40 CFR 152.96 - Claim of data gap.

§ 152.96 Claim of data gap.

(a)When a data gap may be claimed. Except as provided in paragraph (b) of this section, an applicant may defer his obligation to satisfy an applicable data requirement until the Agency requires the data if no other person has previously submitted to the Agency a valid study that would satisfy the data requirement in question.

(b)When a data gap may not be claimed -

(1)Product containing a new active ingredient. An applicant for registration of a product containing a new active ingredient may not defer his obligation by claiming a data gap unless he can demonstrate to the Agency's satisfaction that the data requirement was imposed so recently that insufficient time has elapsed for the study to have been completed and that, in the public interest, the product should be registered during the limited period of time required to complete the study. Refer to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(7)(C).

(2)Product not containing a new active ingredient. An applicant for registration of a product under FIFRA sections 3(c)(7)(A) or (B) (a product not containing a new active ingredient) may not defer his obligation by claiming a data gap if the data are:

(i) Data needed to determine whether the product is identical or substantially similar to another currently registered product or differs only in ways that would substantially increase the risk of unreasonable adverse effects on the environment.

(ii) Efficacy data specific to the product, if required to be submitted to the Agency.

(iii) If a new use is proposed for a product that is identical or substantially similar to an existing product, data to demonstrate whether the new use would substantially increase the risk of unreasonable adverse effects on the environment.

(c)Approval of application with a data gap claim - (1) In accordance with § 152.115(a), any registration that is approved based upon a data gap claim shall be conditioned on the submission of the data no later than the time that the data are required to be submitted for similar products already registered.

(2) Notwithstanding paragraph (c)(1) of this section, the Agency will not approve an application if it determines that the data for which a data gap claim has been made are needed to determine if the product meets the requirements of FIFRA sections 3(c)(5) or (7).

[ 79 FR 6826, Feb. 5, 2014]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code
U.S. Code: Title 7 - AGRICULTURE

§ 136 - Definitions

§ 136a - Registration of pesticides

7 U.S. Code § 136a–1 - Reregistration of registered pesticides

§ 136b - Transferred

§ 136c - Experimental use permits

§ 136d - Administrative review; suspension

§ 136e - Registration of establishments

§ 136f - Books and records

§ 136g - Inspection of establishments, etc.

§ 136h - Protection of trade secrets and other information

§ 136i - Use of restricted use pesticides; applicators

7 U.S. Code § 136i–1 - Pesticide recordkeeping

7 U.S. Code § 136i–2 - Collection of pesticide use information

§ 136j - Unlawful acts

§ 136k - Stop sale, use, removal, and seizure

§ 136l - Penalties

§ 136m - Indemnities

§ 136n - Administrative procedure; judicial review

§ 136o - Imports and exports

§ 136p - Exemption of Federal and State agencies

§ 136q - Storage, disposal, transportation, and recall

§ 136r - Research and monitoring

7 U.S. Code § 136r–1 - Integrated Pest Management

§ 136s - Solicitation of comments; notice of public hearings

§ 136t - Delegation and cooperation

§ 136u - State cooperation, aid, and training

§ 136v - Authority of States

§ 136w - Authority of Administrator

7 U.S. Code § 136w–1 - State primary enforcement responsibility

7 U.S. Code § 136w–2 - Failure by the State to assure enforcement of State pesticide use regulations

7 U.S. Code § 136w–3 - Identification of pests; cooperation with Department of Agriculture’s program

7 U.S. Code § 136w–4 - Omitted

7 U.S. Code § 136w–5 - Minimum requirements for training of maintenance applicators and service technicians

7 U.S. Code § 136w–6 - Environmental Protection Agency minor use program

7 U.S. Code § 136w–7 - Department of Agriculture minor use program

7 U.S. Code § 136w–8 - Pesticide registration service fees

§ 136x - Severability

§ 136y - Authorization of appropriations

Public Laws

Title 40 published on 09-Jun-2018 05:24

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 40 CFR Part 152 after this date.

  • 2018-05-07; vol. 83 # 88 - Monday, May 7, 2018
    1. 83 FR 20004 - Withdrawal of Proposed Rules; Discontinuing Several Rulemaking Efforts Listed in the Semiannual Regulatory Agenda
      GPO FDSys XML | Text
      Withdrawal of proposed rules.
      As of May 7, 2018, the proposed rules published on November 23, 1994, at 59 FR 60519; November 23, 1994, at 59 FR 60525; June 26, 1996, at 61 FR 33260; and September 17, 1999, at 64 FR 50671, are withdrawn.
      40 CFR Parts 152, 156, 174 and 180
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