Keller and Heckman LLP Serving Business through Law and Science. Genetically Modified Organisms and TSCA

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1 Keller and Heckman LLP Serving Business through Law and Science Genetically Modified Organisms and TSCA

2 The Technology Biotechnology s role in sustainable environment Concern: novel behaviors, in some instances, may present a risk to human health or the environment Certain uses assessed under TSCA

3 The Technology Traditional mutation techniques inefficient, difficult to target to specific traits Traits that enhance production or quality in other species can be identified and transferred through biotechnology Yield increased, greater efficiency Leads to new and improved end products

4 source: EPA (Aug. 2003)

5 Categories of Biotechnology (for regulatory purposes) Microorganisms have been employed by business, universities, and government to meet certain R&D and commercial needs for years Majority of these applications are outside TSCA s jurisdiction

6 Regulatory Categories Specifically excluded from TSCA - Foods and beverages Medical applications Pesticides

7 source: EPA (Aug. 2003) Health New Products Feed Processing Agronomic Traits Chemicals

8 TSCA Regulated Uses TSCA 3(2)(A) definition of chemical substance includes microorganisms Any organic or inorganic substance of a particular molecular identity... About 10 percent of the overall market (source: EPA Reg. Impact Anal. (1997))

9 TSCA Regulated Uses Enzyme production, other chemicals in contained fermentation systems Key monomers in polyesters Polymer-grade acrylamide EPA view - High fructose corn syrup industry created by use of these enzymes

10 Polylactic acid

11 Other TSCA Uses Treatment of biological waste Field application to enhance nitrogen fixation on crops (soybeans, alfalfa) Bioethanol, biodiesel

12 Bioethanol

13 The Third Wave source EPA (Aug. 2003)

14 TSCA Rules New, intergenetic microorganisms 40 C.F.R. Part 725; 62 Fed. Reg (April 11, 1997) commercial uses and commercial R&D some old, some new, exemptions significant new use rules (none yet) Must also establish TSCA status for Other feedstocks Reaction product (e.g., the polymer)

15 Defined terms: Microorganism Organism in the kingdoms of Monera (Procaryotae), Protista, Fungi, the Chlorophyta and Rhodophyta of the Plantae, and a virus or virus-like particles Includes bacteria Does not include cell cultures of human cells.

16 Defined terms: Intergeneric Formed by deliberately combining genetic material first isolated in a different taxonomic genus Deliberate combination of certain mobile genetic elements (DNA) Does not include well-characterized, noncoding regulatory regions from another genus If not intergeneric on the TSCA Inventory

17 Defined terms: Noncoding Region A segment of introduced genetic material for which The regulatory region and any inserted flanking nucleotides do not code for a protein, peptide, or functional ribonucleic acid molecules and The regulatory region solely control the activity of other regions Operators, promoters, terminators, etc.

18 Defined terms: Mobil genetic element An element of genetic material that has the ability to move genetic material within and between organisms, including plasmids, viruses, insertion sequences

19 Microbial Commercial Activity Notice (MCAN) 90 day review Requirements recipient and new miccroorganism Genetic construction Phenotypic and ecological characteristics (e.g., habitat, distribution, source) Byproducts Production volume, use, worker exposure Existing data Need to file NOC to place on Inventory Upfront" CBI substantiation

20 Traditional Exemptions FFDCA, FIFRA regulated uses Mixtures (components not exempt) Manufactured and processed solely for export and labeled accordingly

21 Non-commercial R&D Exempt Microorganisms manufactured, imported, or processed for noncommercial purposes, e.g., solely for academic research 40 C.F.R

22 Non-commercial R&D Exempt Commercial indicators company contracts directly with a researcher company gives a conditional grant where the company holds patent rights, or establishes a joint venture where the company has the patent or licensing rights

23 Non-commercial R&D Exempt Commercial if the researcher is not funded directly, but intends to obtain an immediate or eventual commercial advantage, e.g. developing a commercially viable improvement of a product on the market has sought or is seeking commercial funding for commercial development has sought or is seeking a patent

24 Commercial R&D Exemptions Contained structure exemption ( ) National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules ("NIH Guidelines") ( ) Outside a structure/2 strains ( ) Rhizobium meliloti Bradyrhizobium japonicum TSCA Experimental Release Application (TERA) for other releases ( )

25 TERA - 60 day review Organizations manufacturing, importing, or processing "new" microorganisms intended for use in commercial R&D in the environment Identity of organism Phenotypic and ecological characteristics Description of R&D includes # organisms released, target organisms All available data Records must be kept 3 years Report to EPA w/in 1 year

26 Exemptions for Commercial Use Beyond R&D Test Market Same as Traditional (45 day review) Contained Structure/Well- Characterized Microorganisms Tier I Tier II

27 Well-characterized The function of the genetic material has been determined. Includes - Acetobacter aceti Aspergillus niger Asplergillus oryzae Bacillus lichenformis Bacillus subtilis Clostridium acetobutylicum Escherichia coli K-12 Penicillium roqueforti, Saccharomyces cerevisiae Saccharomyces uvarum

28 Well-characterized Limited in the genetic material that can be introduced (e.g., regulatory sequence permitting the expression of solely the genes of interest) Poorly mobilizable Free of encoding sequence for polypeptides that contribute to a toxic effect (list of prohibited sequences)

29 Other Conditions Tier I No filing required... SO LONG AS containment meets EPA specifications system designed to contain organisms controlled access written, published, an implemented safety procedures inactivation procedures steps to minimize release through aerosols and exhaust, other routes emergency clean up

30 Other Conditions Tier II Day Review Affirmative request submitted to EPA If different containment is used

31 SUMMARY Not many MCAN filings so far Many activities qualify for the exemptions Non-confidential MCANs And TERAs biotech_rule/submiss.htm

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