each year, and who knows how many corn hybrids or varieties of soybeans.
Page 83 PREV PAGE TOP OF DOC Now, this is an enormous complexity in terms of our cropping patterns in this country, and so many of them, when it comes to delivering pest defense mechanisms through breeding amounts to the ultimate in minor use.
And even being able to document the cost of something actually does not recognize how many research projects will just remain in academia, continue to be research, but never move beyond 10 acres because it cannot justify a regulatory burden.
Where there are real concerns, we certainly concur that that needs to be looked after, but we must also remember that the cost of this comes as a tax to the research, and the more we divert over into documenting safety concerns and dealing with that side, the less money there is left then to do the research to solve other problems.
Now, it is worth it if there are real concerns, but we want to be sure that there are real concerns and not just perceptions of concerns that, in turn, divert our resources, our very precious resources, thereby limiting the use of this technology to minor crops.
So, again, I want to thank you. I would certainly endorse the statement that the United States is the envy of the world in terms of bringing the new products of biotechnology from the laboratory to the field and into commercial use, and we certainly do not want to jeopardize any aspect of that.
And I hope that my testimony has been helpful.
[The prepared statement of Mr. Cook appears at the conclusion of the hearing.]
Mr. EWING. Thank you, Dr. Cook.
And from my own experience as the chairman of the Specialty Crops Subcommittee, I will say that as we have held hearings around the country, whether it is on crop insurance or whatever, one of the things that producers always bring up is the cost and the availability for minor use crops of the chemicals and of the insecticides and all of the ingredients they need to grow a crop.
Page 84 PREV PAGE TOP OF DOC So I think you make a very good point there, and I am not sure it is one that the EPA has taken into consideration because some producers are really very frightened that what they now have available to them will be taken away, and that their ability to make a living will be greatly impacted.
And in the same right, I am not sure that the agency is considering what impact the name and their whole procedure here will have on our trading partners. We did not sell one bushel of corn to the EU, or that is my understanding. I should never say never, but very little, if any, corn went to the EU last year because of our biotechnology and the nonacceptance in Europe.
And I am not sure that by calling that biotechnology and putting the pesticide label on it will enhance our ability to sell in Europe and that is very important to us.
Dr. Cook, you brought up cost benefit. Do you believe that there is any competition between the big corporations and the little ones for the approval of this rule where it may be beneficial to those who have large research budgets and not to those who do not?
Mr. COOK. Well, I am not sure there is competition between big corporations and little corporations, but I would say that as the rule is now moving forward, so far it has actually been working for what I would call the big ticket items, and years ago, as a person working in biological control, I invented a new term of my own called the FIFRA filter, which is that mechanism by which the smaller applications are filtered out.
And those smaller applications are typically the ones that are followed up not just by smaller companies, but by public plant breeders at Land Grant universities, and that is where the scientific societies' report has beenwe have had a great number of the public sector plant breeders as well as the smaller companies be the first to identify with our concerns. Everybody agrees that these concerns are legitimate.
But I would just say that it is a matter of big ticket versus little, minor use applications where we have a need to really address ourselves.
Page 85 PREV PAGE TOP OF DOC Mr. EWING. Do either of the other witnesses want to comment on that?
Mr. KELMAN. I think that there may be a perception in that regard, and the CAST report examined the questions that were raised by the BIO, which represents most of the industrial elements, and the comments that were made by the 11 science societies, and in our recent meetings, those differences which may have existed were, shall we say, eliminated and a consensus document was prepared.
And it is on the basis of that, I think, a lot of the questions that were raised initially. I think there is a rewarding kind of consensus now as to the need to reexamine these points that we have raised and that EPA has indicated that they are willing to consider.
So I feel very pleased that some of the questions that were raised as to the role of large versus small companies may have been resolved.
Mr. EWING. Mr. Panetta.
Mr. PANETTA. Mr. Chairman, I think one of the important things to recognize about the approach that EPA has taken here is that unlike the traditional testing requirements for chemical pesticides, the approach here is a tiered approach in which risk is very carefully evaluated initially, and so if certain risk hurdles are not met, the cost of registering these types of products is very small.
I will refer to the recent approval for the potato leaf roller virus coat protein that was issued to the Monsanto Company, in which there was almost no testing required for the approval of that product.
So even with a Bt product, where I think the cost was somewhere in the neighborhood of $3 million for registration, where we had a product where we could isolate the substance and test it, as compared to the cost of registering traditional products, which is upwards of $50 to $100 million, this cost is relatively minor.
Page 86 PREV PAGE TOP OF DOC Mr. EWING. The self-regulation that you mentioned, Dr. Cook, do you feel that that was failing to adequately screen these products as they come along?
Mr. COOK. No, I do not believe that that has failed to adequately screen these products as they have come along. I think the point has been made repeatedly that the traits that are being introduced into plants, to the new tools of biotechnology, including traits being accessed from outside the normal range of sexual compatibility, including even across kingdoms, are so well understood and we have so much experience.
Furthermore, we are putting these into crop plants for which we have a great deal of experience. When we put a new trait in to the russet Burbank potato, that variety was developed over 100 years ago. We have 100 years of experience just with that potato, and now we have all of this experience with the Bt going into that potato. So it is very much a matter of looking at the science.
We have had in this country through the peer review process, through the variety approval process, through the USDA and through the FDA a system in place that has done a remarkable job, and everybody agrees that our food is some of the safest in the world, has done a remarkable job to insure the safety.
And if you ask what hazards have there been actually introduced by plant breeding, in fact, we have only done the reverse. We have taken hazards out of crop plants by plant breeding.
Now, as to whether that continues to be adequate, I think that is a very important discussion, but there are, of course, very new combinations that can be generated, as I have pointed out in our sixth category of what would be considered as a class of defense mechanisms, a whole class, a very sharply focused and very narrowly defined set of defense mechanisms that may, in fact, not be adequately covered, although I believe we could examine that to see if it is adequately covered.
Page 87 PREV PAGE TOP OF DOC But we are not saying that therefore, there is no role for EPA. We are just saying it needs to be very much sharpened.
Mr. EWING. Dr. Kelman, you mentioned self-regulation in your comments. Would you agree with Dr. Cook?
Mr. KELMAN. Yes, without any hesitation because the important line that needs to be drawn and reemphasized again is the fact that we are not opposed to regulation of those products which can be demonstrated to be risky. I mean that is not the case.
But in those examples that are clearly safe, where the same type of mechanism that is expressed in this natural habitat, when it is the same genetic, highly defined genetic information produces a product or an effect that we already know is safe, why regulate it?
Mr. EWING. Mr. Panetta, you represent a rather large corporation.
Mr. PANETTA. That is right.
Mr. EWING. Wouldn't your corporation look at anything they put on the market very closely from a liability standpoint? I mean, wouldn't they self-regulate themselves in their research?
I think probably the last thing they want to put out is something that would create harm to the customers.
Mr. PANETTA. Yes, Mr. Chairman, that is correct. We believe that it is appropriate to conduct risk assessment on these products at a level commensurate with the type of risk that the product might potentially present, and so I think the exemption categories that are proposed by EPA are very appropriate relative to the degree of risk posed by those types of products.
And when we get right down to it and we are talking about substances that have activity as pesticides, that it is appropriate to evaluate those products from the standpoint of toxicity and exposure in the environment.
Page 88 PREV PAGE TOP OF DOC Mr. EWING. Thank you very much.
Now I am going to call on the chairman of the other subcommittee that participated here, Mr. Goodlatte.
Mr. GOODLATTE. Thank you, Mr. Chairman, and I apologize for not being here. Unfortunately the Judiciary Committee had two bills of my own that were being marked up, and I needed to be over there.
If there is no objection, I would like to make a statement that I have part of the record. And I would like to ask our witnesses, first thank you for your participation today, but I would like to ask you: who carries the burden for demonstrating that a plant pesticide should be exempted?
Mr. COOK. I would like to address that, which is are you guilty until proven innocent or innocent until proven guilty, and I think that the products that we have dealt with through plant breeding during the course of this century have a remarkable record of safety, and we already have in place policies such as the FDA's generally recognized as safe, and that the new products that are being moved in are considered by another policy of FDA substantially equivalent, and in fact, we start from the assumption that the products that we are working with are safe.
