[Code of Federal Regulations]
[Title 40, Volume 28]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR725.3]

[Page 466-469]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS
--Table of Contents
 
             Subpart A--General Provisions and Applicability
 
Sec. 725.3  Definitions.

    Definitions in section 3 of the Act (15 U.S.C. 2602), as well as 
definitions contained in Secs. 704.3, 720.3, and 721.3 of this chapter, 
apply to this part unless otherwise specified in this section. In 
addition, the following definitions apply to this part:
    Consolidated microbial commercial activity notice or consolidated 
MCAN means any MCAN submitted to EPA that covers more than one 
microorganism (each being assigned a separate MCAN number by EPA) as a 
result of a prenotice agreement with EPA.

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    Containment and/or inactivation controls means any combination of 
engineering, mechanical, procedural, or biological controls designed and 
operated to restrict environmental release of viable microorganisms from 
a structure.
    Director means the Director of the EPA Office of Pollution 
Prevention and Toxics.
    Exemption request means any application submitted to EPA under 
subparts E, F, or G of this part.
    General commercial use means use for commercial purposes other than 
research and development.
    Genome means the sum total of chromosomal and extrachromosomal 
genetic material of an isolate and any descendants derived under pure 
culture conditions from that isolate.
    Health and safety study of a microorganism or health and safety 
study means any study of any effect of a microorganism or microbial 
mixture on health or the environment or on both, including underlying 
data and epidemiological studies, studies of occupational exposure to a 
microorganism or microbial mixture, toxicological, clinical, and 
ecological, or other studies of a microorganism or microbial mixture, 
and any test performed under the Act. Microorganism identity is always 
part of a health and safety study of a microorganism.
    (1) It is intended that the term ``health and safety study of a 
microorganism'' be interpreted broadly. Not only is information which 
arises as a result of a formal, disciplined study included, but other 
information relating to the effects of a microorganism or microbial 
mixture on health or the environment is also included. Any data that 
bear on the effects of a microorganism on health or the environment 
would be included.
    (2) Examples include:
    (i) Tests for ecological or other environmental effects on 
invertebrates, fish, or other animals, and plants, including: Acute 
toxicity tests, chronic toxicity tests, critical life stage tests, 
behavioral tests, algal growth tests, seed germination tests, plant 
growth or damage tests, microbial function tests, bioconcentration or 
bioaccumulation tests, and model ecosystem (microcosm) studies.
    (ii) Long- and short-term tests of mutagenicity, carcinogenicity, or 
teratogenicity; dermatoxicity; cumulative, additive, and synergistic 
effects; and acute, subchronic, and chronic effects.
    (iii) Assessments of human and environmental exposure, including 
workplace exposure, and impacts of a particular microorganism or 
microbial mixture on the environment, including surveys, tests, and 
studies of: Survival and transport in air, water, and soil; ability to 
exchange genetic material with other microorganisms, ability to colonize 
human or animal guts, and ability to colonize plants.
    (iv) Monitoring data, when they have been aggregated and analyzed to 
measure the exposure of humans or the environment to a microorganism.
    (v) Any assessments of risk to health and the environment resulting 
from the manufacture, processing, distribution in commerce, use, or 
disposal of the microorganism.
    Inactivation means that living microorganisms are rendered 
nonviable.
    Institutional Biosafety Committee means the committees described in 
the NIH Guidelines in section IV.B.2.
    Intergeneric microorganism means a microorganism that is formed by 
the deliberate combination of genetic material originally isolated from 
organisms of different taxonomic genera.
    (1) The term ``intergeneric microorganism'' includes a microorganism 
which contains a mobile genetic element which was first identified in a 
microorganism in a genus different from the recipient microorganism.
    (2) The term ``intergeneric microorganism'' does not include a 
microorganism which contains introduced genetic material consisting of 
only well-characterized, non-coding regulatory regions from another 
genus.
    Introduced genetic material means genetic material that is added to, 
and remains as a component of, the genome of the recipient.
    Manufacture, import, or process for commercial purposes means:

