**Attachment F**

**40 CFR Part 725**

40 CFR Protection of Environment

CHAPTER I

ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

SUBCHAPTER R ‑‑ TOXIC SUBSTANCES CONTROL ACT

PART 725 ‑‑ REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR

MICROORGANISMS

Subpart A ‑‑ General Provisions and Applicability

Sec.

725.1 Scope and purpose.

725.3 Definitions.

725.8 Coverage of this part.

725.12 Identification of microorganisms for Inventory and other listing
purposes.

725.15 Determining applicability when microorganism identity or use is
confidential or uncertain.

725.17 Consultation with EPA.

Subpart B ‑‑ Administrative Procedures

725.20 Scope and purpose.

725.25 General administrative requirements.

725.27 Submissions.

725.28 Notice that submission is not required.

725.29 EPA acknowledgement of receipt of submission.

725.32 Errors in the submission.

725.33 Incomplete submissions.

725.36 New information.

725.40 Notice in the FEDERAL REGISTER.

725.50 EPA review.

725.54 Suspension of the review period.

725.56 Extension of the review period.

725.60 Withdrawal of submission by the submitter.

725.65 Recordkeeping.

725.67 Applications to exempt new microorganisms from this part.

725.70 Compliance.

725.75 Inspections.

Subpart C ‑‑ Confidentiality and Public Access to Information

725.80 General provisions for confidentiality claims.

725.85 Microorganism identity.

725.88 Uses of a microorganism.

725.92 Data from health and safety studies of microorganisms.

725.94 Substantiation requirements.

725.95 Public file.

Subpart D ‑‑ Microbial Commercial Activities Notification Requirements

725.100 Scope and purpose.

725.105 Persons who must report.

725.110 Persons not subject to this subpart.

725.150 Procedural requirements for this subpart.

725.155 Information to be included in the MCAN.

725.160 Submission of health and environmental effects data.

725.170 EPA review of the MCAN.

725.190 Notice of commencement of manufacture or import.

Subpart E ‑‑ Exemptions for Research and Development Activities

725.200 Scope and purpose.

725.205 Persons who may report under this subpart.

725.232 Activities subject to the jurisdiction of other Federal programs
or agencies.

725.234 Activities conducted inside a structure.

725.235 Conditions of exemption for activities conducted inside a
structure.

725.238 Activities conducted outside a structure.

725.239 Use of specific microorganisms in activities conducted outside a
structure.

725.250 Procedural requirements for the TERA.

725.255 Information to be included in the TERA.

725.260 Submission of health and environmental effects data.

725.270 EPA review of the TERA.

725.288 Revocation or modification of TERA approval.

Subpart F ‑‑ Exemptions for Test Marketing

725.300 Scope and purpose.

725.305 Persons who may apply under this subpart.

725.350 Procedural requirements for this subpart.

725.355 Information to be included in the TME application.

725.370 EPA review of the TME application.

Subpart G ‑‑ General Exemptions for New Microorganisms

725.400 Scope and purpose.

725.420 Recipient microorganisms.

725.421 Introduced genetic material.

725.422 Physical containment and control technologies.

725.424 Requirements for the Tier I exemption.

725.426 Applicability of the Tier I exemption.

725.428 Requirements for the Tier II exemption.

725.450 Procedural requirements for the Tier II exemption.

725.455 Information to be included in the Tier II exemption request.

725.470 EPA review of the Tier II exemption request.

Subparts H‑K \[Reserved\]

Subpart L ‑‑ Additional Procedures for Reporting on Significant New Uses
of Microorganisms

725.900 Scope and purpose.

725.910 Persons excluded from reporting significant new uses.

725.912 Exemptions.

725.920 Exports and imports.

725.950 Additional recordkeeping requirements.

725.975 EPA approval of alternative control measures.

725.980 Expedited procedures for issuing significant new use rules for
microorganisms subject to section 5(e) orders.

725.984 Modification or revocation of certain notification requirements.

Subpart M ‑‑ Significant New Uses for Specific Microorganisms

725.1000 Scope.

725.1075 Burkholderia cepacia complex.

Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.

Source: 62 FR 17932, April 11, 1997, unless otherwise noted.

Subpart A ‑‑ General Provisions and Applicability

\'725.1 Scope and purpose.

\(a\) This part establishes all reporting requirements under section 5
of TSCA for manufacturers, importers, and processors of microorganisms
subject to TSCA jurisdiction for commercial purposes, including research
and development for commercial purposes. New microorganisms for which
manufacturers and importers are required to report under section
5(a)(1)(A) of TSCA are those that are intergeneric. In addition, under
section 5(a)(1)(B) of TSCA, manufacturers, importers, and processors may
be required to report for any microorganism that EPA determines by rule
is being manufactured, imported, or processed for a significant new use.

\(b\) Any manufacturer, importer, or processor required to report under
section 5 of TSCA (see \'725.100 for new microorganisms and \'725.900
for significant new uses) must file a Microbial Commercial Activity
Notice (MCAN) with EPA, unless the activity is eligible for a specific
exemption as described in this part. The general procedures for filing
MCANs are described in subpart D of this part. The exemptions from the
requirement to file a MCAN are for certain kinds of contained activities
(see \'\'725.424 and 725.428), test marketing activities (see
\'725.300), and

research and development activities described in paragraph (c) of this
section.

\(c\) Any manufacturer, importer, or processor required to file a MCAN
for research and development (R&D) activities may instead file a TSCA
Experimental Release Application (TERA) for a specific test (see
\'725.250). A TERA is not required for certain R&D activities; however a
TERA exemption does not extend beyond the research and development
stage, to general commercial use of the microorganism, for which
compliance with MCAN

requirements is required. The TERA exemptions are for R&D activities
subject to other Federal agencies or programs (see \'725.232), certain
kinds of contained R&D activities (see \'725.234), and R&D activities
using certain listed microorganisms (see \'725.238).

\(d\) New microorganisms will be added to the Inventory established
under section 8 of TSCA once a MCAN has been received, the MCAN review
period has expired, and EPA receives a Notice of Commencement (NOC)
indicating that manufacture or importation has actually begun. New
microorganisms approved for use under a TERA will not be added to the
Inventory until a MCAN has been received, the MCAN review period has
expired, and EPA has received an NOC.

\'725.3 Definitions.

Definitions in section 3 of the Act (15 U.S.C. 2602), as well as
definitions contained in \'\'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.

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:

\(1\) 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, im-ported, or processed solely for
research and development that meet the requirements of \'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
for a research and development activity, which is not eligible for a
full exemption from reporting under \'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.

\'725.8 Coverage of this part.

\(a\) Microorganisms subject to this part. Only microorganisms which are
manufactured, imported, or processed for commercial purposes, as defined
in \'725.3, are subject to the requirements of this part.

\(b\) Microorganisms automatically included on the Inventory.
Microorganisms that are not intergeneric are automatically included on
the Inventory.

\(c\) Microorganisms not subject to this part. The following
microorganisms are not subject to this part, either because they are not
subject to jurisdiction under the Act or are not subject to reporting
under section 5 of the Act.

\(1\) Any microorganism which would be excluded from the definition of
\"chemical substance\" in section 3 of the Act and \'720.3(e) of this
chapter.

\(2\) Any microbial mixture as defined in \'725.3. This exclusion
applies only to a microbial mixture as a whole and not to any
microorganisms and other chemical substances which are part of the
microbial mixture.

\(3\) Any microorganism that is manufactured and processed solely for
export if the following conditions are met:

\(i\) The microorganism is labeled in accordance with section
12(a)(1)(B) of the Act, when the microorganism is distributed in
commerce.

\(ii\) The manufacturer and processor can document at the commencement
of manufacturing or processing that the person to whom the microorganism
will be distributed intends to export it or process it solely for export
as defined in \'721.3 of this chapter.

\'725.12 Identification of microorganisms for Inventory and other
listing purposes.

To identify and list microorganisms on the Inventory, both taxonomic
designations and supplemental information will be used. The supplemental
information required in paragraph (b) of this section will be used to
specifically describe an individual microorganism on the Inventory.
Submitters must provide the supplemental information required by
paragraph (b) of this section to the extent necessary to enable a
microorganism to be accurately and unambiguously identified on the
Inventory.

\(a\) Taxonomic designation. The taxonomic designation of a
microorganism must be provided for the donor organism and the recipient
microorganism to the level of strain, as appropriate. These designations
must be substantiated by a letter from a culture collection, literature
references, or the results of tests conducted for the purpose of
taxonomic classification. Upon EPA\'s request to the submitter, data
supporting the taxonomic designation must be provided to EPA. The
genetic history of the recipient microorganism should be documented back
to the isolate from which it was derived.

\(b\) Supplemental information. The supplemental information described
in paragraphs (b)(1) and (b)(2) of this section is required to the
extent that it enables a microorganism to be accurately and
unambiguously identified.

\(1\) Phenotypic information. Phenotypic information means pertinent
traits that result from the interaction of a microorganism\'s genotype
and the environment in which it is intended to be used and may include
intentionally added biochemical and physiological traits.

\(2\) Genotypic information. Genotypic information means the pertinent
and distinguishing genotypic characteristics of a microorganism, such as
the identity of the introduced genetic material and the methods used to
construct the reported microorganism. This also may include information
on the vector construct, the cellular location, and the number of copies
of the introduced genetic material.

\'725.15 Determining applicability when microorganism identity or use is
confidential or uncertain.

\(a\) Consulting EPA. Persons intending to conduct activities involving
microorganisms may determine their obligations under this part by
consulting the Inventory or the microorganisms and uses specified in
\'725.239 or in subpart M of this part. This section establishes
procedures for EPA to assist persons in determining whether the
microorganism or the use is listed on the Inventory, in \'725.239 or in
subpart M of this part.

\(1\) Confidential identity or use. In some cases it may not be possible
to directly determine if a specific microorganism is listed, because
portions of that entry may contain generic information to protect
confidential business information (CBI). If any portion of the
microorganism\'s identity or use has been claimed as CBI, that portion
does not appear on the public version of the Inventory, in \'725.239 or
in subpart M of this part. Instead, it is contained in a confidential

version held in EPA\'s Confidential Business Information Center (CBIC).
The public versions contain generic information which masks the
confidential business information. A person who intends to conduct an
activity involving a microorganism or use whose entry is described with
generic information will need to inquire of EPA whether the unreported
microorganism or use is on the confidential version.

\(2\) Uncertain microorganism identity. The current state of scientific
knowledge leads to some imprecision in describing a microorganism. As
the state of knowledge increases, EPA will be developing policies to
determine whether one microorganism is equivalent to another. Persons
intending to conduct activities involving microorganisms may inquire of
EPA whether the microorganisms they intend to manufacture, import, or
process are equivalent to specific

microorganisms described on the Inventory, in \'725.239, or in subpart M
of this part.

\(b\) Requirement of bona fide intent. (1) EPA will answer the inquiries
described in paragraph (a) of this section only if the Agency determines
that the person has a bona fide intent to conduct the activity for which
reporting is required or for which any exemption may apply.

\(2\) To establish a bona fide intent to manufacture, import, or process
a microorganism, the person who intends to manufacture, import, or
process the microorganism must submit the following information in
writing to the Office of Pollution Prevention and Toxics, Document
Control Officer, 7407, 1200 Pennsylvania Ave., NW., Washington, DC
20460, ATTN: BIOTECH bona fide submission.

\(i\) Taxonomic designations and supplemental information required by
\'725.12.

\(ii\) A signed statement certifying that the submitter intends to
manufacture, import, or process the microorganism for commercial
purposes.

\(iii\) A description of research and development activities conducted
with the microorganism to date, demonstration of the submitter\'s
ability to produce or obtain the microorganism from a foreign
manufacturer, and the purpose for which the person will manufacture,
import, or process the microorganism.

\(iv\) An indication of whether a related microorganism was previously
reviewed by EPA to the extent known by the submitter.

\(v\) A specific description of the major intended application or use of
the microorganism.

\(c\) If an importer or processor cannot provide all the information
required by paragraph (b) of this section, because it is claimed as
confidential business information by its foreign manufacturer or
supplier, the foreign manufacturer or supplier may supply the
information directly to EPA.

\(d\) EPA will review the information submitted by the manufacturer,
importer, or processor under this paragraph to determine whether that
person has shown a bona fide intent to manufacture, import, or process
the microorganism. If necessary, EPA will compare this information to
the information requested for the confidential microorganism under
\'725.85(b)(3)(iii).

\(e\) In order for EPA to make a conclusive determination of the
microorganism\'s status, the proposed manufacturer, importer, or
processor must show a bona fide intent to manufacture, import, or
process the microorganism and must provide sufficient information to
establish identity unambiguously. After sufficient information has been
provided, EPA will inform the manufacturer, importer, or processor
whether the microorganism is subject to this part and if so, which
sections of this part apply.

\(f\) If the microorganism is found on the confidential version of the
Inventory, in \'725.239 or in subpart M of this part, EPA will notify
the person(s) who originally reported the microorganism that another
person (whose identity will remain confidential, if so requested) has
demonstrated a bona fide intent to manufacture, import, or process the
microorganism and therefore was told that the microorganism is on the
Inventory, in \'725.239, or in subpart M of this part.

\(g\) A disclosure to a person with a bona fide intent to manufacture,
import, or process a particular microorganism that the microorganism is
on the Inventory, in \'725.239, or in subpart M of this part will not be
considered a public disclosure of confidential business information
under section 14 of the Act.

\(h\) EPA will answer an inquiry on whether a particular microorganism
is subject to this part within 30 days after receipt of a complete
submission under paragraph (b) of this section.

\'725.17 Consultation with EPA.

Persons may consult with EPA, either in writing or by telephone, about
their obligations under this part. Written consultation is preferred.
Written inquiries should be sent to the following address: Environmental
Assistance Division (7408), Office of Pollution Prevention and Toxics,
U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460, ATTN: Biotechnology Notice Consultation. Persons
wishing to consult with EPA by

telephone should call (202) 554‑1404; hearing impaired TDD (202)
554‑0551 or e‑mail:

TSCA‑Hotline@epamail.epa.gov.

Subpart B ‑‑ Administrative Procedures

\'725.20 Scope and purpose.

This subpart describes general administrative procedures applicable to
all persons who submit MCANs and exemption requests to EPA under section
5 of the Act for microorganisms.

\'725.25 General administrative requirements.

\(a\) General. (1) Each person who is subject to the notification
provisions of this part must complete, sign, and submit a MCAN or
exemption request containing the information as required for the
appropriate submission under this part. Except as otherwise provided,
each submission must include all referenced attachments. All information
in the submission (unless certain attachments appear in the open
scientific literature) must be in English. All information

submitted must be true and correct.

\(2\) In addition to specific information required, the submitter should
submit all information known to or reasonably ascertainable by the
submitter that would permit EPA to make a reasoned evaluation of the
human health and environmental effects of the microorganism and any
microbial mixture or article that may contain the microorganism.

\(b\) Certification. Persons submitting MCANs and exemption requests to
EPA under this part, and material related to their reporting obligations
under this part, must attach the following statement to any information
submitted to EPA. This statement must be signed and dated by an
authorized official of the submitter:

I certify that to the best of my knowledge and belief: The company named
in this submission intends to manufacture, import, or process for a
commercial purpose, other than in small quantities solely for research
and development, the microorganism identified in this submission. All
information provided in this submission is complete and truthful as of
the date of submission. I am including with this submission all test
data in my possession or control and a description of all other data
known to or reasonably ascertainable by me as required by 40 CFR 725.160
or 725.260.

\(c\) Where to submit information under this part. Persons submitting
MCANs and exemption requests to EPA under this part, and material
related to their reporting obligations under this part, must send them
to: TSCA Document Processing Center (7407), Rm. L‑100, Office of
Pollution Prevention and Toxics, U.S. Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460.

\(d\) General requirements for submission of data. (1) Submissions under
this part must include the information described in \'725.155, 725.255,
725.355, or 725.455, as appropriate, to the extent such information is
known to or reasonably ascertainable by the submitter.

\(2\) In accordance with \'725.160 or 725.260, as appropriate, the
submission must also include any test data in the submitter\'s
possession or control and descriptions of other data which are known to
or reasonably ascertainable by the submitter and which concern the
health and environmental effects of the microorganism.

\(e\) Agency or joint submissions. (1) A manufacturer or importer may
designate an agent to submit the MCAN or exemption request. Both the
manufacturer or importer and the agent must sign the certification
required in paragraph (b) of this section.

\(2\) A manufacturer or importer may authorize another person (e.g., a
foreign manufacturer or supplier, or a toll manufacturer) to report some
of the information required in the MCAN or exemption request to EPA on
its behalf. If separate portions of a joint submission are not submitted
together, the submitter must indicate which information will be supplied
by another person and identify that person. The manufacturer or importer
and any other person supplying

the information must sign the certification required by paragraph (b) of
this section.

\(3\) If EPA receives a submission which does not include the
information required, which the submitter indicates that it has
authorized another person to provide, the review period will not begin
until EPA receives all of the required information.

\(f\) Microorganisms subject to a section 4 test rule. (1) Except as
provided in paragraph (f)(3) of this section, if a person intends to
manufacture or import a new microorganism which is subject to the
notification requirements of this part, and the microorganism is subject
to a test rule promulgated under section 4 of the Act before the notice
is submitted, section 5(b)(1) of the Act requires the person to submit
the test data required by the testing rule with the notice. The person
must submit the data in the form and manner specified in the test rule
and in accordance with

\'725.160. If the person does not submit the test data, the submission
is incomplete and EPA will follow the procedures in \'725.33.