Now, we have enough science
Mr. GOODLATTE. So you would put the burden on the EPA to say that a plant should not be exempt?
Mr. COOK. No, I would put the burden on the scientists who are doing the work to be alert to any changes that they are making that might, in fact, raise questions of safety, and if those questions of safety are raised, there may, in fact, then be taking to the next step to have the right kind of review, including the appropriate Federal review.
Page 89 PREV PAGE TOP OF DOC But up until now we have had plant breeding, moving traits into crop plants by a peer review, self-regulated system that is designed to assure safety just by the fact that we evaluate these materials through performance trials in the field and in a variety of other ways, and that has worked very well.
So I would just state from the beginning that these traits by our own experience are innocent until proven guilty, and we know when the evidence is there to prove them guilty.
Mr. GOODLATTE. Have those who have viewed this otherwise considered the potential cost associated with demonstrating that a product is worthy of an exemption both in terms of time and money? Do you want to address that?
Mr. KELMAN. Well, I think it is very important, and I think part of what we hope will come out of the decisions of EPA as stated today is that such an effort will be made to determine more exactly what those costs are and what the risk benefits are.
But I would like to make one additional comment, and that is any regulatory policy that does not minimize public anxiety about hypothetical hazards is not either wise or sound, and I think unless EPA makes the commitment which they have indicated they plan to make, that the current statements in these areas are not sound or wise.
Mr. GOODLATTE. Thank you.
Mr. Chairman, those are the only questions I have.
Mr. EWING. Thank you, Mr. Goodlatte.
I have a question here from Mrs. Clayton, and gentlemen, the bells mean we have a vote, and we are about out of time, and I think it would be prudent for your time and ours to terminate this hearing now.
I appreciate very much your participation. You will probably be receiving some additional questions in the mail. We would very much appreciate your answering them in writing.
Page 90 PREV PAGE TOP OF DOC This record will stay open for 10 days to accept statements and other material.
And, again, my appreciation to all who have participated, and this meeting is adjourned.
[Whereupon, at 1:10 p.m., the subcommittees were adjourned, subject to the call of the Chair.]
[Material submitted for inclusion in the record follows:]
Testimony of James V. Aidala
Good morning. I am Jim Aidala, the Associate Assistant Administrator for the Office of Prevention, Pesticides, and Toxic Substances. The Office of Prevention, Pesticides, and Toxic Substances is the Office at the U.S. Environmental Protection Agency (EPA) responsible for drafting the rule on plant-pesticides. I welcome the opportunity to appear before you this morning to describe the proposed rule as well as what we are considering for the final rules. The EPA proposed the rules in 1994 and hopes to finalize it this year. In issuing your invitation, you specifically mention the scope and scientific merit of the rule, the benefits and consequences of this regulatory action on agricultural biotechnology, and the effect this regulation might have on the position of the United States in international trade negotiations. I will briefly describe the primary results of issuing the rule, the philosophy EPA adhered to in developing the rule, and address the concerns you mention in your invitation.
DESCRIPTION OF RULES
Why Does EPA Have a Role? Our primary mission at EPA is to ensure that pesticides are safe and to protect human health and the environment.
Page 91 PREV PAGE TOP OF DOC The definition of pesticide in FIFRA is broad; the term pesticide means (1) any substance or mixture of substances intended for preventing, destroying, repelling or mitigating any pest, (2) any substance or mixture of substances intended for use as a plant regulator, defoliant or desiccant, and (3) any nitrogen stabilizer.
FIFRA section 2 defines ''pesticide'' to include any substance or mixture of substances intended for preventing, destroying, repelling or mitigating any pest. Substances plants produce for protection against pests are clearly pesticides under the FIFRA section 2 definition of pesticide when humans intend to use such substances for ''preventing, destroying, repelling, or mitigating any pest.'' Pesticides are subject to FIFRA and pesticide residues are subject to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA). EPA's 1994 Federal Register notice (59 FR 60495 November 23, 1994) does not propose that substances plants produce for protection against pests be considered pesticides. Rather, the 1994 Federal Register notice recognizes that these substances meet the FIFRA section 2 definition of pesticide. The primary proposals of the 1994 Federal Register notice are: exemption of several categories of plant-pesticides from FIFRA and FFDCA section 408 requirements, clarification that plants used as biological control agents are exempt from FIFRA requirements, and creation of a new part in the Code of Federal Regulations (CFR). The 1994 Federal Register notice used the term ''plant-pesticide'' to distinguish these substances, produced and used in living plants, from other types of pesticides. The term ''plant-pesticide'' includes the substances produced and used in living plants, and the genetic material necessary to produce them.
Primary Results of Implementation of Rules. The primary results of implementation of the rule EPA proposed in 1994 would be:
exemption of several broad categories of plant-pesticides from the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA)
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confirmation that plants used as biological control agents are exempt from FIFRA requirements
establishment of a new part in the Federal Code of Regulations (CFR) specifically for plant-pesticides, to consolidate plant-pesticide regulations and thus facilitate ease of use.
Why These Exemptions? In 1994, EPA proposed certain exemptions because the Agency recognized that, although some plant-pesticides require regulation under FIFRA, many qualify for exemption from such regulation. Similarly, although some residues of plant-pesticides would require the establishment of a tolerance under FFDCA section 408, many would qualify for exemption from such regulation. The millennia of human cultivation and breeding of certain plants provide a base of experience of safe use which EPA believes is sufficient to justify exempting certain plant-pesticides from FIFRA and FFDCA section 408 requirements.
None of the exemptions EPA hopes to establish with this rulemaking are based on the mechanism by which the plants acquired the plant-pesticide. The rules are ''process-neutral.'' Rather, the exemptions are based on the characteristics of the plant-pesticides and the probability of exposures to plant-pesticides with unknown toxicological profiles. The exemptions, thus, are based on risk considerations.
I would now like to briefly describe the proposed exemptions, and would like to do so in terms of some recently-appearing reports suggesting that EPA exempt or exclude several categories of plant-pesticides from regulation. For example, the Institute of Food Technologists (IFT) suggested five categories for exclusion. The Agency's three proposed exemptions are remarkably similar to these suggested exclusions. One, IFT suggests EPA should exclude ''naturally-occurring and heritable traits derived for plants of the same or sexually compatible species (i.e., gene transfers from one potato species to another).'' EPA advanced such an exemption in the 1994 proposed plant-pesticide rule. Two, IFT suggested that ''inherited pest-defense traits'' ''new to the plant species and its sexually compatible relatives which results in changes in physical structure or form (i.e., leaves with hairs to prevent or discourage insect attack)'' should be excluded. EPA agrees and proposed such an exemption in 1994. Three, IFT suggested that inherited pest-defense traits ''involved in defense mechanisms expressed as a cascade of biochemical and genetic events triggered by incompatibility between the pest and the plant (i.e., hypersensitive reaction or programmed cell death)'' should be excluded. EPA agrees and one of its proposed exemptions includes these types of actions. Four, IFT suggested that inherited pest-defense traits that are ''responsible for pest defense effects that are widely known and common within the plant, animal and microbial kingdoms, and are not characteristic of pesticides, such as enzymes'' should be excluded. What is included in this category is not clear because the description is very general. However, it may well be that some of the traits that IFT would place in this grouping may be within the proposed exemptions that EPA put forth in 1994. Other compounds in this grouping, however, could pose risks to humans or the environment, a number of enzymes are already regulated as biochemical pesticides, and probably would not be exempt. Five, IFT suggested that inherited pest-defense traits derived from pest genes, such as a viral coat proteinbe excluded. EPA proposed in 1994 to exempt plant-pesticides based on viral coat proteins.
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Potential for Additional Exemptions. EPA recognizes that as we gain additional experience with these types of products, we may very well find that we can safely exempt other categories of plant-pesticides in addition to those that would be exempted by the final rule. EPA is working with other Federal agencies, in particular the U.S. Department of Agriculture (USDA), to develop an expedited exemption process, which EPA will publish at the same time as the final rule. This process could also be used to exempt other categories of plant-pesticides that can be shown to pose a low probability of risk and are not likely to cause unreasonable adverse effects in the absence of regulation.
