Attachment F

40 CFR Part 725
40 CFR Protection of Environment 

CHAPTER I

ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

SUBCHAPTER R -- TOXIC SUBSTANCES CONTROL ACT 

PART 725 -- REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR

MICROORGANISMS

Subpart A -- General Provisions and Applicability

Sec. 

725.1 Scope and purpose.

725.3 Definitions.

725.8 Coverage of this part. 

725.12 Identification of microorganisms for Inventory and other listing purposes. 

725.15 Determining applicability when microorganism identity or use is confidential or 

uncertain. 

725.17 Consultation with EPA.

 Subpart B -- Administrative Procedures

725.20 Scope and purpose. 

725.25 General administrative requirements.

725.27 Submissions.

725.28 Notice that submission is not required.

725.29 EPA acknowledgement of receipt of submission.

725.32 Errors in the submission.

725.33 Incomplete submissions. 

725.36 New information. 

725.40 Notice in the FEDERAL REGISTER. 

725.50 EPA review. 

725.54 Suspension of the review period. 

725.56 Extension of the review period.

725.60 Withdrawal of submission by the submitter. 

725.65 Recordkeeping.

725.67 Applications to exempt new microorganisms from this part.

725.70 Compliance.

725.75 Inspections.

 Subpart C -- Confidentiality and Public Access to Information

725.80 General provisions for confidentiality claims.

725.85 Microorganism identity.

725.88 Uses of a microorganism. 

725.92 Data from health and safety studies of microorganisms. 

725.94 Substantiation requirements.
725.95 Public file. 

 Subpart D -- Microbial Commercial Activities Notification Requirements 

725.100 Scope and purpose. 

725.105 Persons who must report. 

725.110 Persons not subject to this subpart. 

725.150 Procedural requirements for this subpart.

725.155 Information to be included in the MCAN. 

725.160 Submission of health and environmental effects data. 

725.170 EPA review of the MCAN. 

725.190 Notice of commencement of manufacture or import. 

 Subpart E -- Exemptions for Research and Development Activities 

725.200 Scope and purpose. 

725.205 Persons who may report under this subpart. 

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

725.234 Activities conducted inside a structure. 

725.235 Conditions of exemption for activities conducted inside a structure. 

725.238 Activities conducted outside a structure. 

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

725.250 Procedural requirements for the TERA. 

725.255 Information to be included in the TERA. 

725.260 Submission of health and environmental effects data. 

725.270 EPA review of the TERA. 

725.288 Revocation or modification of TERA approval. 

 Subpart F -- Exemptions for Test Marketing 

725.300 Scope and purpose. 

725.305 Persons who may apply under this subpart. 

725.350 Procedural requirements for this subpart. 

725.355 Information to be included in the TME application. 

725.370 EPA review of the TME application. 

 Subpart G -- General Exemptions for New Microorganisms 

725.400 Scope and purpose. 

725.420 Recipient microorganisms. 

725.421 Introduced genetic material. 

725.422 Physical containment and control technologies. 

725.424 Requirements for the Tier I exemption.

725.426 Applicability of the Tier I exemption. 

725.428 Requirements for the Tier II exemption. 

725.450 Procedural requirements for the Tier II exemption. 

725.455 Information to be included in the Tier II exemption request. 
725.470 EPA review of the Tier II exemption request. 

 Subparts H-K [Reserved] 

 Subpart L -- Additional Procedures for Reporting on Significant New Uses of 

Microorganisms 

725.900 Scope and purpose. 

725.910 Persons excluded from reporting significant new uses. 

725.912 Exemptions. 

725.920 Exports and imports. 

725.950 Additional recordkeeping requirements. 

725.975 EPA approval of alternative control measures. 

725.980 Expedited procedures for issuing significant new use rules for microorganisms subject 

to section 5(e) orders. 

725.984 Modification or revocation of certain notification requirements. 

 Subpart M -- Significant New Uses for Specific Microorganisms

725.1000 Scope.

725.1075 Burkholderia cepacia complex.

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

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

 Subpart A -- General Provisions and Applicability

'725.1 Scope and purpose.

(a) This part establishes all reporting requirements under section 5 of TSCA for manufacturers, 

importers, and processors of microorganisms subject to TSCA jurisdiction for commercial 

purposes, including research and development for commercial purposes. New microorganisms 

for which manufacturers and importers are required to report under section 5(a)(1)(A) of TSCA 

are those that are intergeneric. In addition, under section 5(a)(1)(B) of TSCA, manufacturers, 

importers, and processors may be required to report for any microorganism that EPA determines 

by rule is being manufactured, imported, or processed for a significant new use. 

(b) Any manufacturer, importer, or processor required to report under section 5 of TSCA (see 

'725.100 for new microorganisms and '725.900 for significant new uses) must file a Microbial 

Commercial Activity Notice (MCAN) with EPA, unless the activity is eligible for a specific 

exemption as described in this part. The general procedures for filing MCANs are described in 

subpart D of this part. The exemptions from the requirement to file a MCAN are for certain kinds 

of contained activities (see ''725.424 and 725.428), test marketing activities (see '725.300), and

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

(c) Any manufacturer, importer, or processor required to file a MCAN for research and 
development (R&D) activities may instead file a TSCA Experimental Release Application 

(TERA) for a specific test (see '725.250). A TERA is not required for certain R&D activities; 

however a TERA exemption does not extend beyond the research and development stage, to 

general commercial use of the microorganism, for which compliance with MCAN

requirements is required. The TERA exemptions are for R&D activities subject to other Federal 

agencies or programs (see '725.232), certain kinds of contained R&D activities (see '725.234), 

and R&D activities using certain listed microorganisms (see '725.238). 

(d) New microorganisms will be added to the Inventory established under section 8 of TSCA 

once a MCAN has been received, the MCAN review period has expired, and EPA receives a 

Notice of Commencement (NOC) indicating that manufacture or importation has actually begun. 

New microorganisms approved for use under a TERA will not be added to the Inventory until a 

MCAN has been received, the MCAN review period has expired, and EPA has received an 

NOC. 

'725.3 Definitions.

Definitions in section 3 of the Act (15 U.S.C. 2602), as well as definitions contained in ''704.3, 

720.3, and 721.3 of this chapter, apply to this part unless otherwise specified in this section. In 

addition, the following definitions apply to this part: 

Consolidated microbial commercial activity notice or consolidated MCAN means any MCAN 

submitted to EPA that covers more than one microorganism (each being assigned a separate 

MCAN number by EPA) as a result of a prenotice agreement with EPA. 

Containment and/or inactivation controls means any combination of engineering, mechanical, 

procedural, or biological controls designed and operated to restrict environmental release of 

viable microorganisms from a structure. 

Director means the Director of the EPA Office of Pollution Prevention and Toxics. 

Exemption request means any application submitted to EPA under subparts E, F, or G of this 

part. General commercial use means use for commercial purposes other than research and 

development. 

Genome means the sum total of chromosomal and extrachromosomal genetic material of an 

isolate and any descendants derived under pure culture conditions from that isolate. 

Health and safety study of a microorganism or health and safety study means any study of any 

effect of a microorganism or microbial mixture on health or the environment or on both, 

including underlying data and epidemiological studies, studies of occupational exposure to a 

microorganism or microbial mixture, toxicological, clinical, and ecological, or other studies of a 

microorganism or microbial mixture, and any test performed under the Act. Microorganism 

identity is always part of a health and safety study of a microorganism. 

(1) It is intended that the term "health and safety study of a microorganism" be interpreted 

broadly. Not only is information which arises as a result of a formal, disciplined study included, 
but other information relating to the effects of a microorganism or microbial mixture on health or 

the environment is also included. Any data that bear on the effects of a microorganism on health 

or the environment would be included. 

(2) Examples include: 

(i) Tests for ecological or other environmental effects on invertebrates, fish, or other animals, 

and plants, including: Acute toxicity tests, chronic toxicity tests, critical life stage tests, 

behavioral tests, algal growth tests, seed germination tests, plant growth or damage tests, 

microbial function tests, bioconcentration or bioaccumulation tests, and model ecosystem 

(microcosm) studies. 

(ii) Long- and short-term tests of mutagenicity, carcinogenicity, or teratogenicity; dermatoxicity; 

cumulative, additive, and synergistic effects; and acute, subchronic, and chronic effects. 

(iii) Assessments of human and environmental exposure, including workplace exposure, and 

impacts of a particular microorganism or microbial mixture on the environment, including 

surveys, tests, and studies of: Survival and transport in air, water, and soil; ability to exchange 

genetic material with other microorganisms, ability to colonize human or animal guts, and ability

to colonize plants. 

(iv) Monitoring data, when they have been aggregated and analyzed to measure the exposure of 

humans or the environment to a microorganism. 

(v) Any assessments of risk to health and the environment resulting from the manufacture, 

processing, distribution in commerce, use, or disposal of the microorganism. 

Inactivation means that living microorganisms are rendered nonviable. 

Institutional Biosafety Committee means the committees described in the NIH Guidelines in 

section IV.B.2. 

Intergeneric microorganism means a microorganism that is formed by the deliberate combination 

of genetic material originally isolated from organisms of different taxonomic genera. 

(1) The term "intergeneric microorganism" includes a microorganism which contains a mobile 

genetic element which was first identified in a microorganism in a genus different from the 

recipient microorganism. 

(2) The term "intergeneric microorganism" does not include a microorganism which contains 

introduced genetic material consisting of only well-characterized, non-coding regulatory regions 

from another genus. 

Introduced genetic material means genetic material that is added to, and remains as a component 

of, the genome of the recipient. 

Manufacture, import, or process for commercial purposes means: 

(1) To import, produce, manufacture, or process with the purpose of obtaining an immediate or 

eventual commercial advantage for the manufacturer, importer, or processor, and includes, 

among other things, "manufacture" or "processing" of any amount of a microorganism or 
microbial mixture: 

(i) For commercial distribution, including for test marketing. 

(ii) For use by the manufacturer, including use for product research and development or as an 

intermediate. 

(2) The term also applies to substances that are produced coincidentally during the manufacture, 

processing, use, or disposal of another microorganism or microbial mixture, including 

byproducts that are separated from that other microorganism or microbial mixture and impurities 

that remain in that microorganism or microbial mixture. Byproducts and impurities without 

separate commercial value are nonetheless produced for the purpose of obtaining a commercial

advantage, since they are part of the manufacture or processing of a microorganism for 

commercial purposes. 

Microbial commercial activity notice or MCAN means a notice for microorganisms submitted to 

EPA pursuant to section 5(a)(1) of the Act in accordance with subpart D of this part. 

Microbial mixture means any combination of microorganisms or microorganisms and other 

chemical substances, if the combination does not occur in nature and is not an article. 

Microorganism means an organism classified, using the 5-kingdom classification system of 

Whittacker, in the kingdoms Monera (or Procaryotae), Protista, Fungi, and the Chlorophyta and 

the Rhodophyta of the Plantae, and a virus or virus-like particle. 

Mobile genetic element or MGE means an element of genetic material that has the ability to 

move genetic material within and between organisms. "Mobile genetic elements" include all 

plasmids, viruses, transposons, insertion sequences, and other classes of elements with these 

general properties. 

New microorganism means a microorganism not included on the Inventory. 

NIH Guidelines means the National Institutes of Health (NIH) "Guidelines for Research 

Involving Recombinant DNA Molecules" (July 5, 1994). 

Non-coding regulatory region means a segment of introduced genetic material for which: 

(1) The regulatory region and any inserted flanking nucleotides do not code for protein, peptide, 

or functional ribonucleic acid molecules. 

(2) The regulatory region solely controls the activity of other regions that code for protein or 

peptide molecules or act as recognition sites for the initiation of nucleic acid or protein synthesis. 

Small quantities solely for research and development (or "small quantities solely for purposes of 

scientific experimentation or analysis or research on, or analysis of, such substance or another 

substance, including such research or analysis for development of a product") means quantities 

of a microorganism manufactured, imported, or processed or proposed to be manufactured, 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 

unambiguously identified on the Inventory. 

(a) Taxonomic designation. The taxonomic designation of a microorganism must be provided for 

the donor organism and the recipient microorganism to the level of strain, as appropriate. These 

designations must be substantiated by a letter from a culture collection, literature references, or 

the results of tests conducted for the purpose of taxonomic classification. Upon EPA's request to 

the submitter, data supporting the taxonomic designation must be provided to EPA. The genetic 

history of the recipient microorganism should be documented back to the isolate from which it 

was derived. 

(b) Supplemental information. The supplemental information described in paragraphs (b)(1) and 

(b)(2) of this section is required to the extent that it enables a microorganism to be accurately and 

unambiguously identified. 

(1) Phenotypic information. Phenotypic information means pertinent traits that result from the 

interaction of a microorganism's genotype and the environment in which it is intended to be used 

and may include intentionally added biochemical and physiological traits. 

(2) Genotypic information. Genotypic information means the pertinent and distinguishing 

genotypic characteristics of a microorganism, such as the identity of the introduced genetic 

material and the methods used to construct the reported microorganism. This also may include 

information on the vector construct, the cellular location, and the number of copies of the 
introduced genetic material. 

'725.15 Determining applicability when microorganism identity or use is confidential or 

uncertain.

(a) Consulting EPA. Persons intending to conduct activities involving microorganisms may

determine their obligations under this part by consulting the Inventory or the microorganisms 

and uses specified in '725.239 or in subpart M of this part. This section establishes procedures 

for EPA to assist persons in determining whether the microorganism or the use is listed on the 

Inventory, in '725.239 or in subpart M of this part. 

(1) Confidential identity or use. In some cases it may not be possible to directly determine if a 

specific microorganism is listed, because portions of that entry may contain generic information 

to protect confidential business information (CBI). If any portion of the microorganism's identity 

or use has been claimed as CBI, that portion does not appear on the public version of the 

Inventory, in '725.239 or in subpart M of this part. Instead, it is contained in a confidential

version held in EPA's Confidential Business Information Center (CBIC). The public versions 

contain generic information which masks the confidential business information. A person who 

intends to conduct an activity involving a microorganism or use whose entry is described with 

generic information will need to inquire of EPA whether the unreported microorganism or use is 

on the confidential version. 

(2) Uncertain microorganism identity. The current state of scientific knowledge leads to some 

imprecision in describing a microorganism. As the state of knowledge increases, EPA will be 

developing policies to determine whether one microorganism is equivalent to another. Persons 

intending to conduct activities involving microorganisms may inquire of EPA whether the 

microorganisms they intend to manufacture, import, or process are equivalent to specific 

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

(b) Requirement of bona fide intent. (1) EPA will answer the inquiries described in paragraph (a) 

of this section only if the Agency determines that the person has a bona fide intent to conduct the 

activity for which reporting is required or for which any exemption may apply. 

(2) To establish a bona fide intent to manufacture, import, or process a microorganism, the 

person who intends to manufacture, import, or process the microorganism must submit the 

following information in writing to the Office of Pollution Prevention and Toxics, Document 

Control Officer, 7407, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN: 

BIOTECH bona fide submission. 

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

(ii) A signed statement certifying that the submitter intends to manufacture, import, or process 

the microorganism for commercial purposes. 

(iii) A description of research and development activities conducted with the microorganism to 

date, demonstration of the submitter's ability to produce or obtain the microorganism from a 

foreign manufacturer, and the purpose for which the person will manufacture, import, or process 

the microorganism. 

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

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

(c) If an importer or processor cannot provide all the information required by paragraph (b) of 

this section, because it is claimed as confidential business information by its foreign 

manufacturer or supplier, the foreign manufacturer or supplier may supply the information 

directly to EPA. 

(d) EPA will review the information submitted by the manufacturer, importer, or processor under 

this paragraph to determine whether that person has shown a bona fide intent to manufacture, 

import, or process the microorganism. If necessary, EPA will compare this information to the 

information requested for the confidential microorganism under '725.85(b)(3)(iii). 

(e) In order for EPA to make a conclusive determination of the microorganism's status, the 

proposed manufacturer, importer, or processor must show a bona fide intent to manufacture, 

import, or process the microorganism and must provide sufficient information to establish 

identity unambiguously. After sufficient information has been provided, EPA will inform the 

manufacturer, importer, or processor whether the microorganism is subject to this part and if so, 

which sections of this part apply. 