\(2\) If EPA has granted the submitter an exemption under section 4(c)
of the Act from the requirement to conduct tests and submit data, the
person may not file a MCAN or TERA until EPA receives the test data.

\(3\) If EPA has granted the submitter an exemption under section 4(c)
of the Act and if another person previously has submitted the test data
to EPA, the exempted person may either submit the test data or provide
the following information as part of the notice:

\(i\) The name, title, and address of the person who submitted the test
data to EPA.

\(ii\) The date the test data were submitted to EPA.

\(iii\) A citation for the test rule.

\(iv\) A description of the exemption and a reference identifying it.

\(g\) Microorganisms subject to a section 5(b)(4) rule. (1) If a person:

\(i\) Intends to manufacture or import a microorganism which is subject
to the notification requirements of this part and which is subject to a
rule issued under section 5(b)(4) of the Act; and

\(ii\) Is not required by a rule issued under section 4 of the Act to
submit test data for the microorganism before the filing of a
submission, the person must submit to EPA data described in paragraph
(g)(2) of this section at the time the submission is filed.

\(2\) Data submitted under paragraph (g)(1) of this section must be data
which the person submitting the notice believes show that the
manufacture, processing, distribution in commerce, use, and disposal of
the microorganism, or any combination of such activities, will not
present an unreasonable risk of injury to health or the environment.

\(h\) Data that need not be submitted. Specific data requirements are
listed in subparts D, E, F, G, and L of this part. The following is a
list of data that need not be submitted under this part:

\(1\) Data previously submitted to EPA. (i) A person need not submit any
data previously submitted to EPA with no claims of confidentiality if
the new submission includes: the office or person to whom the data were
submitted; the date of submission; and, if appropriate, a standard
literature citation as specified in \'725.160(a)(3)(ii).

\(ii\) For data previously submitted to EPA with a claim of
confidentiality, the person must resubmit the data with the new
submission and any claim of confidentiality, under \'725.80.

\(2\) Efficacy data. This part does not require submission of any data
related solely to product efficacy. However, including efficacy data
will improve EPA\'s ability to assess the benefits of the use of the
microorganism. This does not exempt a person from submitting any of the
data specified in \'725.160 or 725.260.

\(3\) Non‑U.S. exposure data. This part does not require submission of
any data which relates only to exposure of humans or the environment
outside the United States. This does not exclude nonexposure data such
as data on health effects (including epidemiological studies),
ecological effects, physical and chemical properties, or environmental
fate characteristics.

\'725.27 Submissions.

Each person who is required to submit information under this part must
submit the information in the form and manner set forth in the
appropriate subpart.

\(a\) Requirements specific to MCANs are described in \'\'725.150
through 725.160.

\(b\) Requirements specific to TERAs are described in \'\'725.250
through 725.260.

\(c\) Requirements specific to test marketing exemptions (TMEs) are
described in \'\'725.350 and 725.355.

\(d\) Requirements specific to Tier I and Tier II exemptions for certain
general commercial uses are described in \'\'725.424 through 725.470.

\(e\) Additional requirements specific to significant new uses for
microorganisms are described at \'725.950.

\'725.28 Notice that submission is not required.

When EPA receives a MCAN or exemption request, EPA will review it to
determine whether the microorganism is subject to the requirements of
this part. If EPA determines that the microorganism is not subject to
these requirements, EPA will notify the submitter that section 5 of the
Act does not prevent the manufacture, import, or processing of the
microorganism and that the submission is not needed.

\'725.29 EPA acknowledgement of receipt of submission.

\(a\) EPA will acknowledge receipt of each submission by sending the
submitter a letter that identifies the number assigned to each MCAN or
exemption request and the date on which the review period begins. The
review period will begin on the date the MCAN or exemption request is
received by the Office of Pollution Prevention and Toxics Document
Control Officer.

\(b\) The acknowledgement does not constitute a finding by EPA that the
submission is in compliance with this part.

\'725.32 Errors in the submission.

\(a\) Within 30 days of receipt of the submission, EPA may request that
the submitter remedy errors in the submission. The following are
examples of such errors:

\(1\) Failure to date the submission.

\(2\) Typographical errors that cause data to be misleading or answers
to any questions to be unclear.

\(3\) Contradictory information.

\(4\) Ambiguous statements or information.

\(b\) In the request to correct the submission, EPA will explain the
action which the submitter must take to correct the submission.

\(c\) If the submitter fails to correct the submission within 15 days of
receipt of the request, EPA may extend the review period.

\'725.33 Incomplete submissions.

\(a\) A submission under this part is not complete, and the review
period does not begin, if:

\(1\) The wrong person files the submission.

\(2\) The submitter does not attach and sign the certification statement
as required by \'725.25(b).

\(3\) Some or all of the information in the submission or any
attachments are not in English, except for published scientific
literature.

\(4\) The submitter does not provide information that is required by
sections 5(d)(1)(B) and (C) of the Act and \'725.160 or 725.260, as
appropriate.

\(5\) The submitter does not provide information required by \'725.25,
725.155, 725.255, 725.355, or 725.455, as appropriate, or indicate that
it is not known to or reasonably ascertainable by the submitter.

\(6\) The submitter has asserted confidentiality claims and has failed
to:

\(i\) Submit a second copy of the submission with all confidential
information deleted for the public file, as required by \'725.80(b)(2).

\(ii\) Comply with the substantiation requirements as described in
\'725.94.

\(7\) The submitter does not include any information required by section
5(b)(1) of the Act and pursuant to a rule promulgated under section 4 of
the Act, as required by \'725.25(f).

\(8\) The submitter does not submit data which the submitter believes
show that the microorganism will not present an unreasonable risk of
injury to health or the environment, if EPA has listed the microorganism
under section 5(b)(4) of the Act, as required in \'725.25(g).

\(9\) For MCANs, the submitter does not remit the fees required by
\'700.45(b)(1) or (b)(2)(vi) of this chapter.

(b)(1) If EPA receives an incomplete submission under this part, the
Director, or a designee, will notify the submitter within 30 days of
receipt that the submission is incomplete and that the review period
will not begin until EPA receives a complete submission.

\(2\) If EPA obtains additional information during the review period for
any submission that indicates the original submission was incomplete,
the Director, or a designee, may declare the submission incomplete
within 30 days after EPA obtains the additional information and so
notify the submitter.

\(c\) The notification that a submission is incomplete under paragraph
(b) of this section will include:

\(1\) A statement of the basis of EPA\'s determination that the
submission is incomplete.

\(2\) The requirements for correcting the incomplete submission.

\(3\) Information on procedures under paragraph (d) of this section for
filing objections to the determination or requesting modification of the
requirements for completing the submission.

\(d\) Within 10 days after receipt of notification by EPA that a
submission is incomplete, the submitter may file written objections
requesting that EPA accept the submission as complete or modify the
requirements necessary to complete the submission.

(e)(1) EPA will consider the objections filed by the submitter. The
Director, or a designee, will determine whether the submission was
complete or incomplete, or whether to modify the requirements for
completing the submission. EPA will notify the submitter in writing of
EPA\'s response within 10 days of receiving the objections.

\(2\) If the Director, or a designee, determines, in response to the
objection, that the submission was complete, the review period will be
deemed suspended on the date EPA declared the submission incomplete, and
will resume on the date that the submission is declared complete. The
submitter need not correct the submission as EPA originally requested.
If EPA can complete its review within the review period beginning on the
date of the submission, the Director, or a designee, may inform the
submitter that the running of the review period will resume on the date
EPA originally declared it incomplete.

\(3\) If the Director, or a designee, modifies the requirements for
completing the submission or concurs with EPA\'s original determination,
the review period will begin when EPA receives a complete submission.

\(f\) If EPA discovers at any time that a person submitted materially
false or misleading statements in information submitted under this part,
EPA may find that the submission was incomplete from the date it was
submitted, and take any other appropriate action.

\'725.36 New information.

\(a\) During the review period, if a submitter possesses, controls, or
knows of new information that materially adds to, changes, or otherwise
makes significantly more complete the information included in the MCAN
or exemption request, the submitter must send that information to the
address listed in \'725.25(c) within 10 days of receiving the new
information, but no later than 5 days before the end of the review
period.

\(b\) The new submission must clearly identify the submitter, the MCAN
or exemption request to which the new information is related, and the
number assigned to that submission by EPA, if known to the submitter.

\(c\) If the new information becomes available during the last 5 days of
the review period, the submitter must immediately inform the EPA contact
for that submission by telephone of the new information.

\'725.40 Notice in the Federal Register.

\(a\) Filing of FEDERAL REGISTER notice. After EPA receives a MCAN or an
exemption request under this part, EPA will issue a notice in the
FEDERAL REGISTER including the information specified in paragraph (b) of
this section.

\(b\) Contents of notice. (1) In the public interest, the specific
microorganism identity listed in the submission will be published in the
FEDERAL REGISTER unless the submitter has claimed the microorganism
identity confidential. If the submitter claims confidentiality, a
generic name will be published in accordance with \'725.85.

\(2\) The categories of use of the microorganism will be published as
reported in the submission unless this information is claimed
confidential. If confidentiality is claimed, the generic information
which is submitted under \'725.88 will be published.

\(3\) A list of information submitted in accordance with \'725.160(a),
725.255, 725.260, 725.355, or 725.455, as appropriate, will be
published.

\(4\) The submitter\'s identity will be published, unless the submitter
has claimed it confidential.

\(c\) Publication of exemption decisions. Following the expiration of
the appropriate review period for the exemption request, EPA will issue
a notice in the FEDERAL REGISTER indicating whether the request has been
approved or denied and the reasons for the decision.

\'725.50 EPA review.

\(a\) MCANs. The review period specified in section 5(a) of the Act for
MCANs runs for 90 days from the date the Document Control Officer
receives a complete submission, or the date EPA determines the
submission is complete under \'725.33, unless the Agency extends the
review period under section 5(c) of the Act and \'725.56.

\(b\) Exemption requests. The review period starts on the date the
Document Control Officer receives a complete exemption request, or the
date EPA determines the request is complete under \'725.33, unless the
Agency extends the review period under \'725.56. The review periods for
exemption requests run as follows:

\(1\) TERAs. The review period for TERAs is 60 days.

\(2\) TMEs. The review period for TMEs is 45 days.

\(3\) Tier II exemption requests. The review period for Tier II
exemption requests is 45 days.

\'725.54 Suspension of the review period.

\(a\) A submitter may voluntarily suspend the running of the review
period if the Director, or a designee, agrees. If the Director does not
agree, the review period will continue to run, and EPA will notify the
submitter. A submitter may request a suspension at any time during the
review period. The suspension must be for a specified period of time.

\(b\) A request for suspension may be made in writing to the address
listed in \'725.25(c). The suspension also may be made orally, including
by telephone, to the submitter\'s EPA contact for that submission. EPA
will send the submitter a written confirmation that the suspension has
been granted.

\(1\) An oral request may be granted for no longer than 15 days. To
obtain a longer suspension, the Document Control Officer for the Office
of Pollution Prevention and Toxics must receive written confirmation of
the oral request. The review period is suspended as of the date of the
oral request.

\(2\) If the submitter has not made a previous oral request, the running
of the review period is suspended as of the date of receipt of the
written request by the Document Control Officer for the Office of
Pollution Prevention and Toxics.

\'725.56 Extension of the review period.

\(a\) At any time during the review period, EPA may unilaterally
determine that good cause exists to extend the review period specified
for MCANs, or the exemption requests.

\(b\) If EPA makes such a determination, EPA:

\(1\) Will notify the submitter that EPA is extending the review period
for a specified length of time and state the reasons for the extension.

\(2\) For MCANs, EPA may issue a notice for publication in the FEDERAL
REGISTER which states that EPA is extending the review period and gives
the reasons for the extension.

\(c\) The total period of the extension may be for a period of up to the
same length of time as specified for each type of submission in
\'725.50. If the initial extension is for less than the total time
allowed, EPA may make additional extensions. However, the sum of the
extensions may not exceed the total allowed.

\(d\) The following are examples of situations in which EPA may find
that good cause exists for extending the review period:

\(1\) EPA has reviewed the submission and is seeking additional
information.

\(2\) EPA has received significant additional information during the
review period.

\(3\) The submitter has failed to correct a submission after receiving
EPA\'s request under \'725.32.

\(4\) EPA has reviewed the submission and determined that there is a
significant possibility that the microorganism will be regulated under
section 5(e) or section 5(f) of the Act, but EPA is unable to initiate
regulatory action within the initial review period.

\'725.60 Withdrawal of submission by the submitter.

\(a\) A submitter may withdraw a submission during the review period. A
statement of withdrawal must be made in writing to the address listed in
\'725.25(c). The withdrawal is effective upon receipt of the statement
by the Document Control Officer.

\(b\) If a manufacturer, importer, or processor who withdrew a
submission later resubmits a submission for the same microorganism, a
new review period begins.

\'725.65 Recordkeeping.

\(a\) General provisions. (1) Any person who submits a notice under this
part must retain documentation of information in the submission,
including:

\(i\) Any data in the submitter\'s possession or control; and

\(ii\) Records of production volume for the first 3 years of
manufacture, import, or processing.

\(2\) Any person who submits a notice under this part must retain
documentation of the date of commencement of testing, manufacture,
import, or processing.

\(3\) Any person who is exempt from some or all of the reporting
requirements of this part must retain documentation that supports the
exemption.

\(4\) All information required by this section must be retained for 3
years from the date of commencement of each activity for which records
are required under this part.

\(b\) Specific requirements. In addition to the requirements of
paragraph (a) of this section, specific recordkeeping requirements
included in certain subparts must also be followed.

\(1\) Additional recordkeeping requirements for activities conducted
inside a structure are set forth in \'725.235(h).

\(2\) Additional recordkeeping requirements for TERAs are set forth in
\'725.250(f).

\(3\) Additional recordkeeping requirements for TMEs are set forth in
\'725.350(c).

\(4\) Additional recordkeeping requirements for Tier I exemptions under
subpart G of this part are set forth in \'725.424(a)(5).

\(5\) Additional recordkeeping requirements for Tier II exemptions under
subpart G of this part are set forth in \'725.450(d).

\(6\) Additional recordkeeping requirements for significant new uses of
microorganisms reported under subpart L of this part are set forth in
\'725.850. Recordkeeping requirements may also be included when a
microorganism and significant new use are added to subpart M of this
part.

\'725.67 Applications to exempt new microorganisms from this part.

\(a\) Submission. (1) Any manufacturer or importer of a new
microorganism may request, under section 5(h)(4) of the Act, an
exemption, in whole or in part, from this part by sending a Letter of
Application to the Chief, New Chemicals Branch, Chemical Control
Division, Office of Pollution Prevention and Toxics, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

\(2\) General provisions. The Letter of Application should provide
information to show that any activities affected by the requested
exemption will not present an unreasonable risk of injury to health or
the environment. This information should include data described in the
following paragraphs.

\(i\) The effects of the new microorganism on health and the
environment.

\(ii\) The magnitude of exposure of human beings and the environment to
the new microorganism.

\(iii\) The benefits of the new microorganism for various uses and the
availability of substitutes for such uses.

\(iv\) The reasonably ascertainable economic consequences of granting or
denying the exemption, including effects on the national economy, small
business, and technological innovation.

\(3\) Specific requirements. In addition to the requirements of
paragraph (a)(2) of this section, the specific information requirements
of the relevant subpart under which the exemption is sought should be
met.

\(i\) Exemption from MCAN reporting under subpart D. Information
requirements are set forth in \'\'725.155 and 725.160.

\(ii\) Exemption from TERA reporting under subpart E. Information
requirements are set forth in \'\'725.255 and 725.260.

\(iii\) Listing a recipient microorganism as eligible for exemption
under subpart G. Information regarding the following criteria should be
addressed in an application to list a recipient microorganism under
\'725.420:

\(A\) Identification and classification of the microorganism using
available genotypic and phenotypic information;

\(B\) Information to evaluate the relationship of the microorganism to
any other closely related microorganisms which have a potential for
adverse effects on health or the environment;

\(C\) A history of safe commercial use for the microorganism;

\(D\) Commercial uses indicating that the microorganism products might
be subject to TSCA;

\(E\) Studies which indicate the potential for the microorganism to
cause adverse effects to health or the environment; and

\(F\) Studies which indicate the survival characteristics of the
microorganism in the environment.

\(b\) Processing of the Letter of Application by EPA ‑‑ (1) Grant of the
Application. If, after consideration of the Letter of Application and
any other relevant information available to EPA, the Assistant
Administrator for Prevention, Pesticides and Toxic Substances makes a
preliminary determination that the new microorganism will not present an
unreasonable risk of injury to health or the environment, the Assistant
Administrator will propose a rule to grant the

exemption using the applicable procedures in part 750 of this chapter.

\(2\) Denial of the application. If the Assistant Administrator decides
that the preliminary determination described in paragraph (b)(1) of this
section cannot be made, the application will be denied by sending the
applicant a written statement with the Assistant Administrator\'s
reasons for denial.