Is EPA Regulating Plants? No. EPA's approach would exempt plants. EPA would only review the plant-pesticides within plants. EPA believes this approach would give the Agency greater flexibility to grant broad categories of exemptions for plant-pesticides, independent of the process used to introduce the plant-pesticide into the plant. This approach would allow us to focus on any risk issues associated with non-exempt plant-pesticides while avoiding disruption of traditional procedures used in the development and commercialization of plant varieties.
Why Create a New Part in the CFR? Establishment of a new part allows EPA to consolidate regulations specifically applicable to plant-pesticides in one part of the CFR. EPA believes the consolidation will benefit the public by providing greater focus, enhanced clarity and ease of use, because all the regulations specific for plant-pesticides would be in one part of the CFR. The new part would list, for example, exemptions from FIFRA regulation, and exemptions from the requirement of a tolerance or tolerances, issued under section 408 of the FFDCA, specifically for plant-pesticides.
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Why Call These Substances ''Plant-Pesticide''? EPA uses the term ''plant-pesticide'' to distinguish these substances, produced and used in living plants, from other types of pesticides. A distinctive name facilitates creation of a new part in the CFR. However, in response to comment that the term ''plant-pesticide'' may have a negative connotation and raise concerns with consumers, EPA will ask for comment on the advisability of changing the name in the Federal Register package containing the final rule.
EPA PHILOSOPHY IN DEVELOPING RULES
EPA's philosophy is guided by several considerations. First, EPA believes it should fulfill its obligations under the policy choice made by the Reagan Administration in 1986 that existing laws would be used to regulate products of modern biotechnology. It is in the best interests of all stakeholders to ensure that all products developed using modern biotechnology be safely commercialized. Secondly, sound science is very important to EPA in the development of its approach to products of biotechnology. Thus, for this rule, in addition to relying on its own scientific expertise, EPA sought the advice of knowledgeable, independent experts. Third, the EPA believes that biotechnology can provide societal and environmental benefits.
Fulfilling Obligations of Reagan Administration Policy Choice. In the early 1980's, scientists began to apply the new techniques of biotechnology to produce products in medicine and agriculture. Anticipating the arrival of these new products in the marketplace, the Federal Government evaluated whether the existing regulatory framework could be used to regulate such products. In 1986, the Reagan Administration concluded that existing laws could be used, and published the ''Coordinated Framework of Biotechnology'' (51 FR 23302 June 26, 1986) which laid out the basic approach to regulating these products. The Coordinated Framework established that rather than seeking new legislative authority, Federal Agencies would use existing laws, promulgating new regulations as necessary to address novel product categories.
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This approach not only offered more immediate statutory coverage, but also had the advantage that like products would be regulated under the same statutes. Thus, the Coordinated Framework anticipated that pesticides made through the new techniques of biotechnology would be regulated by the Agency with the most experience with pesticides, EPA. EPA already had significant experience with the regulation of biotechnology products. The first biological pesticide was registered in 1948. Since then, EPA has registered hundreds of products created using the older techniques of biotechnology, and several created using the newer techniques.
The advantages of the Coordinated Framework in providing a level playing field in pesticide regulation became increasingly apparent from the mid 1980's to early 1990's. At that time, scientists began using the new techniques of biotechnology to introduce into plants the ability to produce substances, that, were the substances sprayed on the plant, would be regulated by EPA as pesticides. Logically, if EPA regulates these pesticidal substances when they are sprayed on the plant, it would also regulate these same pesticidal substances when the plant is engineered to produce them.
EPA's 1994 proposal is one in a series of Federal Government actions aimed at clarifying how Agencies would use existing authority to address issues raised by new categories of agricultural products as originally envisioned by the 1986 Coordinated Framework. For example, in 1987 (52 FR 22891 June 16, 1987), in 1993 (58 FR 17044 March 31, 1993) and 1997 (62 FR 23945 May 2, 1997), United States Department of Agriculture (USDA) issued regulations under the Plant Pest Act. In 1992 (57 FR 22984 May 29, 1992), the Federal Food and Drug Administration (FDA) issued guidance to food companies seeking to market foods derived from new plant varieties. In 1994, EPA issued regulations under FIFRA for the testing of microbial pesticides (59 FR 45600 September 1, 1994) and in 1997 under the Toxic Substances Control Act, regulations addressing new microbial products of biotechnology (70 FR 17910 April 11, 1997).
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The rule EPA intends to issue in 1999 is a consequence of the Reagan Administration policy choice, which was maintained by the Bush Administration and subsequently reaffirmed by the Clinton Administration. Experience shows that countries that have chosen to use existing statutes to regulate products of biotechnology are getting products to market far more rapidly than those that have elected to seek new legislation. Consumers also appear to be more willing to accept these products when they are regulated by agencies they know.
Employing Sound Science. Making regulatory decisions using sound science and the best available expert advice is very important to EPA. EPA sought to ensure that the rule is based on sound science. The 1994 proposal was drafted with input from scientists in EPA's Office of Research and Development and with frequent consultation with recognized experts in relevant scientific disciplines through the FIFRA Scientific Advisory Panel and the Biotechnology Scientific Advisory Committee. EPA requested the advice of outside experts, from universities and agricultural research stations across the country, in three public meetings. In developing its rule, EPA also coordinated with the U.S. Department of Agriculture and the Food and Drug Administration. EPA also sponsored, or cosponsored with the U.S. Department of Agriculture and the Food and Drug Administration, three conferences on the application of modern biotechnology to plants. EPA believes that information and advice generated through these public fora allow for a more transparent rulemaking process and has significantly enhanced the scientific basis for our proposal. EPA has also discussed the rule, in particular the scientific rationale underlying the proposed exemptions, with EPA's Scientific Advisory Board.
EPA Position on Biotechnology.EPA believes that products of biotechnology, including plant-pesticides, can provide societal and environmental benefits. These benefits could include, for example, reduced reliance on synthetic chemical pesticides, thereby reducing worker exposure to chemical pesticides and other potential problems associated with use of conventional chemical pesticides, such as groundwater contamination. In support of this thesis, information received from Monsanto Company indicates that since cotton seed, engineered to express a plant-pesticide isolated from the microorganism Bacillus thuringiensis, became available to farmers in 1996, the use of chemical pesticides on cotton has been reduced by one million gallons. Associated benefits also included reduction in the number of containers that had to be disposed of, less water contaminated by rinsing pesticide containers and application equipment, and less fossil fuel burned to apply the pesticide.
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EPA recognizes that the future of pest control is increasingly moving towards biological pesticides, including plant-pesticides. For example, half of the active ingredients registered over the past 5 years have been biological. Recognizing the importance of biological pesticides, EPA created in 1994 a new division, the Biopesticides and Pollution Prevention Division, specifically to review these products. This division houses the expertise needed to address biological pesticides, including plant-pesticides. The Biopesticides and Pollution Prevention Division has extensive experience in working with biological pesticides and with the companies, both large and small, and the universities developing and registering biological pesticides.
Benefits to Agricultural Biotechnology.EPA believes this rule would provide a number of benefits to agriculture. The primary result of the rule will be the establishment of exemptions for several broad categories of plant-pesticides. These exemptions will minimize EPA's effect on agricultural biotechnology, and represent cost savings to companies, breeders and researchers. Publication of the rule will provide benefits to companies and researchers by clarifying the status under FIFRA and FFDCA section 408 of numerous plant-pesticides.
Even though EPA believes that the use of modern biotechnology in agriculture holds real promise, we cannot say that there is never going to be any risk associated with the novel products that may result. Those plant-pesticides not exempted by the pending rule may, for example, be isolated from novel sources (e.g., scorpions, spiders, snakes, microorganisms), and thus have a higher probability of presenting novel and unknown toxicological profiles. The IFT in its recent guidance also recognized that some substances should be subject to EPA regulation. Included in that group would be ''plants with pest-defense substances that act as pesticides when extracted from their hosts and tested in vitro and in the environment, such as nicotine, scorpion toxin, spider venom, and crystalline Bt endotoxin.''
