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§158.690 Biochemical pesticides data requirements.
(a) Biochemical pesticide product analysis data requirements -- (1) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the biochemical pesticides -- product analysis data requirements and the substance to be tested.
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General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
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Product identity ......... [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP*............. 151-10
Manufacturing process......... (i) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 151-11
Discussion of formation of (ii) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 151-12
unintentional ingredients.
Analysis of samples........... (iii) [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] MP and TGAI..... EP* and TGAI.... 151-13
Certification of limits....... ......... [R] R [R] R [R] R R R R MP.............. EP*............. 151-15
Analytical methods............ ......... R R R R R R R R R MP.............. EP*............. 151-16
Physical and chemical ......... [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 151-17
properties.
Submittal of samples.......... (iv) [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] MP and TGAI, PAI EP*, TGAI and 151-18
PAI.
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Key: R=Required CR=Conditionally required; MP=Manufacturing-use product; EP*=End-use product (asterisk identifies those data requirements that end-use applicants (i.e., ``formulators'') must
satisfy, provided that their active ingredient(s) (are) purchased from a registered source); TGAI=Technical grade of the active ingredient; [ ]=Brackets (i.e., [R], [CR]) indicate data
requirements that apply when an experimental use permit is being sought.
(2) Notes.The following notes are referenced in column two of the table contained in paragraph (a)(1) of this section.
(i) If an experimental use permit is being sought, a schematic diagram and/or description of the manufacturing process will suffice if the pesticide is not already under full scale production.
(ii) If the product is not already under full scale production and an experimental use permit is being sought, a discussion of unintentional ingredients shall be submitted to the extent this
information is available.
(iii) Required to support registration of each manufacturing-use product and end use products produced by an integrated formulation system. Data on other end use products will be required on a
case-by-case basis. For pesticides in the production stage, a rudimentary product analytical method and data will suffice to support an experimental use permit.
(iv) Routinely required for products produced by an integrated formulation system. Required on a case-by-case basis for other products or materials.
(b) Biochemical pesticides residue data requirements. (1) Table. Sections 158.50 and 158.100 though 158.102 describe how to use this table to determine the biochemical pesticides -- residue data requirements and the substance to be tested.
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General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
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Chemical identity............. (i), [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] TGAI............ TGAI............ 153-3
(ii),
(xiv)
Directions for use............ (i), [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] ................ ................ 153-3
(iii),
(xiv)
Nature of the residue:
Plants.................... (i), [CR] .......... [CR] .......... [CR] ......... ......... [CR] ......... PAIRA........... PAIRA........... 153-3
(xiv)
Livestock................. (i), [CR] .......... [CR] .......... [CR] ......... ......... [CR] ......... PAIRA and plant PAIRA and plant 153-3
(iv), metabo- lites. metabo- lites.
(xiv)
Residue analytical method..... (i), (v), [CR] .......... [CR] .......... [CR] ......... ......... [CR] ......... TGAI and metabo- TGAI and metabo- 153-3
(xiv) lites. lites.
Magnitude of the residue:
Crop field trials......... (i), [CR] .......... [CR] .......... [CR] ......... ......... [CR] ......... TEP............. TEP............. 153-3
(xiv)
Processed food/feed....... (i), (vi) [CR] .......... [CR] .......... [CR] ......... ......... ......... ......... EP.............. EP.............. 153-3
Meat/mild/poultry/eggs.... (i), [CR] .......... [CR] .......... [CR] ......... ......... ......... [CR] TGAI or plant TGAI or plant 153-3
(vii) metabo- lites. metabo- lites.
Potable water............. (i), .......... .......... [CR] [CR] ......... ......... ......... ......... ......... EP.............. EP.............. 153-3
(viii)
Fish...................... (i), (ix) .......... .......... [CR] [CR] ......... ......... ......... ......... ......... EP.............. EP.............. 153-3
Irrigated crops........... (i), (x) .......... .......... [CR] [CR] ......... ......... ......... ......... ......... EP.............. EP.............. 153-3
Food handling............. (i), (xi) .......... .......... .......... .......... ......... ......... ......... ......... [CR] EP.............. EP.............. 153-3
Reduction of residue.......... (i), [CR] .......... [CR] .......... [CR] ......... ......... ......... ......... Residue of Residue of 153-3
(xii) concern. concern.