\(c\) Processing of the exemption ‑‑ (1) Unreasonable risk standard.
Granting a section 5(h)(4) exemption requires a determination that the
activities will not present an unreasonable risk of injury to health or
the environment.

\(i\) An unreasonable risk determination under the Act is an
administrative judgment that requires balancing of the harm to health or
the environment that a chemical substance may cause and the magnitude
and severity of that harm, against the social and economic effects on
society of EPA action to reduce that harm.

\(ii\) A determination of unreasonable risk under section 5(h)(4) of the
Act will examine the reasonably ascertainable economic and social
consequences of granting or denying the exemption after consideration of
the effect on the national economy, small business, technological
innovation, the environment, and public health.

\(2\) Grant of the exemption. The exemption will be granted if the
Assistant Administrator determines, after consideration of all relevant
evidence presented in the rulemaking proceeding described in paragraph
(b)(1) of this section, that the new microorganism will not present an
unreasonable risk of injury to health or the environment.

\(3\) Denial of the exemption. The exemption will be denied if the
Assistant Administrator determines, after consideration of all relevant
evidence presented in the rulemaking proceeding described in paragraph
(b)(1) of this section, that the determination described in paragraph
(c)(2) of this section cannot be made. A final decision terminating the
rulemaking proceeding will be published in the FEDERAL REGISTER.

\'725.70 Compliance.

\(a\) Failure to comply with any provision of this part is a violation
of section 15 of the Act (15 U.S.C. 2614).

\(b\) A person who manufactures or imports a microorganism before a MCAN
is submitted and the MCAN review period expires is in violation of
section 15 of the Act even if that person was not required to submit the
MCAN under \'725.105.

\(c\) Using a microorganism which a person knew or had reason to know
was manufactured, processed, or distributed in commerce in violation of
section 5 of the Act or this part is a violation of section 15 of the
Act (15 U.S.C. 2614).

\(d\) Failure or refusal to establish and maintain records or to permit
access to or copying of records, as required by the Act, is a violation
of section 15 of the Act (15 U.S.C. 2614).

\(e\) Failure or refusal to permit entry or inspection as required by
section 11 of the Act is a violation of section 15 of the Act (15 U.S.C.
2614).

\(f\) Violators may be subject to the civil and criminal penalties in
section 16 of the Act (15 U.S.C. 2615) for each violation. Persons who
submit materially misleading or false information in connection with the
requirements of any provision of this part may be subject to penalties
calculated as if they never filed their submissions.

\(g\) EPA may seek to enjoin the manufacture or processing of a
microorganism in violation of this part or act to seize any
microorganism manufactured or processed in violation of this part or
take other actions under the authority of section 7 of the Act (15
U.S.C. 2606) or section 17 of the Act (15 U.S.C. 2616).

\'725.75 Inspections.

EPA will conduct inspections under section 11 of the Act to assure
compliance with section 5 of the Act and this part, to verify that
information required by EPA under this part is true and correct, and to
audit data submitted to EPA under this part.

Subpart C ‑‑ Confidentiality and Public Access to Information

\'725.80 General provisions for confidentiality claims.

\(a\) A person may assert a claim of confidentiality for any information
submitted to EPA under this part. However,

\(1\) Any person who asserts a claim of confidentiality for portions of
the specific microorganism identity must provide the information as
described in \'725.85.

\(2\) Any person who asserts a claim of confidentiality for a use of a
microorganism must provide the information as described in \'725.88.

\(3\) Any person who asserts a claim of confidentiality for information
contained in a health and safety study of a microorganism must provide
the information described in \'725.92.

\(b\) Any claim of confidentiality must accompany the information when
it is submitted to EPA.

\(1\) When a person submits any information under this part, including
any attachments, for which claims of confidentiality are made, the
claim(s) must be asserted by circling the specific information which is
claimed and marking the page on which that information appears with an
appropriate designation such as \"trade secret,\" \"TSCA CBI,\" or
\"confidential business information.\"

\(2\) If any information is claimed confidential, the person must submit
two copies of the document including the claimed information.

\(i\) One copy of the document must be complete. In that copy, the
submitter must mark the information which is claimed as confidential in
the manner prescribed in paragraph (b)(1) of this section.

\(ii\) The second copy must be complete except that all information
claimed as confidential in the first copy must be deleted. EPA will
place the second copy in the public file.

\(iii\) If the submitter does not provide the second copy, the
submission is incomplete and the review period does not begin to run
until EPA receives the second copy, in accordance with \'725.33.

\(iv\) Any information contained within the copy submitted under
paragraph (b)(2)(ii) of this section which has been in the public file
for more than 30 days will be presumed to be in the public domain,
notwithstanding any assertion of confidentiality made under this
section.

\(3\) A person who submits information to EPA under this part must
reassert a claim of confidentiality and substantiate the claim each time
the information is submitted to EPA.

\(c\) Any person asserting a claim of confidentiality under this part
must substantiate each claim in accordance with the requirements in
\'725.94.

\(d\) EPA will disclose information that is subject to a claim of
confidentiality asserted under this section only to the extent permitted
by the Act, this subpart, and part 2 of this title.

\(e\) If a submitter does not assert a claim of confidentiality for
information at the time it is submitted to EPA, EPA may make the
information public and place it in the public file without further
notice to the submitter.

\'725.85 Microorganism identity.

\(a\) Claims applicable to the period prior to commencement of
manufacture or import for general commercial use ‑‑ (1) When to make a
claim. (i) A person who submits information to EPA under this part may
assert a claim of confidentiality for portions of the specific
microorganism identity at the time of submission of the information.
This claim will apply only to the period prior to the commencement of
manufacture or import for general commercial use.

\(ii\) A person who submits information to EPA under this part must
reassert a claim of confidentiality and substantiate the claim each time
the information is submitted to EPA. For example, if a person claims
certain information confidential in a TERA submission and wishes the
same information to remain confidential in a subsequent TERA or MCAN
submission, the person must reassert and resubstantiate the claim in the
subsequent submission.

\(2\) Assertion of claim. (i) A submitter may assert a claim of
confidentiality only if the submitter believes that public disclosure
prior to commencement of manufacture or import for general commercial
use of the fact that anyone is initiating research and development
activities pertaining to the specific microorganism or intends to
manufacture or import the specific microorganism for general commercial
use would reveal confidential business information. Claims must be
substantiated in accordance with the requirements of \'725.94(a).

\(ii\) If the submission includes a health and safety study concerning
the microorganism and if the claim for confidentiality with respect to
the specific identity is denied in accordance with \'725.92(c), EPA will
deny a claim asserted under paragraph (a) of this section.

\(3\) Development of generic name. Any person who asserts a claim of
confidentiality for portions of the specific microorganism identity
under this paragraph must provide one of the following items at the time
the submission is filed:

\(i\) The generic name which was accepted by EPA in the prenotice
consultation conducted under paragraph (a)(4) of this section.

\(ii\) One generic name that is only as generic as necessary to protect
the confidential identity of the particular microorganism. The name
should reveal the specific identity to the maximum extent possible. The
generic name will be subject to EPA review and approval.

\(4\) Determination by EPA. (i) Any person who intends to assert a claim
of confidentiality for the specific identity of a new microorganism may
seek a determination by EPA of an appropriate generic name for the
microorganism before filing a submission. For this purpose, the person
should submit to EPA:

\(A\) The specific identity of the microorganism.

\(B\) A proposed generic name(s) which is only as generic as necessary
to protect the confidential identity of the new microorganism. The
name(s) should reveal the specific identity of the microorganism to the
maximum extent possible.

\(ii\) Within 30 days, EPA will inform the submitter either that one of
the proposed generic names is adequate or that none is adequate and
further consultation is necessary.

\(5\) Use of generic name. If a submitter claims microorganism identity
as confidential under paragraph (a) of this section, and if the
submitter complies with paragraph (a)(2) of this section, EPA will issue
for publication in the FEDERAL REGISTER notice described in \'725.40 the
generic name proposed by the submitter or one agreed upon by EPA and the
submitter.

\(b\) Claims applicable to the period after commencement of manufacture
or import for general commercial use ‑‑ (1) Maintaining claim. Any claim
of confidentiality under paragraph (a) of this section is applicable
only until the microorganism is manufactured or imported for general
commercial use and becomes eligible for inclusion on the Inventory. To
maintain the confidential status of the microorganism identity when the
microorganism is added to the Inventory, a submitter must reassert the
confidentiality claim and substantiate the claim in the notice of
commencement of manufacture required under \'725.190.

\(i\) A submitter may not claim the microorganism identity confidential
for the period after commencement of manufacture or import for general
commercial use unless the submitter claimed the microorganism identity
confidential under paragraph (a) of this section in the MCAN submitted
for the microorganism.

\(ii\) A submitter may claim the microorganism identity confidential for
the period after commencement of manufacture or import for general
commercial use if the submitter did not claim the microorganism identity
confidential under paragraph (a) of this section in any TERA submitted
for the microorganism, but subsequently did claim microorganism identity
confidential in the MCAN submitted for the microorganism.

\(2\) Assertion of claim. (i) A person who believes that public
disclosure of the fact that anyone manufactures or imports the
microorganism for general commercial use would reveal confidential
business information may assert a claim of confidentiality under
paragraph (b) of this section.

\(ii\) If the notice includes a health and safety study concerning the
new microorganism, and if the claim for confidentiality with respect to
the microorganism identity is denied in accordance with \'725.92(c), EPA
will deny a claim asserted under paragraph (b) of this section.

\(3\) Requirements for assertion. Any person who asserts a
confidentiality claim for microorganism identity must: (i) Comply with
the requirements of paragraph (a)(3) of this section regarding
submission of a generic name.

\(ii\) Agree that EPA may disclose to a person with a bona fide intent
to manufacture or import the microorganism the fact that the particular
microorganism is included on the confidential Inventory for purposes of
notification under section 5(a)(1)(A) of the Act.

\(iii\) Have available and agree to furnish to EPA upon request the
taxonomic designations and supplemental information required by
\'725.12.

\(iv\) Provide a detailed written substantiation of the claim, in
accordance with the requirements of \'725.94(b).

\(4\) Denial of claim. If the submitter does not meet the requirements
of paragraph (b) of this section, EPA will deny the claim of
confidentiality.

\(5\) Acceptance of claim. (i) EPA will publish a generic name on the
public Inventory if:

\(A\) The submitter asserts a claim of confidentiality in accordance
with this paragraph.

\(B\) No claim for confidentiality of the microorganism identity as part
of a health and safety study has been denied in accordance with part 2
of this title or \'725.92.

\(ii\) Publication of a generic name on the public Inventory does not
create a category for purposes of the Inventory. Any person who has a
bona fide intent to manufacture or import a microorganism which is
described by a generic name on the public Inventory may submit an
inquiry to EPA under \'725.15(b) to determine whether the particular
microorganism is included on the confidential Inventory.

\(iii\) Upon receipt of a request described in \'725.15(b), EPA may
require the submitter who originally asserted confidentiality for a
microorganism to submit to EPA the information listed in paragraph
(b)(3)(iii) of this section.

\(iv\) Failure to submit any of the information required under paragraph
(b)(3)(iii) of this section within 10 calendar days of receipt of a
request by EPA under paragraph (b) of this section will constitute a
waiver of the original submitter\'s confidentiality claim. In this
event, EPA may place the specific microorganism identity on the public
Inventory without further notice to the original submitter.

\(6\) Use of generic name on the public Inventory. If a submitter
asserts a claim of confidentiality under paragraph (b) of this section,
EPA will examine the generic microorganism name proposed by the
submitter. (i) If EPA determines that the generic name proposed by the
submitter is only as generic as necessary to protect the confidential
identity of the particular microorganism, EPA will place that generic
name on the public Inventory.

\(ii\) If EPA determines that the generic name proposed by the submitter
is more generic than necessary to protect the confidential identity, EPA
will propose in writing, for review by the submitter, an alternative
generic name that will reveal the identity of the microorganism to the
maximum extent possible.

\(iii\) If the generic name proposed by EPA is acceptable to the
submitter, EPA will place that generic name on the public Inventory.

\(iv\) If the generic name proposed by EPA is not acceptable to the
submitter, the submitter must explain in detail why disclosure of that
generic name would reveal confidential business information and propose
another generic name which is only as generic as necessary to protect
the confidential identity of the microorganism. If EPA does not receive
a response from the submitter within 30 days after the submitter
receives the proposed name, EPA will place EPA\'s

chosen generic name on the public Inventory. If the submitter does
provide the information requested, EPA will review the response. If the
submitter\'s proposed generic name is acceptable, EPA will publish that
generic name on the public Inventory. If the submitter\'s proposed
generic name is not acceptable, EPA will notify the submitter of EPA\'s
choice of a generic name. Thirty days after this notification, EPA will
place the chosen generic name on the public Inventory.

\'725.88 Uses of a microorganism.

\(a\) Assertion of claim. A person who submits information to EPA under
this part on the categories or proposed categories of use of a
microorganism may assert a claim of confidentiality for this
information.

\(b\) Requirements for claim. A submitter that asserts such a claim
must:

\(1\) Report the categories or proposed categories of use of the
microorganism.

\(2\) Provide, in nonconfidential form, a description of the uses that
is only as generic as necessary to protect the confidential business
information. The generic use description will be included in the FEDERAL
REGISTER notice described in \'725.40.

\(c\) Generic use description. The person must submit the information
required by paragraph (b) of this section by describing the uses as
precisely as possible, without revealing the information which is
claimed confidential, to disclose as much as possible how the use may
result in human exposure to the microorganism or its release to the
environment.

\'725.92 Data from health and safety studies of microorganisms.

\(a\) Information other than specific microorganism identity. Except as
provided in paragraph (b) of this section, EPA will deny any claim of
confidentiality with respect to information included in a health and
safety study of a microorganism, unless the information would disclose
confidential business information concerning:

\(1\) Processes used in the manufacture or processing of a
microorganism.

\(2\) Information which is not in any way related to the effects of a
microorganism on health or the environment, such as, the name of the
submitting company, cost or other financial data, product development or
marketing plans, and advertising plans, for which the person submits a
claim of confidentiality in accordance with \'725.80.

\(b\) Microorganism identity ‑‑ (1) Claims applicable to the period
prior to commencement of manufacture or import for general commercial
use. A claim of confidentiality for the period prior to commencement of
manufacture or import for general commercial use for the specific
identity of a microorganism for which a health and safety study was
submitted must be asserted in conjunction with a claim asserted under
\'725.85(a). The submitter must substantiate each claim in accordance
with the requirements of \'725.94(a).

\(2\) Claims applicable to the period after commencement of manufacture
or import for general commercial use. To maintain the confidential
status of the specific identity of a microorganism for which a health
and safety study was submitted after commencement of manufacture or
import for general commercial use, the claim must be reasserted and
substantiated in conjunction with a claim under \'725.85(b). The
submitter must substantiate each claim in accordance with the
requirements of \'725.94(b).

\(c\) Denial of confidentiality claim. EPA will deny a claim of
confidentiality for microorganism identity under paragraph (b) of this
section, unless:

\(1\) The information would disclose processes used in the manufacture
or processing of a microorganism.

\(2\) The microorganism identity is not necessary to interpret a health
and safety study.

\(d\) Use of generic names. When EPA discloses a health and safety study
containing a microorganism identity, which the submitter has claimed
confidential, and if the Agency has not denied the claim under paragraph
(c) of this section, EPA will identify the microorganism by the generic
name selected under \'725.85.

\'725.94 Substantiation requirements.

\(a\) Claims applicable to the period prior to commencement of
manufacture or import for general commercial use B (1) MCAN, TME, Tier I
certification, and Tier II exemption request requirements. Any person
who submits a MCAN, TME, Tier I certification, or Tier II exemption
request should strictly limit confidentiality claims to that information
which is confidential and proprietary to the business.

\(i\) If any information in the submission is claimed as confidential
business information, the submitter must substantiate each claim by
submitting written answers to the questions in paragraphs (c), (d), and
(e) of this section at the time the person submits the information.

\(ii\) If the submitter does not provide written substantiation as
required in paragraph (a)(1)(i) of this section, the submission will be
considered incomplete and the review period will not begin in accordance
with \'725.33.

\(2\) TERA requirements. Any person who submits a TERA, should strictly
limit confidentiality claims to that information which is confidential
and proprietary to the business. If any information in such a submission
is claimed as confidential business information, the submitter must have
available for each of those claims, and agree to furnish to EPA upon
request, written answers to the questions in paragraphs (d) and (e) of
this section.

\(b\) Claims applicable to the period after commencement of manufacture
or import for general commercial use. (1) If a submitter claimed
portions of the microorganism identity confidential in the MCAN and
wants the identity to be listed on the confidential Inventory, the claim
must be reasserted and substantiated at the time the Notice of
Commencement (NOC) is submitted under \'725.190. Otherwise, EPA will
list the specific microorganism identity on the public Inventory.

\(2\) The submitter must substantiate the claim for confidentiality of
the microorganism identity by answering all of the questions in
paragraphs (c), (d), and (e) in this section. In addition, the following
questions must be answered:

\(i\) What harmful effects to the company\'s or institution\'s
competitive position, if any, would result if EPA publishes on the
Inventory the identity of the microorganism? How could a competitor use
such information given the fact that the identity of the microorganism
otherwise would appear on the TSCA Inventory with no link between the
microorganism and the company or institution? How substantial would the
harmful effects of disclosure be? What is the causal

relationship between the disclosure and the harmful effects?