Page 98 PREV PAGE TOP OF DOC EPA has established a good record for those plant-pesticides we have regulated. Since March of 1995, EPA has registered eight plant-pesticides representing 10 pesticide products. Nine of these products were for endotoxins isolated from the microorganism, Bacillus thuringiensis (Bt). These plant-pesticides were registered for use in various crops including potatoes, cotton, field corn, sweet corn, and popcorn. Late in 1998, EPA registered another gene from a plant virus, the replicase gene, from the potato leaf roll virus (PLRV). The replicase gene will be combined with the Bt endotoxin to control both the Colorado potato beetle and the PLRV virus in potatoes. Seed potato is expected to be available for the 1999 growing season. In addition, EPA has approved FFDCA exemptions from the requirement of a tolerance for residues of these plant-pesticides and for seven viral coat proteins. The cost of registering these plant-pesticides was a fraction of the costs associated with registering a conventional chemical pesticide. Time required for registration is approximately 12 months. Increasingly large acreage are being planted with varieties containing these registered plant-pesticides. For example, 1012 million acres of Bt corn were planted in 1998, out of a total 7080 million acres of corn planted. In 1998, 2.3 million acres of Bt cotton were planted, out of a total of 13 million acres of cotton planted. In 1998, 50,000 acres of Bt potatoes were planted, out of a total of 1.4 million acres of potatoes planted.
Those plant-pesticides that have been registered have been enthusiastically embraced by growers, and have been a boon for the biotechnology industry. Since their introduction in 1995, the adoption of these products has increased significantly each year. Sales were estimated to reach the $9 million mark for 1998 and are predicted to reach $20 million in 1999. EPA believes that such user demand will result in the development and use of new pest resistant crop varieties expressing novel plant-pesticides. If experience of the past few years is an indicator, the profits associated with sale of such varieties will outweigh the costs imposed by EPA requirements.
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EPA believes that consumers, both in the U.S. and abroad, are reassured by EPA's continued involvement. The Agency's evaluation of non-exempt plant-pesticides will serve to encourage public confidence in the safety of plants and foods containing these products, thereby facilitating consumer acceptance. Many in industry indicate that review and approval by EPA of plants and foods containing plant-pesticides prior to commercial distribution is important from a marketing (public acceptance) standpoint, as well as reassuring global markets. EPA personnel, under the aegis of the U.S. trade agencies, have participated in numerous meetings with representatives of other governments to assure these officials that products cleared for use and consumption in the U.S. are safe.
Effect on Trade. Since EPA explained in 1994, that substances that plants produce for protection against pests are pesticides if these substances are intended to be used for preventing, destroying, repelling or mitigating any pest, the U.S. has continued to ship numerous foods containing residues of plant-pesticides to foreign markets. The fact that EPA terms these substances plant-pesticides appears to have no detectable negative effect on sales of these products.
A related issue raised by those who are concerned that EPA's approach might have adverse effects on trade is how EPA will apply its labeling authorities for plant-pesticides. EPA is not planning to require labeling of any type for those plant-pesticides that would be exempted by EPA rulemaking. Even for those plant-pesticides not exempted, labeling will be limited. For non-exempt plant-pesticides, the label issued as part of a registration remains on file with the developer. This is the only label required by EPA. The farmer purchasing seed containing a registered plant-pesticide will be provided information by the developer informing the farmer that the seed contains a registered plant-pesticide. The primary purpose of this information is to prevent unnecessary spraying of chemical pesticides. EPA assumes that it would be in the sellers' interest to provide such information, as the pesticidal characteristic is one of the reasons sellers of seed may charge a premium price for the seed.
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No label or information would subsequently be associated with the plant-pesticide. The farmer would not be required to label plants containing the plant-pesticide, nor the produce of the plants. This approach is consistent with EPA's approach to other types of pesticides, e.g., chemical pesticides, which are not labeled as to the pesticides present in food commodities.
There is no current requirement and EPA is not planning to require that produce or commodities containing plant-pesticides, either exempt or not exempt, be segregated in any way, either by the farmer or in the food distribution networks.
Effect on Research. Some scientists have expressed concern that EPA's pending rule will restrict their research. As mentioned earlier, the primary result of the rule would be exemption of broad categories of plant-pesticides from FIFRA and FFDCA, and reconfirmation that plants used as biological control agents are exempt from FIFRA requirements. These actions will not restrict research. Indeed, these actions should facilitate research. For those plant-pesticides that would not be exempted by the rule, researchers need not contact EPA until their activities are pursued on 10 acres or more of land or 1 surface acre of water. At 10 acres of land or 1 surface acre of water, an EPA-issued experimental use permit (EUP) is needed. The presumption that an EUP would not be required for testing on 10 acres or less of land or 1 surface acre of water or less is part of the EUP regulations (40 CFR 172.3) and applies to plant-pesticides as well as to synthetic chemical pesticides. As with chemical pesticides, a tolerance or exemption from the requirement of a tolerance under FFDCA is needed if the produce is going to be sold in interstate commerce.
Page 101 PREV PAGE TOP OF DOC It is EPA's experience with many biological pesticides that, when testing gets to the 10 acre level, researchers typically have either turned the product totally over to a pesticide company or are working in cooperation with a pesticide company who has experience marketing agricultural products. There are only a handful of registrations held by universities, the US Forest Service, or USDA. The Biopesticides and Pollution Prevention Division at EPA also has extensive experience working with small pesticide companies and the few universities which register products because most, if not all of these, are biological pesticides. We recognize that EPA needs to make special efforts to assist seed companies in understanding and complying with pesticide regulations. The Biopesticides and Pollution Prevention Division is assisting several small entities developing plant-pesticides.
Is There Duplication of Oversight Efforts Between Federal Agencies? Since Congress has made EPA the Agency responsible for regulation of pesticides and given EPA statutory tools specifically written to address the risks associated with pesticides, duplication between EPA and FDA and between EPA and USDA is minimal.
With regard to potential duplication between FDA and EPA, since its creation in 1970, the FFDCA responsibility for setting tolerances for pesticide residues in food has been under EPA's jurisdiction, while the FFDCA responsibility for regulating all other substances in food is under FDA's jurisdiction. In general, Agency jurisdiction under the FFDCA is based on whether or not the substance in question is a pesticide. FDA and EPA agree that pesticides fall under EPA's jurisdiction. There is, therefore, no duplication of responsibility between EPA and FDA. FDA and EPA do, however, share information and work closely on developing solutions to generic issues (e.g., allergenicity of food).
Page 102 PREV PAGE TOP OF DOC With regard to USDA and EPA, USDA uses several laws to regulate biotechnology products. USDA primarily relies on two of these laws to address risk issues potentially associated with plants, the Plant Pest Act and the Plant Quarantine Act. These two laws do not address food safety concerns. Thus, there is no duplication of authority with USDA in this sphere. In the area of ecological effects, EPA regulates the plant-pesticide, USDA on the other hand, regulates the plant. The USDA and EPA have worked together sharing information and using their regulatory authorities appropriately to ensure the safe use of the product. For example, in recent reviews of crop plants engineered to express a plant-pesticide (Bt), EPA used information from USDA's analysis of the ability of the plant to disseminate Bt to other varieties and to wild relatives, while USDA, in its review used information from EPA's analysis of Bt. As part of the interagency review process and the ultimate implementation of this rule, EPA and USDA will continue to work on eliminating redundancies and improving information sharing.
This type of cooperation and coordinated use of statutes was envisioned as a key part of the Coordinated Framework. Through its approach to plant-pesticides, EPA is meeting its statutory and Coordinated Framework obligations under FIFRA and FFDCA to protect human health and the environment against any unreasonable adverse effects from pesticides.
Why Not Delay Publication of the Rule? The primary effect of publishing the rule we are considering would be the finalization of exemptions for several categories of plant-pesticides. This rule would also reconfirm that plants are exempt from regulation when used as biological control agents. Delaying finalization of the rule would mean that the regulatory status of most plant-pesticides would remain unclear. Publication of the rule will provide benefits to companies and researchers by clarifying the status under FIFRA and FFDCA section 408 of numerous plant-pesticides. Because of this uncertainty, companies may delay projects until the status of their plant-pesticides becomes clear, potentially delaying important benefits to agriculture and consumers. EPA plans an extensive outreach program once the rule is final to provide additional guidance on what types of products are exempt.
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MISCONCEPTIONS CONCERNING WHAT THE RULE WOULD DO
EPA acknowledges that some members of the academic community have raised concerns about EPA's proposed rule. We believe that many of the objections raised may be due to simple misunderstanding of the proposal's provisions. In an attempt to help shed some light on these controversies, we would like to address directly some of the issues that have been raised.
