[Code of Federal Regulations]
[Title 40, Volume 29]
[Revised as of July 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR725.67]

[Page 500-501]
 
                   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. 725.67  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

[[Page 501]]

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 Sec. Sec. 725.155 and 725.160.
    (ii) Exemption from TERA reporting under subpart E. Information 
requirements are set forth in Sec. Sec. 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 
Sec. 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.