(f) If the microorganism is found on the confidential version of the Inventory, in '725.239 or in 

subpart M of this part, EPA will notify the person(s) who originally reported the microorganism 

that another person (whose identity will remain confidential, if so requested) has demonstrated a 

bona fide intent to manufacture, import, or process the microorganism and therefore was told that 

the microorganism is on the Inventory, in '725.239, or in subpart M of this part. 

(g) A disclosure to a person with a bona fide intent to manufacture, import, or process a 

particular microorganism that the microorganism is on the Inventory, in '725.239, or in subpart 

M of this part will not be considered a public disclosure of confidential business information 

under section 14 of the Act. 

(h) EPA will answer an inquiry on whether a particular microorganism is subject to this part 

within 30 days after receipt of a complete submission under paragraph (b) of this section. 

'725.17 Consultation with EPA.

Persons may consult with EPA, either in writing or by telephone, about their obligations under 

this part. Written consultation is preferred. Written inquiries should be sent to the following 

address: Environmental Assistance Division (7408), Office of Pollution Prevention and Toxics, 

U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, 

ATTN: Biotechnology Notice Consultation. Persons wishing to consult with EPA by

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

TSCA-Hotline@epamail.epa.gov. 

 Subpart B -- Administrative Procedures 

'725.20 Scope and purpose.
This subpart describes general administrative procedures applicable to all persons who submit 

MCANs and exemption requests to EPA under section 5 of the Act for microorganisms. 

'725.25 General administrative requirements.

(a) General. (1) Each person who is subject to the notification provisions of this part must 

complete, sign, and submit a MCAN or exemption request containing the information as required 

for the appropriate submission under this part. Except as otherwise provided, each submission 

must include all referenced attachments. All information in the submission (unless certain 

attachments appear in the open scientific literature) must be in English. All information

submitted must be true and correct. 

(2) In addition to specific information required, the submitter should submit all information 

known to or reasonably ascertainable by the submitter that would permit EPA to make a 

reasoned evaluation of the human health and environmental effects of the microorganism and 

any microbial mixture or article that may contain the microorganism. 

(b) Certification. Persons submitting MCANs and exemption requests to EPA under this part, 

and material related to their reporting obligations under this part, must attach the following 

statement to any information submitted to EPA. This statement must be signed and dated by an 

authorized official of the submitter: 

I certify that to the best of my knowledge and belief: The company named in this submission 

intends to manufacture, import, or process for a commercial purpose, other than in small 

quantities solely for research and development, the microorganism identified in this submission. 

All information provided in this submission is complete and truthful as of the date of submission. 

I am including with this submission all test data in my possession or control and a description of 

all other data known to or reasonably ascertainable by me as required by 40 CFR 725.160 or 

725.260.

(c) Where to submit information under this part. Persons submitting MCANs and exemption 

requests to EPA under this part, and material related to their reporting obligations under this part, 

must send them to: TSCA Document Processing Center (7407), Rm. L-100, Office of Pollution 

Prevention and Toxics, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460. 

(d) General requirements for submission of data. (1) Submissions under this part must include 

the information described in '725.155, 725.255, 725.355, or 725.455, as appropriate, to the 

extent such information is known to or reasonably ascertainable by the submitter. 

(2) In accordance with '725.160 or 725.260, as appropriate, the submission must also include 

any test data in the submitter's possession or control and descriptions of other data which are 

known to or reasonably ascertainable by the submitter and which concern the health and 

environmental effects of the microorganism. 

(e) Agency or joint submissions. (1) A manufacturer or importer may designate an agent to 
submit the MCAN or exemption request. Both the manufacturer or importer and the agent must 

sign the certification required in paragraph (b) of this section. 

(2) A manufacturer or importer may authorize another person (e.g., a foreign manufacturer or 

supplier, or a toll manufacturer) to report some of the information required in the MCAN or 

exemption request to EPA on its behalf. If separate portions of a joint submission are not 

submitted together, the submitter must indicate which information will be supplied by another 

person and identify that person. The manufacturer or importer and any other person supplying

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

(3) If EPA receives a submission which does not include the information required, which the 

submitter indicates that it has authorized another person to provide, the review period will not 

begin until EPA receives all of the required information. 

(f) Microorganisms subject to a section 4 test rule. (1) Except as provided in paragraph (f)(3) of 

this section, if a person intends to manufacture or import a new microorganism which is subject 

to the notification requirements of this part, and the microorganism is subject to a test rule 

promulgated under section 4 of the Act before the notice is submitted, section 5(b)(1) of the Act 

requires the person to submit the test data required by the testing rule with the notice. The person 

must submit the data in the form and manner specified in the test rule and in accordance with

'725.160. If the person does not submit the test data, the submission is incomplete and EPA will 

follow the procedures in '725.33. 

(2) If EPA has granted the submitter an exemption under section 4(c) of the Act from the 

requirement to conduct tests and submit data, the person may not file a MCAN or TERA until 

EPA receives the test data. 

(3) If EPA has granted the submitter an exemption under section 4(c) of the Act and if another 

person previously has submitted the test data to EPA, the exempted person may either submit the 

test data or provide the following information as part of the notice: 

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

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

(iii) A citation for the test rule. 

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

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

(i) Intends to manufacture or import a microorganism which is subject to the notification 

requirements of this part and which is subject to a rule issued under section 5(b)(4) of the Act; 

and 

(ii) Is not required by a rule issued under section 4 of the Act to submit test data for the 

microorganism before the filing of a submission, the person must submit to EPA data described 

in paragraph (g)(2) of this section at the time the submission is filed. 

(2) Data submitted under paragraph (g)(1) of this section must be data which the person 

submitting the notice believes show that the manufacture, processing, distribution in commerce, 
use, and disposal of the microorganism, or any combination of such activities, will not present an 

unreasonable risk of injury to health or the environment. 

(h) Data that need not be submitted. Specific data requirements are listed in subparts D, E, F, G, 

and L of this part. The following is a list of data that need not be submitted under this part: 

(1) Data previously submitted to EPA. (i) A person need not submit any data previously 

submitted to EPA with no claims of confidentiality if the new submission includes: the office or 

person to whom the data were submitted; the date of submission; and, if appropriate, a standard 

literature citation as specified in '725.160(a)(3)(ii). 

(ii) For data previously submitted to EPA with a claim of confidentiality, the person must 

resubmit the data with the new submission and any claim of confidentiality, under '725.80. 

(2) Efficacy data. This part does not require submission of any data related solely to product 

efficacy. However, including efficacy data will improve EPA's ability to assess the benefits of 

the use of the microorganism. This does not exempt a person from submitting any of the data 

specified in '725.160 or 725.260. 

(3) Non-U.S. exposure data. This part does not require submission of any data which relates only 

to exposure of humans or the environment outside the United States. This does not exclude 

nonexposure data such as data on health effects (including epidemiological studies), ecological 

effects, physical and chemical properties, or environmental fate characteristics. 

'725.27 Submissions.

Each person who is required to submit information under this part must submit the information 

in the form and manner set forth in the appropriate subpart. 

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

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

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

725.355. 

(d) Requirements specific to Tier I and Tier II exemptions for certain general commercial uses 

are described in ''725.424 through 725.470. 

(e) Additional requirements specific to significant new uses for microorganisms are described at 

'725.950. 

'725.28 Notice that submission is not required.

When EPA receives a MCAN or exemption request, EPA will review it to determine whether the 

microorganism is subject to the requirements of this part. If EPA determines that the 

microorganism is not subject to these requirements, EPA will notify the submitter that section 5 

of the Act does not prevent the manufacture, import, or processing of the microorganism and that 

the submission is not needed. 

'725.29 EPA acknowledgement of receipt of submission.
(a) EPA will acknowledge receipt of each submission by sending the submitter a letter that 

identifies the number assigned to each MCAN or exemption request and the date on which the 

review period begins. The review period will begin on the date the MCAN or exemption request 

is received by the Office of Pollution Prevention and Toxics Document Control Officer. 

(b) The acknowledgement does not constitute a finding by EPA that the submission is in 

compliance with this part. 

'725.32 Errors in the submission.

(a) Within 30 days of receipt of the submission, EPA may request that the submitter remedy

errors in the submission. The following are examples of such errors: 

(1) Failure to date the submission. 

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

unclear. 

(3) Contradictory information. 

(4) Ambiguous statements or information. 

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

must take to correct the submission. 

(c) If the submitter fails to correct the submission within 15 days of receipt of the request, EPA 

may extend the review period. 

'725.33 Incomplete submissions.

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

(1) The wrong person files the submission. 

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

(3) Some or all of the information in the submission or any attachments are not in English, 

except for published scientific literature. 

(4) The submitter does not provide information that is required by sections 5(d)(1)(B) and (C) of 

the Act and '725.160 or 725.260, as appropriate. 

(5) The submitter does not provide information required by '725.25, 725.155, 725.255, 725.355, 

or 725.455, as appropriate, or indicate that it is not known to or reasonably ascertainable by the 

submitter. 

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

(i) Submit a second copy of the submission with all confidential information deleted for the 

public file, as required by '725.80(b)(2). 

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

(7) The submitter does not include any information required by section 5(b)(1) of the Act and 

pursuant to a rule promulgated under section 4 of the Act, as required by '725.25(f). 

(8) The submitter does not submit data which the submitter believes show that the 

microorganism will not present an unreasonable risk of injury to health or the environment, if 

EPA has listed the microorganism under section 5(b)(4) of the Act, as required in '725.25(g). 

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

this chapter. 
(b)(1) If EPA receives an incomplete submission under this part, the Director, or a designee, will 

notify the submitter within 30 days of receipt that the submission is incomplete and that the 

review period will not begin until EPA receives a complete submission. 

(2) If EPA obtains additional information during the review period for any submission that 

indicates the original submission was incomplete, the Director, or a designee, may declare the 

submission incomplete within 30 days after EPA obtains the additional information and so notify

the submitter. 

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

include: 

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

(2) The requirements for correcting the incomplete submission. 

(3) Information on procedures under paragraph (d) of this section for filing objections to the 

determination or requesting modification of the requirements for completing the submission. 

(d) Within 10 days after receipt of notification by EPA that a submission is incomplete, the 

submitter may file written objections requesting that EPA accept the submission as complete or 

modify the requirements necessary to complete the submission. 

(e)(1) EPA will consider the objections filed by the submitter. The Director, or a designee, will 

determine whether the submission was complete or incomplete, or whether to modify the 

requirements for completing the submission. EPA will notify the submitter in writing of EPA's 

response within 10 days of receiving the objections. 

(2) If the Director, or a designee, determines, in response to the objection, that the submission 

was complete, the review period will be deemed suspended on the date EPA declared the 

submission incomplete, and will resume on the date that the submission is declared complete. 

The submitter need not correct the submission as EPA originally requested. If EPA can complete 

its review within the review period beginning on the date of the submission, the Director, or a 

designee, may inform the submitter that the running of the review period will resume on the date 

EPA originally declared it incomplete. 

(3) If the Director, or a designee, modifies the requirements for completing the submission or 

concurs with EPA's original determination, the review period will begin when EPA receives a 

complete submission. 

(f) If EPA discovers at any time that a person submitted materially false or misleading statements 

in information submitted under this part, EPA may find that the submission was incomplete from 

the date it was submitted, and take any other appropriate action. 

'725.36 New information.

(a) During the review period, if a submitter possesses, controls, or knows of new information that 

materially adds to, changes, or otherwise makes significantly more complete the information 

included in the MCAN or exemption request, the submitter must send that information to the 

address listed in '725.25(c) within 10 days of receiving the new information, but no later than 5 

days before the end of the review period. 

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

known to the submitter. 

(c) If the new information becomes available during the last 5 days of the review period, the 

submitter must immediately inform the EPA contact for that submission by telephone of the new 

information. 

'725.40 Notice in the Federal Register.

(a) Filing of FEDERAL REGISTER notice. After EPA receives a MCAN or an exemption 

request under this part, EPA will issue a notice in the FEDERAL REGISTER including the 

information specified in paragraph (b) of this section. 

(b) Contents of notice. (1) In the public interest, the specific microorganism identity listed in the 

submission will be published in the FEDERAL REGISTER unless the submitter has claimed the 

microorganism identity confidential. If the submitter claims confidentiality, a generic name will 

be published in accordance with '725.85. 

(2) The categories of use of the microorganism will be published as reported in the submission 

unless this information is claimed confidential. If confidentiality is claimed, the generic 

information which is submitted under '725.88 will be published. 

(3) A list of information submitted in accordance with '725.160(a), 725.255, 725.260, 725.355, 

or 725.455, as appropriate, will be published. 

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

(c) Publication of exemption decisions. Following the expiration of the appropriate review period 

for the exemption request, EPA will issue a notice in the FEDERAL REGISTER indicating 

whether the request has been approved or denied and the reasons for the decision. 

'725.50 EPA review.

(a) MCANs. The review period specified in section 5(a) of the Act for MCANs runs for 90 days 

from the date the Document Control Officer receives a complete submission, or the date EPA 

determines the submission is complete under '725.33, unless the Agency extends the review 

period under section 5(c) of the Act and '725.56. 

(b) Exemption requests. The review period starts on the date the Document Control Officer 

receives a complete exemption request, or the date EPA determines the request is complete under 

'725.33, unless the Agency extends the review period under '725.56. The review periods for 

exemption requests run as follows: 

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

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

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

'725.54 Suspension of the review period.

(a) A submitter may voluntarily suspend the running of the review period if the Director, or a 

designee, agrees. If the Director does not agree, the review period will continue to run, and EPA 
will notify the submitter. A submitter may request a suspension at any time during the review 

period. The suspension must be for a specified period of time. 

(b) A request for suspension may be made in writing to the address listed in '725.25(c). The 

suspension also may be made orally, including by telephone, to the submitter's EPA contact for 

that submission. EPA will send the submitter a written confirmation that the suspension has been 

granted. 

(1) An oral request may be granted for no longer than 15 days. To obtain a longer suspension, the 

Document Control Officer for the Office of Pollution Prevention and Toxics must receive written 

confirmation of the oral request. The review period is suspended as of the date of the oral 

request. 

(2) If the submitter has not made a previous oral request, the running of the review period is 

suspended as of the date of receipt of the written request by the Document Control Officer for 

the Office of Pollution Prevention and Toxics. 

'725.56 Extension of the review period.

(a) At any time during the review period, EPA may unilaterally determine that good cause exists 

to extend the review period specified for MCANs, or the exemption requests. 

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

(1) Will notify the submitter that EPA is extending the review period for a specified length of 

time and state the reasons for the extension. 

(2) For MCANs, EPA may issue a notice for publication in the FEDERAL REGISTER which 

states that EPA is extending the review period and gives the reasons for the extension. 

(c) The total period of the extension may be for a period of up to the same length of time as 

specified for each type of submission in '725.50. If the initial extension is for less than the total 

time allowed, EPA may make additional extensions. However, the sum of the extensions may

not exceed the total allowed. 

(d) The following are examples of situations in which EPA may find that good cause exists for 

extending the review period: 

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

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

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

(4) EPA has reviewed the submission and determined that there is a significant possibility that 

the microorganism will be regulated under section 5(e) or section 5(f) of the Act, but EPA is 

unable to initiate regulatory action within the initial review period. 

'725.60 Withdrawal of submission by the submitter.

(a) A submitter may withdraw a submission during the review period. A statement of withdrawal 

must be made in writing to the address listed in '725.25(c). The withdrawal is effective upon 

receipt of the statement by the Document Control Officer. 
(b) If a manufacturer, importer, or processor who withdrew a submission later resubmits a 

submission for the same microorganism, a new review period begins. 

'725.65 Recordkeeping.

(a) General provisions. (1) Any person who submits a notice under this part must retain 

documentation of information in the submission, including: 

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

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

(2) Any person who submits a notice under this part must retain documentation of the date of 

commencement of testing, manufacture, import, or processing. 

(3) Any person who is exempt from some or all of the reporting requirements of this part must 

retain documentation that supports the exemption. 

(4) All information required by this section must be retained for 3 years from the date of 

commencement of each activity for which records are required under this part. 

(b) Specific requirements. In addition to the requirements of paragraph (a) of this section, 

specific recordkeeping requirements included in certain subparts must also be followed. 

