SPEAKERS CONTENTS INSERTS
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56–428 CC
1999
1999
REVIEW THE ENVIRONMENTAL PROTECTION AGENCY'S PROPOSED RULE ON PLANT PESTICIDES
JOINT HEARING
BEFORE THE
SUBCOMMITTEE ON RISK MANAGEMENT, RESEARCH, AND SPECIALTY CROPS
AND THE
SUBCOMMITTEE ON DEPARTMENT OPERATIONS, OVERSIGHT, NUTRITION, AND FORESTRY
OF THE
COMMITTEE ON AGRICULTURE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
FIRST SESSION
MARCH 24, 1999
Serial No. 106–10
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Printed for the use of the Committee on Agriculture
COMMITTEE ON AGRICULTURE
LARRY COMBEST, Texas, Chairman
BILL BARRETT, Nebraska,
Vice Chairman
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
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KEN 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
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MIKE 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
Professional Staff
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,
Vice Chairman
NICK SMITH, Michigan
TERRY EVERETT, Alabama
FRANK D. LUCAS, Oklahoma
SAXBY CHAMBLISS, Georgia
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RAY 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
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LEONARD 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,
Vice Chairman
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
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MIKE THOMPSON, California
GEORGE E. BROWN, Jr. California
DAVID MINGE, Minnesota
(iii)
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
Witnesses
Aidala, James V., Associate Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances, Environmental Protection Agency
Prepared statement
Submitted memorandum of August 28, 1997
Cook, R. James, on behalf of 11 professional scientific societies, and the Institute for Food Technology
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Prepared 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
Prepared statement
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
Prepared statement
''A Comparison of Perspectives on Key Issues Concerning EPA's Proposed Plant Pesticide Regulations''
Submitted Material
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,
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Washington, 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.
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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.
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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.
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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.
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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
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a 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 regulation—as 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.
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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.
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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?
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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?
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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.
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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 mid–1980'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 suggestions—I am sorry.
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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.
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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.
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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.
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Mr. EWING. Thank you, Mr. Berry.
Dr. Cooksey.
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.
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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.
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Dr. COOKSEY. Good. Thank you.
Thank you, Mr. Chairman.
Mr. EWING. Mr. Phelps.
Mr. Boswell.
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.
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.
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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.
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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?
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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.
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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?
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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.
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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.
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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.
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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.
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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.
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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?
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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.
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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.
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.
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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.
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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?
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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?
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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?
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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?
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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.
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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