\(ii\) Has the identity of the microorganism been kept confidential to
the extent that competitors do not know it is being manufactured or
imported for general commercial use by anyone?

\(c\) General questions. The following questions must be answered in
detail for each confidentiality claim:

\(1\) For what period of time is a claim of confidentiality being
asserted? If the claim is to extend until a certain event or point in
time, indicate that event or time period. Explain why the information
should remain confidential until such point.

\(2\) Briefly describe any physical or procedural restrictions within
the company or institution relating to the use and storage of the
information claimed as confidential. What other steps, if any, apply to
use or further disclosure of the information?

\(3\) Has the information claimed as confidential been disclosed to
individuals outside of the company or institution? Will it be disclosed
to such persons in the future? If so, what restrictions, if any, apply
to use or further disclosure of the information?

\(4\) Does the information claimed as confidential appear, or is it
referred to, in any of the following questions? If the answer is yes to
any of these questions, indicate where the information appears and
explain why it should nonetheless be treated as confidential.

\(i\) Advertising or promotional materials for the microorganism or the
resulting end product?

\(ii\) Material safety data sheets or other similar materials for the
microorganism or the resulting end product?

\(iii\) Professional or trade publications?

\(iv\) Any other media available to the public or to competitors?

\(v\) Patents?

\(vi\) Local, State, or Federal agency public files?

\(5\) Has EPA, another Federal agency, a Federal court, or a State made
any confidentiality determination regarding the information claimed as
confidential? If so, provide copies of such determinations.

\(6\) For each type of information claimed confidential, describe the
harm to the company\'s or institution\'s competitive position that would
result if this information were disclosed. Why would this harm be
substantial? How could a competitor use such information? What is the
causal connection between the disclosure and harm?

\(7\) If EPA disclosed to the public the information claimed as
confidential, how difficult would it be for the competitor to enter the
market for the resulting product? Consider such constraints as capital
and marketing cost, specialized technical expertise, or unusual
processes.

\(d\) Microorganism identity and production method. If confidentiality
claims are asserted for the identity of the microorganism or information
on how the microorganism is produced, the following questions must be
answered:

\(1\) Has the microorganism or method of production been patented in the
U.S. or elsewhere? If so, why is confidentiality necessary?

\(2\) Does the microorganism leave the site of production or testing in
a form which is accessible to the public or to competitors? What is the
cost to a competitor, in time and money, to develop appropriate use
conditions? What factors facilitate or impede product analysis?

\(3\) For each additional type of information claimed as confidential,
explain what harm would result from disclosure of each type of
information if the identity of the microorganism were to remain
confidential.

\(e\) Health and safety studies of microorganisms. If confidentiality
claims are asserted for information in a health or safety study of a
microorganism, the following questions must be answered:

\(1\) Would the disclosure of the information claimed confidential
reveal: confidential process information, or information unrelated to
the effects of the microorganism on health and the environment. Describe
the causal connection between the disclosure and harm.

\(2\) Does the company or institution assert that disclosure of the
microorganism identity is not necessary to interpret any health and
safety studies which have been submitted? If so, explain how a less
specific identity would be sufficient to interpret the studies.

\'725.95 Public file.

All information submitted, including any health and safety study of a
microorganism and other supporting documentation, will become part of
the public file for that submission, unless such materials are claimed
confidential. In addition, EPA may add materials to the public file,
unless such materials are claimed confidential. Any of the
nonconfidential material described in this subpart will be available for
public inspection in the TSCA Public Docket Office, Rm. NE‑B607, 401 M
St., SW., Washington, DC, between the hours of noon to 4 p.m., Monday
through Friday, excluding legal holidays.

Subpart D ‑‑ Microbial Commercial Activities Notification Requirements

\'725.100 Scope and purpose.

\(a\) This subpart establishes procedures for submission of a notice to
EPA under section 5(a) of the Act for persons who manufacture, import,
or process microorganisms for commercial purposes. This notice is called
a Microbial Commercial Activity Notice (MCAN). It is expected that MCANs
will in general only be submitted for microorganisms intended for
general commercial use. Persons who manufacture, import, or process a
microorganism in small quantities solely for research and development as
defined in \'725.3 are not required to submit a notice to EPA. Persons
who manufacture, import, or process a microorganism for research and
development activities that do not fit the definition of small
quantities solely for research and development may nonetheless qualify
for more limited reporting requirements in Subpart E, including the TERA
which can be used for review of research and development involving
environmental release.

\(b\) Persons subject to MCAN submission are described in \'725.105.

\(c\) Exclusions and exemptions specific to MCAN submissions are
described in \'725.110.

\(d\) Submission requirements applicable specifically to MCANs are
described at \'725.150.

\(e\) Data requirements for MCANs are set forth in \'\'725.155 and
725.160.

\(f\) EPA review procedures specific to MCANs are set forth in
\'725.170.

\(g\) Subparts A through C of this part apply to any MCAN submitted
under this subpart.

\'725.105 Persons who must report.

\(a\) Manufacturers of new microorganisms. (1) MCAN submission is
required for any person who intends to manufacture for commercial
purposes in the United States a new microorganism. Exclusions are
described in \'725.110.

\(2\) If a person contracts with a manufacturer to produce or process a
new microorganism and the manufacturer produces or processes the
microorganism exclusively for that person, and that person specifies the
identity of the microorganism, and controls the total amount produced
and the basic technology for the plant process, then that person must
submit the MCAN. If it is unclear who must report, EPA should be
contacted to determine who must submit the MCAN.

\(3\) Only manufacturers that are incorporated, licensed, or doing
business in the United States may submit a MCAN.

\(b\) Importers of new microorganisms. (1) MCAN submission is required
for a person who intends to import into the United States for commercial
purposes a new microorganism. Exclusions are described in \'725.110.

\(2\) When several persons are involved in an import transaction, the
MCAN must be submitted by the principal importer. If no one person fits
the principal importer definition in a particular transaction, the
importer should contact EPA to determine who must submit the MCAN for
that transaction.

\(3\) Except as otherwise provided in paragraph (b)(4) of this section,
the provisions of this subpart D apply to each person who submits a MCAN
for a new microorganism which such person intends to import for a
commercial purpose. In addition, each importer must comply with
paragraph (b)(4) of this section.

\(4\) EPA will hold the principal importer, or the importer that EPA
determines must submit the MCAN when there is no principal importer
under paragraph (b)(2) of this section, liable for complying with this
part, for completing the MCAN, and for the completeness and truthfulness
of all information which it submits.

\(c\) Manufacturers, importers, or processors of microorganisms for a
significant new use. MCAN submission is required for any person who
intends to manufacture, import, or process for commercial purposes a
microorganism identified as having one or more significant new uses in
subpart M of this part, and who intends either to engage in a designated
significant new use of the microorganism or intends to distribute it in
commerce. Persons excluded from reporting on significant new uses of
microorganisms and additional procedures for reporting are described in
subpart L of this part.

\'725.110 Persons not subject to this subpart.

Persons are not subject to the requirements of this subpart for the
following activities:

\(a\) Manufacturing, importing, or processing solely for research and
development microorganisms that meet the requirements for an exemption
under subpart E of this part.

\(b\) Manufacturing, importing, or processing microorganisms for test
marketing activities which have been granted an exemption under subpart
F of this part.

\(c\) Manufacturing or importing new microorganisms under the conditions
of a Tier I or Tier II exemption under subpart G of this part.

\'725.150 Procedural requirements for this subpart.

General requirements for all MCANs under this part are contained in
subparts A through C of this part. In addition, the following
requirements apply to MCANs submitted under this subpart:

\(a\) When to submit a MCAN. A MCAN must be submitted at least 90
calendar days prior to manufacturing or importing a new microorganism
and at least 90 calendar days prior to manufacturing, importing, or
processing a microorganism for a significant new use.

\(b\) Section 5(b) of the Act. The submitter must comply with any
applicable requirement of section 5(b) of the Act for the submission of
test data.

\(c\) Contents of a MCAN. Each person who submits a MCAN under this
subpart must provide the information and test data described in
\'\'725.155 and 725.160.

\(d\) Recordkeeping. Each person who submits a MCAN under this subpart
must comply with the recordkeeping requirements of \'725.65.

\'725.155 Information to be included in the MCAN.

\(a\) Each person who is required by this part to submit a MCAN must
include the information specified in paragraphs (c) through (h) of this
section, to the extent it is known to or reasonably ascertainable by
that person. However, no person is required to include information which
relates solely to exposure of humans or ecological populations outside
of the United States.

\(b\) Each person should also submit, in writing, all other information
known to or reasonably ascertainable by that person that would permit
EPA to make a reasoned evaluation of the health and environmental
effects of the microorganism, or any microbial mixture or article,
including information on its effects on humans, animals, plants, and
other microorganisms, and in the environment. The information to be
submitted under this subpart includes the information listed in
paragraphs (c) through (h) of this section relating to the manufacture,
processing, distribution in commerce, use, and disposal of the new
microorganism.

\(c\) Submitter identification. (1) The name and headquarters address of
the submitter.

\(2\) The name, address, and office telephone number (including area
code) of the principal technical contact representing the submitter.

\(d\) Microorganism identity information. Persons must submit sufficient
information to allow the microorganism to be accurately and
unambiguously identified for listing purposes as required by \'725.12.

\(1\) Description of the recipient microorganism and the new
microorganism. (i) Data substantiating the taxonomy of the recipient
microorganism and the new microorganism to the level of strain, as
appropriate. In lieu of data, EPA will accept a letter from a culture
collection substantiating taxonomy, provided EPA, upon request to the
submitter, may have access to the data supporting the taxonomic
designation.

\(ii\) Information on the morphological and physiological features of
the new microorganism.

\(iii\) Other specific data by which the new microorganism may be
uniquely identified for Inventory purposes.

\(2\) Genetic construction of the new microorganism. (i) Data
substantiating the taxonomy of the donor organism(s). In lieu of data,
EPA will accept a letter from a culture collection substantiating
taxonomy, provided EPA, upon request to the submitter, may have access
to the data supporting the taxonomic designation.

\(ii\) Description of the traits for which the new microorganism has
been selected or developed and other traits known to have been added or
modified.

\(iii\) A detailed description of the genetic construction of the new
microorganism, including the technique used to modify the microorganism
(e.g., fusion of cells, injection of DNA, electroporation or chemical
poration, or methods used for induced mutation and selection). The
description should include, for example, a description of the introduced
genetic material, including any regulatory sequences and structural
genes and the products of those genes; how the

introduced genetic material is expected to affect behavior of the
recipient; expression, alteration, and stability of the introduced
genetic material; methods for vector construction and introduction; and
a description of the regulatory and structural genes that are components
of the introduced genetic material, including genetic maps of the
introduced sequences.

\(3\) Phenotypic and ecological characteristics. (i) Habitat,
geographical distribution, and source of the recipient microorganism.

\(ii\) Survival and dissemination under relevant environmental
conditions including a description of methods for detecting the new or
recipient microorganism(s) in the environment and the sensitivity limit
of detection for these techniques.

\(iii\) A description of anticipated biological interactions with and
effects on target organisms and other organisms such as competitors,
prey, hosts, symbionts, parasites, and pathogens; a description of host
range; a description of pathogenicity, infectivity, toxicity, virulence,
or action as a vector of pathogens; and capacity for genetic transfer
under laboratory and relevant environmental conditions.

\(iv\) A description of anticipated involvement in biogeochemical or
biological cycling processes, involvement in rate limiting steps in
mineral or nutrient cycling, or involvement in inorganic compounds
cycling (such as possible sequestration or transformation of heavy
metals).

\(e\) Byproducts. A description of the byproducts resulting from the
manufacture, processing, use, and disposal of the new microorganism.

\(f\) Total production volume. The estimated maximum amount of the new
microorganism intended to be manufactured or imported during the first
year of production and the estimated maximum amount to be manufactured
or imported during any consecutive 12‑month period during the first 3
years of production. This estimate may be by weight or volume and should
include an estimation of viability (i.e., viable cells per unit volume
or colony forming units

per unit dry weight).

\(g\) Use information. A description of intended categories of use by
function and application, the estimated percent of production volume
devoted to each category of use, and the percent of the new
microorganism in the formulation for each commercial or consumer use.

\(h\) Worker exposure and environmental release. (1) For sites
controlled by the submitter:

\(i\) The identity of sites where the new microorganism will be
manufactured, processed, or used. For purposes of this section, the site
for a person who imports a new microorganism is the site of the
operating unit within the person\'s organization which is directly
responsible for importing the new microorganism and which controls the
import transaction. The import site may in some cases be the
organization\'s headquarters office in the United States.

\(ii\) A process description of each manufacture, processing, and use
operation, which includes a diagram of the major unit operations and
conversions, the identity and entry point of all feedstocks, and the
identity of any possible points of release of the new microorganism from
the process, including a description of all controls, including
engineering controls, used to prevent such releases.

\(iii\) Worker exposure information, including worker activities,
physical form of process streams which contain the new microorganism to
which workers may be exposed, the number of workers, and the duration of
activities.

\(iv\) Information on release of the new microorganism to the
environment, including the quantity and media of release and type of
control technology used.

\(v\) A narrative description of the intended transport of the new
microorganism, including the means of transport, containment methods to
be used during transport, and emergency containment procedures to be
followed in case of accidental release.

\(vi\) Procedures for disposal of any articles, waste, clothing, or
other equipment involved in the activity, including procedures for
inactivation of the new microorganism, containment, disinfection, and
disposal of contaminated items.

\(2\) For sites not controlled by the submitter, a description of each
type of processing and use operation involving the new microorganism,
including identification of the estimated number of processing or use
sites, situations in which worker exposure to and/or environmental
release of the new microorganism will occur, the number of workers
exposed and the duration of exposure; procedures for transport of the
new microorganism and for disposal, including procedures for
inactivation of the new microorganism; and control measures which limit
worker exposure and

environmental release.

\'725.160 Submission of health and environmental effects data.

\(a\) Test data on the new microorganism in the possession or control of
the submitter. (1) Except as provided in \'725.25(h), and in addition to
the information required by \'725.155(d)(3), each MCAN must contain all
test data in the submitter\'s possession or control which are related to
the effects on health or the environment of any manufacture, processing,
distribution in commerce, use, or disposal of the new microorganism or
any microbial mixture or article containing the new microorganism, or
any combination of such activities. This includes test data concerning
the new

microorganism in a pure culture or formulated form as used or as
intended to be used in one of the activities listed above.

\(2\) A full report or standard literature citation must be submitted
for the following types of test data: (i) Health effects data.

\(ii\) Ecological effects data.

\(iii\) Physical and chemical properties data.

\(iv\) Environmental fate characteristics.

\(v\) Monitoring data and other test data related to human exposure to
or environmental release of the new microorganism.

(3)(i) If the data do not appear in the open scientific literature, the
submitter must provide a full report. A full report includes the
experimental methods and materials, results, discussion and data
analysis, conclusions, references, and the name and address of the
laboratory that developed the data.

\(ii\) If the data appear in the open scientific literature, the
submitter need only provide a standard literature citation. A standard
literature citation includes author, title, periodical name, date of
publication, volume, and page numbers.

(4)(i) If a study, report, or test is incomplete when a person submits a
MCAN, the submitter must identify the nature and purpose of the study;
name and address of the laboratory developing the data; progress to
date; types of data collected, significant preliminary results; and
anticipated completion date.

\(ii\) If a test or experiment is completed before the MCAN review
period ends, the person must submit the study, report, or test, as
specified in paragraph (a)(3)(i) of this section, to the address listed
in \'725.25(c) within 10 days of receiving it, but no later than 5 days
before the end of the review period. If the test or experiment is
completed during the last 5 days of the review period, the submitter
must immediately inform its EPA contact for that submission by
telephone.

\(5\) For test data in the submitter\'s possession or control which are
not listed in paragraph (a)(2) of this section, a person is not required
to submit a complete report. The person must submit a summary of the
data. If EPA so requests, the person must submit a full report within 10
days of the request, but no later than 5 days before the end of the
review period.

\(6\) All test data described under paragraph (a) of this section are
subject to these requirements, regardless of their age, quality, or
results.

\(b\) Other data concerning the health and environmental effects of the
new microorganism that are known to or reasonably ascertainable by the
submitter. (1) Except as provided in \'725.25(h), and in addition to the
information required by \'725.155(c)(3), any person who submits a MCAN
must describe the following data, including any data from a health and
safety study of a microorganism, if the data are related to effects on
health or the environment of any manufacture, processing, distribution
in commerce, use, or disposal of the microorganism, of any microbial
mixture or article containing the new microorganism, or of any
combination of such activities:

\(i\) Any data, other than test data, in the submitter\'s possession or
control.

\(ii\) Any data, including test data, which are not in the submitter\'s
possession or control, but which are known to or reasonably
ascertainable by the submitter. For the purposes of this section, data
are known to or reasonably ascertainable by the submitter if the data
are known to any of its employees or other agents who are associated
with the research and development, test marketing, or commercial
marketing of the microorganism.

\(2\) Data that must be described include data concerning the new
microorganism in a pure culture or formulated form as used or as
intended to be used in one of the activities listed in paragraph (b)(1)
of this section.

