161.390—Reentry protection data requirements.

(a) Table. Sections 161.100 through 161.102 describe how to use this table to determine the reentry protection data requirements and the substance to be tested.
Kind of data required (b) Notes General use patterns Terrestrial Food crop Nonfood Aquatic Food crop Nonfood Greenhouse Food crop Nonfood Forestry Domestic outdoor Indoor Test substance Data to support MP Data to support EP Guideline reference No.
Foliar dissipation (1) CR CR CR CR CR TEP TEP 132-1
Soil dissipation (1), (4) CR CR CR CR CR TEP TEP 132-1
Dermal exposure (1), (2), (3) CR CR CR CR CR TEP TEP 133-3
Inhalation exposure (1), (2), (3) CR CR CR CR CR TEP TEP 133-4
Key: CR=Conditionally required; 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.
Code of Federal Regulations 222
(1) Data are required if the following conditions are met:
(i)(A) The acute dermal toxicity of the technical grade of active ingredient is less than 200 mg/kg (body weight); or
(B) The acute inhalation toxicity of the technical grade of active ingredient is less than 200 mg/m 3 (for a one-hour exposure); or
(C) The acute oral toxicity of the technical grade of active ingredient is less than 50 mg/kg (body weight); or
(D) Neurotoxic, teratogenic, or oncogenic effects or other adverse effects as evidenced by subchronic, chronic, and reproduction studies would be expected from entry of persons into treated sites; or
(E) The Agency receives other scientifically validated toxicological or epidemiological evidence that a pesticide or residue of a pesticide could cause adverse effects on persons entering treated sites. In the last situation, reentry intervals and supporting data may be required on a case-by-case basis.
(ii) And if: end-use product is to be registered for:
(A) Application to growing crops, such as to or around horticultural and agronomic crops that are field- or orchard-grown.
(B) Application to outdoor tree nursery and forestry operations.
(C) Application to turf crops and commercial applications to turf.
(D) Application to parks and arboretums; or (E) application to aquatic crops.
(iii) And if: human exposure to residues of the pesticide can be reasonably foreseen. This applies primarily to pesticides that will be used on crops where human tasks will involve substantial exposure to residues of the pesticide.
(2) Data required if appropriate surrogate data are not available.
(3) Data required if the applicant chooses to use the allowable exposure level method for proposal of a reentry interval.
(4) Soil dissipation data required if agricultural practice involves human tasks that would cause substantial exposure to residues sorbed to soil.

Code of Federal Regulations

[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988, as amended at 58 FR 34203, June 23, 1993]