[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR172.45]



[Page 262-263]

 

                   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



[[Page 263]]



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 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.