[Code of Federal Regulations]
[Title 40, Volume 28]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR725.25]

[Page 471-473]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS
--Table of Contents
 
                  Subpart B--Administrative Procedures
 
Sec. 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

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

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    (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 Sec. 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 Sec. 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 Sec. 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.