[Code of Federal Regulations]
[Title 40, Volume 21]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR172.45]

[Page 263-264]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 172--EXPERIMENTAL USE PERMITS--Table of Contents
 
   Subpart C--Notification for Certain Genetically Modified Microbial 
                               Pesticides
 
Sec. 172.45  Requirement for a notification.

    (a) Who must submit a Notification. Notwithstanding Sec. 172.3, any 
person who plans to conduct small-scale testing of a type of microbial 
pesticide identified in paragraph (c) of this section must submit a 
Notification to EPA and obtain prior approval for either of the 
following tests:
    (1) Small-scale tests that involve an intentional environmental 
introduction of that microbial pesticide.
    (2) Small-scale tests performed in a facility without adequate 
containment and inactivation controls as provided in paragraph (e) of 
this section.
    (b) Alternative to Notification. In lieu of a Notification, any 
person required to submit a Notification under paragraph (a) of this 
section may submit an application for an experimental use permit (EUP) 
to EPA for approval.
    (c) Small-scale testing that requires a Notification. As provided in 
paragraph (a) of this section, and notwithstanding any other approval by 
any governmental entity, EPA review and approval are required prior to 
the initiation of any small-scale test involving either of the following 
microbial pesticides:
    (1) Microbial pesticides whose pesticidal properties have been 
imparted or enhanced by the introduction of genetic material that has 
been deliberately modified.
    (2) Nonindigenous microbial pesticides that have not been acted upon 
by the U.S. Department of Agriculture (i.e., either by issuing or 
denying a permit or determining that a permit is unnecessary; or a 
permit is not pending with the USDA).
    (d) Small-scale testing that does not require a Notification. (1) 
Testing conducted with microbial pesticides identified in paragraph (c) 
of this section, but made exempt pursuant to Sec. 172.52, does not 
require a Notification. The following microbial pesticides (or classes 
of pesticides) are exempt from the notification requirement in paragraph 
(a) of this section:
    (i) Microbial pesticides resulting from deletions or rearrangements 
within a single genome that are brought about by the introduction of 
genetic material that has been deliberately modified.
    (ii) [Reserved]
    (2) Testing conducted in a facility with adequate containment and 
inactivation controls, as provided in paragraph (e) of this section, 
does not require a Notification.
    (e) Selection and use of containment and inactivation controls. (1) 
Selection

[[Page 264]]

and use of containment and inactivation controls for a particular 
microbial pesticide shall take into account the following:
    (i) Factors relevant to the microbial pesticide'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.
    (iv) Plans for routine or emergency clean-up and test termination.
    (2) For purposes of paragraph (e)(1) of this section, EPA will 
presume that compliance with the containment provisions of the National 
Institutes of Health (NIH) ``Guidelines for Research Involving 
Recombinant DNA Molecules'' (51 FR 16958, May 7, 1986) constitutes 
selection and use of adequate containment and inactivation controls.
    (3) The selection of containment and inactivation controls shall be 
approved by an authorized official of the organization that is 
conducting the test prior to commencement of the test.
    (4) Records shall be developed and maintained describing the 
selection and use of the containment and inactivation controls, 
including contingency plans for emergency clean-up and test termination, 
that will be used during the test. These records shall be available for 
inspection at the test facility. In addition, these records shall be 
submitted to EPA at EPA's request and within the time frame specified in 
EPA's request.
    (5) Subsequent to any EPA review of the containment/inactivation 
controls selected under paragraph (e)(1) of this section, changes to the 
controls necessary to prevent unreasonable adverse effects must be made 
upon EPA request. Failure to comply with EPA's request shall result in 
automatic revocation of the exemption from the requirement to submit a 
Notification.