Proposed tolerance............ (i), [CR] .......... [CR] .......... [CR] ......... ......... ......... ......... Residue of Residue of 153-3
(xiii) concern. concern.
Reasonable grounds in support ......... [CR] .......... [CR] .......... [CR] ......... ......... ......... ......... ................ ................ 153-3
of the petition.
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Key: CR=Conditionally required data; TGAI=Technical grade of the active ingredient; PAIRA=Pure active ingredient, radio labeled; TEP=typical end-use product, MP=Manufacturing-use product; [
]=Brackets (i.e., [CR]) indicate data requirements that apply when an experimental use permit is being sought.
(2) Notes. The following notes are referenced in column two of the table contained in paragraph (b)(1) of this section.
(i) Residue chemistry data requirements shall apply to biochemical pesticide products when any one or more of the following conditions apply:
(A) Tier II or III toxicology data are required, as specified for biochemical agents in (c)(1) of this section.
(B) The application rate of the product exceeds 0.7 ounces (20 grams) active ingredient per acre per application.
(C) The application rate of the product exceeds a level determined to be comparable to 0.7 ounces active ingredient per application but the application rate is not expressable in terms of
ounces per acre per application.
(ii) The same chemical identity data as required in (a)(1) of this section are required, with emphasis on impurities that could constitute a residue problem.
(iii) Required information includes crops to be treated, rate of application, number and timing of applications, preharvest intervals, and relevant restrictions.
(iv) Data on metabolism in livestock are required when residues occur on a livestock feed, or the pesticide is to be applied directly to livestock.
(v) A residue method suitable for enforcement of tolerances is needed whenever a numeric tolerance is proposed Exemptions from the requirement of a tolerance will also usually require an
analytical method.
(vi) Data on the nature and level of residue in processed food/feed are required when detectable residues could concentrate on processing and thus require establishment of a food additive
tolerance.
(vii) Livestock feeding studies are required whenever a pesticide occurs as a residue in an livestock feed. Direct application to livestock uses will require animal treatment residue studies.
(viii) Data on residues in potable water are required whenever a pesticide is to be applied directly to water, unless it can be determined that the treated water would not be used (eventually)
for drinking purpose, by man or animals.
(ix) Data on residues in fish are required whenever a pesticide is to be applied directly to water.
(x) Data on residues in irrigated crops are required when a pesticide is to be applied directly to water that could be used for irrigation or to irrigation facilities such as irrigation
ditches.
(xi) Data or residues in food/feed in food handling establishments are required whenever a pesticide is to be used in food/feed handling establishments.
(xii) Reduction of residue data are required when the assumption of tolerance level residues results in an unsafe level of exposure. Data on the level of residue in food as consumed will be
used to obtain a more precise estimate of potential dietary exposure.
(xiii) The proposed tolerance must reflect the maximum residue likely to occur in crops and meat/milk/poultry/eggs.
(xiv) Residue data for outdoor domestic uses are required if home gardens are to be treated and the home garden use pattern is different from the use pattern on which the tolerances were
established.
(c) Biochemical pesticides toxicology data requirements -- (1) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the biochemical pesticides -- toxicology data requirements and the substances to be tested.
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General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor use MP EP
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Tier I:
Acute oral toxicity....... (i) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* or EP 152-10
dilution* and
TGAI.
Acute dermal toxicity..... (i), (ii) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* or EP 152-11
dilution* and
TGAI.
Acute inhalation.......... (xiv) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 152-12
Primary eye irritation.... (ii) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP.............. 152-13
Primary dermal irritation. (i), (ii) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP.............. 152-14
Hypersensitivity study.... (iii) CR CR CR CR CR CR CR CR CR MP.............. EP.............. 152-15
Hypersensitivity incidents (iv) CR CR CR CR CR CR CR CR CR ................ ................ 152-16
Studies to detect (v) [R] [CR] [R] [CR] [R] [CR] [CR] [CR] [CR] TGAI............ TGAI............ 152-17
genotoxicity.
Immune response........... ......... [R] R [R] R [R] R R R R TGAI............ TGAI............ 152-18
90-day feeding (1 spp.)... (vi) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-20
90-day dermal (1 spp.).... (vii) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-21
90-day inhalation (1 spp.) (viii) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-22
Teratogenicity (1 spp.)... (ix) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-23
Tier II:
Mammalian mutagenicity (x) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-19
tests.
