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Pt. 725
Subpart B—Administrative Procedures
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 section may be
subject to penalties calculated as if
they never filed their notices.
(6) EPA may seek to enjoin the manufacture or processing of a chemical
substance in violation of this section
or act to seize any chemical substance
manufactured or processed in violation
of this section 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).
(m) Inspections. EPA will conduct inspections under section 11 of the Act to
assure compliance with section 5 and
this section, to verify that information
submitted to EPA under this section is
true and correct, and to audit data submitted to EPA under this section.
(n) Confidentiality. If a manufacturer
submits information to EPA under this
section which the manufacturer claims
to be confidential business information, the manufacturer must clearly
identify the information at the time of
submission to EPA by bracketing, circling, or underlining it and stamping it
with ‘‘CONFIDENTIAL’’ or some other
appropriate designation. Any information so identified will be treated in accordance with the procedures in 40 CFR
part 2. Any information not claimed
confidential at the time of submission
may be made available to the public
without further notice.
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.
[60 FR 16332, Mar. 29, 1995, as amended at 62
FR 17932, Apr. 11, 1997; 75 FR 4305, Jan. 27,
2010]
PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES
FOR MICROORGANISMS
Subpart E—Exemptions for Research and
Development Activities
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Subpart A—General Provisions and
Applicability
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.
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.
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§ 725.1
40 CFR Ch. I (7–1–18 Edition)
725.1075
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.
SOURCE: 62 FR 17932, Apr. 11, 1997, unless
otherwise noted.
Subpart A—General Provisions
and Applicability
Subpart F—Exemptions for Test Marketing
§ 725.1
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.
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.
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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,
Subpart G—General Exemptions for New
Microorganisms
Subpart M—Significant New Uses for
Specific Microorganisms
725.1000
Burkholderia cepacia complex.
AUTHORITY: 15 U.S.C. 2604, 2607, 2613, and
2625.
Scope.
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Environmental Protection Agency
§ 725.3
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.
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.
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§ 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.
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§ 725.3
40 CFR Ch. I (7–1–18 Edition)
(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’’)
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Environmental Protection Agency
§ 725.12
means quantities of a microorganism
manufactured, imported, or processed
or proposed to be manufactured, imported, or processed solely for research
and development that meet the requirements of § 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
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§ 725.15
40 CFR Ch. I (7–1–18 Edition)
(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 (including 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 (including import) or
process a microorganism, the person
who proposes to manufacture (including import) or process the microorganism must submit the request to EPA
via CDX. Prior to submission to EPA
via CDX, such bona fide intents to manufacture (including import) or process
must be generated and completed using
e-PMN
software.
See
40
CFR
720.40(a)(2)(ii) for information on how
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.
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§ 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.
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Environmental Protection Agency
§ 725.20
to access the e-PMN software. A bona
fide intent to manufacture (including
import) or process must contain the
following information:
(i) Taxonomic designations and supplemental information required by
§ 725.12.
(ii) A signed statement certifying
that the submitter intends to manufacture (including 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 (including 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 (including importer) or processor under
this paragraph to determine whether
that person has shown a bona fide intent to manufacture (including 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 (including importer) or processor must show a bona fide intent to
manufacture (including 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 (including 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 (including 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 (including 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.
[62 FR 17932, Apr. 11, 1997, as amended at 80
FR 42747, July 20, 2015]
§ 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:
[email protected].
Subpart B—Administrative
Procedures
§ 725.20
Scope and purpose.
This subpart describes general administrative procedures applicable to
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§ 725.25
40 CFR Ch. I (7–1–18 Edition)
ments, must be generated, completed,
and submitted to EPA (via CDX) using
e-PMN
software.
See
40
CFR
720.40(a)(2)(ii) for information on how
to obtain e-PMN software.
(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 assist in submitting
the MCAN. If so, only the manufacturer or importer, and not the agent,
signs the certification on the form.