FIFRA Applies to Biological as well as Chemical Pesticides. The first concern is that the pesticide statutes EPA administers apply only to inanimate chemicals and not to living organisms, and that applying these laws to plant-pesticides is a radical change in the use of the pesticide statutes. This is not so. In 1948, the first pesticide based on a living organism was registered. Hundreds of pesticides based on living organisms have been registered since then. Indeed, the language of the statute contains specific reference to biological pesticides (7 U.S.C. 136a(c)(10)(B).
EPA Does not Propose to Regulate Plant Varieties. The second concern is that EPA proposes to regulate plants and that each variety of plant would have to be registered. This is not so. In 1994, EPA confirmed that plants per se are exempt from FIFRA requirements. EPA intends to reconfirm this exemption in the final rule. An approach which exempts all plants from FIFRA regulation while addressing plant-pesticides, in addition to allowing the Agency to create broad categories of ''process-neutral'' exemptions, also allows the Agency to avoid requiring registration for plant varieties. Rather, EPA registers plant-pesticides for use in a given crop. The plant-pesticide can then be moved into any variety of that same crop without having to contact EPA. USDA has the responsibility for regulating plants.
Page 104 PREV PAGE TOP OF DOC EPA's Approach is not Based on Process. The third concern is that EPA considers to be pesticides only plants into which have been introduced, through genetic engineering, genes encoding pest resistance. As noted above, EPA's proposal would exempt plants. A related misconception is that EPA would determine which plant-pesticides are exempt based on the process by which the plant-pesticides were introduced into plants. This is not so. EPA's approach is process neutral. The exemptions that EPA proposed in 1994 are independent of the way in which the substance becomes a part of the plant. The proposed exemptions are only based on the characteristics and/or the probability of exposure to unknown toxicological profiles. Whether the plant-pesticides are introduced into the plant through evolution, genetic engineering or traditional breeding is immaterial to the exemption.
EPA and Herbicide Tolerant Plants. Another concern is that EPA will regulate the ability of a plant to tolerate (or resist) an herbicide. EPA regulates the use of the herbicide, as it would any other application for a new use of a herbicide. The herbicide tolerant plants themselves would not be subject to any EPA review.
In closing, let me assure you that EPA recognizes the potential benefits that products created through modern biotechnology may bring to U.S. agriculture. We believe that the exemptions that would be established by the rule we are currently considering, and our reconfirmation that plants per se are exempt from FIFRA requirements, will minimize EPA's effect on all aspects of agricultural biotechnology. We also believe that consumer acceptance will be key to the ultimate success of products of modern biotechnology, and that consumer acceptance is strongly influenced by confidence that the regulatory agencies will ensure the safety of the products. EPA believes its activities will contribute to the long-term viability of agricultural products created using modern biotechnology.
Testimony of Joseph Panetta
Page 105 PREV PAGE TOP OF DOC Mr. Chairman, on behalf of the American Crop Protection Association (ACPA) and the Biotechnology Industry Organization (BIO), I want to thank you for the opportunity to appear today in support of the continued implementation of the Federal Government's Coordinated Framework for Regulation of Biotechnology. In particular, our remarks will address the rule proposed by the Environmental Protection Agency (EPA) for regulation of ''plant pesticides'' under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). We will refer to these substances as ''plant-expressed protectants,'' a term that more accurately reflects the manner in which substances that may be subject to regulation under FIFRA are produced by plants.
Before discussing EPA's proposal, I would like to briefly review the events that contributed to development of the underlying regulatory program. In the mid1980's the Reagan administration convened a Domestic Policy Council Working Group on Biotechnology that brought together senior officials from the White House Office of Science and Technology Policy, the National Science Foundation, the National Institutes of Health (NIH) and the regulatory agencies, including EPA, the Department of Agriculture (USDA) and the Food and Drug Administration (FDA). This effort resulted in the publication in June 1986 of the Coordinated Framework for Regulation of Biotechnology (Coordinated Framework) (51 Federal Register 23302). Collectively these early efforts established a framework that has led to the introduction of a large number of biotechnology products in the food, agriculture, and health care arenas that have provided immense benefits to American consumers.
Although the Coordinated Framework took effect immediately, it recognized that additional regulatory requirements would have to be established by the agencies involved. The Coordinated Framework reviewed existing statutes such as FIFRA, the Federal Food, Drug, and Cosmetic Act (FFDCA), and the Federal Plant Pest Act (FPPA), and concluded that no new legislation was needed for products of biotechnology. These products were to be regulated under existing statutory authority based on their intended use in the same manner as products manufactured by more traditional means. For example, FDA would exercise jurisdiction over foods and pharmaceuticals developed through modern genetic techniques to the same degree as any other food or drug products. USDA would continue to regulate the movement of plants and other regulated articles. The same was true with respect to EPA's jurisdiction over products that would be marketed with pesticidal traits.
Page 106 PREV PAGE TOP OF DOC Following established regulatory policy at all three lead agenciesUSDA, FDA and EPAand recognizing the long and successful history of NIH oversight over biotechnology experiments dating back to the 1970's, the Coordinated Framework provided a product based approach to Federal oversight and regulation. All products would be subject to regulation, with individual products or categories of products exempted over time based on sound science and the experience of the regulators. As the regulatory process developed over the past 12 plus years, our industry has been a strong advocate for the design of specific regulatory programs based on sound science and with sufficient flexibility that requirements are commensurate with the potential risk of the product. We agreed with the statement that ''regulatory review should be designed to minimize regulatory burden while assuring protection of public health and welfare.'' Ours is an evolving science and products thought of as potentially risky 10 years ago may be safely introduced into the environment today based on the acquired knowledge base and scientific review.
USDA was the first to issue its implementing regulations, in 1987, followed by various exemptions based on the experience of scientists in the Animal and Plant Health Inspection Service in successfully reviewing hundreds of permit applications for transgenic plants. FDA followed with its policy on foods derived from new plant varieties in 1992. EPA issued regulations for microbial products under FIFRA in 1994 and the Toxic Substances Control Act in 1997. Without the benefit of formal policies and procedures, EPA has exercised jurisdiction over plant-expressed protectants under FIFRA and FFDCA for several years now, and has gained considerable knowledge and experience in the process.
FIFRA gives EPA broad regulatory authority over pesticidal substances at all stages of development. It is a licensing statute that requires the registration of products whose intended use is pesticidal. The registration process for commercial products insures that human health and environmental concerns are fully addressed, and includes an evaluation of food safety issues under the FFDCA for all pesticidal substances found in plants that have potential food or feed uses. Although FDA is responsible for the safety of whole foods and food additives, EPA has statutory responsibility for the safety of pesticidal substances in food. Similarly, although USDA evaluates potential plant pests under the FPPA and conducts environmental assessments prior to the movement of regulated articles, these reviews are typically conducted at a relatively early stage in the product development process and are not specifically focused on the toxicity of plant-enhanced protectants.
Page 107 PREV PAGE TOP OF DOC The EPA's proposal for plant-expressed protectants was published in 1994. The policies and procedures proposed by EPA were important as they directly addressed the regulatory responsibilities for commercialization of plants containing novel pest resistance traits. Through biotechnology, crops can be developed by the direct transfer of disease and insect resistance traits with an improved degree of precision relative to traditional plant breeding. As a practical matter, the rule would not change the manner in which the Agency has been regulating these products since approval of the first experimental use permit in 1992 and the first registration in 1995. Nor would the rule affect the important roles played by USDA and FDA with respect to the introduction of enhanced food crops. Research in this important area would not be regulated by the rule, but would continue to be subject to the requirement for an experimental use permit once field testing reaches the prescribed level.
The rule would accomplish two critical objectives. First, the rule would provide certainty for everyone with an interest in the development and commercialization of new plant and seed varieties, including growers and food processors. Regulatory certainty is a key element for public acceptance of any regulatory framework. There must be a clear path regarding data requirements and submissions so that products can move smoothly from research to commercialization. Because of the vast environmental and public health benefits that biotechnology has to offer, regulatory certainty is critical to assuring the public that these products will be available as soon as the appropriate compliance issues have been addressed. Because the initial regulatory approvals have been sought and obtained by a handful of industry leaders, published policies and procedures are also important in order to provide all potential entrants with access to a roadmap that leads to commercialization.
