TSCA and the Regulation of Renewable Chemicals

Williamson MA . U.S. Biobased Products Market Potential and Projections Through 2025. Hauppage, NY: Nova Science Publishers, 2010; 1.

Lux Research, Inc. Global Bio-based Chemical Capacity Springs to Scale. 2011. www.portal.luxresearchinc.com/research/report_excerpt/9418. 2012 July .

Pub. L. No. 107–171, §9001,2 2002.

Danner H , Braun R . Biotechnology for the production of commodity chemicals from biomass. Chem Soc Rev, 1999; 28:395–405.

Pike Research. Green Chemistry: Biobased chemicals, renewable feedstocks, green polymers, less-toxic alternative chemical formulations, the foundations of a sustainable chemical industry. 2011. www.pikeresearch.com/research/green-chemistry. 2012 July .

Executive Order 13134. Developing and Promoting Biobased Products and Bioenergy. 1999. www.archives.gov/federal-register/executive-orders/1999.html#13134. 2012 July .

See id. (stating part “It is the policy of this Administration, therefore, to develop a comprehensive national strategy, including research, development, and private sector incentives, to stimulate the creation and early adoption of technologies needed to make biobased products and bioenergy cost-competitive in large national and international markets.”)

7 U.S.C. §§ 8601–8609.

United States Department of Agriculture. The Farm Security Act. 2002. www.ers.usda.gov/publications/ap-administrative-publication/ap-022.aspx. 2012 July .

Pub. L. No. 110–234, 122 Stat. 923. 2008. www.gpo.gov/fdsys/pkg/PLAW-110publ234/html/PLAW-110publ234.htm. 2012 July .

J. Pub. L. No. 109–58, 119 Stat. 594. 2005. www.gpo.gov/fdsys/pkg/PLAW-109publ58/content-detail.html. 2012 July .

Singh R . The National Bioeconomy Blueprint: Meeting grand challenges. Ind Biotech, 2012; 8,3:94–96.

42 U.S.C. § 13101.

EPA. Green Chemistry. 2012. www.epa.gov/oppt/greenchemistry. 2012 July .

EPA. Presidential Green Chemistry Challenge. 2012. www.epa.gov/oppt/greenchemistry/pubs/pgcc/presgcc.html. 2012 July .

15 U.S.C. §§ 2601–2692.

TSCA § 2(b), 15 U.S.C. § 2601(b)TSCA jurisdiction also extends to “mixtures.”

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

TSCA § 3(2)(B), 15 U.S.C. § 2602,2(B).

TSCA § 2(b), 15 U.S.C. § 2601(b).

TSCA § 2 (c), 15 U.S.C. § 2601(c).

TSCA § 8(b)(1), 15 U.S.C. § 2607(b)(1).

EPA. TSCA Inventory Representation for Chemical Substances of Unknown or Variable Composition, Complex Reaction Products and Biological Materials: UVCB Substances. www.epa.gov/oppt/newchems/pubs/uvcb.txt. 2012 July .

TSCA § 3(9), 15 U.S.C. § 2602(9); see also 40 C.F.R. §§ 710.3, 720.3(v), 720.25(a).

TSCA § 5(a)(1)(A), 15 U.S.C. § 2604(a)(1)(A). EPA's PMN regulations appear at 40 C.F.R. Part 720, and several PMN exemptions are contained in 40 C.F.R. Part 723.

There are exemptions from the requirement to submit a PMN. Exemptions are either “self-executing” or require prior EPA approval. See 40 C.F.R. §§ 723.50(a),(c).

TSCA §5(d)(1), 15 U.S.C. § 2604(d)(1).

TSCA § 5(e)(1)(A)(ii)(I), 15 U.S.C. § 2604(e)(1)(A)(ii)(I).

TSCA § 5(e)(1)(A)(ii)(I), 15 U.S.C. § 2604(e)(1)(A)(ii)(II).

EPA. Toxic Substances Control Act Inventory Representation For Certain Chemical Substances Containing Varying Carbon Chain Lengths (Alkyl Ranges Using the CX-Y Notation) www.epa.gov/oppt/newchems/pubs/alkyl-rg.txt. 2012 July .

EPA. Toxic Substances Control Act Inventory Representation For Combinations of Two or More Substances: Complex Reaction Products. www.epa.gov/oppt/newchems/pubs/rxnprods.txt. 2012 July .

40 C.F.R. § 720.45(a)(3).

40 C.F.R. § 720.30(g).

EPA. Chemistry Assistance Manual for Premanufacture Notification Submitters. www.epa.gov/opptintr/newchems/pubs/chem-pmn. 2012 July .

EPA. Instruction Manual for Reporting Under The TSCA §5 New Chemical Program at 35 (“Where EPA has available only limited information on worker exposure and environmental release, its evaluation will be based on reasonable worst case assumptions”) www.epa.gov/oppt/newchems/pubs/tscaman2.pdf. 2012 July .

Auer C , Alter J . The management of industrial chemicals in the USA. van Leeuwen CJ , Vermeire TG . Risk Assessment of Chemicals: An Introduction. New York, NY: Springer, 2007; 553–574.

EPA. Chemical Categories Report. 2010. www.epa.gov/opptintr/newchems/pubs/chemcat.htm. 2012 July .

EPA. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances64 Fed. Reg. 601941999.

TSCA § 5(e)(1)(A)(ii)(I), 15 U.S.C. § 2604(e)(1)(A)(ii)(II).

EPA. TSCA 5(e) Exposure-Based Policy: Criteria. www.epa.gov/opptintr/newchems/pubs/expbased.htm. 2012 July .

TSCA § 5(e)(1)(A), 15 U.S.C. § 2604(e)(1)(A).

TSCA § 5(e)(1)(C), 15 U.S.C. § 2604(e)(1)(C).

TSCA § 5(c), 15 U.S.C. § 2604(c).

TSCA § 5(a)(2), 15 U.S.C. § 2604(a)(2).

Burchi L , Auer C , Bergeson L . Significant New Use Rules. Bureau of National Affairs176 DEN B-1Sept. 12, 2011.

40 C.F.R. § 721.63.

Id. § 721.72.

Id. § 721.80.

Id. §§ 721.160, 721.170. See also 54 Fed. Reg. 31298 (July 27, 1989); 60 Fed. Reg. 15311 (Mar. 29, 1995).

40 C.F.R. § 721.160(b).

Id., 40 C.F.R. § 721.70(b).

Id. §§ 721.160(c), 721.170(d).

EPA. Questions and Answers for the New Chemicals Program at 1-164. epa.gov/oppt/newchems/pubs/qanda-newchems.pdf. 2012 July .

40 C.F.R. § 721.25(a).

TSCA §§ 5(e), 5(f), 6, 7, 15 U.S.C. §§ 2604(e), 2604(f), 2605, and 2606.

TSCA § 5(g), 15 U.S.C. § 2604(g).

EPA. Overview: Office of Pollution Prevention and Toxics Laws and Programs. 2008. www.epa.gov/oppt/pubs/oppt101-032008.pdf. 2012 July .

EPA. PMN Instructions Manual for Content. www.epa.gov/oppt/newchems/pubs/pmnforms.htm. 2012 July .

EPA. Amended TSCA Section 5 Enforcement Response Policy. 1989. www.epa.gov/compliance/resources/policies/civil/tsca/tscasec5erpamend-060889.pdf. 2012 July .

EPA. New Chemicals Program Policies. www.epa.gov/opptintr/newchems/pubs/policies.htm. 2012 July .

EPA. What Happens to My PMN? www.epa.gov/opptintr/newchems/pubs/pmnstatflow.htm. 2012 July .