\(3\) The description of data reported under paragraph (b) of this
section must include:

\(i\) If the data appear in the open scientific literature, a standard
literature citation, which includes the author, title, periodical name,
date of publication, volume, and pages.

\(ii\) If the data are not available in the open scientific literature,
a description of the type of data and summary of the results, if
available, and the names and addresses of persons the submitter believes
may have possession or control of the data.

\(4\) All data described in paragraph (b) of this section are subject to
these requirements, regardless of their age, quality, or results; and
regardless of whether they are complete at the time the MCAN is
submitted.

\'725.170 EPA review of the MCAN.

General procedures for review of all submissions under this part are
contained in \'\'725.28 through 725.60. In addition, the following
procedures apply to EPA review of MCANs submitted under this subpart:

\(a\) Length of the review period. The MCAN review period specified in
section 5(a) of the Act runs for 90 days from the date the Document
Control Officer for the Office of Pollution Prevention and Toxics
receives a complete MCAN, or the date EPA determines the MCAN is
complete under \'725.33, unless the Agency extends the period under
section 5(c) of the Act and \'725.56.

\(b\) Notice of expiration of MCAN review period. (1) EPA will notify
the submitter that the MCAN review period has expired or that EPA has
completed its review of the MCAN. Expiration of the review period does
not constitute EPA approval or certification of the new microorganism,
and does not mean that EPA may not take regulatory action against the
microorganism in the future.

\(2\) After expiration of the MCAN review period, in the absence of
regulatory action by EPA under section 5(e), 5(f), or 6(a) of the Act,
the submitter may manufacture or import the microorganism even if the
submitter has not received notice of expiration.

\(3\) Early notification that EPA has completed its review does not
permit commencement of manufacture or import prior to the expiration of
the 90‑day MCAN review period.

\(c\) No person submitting a MCAN in response to the requirements of
this subpart may manufacture, import, or process a microorganism subject
to this subpart until the review period, including all extensions and
suspensions, has expired.

\'725.190 Notice of commencement of manufacture or import.

\(a\) Applicability. Any person who commences the manufacture or import
of a new microorganism for nonexempt, commercial purposes for which that
person previously submitted a section 5(a) notice under this part must
submit a notice of commencement (NOC) of manufacture or import.

\(b\) When to report. (1) If manufacture or import for nonexempt,
commercial purposes begins on or after May 27, 1997, the submitter must
submit the NOC to EPA no later than 30 calendar days after the first day
of such manufacture or import.

\(2\) If manufacture or import for nonexempt, commercial purposes began
or will begin before May 27, 1997, the submitter must submit the NOC by
May 27, 1997.

\(3\) Submission of an NOC prior to the commencement of manufacture or
import is a violation of section 15 of the Act.

\(c\) Information to be reported. The NOC must contain the following
information: Specific microorganism identity, MCAN number, and the date
when manufacture or import commences. If the person claimed
microorganism identity confidential in the MCAN, and wants the identity
to be listed on the confidential Inventory, the claim must be reasserted
and resubstantiated in accordance with \'725.85(b). Otherwise, EPA will
list the specific microorganism identity on the public Inventory.

\(d\) Where to submit. NOCs should be submitted to the address listed in
\'725.25(c).

Subpart E ‑‑ Exemptions for Research and Development Activities

\'725.200 Scope and purpose.

\(a\) This subpart describes exemptions from the reporting requirements
under subpart D of this part for research and development activities
involving microorganisms.

\(b\) In lieu of complying with subpart D of this part, persons
described in \'725.205 may submit a TSCA Experimental Release
Application (TERA) for research and development activities involving
microorganisms or otherwise comply with this subpart.

\(c\) Exemptions from part 725 are provided at \'\'725.232, 725.234, and
725.238.

\(d\) Submission requirements specific for TERAs are described at
\'725.250.

\(e\) Data requirements for TERAs are set forth in \'\'725.255 and
725.260.

\(f\) EPA review procedures specific for TERAs are set forth in
\'\'725.270 and 725.288.

\(g\) Subparts A through C of this part apply to any submission under
this subpart.

\'725.205 Persons who may report under this subpart.

\(a\) Commercial research and development activities involving new
microorganisms or significant new uses of microorganisms are subject to
reporting under this part unless they qualify for an exemption under
this part.

\(b\) Commercial purposes for research and development means that the
activities are conducted with the purpose of obtaining an immediate or
eventual commercial advantage for the researcher and would include:

\(1\) All research and development activities which are funded directly,
in whole or in part, by a commercial entity regardless of who is
actually conducting the research. Indications that the research and
development activities are funded directly, in whole or in part, may
include, but are not limited to:

\(i\) Situations in which a commercial entity contracts directly with a
university or researcher; or

\(ii\) Situations in which a commercial entity gives a conditional grant
where the commercial entity holds patent rights, or establishes a joint
venture where the commercial entity holds patent or licensing rights; or

\(iii\) Any other situation in which the commercial entity intends to
obtain an immediate or eventual commercial advantage for the commercial
entity and/or the researcher.

\(2\) Research and development activities that are not funded directly
by a commercial entity, if the researcher intends to obtain an immediate
or eventual commercial advantage. Indications that the researcher
intends to obtain an immediate or eventual commercial advantage may
include, but are not limited to:

\(i\) The research is directed toward developing a commercially viable
improvement of a product already on the market; or

\(ii\) The researcher has sought or is seeking commercial funding for
the purpose of developing a commercial application; or

\(iii\) The researcher or university has sought or is seeking a patent
to protect a commercial application which the research is developing; or

\(iv\) Other evidence that the researcher is aware of a commercial
application for the research and has directed the research toward
developing that application.

\(c\) Certain research and development activities involving
microorganisms subject to jurisdiction under the Act are exempt from
reporting under this part. A person conducting research and development
activities which meet the conditions for the exemptions described in
\'\'725.232, 725.234, or 725.238 is exempt from TERA reporting under
this subpart.

\(d\) A microorganism is not exempt from reporting under subpart D of
this part if any amount of the microorganism, including as part of a
mixture, is processed, distributed in commerce, or used, for any
commercial purpose other than research and development.

\(e\) Quantities of the inactivated microorganism, or mixtures or
articles containing the inactivated microorganism, remaining after
completion of research and development activities may be disposed of as
a waste in accordance with applicable Federal, State, and local
regulations.

\(f\) A person who manufactures, imports, or processes a microorganism
solely for research and development is not required to comply with the
requirements of this section if:

\(1\) The person is manufacturing a microbial pesticide identified in
\'172.45(c), or

\(2\) The person is manufacturing a microbial pesticide for which an
Experimental Use Permit is required, pursuant to \'172.3; or

\(3\) The person is manufacturing a microbial pesticide for which a
notification or an Experimental Use Permit is not required to be
submitted.

\'725.232 Activities subject to the jurisdiction of other Federal
programs or agencies.

This part does not apply to any research and development activity that
meets all of the following conditions.

\(a\) The microorganism is manufactured, imported, or processed solely
for research and development activities.

\(b\) There is no intentional testing of a microorganism outside of a
structure, as structure is defined in \'725.3.

(c)(1) The person receives research funds from another Federal agency,
and the funds are awarded on the condition that the research will be
conducted in accordance with the relevant portions of the NIH
Guidelines, or

\(2\) A Federal agency or program otherwise imposes the legally binding
requirement that the research is to be conducted in accordance with
relevant portions of the NIH Guidelines.

\'725.234 Activities conducted inside a structure.

A person who manufactures, imports, or processes a microorganism is not
subject to the reporting requirements under subpart D of this part if
all of the following conditions are met:

\(a\) The microorganism is manufactured, imported, or processed solely
for research and development activities.

\(b\) The microorganism is used by, or directly under the supervision
of, a technically qualified individual, as defined in \'725.3. The
technically qualified individual must maintain documentation of the
procedures selected to comply with paragraph (d) of this section and
must ensure that the procedures are used.

\(c\) There is no intentional testing of a microorganism outside of a
structure, as structure is defined in \'725.3.

\(d\) Containment and/or inactivation controls. (1) Selection and use of
containment and/or inactivation controls inside a structure for a
particular microorganism shall take into account the following: (i)
Factors relevant to the organism\'s ability to survive in the
environment.

\(ii\) Potential routes of release in air, solids and liquids; in or on
waste materials and equipment; in or on people, including maintenance
and custodial personnel; and in or on other organisms, such as insects
and rodents.

\(iii\) Procedures for transfer of materials between facilities.

\(2\) The technically qualified individual\'s selection of containment
and/or inactivation controls shall be approved and certified by an
authorized official (other than the TQI) of the institution that is
conducting the test prior to the commencement of the test.

\(3\) Records shall be developed and maintained describing the selection
and use of containment and/or inactivation controls, as specified in
\'725.235(c). These records, which must be maintained at the location
where the research and development activity is being conducted, shall be
submitted to EPA upon written request and within the time frame
specified in EPA\'s request.

\(4\) Subsequent to EPA review of records in accordance with paragraph
(d)(3) of this section, changes to the containment/inactivation controls
selected under paragraph (d)(1) of this section must be made upon EPA
order. Failure to comply with EPA\'s order shall result in automatic
loss of eligibility for an exemption under this section.

\(e\) The manufacturer, importer, or processor notifies all persons in
its employ or to whom it directly distributes the microorganism, who are
engaged in experimentation, research, or analysis on the microorganism,
including the manufacture, processing, use, transport, storage, and
disposal of the microorganism associated with research and development
activities, of any risk to health, identified under \'725.235(a), which
may be associated with the microorganism. The notification must be made
in accordance with \'725.235(b).

\'725.235 Conditions of exemption for activities conducted inside a
structure.

\(a\) Determination of risks. To determine whether notification under
\'725.234(e) is required, the manufacturer, importer, or processor must
do one of the following:

\(1\) For research conducted in accordance with the NIH Guidelines, the
manufacturer, importer, or processor must meet the conditions laid out
at IV‑B‑4‑d of the NIH Guidelines; or

\(2\) For all other research conducted in accordance with \'725.234, the
manufacturer, importer, or processor must review and evaluate the
following information to determine whether there is reason to believe
there is any risk to health which may be associated with the
microorganism:

\(i\) Information in its possession or control concerning any
significant adverse reaction of persons exposed to the microorganism
which may reasonably be associated with such exposure.

\(ii\) Information provided to the manufacturer, importer, or processor
by a supplier or any other person concerning a health risk believed to
be associated with the microorganism.

\(iii\) Health and environmental effects data in its possession or
control concerning the microorganism.

\(iv\) Information on health effects which accompanies any EPA rule or
order issued under TSCA section 4, 5, or 6 of the Act that applies to
the microorganism and of which the manufacturer, importer, or processor
has knowledge.

\(b\) Notification to employees and others. (1) The manufacturer,
importer, or processor must notify the persons identified in
\'725.234(e) by means of a container labeling system, conspicuous
placement of notices in areas where exposure may occur, written
notification to each person potentially exposed, or any other method of
notification which adequately informs persons of health risks which the
manufacturer, importer, or processor has reason to believe may

be associated with the microorganism, as determined under paragraph (a)
of this section.

\(2\) If the manufacturer, importer, or processor distributes a
microorganism manufactured, imported, or processed under this section to
persons not in its employ, the manufacturer, importer, or processor must
in written form:

\(i\) Notify those persons that the microorganism is to be used only for
research and development purposes and the requirements of \'725.234 are
to be met.

\(ii\) Provide the notice of health risks specified in paragraph (b)(1)
of this section.

\(3\) The adequacy of any notification under this section is the
responsibility of the manufacturer, importer, or processor.

\(c\) Recordkeeping. (1) For research conducted in accordance with the
NIH Guidelines, a person who manufactures, imports, or processes a
microorganism under this section must retain the following records: (i)
Documentation that the NIH Guidelines have been adhered to. Such
documentation shall include: (A) For experiments subject to
Institutional Biosafety Committee review, or notification simultaneous
with initiation of the experiment, the information submitted for review
or notification, along with standard laboratory records, shall satisfy
the recordkeeping requirements specified in \'725.234(d)(3).

\(B\) For experiments exempt from Institutional Biosafety Committee
review or notification simultaneous with initiation of the experiment,
documentation of the exemption, along with standard laboratory records,
shall satisfy the recordkeeping requirement specified in
\'725.234(d)(3).

\(ii\) Documentation of how the following requirements are satisfied
under the NIH Guidelines:

\(A\) Copies or citations to information reviewed and evaluated to
determine the need to make any notification of risk.

\(B\) Documentation of the nature and method of notification of risk,
including copies of any labels or written notices used.

\(C\) The names and addresses of any persons other than the
manufacturer, importer, or processor to whom the substance is
distributed, the identity of the microorganism, the amount distributed,
and copies of the notifications required.

\(2\) For all other research conducted in accordance with \'725.234, a
person who manufacturers, imports, or processes a microorganism under
this section, must maintain the following records:

\(i\) Records describing selection and use of containment and/or
inactivation controls required by \'725.234(d)(3) and certification by
an authorized official required by \'725.234(d)(2) for each
microorganism.

\(ii\) Copies or citations to information reviewed and evaluated under
paragraph (a) of this section to determine the need to make any
notification of risk.

\(iii\) Documentation of the nature and method of notification under
paragraph (b)(1) of this section, including copies of any labels or
written notices used.

\(iv\) The names and addresses of any persons other than the
manufacturer, importer, or processor to whom the substance is
distributed, the identity of the microorganism, the amount distributed,
and copies of the notifications required under paragraph (b)(2) of this
section.

\'725.238 Activities conducted outside a structure.

\(a\) Exemption. (1) Research and development activities involving
intentional testing in the environment of certain microorganisms listed
in \'725.239 may be conducted without prior review by EPA if all of the
conditions of this section and \'725.239 are met.

\(2\) The research and development activity involving a microorganism
listed in \'725.239 must be conducted by, or directly under the
supervision of, a technically qualified individual, as defined in
\'725.3.

\(b\) Certification. To be eligible for the exemption under this
section, a manufacturer or importer must submit to EPA prior to
initiation of the activity a document signed by an authorized official
containing the following information:

\(1\) Name, address, and telephone number of the manufacturer or
importer.

\(2\) Location, estimated duration, and planned start date of the test.

\(3\) Certification of the following: (i) Compliance with the conditions
of the exemption specified for the microorganism in \'725.239.

\(ii\) If state and/or local authorities have been notified of the
activity, evidence of notification.

\(c\) Recordkeeping. Persons who conduct research and development
activities under this section must comply with the recordkeeping
requirements of \'725.65 and retain documentation that supports their
compliance with the requirements of this section and the specific
requirements for the microorganism listed in \'725.239.

\'725.239 Use of specific microorganisms in activities conducted outside
a structure.

\(a\) Bradyrhizobium japonicum. To qualify for an exemption under this
section, all of the following conditions must be met for a test
involving Bradyrhizobium japonicum:

\(1\) Characteristics of recipient microorganism. The recipient
microorganism is limited to strains of Bradyrhizobium japonicum.

\(2\) Modification of traits. (i) The introduced genetic material must
meet the criteria for poorly mobilizable listed in \'725.421(c).

\(ii\) The introduced genetic material must consist only of the
following components:

\(A\) The structural gene(s) of interest, which have the following
limitations:

\(1\) For structural genes encoding marker sequences, the gene is
limited to the aadH gene, which confers resistance to the antibiotics
streptomycin and spectinomycin.

\(2\) For traits other than antibiotic resistance, the structural gene
must be limited to the genera Bradyrhizobium and Rhizobium.

\(B\) The regulatory sequences permitting the expression of solely the
gene(s) of interest.

\(C\) Associated nucleotide sequences needed to move genetic material,
including linkers, homopolymers, adaptors, transposons, insertion
sequences, and restriction enzyme sites.

\(D\) The vector nucleotide sequences needed for vector transfer.

\(E\) The vector nucleotide sequences needed for vector maintenance.

\(3\) Limitations on exposure. (i) The test site area must be no more
than 10 terrestrial acres.

\(ii\) The technically qualified individual must select appropriate
methods to limit the dissemination of modified Bradyrhizobium japonicum.

\(b\) Rhizobium meliloti. To qualify for an exemption under this
section, all of the following conditions must be met for a test
involving Rhizobium meliloti:

\(1\) Characteristics of recipient microorganism. The recipient
microorganism is limited to strains of Rhizobium meliloti.

\(2\) Modification of traits. (i) The introduced genetic material must
meet the criteria for poorly mobilizable listed in \'725.421(c) of this
part.

\(ii\) The introduced genetic material must consist only of the
following components:

\(A\) The structural gene(s) of interest, which have the following
limitations:

\(1\) For structural genes encoding marker sequences, the gene is
limited to the aadH gene, which confers resistance to the antibiotics
streptomycin and spectinomycin.

\(2\) For traits other than antibiotic resistance, the structural gene
must be limited to the genera Bradyrhizobium and Rhizobium.

\(B\) The regulatory sequences permitting the expression of solely the
gene(s) of interest.

\(C\) Associated nucleotide sequences needed to move genetic material,
including linkers, homopolymers, adaptors, transposons, insertion
sequences, and restriction enzyme sites.

\(D\) The vector nucleotide sequences needed for vector transfer.

\(E\) The vector nucleotide sequences needed for vector maintenance.

\(3\) Limitations on exposure. (i) The test site area must be no more
than 10 terrestrial acres.

