Environmental Protection Agency's Role Under Federal Food, Drug and Cosmetic Act

In my previous article, I discussed the role of the Environmental Protection Agency (“EPA” or the “Agency”) under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”). In this article, the role of EPA under the FFDCA will be examined.

FFDCA

Under the FFDCA, food is deemed adulterated, and therefore prohibited from sale, if it, among other things, “bears or contains any poisonous or deleterious substance which may render it injurious to health.”[i] The FFDCA states that a pesticide chemical residue in or on food is not safe unless it meets a tolerance (maximum allowable) level that the EPA has established for that pesticide or the EPA has exempted the pesticide from the requirement of a tolerance for the residue.[ii]

In other words, when the EPA sets a tolerance level it is establishing a “safe level” of pesticide residue allowed, or the EPA exempt that pesticide altogether.[iii] A “safe level” of the pesticide residue is defined as that level at which there is “a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.”[iv]

Under FFDCA, the EPA can exempt a pesticide from the requirement of a tolerance if “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.”[v]

The EPA has, in fact, established tolerance exemptions for many registered genetically modified microbial pesticides and plant-incorporated protectants.[vi] In other words, the EPA alleges that the tolerance exemptions are safe.[vii]

In the case of herbicide-tolerant crops, EPA establishes tolerances for the allowable amount of herbicide residues that may remain on the crop.[viii]

My next article will address EPA’s role under the Toxic Substances Control Act (“TSCA”) and subsequent articles will address the question whether the existing United States regulatory framework is adequate to protect human and animal life and whether it adequately considers dangers to the environment.


[i] 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 16, 2009), citing 21 U.S.C. §342; see also 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).

[ii] Pew Initiative, supra note i, citing 21 U.S.C. §346a(a)(1).

[iii] Pew Initiative, supra note i, citing 21 U.S.C. §346a(a)(1) ; 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).

[iv] Id. (citing Section 408 of the FFDCA as amended by the Food Quality Protection Act of 1996).

[v] Pew Initiative, supra note i, citing 21 U.S.C. §346a(c)(2)(A).

[vi] Vogt and Parish, supra note iii.

[vii] EPA, Questions and Answers, Biotechnology: Final Plant-Pesticide/Plant Incorporated Protectants (PIPs) Rules, (2001) available at http://www.epa.gov/scipoly/biotech/pubs/qanda.pdf (last visited on August 16, 2009).

[viii] EPA’s Regulation of Biotechnology, supra note i.