(1) Additional recordkeeping requirements for activities conducted inside a structure are set forth 

in '725.235(h). 

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

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

(4) Additional recordkeeping requirements for Tier I exemptions under subpart G of this part are 

set forth in '725.424(a)(5). 

(5) Additional recordkeeping requirements for Tier II exemptions under subpart G of this part are 

set forth in '725.450(d). 

(6) Additional recordkeeping requirements for significant new uses of microorganisms reported 

under subpart L of this part are set forth in '725.850. Recordkeeping requirements may also be 

included when a microorganism and significant new use are added to subpart M of this part. 

'725.67 Applications to exempt new microorganisms from this part.

(a) Submission. (1) Any manufacturer or importer of a new microorganism may request, under 

section 5(h)(4) of the Act, an exemption, in whole or in part, from this part by sending a Letter of 

Application to the Chief, New Chemicals Branch, Chemical Control Division, Office of 

Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460. 

(2) General provisions. The Letter of Application should provide information to show that any

activities affected by the requested exemption will not present an unreasonable risk of injury to 

health or the environment. This information should include data described in the following 

paragraphs. 

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

(ii) The magnitude of exposure of human beings and the environment to the new microorganism. 
(iii) The benefits of the new microorganism for various uses and the availability of substitutes for 

such uses. 

(iv) The reasonably ascertainable economic consequences of granting or denying the exemption, 

including effects on the national economy, small business, and technological innovation. 

(3) Specific requirements. In addition to the requirements of paragraph (a)(2) of this section, the 

specific information requirements of the relevant subpart under which the exemption is sought 

should be met. 

(i) Exemption from MCAN reporting under subpart D. Information requirements are set forth in 

''725.155 and 725.160. 

(ii) Exemption from TERA reporting under subpart E. Information requirements are set forth in 

''725.255 and 725.260. 

(iii) Listing a recipient microorganism as eligible for exemption under subpart G. Information 

regarding the following criteria should be addressed in an application to list a recipient 

microorganism under '725.420: 

(A) Identification and classification of the microorganism using available genotypic and 

phenotypic information; 

(B) Information to evaluate the relationship of the microorganism to any other closely related 

microorganisms which have a potential for adverse effects on health or the environment; 

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

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

(E) Studies which indicate the potential for the microorganism to cause adverse effects to health 

or the environment; and 

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

(b) Processing of the Letter of Application by EPA -- (1) Grant of the Application. If, after 

consideration of the Letter of Application and any other relevant information available to EPA, 

the Assistant Administrator for Prevention, Pesticides and Toxic Substances makes a preliminary

determination that the new microorganism will not present an unreasonable risk of injury to 

health or the environment, the Assistant Administrator will propose a rule to grant the

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

(2) Denial of the application. If the Assistant Administrator decides that the preliminary

determination described in paragraph (b)(1) of this section cannot be made, the application will 

be denied by sending the applicant a written statement with the Assistant Administrator's reasons 

for denial. 

(c) Processing of the exemption -- (1) Unreasonable risk standard. Granting a section 5(h)(4) 

exemption requires a determination that the activities will not present an unreasonable risk of 

injury to health or the environment. 

(i) An unreasonable risk determination under the Act is an administrative judgment that requires 

balancing of the harm to health or the environment that a chemical substance may cause and the 

magnitude and severity of that harm, against the social and economic effects on society of EPA 

action to reduce that harm. 

(ii) A determination of unreasonable risk under section 5(h)(4) of the Act will examine the 
reasonably ascertainable economic and social consequences of granting or denying the 

exemption after consideration of the effect on the national economy, small business, 

technological innovation, the environment, and public health. 

(2) Grant of the exemption. The exemption will be granted if the Assistant Administrator 

determines, after consideration of all relevant evidence presented in the rulemaking proceeding 

described in paragraph (b)(1) of this section, that the new microorganism will not present an 

unreasonable risk of injury to health or the environment. 

(3) Denial of the exemption. The exemption will be denied if the Assistant Administrator 

determines, after consideration of all relevant evidence presented in the rulemaking proceeding 

described in paragraph (b)(1) of this section, that the determination described in paragraph (c)(2) 

of this section cannot be made. A final decision terminating the rulemaking proceeding will be 

published in the FEDERAL REGISTER. 

'725.70 Compliance.

(a) Failure to comply with any provision of this part is a violation of section 15 of the Act (15 

U.S.C. 2614). 

(b) A person who manufactures or imports a microorganism before a MCAN is submitted and 

the MCAN review period expires is in violation of section 15 of the Act even if that person was 

not required to submit the MCAN under '725.105. 

(c) Using a microorganism which a person knew or had reason to know was manufactured, 

processed, or distributed in commerce in violation of section 5 of the Act or this part is a 

violation of section 15 of the Act (15 U.S.C. 2614). 

(d) Failure or refusal to establish and maintain records or to permit access to or copying of 

records, as required by the Act, is a violation of section 15 of the Act (15 U.S.C. 2614). 

(e) Failure or refusal to permit entry or inspection as required by section 11 of the Act is a 

violation of section 15 of the Act (15 U.S.C. 2614). 

(f) Violators may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C. 

2615) for each violation. Persons who submit materially misleading or false information in 

connection with the requirements of any provision of this part may be subject to penalties 

calculated as if they never filed their submissions. 

(g) EPA may seek to enjoin the manufacture or processing of a microorganism in violation of 

this part or act to seize any microorganism manufactured or processed in violation of this part or 

take other actions under the authority of section 7 of the Act (15 U.S.C. 2606) or section 17 of 

the Act (15 U.S.C. 2616). 

'725.75 Inspections.

EPA will conduct inspections under section 11 of the Act to assure compliance with section 5 of 

the Act and this part, to verify that information required by EPA under this part is true and 
correct, and to audit data submitted to EPA under this part. 

 Subpart C -- Confidentiality and Public Access to Information

'725.80 General provisions for confidentiality claims.

(a) A person may assert a claim of confidentiality for any information submitted to EPA under 

this part. However, 

(1) Any person who asserts a claim of confidentiality for portions of the specific microorganism 

identity must provide the information as described in '725.85. 

(2) Any person who asserts a claim of confidentiality for a use of a microorganism must provide 

the information as described in '725.88. 

(3) Any person who asserts a claim of confidentiality for information contained in a health and 

safety study of a microorganism must provide the information described in '725.92. 

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

(1) When a person submits any information under this part, including any attachments, for which 

claims of confidentiality are made, the claim(s) must be asserted by circling the specific 

information which is claimed and marking the page on which that information appears with an 

appropriate designation such as "trade secret," "TSCA CBI," or "confidential business 

information." 

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

document including the claimed information. 

(i) One copy of the document must be complete. In that copy, the submitter must mark the 

information which is claimed as confidential in the manner prescribed in paragraph (b)(1) of this 

section. 

(ii) The second copy must be complete except that all information claimed as confidential in the 

first copy must be deleted. EPA will place the second copy in the public file. 

(iii) If the submitter does not provide the second copy, the submission is incomplete and the 

review period does not begin to run until EPA receives the second copy, in accordance with 

'725.33. 

(iv) Any information contained within the copy submitted under paragraph (b)(2)(ii) of this 

section which has been in the public file for more than 30 days will be presumed to be in the 

public domain, notwithstanding any assertion of confidentiality made under this section. 

(3) A person who submits information to EPA under this part must reassert a claim of 

confidentiality and substantiate the claim each time the information is submitted to EPA. 

(c) Any person asserting a claim of confidentiality under this part must substantiate each claim in 

accordance with the requirements in '725.94. 

(d) EPA will disclose information that is subject to a claim of confidentiality asserted under this 

section only to the extent permitted by the Act, this subpart, and part 2 of this title. 

(e) If a submitter does not assert a claim of confidentiality for information at the time it is 

submitted to EPA, EPA may make the information public and place it in the public file without 

further notice to the submitter. 
'725.85 Microorganism identity.

(a) Claims applicable to the period prior to commencement of manufacture or import for general 

commercial use -- (1) When to make a claim. (i) A person who submits information to EPA 

under this part may assert a claim of confidentiality for portions of the specific microorganism 

identity at the time of submission of the information. This claim will apply only to the period 

prior to the commencement of manufacture or import for general commercial use. 

(ii) A person who submits information to EPA under this part must reassert a claim of 

confidentiality and substantiate the claim each time the information is submitted to EPA. For 

example, if a person claims certain information confidential in a TERA submission and wishes 

the same information to remain confidential in a subsequent TERA or MCAN submission, the 

person must reassert and resubstantiate the claim in the subsequent submission. 

(2) Assertion of claim. (i) A submitter may assert a claim of confidentiality only if the submitter 

believes that public disclosure prior to commencement of manufacture or import for general 

commercial use of the fact that anyone is initiating research and development activities 

pertaining to the specific microorganism or intends to manufacture or import the specific 

microorganism for general commercial use would reveal confidential business information. 

Claims must be substantiated in accordance with the requirements of '725.94(a). 

(ii) If the submission includes a health and safety study concerning the microorganism and if the 

claim for confidentiality with respect to the specific identity is denied in accordance with 

'725.92(c), EPA will deny a claim asserted under paragraph (a) of this section. 

(3) Development of generic name. Any person who asserts a claim of confidentiality for portions 

of the specific microorganism identity under this paragraph must provide one of the following 

items at the time the submission is filed: 

(i) The generic name which was accepted by EPA in the prenotice consultation conducted under 

paragraph (a)(4) of this section. 

(ii) One generic name that is only as generic as necessary to protect the confidential identity of 

the particular microorganism. The name should reveal the specific identity to the maximum 

extent possible. The generic name will be subject to EPA review and approval. 

(4) Determination by EPA. (i) Any person who intends to assert a claim of confidentiality for the 

specific identity of a new microorganism may seek a determination by EPA of an appropriate 

generic name for the microorganism before filing a submission. For this purpose, the person 

should submit to EPA: 

(A) The specific identity of the microorganism. 

(B) A proposed generic name(s) which is only as generic as necessary to protect the confidential 

identity of the new microorganism. The name(s) should reveal the specific identity of the 

microorganism to the maximum extent possible. 

(ii) Within 30 days, EPA will inform the submitter either that one of the proposed generic names 

is adequate or that none is adequate and further consultation is necessary. 

(5) Use of generic name. If a submitter claims microorganism identity as confidential under 

paragraph (a) of this section, and if the submitter complies with paragraph (a)(2) of this section, 

EPA will issue for publication in the FEDERAL REGISTER notice described in '725.40 the 

generic name proposed by the submitter or one agreed upon by EPA and the submitter. 
(b) Claims applicable to the period after commencement of manufacture or import for general 

commercial use -- (1) Maintaining claim. Any claim of confidentiality under paragraph (a) of 

this section is applicable only until the microorganism is manufactured or imported for general 

commercial use and becomes eligible for inclusion on the Inventory. To maintain the 

confidential status of the microorganism identity when the microorganism is added to the 

Inventory, a submitter must reassert the confidentiality claim and substantiate the claim in the 

notice of commencement of manufacture required under '725.190. 

(i) A submitter may not claim the microorganism identity confidential for the period after 

commencement of manufacture or import for general commercial use unless the submitter 

claimed the microorganism identity confidential under paragraph (a) of this section in the 

MCAN submitted for the microorganism. 

(ii) A submitter may claim the microorganism identity confidential for the period after 

commencement of manufacture or import for general commercial use if the submitter did not 

claim the microorganism identity confidential under paragraph (a) of this section in any TERA 

submitted for the microorganism, but subsequently did claim microorganism identity

confidential in the MCAN submitted for the microorganism. 

(2) Assertion of claim. (i) A person who believes that public disclosure of the fact that anyone 

manufactures or imports the microorganism for general commercial use would reveal 

confidential business information may assert a claim of confidentiality under paragraph (b) of 

this section. 

(ii) If the notice includes a health and safety study concerning the new microorganism, and if the 

claim for confidentiality with respect to the microorganism identity is denied in accordance with 

'725.92(c), EPA will deny a claim asserted under paragraph (b) of this section. 

(3) Requirements for assertion. Any person who asserts a confidentiality claim for 

microorganism identity must: (i) Comply with the requirements of paragraph (a)(3) of this 

section regarding submission of a generic name. 

(ii) Agree that EPA may disclose to a person with a bona fide intent to manufacture or import the 

microorganism the fact that the particular microorganism is included on the confidential 

Inventory for purposes of notification under section 5(a)(1)(A) of the Act. 

(iii) Have available and agree to furnish to EPA upon request the taxonomic designations and 

supplemental information required by '725.12. 

(iv) Provide a detailed written substantiation of the claim, in accordance with the requirements of 

'725.94(b). 

(4) Denial of claim. If the submitter does not meet the requirements of paragraph (b) of this 

section, EPA will deny the claim of confidentiality. 

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

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

(B) No claim for confidentiality of the microorganism identity as part of a health and safety 

study has been denied in accordance with part 2 of this title or '725.92. 

(ii) Publication of a generic name on the public Inventory does not create a category for purposes 

of the Inventory. Any person who has a bona fide intent to manufacture or import a 

microorganism which is described by a generic name on the public Inventory may submit an 
inquiry to EPA under '725.15(b) to determine whether the particular microorganism is included 

on the confidential Inventory. 

(iii) Upon receipt of a request described in '725.15(b), EPA may require the submitter who 

originally asserted confidentiality for a microorganism to submit to EPA the information listed in 

paragraph (b)(3)(iii) of this section. 

(iv) Failure to submit any of the information required under paragraph (b)(3)(iii) of this section 

within 10 calendar days of receipt of a request by EPA under paragraph (b) of this section will 

constitute a waiver of the original submitter's confidentiality claim. In this event, EPA may place 

the specific microorganism identity on the public Inventory without further notice to the original 

submitter. 

(6) Use of generic name on the public Inventory. If a submitter asserts a claim of confidentiality

under paragraph (b) of this section, EPA will examine the generic microorganism name proposed 

by the submitter. (i) If EPA determines that the generic name proposed by the submitter is only

as generic as necessary to protect the confidential identity of the particular microorganism, EPA 

will place that generic name on the public Inventory. 

(ii) If EPA determines that the generic name proposed by the submitter is more generic than 

necessary to protect the confidential identity, EPA will propose in writing, for review by the 

submitter, an alternative generic name that will reveal the identity of the microorganism to the 

maximum extent possible. 

(iii) If the generic name proposed by EPA is acceptable to the submitter, EPA will place that 

generic name on the public Inventory. 

(iv) If the generic name proposed by EPA is not acceptable to the submitter, the submitter must 

explain in detail why disclosure of that generic name would reveal confidential business 

information and propose another generic name which is only as generic as necessary to protect 

the confidential identity of the microorganism. If EPA does not receive a response from the 

submitter within 30 days after the submitter receives the proposed name, EPA will place EPA's

chosen generic name on the public Inventory. If the submitter does provide the information 

requested, EPA will review the response. If the submitter's proposed generic name is acceptable, 

EPA will publish that generic name on the public Inventory. If the submitter's proposed generic 

name is not acceptable, EPA will notify the submitter of EPA's choice of a generic name. Thirty 

days after this notification, EPA will place the chosen generic name on the public Inventory. 

'725.88 Uses of a microorganism.

(a) Assertion of claim. A person who submits information to EPA under this part on the 

categories or proposed categories of use of a microorganism may assert a claim of confidentiality

for this information. 

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

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

(2) Provide, in nonconfidential form, a description of the uses that is only as generic as necessary

to protect the confidential business information. The generic use description will be included in 

the FEDERAL REGISTER notice described in '725.40. 

(c) Generic use description. The person must submit the information required by paragraph (b) of 

this section by describing the uses as precisely as possible, without revealing the information 
which is claimed confidential, to disclose as much as possible how the use may result in human 

exposure to the microorganism or its release to the environment. 

'725.92 Data from health and safety studies of microorganisms.

(a) Information other than specific microorganism identity. Except as provided in paragraph (b) 

of this section, EPA will deny any claim of confidentiality with respect to information included 

in a health and safety study of a microorganism, unless the information would disclose 

confidential business information concerning: 

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

(2) Information which is not in any way related to the effects of a microorganism on health or the 

environment, such as, the name of the submitting company, cost or other financial data, product 

development or marketing plans, and advertising plans, for which the person submits a claim of 

confidentiality in accordance with '725.80. 