Immune response........... (xi) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-24
Tier III:
Chronic exposure.......... (xii) CR .......... CR .......... CR ......... ......... ......... CR TGAI............ TGAI............ 152-26
Oncogenicity.............. (xiii) CR .......... CR .......... CR ......... ......... ......... CR TGAI............ TGAI............ 152-29
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Key: R=Required; CR=Conditionally Required; MP=Manufacturing-use product; 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); TGAI=Technical Grade of the Active Ingredient; [ ]=Brackets (i.e., [R], [CR]] indicate data
requirement that apply when an experimental use permit is being sought.
(2) Notes. The following notes are referenced in column two of the table contained in paragraph (c)(1) of this section.
(i) Not required if test material is a gas or is highly volatile.
(ii) Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified toxicity category I on the basis of potential eye and
dermal irritation effects.
(iii) Required if repeated contact with human skin results under condition of use.
(iv) Incidents must be reported, if they occur.
(v) Required to support non-food uses if use is likely to result in significant human exposure; or the active ingredient or its metabolites is (are) structurally related to a known mutagen, or
belongs(s) to any chemical class of compounds containing known mutagens.
(vi) Required if the use requires a tolerance or an exemption from the requirement for a tolerance, or its use requires a food additive regulation; or the use of the product is otherwise
likely to result in repeated human exposure by the oral route.
(vii) Required if pesticidal use will involve purposeful application to the human skin or will result in comparable prolonged human exposure to the product, (e.g., swimming pool algaecides,
pesticides for impregnating clothing), and if either of the following criteria are met:
(A) Data from a subchronic oral study are not required.
(B) The active ingredient of the product is known or expected to be metabolized differently by the dermal route of exposure than by the oral route, and a metabolite of the active ingredient is
the toxic moiety.
(viii) Required if pesticidal use may result in repeated inhalation exposure at a concentration which is likely to be toxic.
(ix) Required if any of the following criteria are met:
(A) Use of the product under widespread and recognized practice may reasonably be expected to result in significant exposure to female humans.
(B) Its use requires a tolerance or an exemption from the requirement for a tolerance, or its use requires issuance of a food additive regulation.
(x) Required if results from any one of the Tier I mutagenicity tests were positive.
(xi) Required if adverse effects are observed in the Tier I immune response studies.
(xii) Required if the potential for adverse chronic effects are indicated based on:
(A) The subchronic effect levels established in the Tier I subchronic oral toxicity studies, the Tier I subchronic dermal toxicity studies or the Tier I subchronic inhalation toxicity studies.
(B) The pesticide use pattern (e.g., rate, frequency, and site of application).
(C) The frequency and level of repeated human exposure that is expected.
(xiii) Required if the product meets either of the following criteria:
(A) The active ingredient(s) or any of its (their) metabolites, degradation products, or impurities produce(s) in Tier I subchronic studies a morphologic effect (e.g., hyperplasia, metaplasia)
in any organ that potentially could lead to neoplastic change.
(B) If adverse cellular effects suggesting oncogenic potential are observed in Tier I or Tier II immune response studies or in Tier II mammalian mutagenicity assays.
(xiv) Required if the product consists of, or under conditions of use results in, an inhalable material (e.g., gas, volatile substance, or aerosol/particulate).
(d) Nontarget organism, fate and expression data requirements -- (1) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the biochemical pesticides non-target organism, fate and expression data requirements and substances to be tested.
