40 CFR 158.2173 - Experimental use permit microbial pesticides toxicology data requirements table.

§ 158.2173 Experimental use permit microbial pesticides toxicology data requirements table.

(a)General. Sections 158.100 through 158.130 describe how to use this table to determine the toxicology data requirements for a particular microbial pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (d) of this section.

(b)Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (d) of this section, and apply to the individual tests in the following table:

(c)Table. The following table shows the data requirements for microbial pesticide toxicology. The test notes are shown in paragraph (d) of this section.

Table - EUP Microbial Pesticides Toxicology Data Requirements

Guideline Number Data Requirement All Use Patterns Test Substance Test Notes
885.3050 Acute oral toxicity/pathogenicity R TGAI 1
885.3150 Acute pulmonary toxicity/pathogenicity R TGAI --
885.3200 Acute injection toxicity/pathogenicity/(intravenous)
Acute injection toxicity/pathogenicity/(intraperitoneal)
885.3400 Hypersensitivity incidents R All 3
885.3500 Cell culture R TGAI 4
870.1100 Acute oral toxicity R MP, EP 1, 5
870.1200 Acute dermal toxicity R MP, EP 5
870.1300 Acute inhalation toxicity R MP, EP 5, 6
870.2400 Acute eye irritation R MP, EP 5
870.2500 Primary dermal irritation CR MP, EP 5

(d)Test notes. The following test notes are applicable to the data requirements for experimental use permit microbial pesticides toxicology as referenced in the last column of the table contained in paragraph (c) of this section:

1. The acute oral toxicity/pathogenicity study is required to support the TGAI. However, it can be combined with the unit dose portion of the acute oral toxicity study, with an EP or MP test material to fulfill the requirement for the TGAI and the MP or EP in a single study, if the new protocol is designed to address the endpoints of concern.

2. Data not required for products whose active ingredient is a virus. For test materials whose size or consistency may prevent use of an intravenous injection, the intraperitoneal injection procedure may be employed.

3. Hypersensitivity incidents, including immediate type and delayed type reactions of humans or domestic animals occur during the testing or production of the TGAI, MP, or EP, or are otherwise known to the applicant must be reported if they occur.

4. Data must be submitted only for products whose active ingredient is a virus.

5. The 870 series studies for the MP and EP are intended to provide data on the acute toxicity of the product. Waivers for any or all of these studies may be granted when the applicant can demonstrate that the combination of inert ingredients is not likely to pose any significant human health risks. Where appropriate, the limit dose approach to testing is recommended.

6. Required when the product consists of, or under conditions of use that would result in an inhalable material (e.g., gas, volatile substances, or aerosol particulate).

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

U.S. Code: Title 21 - FOOD AND DRUGS