(b) Microorganism identity -- (1) Claims applicable to the period prior to commencement of 

manufacture or import for general commercial use. A claim of confidentiality for the period prior 

to commencement of manufacture or import for general commercial use for the specific identity

of a microorganism for which a health and safety study was submitted must be asserted in 

conjunction with a claim asserted under '725.85(a). The submitter must substantiate each claim 

in accordance with the requirements of '725.94(a). 

(2) Claims applicable to the period after commencement of manufacture or import for general 

commercial use. To maintain the confidential status of the specific identity of a microorganism 

for which a health and safety study was submitted after commencement of manufacture or import 

for general commercial use, the claim must be reasserted and substantiated in conjunction with a 

claim under '725.85(b). The submitter must substantiate each claim in accordance with the 

requirements of '725.94(b). 

(c) Denial of confidentiality claim. EPA will deny a claim of confidentiality for microorganism 

identity under paragraph (b) of this section, unless: 

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

microorganism. 

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

(d) Use of generic names. When EPA discloses a health and safety study containing a 

microorganism identity, which the submitter has claimed confidential, and if the Agency has not 

denied the claim under paragraph (c) of this section, EPA will identify the microorganism by the 

generic name selected under '725.85. 

'725.94 Substantiation requirements. 

(a) Claims applicable to the period prior to commencement of manufacture or import for general 

commercial use B (1) MCAN, TME, Tier I certification, and Tier II exemption request 

requirements. Any person who submits a MCAN, TME, Tier I certification, or Tier II exemption 
request should strictly limit confidentiality claims to that information which is confidential and 

proprietary to the business. 

(i) If any information in the submission is claimed as confidential business information, the 

submitter must substantiate each claim by submitting written answers to the questions in 

paragraphs (c), (d), and (e) of this section at the time the person submits the information. 

(ii) If the submitter does not provide written substantiation as required in paragraph (a)(1)(i) of 

this section, the submission will be considered incomplete and the review period will not begin 

in accordance with '725.33. 

(2) TERA requirements. Any person who submits a TERA, should strictly limit confidentiality

claims to that information which is confidential and proprietary to the business. If any

information in such a submission is claimed as confidential business information, the submitter 

must have available for each of those claims, and agree to furnish to EPA upon request, written 

answers to the questions in paragraphs (d) and (e) of this section. 

(b) Claims applicable to the period after commencement of manufacture or import for general 

commercial use. (1) If a submitter claimed portions of the microorganism identity confidential in 

the MCAN and wants the identity to be listed on the confidential Inventory, the claim must be 

reasserted and substantiated at the time the Notice of Commencement (NOC) is submitted under 

'725.190. Otherwise, EPA will list the specific microorganism identity on the public Inventory. 

(2) The submitter must substantiate the claim for confidentiality of the microorganism identity

by answering all of the questions in paragraphs (c), (d), and (e) in this section. In addition, the 

following questions must be answered: 

(i) What harmful effects to the company's or institution's competitive position, if any, would 

result if EPA publishes on the Inventory the identity of the microorganism? How could a 

competitor use such information given the fact that the identity of the microorganism otherwise 

would appear on the TSCA Inventory with no link between the microorganism and the company 

or institution? How substantial would the harmful effects of disclosure be? What is the causal

relationship between the disclosure and the harmful effects? 

(ii) Has the identity of the microorganism been kept confidential to the extent that competitors do 

not know it is being manufactured or imported for general commercial use by anyone? 

(c) General questions. The following questions must be answered in detail for each 

confidentiality claim: 

(1) For what period of time is a claim of confidentiality being asserted? If the claim is to extend 

until a certain event or point in time, indicate that event or time period. Explain why the 

information should remain confidential until such point.

(2) Briefly describe any physical or procedural restrictions within the company or institution 

relating to the use and storage of the information claimed as confidential. What other steps, if 

any, apply to use or further disclosure of the information? 

(3) Has the information claimed as confidential been disclosed to individuals outside of the 

company or institution? Will it be disclosed to such persons in the future? If so, what restrictions, 

if any, apply to use or further disclosure of the information? 
(4) Does the information claimed as confidential appear, or is it referred to, in any of the 

following questions? If the answer is yes to any of these questions, indicate where the 

information appears and explain why it should nonetheless be treated as confidential. 

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

(ii) Material safety data sheets or other similar materials for the microorganism or the resulting 

end product? 

(iii) Professional or trade publications? 

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

(v) Patents? 

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

(5) Has EPA, another Federal agency, a Federal court, or a State made any confidentiality

determination regarding the information claimed as confidential? If so, provide copies of such 

determinations. 

(6) For each type of information claimed confidential, describe the harm to the company's or 

institution's competitive position that would result if this information were disclosed. Why would 

this harm be substantial? How could a competitor use such information? What is the causal 

connection between the disclosure and harm? 

(7) If EPA disclosed to the public the information claimed as confidential, how difficult would it 

be for the competitor to enter the market for the resulting product? Consider such constraints as 

capital and marketing cost, specialized technical expertise, or unusual processes. 

(d) Microorganism identity and production method. If confidentiality claims are asserted for the 

identity of the microorganism or information on how the microorganism is produced, the 

following questions must be answered: 

(1) Has the microorganism or method of production been patented in the U.S. or elsewhere? If 

so, why is confidentiality necessary? 

(2) Does the microorganism leave the site of production or testing in a form which is accessible 

to the public or to competitors? What is the cost to a competitor, in time and money, to develop 

appropriate use conditions? What factors facilitate or impede product analysis? 

(3) For each additional type of information claimed as confidential, explain what harm would 

result from disclosure of each type of information if the identity of the microorganism were to 

remain confidential. 

(e) Health and safety studies of microorganisms. If confidentiality claims are asserted for 

information in a health or safety study of a microorganism, the following questions must be 

answered: 

(1) Would the disclosure of the information claimed confidential reveal: confidential process 

information, or information unrelated to the effects of the microorganism on health and the 

environment. Describe the causal connection between the disclosure and harm. 

(2) Does the company or institution assert that disclosure of the microorganism identity is not 

necessary to interpret any health and safety studies which have been submitted? If so, explain 
how a less specific identity would be sufficient to interpret the studies. 

'725.95 Public file.

All information submitted, including any health and safety study of a microorganism and other 

supporting documentation, will become part of the public file for that submission, unless such 

materials are claimed confidential. In addition, EPA may add materials to the public file, unless 

such materials are claimed confidential. Any of the nonconfidential material described in this 

subpart will be available for public inspection in the TSCA Public Docket Office, Rm. NE-B607, 

401 M St., SW., Washington, DC, between the hours of noon to 4 p.m., Monday through Friday, 

excluding legal holidays. 

 Subpart D -- Microbial Commercial Activities Notification Requirements

'725.100 Scope and purpose.

(a) This subpart establishes procedures for submission of a notice to EPA under section 5(a) of 

the Act for persons who manufacture, import, or process microorganisms for commercial 

purposes. This notice is called a Microbial Commercial Activity Notice (MCAN). It is expected 

that MCANs will in general only be submitted for microorganisms intended for general 

commercial use. Persons who manufacture, import, or process a microorganism in small 

quantities solely for research and development as defined in '725.3 are not required to submit a 

notice to EPA. Persons who manufacture, import, or process a microorganism for research and 

development activities that do not fit the definition of small quantities solely for research and 

development may nonetheless qualify for more limited reporting requirements in Subpart E, 

including the TERA which can be used for review of research and development involving 

environmental release. 

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

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

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

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

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

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

'725.105 Persons who must report.

(a) Manufacturers of new microorganisms. (1) MCAN submission is required for any person 

who intends to manufacture for commercial purposes in the United States a new microorganism. 

Exclusions are described in '725.110. 

(2) If a person contracts with a manufacturer to produce or process a new microorganism and the 

manufacturer produces or processes the microorganism exclusively for that person, and that 

person specifies the identity of the microorganism, and controls the total amount produced and 

the basic technology for the plant process, then that person must submit the MCAN. If it is 

unclear who must report, EPA should be contacted to determine who must submit the MCAN. 

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

(b) Importers of new microorganisms. (1) MCAN submission is required for a person who 

intends to import into the United States for commercial purposes a new microorganism. 

Exclusions are described in '725.110. 

(2) When several persons are involved in an import transaction, the MCAN must be submitted by

the principal importer. If no one person fits the principal importer definition in a particular 

transaction, the importer should contact EPA to determine who must submit the MCAN for that 

transaction. 

(3) Except as otherwise provided in paragraph (b)(4) of this section, the provisions of this 

subpart D apply to each person who submits a MCAN for a new microorganism which such 

person intends to import for a commercial purpose. In addition, each importer must comply with 

paragraph (b)(4) of this section. 

(4) EPA will hold the principal importer, or the importer that EPA determines must submit the 

MCAN when there is no principal importer under paragraph (b)(2) of this section, liable for 

complying with this part, for completing the MCAN, and for the completeness and truthfulness 

of all information which it submits. 

(c) Manufacturers, importers, or processors of microorganisms for a significant new use. MCAN 

submission is required for any person who intends to manufacture, import, or process for 

commercial purposes a microorganism identified as having one or more significant new uses in 

subpart M of this part, and who intends either to engage in a designated significant new use of 

the microorganism or intends to distribute it in commerce. Persons excluded from reporting on 

significant new uses of microorganisms and additional procedures for reporting are described in 

subpart L of this part. 

'725.110 Persons not subject to this subpart. 

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

(a) Manufacturing, importing, or processing solely for research and development 

microorganisms that meet the requirements for an exemption under subpart E of this part. 

(b) Manufacturing, importing, or processing microorganisms for test marketing activities which 

have been granted an exemption under subpart F of this part. 

(c) Manufacturing or importing new microorganisms under the conditions of a Tier I or Tier II 

exemption under subpart G of this part. 

'725.150 Procedural requirements for this subpart.

General requirements for all MCANs under this part are contained in subparts A through C of 

this part. In addition, the following requirements apply to MCANs submitted under this subpart: 

(a) When to submit a MCAN. A MCAN must be submitted at least 90 calendar days prior to 

manufacturing or importing a new microorganism and at least 90 calendar days prior to 

manufacturing, importing, or processing a microorganism for a significant new use. 
(b) Section 5(b) of the Act. The submitter must comply with any applicable requirement of 

section 5(b) of the Act for the submission of test data. 

(c) Contents of a MCAN. Each person who submits a MCAN under this subpart must provide 

the information and test data described in ''725.155 and 725.160. 

(d) Recordkeeping. Each person who submits a MCAN under this subpart must comply with the 

recordkeeping requirements of '725.65. 

'725.155 Information to be included in the MCAN.

(a) Each person who is required by this part to submit a MCAN must include the information 

specified in paragraphs (c) through (h) of this section, to the extent it is known to or reasonably 

ascertainable by that person. However, no person is required to include information which relates 

solely to exposure of humans or ecological populations outside of the United States. 

(b) Each person should also submit, in writing, all other information known to or reasonably

ascertainable by that person that would permit EPA to make a reasoned evaluation of the health 

and environmental effects of the microorganism, or any microbial mixture or article, including 

information on its effects on humans, animals, plants, and other microorganisms, and in the 

environment. The information to be submitted under this subpart includes the information listed 

in paragraphs (c) through (h) of this section relating to the manufacture, processing, distribution 

in commerce, use, and disposal of the new microorganism. 

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

(2) The name, address, and office telephone number (including area code) of the principal 

technical contact representing the submitter. 

(d) Microorganism identity information. Persons must submit sufficient information to allow the 

microorganism to be accurately and unambiguously identified for listing purposes as required by 

'725.12. 

(1) Description of the recipient microorganism and the new microorganism. (i) Data 

substantiating the taxonomy of the recipient microorganism and the new microorganism to the 

level of strain, as appropriate. In lieu of data, EPA will accept a letter from a culture collection 

substantiating taxonomy, provided EPA, upon request to the submitter, may have access to the 

data supporting the taxonomic designation. 

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

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

Inventory purposes. 

(2) Genetic construction of the new microorganism. (i) Data substantiating the taxonomy of the 

donor organism(s). In lieu of data, EPA will accept a letter from a culture collection 

substantiating taxonomy, provided EPA, upon request to the submitter, may have access to the 

data supporting the taxonomic designation. 

(ii) Description of the traits for which the new microorganism has been selected or developed 

and other traits known to have been added or modified. 

(iii) A detailed description of the genetic construction of the new microorganism, including the 

technique used to modify the microorganism (e.g., fusion of cells, injection of DNA, 
electroporation or chemical poration, or methods used for induced mutation and selection). The 

description should include, for example, a description of the introduced genetic material, 

including any regulatory sequences and structural genes and the products of those genes; how the

introduced genetic material is expected to affect behavior of the recipient; expression, alteration, 

and stability of the introduced genetic material; methods for vector construction and 

introduction; and a description of the regulatory and structural genes that are components of the 

introduced genetic material, including genetic maps of the introduced sequences. 

(3) Phenotypic and ecological characteristics. (i) Habitat, geographical distribution, and source of 

the recipient microorganism. 

(ii) Survival and dissemination under relevant environmental conditions including a description 

of methods for detecting the new or recipient microorganism(s) in the environment and the 

sensitivity limit of detection for these techniques. 

(iii) A description of anticipated biological interactions with and effects on target organisms and 

other organisms such as competitors, prey, hosts, symbionts, parasites, and pathogens; a 

description of host range; a description of pathogenicity, infectivity, toxicity, virulence, or action 

as a vector of pathogens; and capacity for genetic transfer under laboratory and relevant 

environmental conditions. 

(iv) A description of anticipated involvement in biogeochemical or biological cycling processes, 

involvement in rate limiting steps in mineral or nutrient cycling, or involvement in inorganic 

compounds cycling (such as possible sequestration or transformation of heavy metals). 

(e) Byproducts. A description of the byproducts resulting from the manufacture, processing, use, 

and disposal of the new microorganism. 

(f) Total production volume. The estimated maximum amount of the new microorganism 

intended to be manufactured or imported during the first year of production and the estimated 

maximum amount to be manufactured or imported during any consecutive 12-month period 

during the first 3 years of production. This estimate may be by weight or volume and should 

include an estimation of viability (i.e., viable cells per unit volume or colony forming units

per unit dry weight). 

(g) Use information. A description of intended categories of use by function and application, the 

estimated percent of production volume devoted to each category of use, and the percent of the 

new microorganism in the formulation for each commercial or consumer use. 

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

(i) The identity of sites where the new microorganism will be manufactured, processed, or used. 

For purposes of this section, the site for a person who imports a new microorganism is the site of 

the operating unit within the person's organization which is directly responsible for importing the 

new microorganism and which controls the import transaction. The import site may in some 

cases be the organization's headquarters office in the United States. 

(ii) A process description of each manufacture, processing, and use operation, which includes a 

diagram of the major unit operations and conversions, the identity and entry point of all 

feedstocks, and the identity of any possible points of release of the new microorganism from the 

process, including a description of all controls, including engineering controls, used to prevent 

such releases. 
(iii) Worker exposure information, including worker activities, physical form of process streams 

which contain the new microorganism to which workers may be exposed, the number of 

workers, and the duration of activities. 

(iv) Information on release of the new microorganism to the environment, including the quantity

and media of release and type of control technology used. 

(v) A narrative description of the intended transport of the new microorganism, including the 

means of transport, containment methods to be used during transport, and emergency 

containment procedures to be followed in case of accidental release. 

(vi) Procedures for disposal of any articles, waste, clothing, or other equipment involved in the 

activity, including procedures for inactivation of the new microorganism, containment, 

disinfection, and disposal of contaminated items. 

(2) For sites not controlled by the submitter, a description of each type of processing and use 

operation involving the new microorganism, including identification of the estimated number of 

processing or use sites, situations in which worker exposure to and/or environmental release of 

the new microorganism will occur, the number of workers exposed and the duration of exposure; 

procedures for transport of the new microorganism and for disposal, including procedures for 

inactivation of the new microorganism; and control measures which limit worker exposure and

environmental release. 

'725.160 Submission of health and environmental effects data.

