TSCA Section 5(a)(3)(C) Determination for Microbial Commercial Activity Notice
(MCAN) J-22-0007

Number: J-22-0007

TSCA Section 5(a)(3) Determination: The microorganism is not likely to present an
unreasonable risk (5(a)(3)(C))

Chemical Name:

Generic: Strain of Escherichia coli modified with genetically-stable, plasmid-borne DNA for the
production of plasmid-borne DNA.

Conditions of Use (intended, known, or reasonably foreseen)1:

Intended use(s) (generic): Manufacture for use in production of DNA for use in internal

manufacturing, consistent with the manufacturing, processing, use, distribution, and
disposal information described in the MCAN.

Known conditions of use: Applying such factors as described in footnote 1, EPA evaluated

whether there are known conditions of use and found none.

Reasonably foreseen conditions of use(s): Applying such factors as described in footnote 1, EPA
evaluated whether there are reasonably foreseen conditions of use and found none.

Summary: The microorganism is not likely to present an unreasonable risk based on low human
health hazard and low environmental hazard associated with the recipient microorganism and
introduced genetic material. The recipient microorganism is not pathogenic to humans or animals
and has an extensive history of safe use. The introduced genetic modifications pose low concern
for health and environmental hazard and do not include antibiotic resistance markers.

Human Health Hazard2: Human health hazard is relevant to whether a new microorganism is
likely to present an unreasonable risk because the significance of the risk is dependent upon both

1	1 Under TSCA § 3(4), the term "conditions of use" means "the circumstances, as determined by the Administrator,
under which a chemical substance (including an intergeneric microorganism) is intended, known, or reasonably
foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." In general, EPA considers
the intended conditions of use of a new microorganism to be those identified in the section 5(a) notification. Known
conditions of use include activities within the United States that result from manufacture that is exempt from MCAN
submission requirements. Reasonably foreseen conditions of use are future circumstances, distinct from known or
intended conditions of use, under which the MCAN microorganism may be manufactured, processed, distributed,
used, or disposed of. EPA expects that the identification of "reasonably foreseen" conditions of use will be made on
a fact-specific, case-by-case basis. EPA will apply its professional judgment and experience when considering
factors such as evidence of current use of the MCAN microorganism outside the United States, information about
known or intended uses of microorganisms that are structurally analogous to the MCAN microorganism, and
conditions of use identified in an initial MCAN submission that the submitter omits in a revised MCAN. The
sources EPA uses to identify reasonably foreseen conditions of use include searches of internal confidential EPA
MCAN databases (containing use information on analogue chemicals), other U.S. government public sources, and
Internet searches.

2	A microorganism is considered to have low human health hazard if it is not known to be a frank human pathogen
that causes disease in healthy adults, and/or animal studies have demonstrated a lack of pathogenicity or toxicity; a
microorganism is considered to have high human health hazard if there is evidence of adverse effects in humans or
conclusive evidence of severe effects in animal studies. In the absence of animal data on a microorganism, EPA may
use other data or information obtained through literature searches.

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TSCA Section 5(a)(3)(C) Determination for Microbial Commercial Activity Notice
(MCAN) J-22-0007

the hazard (e.g., pathogenicity/toxicity) of the microorganism and the extent of exposure to the
microorganism. EPA estimated the human health hazard of this microorganism based on data for
the recipient strain as well as the genetic modifications. There is low concern for human health
hazard for the microorganism based on the recipient strain not being a human pathogen and
because the introduced genetic material is not expected to increase the potential for adverse
human health effects.

Environmental Hazard3: Environmental hazard is relevant to whether a new microorganism is
likely to present unreasonable risks because the significance of the risk is dependent upon both
the hazard (e.g., pathogenicity/toxicity) of the microorganism and the extent of exposure to the
microorganism. EPA estimated the environmental hazard of this microorganism based on data
for the recipient strain as well as information on the genetic modifications. There is low concern
for environmental hazard for the microorganism based on the recipient strain not being an animal
or plant pathogen and because the introduced genetic material is not expected to increase the
potential for adverse effects on animals or plants.

Exposure and Risk Characterization: The exposure to a new microorganism is potentially
relevant to whether a new microorganism is likely to present unreasonable risks because the
significance of the risk is dependent upon both the hazard (e.g., pathogenicity/toxicity) of the
microorganism and the nature and extent of exposure to the substance.

EPA considers workers to be a potentially exposed or susceptible subpopulation (PESS) on the
basis of greater exposure potential compared to the general population. EPA also considers PESS
in conducting general population drinking water exposures by evaluating risks associated with
water intake rates for multiple age groups, ranging from infants to adults. EPA considers
consumers of specific products to be a potentially exposed or susceptible subpopulation on the
basis of greater exposure potential compared to the general population who do not use specific
products.

EPA estimated occupational and environmental exposures to the new microorganism. No
consumer use was identified, so exposures to consumers were not assessed. Due to low hazard,
EPA believes that this microorganism would be not likely to present an unreasonable risk even if
exposures were high. Therefore, EPA concludes that the new microorganism is not likely to
present unreasonable risk under the conditions of use.

1/20/2022	/s/

Date:	Madison H. Le, Director

New Chemicals Division
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency

3 A microorganism is considered to be of low ecological hazard if it is not known to be an animal or plant pathogen,
and the genetic modifications do not impart pathogenic or toxigenic traits, and the introduced genetic material does
not provide a selective growth advantage in outcompeting indigenous microbial communities in the environment.

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