(2) A manufacturer or importer may
authorize another person, (e.g., a supplier or a toll manufacturer) to report
some of the information required in the
MCAN to EPA on its behalf. The manufacturer or importer should indicate in
a cover letter accompanying the MCAN
which information will be supplied by
another person and identify that other
person as a joint submitter where indicated in their MCAN. The other person
supplying information (i.e., the joint
submitter) may submit the information to EPA either in the MCAN or a
Letter of Support, except that if the
joint submitter is not incorporated, licensed, or doing business in the United
States, the joint submitter must submit the information to EPA in a Letter
of Support only, rather than the
MCAN. The joint submitter must indicate in the MCAN or Letter of Support
the identity of the manufacturer or importer. Any person who submits the
MCAN or Letter of Support for a joint
submission must sign and certify the
MCAN or Letter of Support.
(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
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:
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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. MCANs and exemption requests, and any support documents related to these submissions, may only
be submitted in a manner set forth in
this paragraph. MCANs and exemption
requests, and any related support docu-
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Environmental Protection Agency
§ 725.27
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.
[62 FR 17932, Apr. 11, 1997, as amended at 75
FR 788, Jan. 6, 2010; 78 FR 72828, Dec. 4, 2013]
§ 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.
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§ 725.28
40 CFR Ch. I (7–1–18 Edition)
(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.
(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.
§ 725.33
§ 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 a letter via
CDX or U.S. mail to the submitter 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.
[62 FR 17932, Apr. 11, 1997, as amended at 75
FR 788, Jan. 6, 2010]
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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.
§ 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.
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Environmental Protection Agency
§ 725.36
(10) The submitter does not include
an identifying number and a payment
identity number as required by
§ 700.45(e)(3) of this chapter.
(11) The submitter does not submit
the notice in the manner set forth in
§ 725.25(c).
(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.
[62 FR 17932, Apr. 11, 1997, as amended at 75
FR 788, Jan. 6, 2010]
§ 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 within 10 days of receiving the new information, but no
later than 5 days before the end of the
review period. The new information
must be sent in the same manner the
original notice or exemption was sent,
as described in § 725.25(c)(1), (c)(2), and
(c)(3).
(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.
[62 FR 17932, Apr. 11, 1997, as amended at 75
FR 789, Jan. 6, 2010]
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§ 725.40
§ 725.40
40 CFR Ch. I (7–1–18 Edition)
(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.
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.
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§ 725.50
§ 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)(1) Request for suspension. A request for suspension may only be submitted in a manner set forth in this
paragraph. The request for suspension
also may be made orally, including by
telephone, to the submitter’s EPA contact for that notice, subject to paragraph (c) of this section.
(2) Submission of suspension notices.
EPA will accept requests for suspension only if submitted in accordance
with this paragraph. Requests for suspension, must be generated, completed,
and submitted to EPA (via CDX) using
e-PMN
software.
See
40
CFR
720.40(a)(2)(ii) for information on how
to obtain e-PMN software.
(c) An oral request for suspension
may be granted by EPA for a maximum
of 15 days only. Requests for longer
suspension must only be submitted in
the manner set forth in this paragraph.
(d) If the submitter has not made a
previous oral request, the running of
the notice review period is suspended
as of the date of receipt of the CDX
submission by EPA.
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:
[62 FR 17932, Apr. 11, 1997, as amended at 75
FR 789, Jan. 6, 2010; 78 FR 72828, Dec. 4, 2013]
§ 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:
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Environmental Protection Agency
§ 725.65
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(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.
same microorganism, a new review period begins.
[62 FR 17932, Apr. 11, 1997, as amended at 75
FR 789, Jan. 6, 2010; 78 FR 72828, Dec. 4, 2013]
§ 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
§ 725.60 Withdrawal of submission by
the submitter.
(a)(1) Withdrawal of notice by the submitter. A submitter may withdraw a notice during the notice review period by
submitting a statement of withdrawal
in a manner set forth in this paragraph. The withdrawal is effective upon
receipt of the CDX submission by EPA.
(2) Submission of withdrawal notices.
EPA will accept statements of withdrawal only if submitted in accordance
with this paragraph. Statements of
withdrawal must be generated, completed, and submitted to EPA (via
CDX) using e-PMN software. See 40
CFR 720.40(a)(2)(ii) for information on
how to obtain e-PMN software.
(b) If a manufacturer, importer, or
processor who withdrew a submission
later resubmits a submission for the
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§ 725.67
40 CFR Ch. I (7–1–18 Edition)
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significant new use are added to subpart M of this part.
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 Chemical Safety and Pollution Prevention
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
§ 725.67 Applications to exempt new
microorganisms from this part.