(a) Test data on the new microorganism in the possession or control of the submitter. (1) Except 

as provided in '725.25(h), and in addition to the information required by '725.155(d)(3), each 

MCAN must contain all test data in the submitter's possession or control which are related to the 

effects on health or the environment of any manufacture, processing, distribution in commerce, 

use, or disposal of the new microorganism or any microbial mixture or article containing the new 

microorganism, or any combination of such activities. This includes test data concerning the new

microorganism in a pure culture or formulated form as used or as intended to be used in one of 

the activities listed above. 

(2) A full report or standard literature citation must be submitted for the following types of test 

data: (i) Health effects data. 

(ii) Ecological effects data. 

(iii) Physical and chemical properties data. 

(iv) Environmental fate characteristics. 

(v) Monitoring data and other test data related to human exposure to or environmental release of 

the new microorganism. 

(3)(i) If the data do not appear in the open scientific literature, the submitter must provide a full 

report. A full report includes the experimental methods and materials, results, discussion and 

data analysis, conclusions, references, and the name and address of the laboratory that developed 

the data. 

(ii) If the data appear in the open scientific literature, the submitter need only provide a standard 

literature citation. A standard literature citation includes author, title, periodical name, date of 

publication, volume, and page numbers. 
(4)(i) If a study, report, or test is incomplete when a person submits a MCAN, the submitter must 

identify the nature and purpose of the study; name and address of the laboratory developing the 

data; progress to date; types of data collected, significant preliminary results; and anticipated 

completion date. 

(ii) If a test or experiment is completed before the MCAN review period ends, the person must 

submit the study, report, or test, as specified in paragraph (a)(3)(i) of this section, to the address 

listed in '725.25(c) within 10 days of receiving it, but no later than 5 days before the end of the 

review period. If the test or experiment is completed during the last 5 days of the review period, 

the submitter must immediately inform its EPA contact for that submission by telephone. 

(5) For test data in the submitter's possession or control which are not listed in paragraph (a)(2) 

of this section, a person is not required to submit a complete report. The person must submit a 

summary of the data. If EPA so requests, the person must submit a full report within 10 days of 

the request, but no later than 5 days before the end of the review period. 

(6) All test data described under paragraph (a) of this section are subject to these requirements, 

regardless of their age, quality, or results. 

(b) Other data concerning the health and environmental effects of the new microorganism that 

are known to or reasonably ascertainable by the submitter. (1) Except as provided in '725.25(h), 

and in addition to the information required by '725.155(c)(3), any person who submits a MCAN 

must describe the following data, including any data from a health and safety study of a 

microorganism, if the data are related to effects on health or the environment of any

manufacture, processing, distribution in commerce, use, or disposal of the microorganism, of any 

microbial mixture or article containing the new microorganism, or of any combination of such 

activities: 

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

(ii) Any data, including test data, which are not in the submitter's possession or control, but 

which are known to or reasonably ascertainable by the submitter. For the purposes of this 

section, data are known to or reasonably ascertainable by the submitter if the data are known to 

any of its employees or other agents who are associated with the research and development, test 

marketing, or commercial marketing of the microorganism. 

(2) Data that must be described include data concerning the new microorganism in a pure culture 

or formulated form as used or as intended to be used in one of the activities listed in paragraph 

(b)(1) of this section. 

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

(i) If the data appear in the open scientific literature, a standard literature citation, which includes 

the author, title, periodical name, date of publication, volume, and pages. 

(ii) If the data are not available in the open scientific literature, a description of the type of data 

and summary of the results, if available, and the names and addresses of persons the submitter 

believes may have possession or control of the data. 

(4) All data described in paragraph (b) of this section are subject to these requirements, 

regardless of their age, quality, or results; and regardless of whether they are complete at the time 

the MCAN is submitted. 
'725.170 EPA review of the MCAN.

General procedures for review of all submissions under this part are contained in ''725.28 

through 725.60. In addition, the following procedures apply to EPA review of MCANs submitted 

under this subpart: 

(a) Length of the review period. The MCAN review period specified in section 5(a) of the Act 

runs for 90 days from the date the Document Control Officer for the Office of Pollution 

Prevention and Toxics receives a complete MCAN, or the date EPA determines the MCAN is 

complete under '725.33, unless the Agency extends the period under section 5(c) of the Act and 

'725.56. 

(b) Notice of expiration of MCAN review period. (1) EPA will notify the submitter that the 

MCAN review period has expired or that EPA has completed its review of the MCAN. 

Expiration of the review period does not constitute EPA approval or certification of the new 

microorganism, and does not mean that EPA may not take regulatory action against the 

microorganism in the future. 

(2) After expiration of the MCAN review period, in the absence of regulatory action by EPA 

under section 5(e), 5(f), or 6(a) of the Act, the submitter may manufacture or import the 

microorganism even if the submitter has not received notice of expiration. 

(3) Early notification that EPA has completed its review does not permit commencement of 

manufacture or import prior to the expiration of the 90-day MCAN review period. 

(c) No person submitting a MCAN in response to the requirements of this subpart may

manufacture, import, or process a microorganism subject to this subpart until the review period, 

including all extensions and suspensions, has expired. 

'725.190 Notice of commencement of manufacture or import.

(a) Applicability. Any person who commences the manufacture or import of a new 

microorganism for nonexempt, commercial purposes for which that person previously submitted 

a section 5(a) notice under this part must submit a notice of commencement (NOC) of 

manufacture or import. 

(b) When to report. (1) If manufacture or import for nonexempt, commercial purposes begins on 

or after May 27, 1997, the submitter must submit the NOC to EPA no later than 30 calendar days 

after the first day of such manufacture or import. 

(2) If manufacture or import for nonexempt, commercial purposes began or will begin before 

May 27, 1997, the submitter must submit the NOC by May 27, 1997. 

(3) Submission of an NOC prior to the commencement of manufacture or import is a violation of 

section 15 of the Act. 

(c) Information to be reported. The NOC must contain the following information: Specific 

microorganism identity, MCAN number, and the date when manufacture or import commences. 

If the person claimed microorganism identity confidential in the MCAN, and wants the identity
to be listed on the confidential Inventory, the claim must be reasserted and resubstantiated in 

accordance with '725.85(b). Otherwise, EPA will list the specific microorganism identity on the 

public Inventory. 

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

 Subpart E -- Exemptions for Research and Development Activities

'725.200 Scope and purpose.

(a) This subpart describes exemptions from the reporting requirements under subpart D of this 

part for research and development activities involving microorganisms. 

(b) In lieu of complying with subpart D of this part, persons described in '725.205 may submit a 

TSCA Experimental Release Application (TERA) for research and development activities 

involving microorganisms or otherwise comply with this subpart. 

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

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

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

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

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

'725.205 Persons who may report under this subpart. 

(a) Commercial research and development activities involving new microorganisms or 

significant new uses of microorganisms are subject to reporting under this part unless they

qualify for an exemption under this part. 

(b) Commercial purposes for research and development means that the activities are conducted 

with the purpose of obtaining an immediate or eventual commercial advantage for the researcher 

and would include: 

(1) All research and development activities which are funded directly, in whole or in part, by a 

commercial entity regardless of who is actually conducting the research. Indications that the 

research and development activities are funded directly, in whole or in part, may include, but are 

not limited to: 

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

(ii) Situations in which a commercial entity gives a conditional grant where the commercial 

entity holds patent rights, or establishes a joint venture where the commercial entity holds patent 

or licensing rights; or 

(iii) Any other situation in which the commercial entity intends to obtain an immediate or 

eventual commercial advantage for the commercial entity and/or the researcher. 

(2) Research and development activities that are not funded directly by a commercial entity, if 

the researcher intends to obtain an immediate or eventual commercial advantage. Indications that 

the researcher intends to obtain an immediate or eventual commercial advantage may include, 

but are not limited to: 

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

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

commercial application; or 

(iii) The researcher or university has sought or is seeking a patent to protect a commercial 

application which the research is developing; or 

(iv) Other evidence that the researcher is aware of a commercial application for the research and 

has directed the research toward developing that application. 

(c) Certain research and development activities involving microorganisms subject to jurisdiction 

under the Act are exempt from reporting under this part. A person conducting research and 

development activities which meet the conditions for the exemptions described in ''725.232, 

725.234, or 725.238 is exempt from TERA reporting under this subpart. 

(d) A microorganism is not exempt from reporting under subpart D of this part if any amount of 

the microorganism, including as part of a mixture, is processed, distributed in commerce, or 

used, for any commercial purpose other than research and development. 

(e) Quantities of the inactivated microorganism, or mixtures or articles containing the inactivated 

microorganism, remaining after completion of research and development activities may be 

disposed of as a waste in accordance with applicable Federal, State, and local regulations. 

(f) A person who manufactures, imports, or processes a microorganism solely for research and 

development is not required to comply with the requirements of this section if: 

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

(2) The person is manufacturing a microbial pesticide for which an Experimental Use Permit is 

required, pursuant to '172.3; or 

(3) The person is manufacturing a microbial pesticide for which a notification or an 

Experimental Use Permit is not required to be submitted. 

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

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

conditions. 

(a) The microorganism is manufactured, imported, or processed solely for research and 

development activities. 

(b) There is no intentional testing of a microorganism outside of a structure, as structure is 

defined in '725.3. 

(c)(1) The person receives research funds from another Federal agency, and the funds are 

awarded on the condition that the research will be conducted in accordance with the relevant 

portions of the NIH Guidelines, or 

(2) A Federal agency or program otherwise imposes the legally binding requirement that the 

research is to be conducted in accordance with relevant portions of the NIH Guidelines. 

'725.234 Activities conducted inside a structure.
A person who manufactures, imports, or processes a microorganism is not subject to the 

reporting requirements under subpart D of this part if all of the following conditions are met: 

(a) The microorganism is manufactured, imported, or processed solely for research and 

development activities. 

(b) The microorganism is used by, or directly under the supervision of, a technically qualified 

individual, as defined in '725.3. The technically qualified individual must maintain 

documentation of the procedures selected to comply with paragraph (d) of this section and must 

ensure that the procedures are used. 

(c) There is no intentional testing of a microorganism outside of a structure, as structure is 

defined in '725.3. 

(d) Containment and/or inactivation controls. (1) Selection and use of containment and/or 

inactivation controls inside a structure for a particular microorganism shall take into account the 

following: (i) Factors relevant to the organism's ability to survive in the environment. 

(ii) Potential routes of release in air, solids and liquids; in or on waste materials and equipment; 

in or on people, including maintenance and custodial personnel; and in or on other organisms, 

such as insects and rodents. 

(iii) Procedures for transfer of materials between facilities. 

(2) The technically qualified individual's selection of containment and/or inactivation controls 

shall be approved and certified by an authorized official (other than the TQI) of the institution 

that is conducting the test prior to the commencement of the test. 

(3) Records shall be developed and maintained describing the selection and use of containment 

and/or inactivation controls, as specified in '725.235(c). These records, which must be 

maintained at the location where the research and development activity is being conducted, shall 

be submitted to EPA upon written request and within the time frame specified in EPA's request. 

(4) Subsequent to EPA review of records in accordance with paragraph (d)(3) of this section, 

changes to the containment/inactivation controls selected under paragraph (d)(1) of this section 

must be made upon EPA order. Failure to comply with EPA's order shall result in automatic loss 

of eligibility for an exemption under this section. 

(e) The manufacturer, importer, or processor notifies all persons in its employ or to whom it 

directly distributes the microorganism, who are engaged in experimentation, research, or analysis 

on the microorganism, including the manufacture, processing, use, transport, storage, and 

disposal of the microorganism associated with research and development activities, of any risk to 

health, identified under '725.235(a), which may be associated with the microorganism. The 

notification must be made in accordance with '725.235(b). 

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

(a) Determination of risks. To determine whether notification under '725.234(e) is required, the 

manufacturer, importer, or processor must do one of the following: 

(1) For research conducted in accordance with the NIH Guidelines, the manufacturer, importer, 

or processor must meet the conditions laid out at IV-B-4-d of the NIH Guidelines; or 
(2) For all other research conducted in accordance with '725.234, the manufacturer, importer, or 

processor must review and evaluate the following information to determine whether there is 

reason to believe there is any risk to health which may be associated with the microorganism: 

(i) Information in its possession or control concerning any significant adverse reaction of persons 

exposed to the microorganism which may reasonably be associated with such exposure. 

(ii) Information provided to the manufacturer, importer, or processor by a supplier or any other 

person concerning a health risk believed to be associated with the microorganism. 

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

microorganism. 

(iv) Information on health effects which accompanies any EPA rule or order issued under TSCA 

section 4, 5, or 6 of the Act that applies to the microorganism and of which the manufacturer, 

importer, or processor has knowledge. 

(b) Notification to employees and others. (1) The manufacturer, importer, or processor must 

notify the persons identified in '725.234(e) by means of a container labeling system, 

conspicuous placement of notices in areas where exposure may occur, written notification to 

each person potentially exposed, or any other method of notification which adequately informs 

persons of health risks which the manufacturer, importer, or processor has reason to believe may

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

(2) If the manufacturer, importer, or processor distributes a microorganism manufactured, 

imported, or processed under this section to persons not in its employ, the manufacturer, 

importer, or processor must in written form: 

(i) Notify those persons that the microorganism is to be used only for research and development 

purposes and the requirements of '725.234 are to be met. 

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

(3) The adequacy of any notification under this section is the responsibility of the manufacturer, 

importer, or processor.

(c) Recordkeeping. (1) For research conducted in accordance with the NIH Guidelines, a person 

who manufactures, imports, or processes a microorganism under this section must retain the 

following records: (i) Documentation that the NIH Guidelines have been adhered to. Such 

documentation shall include: (A) For experiments subject to Institutional Biosafety Committee 

review, or notification simultaneous with initiation of the experiment, the information submitted 

for review or notification, along with standard laboratory records, shall satisfy the recordkeeping 

requirements specified in '725.234(d)(3). 

(B) For experiments exempt from Institutional Biosafety Committee review or notification 

simultaneous with initiation of the experiment, documentation of the exemption, along with 

standard laboratory records, shall satisfy the recordkeeping requirement specified in 

'725.234(d)(3). 

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

(A) Copies or citations to information reviewed and evaluated to determine the need to make any 

notification of risk. 

(B) Documentation of the nature and method of notification of risk, including copies of any 

labels or written notices used. 
(C) The names and addresses of any persons other than the manufacturer, importer, or processor 

to whom the substance is distributed, the identity of the microorganism, the amount distributed, 

and copies of the notifications required. 

(2) For all other research conducted in accordance with '725.234, a person who manufacturers, 

imports, or processes a microorganism under this section, must maintain the following records: 

(i) Records describing selection and use of containment and/or inactivation controls required by

'725.234(d)(3) and certification by an authorized official required by '725.234(d)(2) for each 

microorganism. 

(ii) Copies or citations to information reviewed and evaluated under paragraph (a) of this section 

to determine the need to make any notification of risk. 

(iii) Documentation of the nature and method of notification under paragraph (b)(1) of this 

section, including copies of any labels or written notices used. 

(iv) The names and addresses of any persons other than the manufacturer, importer, or processor 

to whom the substance is distributed, the identity of the microorganism, the amount distributed, 

and copies of the notifications required under paragraph (b)(2) of this section. 

'725.238 Activities conducted outside a structure.

(a) Exemption. (1) Research and development activities involving intentional testing in the 

environment of certain microorganisms listed in '725.239 may be conducted without prior 

review by EPA if all of the conditions of this section and '725.239 are met. 

(2) The research and development activity involving a microorganism listed in '725.239 must be 

conducted by, or directly under the supervision of, a technically qualified individual, as defined 

in '725.3. 

(b) Certification. To be eligible for the exemption under this section, a manufacturer or importer 

must submit to EPA prior to initiation of the activity a document signed by an authorized official 

containing the following information: 

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

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

(3) Certification of the following: (i) Compliance with the conditions of the exemption specified 

for the microorganism in '725.239. 

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

(c) Recordkeeping. Persons who conduct research and development activities under this section 

must comply with the recordkeeping requirements of '725.65 and retain documentation that 

supports their compliance with the requirements of this section and the specific requirements for 

the microorganism listed in '725.239. 