\(ii\) The technically qualified individual must select appropriate
methods to limit the dissemination of modified Rhizobium meliloti.

\'725.250 Procedural requirements for the TERA.

General requirements for all submissions under this part are contained
in subparts A through C of this part. In addition, the following
requirements apply to TERAs submitted under this subpart:

\(a\) When to submit the TERA. Each person who is eligible to submit a
TERA under this subpart must submit the TERA at least 60 calendar days
before the person intends to initiate the proposed research and
development activity.

\(b\) Contents of the TERA. Each person who submits a TERA under this
subpart must provide the information and test data described in
\'\'725.255 and 725.260. In addition, the submitter must supply
sufficient information to enable EPA to evaluate the effects of all
activities for which approval is requested.

\(c\) A person may submit a TERA for one or more microorganisms and one
or more research and development activities, including a research
program.

\(d\) EPA will either approve the TERA, with or without conditions, or
disapprove it under procedures established in this subpart.

\(e\) The manufacturer, importer, or processor who receives a TERA
approval must comply with all terms of the approval, as well as
conditions described in the TERA, and remains liable for compliance with
all terms and conditions, regardless of who conducts the research and
development activity. Any person conducting the research and development
activity approved under the TERA must comply with all terms of the TERA
approval, as well as the conditions described in the TERA.

\(f\) Recordkeeping. Persons submitting a TERA must comply with the
recordkeeping requirements of \'725.65. In addition, the following
requirements apply to TERAs:

\(1\) Each person submitting a TERA under this part must retain
documentation of information contained in the TERA for a period of 3
years from the date that the results of the study are submitted to the
Agency.

\(2\) Summaries of all data, conclusions, and reports resulting from the
conduct of the research and development activity under the TERA must be
submitted to the EPA address identified in \'725.25(c) within 1 year of
the termination of the activity.

\'725.255 Information to be included in the TERA.

\(a\) To review a TERA, EPA must have sufficient information to permit a
reasoned evaluation of the health and environmental effects of the
planned test in the environment. The person seeking EPA approval must
submit all information known to or reasonably ascertainable by the
submitter on the microorganism(s) and the research and development
activity, including information not listed in paragraphs (c), (d), and
(e) of this section that the person believes will be useful for EPA\'s
risk assessment. The TERA must be in writing and must include at least
the information described in the following paragraphs.

\(b\) When specific information is not submitted, an explanation of why
such information is not available or not applicable must be included.

\(c\) Persons applying for a TERA, must include the submitter
identification and microorganism identity information required for MCANs
in \'725.155(c), (d)(1), and (d)(2).

\(d\) Persons applying for a TERA must submit phenotypic and ecological
characteristics information required in \'725.155(d)(3) as it relates
directly to the conditions of the proposed research and development
activity.

\(e\) Persons applying for a TERA must also submit the following
information about the proposed research and development activity:

\(1\) A detailed description of the proposed research and development
activity. (i) The objectives and significance of the activity and a
rationale for testing the microorganisms in the environment.

\(ii\) Number of microorganisms released (including viability per volume
if applicable) and the method(s) of application or release.

\(iii\) Characteristics of the test site(s), including location,
geographical, physical, chemical, and biological features, proximity to
human habitation or activity, and description of site characteristics
that would influence dispersal or confinement.

\(iv\) Target organisms (if the microorganism(s) to be tested has an
intended target), including identification of each target organism and
anticipated mechanism and result of interaction.

\(v\) Planned start date and duration of each activity.

\(vi\) If State and/or local authorities have been notified of the
activity, evidence of notification.

\(2\) Information on monitoring, confinement, mitigation, and emergency
termination procedures. (i) Confinement procedures for the activity,
access and security measures, and procedures for routine termination of
the activity.

\(ii\) Mitigation and emergency procedures.

\(iii\) Measures to detect and control potential adverse effects.

\(iv\) Name of principal investigator and chief of site personnel
responsible for emergency procedures.

\(v\) Personal protective equipment, engineering controls, and
procedures to be followed to minimize dispersion of the microorganism(s)
by people, machinery, or equipment.

\(vi\) Procedures for disposal of any articles, waste, clothing,
machinery, or other equipment involved in the experimental release,
including methods for inactivation of the microorganism(s), containment,
disinfection, and disposal of contaminated items.

\'725.260 Submission of health and environmental effects data.

Each TERA must contain all available data concerning actual or potential
effects on health or the environment of the new microorganism that are
in the possession or control of the submitter and a description of other
data known to or reasonably ascertainable by the submitter that will
permit a reasoned evaluation of the planned test in the environment. The
data must be reported in the manner described in \'725.160(a)(3) and
(b)(3).

\'725.270 EPA review of the TERA.

General procedures for review of all submissions under this part are
contained in \'\'725.28 through 725.60. In addition, the following
procedures apply to EPA review of applications submitted under this
subpart:

\(a\) Length of the review period. (1) The review period for the TERA
will be 60 days from the date the Document Control Officer for the
Office of Pollution Prevention and Toxics receives a

complete TERA, or the date EPA determines the TERA is complete under
\'725.33, unless EPA finds good cause for an extension under \'725.56.

\(2\) A submitter shall not proceed with the research and development
activity described in the TERA unless and until EPA provides written
approval of the TERA. A submitter may receive early approval if a review
is completed in less than 60 days.

\(b\) EPA decision regarding proposed TERA activity. (1) A decision
concerning a TERA under this subpart will be made by the Administrator,
or a designee.

\(2\) If EPA determines that the proposed research and development
activity for the microorganism does not present an unreasonable risk of
injury to health or the environment, EPA will notify the submitter that
the TERA is approved and that the submitter can proceed with the
proposed research and development activity described in the TERA.

\(3\) EPA may include requirements and conditions in its approval of the
TERA that would be stated in the TERA approval under paragraph (c) of
this section.

\(4\) If EPA concludes that it cannot determine that the proposed
research and development activity described in the TERA will not present
an unreasonable risk of injury to health or the environment, EPA will
deny the TERA and will provide reasons for the denial in writing.

\(c\) TERA approval. (1) A TERA approval issued by EPA under this
section is legally binding on the TERA submitter.

\(2\) When EPA approves a TERA, the submitter must conduct the research
and development activity only as described in the TERA and in accordance
with any requirements and conditions prescribed by EPA in its approval
of the TERA.

\(3\) Any person who fails to conduct the research and development
activity as described in the TERA and in accordance with any
requirements and conditions prescribed by EPA in its approval of the
TERA under this section, shall be in violation of sections 5 and 15 of
the Act and be subject to civil and criminal penalties under section 16
of the Act.

\'725.288 Revocation or modification of TERA approval.

\(a\) Significant questions about risk. (1) If, after approval of a TERA
under this subpart, EPA receives information which raises significant
questions about EPA\'s determination that the activity does not present
an unreasonable risk of injury to health or the environment, EPA will
notify the submitter in writing of those questions.

\(2\) The submitter may, within 10 days of receipt of EPA\'s notice,
provide in writing additional information or arguments concerning the
significance of the questions and whether EPA should modify or revoke
the approval of the TERA.

\(3\) After considering any such information and arguments, EPA will
decide whether to change its determination regarding approval of the
TERA.

\(i\) If EPA determines that the activity will not present an
unreasonable risk of injury to health or the environment, it will notify
the submitter in writing. To make this finding, EPA may prescribe
additional conditions which must be followed by the submitter.

\(ii\) If EPA determines that it can no longer conclude that the
activity will not present an unreasonable risk of injury to health or
the environment, it will notify the submitter in writing that EPA is
revoking its approval and state its reasons. In that event, the
submitter must terminate the research and development activity within 48
hours of receipt of the notice in accordance with directions provided by
EPA in the notice.

\(b\) Evidence of unreasonable risk. (1) If, after approval of a TERA
under this subpart, EPA determines that the proposed research and
development activity will present an unreasonable risk of injury to
health or the environment, EPA will notify the submitter in writing and
state its reasons.

\(2\) In the notice, EPA may prescribe additional safeguards to address
or reduce the risk, or may instruct the submitter to suspend the
research and development activities.

\(3\) Within 48 hours, the submitter must implement the instructions
contained in the notice. The submitter may then submit additional
information or arguments concerning the matters raised by EPA and
whether EPA should modify or revoke the approval of the TERA in
accordance with paragraph (a)(2) of this section.

\(4\) EPA will consider the information and arguments in accordance with
paragraph (a)(3) of this section.

\(5\) Following consideration of the information and arguments under
paragraph (a)(3) of this section, if EPA notifies the submitter that the
R&D activity must be suspended or terminted, the submitter may resume
the activity only upon written notice from EPA that EPA has approved
resumption of the activity. In approving resumption of an activity, EPA
may prescribe additional conditions which must be followed by the
submitter.

\(c\) Modifications. If, after approval of a TERA under this subpart,
the submitter concludes that it is necessary to alter the conduct of the
research and development activity in a manner which would result in the
activity being different from that described in the TERA agreement and
any conditions EPA prescribed in its approval, the submitter must inform
the EPA contact for the TERA and may not modify the activity without the
approval of EPA.

Subpart F ‑‑ Exemptions for Test Marketing

\'725.300 Scope and purpose.

\(a\) This subpart describes exemptions from the reporting requirements
under subpart D of this part for test marketing activities involving
microorganisms.

\(b\) In lieu of complying with subpart D of this part, persons
described in \'725.305 may submit an application for a test marketing
exemption (TME).

\(c\) Submission requirements specific for TME applications are
described at \'725.350.

\(d\) Data requirements for TME applications are set forth in \'725.355.

\(e\) EPA review procedures specific for TMEs are set forth in
\'725.370.

\(f\) Subparts A through C of this part apply to any submission under
this subpart.

\'725.305 Persons who may apply under this subpart.

A person identified in this section may apply for a test marketing
exemption. EPA may grant the exemption if the person demonstrates that
the microorganism will not present an unreasonable risk of injury to
health or the environment as a result of the test marketing. A person
may apply under this subpart for the following test marketing
activities:

\(a\) A person who intends to manufacture or import for commercial
purposes a new microorganism.

\(b\) A person who intends to manufacture, import, or process for
commercial purposes a microorganism identified in subpart M of this part
for a significant new use.

\'725.350 Procedural requirements for this subpart.

General requirements for all submissions under this part are contained
in subparts A through C of this part. In addition, the following
requirements apply to applications submitted under this subpart:

\(a\) Prenotice consultation. EPA strongly suggests that for a TME, the
applicant contact EPA for a prenotice consultation regarding eligibility
for a TME.

\(b\) When to submit a TME application. Each person who is eligible to
apply for a TME under this subpart must submit the application at least
45 calendar days before the person intends to commence the test
marketing activity.

\(c\) Recordkeeping. Each person who is granted a TME must comply with
the recordkeeping requirements of \'725.65. In addition, any person who
obtains a TME must retain documentation of compliance with any
restrictions imposed by EPA when it grants the TME. This information
must be retained for 3 years from the final date of manufacture or
import under the exemption.

\'725.355 Information to be included in the TME application.

\(a\) To review a TME application, EPA must have sufficient information
to permit a reasoned evaluation of the health and environmental effects
of the planned test marketing activity. The person seeking EPA approval
must submit all information known to or reasonably ascertainable by the
person on the microorganism and the test marketing activity, including
information not listed in paragraphs (c), (d), and (e) of this section
that the person believes will demonstrate

that the microorganism will not present an unreasonable risk of injury
to health or the environment as a result of the test marketing. The TME
application must be in writing and must include at least the information
described in paragraphs (b), (c), (d), and (e) of this section.

\(b\) When specific information is not submitted, an explanation of why
such information is not available or not applicable must be included.

\(c\) Persons applying for a TME must submit the submitter
identification and microorganism identity information required for MCANs
in \'725.155(c), (d)(1), and (d)(2).

\(d\) Persons applying for a TME must submit phenotypic and ecological
characteristics information required in \'725.155(d)(3) as it relates
directly to the conditions of the proposed test marketing activity.

\(e\) Persons applying for a TME must also submit the following
information about the proposed test marketing activity:

\(1\) Proposed test marketing activity. (i) The maximum quantity of the
microorganism which the applicant will manufacture or import for test
marketing.

\(ii\) The maximum number of persons who may be provided the
microorganism during test marketing.

\(iii\) The maximum number of persons who may be exposed to the
microorganism as a result of test marketing, including information
regarding duration and route of such exposures.

\(iv\) A description of the test marketing activity, including its
duration and how it can be distinguished from full‑scale commercial
production and research and development activities.

\(2\) Health and environmental effects data. All existing data regarding
health and environmental effects of the microorganism must be reported
in accordance with \'725.160.

\'725.370 EPA review of the TME application.

General procedures for review of all submissions under this part are
contained in \'\'725.28 through 725.60. In addition, the following
procedures apply to EPA review of TME applications submitted under this
subpart:

\(a\) No later than 45 days after EPA receives a TME, the Agency will
either approve or deny the application.

\(b\) A submitter may only proceed with test marketing activities after
receipt of EPA approval.

\(c\) In approving a TME application, EPA may impose any restrictions
necessary to ensure that the microorganism will not present an
unreasonable risk of injury to health and the environment as a result of
test marketing.

Subpart G ‑‑ General Exemptions for New Microorganisms

\'725.400 Scope and purpose.

\(a\) This subpart describes exemptions from reporting under subpart D
of this part, and from review under this part altogether, for
manufacturing and importing of certain new microorganisms for commercial
purposes.

\(b\) Recipient microorganisms eligible for the tiered exemption from
review under this part are listed in \'725.420.

\(c\) Criteria for the introduced genetic material contained in the new
microorganisms are described in \'725.421.

\(d\) Physical containment and control technologies are described in
\'725.422.

\(e\) The conditions for the Tier I exemption are listed in \'725.424.

\(f\) In lieu of complying with subpart D of this part, persons using
recipient microorganisms eligible for the tiered exemption may submit a
Tier II exemption request. The limited reporting requirements for the
Tier II exemption, including data requirements, are described in
\'\'725.450 and 725.455.

\(g\) EPA review procedures for the Tier II exemption are set forth in
\'725.470.

\(h\) Subparts A through C of this part apply to any submission under
this subpart.

\'725.420 Recipient microorganisms.

The following recipient microorganisms are eligible for either exemption
under this subpart:

\(a\) Acetobacter aceti.

\(b\) Aspergillus niger.

\(c\) Aspergillus oryzae.

\(d\) Bacillus licheniformis.

\(e\) Bacillus subtilis.

\(f\) Clostridium acetobutylicum.

\(g\) Escherichia coli K‑12.

\(h\) Penicillium roqueforti.

\(i\) Saccharomyces cerevisiae.

\(j\) Saccharomyces uvarum.

\'725.421 Introduced genetic material.

For a new microorganism to qualify for either exemption under this
subpart, introduced genetic material must meet all of the criteria
listed in this section.

\(a\) Limited in size. The introduced genetic material must consist only
of the following:

\(1\) The structural gene(s) of interest.

\(2\) The regulatory sequences permitting the expression of solely the
gene(s) of interest.

\(3\) Associated nucleotide sequences needed to move genetic material,
including linkers, homopolymers, adaptors, transposons, insertion
sequences, and restriction enzyme sites.

\(4\) The nucleotide sequences needed for vector transfer.

\(5\) The nucleotide sequences needed for vector maintenance.

\(b\) Well‑characterized. For introduced genetic material,
well‑characterized 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.

\(c\) Poorly mobilizable. The ability of the introduced genetic material
to be transferred and mobilized is inactivated, with a resulting
frequency of transfer of less than 10‑8 transfer events per recipient.

\(d\) Free of certain sequences. (1) The introduced genetic material
must not contain a functional portion of any of the toxin‑encoding
sequences described in this paragraph (d).

\(i\) For the purposes of this section, a functional portion of a
toxin‑encoding sequence means any sequence which codes for a polypeptide
that has one of the following effects:

\(A\) It directly or indirectly contributes to toxic effects in humans.
Directly contributes to toxic effects in humans means those sequences
encoding polypeptides that have direct toxicity to target cells. An
example of a sequence which directly contributes to toxic effects in
humans is one which encodes the portion of diphtheria toxin, listed in
paragraph (d)(2) of this section, capable of interacting with elongation
factor 2, leading to inhibition of protein synthesis in target

respiratory, heart, kidney, and nerve tissues. Indirectly contributes to
toxic effects in humans means a sequence whose encoded polypeptide is
not directly toxic to target cells, yet still adversely affects humans.
An example of a sequence which indirectly contributes to toxic effects
is the sequence which encodes the portion of the botulinum toxin, listed
in paragraph (d)(3) of this section, capable of blocking the release of
acetylcholine from gangliosides. Botulinum toxin

affects neuromuscular junctions by its blockage of acetylcholine
release, leading to irreversible relaxation of muscles and respiratory
arrest.

\(B\) It binds a toxin or toxin precursor to target human cells.

\(C\) It facilitates intracellular transport of a toxin in target human
cells.

\(ii\) While these toxins are listed (with synonyms in parentheses) in
paragraphs (d)(2) through (d)(7) of this section according to the source
organism, it is use of the nucleotide sequences that encode the toxins
that is being restricted and not the use of the source organisms. The
source organisms are listed to provide specificity in identification of
sequences whose use is restricted. Although similar or identical
sequences may be isolated from organisms other than hose listed below in
paragraphs (d)(2) through (d)(7) of this section, these comparable toxin
sequences, regardless of the organism from which they are derived, must
not be included in the introduced genetic material.