(a) Submission. (1) Any manufacturer
or importer of a new microorganism
may request, under TSCA section
5(h)(4), an exemption, in whole or in
part, from this part by sending a Letter of Application in the manner set
forth in § 725.25(c).
(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
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Environmental Protection Agency
§ 725.80
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).
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.
§ 725.75 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
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[62 FR 17932, Apr. 11, 1997, as amended at 75
FR 789, Jan. 6, 2010; 77 FR 46292, Aug. 3, 2012]
§ 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.’’
§ 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
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§ 725.85
40 CFR Ch. I (7–1–18 Edition)
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
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(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
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Environmental Protection Agency
§ 725.85
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:
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§ 725.88
40 CFR Ch. I (7–1–18 Edition)
(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.
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Environmental Protection Agency
§ 725.94
(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.
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§ 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.
§ 725.94
Substantiation requirements.
(a) Claims applicable to the period prior
to commencement of manufacture or import for general commercial use—(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,
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§ 725.94
40 CFR Ch. I (7–1–18 Edition)
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?
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Environmental Protection Agency
§ 725.105
(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.
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.
§ 725.95 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. Publically available docket materials are
available
at
the
addresses
in
§ 700.17(b)(1) and (2) of this chapter
§ 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
[62 FR 17932, Apr. 11, 1997, 77 FR 46292, Aug.
3, 2012]
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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
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§ 725.110
40 CFR Ch. I (7–1–18 Edition)
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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.
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
§ 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
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Environmental Protection Agency
§ 725.155
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
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§ 725.160
40 CFR Ch. I (7–1–18 Edition)
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, includ-
ing 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
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Environmental Protection Agency
§ 725.170
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 man-
ufacture, 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
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§ 725.190
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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.
(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) How to submit. All notices of commencement must be generated, completed, and submitted to EPA (via
CDX) using e-PMN software. See 40
CFR 720.40(a)(2)(ii) for information on
how to obtain e-PMN software.
[62 FR 17932, Apr. 11, 1997, as amended at 75
FR 789, Jan. 6, 2010; 78 FR 72828, Dec. 4, 2013]
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.
§ 725.190 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.
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§ 725.205 Persons who
under this subpart.
may
§ 725.232
(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.
report
(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
§ 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.
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§ 725.234
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(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.
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).
§ 725.234 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
§ 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-4d 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
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Environmental Protection Agency
§ 725.235
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
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§ 725.238
40 CFR Ch. I (7–1–18 Edition)
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
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.
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(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
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§ 725.255
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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.
(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.
§ 725.250 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.
§ 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.
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§ 725.260
40 CFR Ch. I (7–1–18 Edition)
(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
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§ 725.288
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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.
cide 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.
§ 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 de-
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§ 725.300
40 CFR Ch. I (7–1–18 Edition)
(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.
§ 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.
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.
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§ 725.305 Persons who
under this subpart.
may
§ 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
apply
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.
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Environmental Protection Agency
§ 725.421
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.
Subpart G—General Exemptions
for New Microorganisms
§ 725.400
§ 725.420
§ 725.370 EPA review of the TME application.
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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.
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.
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.
§ 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.
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§ 725.421
40 CFR Ch. I (7–1–18 Edition)
(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 those 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
Corynebacterium diphtheriae
& C. ulcerans
Pseudomonas aeruginosa
Shigella dysenteriae
Abrus precatorius, seeds
Ricinus communis, seeds
Toxin Name
Diphtheria toxin
Exotoxin A
Shigella toxin (Shiga toxin,
Shigella dysenteriae type I
toxin, Vero cell toxin)
Abrin
Ricin
(3) Sequences for neurotoxins.
Sequence Source
Clostridium botulinum
Toxin Name
Neurotoxins A, B, C1, D, E,
F, G (Botulinum toxins,
botulinal toxins)
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Sequence Source
§ 725.422
Toxin Name
Clostridium tetani
Sequence Source
Clostridium bifermentans &
other Clostridium spp
Clostridium perfringens
Tetanus toxin
(tetanospasmin)
Neurotoxin
Alpha toxin (alpha lysin)
Murine toxin
Proteus mirabilis
Staphylococcus aureus
Yersinia pestis
Snake toxins
Bungarus caeruleus
Bungarus multicinctus
Crotalus spp.