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

(a) Bradyrhizobium japonicum. To qualify for an exemption under this section, all of the 

following conditions must be met for a test involving Bradyrhizobium japonicum: 

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

of Bradyrhizobium japonicum. 
(2) Modification of traits. (i) The introduced genetic material must meet the criteria for poorly 

mobilizable listed in '725.421(c). 

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

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

(1) For structural genes encoding marker sequences, the gene is limited to the aadH gene, which 

confers resistance to the antibiotics streptomycin and spectinomycin. 

(2) For traits other than antibiotic resistance, the structural gene must be limited to the genera 

Bradyrhizobium and Rhizobium. 

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

(C) Associated nucleotide sequences needed to move genetic material, including linkers, 

homopolymers, adaptors, transposons, insertion sequences, and restriction enzyme sites. 

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

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

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

(ii) The technically qualified individual must select appropriate methods to limit the 

dissemination of modified Bradyrhizobium japonicum. 

(b) Rhizobium meliloti. To qualify for an exemption under this section, all of the following 

conditions must be met for a test involving Rhizobium meliloti: 

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

of Rhizobium meliloti. 

(2) Modification of traits. (i) The introduced genetic material must meet the criteria for poorly 

mobilizable listed in '725.421(c) of this part. 

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

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

(1) For structural genes encoding marker sequences, the gene is limited to the aadH gene, which 

confers resistance to the antibiotics streptomycin and spectinomycin. 

(2) For traits other than antibiotic resistance, the structural gene must be limited to the genera 

Bradyrhizobium and Rhizobium. 

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

(C) Associated nucleotide sequences needed to move genetic material, including linkers, 

homopolymers, adaptors, transposons, insertion sequences, and restriction enzyme sites. 

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

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

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

(ii) The technically qualified individual must select appropriate methods to limit the 

dissemination of modified Rhizobium meliloti. 

'725.250 Procedural requirements for the TERA.

General requirements for all submissions under this part are contained in subparts A through C 

of this part. In addition, the following requirements apply to TERAs submitted under this 
subpart: 

(a) When to submit the TERA. Each person who is eligible to submit a TERA under this subpart 

must submit the TERA at least 60 calendar days before the person intends to initiate the 

proposed research and development activity. 

(b) Contents of the TERA. Each person who submits a TERA under this subpart must provide 

the information and test data described in ''725.255 and 725.260. In addition, the submitter 

must supply sufficient information to enable EPA to evaluate the effects of all activities for 

which approval is requested. 

(c) A person may submit a TERA for one or more microorganisms and one or more research and 

development activities, including a research program. 

(d) EPA will either approve the TERA, with or without conditions, or disapprove it under 

procedures established in this subpart. 

(e) The manufacturer, importer, or processor who receives a TERA approval must comply with 

all terms of the approval, as well as conditions described in the TERA, and remains liable for 

compliance with all terms and conditions, regardless of who conducts the research and 

development activity. Any person conducting the research and development activity approved 

under the TERA must comply with all terms of the TERA approval, as well as the conditions 

described in the TERA. 

(f) Recordkeeping. Persons submitting a TERA must comply with the recordkeeping 

requirements of '725.65. In addition, the following requirements apply to TERAs: 

(1) Each person submitting a TERA under this part must retain documentation of information 

contained in the TERA for a period of 3 years from the date that the results of the study are 

submitted to the Agency. 

(2) Summaries of all data, conclusions, and reports resulting from the conduct of the research 

and development activity under the TERA must be submitted to the EPA address identified in 

'725.25(c) within 1 year of the termination of the activity. 

'725.255 Information to be included in the TERA.

(a) To review a TERA, EPA must have sufficient information to permit a reasoned evaluation of 

the health and environmental effects of the planned test in the environment. The person seeking 

EPA approval must submit all information known to or reasonably ascertainable by the submitter 

on the microorganism(s) and the research and development activity, including information not 

listed in paragraphs (c), (d), and (e) of this section that the person believes will be useful for 

EPA's risk assessment. The TERA must be in writing and must include at least the information 

described in the following paragraphs. 

(b) When specific information is not submitted, an explanation of why such information is not 

available or not applicable must be included. 
(c) Persons applying for a TERA, must include the submitter identification and microorganism 

identity information required for MCANs in '725.155(c), (d)(1), and (d)(2). 

(d) Persons applying for a TERA must submit phenotypic and ecological characteristics 

information required in '725.155(d)(3) as it relates directly to the conditions of the proposed 

research and development activity. 

(e) Persons applying for a TERA must also submit the following information about the proposed 

research and development activity: 

(1) A detailed description of the proposed research and development activity. (i) The objectives 

and significance of the activity and a rationale for testing the microorganisms in the 

environment. 

(ii) Number of microorganisms released (including viability per volume if applicable) and the 

method(s) of application or release. 

(iii) Characteristics of the test site(s), including location, geographical, physical, chemical, and 

biological features, proximity to human habitation or activity, and description of site 

characteristics that would influence dispersal or confinement. 

(iv) Target organisms (if the microorganism(s) to be tested has an intended target), including 

identification of each target organism and anticipated mechanism and result of interaction. 

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

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

(2) Information on monitoring, confinement, mitigation, and emergency termination procedures. 

(i) Confinement procedures for the activity, access and security measures, and procedures for 

routine termination of the activity. 

(ii) Mitigation and emergency procedures. 

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

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

procedures. 

(v) Personal protective equipment, engineering controls, and procedures to be followed to 

minimize dispersion of the microorganism(s) by people, machinery, or equipment. 

(vi) Procedures for disposal of any articles, waste, clothing, machinery, or other equipment 

involved in the experimental release, including methods for inactivation of the microorganism(s), 

containment, disinfection, and disposal of contaminated items. 

'725.260 Submission of health and environmental effects data.

Each TERA must contain all available data concerning actual or potential effects on health or the 

environment of the new microorganism that are in the possession or control of the submitter and 

a description of other data known to or reasonably ascertainable by the submitter that will permit 

a reasoned evaluation of the planned test in the environment. The data must be reported in the 

manner described in '725.160(a)(3) and (b)(3). 

'725.270 EPA review of the TERA.

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

submitted under this subpart: 

(a) Length of the review period. (1) The review period for the TERA will be 60 days from the 

date the Document Control Officer for the Office of Pollution Prevention and Toxics receives a 

complete TERA, or the date EPA determines the TERA is complete under '725.33, unless EPA 

finds good cause for an extension under '725.56. 

(2) A submitter shall not proceed with the research and development activity described in the 

TERA unless and until EPA provides written approval of the TERA. A submitter may receive 

early approval if a review is completed in less than 60 days. 

(b) EPA decision regarding proposed TERA activity. (1) A decision concerning a TERA under 

this subpart will be made by the Administrator, or a designee. 

(2) If EPA determines that the proposed research and development activity for the 

microorganism does not present an unreasonable risk of injury to health or the environment, EPA 

will notify the submitter that the TERA is approved and that the submitter can proceed with the 

proposed research and development activity described in the TERA. 

(3) EPA may include requirements and conditions in its approval of the TERA that would be 

stated in the TERA approval under paragraph (c) of this section. 

(4) If EPA concludes that it cannot determine that the proposed research and development 

activity described in the TERA will not present an unreasonable risk of injury to health or the 

environment, EPA will deny the TERA and will provide reasons for the denial in writing. 

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

the TERA submitter. 

(2) When EPA approves a TERA, the submitter must conduct the research and development 

activity only as described in the TERA and in accordance with any requirements and conditions 

prescribed by EPA in its approval of the TERA. 

(3) Any person who fails to conduct the research and development activity as described in the 

TERA and in accordance with any requirements and conditions prescribed by EPA in its 

approval of the TERA under this section, shall be in violation of sections 5 and 15 of the Act and 

be subject to civil and criminal penalties under section 16 of the Act. 

'725.288 Revocation or modification of TERA approval.

(a) Significant questions about risk. (1) If, after approval of a TERA under this subpart, EPA 

receives information which raises significant questions about EPA's determination that the 

activity does not present an unreasonable risk of injury to health or the environment, EPA will 

notify the submitter in writing of those questions. 

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

modify or revoke the approval of the TERA. 

(3) After considering any such information and arguments, EPA will decide whether to change 

its determination regarding approval of the TERA. 

(i) If EPA determines that the activity will not present an unreasonable risk of injury to health or 

the environment, it will notify the submitter in writing. To make this finding, EPA may prescribe 

additional conditions which must be followed by the submitter. 

(ii) If EPA determines that it can no longer conclude that the activity will not present an 

unreasonable risk of injury to health or the environment, it will notify the submitter in writing 

that EPA is revoking its approval and state its reasons. In that event, the submitter must terminate 

the research and development activity within 48 hours of receipt of the notice in accordance with 

directions provided by EPA in the notice. 

(b) Evidence of unreasonable risk. (1) If, after approval of a TERA under this subpart, EPA 

determines that the proposed research and development activity will present an unreasonable risk 

of injury to health or the environment, EPA will notify the submitter in writing and state its 

reasons. 

(2) In the notice, EPA may prescribe additional safeguards to address or reduce the risk, or may

instruct the submitter to suspend the research and development activities. 

(3) Within 48 hours, the submitter must implement the instructions contained in the notice. The 

submitter may then submit additional information or arguments concerning the matters raised by 

EPA and whether EPA should modify or revoke the approval of the TERA in accordance with 

paragraph (a)(2) of this section. 

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

section.

(5) Following consideration of the information and arguments under paragraph (a)(3) of this 

section, if EPA notifies the submitter that the R&D activity must be suspended or terminted, the 

submitter may resume the activity only upon written notice from EPA that EPA has approved 

resumption of the activity. In approving resumption of an activity, EPA may prescribe additional 

conditions which must be followed by the submitter. 

(c) Modifications. If, after approval of a TERA under this subpart, the submitter concludes that it 

is necessary to alter the conduct of the research and development activity in a manner which 

would result in the activity being different from that described in the TERA agreement and any 

conditions EPA prescribed in its approval, the submitter must inform the EPA contact for the 

TERA and may not modify the activity without the approval of EPA. 

 Subpart F -- Exemptions for Test Marketing

'725.300 Scope and purpose.

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

(b) In lieu of complying with subpart D of this part, persons described in '725.305 may submit 

an application for a test marketing exemption (TME). 

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

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

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

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

 

'725.305 Persons who may apply under this subpart.

A person identified in this section may apply for a test marketing exemption. EPA may grant the 

exemption if the person demonstrates that the microorganism will not present an unreasonable 

risk of injury to health or the environment as a result of the test marketing. A person may apply 

under this subpart for the following test marketing activities: 

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

microorganism. 

(b) A person who intends to manufacture, import, or process for commercial purposes a 

microorganism identified in subpart M of this part for a significant new use. 

'725.350 Procedural requirements for this subpart.

General requirements for all submissions under this part are contained in subparts A through C 

of this part. In addition, the following requirements apply to applications submitted under this 

subpart: 

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

a prenotice consultation regarding eligibility for a TME. 

(b) When to submit a TME application. Each person who is eligible to apply for a TME under 

this subpart must submit the application at least 45 calendar days before the person intends to 

commence the test marketing activity. 

(c) Recordkeeping. Each person who is granted a TME must comply with the recordkeeping 

requirements of '725.65. In addition, any person who obtains a TME must retain documentation 

of compliance with any restrictions imposed by EPA when it grants the TME. This information 

must be retained for 3 years from the final date of manufacture or import under the exemption. 

'725.355 Information to be included in the TME application.

(a) To review a TME application, EPA must have sufficient information to permit a reasoned 

evaluation of the health and environmental effects of the planned test marketing activity. The 

person seeking EPA approval must submit all information known to or reasonably ascertainable 

by the person on the microorganism and the test marketing activity, including information not 

listed in paragraphs (c), (d), and (e) of this section that the person believes will demonstrate

that the microorganism will not present an unreasonable risk of injury to health or the 
environment as a result of the test marketing. The TME application must be in writing and must 

include at least the information described in paragraphs (b), (c), (d), and (e) of this section. 

(b) When specific information is not submitted, an explanation of why such information is not 

available or not applicable must be included. 

(c) Persons applying for a TME must submit the submitter identification and microorganism 

identity information required for MCANs in '725.155(c), (d)(1), and (d)(2). 

(d) Persons applying for a TME must submit phenotypic and ecological characteristics 

information required in '725.155(d)(3) as it relates directly to the conditions of the proposed test 

marketing activity. 

(e) Persons applying for a TME must also submit the following information about the proposed 

test marketing activity: 

(1) Proposed test marketing activity. (i) The maximum quantity of the microorganism which the 

applicant will manufacture or import for test marketing. 

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

marketing. 

(iii) The maximum number of persons who may be exposed to the microorganism as a result of 

test marketing, including information regarding duration and route of such exposures. 

(iv) A description of the test marketing activity, including its duration and how it can be 

distinguished from full-scale commercial production and research and development activities. 

(2) Health and environmental effects data. All existing data regarding health and environmental 

effects of the microorganism must be reported in accordance with '725.160. 

'725.370 EPA review of the TME application.

General procedures for review of all submissions under this part are contained in ''725.28 

through 725.60. In addition, the following procedures apply to EPA review of TME applications 

submitted under this subpart: 

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

application. 

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

(c) In approving a TME application, EPA may impose any restrictions necessary to ensure that 

the microorganism will not present an unreasonable risk of injury to health and the environment 

as a result of test marketing. 

 Subpart G -- General Exemptions for New Microorganisms

'725.400 Scope and purpose.

(a) This subpart describes exemptions from reporting under subpart D of this part, and from 

review under this part altogether, for manufacturing and importing of certain new 

microorganisms for commercial purposes. 
(b) Recipient microorganisms eligible for the tiered exemption from review under this part are 

listed in '725.420. 

(c) Criteria for the introduced genetic material contained in the new microorganisms are 

described in '725.421. 

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

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

(f) In lieu of complying with subpart D of this part, persons using recipient microorganisms 

eligible for the tiered exemption may submit a Tier II exemption request. The limited reporting 

requirements for the Tier II exemption, including data requirements, are described in ''725.450 

and 725.455. 

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

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

'725.420 Recipient microorganisms. 

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

(a) Acetobacter aceti. 

(b) Aspergillus niger. 

(c) Aspergillus oryzae. 

(d) Bacillus licheniformis. 

(e) Bacillus subtilis. 

(f) Clostridium acetobutylicum. 

(g) Escherichia coli K-12. 

(h) Penicillium roqueforti. 

(i) Saccharomyces cerevisiae. 

(j) Saccharomyces uvarum. 

'725.421 Introduced genetic material.

For a new microorganism to qualify for either exemption under this subpart, introduced genetic 

material must meet all of the criteria listed in this section. 

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

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

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

(3) Associated nucleotide sequences needed to move genetic material, including linkers, 

homopolymers, adaptors, transposons, insertion sequences, and restriction enzyme sites. 

(4) The nucleotide sequences needed for vector transfer. 

(5) The nucleotide sequences needed for vector maintenance. 

(b) Well-characterized. For introduced genetic material, well-characterized means that the 

following have been determined: 

(1) The function of all of the products expressed from the structural gene(s). 

(2) The function of sequences that participate in the regulation of expression of the structural 
gene(s). 

(3) The presence or absence of associated nucleotide sequences and their associated functions, 

where associated nucleotide sequences are those sequences needed to move genetic material 

including linkers, homopolymers, adaptors, transposons, insertion sequences, and restriction 

enzyme sites. 

(c) Poorly mobilizable. The ability of the introduced genetic material to be transferred and 

mobilized is inactivated, with a resulting frequency of transfer of less than 10-8 transfer events 

per recipient. 

(d) Free of certain sequences. (1) The introduced genetic material must not contain a functional 

portion of any of the toxin-encoding sequences described in this paragraph (d). 

(i) For the purposes of this section, a functional portion of a toxin-encoding sequence means any 

sequence which codes for a polypeptide that has one of the following effects: 

(A) It directly or indirectly contributes to toxic effects in humans. Directly contributes to toxic 

effects in humans means those sequences encoding polypeptides that have direct toxicity to 

target cells. An example of a sequence which directly contributes to toxic effects in humans is 

one which encodes the portion of diphtheria toxin, listed in paragraph (d)(2) of this section, 

capable of interacting with elongation factor 2, leading to inhibition of protein synthesis in target

respiratory, heart, kidney, and nerve tissues. Indirectly contributes to toxic effects in humans 

means a sequence whose encoded polypeptide is not directly toxic to target cells, yet still 

adversely affects humans. An example of a sequence which indirectly contributes to toxic effects 

is the sequence which encodes the portion of the botulinum toxin, listed in paragraph (d)(3) of 

this section, capable of blocking the release of acetylcholine from gangliosides. Botulinum toxin

affects neuromuscular junctions by its blockage of acetylcholine release, leading to irreversible 

relaxation of muscles and respiratory arrest. 

