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Notes

40 C.F.R. §§ 158.2030–158.2070

5 sections in range

§158.2030. Biochemical pesticides product chemistry data requirements table.

40 C.F.R. § 158.2030

(a)
General.
(1)
Sections 158.100 through 158.130 describe how to use this table to determine the product chemistry data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of the section.
(2)
Definitions in § 158.300 apply to data requirements in this section.
(b)
Use patterns. Product chemistry data are required for all pesticide products and are not use specific.
(c)
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; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above.
(d)
Table. The following table shows the data requirements for biochemical pesticides product chemistry. The test notes are shown in paragraph (e) of this section.
(e)
Test notes. The following test notes are applicable to the data requirements for biochemical pesticides product chemistry and are referenced in the last column of the table in paragraph (d) of this section.
Notes, amendments, and revision history

Source

Source: 72 FR 61002, Oct. 26, 2007, unless otherwise noted.

Authority

Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a.

Source

Source: 72 FR 60957, Oct. 26, 2007, unless otherwise noted.

§158.2040. Biochemical pesticides residue data requirements table.

40 C.F.R. § 158.2040

(a)
General. Sections 158.100 through 158.130 describe how to use this table to determine the biochemical pesticides residue data requirements for a particular pesticide product and the substance that needs to be tested. These data requirements apply to all biochemical pesticides, i.e., naturally occurring insect repellents and attractants, semiochemicals (e.g., insect pheromones), natural and plant growth regulators. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.
(b)
Use patterns.
(1)
Data are required or conditionally required for all pesticides used in or on food and for residential outdoor uses where food crops are grown. Food use patterns include products classified under the general use patterns of terrestrial food crop use, terrestrial feed crop use, aquatic food crop use, greenhouse food crop use, and indoor food use. Data are also conditionally required for aquatic nonfood use if there is direct application to water that could subsequently result in exposure to food.
(2)
Data are conditionally required for nonfood uses if pesticide residues may occur in food or feed as a result of the use. Data requirements for these nonfood uses would be determined on a case-by-case basis. For example, most products used in or near kitchens require residue data for risk assessment purposes even though tolerances may not be necessary in all cases.
(c)
Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing end-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table:
(d)
Data requirements table. The following table shows the data requirements for biochemical pesticides residue. The test notes are shown in paragraph (e) of this section.
(e)
Test notes. The following test notes are applicable to the data requirements for biochemical pesticides product chemistry and are in the last column of the table contained in paragraph (d) of this section.
Notes, amendments, and revision history

Source

Source: 72 FR 61002, Oct. 26, 2007, unless otherwise noted.

Authority

Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a.

Source

Source: 72 FR 60957, Oct. 26, 2007, unless otherwise noted.

§158.2050. Biochemical pesticides human health assessment data requirements table.

40 C.F.R. § 158.2050

(a)
General.
(1)
Sections 158.100 through 158.130 describe how to use this table to determine the biochemical human health assessment data requirements for a particular biochemical pesticide product.
(2)
The data in this section are not required for straight chain lepidopteran pheromones when applied up to a maximum use rate of 150 grams active ingredient/acre/year.
(b)
Use patterns.
(1)
Food use patterns, in general, include products classified under the following general uses— terrestrial food crop use; terrestrial feed crop use; aquatic food crop use; greenhouse food crop use.
(2)
Nonfood use patterns include products classified under the general use patterns of terrestrial nonfood crop use; aquatic nonfood residential use; aquatic nonfood outdoor use; aquatic nonfood industrial use; greenhouse nonfood crop use; forestry use; residential outdoor use; residential indoor use; indoor food use; indoor nonfood use; indoor medical use.
(c)
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; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table:
(d)
Table. The following table shows the data requirements for biochemical pesticides human health assessment. The test notes are shown in paragraph (e) of this section.
(e)
Test notes. The following test notes are applicable to the data requirements for biochemical pesticides human health assessment as referenced in the last column of the table in paragraph (d) of this section.
Notes, amendments, and revision history

Source

Source: 72 FR 61002, Oct. 26, 2007, unless otherwise noted.

Authority

Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a.

Source

Source: 72 FR 60957, Oct. 26, 2007, unless otherwise noted.

§158.2060. Biochemical pesticides nontarget organisms and environmental fate data requirements table.

40 C.F.R. § 158.2060

(a)
General.
(1)
Sections 158.100 through 158.130 describe how to use this table to determine the terrestrial and aquatic nontarget organisms and fate data requirements for a particular biochemical pesticide product. Notes that apply to an individual test including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section. In general, for all outdoor end-use products including turf, the following studies are required: one avian acute oral, one avian dietary, one acute freshwater fish, one acute freshwater invertebrate study, plant toxicity testing, and a honeybee acute contact study.
(2)
The data in this section are not required for arthropod pheromones when applied at up to a maximum use rate of 150 grams active ingredient/acre/year except when the product is expected to be available to avian species (i.e., granular formulation).
(b)
Use patterns. The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood/nonfeed 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 nonfood use. The remaining terrestrial uses include: forestry and residential outdoor use. Data are also required for the general use patterns of aquatic food and nonfood crop use.
(c)
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; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table:
(d)
Table. The following table shows the data requirements for biochemical pesticides nontarget organisms and environmental fate. The test notes are shown in paragraph (e) of this section.
(e)
Test notes. The following test notes are applicable to the data requirements for biochemical pesticides nontarget organisms and environmental fate as referenced in the last column of the table contained in paragraph (d) of this section.
Notes, amendments, and revision history

Source

Source: 72 FR 61002, Oct. 26, 2007, unless otherwise noted.

Authority

Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a.

Source

Source: 72 FR 60957, Oct. 26, 2007, unless otherwise noted.

§158.2070. Biochemical pesticides product performance data requirements.

40 C.F.R. § 158.2070

(a)
General. Product performance data must be developed for all biochemical pesticides. Each applicant must ensure through testing that the product is efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency may require, on a case-by-case basis, submission of product performance data for any pesticide product registered or proposed for registration or amendment.
(b)
Product performance data for each product that bears a claim against an invertebrate pest that is covered by subpart R of this part. The product performance data requirements and performance standards of subpart R of this part apply to biochemical products covered by this subpart. Product performance data must be submitted with any application for registration or amended registration. However, data requirements and the performance standards that determine the acceptability of data may be waived or modified on a case-by-case basis pursuant to the waiver provisions in § 158.45 and modification provisions in § 158.1707.
(c)
Product performance data for each product that bears a public health pest claim, excluding those covered under paragraph (b). Product performance data must be submitted with any application for registration or amended registration, if the product bears a claim to control public health pests, such as pest microorganisms infectious to humans in any area of the inanimate environment, or a claim to control vertebrates, including but not limited to, rodents, birds, bats, canids, and skunks.
Notes, amendments, and revision history

Amendments

[87 FR 22484, Apr. 15, 2022]

Source

Source: 72 FR 61002, Oct. 26, 2007, unless otherwise noted.

Authority

Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a.

Source

Source: 72 FR 60957, Oct. 26, 2007, unless otherwise noted.

Amendments

[87 FR 22484, Apr. 15, 2022]