Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 40 - Protection of Environment |
Chapter I - Environmental Protection Agency |
SubChapter E - Pesticide Programs |
Part 161 - DATA REQUIREMENTS FOR REGISTRATION OF ANTIMICROBIAL PESTICIDES |
Subpart D - Data Requirement Tables |
§ 161.640 - Product performance data requirements table.
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(a) Table. Sections 161.100 through 161.102 describe how to use this table to determine the product performance data requirements and the substance to be tested.
Kind of data required (b) Notes General use patterns Test substance Guidelines reference No. Terrestrial Aquatic Greenhouse Forestry Domestic outdoor Indoor Data to support MP Data to support EP Food crop Nonfood Food crop Nonfood Food crop Nonfood Efficacy of antimicrobial agents Products for use on hard surfaces (1) CR EP* 91-2 Products requiring confirmatory data (1) CR EP* 91-3 Products for use on fabrics and textiles (1) CR EP* 91-4 Air sanitizers (1) CR EP* 91-5 Products for control of microbial pests associated with human and animal wastes (1) CR EP* 91-7 Products for treating water systems (1) [CR] CR EP* 91-8 Efficacy of fungicides and nematicides Products for control of organisms producing mycotoxins (1) [CR] [CR] [CR] EP* 93-16 Efficacy of Vertebrate Control Agents Avian toxicants (1) (R) (R) (R) (R) EP* 96-5 Avian repellents (1) (R) (R) (R) EP* 96-6 Avian frightening agents (1) (R) (R) (R) EP* 96-7 Bat toxicants and repellents (1) (R) EP* 96-9 Commensal rodenticides (1) (R) (R) (R) (R) TEP EP* 96-10 Rodenticides on farm and rangelands (1) (R) (R) (R) EP* 96-12 Rodent fumigants (1) (R) (R) (R) (R) EP* 96-13 Rodent reproductive inhibitors (1) (R) (R) (R) (R) EP* 96-16 Mammalian predacides (1) (R) (R) (R) EP* 96-17 Products with prion-related claims * R EP * 810.2700 Key: R=Required; CR=Conditionally required; [ ]=Brackets (i.e., [R], [CR]) indicate data requirements that apply to products for which an experimental use permit is being sought; EP=End-use product* (asterisk identifies those data requirements that end-use applicants (i.e., “formulators”) must satisfy, provided that their active ingredient(s) is (are) purchased from a registered source); MP=Manufacturing use product; TEP=Typical end-use product.
(b) Notes: The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) The Agency has waived all requirements to submit efficacy data unless the pesticide product bears a claim to control pest microorganisms that pose a threat to human health and whose presence cannot readily be observed by the user including, but not limited to, microorganisms infectious to man in any area of the inanimate environment or a claim to control vertebrates (such as rodents, birds, bats, canids, and skunks) that may directly or indirectly transmit diseases to humans. However, each registrant must ensure through testing that his products are efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency reserves the right to require, on a case-by-case basis, submission of efficacy data for any pesticide product registered or proposed for registration.
(2) [Reserved]
[49 FR 42881, Oct. 24, 1984, as amended at 50 FR 46766, Nov. 13, 1985. Redesignated at 53 FR 15993, May 4, 1988, as amended at 58 FR 34203, June 23, 1993; 78 FR 13507, Feb. 28, 2013]