Code of Federal Regulations (Last Updated: October 10, 2024) |
Title 40 - Protection of Environment |
Chapter I - Environmental Protection Agency |
SubChapter E - Pesticide Programs |
Part 162 - State Registration of Pesticide Products |
Subpart D - Regulations Pertaining to State Registration of Pesticides To Meet Special Local Needs |
§ 162.154 - Disapproval of State registrations.
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§ 162.154 Disapproval of State registrations.
(a) General disapprovals.
(1) Except as provided in paragraph (b) of this section, the Administrator may disapprove, on any reasonable grounds, any state registration which, when compared to a federally registered product, does not have both a similar composition and a similar use pattern; provided that the Administrator may not disapprove such a registration solely because of a lack of essentiality. Grounds for disapproval of State registrations not involving similar products may include, but are not limited to:
(i) Probable creation of unreasonable adverse effects on man or the environment by the registered use.
(ii) Refusal of the registering State to submit information supporting the registration as required by § 162.153(h).
(iii) Failure of information submitted by the State to support the State's decision to issue the registration under standards established by § 162.153.
(2) Prior to disapproval of any State registration under this paragraph, the Administrator shall notify the registering State, in writing, of the Administrator's intent to disapprove, and of the reasons for disapproval. The notice of intent will provide a reasonable time, not less than ten days from the date the notice is received by the State, for the State to respond, and will invite the State to consult with the Administrator or his designee. If the grounds for disapproval are based on actions or omissions by the State, the notice will, if possible, also provide the State with a reasonable amount of time in which to take corrective action, not to exceed the time allowed for disapproval under paragraph (c) of this section.
(3) The registering State may, within ten days of receipt of a notice of intent to disapprove, request that the Administrator, or his designee, consult with appropriate State officials prior to the Administrator's final decision on disapproval. The Administrator will consider any relevant information presented at such a consultation, or in any other timely and appropriate fashion, in deciding whether to withdraw the notice of intent to disapprove.
(b) Special disapprovals.
(1) The Administrator may disapprove any State registration, including a registration for a similar product, at any time, if the Administrator determines that use of the product under the State registration:
(i) Would constitute an imminent hazard.
(ii) May result in a residue on food or feed exceeding, or not covered by, a tolerance, exemption, or other clearance under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 346a et seq.).
(2) If the Administrator disapproves a registration under this paragraph, the Administrator shall provide the registering State with written notification of disapproval, in accordance with paragraph (c) of this section, as soon thereafter as practicable. Such notification will specify the grounds for disapproval and invite the State to comment on the decision.
(3) If requested by the State within ten days of its receipt of a notice of disapproval, the Administrator, or his designee, will consult with appropriate State officials. The Administrator may consider any information presented at such a consultation, or in any other appropriate fashion, in determining whether the disapproval should be rescinded.
(c) Decision and notification of disapproval. Except as provided in paragraph (b)(1) of this section, the Administrator will make a final decision on disapproval of a State registration, and provide written notification thereof to the State, within 90 days of the effective date of the registration; provided that, if the State does not notify the Agency of a registration within ten days of its effective date, then the Administrator will make a final decision on disapproval within 90 days of the date on which EPA receives notification of the State registration. The notice of disapproval will specify an appropriate date on which the disapproval will become effective. Disapproval may become effective immediately, or at anytime within the period allowed for the Administrator to make a final decision on disapproval. The notice of disapproval will also, when appropriate, give instructions for use or disposal of the pesticide. Each notice of disapproval will be published in the Federal Register.
(d) Effect of disapproval. If a registration issued by a State is disapproved by the Administrator, that registration will not be valid for any purpose under FIFRA, as of the date the disapproval becomes effective. Thereafter, distribution or sale of the pesticide, in either interstate or intrastate commerce, for uses subject to the disapproval will be a violation of sec. 12(a)(1) of FIFRA.
(e) Rescission of disapproval. If the Administrator determines, after consultation with the State lead agency, that a registration, previously issued by the State and disapproved by the Administrator, should not have been disapproved under FIFRA, then the Administrator shall rescind the disapproval. The Administrator shall send written notification of the rescission to the State. In addition, the Administrator shall publish notice of any rescission of disapproval in the Federal Register.
(f) Notification of registrants. Any State that issues a registration which has been disapproved, or which is subject to a notice of intent to disapprove, shall be responsible for notifying the affected registrant of any such notice of intent or disapproval, and of any recession of disapproval by the Administrator.