§ 155.58 - Procedures for issuing a decision on a registration review case.

§ 155.58 Procedures for issuing a decision on a registration review case.

(a) The Agency will publish a notice in the Federal Register announcing the availability of a proposed registration review decision or a proposed interim registration review decision. At that time, the Agency will place in the pesticide's registration review docket the Agency's proposed decision and the bases for the decision. There will be a comment period of at least 60 calendar days on the proposed decision.

(b) In its proposed decision, the Agency will, among other things:

(1) State its proposed findings with respect to the FIFRA standard for registration and describe the basis for such proposed findings.

(2) Identify proposed risk mitigation measures or other remedies as needed and describe the basis for such proposed requirements.

(3) State whether it believes that additional data are needed and, if so, describe what is needed. A FIFRA 3(c)(2)(B) notice requiring such data may be issued in conjunction with a proposed or final decision on the registration review case or a proposed or final interim decision on a registration review case.

(4) Specify proposed labeling changes; and

(5) Identify deadlines that it intends to set for completing any required actions.

(c) After considering any comments on the proposed decision, the Agency will issue a registration review decision or interim registration review decision. This decision will include an explanation of any changes to the proposed decision and the Agency's response to significant comments. The Agency will publish a notice in the Federal Register announcing the availability of a registration review decision or interim registration review decision. The registration review case docket will remain open until all actions required in the final decision on the registration review case have been completed.

(d) If the registrant fails to take the action required in a registration review decision or interim registration review decision, the Agency may take appropriate action under FIFRA.