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General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor use MP EP
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Tier I:
Avian acute oral.......... (i), (ii) [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 154-6
Avian dietary............. (i), [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 154-7
(ii),
(vi)
Freshwater fish LC[INF]50[/ (i), [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 154-8
INF]. (ii), (v)
Freshwater invertebrate (i), [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 154-9
LC[INF]50[/INF]. (ii),
(vii)
Nontarget plant studies... (iii) .......... R .......... R ......... ......... R ......... ......... TGAI............ TGAI............ 154-10
Nontarget insect testing.. (iv), (v) CR CR CR CR CR CR CR CR ......... TGAI............ TGAI............ 154-11
Tier II:
Volatility................ (viii) CR CR CR CR ......... ......... CR CR ......... TEP............. TEP............. 155-4
Dispenser-water leaching.. (ix) CR CR CR CR ......... ......... CR CR ......... EP.............. EP.............. 155-5
Adsorption-desorption..... (x) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 155-6
Octanol/Water Partition... (x) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 155-7
U.V. absorption........... (xi) CR CR CR CR ......... ......... CR CR ......... PAI............. PAI............. 155-8
Hydrolysis................ (x) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 155-9
Aerobic soil metabolism... (x) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 155-10
Aerobic aquatic metabolism (x) CR CR CR CR ......... CR CR ......... TGAI............ TGAI............ 155-11
Soil photolysis........... (x) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 155-12
Aquatic photolysis........ (x) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 155-13
Tier III:
Terrestrial wildlife (xii) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 15-12
testing.
Aquatic animal testing.... (xiii) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 154-13
Nontarget plant studies... (xiv) .......... .......... .......... .......... ......... ......... ......... ......... ......... TGAI............ TGAI............ 154-14
Nontarget insect testing.. (xv) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 154-15
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Key: R=Required; CR=Conditionally reguired; [ ]=Brackets (i.e., [R], [CR]) indicates data requirements that apply to products for which an experimental use permit is being sought;
MP=Manufacturing-use product; TEP=Typical end-Use product; TGAI=Technical grade of the active ingredient; EP=End-use product, PAI=``Pure'' active ingredient.
(2) Notes. The following notes are referenced in column two of the table contained in paragraph (d)(1) of this section.
(i) Tests for pesticides intended solely for indoor application will be required on a case-by-case basis, depending on use pattern, production volume, and other pertinent factors.
(ii) Preferable test species are: bobwhite quail or mallard for avian acute oral and avian dietary studies: rainbow trout for freshwater fish studies; and Daphnia for freshwater invertebrate
studies on biochemicals.
(iii) Data are required for pesticides to be used in forests and natural grasslands. For herbicides used in forest site preparation; the aquatic plant growth tests will be required. Data are
required when to support products to be used in other locations when any of the following conditions are met.
(A) Phytotoxicity problems arise and open literature data are not available.
(B) The product may pose hazards to endangered or threatened species.
(C) A rebuttable presumption against registration Special Review has been initiated on the product.
(iv) Required depending on pesticide mode of action and results of any available product performance data.
(v) Biochemicals introduced directly into an aquatic environment when used as directed shall be tested as specified in § 158.145.
(vi) Not required if pesticide is highly volatile (estimated volatility greater than 5x10[SU]-5[/SU] atm. m[SU]3[/SU]/mol).
(vii) If the pesticide will be introduced directly into an aquatic environment when used as directed, then it must be tested as indicated in § 158.145.
(viii) Required when results of any one or more of the Tier I tests indicate potential adverse effects on nontarget organisms and the biochemical agent is to be applied on land.
(ix) Required when results of any one or more of the Tier I tests indicate potential adverse effects on nontarget organisms and the biochemical agent is to be applied on land in a passive
dispenser.
(x) Required on a case-by-case basis when results of Tier I tests indicate environmental fate data are needed.
(xi) Required when results of Tier I tests indicate potential adverse effects on beneficial insects and the intended route of exposure of the pesticide is through vapor phase contact.
(xii) Required if either of the following criteria are met:
(A) Environmental fate characteristics indicate that the estimated concentration of the biochemical pesticide in the terrestrial environment is equal to or greater than \1/5\ the avian dietary
LC50 or the avian single dose oral LD[INF]50[/INF] (converted to ppm).
(B) The pesticide or any of its metabolites or degradation products are stable in the environment to the extent that potentially toxic amounts may persist in the avian feed.
(xiii) Required if environmental fate characteristics indicate that the estimated environmental concentration of the biochemical agent in the aquatic environment is equal to or greater than
0.01 of any EC[INF]50[/INF] or LC[INF]50[/INF] determined in testing required by Tier I aquatic tests.
(xiv) Required if the product is expected to be transported from the site of application by air, soil, or water. The extent of movement will be determined by the Tier II environmental fate
tests.
(xv) Required when results of Tier I tests indicate potential adverse effects on nontarget insects and results of Tier II tests indicate exposure of nontarget insects.
[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988,
and amended at 58 FR 34203, June 23, 1993]