Remarks Concerning the Regulation of Plant-incorporated Protectants

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Remarks of the Biotechnology Industry Organization Concerning the Regulation of Plant-incorporated Protectants under Federal Pesticide Law

U.S. Environmental Protection Agency
Advance Notice of Proposed Rulemaking
Docket ID No. EPA-HQ-OPP-2006-1003
Public Meeting
Washington, DC
May 22, 2007

My name is Dr. Russell Schneider, Director of Regulatory Affairs, Monsanto Company. I am currently the Chair of the Biotechnology Industry Organization (BIO) Environmental Protection Agency Task Force. I am pleased to participate in this public meeting and offer a few brief remarks on behalf of BIO. BIO is a not-for-profit trade association that represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products.

Nature and traditional plant breeders have given us many varieties of fruit and vegetable plants and flowers that are able to protect themselves from insects, viruses and other enemies. Over the past twenty-five years, using the techniques of modern biotechnology, scientists have been able to modify or "genetically engineer" commodity crops such as corn, cotton, soybeans and canola to express a pesticidal substance in the plant itself in order to protect the plants from harmful insect pests. The pesticidal substance or "plant-incorporated protectant" is typically a protein, produced in nature that is designed to be harmful only to the target pest. With the active support of BIO and its food and agriculture member companies, these innovative new products are regulated by three separate federal agencies to ensure that they are as safe to grow and as safe to eat as conventional crops.

The U.S. Environmental Protection Agency (EPA) regulates PIPs under two federal statutes - the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA). Together these statutes address any potential adverse effects on health, safety or the environment that might be presented by the PIP, or any other pesticidal substance. In addition, the potential environmental and agricultural effects of the plant itself are regulated by the U.S. Department of Agriculture under the Plant Protection Act and the safety of the whole food produced by the plant is reviewed by the U.S. Food and Drug Administration (FDA), where it is subject to regulation under Section 409 of the FFDCA.

Plants expressing pesticidal substances have been safely tested in the field under EPA and USDA permits since 1986, and have been cleared for commercial use following review by EPA, USDA and FDA since 1995. Notwithstanding intensive governmental, academic and commercial oversight, not a single instance of actual harm to health, safety or the environment has ever been confirmed for any biotechnology crop that has satisfactorily completed the U.S. regulatory process.

As EPA has repeatedly acknowledged, PIPs possess certain characteristics that distinguish them from traditional chemical pesticides and, as a result, EPA has developed certain regulatory requirements, criteria and procedures that are unique to PIPs. One area in which PIPs differ markedly from traditional chemical pesticides relates to the manner in which they are produced. In contrast to the production of chemical pesticides in "bricks and mortar" facilities, PIPs are produced in a unique, one-time event that takes place in a laboratory. Afterwards, seeds and other propagative materials in which the new genetic material has been successfully incorporated are produced by seed companies and planted by farmers in the exact same manner as they have always been.

As a result, industry has long maintained that plants engineered to express pesticidal substances are "treated articles" for purposes of FIFRA - items such as lumber, paints, shower curtains, kitchen cutting boards, and conventional corn seed that contain a pesticidal substance in order to protect the article itself from harmful insects, mold or bacteria. Moreover BIO believes that, regardless of the status of PIP-containing plants as treated articles, PIPs themselves are of a character that does not require regulation under certain of the recordkeeping and reporting provisions that apply to conventional chemical pesticides in order to carry out the purposes of FIFRA.

To be clear, our members have always provided EPA with all required information pertaining to PIPs, at both the experimental field test stage and following approval and commercialization. Moreover, we intend to continue to provide such information as long as EPA deems it necessary. What we ask is for the relevant information to be provided in a manner and format that is most appropriate for PIPs and that takes into account the differences between PIPs and conventional chemical pesticides. Our goal is to avoid the rather serious, negative impacts that could result to researchers, growers, registrants and the regulatory process were the Agency to attempt to fit a round peg in a square hole by applying FIFRA's recordkeeping and reporting requirements to PIPs in the same manner that they are applied to traditional chemical products.

For all of these reasons, we ask that EPA consider amending the existing regulations to clarify the reporting and recordkeeping requirements that apply to PIPs. In particular, for registrants and holders of experimental use permits (EUPs), the rule should clearly identify requirements for record keeping based upon authorities under Sections 3, 5, and any other appropriate Sections of FIFRA such as Section 8. In addition, each PIP registrant and each holder of an EUP for a PIP should be required to maintain the records required by EPA at a designated location or locations for that PIP. Records maintained at these locations would be available for inspection by EPA. Furthermore, EPA's rule needs to distinguish between records to be maintained (and accessible to EPA on request) and information to be routinely submitted to EPA, which should only be required where a need has been clearly established. Those requirements for EUPs and Section 3 registrations that are consistent for all PIPs should be included in the rule. Requirements that apply to individual PIPs or categories of PIPs should be imposed through the terms and conditions of individual registrations and permits.

BIO appreciates the opportunity to offer its views on this important subject and looks forward to submitting written comments in response to EPA's Federal Register notice of April 4, 2007.