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

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

(ii) While these toxins are listed (with synonyms in parentheses) in paragraphs (d)(2) through 

(d)(7) of this section according to the source organism, it is use of the nucleotide sequences that 

encode the toxins that is being restricted and not the use of the source organisms. The source 

organisms are listed to provide specificity in identification of sequences whose use is restricted. 

Although similar or identical sequences may be isolated from organisms other than hose listed 

below in paragraphs (d)(2) through (d)(7) of this section, these comparable toxin sequences, 

regardless of the organism from which they are derived, must not be included in the introduced 

genetic material. 

(2) Sequences for protein synthesis inhibitor. 

 Sequence Source Toxin Name

Corynebacterium diphtheriae & C. Diphtheria toxin

ulcerans

Pseudomonas aeruginosa Exotoxin A

Shigella dysenteriae Shigella toxin (Shiga toxin,

 Shigella dysenteriae type I
 toxin, Vero cell toxin)

Abrus precatorius, seeds Abrin

Ricinus communis, seeds Ricin

(3) Sequences for neurotoxins. 

 Sequence Source Toxin Name

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

 F, G (Botulinum toxins,

botulinal toxins)

Clostridium tetani Tetanus toxin

 (tetanospasmin)

Proteus mirabilis Neurotoxin

Staphylococcus aureus Alpha toxin (alpha lysin)

Yersinia pestis Murine toxin

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

Bungarus caeruleus Caeruleotoxin

Bungarus multicinctus Beta-bungarotoxin

 (phospholipase)

Crotalus spp. Crotoxin (phospholipase)

Dendroaspis viridis Neurotoxin

Naja naja varieties Neurotoxin

Notechia scutatus Notexin (phospholipase)

Oxyuranus scutellatus Taipoxin

 Invertebrate toxins

Chironex fleckeri Neurotoxin

Androctnus australis Neurotoxin

Centruroides sculpturatus Neurotoxin

(4) Sequences for oxygen labile cytolysins. 

 Sequence Source Toxin Name

Bacillus alve Alveolysin

Bacillus cereus Cereolysin

Bacillus laterosporus Laterosporolysin

Bacillus thuringiensis Thuringiolysin

Clostridium bifermentans Lysin

Clostridium botulinum Lysin

Clostridium caproicum Lysin

Clostridium chauvoei Delta-toxin

Clostridium histolyticum Epsilon-toxin

Clostridium novyi Gamma-toxin

Clostridium oedematiens Delta-toxin

Clostridium perfringens Theta-toxin (Perfringolysin)
Clostridium septicum Delta-toxin

Clostridium sordellii Lysin

Clostridium tetani Tetanolysin

Listeria monocytogenes Listeriolysin (A B)

Streptococcus pneumoniae Pneumolysin

Streptococcus pyogene Streptolysin O (SLO)

(5) Sequences for toxins affecting membrane function. 

 Sequence Source Toxin Name

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

Bacillus cereus Enterotoxin (diarrheagenic

 toxin, mouse lethal factor)

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

 (pertussis toxin, islet activating factor, histamine sensitizing

factor, lymphocytosis promoting factor)

Clostridium botulinum C2 toxin

Clostridium difficile Enterotoxin (toxin A)

Clostridium perfringens Beta-toxin; Delta-toxin

Escherichia coli & other Heat-labile enterotoxins

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

 subtypes ST1a ST1b; also STb, STII)

Legionella pneumophila Cytolysin

Vibrio cholerae & Vibrio mimicus Cholera toxin (choleragen)

(6) Sequences that affect membrane integrity. 

 Sequence Source Toxin Name

Clostridium bifermentans & other Lecithinase

Clostridium spp

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

Corynebacterium pyogenes & other Cytolysin (phospholipase C),

Corynebacterium spp. Ovis toxin (sphingomyelinase D)

Staphylococcus aureus Beta-lysin (beta toxin)

(7) Sequences that are general cytotoxins. 

 Sequence Source Toxin Name

Adenia digitata Modeccin

Aeromonas hydrophila Aerolysin (beta-lysin, cytotoxic lysin)

Clostridium difficile Cytotoxin (toxin B)

Clostridium perfringens Beta-toxin; Epsilon-toxin; Kappa-toxin

Escherichia coli & other Cytotoxin (Shiga-like toxin,

Enterobacteriaceae spp. Vero cell toxin)

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

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

 syndrome toxins (TSST-1)

Staphylococcus aureus & 

Pseudomonas aeruginosa Leucocidin (leukocidin, cytotoxin)

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

 toxins, pyrogenic exotoxins)

Yersinia enterocolitica Heat-stable enterotoxins (ST)

'725.422 Physical containment and control technologies.

The manufacturer must meet all of the following criteria for physical containment and control 

technologies for any facility in which the new microorganism will be used for a Tier I 

exemption; these criteria also serve as guidance for a Tier II exemption. 

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

(b) Control access to the structure. 

(c) Provide written, published, and implemented procedures for the safety of personnel and 

control of hygiene. 

(d) Use inactivation procedures demonstrated and documented to be effective against the new 

microorganism contained in liquid and solid wastes prior to disposal of the wastes. The 

inactivation procedures must reduce viable microbial populations by at least 6 logs in liquid and 

solid wastes. 

(e) Use features known to be effective in minimizing viable microbial populations in aerosols 

and exhaust gases released from the structure, and document use of such features. 

(f) Use systems for controlling dissemination of the new microorganism through other routes, 

and document use of such features. 

(g) Have in place emergency clean-up procedures. 

'725.424 Requirements for the Tier I exemption.

(a) Conditions of exemption. The manufacture or import of a new microorganism for commercial 

purposes is not subject to review under this part if all of the following conditions are met for all 

activities involving the new microorganism: 

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

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

(3) The physical containment and control technologies of any facility in which the 

microorganism will be manufactured, processed, or used meet the criteria under '725.422. 

(4) The manufacturer or importer submits a certification described in paragraph (b) of this 

section to EPA at least 10 days before commencing initial manufacture or import of a new 

microorganism derived from a recipient microorganism listed in '725.420. 

(5) The manufacturer or importer complies with the recordkeeping requirements of '725.65 and 

maintains records for the initial and subsequent uses of the new microorganism that verify

compliance with the following: 

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

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

technologies. 

(b) Certification. To be eligible for the Tier I exemption under this subpart, the manufacturer or 

importer must submit to EPA a document signed by a responsible company official containing 

the information listed in this paragraph. 

(1) Name and address of manufacturer or importer. 

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

(3) The identification (genus, species) of the recipient microorganism listed in '725.420 which is 

being used to create the new microorganism which will be used under the conditions of the Tier I 

exemption. 

(4) Certification of the following: 

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

(ii) Compliance with the containment requirements described in '725.422, including the 

provision in paragraph (a)(3) of this section. 

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

institutions issuing the permits. 

(6) The certification statement required in '725.25(b). Certification of submission of test data is 

not required for the Tier I exemption. 

'725.426 Applicability of the Tier I exemption.

The Tier I exemption under '725.424 applies only to a manufacturer or importer of a new 

microorganism that certifies that the microorganism will be used in all cases in compliance with 

''725.420, 725.421, and 725.422. 

'725.428 Requirements for the Tier II exemption.

The manufacturer or importer of a new microorganism for commercial purposes may submit to 

EPA a Tier II exemption request in lieu of a MCAN under subpart D of this part if all of the 

following conditions are met: 

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

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

(c) Adequate physical containment and control technologies are used. The criteria listed under 

'725.422 for physical containment and control technologies of facilities should be used as 

guidance to satisfy the Tier II exemption request data requirements listed at '725.455(d). EPA 

will review proposed process and containment procedures as part of the submission for a Tier II 

exemption under this section. 

'725.450 Procedural requirements for the Tier II exemption.

General requirements for all submissions under this part are contained in '725.25. In addition, 

the following requirements apply to requests submitted under this subpart: 

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

(b) When to submit the Tier II exemption request. Each person who is eligible to submit a Tier II 

exemption request under this subpart must submit the request at least 45 calendar days before the 

person intends to commence manufacture or import. 

(c) Contents of the Tier II exemption request. Each person who submits a request under this 

subpart must provide the information described in ''725.428 and 725.455, as well as 

information known to or reasonably ascertainable by the person that would permit EPA to 

determine that use of the microorganism, under the conditions specified in the

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

(d) Recordkeeping. Each person who submits a request under this subpart must comply with the 

recordkeeping requirements of '725.65. In addition, the submitter should maintain records which 

contain information that verifies compliance with the following: 

(1) The certifications made in the request. 

(2) All the eligibility criteria for the Tier II exemption request including the criteria for the 

recipient microorganism, the introduced genetic material, the physical containment and control 

technologies. 

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

The submitter must indicate clearly that the submission is a Tier II exemption request for a 

microorganism instead of the MCAN under subpart D of this part and must submit the following 

information: 

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

(2) The name, address, and office telephone number (including area code) of the principal 

technical contact representing the submitter. 

(b) Microorganism identity information. (1) Identification (genus, species, and strain) of the 

recipient microorganism. Genus, species designation should be substantiated by a letter from a 

culture collection or a brief summary of the results of tests conducted for taxonomic 

identification. 

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

(3) Site of insertion. 

(4) Certification of compliance with the introduced genetic material criteria described in 

'725.421. 

(c) Production volume. Production volume, including total liters per year, and the maximum cell 

concentration achieved during the production process. 

(d) Process and containment information. (1) A description of the process including the 

following: (i) Identity and location of the manufacturing site(s). 

(ii) Process flow diagram illustrating the production process, including downstream separations, 

and indicating the containment envelope around the appropriate equipment. 
(iii) Identities and quantities of feedstocks. 

(iv) Sources and quantities of potential releases to both the workplace and environment, and a 

description of engineering controls, inactivation procedures, and other measures which will 

reduce worker exposure and environmental releases. 

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

detection and repair program. 

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

workplace and the environment. 

(2) Certification of those elements of the containment criteria described in '725.422 with which 

the manufacturer is in compliance, including stating by number the elements with which the 

manufacturer is in full compliance. 

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

institutions issuing the permits. 

(f) The certification statement required in '725.25(b). Certification of submission of test data is 

not required for the Tier II exemption. 

'725.470 EPA review of the Tier II exemption request.

General procedures for review of all submissions under this part are contained in ''725.28 

through 725.60. In addition, the following procedures apply to EPA review of Tier II exemption 

requests submitted under this subpart: 

(a) Length of the review period. The review period for the request will be 45 days from the date 

the Document Control Officer for the Office of Pollution Prevention and Toxics receives a 

complete request, or the date EPA determines the request is complete under '725.33, unless the 

Agency extends the review period for good cause under '725.56. 

(b) Criteria for review. EPA will review the request to determine that the new microorganism 

complies with '725.428 and that its manufacture, processing, use, and disposal as described in 

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

(c) EPA decision regarding the Tier II exemption request. A decision concerning a request under 

this subpart will be made by the Administrator, or a designee. 

(d) Determination that the microorganism is ineligible for a Tier II review. (1) EPA may 

determine that the manufacturer or importer is not eligible for Tier II review, because the 

microorganism does not meet the criteria under '725.428 or the Administrator, or a designee, 

decides that there is insufficient information to determine that the conditions of manufacture, 

processing, use, or disposal of the microorganism as described in the request will not present an 

unreasonable risk to health or the environment. 

(2) If the Agency makes this determination, the Administrator, or a designee will notify the 

manufacturer or importer by telephone, followed by a letter, that the request has been denied. 

The letter will explain reasons for the denial. 

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

(e) Approval or denial of the Tier II exemption request. (1) No later than 45 days after EPA 

receives a request, the Agency will either approve or deny the request. 

(2) In approving a request, EPA may impose any restrictions necessary to ensure that the 

microorganism will not present an unreasonable risk of injury to health and the environment as a 

result of general commercial use. 

(f) EPA may seek to enjoin the manufacture or import of a microorganism in violation of this 

subpart, or act to seize any microorganism manufactured or imported in violation of this section 

or take other actions under the authority of sections 7 or 17 of the Act. 

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

 Subparts H-K [Reserved]

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

'725.900 Scope and purpose.

(a) This subpart describes additional provisions governing submission of MCANs for 

microorganisms subject to significant new use rules identified in subpart M of this part. 

(b) Manufacturers, importers, and processors described in '725.105(c) must submit a MCAN 

under subpart D of this part for significant new uses of microorganisms described in subpart M 

of this part, unless they are excluded under ''725.910 or 725.912. 

(c) Section 725.920 discusses exports and imports. 

(d) Additional recordkeeping requirements specific to significant new uses of microorganisms 

are described in '725.950. 

(e) Section 725.975 describes how EPA will approve alternative means of complying with 

significant new use requirements designated in subpart M of this part. 

(f) Expedited procedures for promulgating significant new use requirements under subpart M of 

this part for microorganisms subject to section 5(e) orders are discussed in ''725.980 and 

725.984. 

(g) This subpart L contains provisions governing submission and review of notices for the 

microorganisms and significant new uses identified in subpart M of this part. The provisions of 

this subpart L apply to the microorganisms and significant new uses identified in subpart M of 

this part, except to the extent that they are specifically modified or supplanted by specific 

requirements in subpart M of this part. In the event of a conflict between the provisions of this

subpart L and the provisions of subpart M of this part, the provisions of subpart M of this part 

shall govern. 
(h) The provisions of subparts A through F of this part also apply to subparts L and M of this 

part. For purposes of subparts L and M of this part, wherever the words "microorganism" or 

"new microorganism" appear in subparts A through F of this part, it shall mean the 

microorganism subject to subparts L and M of this part. In the event of a conflict between the 

provisions of subparts A through F and the provisions of subparts L and M of this part, the 

provisions of subparts L and M of this part shall govern. 

'725.910 Persons excluded from reporting significant new uses.

(a) A person who intends to manufacture, import, or process a microorganism identified in 

subpart M of this part and who intends to distribute it in commerce is not required to submit a 

MCAN under subpart D of this part, if that person can document one or more of the following as 

to each recipient of the microorganism from that person: 

(1) That the person has notified the recipient, in writing, of the specific section in subpart M of 

this part which identifies the microorganism and its designated significant new uses, or 

(2) That the recipient has knowledge of the specific section in subpart M of this part which 

identifies the microorganism and its designated significant new uses, or 

(3) That the recipient cannot undertake any significant new use described in the specific section 

in subpart M of this part. 

(b) The manufacturer, importer, or processor described in paragraph (a) of this section must 

submit a MCAN under subpart D of this part, if such person has knowledge at the time of 

commercial distribution of the microorganism identified in the specific section in subpart M of 

this part that a recipient intends to engage in a designated significant new use of that 

microorganism without submitting a MCAN under this part. 

(c) A person who processes a microorganism identified in a specific section in subpart M of this 

part for a significant new use of that microorganism is not required to submit a MCAN if that 

person can document each of the following: 

(1) That the person does not know the specific microorganism identity of the microorganism 

being processed, and 

(2) That the person is processing the microorganism without knowledge that the microorganism 

is identified in subpart M of this part. 

(d)(1) If at any time after commencing distribution in commerce of a microorganism identified in 

a specific section in subpart M of this part, a person who manufactures, imports, or processes a 

microorganism described in subpart M of this part and distributes it in commerce has knowledge 

that a recipient of the microorganism is engaging in a significant new use of that microorganism 

designated in that section without submitting a MCAN under this part, the person is required to 

cease supplying the microorganism to that recipient and to submit a MCAN for that 

microorganism and significant new use, unless the person is able to document each of the 

following: 

(i) That the person has notified the recipient and EPA enforcement authorities (at the address in 
paragraph (d)(1)(iii) of this section), in writing within 15 working days of the time the person 

develops knowledge that the recipient is engaging in a significant new use, that the recipient is 

engaging in a significant new use without submitting a MCAN. 

