Experimental use permit data requirements for product performance.

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§ 158.220 Experimental use permit data requirements for product performance.

All product performance data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit.

(a) Use patterns.

(1) The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop and terrestrial nonfood crop. The aquatic use pattern includes products classified under the general use patterns of aquatic food crop and aquatic nonfood crop. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. The indoor use pattern includes products classified under the general use patterns of indoor food and indoor nonfood use.

(2) Data are also required for forestry and residential outdoor uses.

(b) Key. CR = Conditionally required; NR = Not required; R = Required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product.

(c) Table. The following table shows the experimental use data requirements for product performance. The test notes are shown in paragraph (d) of this section.

Expand Table

Table - Experimental Use Permit Data Requirements for Product Performance

Guideline No. Data Requirement Use Pattern Test substance to support Test Note No.
Terrestrial Aquatic Greenhouse Forestry Residential Outdoors Indoor MP EP
Food Crop Nonfood Crop Food Crop Nonfood Crop Food Crop Nonfood Crop
Efficacy of antimicrobial agents
91-8 Products for treating water systems NR NR CR NR NR NR NR NR NR NR EP 1
Efficacy of fungicides and nematicides
93-16 Products for control of organisms producing mycotoxins CR NR CR NR CR NR NR NR NR NR EP 1
Efficacy of vertebrate control agents
96-5 Avian toxicants R R NR NR NR NR NR R R NR EP 1
96-6 Avian repellents R R NR NR NR NR NR R NR NR EP 1
96-7 Avian frightening agents R R NR NR NR NR NR R NR NR EP 1
96-9 Bat toxicants and repellents NR NR NR NR NR NR NR NR R NR EP 1
96-10 Commensal rodenticides R R NR NR NR NR NR R R TEP EP 1
96-12 Rodenticides on farm and rangelands R R NR NR NR NR NR R NR NR EP 1
95-13 Rodent fumigants R R NR NR NR NR NR R R NR EP 1
95-16 Rodent reproductive inhibitors R R NR NR NR NR NR R R NR EP 1
95-17 Mammalian predacides R R NR NR NR NR NR R NR NR EP 1

(d) Test notes. The following test notes apply to the data requirements in the table to paragraph (c) of this section.

1. The Agency has waived the requirement 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 product is 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]

[72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008]


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