§ 172.45 - Requirement for a notification.

§ 172.45 Requirement for a notification.

(a) Who must submit a Notification. Notwithstanding § 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 § 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.