\(2\) Sequences for protein synthesis inhibitor.

Sequence Source Toxin Name

Corynebacterium diphtheriae & C. Diphtheria toxin

ulcerans

Pseudomonas aeruginosa Exotoxin A

Shigella dysenteriae Shigella toxin (Shiga toxin,

Shigella dysenteriae type I

toxin, Vero cell toxin)

Abrus precatorius, seeds Abrin

Ricinus communis, seeds Ricin

\(3\) Sequences for neurotoxins.

Sequence Source Toxin Name

Clostridium botulinum Neurotoxins A, B, C1, D, E,

F, G (Botulinum toxins,

botulinal toxins)

Clostridium tetani Tetanus toxin

(tetanospasmin)

Proteus mirabilis Neurotoxin

Staphylococcus aureus Alpha toxin (alpha lysin)

Yersinia pestis Murine toxin

1 1 Snake toxins \...\...\...\...\...\...\...\...\....

Bungarus caeruleus Caeruleotoxin

Bungarus multicinctus Beta‑bungarotoxin

(phospholipase)

Crotalus spp. Crotoxin (phospholipase)

Dendroaspis viridis Neurotoxin

Naja naja varieties Neurotoxin

Notechia scutatus Notexin (phospholipase)

Oxyuranus scutellatus Taipoxin

Invertebrate toxins

Chironex fleckeri Neurotoxin

Androctnus australis Neurotoxin

Centruroides sculpturatus Neurotoxin

\(4\) Sequences for oxygen labile cytolysins.

Sequence Source Toxin Name

Bacillus alve Alveolysin

Bacillus cereus Cereolysin

Bacillus laterosporus Laterosporolysin

Bacillus thuringiensis Thuringiolysin

Clostridium bifermentans Lysin

Clostridium botulinum Lysin

Clostridium caproicum Lysin

Clostridium chauvoei Delta‑toxin

Clostridium histolyticum Epsilon‑toxin

Clostridium novyi Gamma‑toxin

Clostridium oedematiens Delta‑toxin

Clostridium perfringens Theta‑toxin (Perfringolysin)

Clostridium septicum Delta‑toxin

Clostridium sordellii Lysin

Clostridium tetani Tetanolysin

Listeria monocytogenes Listeriolysin (A B)

Streptococcus pneumoniae Pneumolysin

Streptococcus pyogene Streptolysin O (SLO)

\(5\) Sequences for toxins affecting membrane function.

Sequence Source Toxin Name

Bacillus anthracis Edema factor (Factors I II); Lethal factor (Factors
II III)

Bacillus cereus Enterotoxin (diarrheagenic

toxin, mouse lethal factor)

Bordetella pertussis Adenylate cyclase (Heat‑labile factor); Pertussigen

(pertussis toxin, islet activating factor, histamine sensitizing factor,
lymphocytosis promoting factor)

Clostridium botulinum C2 toxin

Clostridium difficile Enterotoxin (toxin A)

Clostridium perfringens Beta‑toxin; Delta‑toxin

Escherichia coli & other Heat‑labile enterotoxins

Enterobacteriaceae spp. (LT); Heat‑stable enterotoxins (STa, ST1

subtypes ST1a ST1b; also STb, STII)

Legionella pneumophila Cytolysin

Vibrio cholerae & Vibrio mimicus Cholera toxin (choleragen)

\(6\) Sequences that affect membrane integrity.

Sequence Source Toxin Name

Clostridium bifermentans & other Lecithinase

Clostridium spp

Clostridium perfringens Alpha‑toxin (phospholipase C, lecithinase);
Enterotoxin

Corynebacterium pyogenes & other Cytolysin (phospholipase C),

Corynebacterium spp. Ovis toxin (sphingomyelinase D)

Staphylococcus aureus Beta‑lysin (beta toxin)

\(7\) Sequences that are general cytotoxins.

Sequence Source Toxin Name

Adenia digitata Modeccin

Aeromonas hydrophila Aerolysin (beta‑lysin, cytotoxic lysin)

Clostridium difficile Cytotoxin (toxin B)

Clostridium perfringens Beta‑toxin; Epsilon‑toxin; Kappa‑toxin

Escherichia coli & other Cytotoxin (Shiga‑like toxin,

Enterobacteriaceae spp. Vero cell toxin)

Pseudomonas aeruginosa Proteases

Staphylococcus aureus Gamma lysin (Gamma toxin); Enterotoxins (SEA, SEB,

SEC, SED SEE); Pyrogenic exotoxins A B; Toxic shock

syndrome toxins (TSST‑1)

Staphylococcus aureus &

Pseudomonas aeruginosa Leucocidin (leukocidin, cytotoxin)

Streptococcus pyogenes Streptolysin S (SLS); Erythrogenic toxins(scarlet
fever

toxins, pyrogenic exotoxins)

Yersinia enterocolitica Heat‑stable enterotoxins (ST)

\'725.422 Physical containment and control technologies.

The manufacturer must meet all of the following criteria for physical
containment and control technologies for any facility in which the new
microorganism will be used for a Tier I exemption; these criteria also
serve as guidance for a Tier II exemption.

\(a\) Use a structure that is designed and operated to contain the new
microorganism.

\(b\) Control access to the structure.

\(c\) Provide written, published, and implemented procedures for the
safety of personnel and control of hygiene.

\(d\) Use inactivation procedures demonstrated and documented to be
effective against the new microorganism contained in liquid and solid
wastes prior to disposal of the wastes. The inactivation procedures must
reduce viable microbial populations by at least 6 logs in liquid and
solid wastes.

\(e\) Use features known to be effective in minimizing viable microbial
populations in aerosols and exhaust gases released from the structure,
and document use of such features.

\(f\) Use systems for controlling dissemination of the new microorganism
through other routes, and document use of such features.

\(g\) Have in place emergency clean‑up procedures.

\'725.424 Requirements for the Tier I exemption.

\(a\) Conditions of exemption. The manufacture or import of a new
microorganism for commercial purposes is not subject to review under
this part if all of the following conditions are met for all activities
involving the new microorganism:

\(1\) The recipient microorganism is listed in and meets any
requirements specified in \'725.420.

\(2\) The introduced genetic material meets the criteria under
\'725.421.

\(3\) The physical containment and control technologies of any facility
in which the microorganism will be manufactured, processed, or used meet
the criteria under \'725.422.

\(4\) The manufacturer or importer submits a certification described in
paragraph (b) of this section to EPA at least 10 days before commencing
initial manufacture or import of a new microorganism derived from a
recipient microorganism listed in \'725.420.

\(5\) The manufacturer or importer complies with the recordkeeping
requirements of \'725.65 and maintains records for the initial and
subsequent uses of the new microorganism that verify compliance with the
following:

\(i\) The certifications made in paragraph (b) of this section.

\(ii\) All the eligibility criteria for the Tier I exemption including
the criteria for the recipient microorganism, the introduced genetic
material, the physical containment and control technologies.

\(b\) Certification. To be eligible for the Tier I exemption under this
subpart, the manufacturer or importer must submit to EPA a document
signed by a responsible company official containing the information
listed in this paragraph.

\(1\) Name and address of manufacturer or importer.

\(2\) Date when manufacture or import is expected to begin.

\(3\) The identification (genus, species) of the recipient microorganism
listed in \'725.420 which is being used to create the new microorganism
which will be used under the conditions of the Tier I exemption.

\(4\) Certification of the following:

\(i\) Compliance with the introduced genetic material criteria described
in \'725.421.

\(ii\) Compliance with the containment requirements described in
\'725.422, including the provision in paragraph (a)(3) of this section.

\(5\) The site of waste disposal and the type of permits for disposal,
the permit numbers and the institutions issuing the permits.

\(6\) The certification statement required in \'725.25(b). Certification
of submission of test data is not required for the Tier I exemption.

\'725.426 Applicability of the Tier I exemption.

The Tier I exemption under \'725.424 applies only to a manufacturer or
importer of a new microorganism that certifies that the microorganism
will be used in all cases in compliance with \'\'725.420, 725.421, and
725.422.

\'725.428 Requirements for the Tier II exemption.

The manufacturer or importer of a new microorganism for commercial
purposes may submit to EPA a Tier II exemption request in lieu of a MCAN
under subpart D of this part if all of the following conditions are met:

\(a\) The recipient microorganism is listed in and meets any
requirements specified in \'725.420.

\(b\) The introduced genetic material meets the criteria under
\'725.421.

\(c\) Adequate physical containment and control technologies are used.
The criteria listed under \'725.422 for physical containment and control
technologies of facilities should be used as guidance to satisfy the
Tier II exemption request data requirements listed at \'725.455(d). EPA
will review proposed process and containment procedures as part of the
submission for a Tier II exemption under this section.

\'725.450 Procedural requirements for the Tier II exemption.

General requirements for all submissions under this part are contained
in \'725.25. In addition, the following requirements apply to requests
submitted under this subpart:

\(a\) Prenotice consultation. EPA strongly suggests that for a Tier II
exemption, the submitter contact the Agency for a prenotice consultation
regarding eligibility for the exemption.

\(b\) When to submit the Tier II exemption request. Each person who is
eligible to submit a Tier II exemption request under this subpart must
submit the request at least 45 calendar days before the person intends
to commence manufacture or import.

\(c\) Contents of the Tier II exemption request. Each person who submits
a request under this subpart must provide the information described in
\'\'725.428 and 725.455, as well as information known to or reasonably
ascertainable by the person that would permit EPA to determine that use
of the microorganism, under the conditions specified in the

request, will not present an unreasonable risk of injury to health or
the environment.

\(d\) Recordkeeping. Each person who submits a request under this
subpart must comply with the recordkeeping requirements of \'725.65. In
addition, the submitter should maintain records which contain
information that verifies compliance with the following:

\(1\) The certifications made in the request.

\(2\) All the eligibility criteria for the Tier II exemption request
including the criteria for the recipient microorganism, the introduced
genetic material, the physical containment and control technologies.

\'725.455 Information to be included in the Tier II exemption request.

The submitter must indicate clearly that the submission is a Tier II
exemption request for a microorganism instead of the MCAN under subpart
D of this part and must submit the following information:

\(a\) Submitter identification. (1) The name and headquarters address of
the submitter.

\(2\) The name, address, and office telephone number (including area
code) of the principal technical contact representing the submitter.

\(b\) Microorganism identity information. (1) Identification (genus,
species, and strain) of the recipient microorganism. Genus, species
designation should be substantiated by a letter from a culture
collection or a brief summary of the results of tests conducted for
taxonomic identification.

\(2\) Type of genetic modification and the function of the introduced
genetic material.

\(3\) Site of insertion.

\(4\) Certification of compliance with the introduced genetic material
criteria described in \'725.421.

\(c\) Production volume. Production volume, including total liters per
year, and the maximum cell concentration achieved during the production
process.

\(d\) Process and containment information. (1) A description of the
process including the following: (i) Identity and location of the
manufacturing site(s).

\(ii\) Process flow diagram illustrating the production process,
including downstream separations, and indicating the containment
envelope around the appropriate equipment.

\(iii\) Identities and quantities of feedstocks.

\(iv\) Sources and quantities of potential releases to both the
workplace and environment, and a description of engineering controls,
inactivation procedures, and other measures which will reduce worker
exposure and environmental releases.

\(v\) A description of procedures which will be undertaken to prevent
fugitive emissions, i.e. leak detection and repair program.

\(vi\) A description of procedures/safeguards to prevent and mitigate
accidental releases to the workplace and the environment.

\(2\) Certification of those elements of the containment criteria
described in \'725.422 with which the manufacturer is in compliance,
including stating by number the elements with which the manufacturer is
in full compliance.

\(e\) The site of waste disposal and the type of permits for disposal,
the permit numbers and the institutions issuing the permits.

\(f\) The certification statement required in \'725.25(b). Certification
of submission of test data is not required for the Tier II exemption.

\'725.470 EPA review of the Tier II exemption request.

General procedures for review of all submissions under this part are
contained in \'\'725.28 through 725.60. In addition, the following
procedures apply to EPA review of Tier II exemption requests submitted
under this subpart:

\(a\) Length of the review period. The review period for the request
will be 45 days from the date the Document Control Officer for the
Office of Pollution Prevention and Toxics receives a complete request,
or the date EPA determines the request is complete under \'725.33,
unless the Agency extends the review period for good cause under
\'725.56.

\(b\) Criteria for review. EPA will review the request to determine that
the new microorganism complies with \'725.428 and that its manufacture,
processing, use, and disposal as described in the request will not
present an unreasonable risk of injury to health or the environment.

\(c\) EPA decision regarding the Tier II exemption request. A decision
concerning a request under this subpart will be made by the
Administrator, or a designee.

\(d\) Determination that the microorganism is ineligible for a Tier II
review. (1) EPA may determine that the manufacturer or importer is not
eligible for Tier II review, because the microorganism does not meet the
criteria under \'725.428 or the Administrator, or a designee, decides
that there is insufficient information to determine that the conditions
of manufacture, processing, use, or disposal of the microorganism as
described in the request will not present an unreasonable risk to health
or the environment.

\(2\) If the Agency makes this determination, the Administrator, or a
designee will notify the manufacturer or importer by telephone, followed
by a letter, that the request has been denied. The letter will explain
reasons for the denial.

\(3\) If the request is denied, the manufacturer or importer may submit
the information necessary to constitute a MCAN under subpart D of this
part.

\(e\) Approval or denial of the Tier II exemption request. (1) No later
than 45 days after EPA receives a request, the Agency will either
approve or deny the request.

\(2\) In approving a request, EPA may impose any restrictions necessary
to ensure that the microorganism will not present an unreasonable risk
of injury to health and the environment as a result of general
commercial use.

\(f\) EPA may seek to enjoin the manufacture or import of a
microorganism in violation of this subpart, or act to seize any
microorganism manufactured or imported in violation of this section or
take other actions under the authority of sections 7 or 17 of the Act.

\(g\) A manufacturer or importer may only proceed after receipt of EPA
approval.

Subparts H‑K \[Reserved\]

Subpart L ‑‑ Additional Procedures for Reporting on Significant New Uses
of Microorganisms

\'725.900 Scope and purpose.

\(a\) This subpart describes additional provisions governing submission
of MCANs for microorganisms subject to significant new use rules
identified in subpart M of this part.

\(b\) Manufacturers, importers, and processors described in \'725.105(c)
must submit a MCAN under subpart D of this part for significant new uses
of microorganisms described in subpart M of this part, unless they are
excluded under \'\'725.910 or 725.912.

\(c\) Section 725.920 discusses exports and imports.

\(d\) Additional recordkeeping requirements specific to significant new
uses of microorganisms are described in \'725.950.

\(e\) Section 725.975 describes how EPA will approve alternative means
of complying with significant new use requirements designated in subpart
M of this part.

\(f\) Expedited procedures for promulgating significant new use
requirements under subpart M of this part for microorganisms subject to
section 5(e) orders are discussed in \'\'725.980 and 725.984.

\(g\) This subpart L contains provisions governing submission and review
of notices for the microorganisms and significant new uses identified in
subpart M of this part. The provisions of this subpart L apply to the
microorganisms and significant new uses identified in subpart M of this
part, except to the extent that they are specifically modified or
supplanted by specific requirements in subpart M of this part. In the
event of a conflict between the provisions of this

subpart L and the provisions of subpart M of this part, the provisions
of subpart M of this part shall govern.

\(h\) The provisions of subparts A through F of this part also apply to
subparts L and M of this part. For purposes of subparts L and M of this
part, wherever the words \"microorganism\" or \"new microorganism\"
appear in subparts A through F of this part, it shall mean the
microorganism subject to subparts L and M of this part. In the event of
a conflict between the provisions of subparts A through F and the
provisions of subparts L and M of this part, the provisions of subparts
L and M of this part shall govern.

\'725.910 Persons excluded from reporting significant new uses.

\(a\) A person who intends to manufacture, import, or process a
microorganism identified in subpart M of this part and who intends to
distribute it in commerce is not required to submit a MCAN under subpart
D of this part, if that person can document one or more of the following
as to each recipient of the microorganism from that person:

\(1\) That the person has notified the recipient, in writing, of the
specific section in subpart M of this part which identifies the
microorganism and its designated significant new uses, or

\(2\) That the recipient has knowledge of the specific section in
subpart M of this part which identifies the microorganism and its
designated significant new uses, or

\(3\) That the recipient cannot undertake any significant new use
described in the specific section in subpart M of this part.

\(b\) The manufacturer, importer, or processor described in paragraph
(a) of this section must submit a MCAN under subpart D of this part, if
such person has knowledge at the time of commercial distribution of the
microorganism identified in the specific section in subpart M of this
part that a recipient intends to engage in a designated significant new
use of that microorganism without submitting a MCAN under this part.

\(c\) A person who processes a microorganism identified in a specific
section in subpart M of this part for a significant new use of that
microorganism is not required to submit a MCAN if that person can
document each of the following:

\(1\) That the person does not know the specific microorganism identity
of the microorganism being processed, and

\(2\) That the person is processing the microorganism without knowledge
that the microorganism is identified in subpart M of this part.