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    (1) To import, produce, manufacture, or process with the purpose of 
obtaining an immediate or eventual commercial advantage for the 
manufacturer, importer, or processor, and includes, among other things, 
``manufacture'' or ``processing'' of any amount of a microorganism or 
microbial mixture:
    (i) For commercial distribution, including for test marketing.
    (ii) For use by the manufacturer, including use for product research 
and development or as an intermediate.
    (2) The term also applies to substances that are produced 
coincidentally during the manufacture, processing, use, or disposal of 
another microorganism or microbial mixture, including byproducts that 
are separated from that other microorganism or microbial mixture and 
impurities that remain in that microorganism or microbial mixture. 
Byproducts and impurities without separate commercial value are 
nonetheless produced for the purpose of obtaining a commercial 
advantage, since they are part of the manufacture or processing of a 
microorganism for commercial purposes.
    Microbial commercial activity notice or MCAN means a notice for 
microorganisms submitted to EPA pursuant to section 5(a)(1) of the Act 
in accordance with subpart D of this part.
    Microbial mixture means any combination of microorganisms or 
microorganisms and other chemical substances, if the combination does 
not occur in nature and is not an article.
    Microorganism means an organism classified, using the 5-kingdom 
classification system of Whittacker, in the kingdoms Monera (or 
Procaryotae), Protista, Fungi, and the Chlorophyta and the Rhodophyta of 
the Plantae, and a virus or virus-like particle.
    Mobile genetic element or MGE means an element of genetic material 
that has the ability to move genetic material within and between 
organisms. ``Mobile genetic elements'' include all plasmids, viruses, 
transposons, insertion sequences, and other classes of elements with 
these general properties.
    New microorganism means a microorganism not included on the 
Inventory.
    NIH Guidelines means the National Institutes of Health (NIH) 
``Guidelines for Research Involving Recombinant DNA Molecules'' (July 5, 
1994).
    Non-coding regulatory region means a segment of introduced genetic 
material for which:
    (1) The regulatory region and any inserted flanking nucleotides do 
not code for protein, peptide, or functional ribonucleic acid molecules.
    (2) The regulatory region solely controls the activity of other 
regions that code for protein or peptide molecules or act as recognition 
sites for the initiation of nucleic acid or protein synthesis.
    Small quantities solely for research and development (or ``small 
quantities solely for purposes of scientific experimentation or analysis 
or research on, or analysis of, such substance or another substance, 
including such research or analysis for development of a product'') 
means quantities of a microorganism manufactured, imported, or processed 
or proposed to be manufactured, imported, or processed solely for 
research and development that meet the requirements of Sec. 725.234.
    Structure means a building or vessel which effectively surrounds and 
encloses the microorganism and includes features designed to restrict 
the microorganism from leaving.
    Submission means any MCAN or exemption request submitted to EPA 
under this part.
    Technically qualified individual means a person or persons:
    (1) Who, because of education, training, or experience, or a 
combination of these factors, is capable of understanding the health and 
environmental risks associated with the microorganism which is used 
under his or her supervision,
    (2) Who is responsible for enforcing appropriate methods of 
conducting scientific experimentation, analysis, or microbiological 
research to minimize such risks, and
    (3) Who is responsible for the safety assessments and clearances 
related to the procurement, storage, use, and disposal of the 
microorganism as may be appropriate or required within the scope of 
conducting a research and development activity.
    TSCA Experimental Release Application or TERA means an exemption 
request

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for a research and development activity, which is not eligible for a 
full exemption from reporting under Sec. 725.232, 725.234, or 725.238, 
submitted to EPA in accordance with subpart E of this part.
    Well-characterized for introduced genetic material means that the 
following have been determined:
    (1) The function of all of the products expressed from the 
structural gene(s).
    (2) The function of sequences that participate in the regulation of 
expression of the structural gene(s).
    (3) The presence or absence of associated nucleotide sequences and 
their associated functions, where associated nucleotide sequences are 
those sequences needed to move genetic material including linkers, 
homopolymers, adaptors, transposons, insertion sequences, and 
restriction enzyme sites.