Tuesday, April 15, 2014

Are cyanobacteria deemed microorganisms under TSCA?

from within -- Finding Promise in Pond Scum: Algal Biofuels, Regulation, and the Potential for Environmental Problems --, 42 Tex. Envtl. L.J. 59 (2011) :

EPA has extended TSCA oversight to commercial and research activities involving microorganisms by defining "chemical substance" broadly to include microorganisms. n116 However, TSCA pre-manufacture reporting requirements only apply to a "new microorganism," which is further limited to an "intergeneric microorganism." n117 In other words, the requirements apply only to "a microorganism that is formed by the deliberate combination of genetic material originally isolated from organisms of different taxonomic genera." n118 Under TSCA, the term "microorganism" encompasses red and green algae (i.e., microalgae and macroalgae, although notably not cyanobacteria). n119 Under this formulation, microorganisms that are not intergeneric - including naturally occurring and classically mutated or selected microbes, as well as genetically modified microbes whose genetic material originates in a single genus - are not considered to be new and are exempt from TSCA's reporting requirements. n120 To clarify: only those micro-and macroalgal species that have been purposefully cross- [*72] bred or genetically modified to include genes from more than one genera fall under TSCA.


Kudzu is known as "the plant that ate the South" because it has so rapidly taken over the southern U.S. n175 Estimated losses and control efforts due to invasive plants cost roughly $ 34 billion annually. n176 NISC has expressed concern that "a number of potentially harmful non-native algal species are being considered for use in the production of biodiesel, renewable biodiesel, and jet fuel (e.g. the toxic freshwater cyanobacteria, Anabaena circinalis)." n177 The theory is that, because these algae strains are bred to self-replicate and have no natural adversary in the area, once released into the environment they would be very hardy and could outcompete and displace native species, eventually overpopulating and reducing biodiversity. n178 Indeed, the very traits that maximize biofuel crop yield and foster the ability for biofuels to be cultivated in marginal environments, including perennial growth patterns and tolerance to salinity, increase the risk of invasiveness. n179

Some footnotes

n119. Id.; see Microbial Products of Biotechnology, 62 Fed. Reg. at 17,926.

n120. See Microbial Products of Biotechnology: Summary of Regulations under the Toxic Substances Control Act, Envtl. Prot. Agency, http://www.epa.gov/biotech_rule/pubs/pdf/fs-002.pdf (last visited Sept. 26, 2011).

n121. 40 C.F.R. §§725.3, 725.234 (2010).

n122. Premanufacture Notification, 48 Fed. Reg. 21,722, 21,722-24 (May 13, 1983); see Rodgers, supra note 113, at § 6:5(B)(1) (demonstrating that, historically, EPA takes no action on about 85% of premanufacture notices and grants post-notice exemptions from regulation to about 88% of applicants, allowing commercial production to proceed in both cases).

n123. Plant Protection Act, 7 U.S.C.§§7701-7758 (2010).

n124. 7 C.F.R. § 340.2 (2010).

n125. Regulations Affecting the Use of Genetically Modified Algae for Biofuel Production, D. Glass Assoc., Inc., (June 09, 2010, 7:55 PM), http://dglassassociates.wordpress.com/2010/06/09/regulations-affecting-the-use-of-genetically-modified-algae-for-biofuel- production-2.


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