(d)(1) If at any time after commencing distribution in commerce of a
microorganism identified in a specific section in subpart M of this
part, a person who manufactures, imports, or processes a microorganism
described in subpart M of this part and distributes it in commerce has
knowledge that a recipient of the microorganism is engaging in a
significant new use of that microorganism designated in that section
without submitting a MCAN under this part, the person is required to
cease supplying the microorganism to that recipient and to submit a MCAN
for that microorganism and significant new use, unless the person is
able to document each of the following:

\(i\) That the person has notified the recipient and EPA enforcement
authorities (at the address in paragraph (d)(1)(iii) of this section),
in writing within 15 working days of the time the person develops
knowledge that the recipient is engaging in a significant new use, that
the recipient is engaging in a significant new use without submitting a
MCAN.

\(ii\) That, within 15 working days of notifying the recipient as
described in paragraph (d)(1)(i) of this section, the person received
from the recipient, in writing, a statement of assurance that the
recipient is aware of the terms of the applicable section in subpart M
of this part and will not engage in the significant new use.

\(iii\) That the person has promptly provided EPA enforcement
authorities with a copy of the recipient\'s statement of assurance
described in paragraph (d)(1)(ii) of this section. The copy must be sent
to the Director, Office of Compliance (2221A), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

\(2\) If EPA notifies the manufacturer, importer, or processor that the
recipient is engaging in a significant new use after providing the
statement of assurance described in paragraph (d)(1)(ii) of this section
and without submitting a MCAN under this part, the manufacturer,
importer, or processor shall immediately cease distribution to that
recipient until the manufacturer, importer, or processor or the
recipient has submitted a MCAN under this part and the MCAN review

period has ended.

\(3\) If, after receiving a statement of assurance from a recipient
under paragraph (d)(1)(ii) of this section, a manufacturer, importer, or
processor has knowledge that the recipient is engaging in a significant
new use without submitting a MCAN under this part, the manufacturer,
importer, or processor must immediately cease distributing the
microorganism to that recipient and notify EPA enforcement authorities
at the address identified in paragraph (d)(1)(iii) of this section. The
manufacturer, importer, or processor may not resume distribution to that
recipient until any one of the following has occurred:

\(i\) The manufacturer, importer, or processor has submitted a MCAN
under this part and the MCAN review period has ended.

\(ii\) The recipient has submitted a MCAN under this part and the MCAN
review period has ended.

\(iii\) The manufacturer, importer, or processor has received notice
from EPA enforcement authorities that it may resume distribution to that
recipient.

\'725.912 Exemptions.

Persons identified in \'725.105(c) are not required to submit a MCAN
under subpart D of this part for a microorganism identified in subpart M
of this part, unless otherwise specified in a specific section in
subpart M, if:

\(a\) The person submits a MCAN for the microorganism prior to the
promulgation date of the section in subpart M of this part which
identifies the microorganism, and the person receives written
notification of compliance from EPA prior to the effective date of such
section. The MCAN submitter must comply with any applicable requirement
of section 5(b) of the Act. The MCAN must include the information and
test data specified in section 5(d)(1) of the Act. For

purposes of this exemption, the specific section in subpart M of this
part which identifies the microorganism and \'\'725.3, 725.15, 725.65,
725.70, 725.75, 725.100, and 725.900 apply; after the effective date of
the section in subpart M of this part which identifies the
microorganism, \'\'725.105 and 725.910 apply and \'725.920 continues to
apply. EPA will provide the MCAN submitter with written notification of
compliance only if one of the following occurs:

\(1\) EPA is unable to make the finding that the activities described in
the MCAN will or may present an unreasonable risk of injury to health or
the environment under reasonably foreseeable circumstances, or

\(2\) EPA and the person negotiate a consent order under section 5(e) of
the Act, such order to take effect on the effective date of the section
in subpart M of this part which identifies the microorganism.

\(b\) The person is operating under the terms of a consent order issued
under section 5(e) of the Act applicable to that person. If a provision
of such section 5(e) order is inconsistent with a specific significant
new use identified in subpart M of this part, abiding by the provision
of the section 5(e) order exempts the person from submitting a MCAN for
that specific significant new use.

\'725.920 Exports and imports.

\(a\) Exports. Persons who intend to export a microorganism identified
in subpart M of this part, or in any proposed rule which would amend
subpart M of this part, are subject to the export notification
provisions of section 12(b) of the Act. The regulations that interpret
section 12(b) appear at part 707 of this chapter.

\(b\) Imports. Persons who import a substance identified in a specific
section in subpart M of this part are subject to the import
certification requirements under section 13 of the Act, which are
codified at 19 CFR \'\'12.118 through 12.127 and 127.28(i). The EPA
policy in support of the import certification requirements appears at
part 707 of this chapter.

\'725.950 Additional recordkeeping requirements.

Persons submitting a MCAN for a significant new use of a microorganism
must comply with the recordkeeping requirements of \'725.65. In
addition, the following requirements apply:

\(a\) At the time EPA adds a microorganism to subpart M of this part,
EPA may specify appropriate recordkeeping requirements. Each
manufacturer, importer, and processor of the microorganism shall
maintain the records for 3 years from the date of their creation.

\(b\) The records required to be maintained under this section may
include the following:

\(1\) Records documenting the information contained in the MCAN
submitted to EPA.

\(2\) Records documenting the manufacture and importation volume of the
microorganism and the corresponding dates of manufacture and import.

\(3\) Records documenting volumes of the microorganism purchased
domestically by processors of the microorganism, names and addresses of
suppliers and corresponding dates of purchase.

\(4\) Records documenting the names and addresses (including shipment
destination address, if different) of all persons outside the site of
manufacture or import to whom the manufacturer, importer, or processor
directly sells or transfers the microorganism, the date of each sale or
transfer, and the quantity of the microorganism sold or transferred on
such date.

\'725.975 EPA approval of alternative control measures.

\(a\) In certain sections of subpart M of this part, significant new
uses for the identified microorganisms are described as the failure to
establish and implement programs providing for the use of either:
specific measures to control worker exposure to or release of
microorganisms which are identified in such sections, or alternative
measures to control worker exposure or environmental release which EPA
has determined provide substantially the same degree of

protection as the specified control measures. Persons who manufacture,
import, or process a microorganism identified in such sections and who
intend to employ alternative measures to control worker exposure or
environmental release must submit a request to EPA for a

determination of equivalency before commencing manufacture, import, or
processing involving the alternative control measures.

\(b\) A request for a determination of equivalency must be submitted in
writing to the Office of Pollution Prevention and Toxics, Document
Control Officer, 7407, 1200 Pennsylvania Ave., NW., Washington, DC
20460: ATTN: SNUR Equivalency Determination, and must contain:

\(1\) The name of the submitter.

\(2\) The specific identity of the microorganism.

\(3\) The citation for the specific section in subpart M of this part
which pertains to the microorganism for which the request is being
submitted.

\(4\) A detailed description of the activities involved.

\(5\) The specifications of the alternative worker exposure control
measures or environmental release control measures.

\(6\) A detailed analysis explaining why such alternative control
measures provide substantially the same degree of protection as the
specific control measures identified in the specific section in subpart
M of this part which pertains to the microorganism for which the request
is being submitted.

\(7\) The data and information described in \'\'725.155 and 725.160. If
such data and information have already been submitted to EPA\'s Office
of Pollution Prevention and Toxics, the submitter need only document
that it was previously submitted, to whom, and the date it was
submitted.

\(c\) Requests for determinations of equivalency will be reviewed by EPA
within 45 days. Determinations under this paragraph will be made by the
Director, or a designee. Notice of the results of such determinations
will be mailed to the submitter.

\(d\) If EPA notifies the submitter under paragraph (c) of this section
that EPA has determined that the alternative control measures provide
substantially the same degree of protection as the specified control
measures identified in the specific section of subpart M of this part
which pertains to the microorganism for which the request is being
submitted, the submitter may commence manufacture, import, or processing
in accordance with the specifications for alternative worker exposure
control measures or environmental release control measures identified in
the submitter\'s request, and may alter any corresponding notification
to workers to reflect such alternative controls. Deviations from the
activities described in the EPA notification constitute a significant
new use and are subject to the requirements of this part.

\'725.980 Expedited procedures for issuing significant new use rules for
microorganisms subject to section 5(e) orders.

\(a\) Selection of microorganisms. (1) In accordance with the expedited
process specified in this section, EPA will issue significant new use
notification requirements for each new microorganism that, after MCAN
review under subpart D of this part, becomes subject to a final order
issued under section 5(e) of the Act, except for an order that prohibits
manufacture and import of the microorganism, unless EPA determines that
significant new use notification

requirements are not needed for the microorganism.

\(2\) If EPA determines that significant new use notifications
requirements are not needed for a microorganism that is subject to a
final order issued under section 5(e) of the Act, EPA will issue a
notice in the FEDERAL REGISTER explaining why the significant new use
requirements are not needed.

\(b\) Designation of requirements. (1) The significant new use
notification and other specific requirements will be based on and be
consistent with the provisions included in the final order issued for
the microorganism under section 5(e) of the Act. EPA may also designate
additional activities as significant new uses which will be subject to
notification.

\(2\) Significant new use requirements and other specific requirements
designated under this section will be listed in subpart M of this part.
For each microorganism, subpart M of this part will identify:

\(i\) The microorganism name.

\(ii\) The activities designated as significant new uses.

\(iii\) Other specific requirements applicable to the microorganism,
including recordkeeping requirements or any other requirements included
in the final section 5(e) order.

\(c\) Procedures for issuing significant new use rules. (1) Possible
processes. EPA will issue significant new use rules (SNURs) under this
section by one of the following three processes: direct final
rulemaking, interim final rulemaking, or notice and comment rulemaking.
EPA will use the direct final rulemaking process to issue significant
new use rules unless it determines that, in a particular case, one of
the other processes is more appropriate.

\(2\) Notice in the FEDERAL REGISTER. FEDERAL REGISTER documents issued
to propose or establish significant new uses under this section will
contain the following:

\(i\) The microorganism identity or, if its specific identity is claimed
confidential, an appropriate generic microorganism name and an accession
number assigned by EPA.

\(ii\) The MCAN number.

\(iii\) A summary of EPA\'s findings under section 5(e)(1)(A) of the Act
for the final order issued under section 5(e).

\(iv\) Designation of the significant new uses subject to, or proposed
to be subject to, notification and any other applicable requirements.

\(v\) Any modification of subpart L of this part applicable to the
specific microorganism and significant new uses.

\(vi\) If the FEDERAL REGISTER document establishes a final rule, or
notifies the public that a final rule will not be issued after public
comment has been received, the document will describe comments received
and EPA\'s response.

\(3\) Direct final rulemaking. (i) EPA will use direct final rulemaking
to issue a significant new use rule, when specific requirements will be
based on and be consistent with the provisions included in the final
order issued for the microorganism under section 5(e) of the Act. EPA
will issue a final rule in the FEDERAL REGISTER following its decision
to develop a significant new use rule under this section for a specific
new microorganism.

\(ii\) The FEDERAL REGISTER document will state that, unless written
notice is received by EPA within 30 days of publication that someone
wishes to submit adverse or critical comments, the rule will be
effective 60 days from the date of publication. The written notice of
intent to submit adverse or critical comments should state which SNUR(s)
will be the subject of the adverse or critical comments, if several
SNURs are established through the direct final rule. If

notice is received within 30 days that someone wishes to submit adverse
or critical comments, the section(s) of the direct final rule containing
the SNUR(s) for which a notice of intent to comment was received will be
withdrawn by EPA issuing a document in the final rule section of the
FEDERAL REGISTER, and a proposal will be published in the proposed rule
section of the FEDERAL REGISTER. The proposal will establish a 30‑day
comment period.

\(iii\) If EPA, having considered any timely comments submitted in
response to the proposal, decides to establish notification requirements
under this section, EPA will issue a final rule adding the microorganism
to subpart M of this part and designating the significant new uses
subject to notification.

\(4\) Interim final rulemaking. (i) EPA will use the interim final
rulemaking procedure to issue a significant new use rule, when specific
requirements will be based on and be consistent with the provisions
included in the final order issued for the microorganism under section
5(e) of the Act. The Agency will issue an interim final rule in the
FEDERAL REGISTER following its decision to develop a significant new use
rule for a specific new microorganism. The document will state EPA\'s
reasons for using the interim final rulemaking procedure.

\(A\) The significant new use rule will take effect on the date of
publication.

\(B\) Persons will be given 30 days from the date of publication to
submit comments.

\(ii\) Interim final rules issued under this section shall cease to be
in effect 180 days after publication unless, within the 180‑day period,
EPA issues a final rule in the FEDERAL REGISTER responding to any
written comments received during the 30‑day comment period specified in
paragraph (c)(4)(i)(B) of this section and promulgating final
significant

new use notification requirements and other requirements for the
microorganism.

\(5\) Notice and comment rulemaking. (i) EPA will use a notice and
comment procedure to issue a significant new use rule, when EPA is
designating additional activities which are not provisions included in
the final order issued for the microorganism under section 5(e) of the
Act as significant new uses which will be subject to notification. EPA
will issue a proposal in the FEDERAL REGISTER following its decision to
develop a significant new use rule under this

section for a specific new microorganism. Persons will be given 30 days
to comment on whether EPA should establish notification requirements for
the microorganism under this part.

\(ii\) If EPA, having considered any timely comments, decides to
establish notification requirements under this section, EPA will issue a
final rule adding the microorganism to subpart M of this part and
designating the significant new uses subject to notification.

\(d\) Schedule for issuing significant new use rules. (1) Unless EPA
determines that a significant new use rule should not be issued under
this section, EPA will issue a proposed rule, a direct final rule, or an
interim final rule within180 days of receipt of a valid notice of
commencement under \'725.190.

\(2\) If EPA receives adverse or critical significant comments following
publication of a proposed or interim final rule, EPA will either
withdraw the rule or issue a final rule addressing the comments
received.

\'725.984 Modification or revocation of certain notification
requirements.

\(a\) Criteria for modification or revocation. EPA may at any time
modify or revoke significant new use notification requirements for a
microorganism which has been added to subpart M of this part using the
procedures of \'725.980. Such action may be taken under this section if
EPA makes one of the following determinations, unless other information
shows that the requirements should be retained:

\(1\) Test data or other information obtained by EPA provide a
reasonable basis for concluding that activities designated as
significant new uses of the microorganism will not present an
unreasonable risk of injury to health or the environment.

\(2\) EPA has promulgated a rule under section 4 or 6 of the Act, or EPA
or another agency has taken action under another law, for the
microorganism that eliminates the need for significant new use
notification under section 5(a)(2) of the Act.

\(3\) EPA has received MCANs for some or all of the activities
designated as significant new uses of the microorganism and, after
reviewing such MCANs, concluded that there is no need to require
additional notice from persons who propose to engage in identical or
similar activities.

\(4\) EPA has examined new information, or has reexamined the test data
or other information supporting its finding under section
5(e)(1)(A)(ii)(I) of the Act and has concluded that a rational basis no
longer exists for the findings that activities involving the
microorganism may present an unreasonable risk of injury to health or
the environment required under section 5(e)(1)(A) of the Act.

\(5\) Certain activities involving the microorganism have been
designated as significant new uses pending the completion of testing,
and adequate test data developed in accordance with applicable
procedures and criteria have been submitted to EPA.

\(b\) Procedures for limitation or revocation. Modification or
revocation of significant new use notification requirements for a
microorganism that has been added to subpart M of this part using the
procedures described in \'725.980 may occur either at EPA\'s initiative
or in response to a written request.

\(1\) Any affected person may request modification or revocation of
significant new use notification requirements for a microorganism that
has been added to subpart M of this part using the procedures described
in \'725.980 by writing to the Director, or a designee, and stating the
basis for such request. The request must be accompanied by information
sufficient to support the request. All requests should be sent to the
TSCA Document Processing Center (7407), Room

L‑100, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW., Washington, DC 20460, ATTN: Request to amend SNUR.

\(2\) The Director, or a designee, will consider the request, make a
determination whether to initiate rulemaking to modify the requirements,
and notify the requester of that determination by certified letter. If
the request is denied, the letter will explain why EPA has concluded
that the significant new use notification requirements for that
microorganism should remain in effect.

\(3\) If EPA concludes that significant new use notification
requirements for a microorganism should be limited or revoked, EPA will
propose the changes in a notice in the FEDERAL REGISTER, briefly
describe the grounds for the action, and provide interested parties an
opportunity to comment.

Subpart M ‑‑ Significant New Uses for Specific Microorganisms

\'725.1000 Scope.

This subpart identifies uses of microorganisms which EPA has determined
to be significant new uses under the authority of section 5(a)(2) of the
Toxic Substances Control Act.

\'725.1075 Burkholderia cepacia complex.

\(a\) Microorganism and significant new uses subject to reporting. (1)
The microorganisms identified as the Burkholderia cepacia complex
defined as containing the following nine species, Burkholderia cepacia,
Burkholderia multivorans, Burkholderia stabilis, Burkholderia
vietnamiensis, Burkholderia ambifaria, Burkholderia pyrrocinia,
Burkholderia cepacia genomovar VIII (Burkholderia anthina), and
Burkholderia cepacia genomovars III and VI are subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.

\(2\) The significant new use is any use other than research and
development in the degradation of chemicals via injection into
subsurface groundwater.

\(b\) \[Reserved\]

\[68 FR 35320, June 13, 2003\]