In two of my recent articles, the Environmental Protection Agency’s (“EPA” or “Agency”) role under the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug and Cosmetic Act was evaluated. In the article below, I will analyze the EPA’s role under the TSCA.
TSCA provides the EPA with authority to regulate chemical substances which may present an unreasonable risk of injury to health or the environment during manufacture, processing, distribution in commerce, use, or disposal.[i] TSCA applies to uses of substances that are not specifically covered by another statute, i.e., TSCA does not apply to pesticides, food, drugs or cosmetics.[ii] TSCA is therefore a “catch-all” or “gap-filler” statute.
A “chemical substance” is defined to include “any organic or inorganic substance of a particular molecular identity, including any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature and any element or uncombined radical.”[iii]
The EPA has interpreted the definition of a chemical substance to cover intergeneric microorganisms (microorganisms created by the insertion of genes from another genera).[iv]Examples of commercial uses of microorganisms subject to TSCA regulation include specialty chemical and enzyme production, bioremediation (process of using microorganisms, fungi or plants for remediation purposes), biosensors of environmental contaminants, biofertilizers, ore mining, oil recovery, and biomass conversion.[v]
Under TSCA, a party seeking to market a “new chemical substance” must submit a pre-manufacture notification (“PMN”) at least 90 days prior to initiating such manufacture.[vi]New chemical substances are substances which are not listed on the EPA’s Toxic Substances Control Act Chemical Substance Inventory.[vii] This PMN must include test data and information regarding the manufacture, processing, use, intended commercial distribution, and environmental and health effects of the new chemical.[viii] If the EPA does not act within this 90-day period the submitter may begin commercial production of the chemical.[ix]
Exemptions Under TSCA
Ordinarily manufacturers are required to submit a Microbial Commercial Activity Notice (MCAN) as part of the PMN requirements.[x]Such notification, however, is not needed for intergeneric microorganisms when criteria are met that define eligible microorganisms, introduced DNA, and containment practices. [xi] This exemption is most applicable to specialty and commodity chemicals, including industrial enzymes.[xii]
Intergeneric microorganisms used for research in contained structures are exempt from EPA reporting requirements, but researchers must maintain records demonstrating eligibility for exemption.[xiii]In addition, certain intergeneric microorganisms also are exempt from reporting requirements when used in field tests because prior test experience indicates low environmental risk.[xiv]
As with other agencies that have regulatory control over GM foods, the EPA’s regulatory authority over GMOs is an attempt to adapt a pre-existing legal framework to new technologies in ways that could not have been foreseen when the laws were first enacted. There are serious questions, to be examined in future posts, as to whether this approach is successful.
[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 17, 2009)
[ii] Pew Initiative, supra note i at 17; see also U.S. Regulatory Agencies Unified Biotechnology Website, Roles of U.S. Agencies, available at http://usbiotechreg.nbii.gov/roles.asp (last visited on August 17, 2009); EPA, Summary of Toxic Substance Control Act, available at http://www.epa.gov/lawsregs/laws/tsca.html (last visited on August 17, 2009).
[iii] Pew Initiative, supra note i at 17, citing 15 U.S.C. 2602(2)(A).
[iv] Pew Initiative, supra, note i at 17, citing 40 CFR Part 725.
[v] Pew Initiative, supra note i at 17.
[vi]Neil A. Belson, AgBioForum, US Regulation of Agricultural Biotechnology: An Overview, (Vol. 3, No. IV), available at http://www.agbioforum.org/v3n4/v3n4a15-belson.htm (last visited on August 17, 2009), citing15 USC § 2604(a); see also Pew Initiative, supra note i at 18.
[vii]Pew Initiataive, supra note i at 18.