The EPA’s role in regulating GMOs extends to regulating pesticide substances inside the plant. The EPA derives its regulatory authority from three federal acts: 1) the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”);[i] 2) the Federal Food, Drug and Cosmetic Act (“FFDCA”);[ii] and 3) the Toxic Substances Control Act (“TSCA”).[iii]
In general, under the FIFRA the EPA is responsible for regulating the distribution, sale, use, and testing of pesticides to protect humans and the environment. [iv] The FFDCA authorizes EPA to set tolerances or establish exemptions from the requirement of a tolerance for pesticide residues in or on food crops. A tolerance is the amount of pesticide that may legally remain on a crop after harvesting.[v] Pursuant to TSCA, the EPA acquires information in order to identify and regulate potential hazards and exposures that are not covered by other acts.[vi]
This article will discuss the EPA’s regulatory role under FIFRA and subsequent articles will address EPA’s authority under FFDCA and TSCA.
EPA uses its authority under FIFRA to regulate plant incorporated protectants (“PIPs”), or substances produced to control pests, both, to ensure that the production of such a pesticide in plants is safe for the environment, and to establish allowable levels of the pesticide in the food supply.[vii]
FIFRA requires that all pesticides be registered with the EPA.[viii] When an application for approval of a pesticide is presented to the EPA, the Agency evaluates the proposed pesticide to assure that its use will not pose unreasonable risks of harm to human health and the environment ( i.e. sets the tolerance levels).[ix] Through the registration process the EPA determines whether the intended use of the pesticide is safe for the environment and places conditions upon its use to ensure that environmental safety is protected.[x] This determination involves balancing risks from the pesticide with benefits associated with its use.[xi] A pesticide, including PIPs, cannot be sold or distributed in the United States unless it is registered with EPA.[xii]
Before EPA grants the registration of a pesticide, the applicant must show that the pesticide, when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment.[xiii]
According to the EPA, the Agency considers many factors when evaluating PIPs under FIFRA:[xiv]
- Studies assessing the risks to human health
- Studies assessing risks to nontarget organisms and the environment
- The potential for gene flow
- The need for insect resistance management plans[xv]
Additionally, the EPA’s stated that its biotechnology regulatory program is based on five principles that guide the Agency’s decision-making policy:[xvi]
- Using sound science
- Ensuring transparency of the decision-making process
- Maintaining consistency and fairness
- Collaborating with our regulatory partners
- Building public trust
Permitted Exemptions Under FIFRA
The FIFRA allows the EPA to exempt from registration requirements a pesticide or category of pesticides for which registration is not necessary to meet the goal of environmental protection.[xvii] To qualify for an exemption under the EPA regulations, a pesticide must pose a low probability of risk to the environment (including humans and other animals, plants, water, air and land) and be unlikely to cause unreasonable adverse effects to the environment even in the absence of regulatory oversight.[xviii]
Whether the FIFRA, in combination with FFDCA, TSCA and other Federal agencies provides an adequate framework for regulating genetically modified organisms will be evaluated in an upcoming articles.
[i] 7 U.S.C. § 136 et seq.
[ii] 21 U.S.C. § 301 et seq.
[iii] 15 U.S.C. §2601 et seq.
[iv] EPA’s Regulation of Biotechnology for Use in Pest Management (June 2003), available at http://www.epa.gov/opp00001/biopesticides/reg_of_biotech/eparegofbiotech.htm (last visited on August 9, 2005).
[vii] Pew Initiative on Food and Biotechnology, Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology Products (2001), available at http://www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/Reports/Food_and_Biotechnology/hhs_biotech_0901.pdf (last visited on August 12, 2009); see also Donna U. Vogt and Mickey Parish, Food Biotechnology in the United States: Science, Regulation, and Issues (United Stated Dept of State), available at http://fpc.state.gov/fpc/6176.htm (last visited on August 14, 2009).
[viii] EPA’s Regulation of Biotechnology, supra note iv.
[ix] Id.; see also Pew Initiative, supra note vii at 12.
[x] Pew Initiative, supra note vii at 13.
[xi] Vogt and Parish, supra note vii.
[xii] Vogt and Parish, supra note vii; see also Pew Initiative, supra note vii, at 13.
[xiii] Pew Initiative, supra note vii, citing 7 U.S.C. 136a(c)(5).
[xiv] EPA’s Regulation of Biotechnology, supra note iv.
[xv] EPA’s Regulation of Biotechnology, supra note iv; see also Pew Initiative, supra note vii at 13 (stating that EPA’s evaluation includes an assessment of date from tests done by the producer of the pesticide according to EPA guidelines, and an evaluation of whether a pesticide has the potential to cause adverse effects on humans, wildlife, fish and plants, including endangered species and non-target organisms, as well as possible contamination of surface water and groundwater).
[xvi] EPA’s Regulation of Biotechnology, supra note iv; see also Glenda D. Webber, Office of Biotechnology, Iowa State University, Ames, Iowa, available at http://www.biotech.iastate.edu/biotech_info_series/bio11.html (last visited on August 11, 2009).
[xvii] Pew Initiative, supra note vii, at 13, citing 7 U.S.C. 136w(b)(2).
[xviii] Pew Initiative, supra note vii, citing 40 CFR 152.25 (full text of the federal regulation available at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=86588f501e0ad208660ccb9da11080fe&rgn=div8&view=text&node=40:184.108.40.206.220.127.116.11&idno=40, last visited on August 14, 2009).