(ii) That, within 15 working days of notifying the recipient as described in paragraph (d)(1)(i) of 

this section, the person received from the recipient, in writing, a statement of assurance that the 

recipient is aware of the terms of the applicable section in subpart M of this part and will not 

engage in the significant new use. 

(iii) That the person has promptly provided EPA enforcement authorities with a copy of the 

recipient's statement of assurance described in paragraph (d)(1)(ii) of this section. The copy must 

be sent to the Director, Office of Compliance (2221A), Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, DC 20460. 

(2) If EPA notifies the manufacturer, importer, or processor that the recipient is engaging in a 

significant new use after providing the statement of assurance described in paragraph (d)(1)(ii) of 

this section and without submitting a MCAN under this part, the manufacturer, importer, or 

processor shall immediately cease distribution to that recipient until the manufacturer, importer, 

or processor or the recipient has submitted a MCAN under this part and the MCAN review 

period has ended. 

(3) If, after receiving a statement of assurance from a recipient under paragraph (d)(1)(ii) of this 

section, a manufacturer, importer, or processor has knowledge that the recipient is engaging in a 

significant new use without submitting a MCAN under this part, the manufacturer, importer, or 

processor must immediately cease distributing the microorganism to that recipient and notify 

EPA enforcement authorities at the address identified in paragraph (d)(1)(iii) of this section. The 

manufacturer, importer, or processor may not resume distribution to that recipient until any one 

of the following has occurred: 

(i) The manufacturer, importer, or processor has submitted a MCAN under this part and the 

MCAN review period has ended. 

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

ended. 

(iii) The manufacturer, importer, or processor has received notice from EPA enforcement 

authorities that it may resume distribution to that recipient. 

'725.912 Exemptions.

Persons identified in '725.105(c) are not required to submit a MCAN under subpart D of this 

part for a microorganism identified in subpart M of this part, unless otherwise specified in a 

specific section in subpart M, if: 

(a) The person submits a MCAN for the microorganism prior to the promulgation date of the 

section in subpart M of this part which identifies the microorganism, and the person receives 

written notification of compliance from EPA prior to the effective date of such section. The 

MCAN submitter must comply with any applicable requirement of section 5(b) of the Act. The 

MCAN must include the information and test data specified in section 5(d)(1) of the Act. For

purposes of this exemption, the specific section in subpart M of this part which identifies the 

microorganism and ''725.3, 725.15, 725.65, 725.70, 725.75, 725.100, and 725.900 apply; after 

the effective date of the section in subpart M of this part which identifies the microorganism, 
''725.105 and 725.910 apply and '725.920 continues to apply. EPA will provide the MCAN 

submitter with written notification of compliance only if one of the following occurs: 

(1) EPA is unable to make the finding that the activities described in the MCAN will or may

present an unreasonable risk of injury to health or the environment under reasonably foreseeable 

circumstances, or 

(2) EPA and the person negotiate a consent order under section 5(e) of the Act, such order to 

take effect on the effective date of the section in subpart M of this part which identifies the 

microorganism. 

(b) The person is operating under the terms of a consent order issued under section 5(e) of the 

Act applicable to that person. If a provision of such section 5(e) order is inconsistent with a 

specific significant new use identified in subpart M of this part, abiding by the provision of the 

section 5(e) order exempts the person from submitting a MCAN for that specific significant new 

use. 

'725.920 Exports and imports.

(a) Exports. Persons who intend to export a microorganism identified in subpart M of this part, or 

in any proposed rule which would amend subpart M of this part, are subject to the export 

notification provisions of section 12(b) of the Act. The regulations that interpret section 12(b) 

appear at part 707 of this chapter. 

(b) Imports. Persons who import a substance identified in a specific section in subpart M of this 

part are subject to the import certification requirements under section 13 of the Act, which are 

codified at 19 CFR ''12.118 through 12.127 and 127.28(i). The EPA policy in support of the 

import certification requirements appears at part 707 of this chapter. 

'725.950 Additional recordkeeping requirements.

Persons submitting a MCAN for a significant new use of a microorganism must comply with the 

recordkeeping requirements of '725.65. In addition, the following requirements apply: 

(a) At the time EPA adds a microorganism to subpart M of this part, EPA may specify

appropriate recordkeeping requirements. Each manufacturer, importer, and processor of the 

microorganism shall maintain the records for 3 years from the date of their creation. 

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

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

(2) Records documenting the manufacture and importation volume of the microorganism and the 

corresponding dates of manufacture and import. 

(3) Records documenting volumes of the microorganism purchased domestically by processors 

of the microorganism, names and addresses of suppliers and corresponding dates of purchase. 
(4) Records documenting the names and addresses (including shipment destination address, if 

different) of all persons outside the site of manufacture or import to whom the manufacturer, 

importer, or processor directly sells or transfers the microorganism, the date of each sale or 

transfer, and the quantity of the microorganism sold or transferred on such date. 

'725.975 EPA approval of alternative control measures.

(a) In certain sections of subpart M of this part, significant new uses for the identified 

microorganisms are described as the failure to establish and implement programs providing for 

the use of either: specific measures to control worker exposure to or release of microorganisms 

which are identified in such sections, or alternative measures to control worker exposure or 

environmental release which EPA has determined provide substantially the same degree of

protection as the specified control measures. Persons who manufacture, import, or process a 

microorganism identified in such sections and who intend to employ alternative measures to 

control worker exposure or environmental release must submit a request to EPA for a 

determination of equivalency before commencing manufacture, import, or processing involving 

the alternative control measures. 

(b) A request for a determination of equivalency must be submitted in writing to the Office of 

Pollution Prevention and Toxics, Document Control Officer, 7407, 1200 Pennsylvania Ave., 

NW., Washington, DC 20460: ATTN: SNUR Equivalency Determination, and must contain: 

(1) The name of the submitter. 

(2) The specific identity of the microorganism. 

(3) The citation for the specific section in subpart M of this part which pertains to the 

microorganism for which the request is being submitted. 

(4) A detailed description of the activities involved. 

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

release control measures. 

(6) A detailed analysis explaining why such alternative control measures provide substantially

the same degree of protection as the specific control measures identified in the specific section in 

subpart M of this part which pertains to the microorganism for which the request is being 

submitted. 

(7) The data and information described in ''725.155 and 725.160. If such data and information 

have already been submitted to EPA's Office of Pollution Prevention and Toxics, the submitter 

need only document that it was previously submitted, to whom, and the date it was submitted. 

(c) Requests for determinations of equivalency will be reviewed by EPA within 45 days. 

Determinations under this paragraph will be made by the Director, or a designee. Notice of the 

results of such determinations will be mailed to the submitter. 

(d) If EPA notifies the submitter under paragraph (c) of this section that EPA has determined that 

the alternative control measures provide substantially the same degree of protection as the 

specified control measures identified in the specific section of subpart M of this part which 

pertains to the microorganism for which the request is being submitted, the submitter may

commence manufacture, import, or processing in accordance with the specifications for 
alternative worker exposure control measures or environmental release control measures 

identified in the submitter's request, and may alter any corresponding notification to workers to 

reflect such alternative controls. Deviations from the activities described in the EPA notification 

constitute a significant new use and are subject to the requirements of this part. 

'725.980 Expedited procedures for issuing significant new use rules for microorganisms 

subject to section 5(e) orders.

(a) Selection of microorganisms. (1) In accordance with the expedited process specified in this 

section, EPA will issue significant new use notification requirements for each new 

microorganism that, after MCAN review under subpart D of this part, becomes subject to a final 

order issued under section 5(e) of the Act, except for an order that prohibits manufacture and 

import of the microorganism, unless EPA determines that significant new use notification

requirements are not needed for the microorganism. 

(2) If EPA determines that significant new use notifications requirements are not needed for a 

microorganism that is subject to a final order issued under section 5(e) of the Act, EPA will issue 

a notice in the FEDERAL REGISTER explaining why the significant new use requirements are 

not needed. 

(b) Designation of requirements. (1) The significant new use notification and other specific 

requirements will be based on and be consistent with the provisions included in the final order 

issued for the microorganism under section 5(e) of the Act. EPA may also designate additional 

activities as significant new uses which will be subject to notification. 

(2) Significant new use requirements and other specific requirements designated under this 

section will be listed in subpart M of this part. For each microorganism, subpart M of this part 

will identify: 

(i) The microorganism name. 

(ii) The activities designated as significant new uses. 

(iii) Other specific requirements applicable to the microorganism, including recordkeeping 

requirements or any other requirements included in the final section 5(e) order. 

(c) Procedures for issuing significant new use rules. (1) Possible processes. EPA will issue 

significant new use rules (SNURs) under this section by one of the following three processes: 

direct final rulemaking, interim final rulemaking, or notice and comment rulemaking. EPA will 

use the direct final rulemaking process to issue significant new use rules unless it determines 

that, in a particular case, one of the other processes is more appropriate. 

(2) Notice in the FEDERAL REGISTER. FEDERAL REGISTER documents issued to propose 

or establish significant new uses under this section will contain the following: 

(i) The microorganism identity or, if its specific identity is claimed confidential, an appropriate 

generic microorganism name and an accession number assigned by EPA. 

(ii) The MCAN number. 

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

under section 5(e). 

(iv) Designation of the significant new uses subject to, or proposed to be subject to, notification 

and any other applicable requirements. 

(v) Any modification of subpart L of this part applicable to the specific microorganism and 

significant new uses. 
(vi) If the FEDERAL REGISTER document establishes a final rule, or notifies the public that a 

final rule will not be issued after public comment has been received, the document will describe 

comments received and EPA's response. 

(3) Direct final rulemaking. (i) EPA will use direct final rulemaking to issue a significant new 

use rule, when specific requirements will be based on and be consistent with the provisions 

included in the final order issued for the microorganism under section 5(e) of the Act. EPA will 

issue a final rule in the FEDERAL REGISTER following its decision to develop a significant 

new use rule under this section for a specific new microorganism. 

(ii) The FEDERAL REGISTER document will state that, unless written notice is received by 

EPA within 30 days of publication that someone wishes to submit adverse or critical comments, 

the rule will be effective 60 days from the date of publication. The written notice of intent to 

submit adverse or critical comments should state which SNUR(s) will be the subject of the 

adverse or critical comments, if several SNURs are established through the direct final rule. If

notice is received within 30 days that someone wishes to submit adverse or critical comments, 

the section(s) of the direct final rule containing the SNUR(s) for which a notice of intent to 

comment was received will be withdrawn by EPA issuing a document in the final rule section of 

the FEDERAL REGISTER, and a proposal will be published in the proposed rule section of the 

FEDERAL REGISTER. The proposal will establish a 30-day comment period. 

(iii) If EPA, having considered any timely comments submitted in response to the proposal, 

decides to establish notification requirements under this section, EPA will issue a final rule 

adding the microorganism to subpart M of this part and designating the significant new uses 

subject to notification. 

(4) Interim final rulemaking. (i) EPA will use the interim final rulemaking procedure to issue a 

significant new use rule, when specific requirements will be based on and be consistent with the 

provisions included in the final order issued for the microorganism under section 5(e) of the Act. 

The Agency will issue an interim final rule in the FEDERAL REGISTER following its decision 

to develop a significant new use rule for a specific new microorganism. The document will state 

EPA's reasons for using the interim final rulemaking procedure. 

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

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

(ii) Interim final rules issued under this section shall cease to be in effect 180 days after 

publication unless, within the 180-day period, EPA issues a final rule in the FEDERAL 

REGISTER responding to any written comments received during the 30-day comment period 

specified in paragraph (c)(4)(i)(B) of this section and promulgating final significant

new use notification requirements and other requirements for the microorganism. 

(5) Notice and comment rulemaking. (i) EPA will use a notice and comment procedure to issue a 

significant new use rule, when EPA is designating additional activities which are not provisions 

included in the final order issued for the microorganism under section 5(e) of the Act as 

significant new uses which will be subject to notification. EPA will issue a proposal in the 

FEDERAL REGISTER following its decision to develop a significant new use rule under this

section for a specific new microorganism. Persons will be given 30 days to comment on whether 

EPA should establish notification requirements for the microorganism under this part. 

(ii) If EPA, having considered any timely comments, decides to establish notification 

requirements under this section, EPA will issue a final rule adding the microorganism to subpart 
M of this part and designating the significant new uses subject to notification. 

(d) Schedule for issuing significant new use rules. (1) Unless EPA determines that a significant 

new use rule should not be issued under this section, EPA will issue a proposed rule, a direct 

final rule, or an interim final rule within180 days of receipt of a valid notice of commencement 

under '725.190. 

(2) If EPA receives adverse or critical significant comments following publication of a proposed 

or interim final rule, EPA will either withdraw the rule or issue a final rule addressing the

comments received.

'725.984 Modification or revocation of certain notification requirements.

(a) Criteria for modification or revocation. EPA may at any time modify or revoke significant 

new use notification requirements for a microorganism which has been added to subpart M of 

this part using the procedures of '725.980. Such action may be taken under this section if EPA 

makes one of the following determinations, unless other information shows that the requirements 

should be retained: 

(1) Test data or other information obtained by EPA provide a reasonable basis for concluding

that activities designated as significant new uses of the microorganism will not present an 

unreasonable risk of injury to health or the environment. 

(2) EPA has promulgated a rule under section 4 or 6 of the Act, or EPA or another agency has 

taken action under another law, for the microorganism that eliminates the need for significant 

new use notification under section 5(a)(2) of the Act. 

(3) EPA has received MCANs for some or all of the activities designated as significant new uses 

of the microorganism and, after reviewing such MCANs, concluded that there is no need to 

require additional notice from persons who propose to engage in identical or similar activities. 

(4) EPA has examined new information, or has reexamined the test data or other information 

supporting its finding under section 5(e)(1)(A)(ii)(I) of the Act and has concluded that a rational 

basis no longer exists for the findings that activities involving the microorganism may present an 

unreasonable risk of injury to health or the environment required under section 5(e)(1)(A) of the 

Act. 

(5) Certain activities involving the microorganism have been designated as significant new uses 

pending the completion of testing, and adequate test data developed in accordance with 

applicable procedures and criteria have been submitted to EPA. 

(b) Procedures for limitation or revocation. Modification or revocation of significant new use 

notification requirements for a microorganism that has been added to subpart M of this part using 

the procedures described in '725.980 may occur either at EPA's initiative or in response to a 

written request. 

(1) Any affected person may request modification or revocation of significant new use 
notification requirements for a microorganism that has been added to subpart M of this part using 

the procedures described in '725.980 by writing to the Director, or a designee, and stating the 

basis for such request. The request must be accompanied by information sufficient to support the 

request. All requests should be sent to the TSCA Document Processing Center (7407), Room

L-100, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 

20460, ATTN: Request to amend SNUR. 

(2) The Director, or a designee, will consider the request, make a determination whether to 

initiate rulemaking to modify the requirements, and notify the requester of that determination by

certified letter. If the request is denied, the letter will explain why EPA has concluded that the 

significant new use notification requirements for that microorganism should remain in effect. 

(3) If EPA concludes that significant new use notification requirements for a microorganism 

should be limited or revoked, EPA will propose the changes in a notice in the FEDERAL 

REGISTER, briefly describe the grounds for the action, and provide interested parties an 

opportunity to comment. 

 Subpart M -- Significant New Uses for Specific Microorganisms

'725.1000 Scope. 

This subpart identifies uses of microorganisms which EPA has determined to be significant new 

uses under the authority of section 5(a)(2) of the Toxic Substances Control Act. 

'725.1075 Burkholderia cepacia complex.

(a) Microorganism and significant new uses subject to reporting. (1) The microorganisms 

identified as the Burkholderia cepacia complex defined as containing the following nine species, 

Burkholderia cepacia, Burkholderia multivorans, Burkholderia stabilis, Burkholderia 

vietnamiensis, Burkholderia ambifaria, Burkholderia pyrrocinia, Burkholderia cepacia 

genomovar VIII (Burkholderia anthina), and Burkholderia cepacia genomovars III and VI are 

subject to reporting under this section for the significant new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new use is any use other than research and development in the degradation of 

chemicals via injection into subsurface groundwater. 

(b) [Reserved] 

[68 FR 35320, June 13, 2003]