Dendroaspis viridis
Naja naja varieties
Notechia scutatus
Oxyuranus scutellatus
Caeruleotoxin
Beta-bungarotoxin
(phospholipase)
Crotoxin (phospholipase)
Neurotoxin
Neurotoxin
Notexin (phospholipase)
Taipoxin
Invertebrate toxins
Chironex fleckeri
Androctnus australis
Centruroides sculpturatus
Neurotoxin
Neurotoxin
Neurotoxin
(4)
Sequences
cytolysins.
for
Sequence Source
oxygen
(7)
Sequences
cytotoxins.
Sequence Source
Clostridium difficile
Clostridium perfringens
Escherichia coli & other
Enterobacteriaceae spp.
Pseudomonas aeruginosa
Staphylococcus aureus
labile
Staphylococcus aureus &
Pseudomonas aeruginosa
Streptococcus pyogenes
Yersinia enterocolitica
Bordetella pertussis
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Clostridium botulinum
Clostridium difficile
Clostridium perfringens
Escherichia coli & other
Enterobacteriaceae spp.
Legionella pneumophila
Vibrio cholerae & Vibrio
mimicus
Edema factor (Factors I II);
Lethal factor (Factors II III)
Enterotoxin (diarrheagenic
toxin, mouse lethal factor)
Adenylate cyclase (Heat-labile factor); Pertussigen
(pertussis toxin, islet activating factor, histamine
sensitizing factor,
lymphocytosis promoting
factor)
C2 toxin
Enterotoxin (toxin A)
Beta-toxin; Delta-toxin
Heat-labile enterotoxins (LT);
Heat-stable enterotoxins
(STa, ST1 subtypes ST1a
ST1b; also STb, STII)
Cytolysin
Cholera toxin (choleragen)
(6) Sequences that affect membrane
integrity.
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general
Toxin Name
Modeccin
Aerolysin (beta-lysin,
cytotoxic lysin)
Cytotoxin (toxin B)
Beta-toxin; Epsilon-toxin;
Kappa-toxin
Cytotoxin (Shiga-like toxin,
Vero cell toxin)
Proteases
Gamma lysin (Gamma toxin);
Enterotoxins (SEA, SEB,
SEC, SED SEE);
Pyrogenic exotoxins A B;
Toxic shock syndrome toxins (TSST-1)
Leucocidin (leukocidin,
cytotoxin)
Streptolysin S (SLS);
Erythrogenic toxins (scarlet
fever toxins, pyrogenic
exotoxins)
Heat-stable enterotoxins (ST)
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are
§ 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.
Toxin Name
Bacillus cereus
that
Adenia digitata
Aeromonas hydrophila
Alveolysin
Cereolysin
Laterosporolysin
Thuringiolysin
Lysin
Lysin
Lysin
Delta-toxin
Epsilon-toxin
Gamma-toxin
Delta-toxin
Theta-toxin (Perfringolysin)
Delta-toxin
Lysin
Tetanolysin
Listeriolysin (A B)
Pneumolysin
Streptolysin O (SLO)
Sequence Source
Alpha-toxin (phospholipase
C, lecithinase); Enterotoxin
Cytolysin (phospholipase C),
Ovis toxin
(sphingomyelinase D)
Beta-lysin (beta toxin)
Staphylococcus aureus
(5) Sequences for toxins affecting membrane function.
Bacillus anthracis
Lecithinase
Corynebacterium pyogenes &
other Corynebacterium spp.
Toxin Name
Bacillus alve
Bacillus cereus
Bacillus laterosporus
Bacillus thuringiensis
Clostridium bifermentans
Clostridium botulinum
Clostridium caproicum
Clostridium chauvoei
Clostridium histolyticum
Clostridium novyi
Clostridium oedematiens
Clostridium perfringens
Clostridium septicum
Clostridium sordellii
Clostridium tetani
Listeria monocytogenes
Streptococcus pneumoniae
Streptococcus pyogene
Toxin Name
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§ 725.424
40 CFR Ch. I (7–1–18 Edition)
(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.
(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.
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§ 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.
§ 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.
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Environmental Protection Agency
§ 725.455
(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
§ 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.
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§ 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.
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§ 725.470
40 CFR Ch. I (7–1–18 Edition)
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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.
(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.
§ 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.
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.