The second major benefit of the rule relates to the issuance of exemptions from certain requirements of FIFRA and FFDCA. Section 25(b) of FIFRA gives EPA the flexibility to exempt by regulation any pesticide determined to be: (1) adequately regulated by another Federal agency, or (2) not of a character which requires FIFRA regulation. Pursuant to this authority, EPA has for many years exempted entire classes of plants and animals that function as biological control agents. The proposed rule follows a consistent approach by clearly avoiding regulation of the plants themselves. Only the plant-expressed protectant, such as the Bacillus thuringiensis or ''Bt'' protein, would be subject to regulation, and then only those protectants that did not qualify for one of the science-based exemptions. The Agency can also establish an exemption from the requirement of a tolerance for a pesticide chemical if the Agency determines that such an exemption will meet the FFDCA safety standard, and the proposed rule contained several of these exemptions as well.
Page 108 PREV PAGE TOP OF DOC BIO submitted lengthy comments to the docket in response to the EPA's 1994 proposal, which have subsequently been endorsed by ACPA's Biotechnology Committee. Although we found the policy and proposed rule generally appealing, we did have some specific suggestions about how the regulation of plant-expressed protectants could be improved:
1. EPA should narrow the definition of regulated substances to focus on the active ingredient, not on the genetic material necessary for its production in the plant.
2. EPA should clarify its approach to inert ingredients so that incidental genetic sequences, inserted proteins involved in metabolic pathways, and marker genes are not regulated under FIFRA.
3. EPA should exempt those substances that are transferred within the food supply where there is already a history of dietary and environmental exposure.
4. EPA should include in the final rule an exemption provision by which those classes of regulated substances that pose little risk to the environment can be exempted from FIFRA.
5.EPA should modernize the experimental use permit (EUP) provisions that apply to plant-expressed protectants.
Incorporation of these suggestions in a final rule would focus EPA's regulatory program on novel products capable of new environmental exposures and would deregulate an increased number of products. BIO subsequently developed a white paper outlining what we believed to be appropriate data requirements for registering plant-expressed protectants. This document, delivered to EPA in the fall of 1995, presented an evaluation process for new proteinaceous active ingredients produced by plants. The document covers the assessment of food safety and ecological effects with the guiding paradigm, the risk posed by the new active ingredient. Risk is defined as the product of toxicity and exposure. As either of these factors approaches zero, risk becomes negligible.
Page 109 PREV PAGE TOP OF DOC Since the initial approval of an insect resistant potato in 1995, companies have successfully used the evaluation process outlined in the BIO paper to register corn, potato, and cotton varieties containing new plant-expressed protectants. These varieties have been grown on millions of acres of American farmland with significant environmental benefit. All of these varieties have received exemptions from the requirement for a tolerance. Grain from an insect-resistant corn crop can be co-mingled with grain from a non-transformed crop and entered into commerce. There is no requirement that products of transgenic crops be identified as containing plant-expressed protectants, just as there is no requirement that foods be identified as having been treated with conventional pesticides. Seed bags sold to farmers are labeled only indicating that the variety expresses a protein that controls resistance to the target insect pest.
In July 1996, 11 professional scientific societies issued a report entitled: ''Appropriate Oversight for Plants with Inherited Traits for Resistance to Pests.'' This report, prepared by eminent scientists and submitted to EPA, raised questions about the Agency's proposed approach to regulating ''plant pesticides.'' A follow-up report entitled ''Issue Paper-The Proposed EPA Plant Pesticide Rule'' focusing on differing points of view on the rule between the industry and the scientific societies was issued by the Council for Agricultural Science and Technology last year. Our industry has met on several occasions with representatives of these societies to discuss the EPA proposalmost recently in a meeting convened just last week by ACPA.
I am pleased to report that this meeting brought about a fundamental agreement between the industry and the scientific societies, both with respect to nomenclature and the scope of the proposed rule. First, as to the name assigned to this category of ''pesticide'' substances, there appears to be general consensus that ''plant-expressed protectant'' is a more acceptable and accurate term. Next, as regards the scope of products that EPA should regulate under FIFRA, the Agency's program must continue to be science-based and recognize the safety of traditional breeding techniques. Regulation should be limited to those protectants whose toxicity and new avenue of environmental exposure warrant evaluation. Categories of products should be exempted where there is no demonstrable risk to human health or the environment. Finally, an expedited exemption process should be incorporated in the rule in recognition of experience and advances in scientific knowledge.
Page 110 PREV PAGE TOP OF DOC Because of the importance to the plant biotechnology industry of having a final rule, supported by the scientific community and issued by EPA at the earliest possible time, we would propose that the Agency immediately make the report of the 11 scientific societies available for public comment. The Federal Register notice should advise interested parties that their comments will be taken into account in finalizing the 1994 proposed rule, but that the rule itself is not being reopened for comment. Certainly in terms of scope and the authority to issue exemptions, it is fair to say that EPA has far more experience today with plant-expressed protectants than it had in 1994. Finally, EPA should move expeditiously to make whatever changes are needed based on the comments received and issue the rule in final form.
Mr. Chairman, we would like to commend the members of this subcommittee and the House Agriculture Committee for the leadership role that you have played in facilitating the development of consensus by the industrial and scientific communities. The framework for regulation of products of biotechnology here in the United States continues to set the gold standard and is well-respected amongst scientists and regulators worldwide. When one considers the inertia that exists currently in Europe as a result of the lack of a consistent and transparent regulatory process for crops produced through biotechnology, it becomes exceedingly clear that we must set the example. We look forward to working with the EPA as it increases regulatory certainty and makes important improvements to the existing process for regulation of plant-expressed protectants. I would be pleased to answer any questions at this time.
Statement of Arthur Kelman
Mr. Chairman and members of the committee, I greatly appreciate the invitation to present testimony to the Risk Management, Research and Specialty Crops Subcommittee and the Department Operations, Oversight, Nutrition, and Forestry Subcommittee. I hope my testimony will be helpful in understanding certain aspects of the proposed Environmental Protection Agency (EPA) regulations governing plants containing genes that enhance resistance to pests.
Page 111 PREV PAGE TOP OF DOC I am Arthur Kelman; I continue to have faculty status in the Department of Plant Pathology of North Carolina State University. My primary professional experience involves appointments at North Carolina State University and the University of Wisconsin-Madison from 1965 to 1989. The focus of my research has been a search to understand how bacterial plant pathogens cause disease and how plants resist infection. Many studies were completed to improve procedures that can be used to screen plants for disease resistance. My primary involvement in the topic of interest to these committees was an assignment as Chairman of the committee that prepared a ''white paper'' or policy statement for the Council of the National Academy of Sciences entitled the ''Introduction of R-DNA Modified Organisms into the Environment'' published in 1987. Recently, I served as a member of the Council for Agricultural Science and Technology (CAST) panel that prepared the issue paper entitled The Proposed EPA Plant Pesticide Rule (1998, Issue Paper 10, Council for Agricultural Science and Technology, Ames, Iowa, copy attached).
I am testifying on behalf of CAST, which is a nonprofit organization composed of 36 scientific societies and other members in related areas. Its primary mission is to identify food and fiber, environmental, and other agricultural issues and to interpret related scientific research information for legislators, regulators, and the media for use in public policy decision making.
My desire today is to present the conclusions of the CAST panel on the proposal to regulate genetically engineered plants containing genes that would enhance resistance to pests and to designate such plants as pesticides. As you are aware, many plant scientists have been engaged in a large effort to improve the resistance of major food crops to the range of organisms with the capacity to damage plants. One of the beneficial objectives of this intensive development of pest resistant crops was to be the reduction in the use of pesticides. Furthermore, with application of the powerful tools of molecular biology, the time needed to develop varieties with enhanced resistance to specific diseases would be greatly reduced. Thus, it is quite ironic that we are confronted with the prospect that all plants with pest resistance are to be considered plant pesticides and placed under regulations that certainly were never originally intended for oversight of resistant plants. In addition, although some resistant plants may not form compounds that are in fact pesticidal, under the proposed regulations they would still be classified as plant pesticides. This is based on the fact that they would have properties that would inhibit or prevent the development of pests and not whether such properties present a risk of harm to living systems or to the environment. This also would apply in a legal sense if they are ''intended'' to be used to control pests. In good measure, some of the difficulties have arisen because the terms ''pesticide'' and ''pesticidal'' are global in meaning (killing or inhibiting pests in general), whereas resistance in genetically modified plants (particularly those that are produced by recombinant DNA techniques) are highly specific with respect to the pests that are inhibited.
