Industrial Biotechnology: Coordinated Framework Make-Over and Lots More

51 Fed. Reg. 23302 (June 26, 1986); 57 Fed. Reg. 6753 (Feb. 27, 1992).

Paradise J , Does Fitzpatrick E. Re-Writing Nature Require Re-Writing Regulation?. Penn. State Law Review 20xx;Vol. 117: at 53 (Paradise and Fitzpatrick).

J. Craig Venter Institute. Synthetic Biology and the U.S. Biotechnology Regulatory System: Challenges and Options. (Venter report) May 2014, pgs 18–22. Available at www.jcvi.org/cms/fileadmin/site/research/projects/synthetic-biology-and-the-us-regulatory-system/full-report.pdf (Last accessed August 2015 ).

NEPA § 102(2)(C), 42 U.S.C. § 4332(2)(C): Under NEPA, federal agencies engaged in “major Federal actions significantly affecting the quality of the human environment” must prepare detailed statements assessing the environmental impact of and alternatives to such actions.

FDA. Guidance for Industry: Safety of Nanomaterials in Cosmetic Products. (Guidance on Nanomaterials in Cosmetics). Available at www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm300886.htm (Last accessed August 2015 ).

FDA. Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives” (Guidance on Effects of Emerging Technologies on Food Ingredients and Food Contact Substances). Available at www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm300661.htm (Last accessed August 2015 ).

40 C.F.R. § 152.15(a)-(c). EPA's regulations provide exemptions from FIFRA regulation. These include the following: certain substances or articles are not intended for use against “pests” and thus are not pesticides; certain products are not intended to prevent, destroy, mitigate, or repel pests and thus are not pesticides; certain pesticides are regulated by other federal agencies and are exempt from all FIFRA requirements; certain pesticides or classes of pesticides are of a character not requiring FIFRA registration; and certain otherwise regulated pesticides may be transferred, sold, or distributed without registration.

FIFRA § 2(bb), 7 U.S.C. § 136(bb).

40 C.F.R. § 172.48.

40 C.F.R. § 172.50.

TSCA § 3(2)(A), 15 U.S.C. § 2602(A).

40 C.F.R. § 725.3.

40 C.F.R. §§ 725.1(a), 725.3.

40 C.F.R. § 725.3.

40 C.F.R. § 725.8(b).

Mandel G , Marchant G . Evolving technology regulation: Governance at a temporal distance. In: Leenes R , Kosta E (eds). Bridging Distances in Technology and Regulation. Oisterwijk, The Netherlands: Wolf Legal Publishers, 2013.

40 C.F.R. § 725.67(a), (b). Exemptions from notification requirements include: (1) the R&D exemption; (2) the Tier I or Tier II exemption; and (3) the Test Market Exemption (TME). If the company can satisfy the criteria for any of these exemptions, it may, depending on the particular exemption, commence manufacture or importation without notifying EPA (in the case of R&D activities conducted “inside a structure”) or may obtain expedited EPA review (i.e., a 45-day review for a TME rather than a 90-day MCAN review).

62 Fed. Reg. 17909, 17923. (Apr. 11, 1997).

40 C.F.R. §§ 725.234(d), 725.3. EPA further provides the following regarding the containment and/or inactivation controls: “(1) Selection and use of containment and/or inactivation controls inside a structure for a particular microorganism shall take into account the following: (i) Factors relevant to the organism's ability to survive in the environment. (ii) Potential routes of release in air, solids and liquids; in or on waste materials and equipment; in or on people, including maintenance and custodial personnel; and in or on other organisms, such as insects and rodents. (iii) Procedures for transfer of materials between facilities. (2) The technically qualified individual's selection of containment and/or inactivation controls shall be approved and certified by an authorized official (other than the TQI) of the institution that is conducting the test prior to the commencement of the test. (3) Records shall be developed and maintained describing the selection and use of containment and/or inactivation controls, as specified in Section 725.235(c). These records, which must be maintained at the location where the research and development activity is being conducted, shall be submitted to EPA upon written request and within the time frame specified in EPA's request. (4) Subsequent to EPA review of records in accordance with paragraph (d)(3) of this section, changes to the containment/inactivation controls selected under paragraph (d)(1) of this section must be made upon EPA order. Failure to comply with EPA's order shall result in automatic loss of eligibility for an exemption under this section.”

40 C.F.R. §§ 725.205, 725.234(a).

40 C.F.R. § 725.234(c).

40 C.F.R. § 725.234(b).

40 C.F.R. § 725.3.

40 C.F.R. § 725.234(e). EPA's regulations set forth when notification procedures are required, and if so, the procedure in which such notifications must be made. See 40 C.F.R. § 725.235(a), (b).

40 C.F.R. § 725.255.

40 C.F.R. §§ 725.260, 725.3.

40 C.F.R. § 725.260.

40 C.F.R. § 725.270(b).

40 C.F.R. § 725.270(b).

40 C.F.R. Part 725, Subpart D.

40 C.F.R. § 725.424. EPA is considering adding certain strains of two additional microorganisms to this general exemption (77 Fed. Reg. 54499 [Sept. 5, 2012]).

40 C.F.R. § 725.428.

40 C.F.R. § 725.450(b).

40 C.F.R. § 725.470(e).

40 C.F.R. §§ 725.300, 725.305.

EPA. Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms. June 2, 1997: pg 13. Available at www.epa.gov/biotech_rule/pubs/pdf/ptcbio.pdf (Last accessed August 2015 ).

40 C.F.R. § 725.370.

40 C.F.R. § 725.370.

7 U.S.C. § 7701 et seq.

Center for Food Safety v. Vilsack, 718 F.3d 829, 834 (9th Cir. 2013).

7 U.S.C. § 7702(14). The PPA defines “plant” as “any plant (including any plant part) for or capable of propagation, including a tree, a tissue culture, a plantlet culture, pollen, a shrub, a vine, a cutting, a graft, a scion, a bud, a bulb, a root, and a seed.” 7 U.S.C. § 7702(13). It defines “plant product” as “(A) any flower, fruit, vegetable, root, bulb, seed, or other plant part that is not included in the definition of plant; or (B) any manufactured or processed plant or plant part.” 7 U.S.C. § 7702(15).

7 C.F.R. Part 340 is entitled “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests.”

7 C.F.R. § 340.1. This regulatory definition closely tracks the definition of “plant pest” in the PPA, at 7 U.S.C. § 7702(14).

7 C.F.R. § 340.1. The corresponding “groups of organisms which are or contain plant pests” are listed at length in Section 340.2(a), subject to the exemptions identified in Section 340.2(b).

Montgomery E. Genetically Modified Plants and Regulatory Loopholes and Weaknesses Under the Plant Protection Act, 37 Vt. L. Rev 351, 366–367 (2012–2013) (Montgomery). Notification is characterized as applying typically to low-risk plants, but a critic of APHIS's implementation of the PPA cites widespread use of this pathway and points to what she views as pervasive deficiencies in the process.

See 7 C.F.R. § 340.4, addressing “permits for the introduction of a regulated article.”

7 C.F.R. § 340.6.

Venter report, pg 25.

80 Fed. Reg. 51561 (Aug. 25, 2015).

National Academy of Sciences. Industrialization of Biology: A Roadmap to Accelerate the Advanced Manufacture of Chemicals. Washington, DC: National Academies Press, 2015. Available at: www.nap.edu/catalog/19001/industrialization-of-biology-a-roadmap-to-accelerate-the-advanced-manufacturing (Last accessed August 2015 ).

Oxitec. Available at: www.oxitec.com (Last accessed August 2015 ).