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Environmental Protection Agency
§ 725.910
(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.
(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.
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§ 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
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§ 725.912
40 CFR Ch. I (7–1–18 Edition)
(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.
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Environmental Protection Agency
§ 725.975
tity of the microorganism sold or
transferred on such date.
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§ 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.
§ 725.975 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) Persons submitting a request for
a determination of equivalency to EPA
under this part must submit the request to EPA (via CDX) using e-PMN
software. See 40 CFR 720.40(a)(2)(ii) for
information on how to obtain e-PMN
software. Support documents related to
these requests must also be submitted
to EPA via CDX using e-PMN software.
A request for a determination of
equivalency 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
§ 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 quan-
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§ 725.980
40 CFR Ch. I (7–1–18 Edition)
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.
cation 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.
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[62 FR 17932, Apr. 11, 1997, as amended at 75
FR 790, Jan. 6, 2010; 78 FR 72828, Dec. 4, 2013]
§ 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 notifi-
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Environmental Protection Agency
§ 725.980
(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 es-
tablish
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
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§ 725.984
40 CFR Ch. I (7–1–18 Edition)
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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 within 180
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.
tional 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.
The request must be accompanied by
information sufficient to support the
request. Persons submitting a request
to EPA under this part must submit
the request to EPA (via CDX) using ePMN
software.
See
40
CFR
720.40(a)(2)(ii) for information on how
to obtain e-PMN software. Support
documents related to these requests
must also be submitted to EPA via
CDX using e-PMN software.
(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,
§ 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 ra-
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Environmental Protection Agency
Pt. 745
745.84 Information
distribution
requirements.
745.85 Work practice standards.
745.86 Recordkeeping and reporting requirements.
745.87 Enforcement and inspections.
745.88 Recognized test kits.
745.89 Firm certification.
745.90 Renovator certification and dust
sampling technician certification.
745.91 Suspending, revoking, or modifying
an individual’s or firm’s certification.
745.92 Fees for the accreditation of renovation and dust sampling technician training and the certification of renovation
firms.
briefly describe the grounds for the action, and provide interested parties an
opportunity to comment.
[62 FR 17932, Apr. 11, 1997, as amended at 75
FR 790, Jan. 6, 2010; 78 FR 72828, Dec. 4, 2013]
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.
Subpart F—Disclosure of Known LeadBased Paint and/or Lead-Based Paint
Hazards Upon Sale or Lease of Residential Property
§ 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]
745.100 Purpose.
745.101 Scope and applicability.
745.102 Effective dates.
745.103 Definitions.
745.107 Disclosure requirements for sellers
and lessors.
745.110 Opportunity to conduct an evaluation.
745.113 Certification and acknowledgment
of disclosure.
745.115 Agent responsibilities.
745.118 Enforcement.
745.119 Impact on State and local requirements.
Subparts G–K [Reserved]
Subpart L—Lead-Based Paint Activities
745.220 Scope and applicability.
745.223 Definitions.
745.225 Accreditation of training programs:
target housing and child-occupied facilities.
745.226 Certification of individuals and
firms engaged in lead-based paint activities: target housing and child-occupied
facilities.
745.227 Work practice standards for conducting lead-based paint activities: target housing and child-occupied facilities.
745.228 Accreditation of training programs:
public and commercial buildings, bridges
and superstructures. [Reserved]
745.229 Certification of individuals and
firms engaged in lead-based paint activities: public and commercial buildings,
bridges and superstructures. [Reserved]
745.230 Work practice standards for conducting lead-based paint activities: public and commercial buildings, bridges
and superstructures. [Reserved]
745.233 Lead-based paint activities requirements.
745.235 Enforcement.
[68 FR 35320, June 13, 2003]
PART 745—LEAD-BASED PAINT POISONING PREVENTION IN CERTAIN RESIDENTIAL STRUCTURES
Subparts A–C [Reserved]
Subpart D—Lead-Based Paint Hazards
Sec.
745.61
745.63
745.65
Scope and applicability.
Definitions.
Lead-based paint hazards.
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Subpart E—Residential Property Renovation
745.80
745.81
745.82
745.83
Purpose.
Effective dates.
Applicability.
Definitions.
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| File Type | application/pdf |
| File Modified | 2018-09-14 |
| File Created | 2018-09-14 |