Page 112 PREV PAGE TOP OF DOC Pest resistant plants produced by genetic engineering are, in general, indistinguishable in behavior and appearance from plants bred by conventional methods. However, the latter types of plants are exempted from the EPA regulations although they may be highly resistant and may in fact have several pesticidal compounds that can be identified. It is very likely that plants selected for genetic modification have already been modified by plant breeding and selection for resistance to a range of pests, and simply still lack resistance to the one pathogen or insect for which resistance cannot be introduced by conventional means.
The proposed EPA regulations differ from the principle accepted by a number of panels of scientists. This is the principle that genetically modified crops should be evaluated on the basis of safety, allergenic effects, toxicity to humans or animals or nontarget organisms, or other characteristics indicating possible risk. There is general agreement that regulations should not be based, at the outset, on the process by which the genetic information was inserted into the plant.
All plants have differing levels of resistance to most pests, and resistance in plants results from a number of very different mechanisms. One effective means of resistance results from processes in plants that do not produce highly specific toxic compounds. Furthermore, the role of a specific compound often is still unknown. Conceptually, the EPA was correctly empowered
to oversee the use of specific materials such as insecticides and fungicides and others that might entail risks to humans, animals, and the environment. Logically, if a resistant plant does not produce pesticidal compounds as a result of the genes introduced, it should not be covered by such regulations. Furthermore, the judgment as to whether to regulate any plant should not be based on its ability to protect itself from a pest, but whether or not the substance shown to be involved in resistance is toxic and whether it may present a hazard to the environment.
In general, scientists, workers in industry, and the public understand what is meant by the words ''pesticide'' and ''pesticidal.'' Under the proposed regulations, the words ''plant pesticide'' are being used in a context that is strongly opposed by the scientific community as well as by representatives of a spectrum of organizations concerned with the food industry and crop production. This terminology is likely to adversely affect public perceptions of what is being accomplished by genetic engineering research and its application by industry.
Page 113 PREV PAGE TOP OF DOC The term ''plant-expressed protectant'' agreed to by representatives of industry and scientists at a March 16, 1999 meeting, should be used to replace the ''plant pesticide'' terminology. It was further agreed, contingent upon a name change for the rule, that four categories of the decision guide and a fifth to be further debated be exempted from the rule (decision guide attached). Only those products that fall within category six should be subject to regulation. Scientists believe regulation is needed for health and safety assurances, but regulations should be appropriately targeted.
CAST has been informed that scientists consulted by the EPA were in full support of the regulations that were first proposed in 1994. However, in view of the recent major advances in our understanding of the genetic processes involved and the major concerns raised in a consensus report by scientists representing 11 plant science societies, the question can be raised as to whether the EPA scientific advisory committee cited as providing full approval of the regulations is still of the same opinion that was developed 6 years ago. Federal regulatory proposals should be guided by policies that encourage research and its application, resist unduly burdensome regulations, and also minimize public anxieties about hypothetical hazards. Unfortunately, the current EPA proposed rule, even with proposed exemptions, fails to meet these objectives.
Testimony of R. James Cook
Thank you, Chairman Ewing and Chairman Goodlatte, for this invitation to speak to the matter of the Environmental Protection Agency's proposed Plant Pesticide Rule. My name is R. James Cook. I am a plant pathologist and the Endowed Chair in Wheat Research at Washington State University. For the past 34 years, including 33 years with the U.S. Department of Agriculture, Agricultural Research Service, and now 1 year in my current position with WSU, I have done research on biological and cultural practices as alternatives to pesticides for the management of root diseases of wheat and barley. My testimony today is given on behalf of 11 scientific societies that released a report in July 1996, entitled ''Appropriate Oversight for the Inherited Traits of Plants for Resistance to Pests,'' that is critical of the EPA proposed Plant Pesticide Rule. Copies of this report have been made available as part of my written testimony.
Page 114 PREV PAGE TOP OF DOC I would point out that the development of this report and the endorsement of its conclusions by 11 scientific societies representing some 80,000 scientists is without precedent and speaks to the depths of our concerns for this proposed rule. I say ''without precedent'' because this response from 11 scientific societies, while guided under the leadership of the Institute of Food Technologists and the American Society of Agronomy, happened spontaneously without invitation from a government agency and without the aid of an organization such as the National Research Council. I would add that I am gravely disappointed that EPA was dismissive of our concerns and refused to even solicit public comment on our report.
Of the many concerns shared by the members of these societies, the one concern that has united us most strongly is the EPA proposal to define all the myriad mechanisms used by plants to defend themselves against pests and diseases as ''plant pesticides'' and make them subject to regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Even the hairs on the leaves of plants that serve to repel insect pests would be called plant pesticides under this proposed rule if a plant breeder used this kind of trait as a source of crop-plant resistance to insects. Since the hairs on a leaf are made up of substances and there are specific genes required to make and assemble these substances, when intended for pest control these hairs and the genes needed to make them become plant pesticides under the EPA expanded FIFRA definition of pesticide.
We realize that the proposed Plant Pesticide Rule will exempt from the regulatory burdens of FIFRA whole categories of pest defense mechanisms, including traits for pest and disease resistance introduced by conventional plant breeding. However, we believe these defense mechanisms should not be considered pesticides in the first place.
As we point out in our report, all plants are able to prevent, destroy, repel or mitigate pests or they could not survive. The EPA proposed rule proclaims that all plants contain pesticides, or worse, that all plants are pesticides. Looking ahead, we are concerned that this rule sends the message that food plants are being developed to make even more or better pesticides, a message that will only add to the confusion within society and especially among American consumers and our foreign customers about the safety of plant biotechnology.
Page 115 PREV PAGE TOP OF DOC Therefore, the scientific societies are unanimously opposed to the term ''plant pesticide'' as scientifically indefensible. Based on discussions among scientists, including representatives of the scientific societies and the biotechnology and crop protection industries at a meeting hosted by the American Crop Protection Association here in Washington on March 16, we respectfully submit that the term ''plant pesticide'' should be replaced.
A term for which there is consensus among representatives of the scientific societies and the biotechnology and crop protection industries is the term ''plant-expressed protectant.'' ''Plant expressed protectant'' means that the protectant is made by the plant. Hairs produced on the leaves of plants for defense against insects is both made by and protects the plant and therefore hairs are ''plant-expressed protectants.'' Similarly, the Bt protein produced in a genetically-engineered crop plant is a plant-expressed protectant.
The representatives of the scientific societies that developed the report recognize that oversight is needed in a way that protects the environment and human health while providing a clear path to commercialization regardless of the tools used to develop the crop plant. Thus, as a follow-up to our 1996 report, we have developed a ''Decision Guide for EPA Review of Plants with Inherited Traits for Resistance to Pests.'' Within this Decision Guide, we include five categories of pest defense mechanisms that we submit are not appropriately regulated as pesticides or are already adequately regulated by another Federal agency. A sixth and last category of pest defense mechanisms in this Decision Guide includes introduced traits that would be subject to regulation under FIFRA, although many of these could also be subject to the EPA exemption process. I would add that the categories of pest-defense mechanisms described in this Decision Guide are focused on the products without regard to the method by which the genes were obtained or introduced into the plant. Copies of this Decision Guide have been submitted as part of my written testimony.
One of the categories of pest defense mechanisms that I would submit is outside the scope of ''plant pesticide'' is a well-studied and widely used mechanism known among scientist as the ''hypersensitive response'' of plants to pests. This response is due to an incompatibility between the plant and the pest not unlike the process that leads to rejection of an organ when transplanted. The process is very complex, involving the coordinate expression of many genes and biochemical interactions. Imagine, by analogy, what happens as a bowling ball rolls up the incline and taps the first ball in a long line up of bowling balls; the last ball on the other end of the line up pops loose and then stands alone. The first tap represents the initial event in recognition of the pest by the plant, and the last ball that pops loose is the outcome of the interaction-compatible, meaning the plant is susceptible or incompatible, meaning the plant is resistant. All the balls in between represent the hundreds of proteins that did their part to reject the pest, both locally and systemically within the plant. No one substance or gene can be meaningfully singled out for tier I or any other test for effects on the environment or human health. EPA agrees that this mechanism of defense should be exempted on the basis of its complete safety, but we would go further and say that the FIFRA definition of pesticide need not be expanded to include the incompatible-type resistance response in the first place.
