An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders

Pub. L. No. 114-182, 130 Stat. 448; and Pub. L. No. 94-469, 90 Stat. (2003) Available at: www.gpo.gov/fdsys.

TSCA § 2(b), 15 U.S.C. § 2601(b).

TSCA § 3(2)(A), 15 U.S.C. § 2602(2)(A); see also 40 C.F.R. §§ 710.3(d), 720.3(e).

62 Fed. Reg. 17910 (Apr. 11, 1997). More recently EPA has stated that “chemically synthesized genes” can be considered “intergeneric,” thus clarifying that microorganisms created via synthetic biology can fall within the scope of these regulations.

TSCA § 2(b), 15 U.S.C. § 2601(b). In remarks expressed in the Senate on June 7, 2016, Senator David Vitter reinforced TSCA's policy and stated, “We also needed to ensure that American companies, which are world leaders today in science, research, and innovation remain so and do not get put behind a regulatory system which is overly burdensome and unavailable.” 114 Cong. Rec. S3511-3513 (daily ed. June 7, 2016).

TSCA § 2(b)(3), 15 U.S.C. § 2601(b)(3).

TSCA § 2(c), 15 U.S.C. § 2601(c).

40 C.F.R. § 725.1(a). “Microorganisms that are not intergeneric are automatically included on the Inventory.” 40 C.F.R. § 725.8(b). Further, manufacturers, importers, or processors required to file an MCAN for research and development (R&D) activities may instead file a TSCA Experimental Release Application (TERA) for a specific test under certain situations. 40 C.F.R. § 725.1(c).

40 C.F.R. § 725.150. If an MCAN is submitted and not needed, EPA will notify the submitter. 40 C.F.R. § 725.28.

40 C.F.R. § 725.1(b).

40 C.F.R. § 725.3. If it is not possible to determine if a microorganism or use is listed on the Inventory, the regulations outline procedures that persons intending to conduct activities involving microorganisms should use to determine their obligations. See 40 C.F.R. § 725.15; EPA, Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (Points to Consider) (June 1997) at 8. Available at www.epa.gov/sites/production/files/2015-08/documents/biotech_points_to_consider.pdf. The review process for a “bona fide” submission generally takes 30 days after submission. Points to Consider at 8.

40 C.F.R. § 725.3.

Id.. An “intergeneric microorganism” includes “a microorganism which contains a mobile genetic element which was first identified in a microorganism in a genus different from the recipient microorganism.” It “does not include a microorganism which contains introduced genetic material consisting of only well-characterized, non-coding regulatory regions from another genus.” Id. The regulations provide further guidance on the types of microorganisms subject to the requirements, and we would be pleased to provide a more detailed analysis upon your request.

TSCA § 5(h)(4), 15 U.S.C. § 2604(h)(4). New TSCA Section 26(p)(1) makes clear that the Section 5(h)(4) exemptions promulgated under old TSCA remain available to notifiers under the new law.

40 C.F.R. § 725.67(a), (b).

EPA Biotechnology Algae Project (2015) at 1. Available at: www.epa.gov/sites/production/files/2015-09/documents/biotechnology_algae_project.pdf (Last accessed July 2016 ).

We note also that the Obama Administration in July 2015 commenced a multi-phase process to modernize the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) by directing EPA, the U.S. Food and Drug Administration, and the U.S. Department of Agriculture to update the Coordinated Framework. Last updated in 1992 (57 Fed. Reg. 6753 (Feb. 27, 1992)) and first rolled out in 1986, the Coordinated Framework outlines a comprehensive federal regulatory policy for products of biotechnology. The memorandum directs the federal agencies to develop a long-term strategy to ensure that the regulatory system for biotechnology products is prepared for future products, and commissions an expert analysis of the future landscape of biotechnology products. The Administration readily admitted that the complexity of the regulatory system can make it difficult for the public to understand how the safety of biotechnology products is evaluated, and navigating the regulatory process for these products can be unduly challenging, especially for small companies. Per the Administration's Memorandum Modernizing the Regulatory System for Biotechnology Products (July 2, 2015), the objectives of the updating process “are to ensure public confidence in the regulatory system and to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products while continuing to protect health and the environment.” As the Coordinated Framework document addresses EPA's role in the regulation of products of biotechnology under TSCA, the modernizing process could indirectly identify areas where EPA might discharge its new authorities under TSCA to fulfill the goals of the modernization exercise.

EPA Biotechnology Algae Project at 1.

EPA. TSCA Biotechnology Notifications Status (2016). Available at: www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/tsca-biotechnology-notifications-status (Last accessed July 2016 ).

As currently defined in 40 C.F.R. § 704.3, a small manufacturer or importer must meet either of the following standards: (1) First standard. A manufacturer or importer of a substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $40 million. However, if the annual production or importation volume of a particular substance at any individual site owned or controlled by the manufacturer or importer is greater than 45,400 kilograms (100,000 pounds), the manufacturer or importer shall not qualify as small for purposes of reporting on the production or importation of that substance at that site, unless the manufacturer or importer qualifies as small under standard (2) of this definition. (2) Second standard. A manufacturer or importer of a substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $4 million, regardless of the quantity of substances produced or imported by that manufacturer or importer.