Page 116 PREV PAGE TOP OF DOC Another example that would not be appropriately regulated as a pesticide is a new category of pest defense mechanisms pioneered by Dr. Roger Beachy and known as ''pathogen-derived'' resistance. This resistance is achieved by transferring a gene from the pathogen into the plant genome, which then makes that plant resistant to that pathogen. The method is much like vaccination of plants, and it works for a broad range of plant viruses. Our Decision Guide recommends that this kind of plant defense is already effectively and appropriately reviewed by the USDA under the Federal Plant Pest Act.
Our sixth category of pest defense mechanisms includes the plant-expression of chemical substances that we would agree are of a character to be considered pesticides, such that, when extracted from the plant and tested in some purified form, can be shown to act as pesticides. Examples in this category include the Bt toxin now used as a plant-expressed protectant of cotton, potatoes, and corn against certain insect pests. However, it should be pointed out that the Bt protein along with other known mechanisms of plant defense that might appropriately be regulated as pesticides have a remarkable safety record and that the self-regulation and peer-review approaches used by plant breeders during most of this century has worked remarkably well to assure the safety of new crop plants to people and the environment.
The United States is the envy of the world for the way by which this country has successfully and safely moved crop plants developed by the new tools of biotechnology from the laboratory to the field and then into commercial use. The reason for our success is that our approach has been science based, going back to recommendations made by the scientific community through the National Academy of Sciences, the Council on Agricultural Science and Technology, and other highly respected scientific organizations. I personally believe that the EPA proposed Plant Pesticide Rule as it now stands based on the definition and scope of plant-pesticide is seriously flawed and would represent a major exception to an otherwise economical and scientifically defensible regulatory framework. The high cost this regulation would impose represents a serious deterrent to the transfer of pest resistance genes. This deterrent would be felt most strongly by smaller companies and land grant universities, and by any plant breeders working with minor crops.
Page 117 PREV PAGE TOP OF DOC Thank you again for the opportunity to testify before these two subcommittees of the House Agriculture Committee on behalf of the 11 scientific societies.
Statement of the American Seed Trade Association
The American Seed Trade Association (ASTA) is pleased to provide this written statement on behalf of its members. We and our members would like to thank you very much for this opportunity to provide our written comments on the proposed rule by the Environmental Protection Agency governing the regulation of so-called ''plant pesticides'' under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
ASTA represents companies who develop and market improved seed products that ensure the competitiveness of American farmers and growers and provide the consumer with a varied selection of nutritious and reasonably priced foods. Our members are engaged in research and development activities designed to further enhance the quality, variety, productivity, and availability of agricultural seeds. They rely heavily on ''traditional'' methods of plant breeding to develop new plant varieties, but are also applying the techniques of modern biotechnology to crop improvement. ASTA members are enthusiastic about the prospects for the new genetic technologies to ensure a sustainable supply of our major grain, oilseed and vegetable crops, produced with reduced quantities of chemical pesticides.
ASTA supports sound science-based and risk-focused regulation that encourages high production standards and promotes public confidence in the health and environmental safety of new crop varieties from which food products are developed. We generally support the Agency on its proposed plant-pesticide rulemaking with respect to its science-based and risk-focused orientation, and with respect to its endorsement of the widely enunciated principle that the safety of new products should be evaluated on the basis of their properties, not the process by which they were developed. Nonetheless, we should emphasize that EPA's proposed rule does not always fit the economic and product development realities of the seed industry. In particular, the proposed regulations likely will have serious adverse effects on vegetable and flower and seed companies, where the markets are small and the margins are low. Promulgation of appropriate exemptions and expedited procedures for adopting such exemptions, as described below, will help to reduce some of the impact on these and other seed industries.
Page 118 PREV PAGE TOP OF DOC The history and nature of crop development now and in the past helps bring this area into proper focus. Crop development has always been based on the selection of the varieties that were most fit to thrive and yield in different growing environments. Selection for pest resistance was important in ensuring a consistent food supply. More recently, plant breeders have employed the science of genetics to manipulate naturally occurring endogenous plant-pesticides to protect crops. Genes encoding these natural plant-pesticides are frequently introduced from related species through crosses between sexually compatible species. ASTA members have used these traditional methods of plant breeding to develop thousands of commercial crop varieties that show tolerance or resistance to important pests and diseases. Only in extremely rare instances have such products posed a hazard to human health (e.g., high solanine levels in potatoes selected for pest resistance). Wide-scale commercial deployment of pest resistant crops has had no apparent adverse effects on partially managed or non-managed environments. The Agency must continue to ensure that such traditionally-derived pest resistant crops do not become the subject of unnecessary oversight.
The modern genetic technologies now make it feasible to introduce genes that code for proteins which have a toxic mode of action on plant pests, or which lead to synthesis of non-proteinaceous pesticidal compounds that are completely new to the plant and/or its cultivated or wild relatives. Such strategies for pest control are not inherently less safe than traditional plant breeding techniques.
Further, all plants have differing resistance to most pests. This resistance can result from a variety of different mechanisms, such as those related to the production of highly specific toxic compounds mentioned above. Other mechanisms can involve the so-called ''hypersensitive response'' of plants to pests, which is based upon an incompatibility between the plant and the pest, similar to the process that leads to rejection of a transplant organ. In this example, there is a cascade of events that occur and no one substance or gene necessarily can be identified to be the only determinator of pest resistance. Another type of resistance is ''pathogen-derived,'' which makes the plant resistant to a specific pathogen. This type of mechanism is similar to the vaccination of animals.
Page 119 PREV PAGE TOP OF DOC From these perspectives, all plants are able, to some degree, to prevent, destroy, repel, or mitigate pests or they would not survive. To apply FIFRA, the pesticide statute, to plant substances in situ, seems to be a contorted and strained exercise that raises a host of regulatory issues. For this reason, EPA needs to take into account the various comments that have been submitted by ASTA and BIO on this subject. More particularly, EPA should:
narrow the definition of regulated substances to focus on the active ingredient, not on the genetic materials necessary for its production in the plant;
clarify its approach to inert ingredients so that incidental genetic sequences, inserted proteins involved metabolic pathways, and marker genes are not regulated under FIFRA;
exempt those substances that are transferred within the food supply where there is already a history of dietary and environmental exposure;
include in the final rule an exemption provision and expedited process by which those classes of regulated substances that pose little risk to the environment can be exempted from FIFRA; and
modernize the experimental use permit (EUP) provisions that apply to plant-expressed protectants.
ASTA also supports, as part of the 1996 guide entitled ''Decision Guide for EPA Review of Plants With Inherited Traits for Resistance to Pests'' the exclusion of categories of host defense mechanisms where the trait is:
naturally-occurring and heritable, derived from plants of the same or sexually compatible species;
new to the plant species and its sexually compatible relatives and results in changes in physical structure or form (e.g., leaves with hairs that prevent or discourage insect attack);
Page 120 PREV PAGE TOP OF DOC involved in defense mechanisms expressed as a cascade of biochemical and genetic events triggered by incompatibility between the pest and the plant (e.g., hypersensitive reaction or programmed plant cell death); and
derived from pest genes, such as viral coat proteins.
Finally, instead of the use of the misleading and potentially pejorative term ''plant-pesticide'' we recommend, as has been suggested by others, the use of the term ''plant-expressed protectant.''
Mr. Chairman, we appreciate the opportunity to submit to you this written statement of our views. We would like to compliment the members of the subcommittee and the House Agriculture Committee for the leadership all of you have played in encouraging open and candid debate about EPA's proposed regulations. We look forward to working with both the members of the subcommittee and the House Agriculture Committee, as well as with EPA, in achieving a science-based system of regulation and one that ensures that the costs of regulation does not outweigh its benefits.
"The Official Committee record contains additional material here."