40 CFR 180.930 - Inert ingredients applied to animals; exemptions from the requirement of a tolerance.

Text


Title 40: Protection of Environment

CHAPTER I: ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

SUBCHAPTER E: PESTICIDE PROGRAMS

PART 180: TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD

Subpart D: Exemptions From Tolerances

180.930 - Inert ingredients applied to animals; exemptions from the requirement of a tolerance.

The following materials are exempted from the requirement of a tolerance when used in accordance with good agricultural practice as inert (or occasionally active) ingredients in pesticide formulations applied to animals:

Inert ingredientsLimitsUses
Acetic acid (CAS Reg. No. 64-19-7)Not more than 0.5% of pesticide formulationCatalyst
Acetic anhydride

Solvent, cosolvent, stabilizer
Alkanoic and alkenoic acids, mono- and diesters of ?-hydro-?-hydroxypoly(oxyethylene) with molecular weight (in amu) range of 200 to 6,000

Emulsifiers
Alkyl (C8-C24) benzenesulfonic acid and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts

Surfactants, emulsifier, related adjuvants of surfactants
Alkyl (C12-C16) dimethyl ammonio acetate (CAS Reg. Nos. 683-10-3, 2601-33-4 and 693-33-420% by weight in pesticide formulationSurfactant
?-Alkyl(C6-C15)-?-hydroxypoly(oxyethylene)sulfate, and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts, poly(oxyethylene) content averages 2-4 moles (CAS Reg. Nos. 3088-31-1, 9004-82-4, 9004-84-6, 13150-00-0, 25446-78-0, 26183-44-8, 32612-48-9, 50602-06-7, 62755-21-9, 68424-50-0, 68511-39-7, 68585-34-2, 68611-55-2, 68891-38-3, 73665-22-2)Not to exceed 30% of pesticide formulationSurfactants, related adjuvants of surfactants
?-alkyl (C12-C15)-?-hydroxypoly(oxypropylene)poly(oxyethylene)copolymers (where the poly(oxypropylene) content is 3-60 moles and the poly(oxyethylene) content is 5-80 moles), the resulting ethoxylated propoxylated (C12-C15) alcohols having a minimum molecular weight (in amu) of 1,500, CAS Reg. No. 68551-13-3Not to exceed 20% of pesticide formulationsSurfactant
?-alkyl-?-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons (CAS Reg. Nos. 9002-92-0, 9004-95-9, 9005-00-9, 26183-52-8, 34398-01-1, 52292-17-8, 66455-14-9, 66455-15-0, 68002-97-1, 68131-39-5, 68131-40-8, 68154-96-1, 68213-23-0, 68439-45-2, 68439-46-3, 68526-94-3, 68439-50-9, 68439-49-6, 68551-12-2, 68951-67-7, 71243-46-4, 97043-91-9, 9043-30-5, 60828-78-6, 61827-42-7, 24938-91-8, 68439-54-3, 69011-36-5, 78330-20-8, 78330-21-9, 106232-83-1, 127036-24-2, 160875-66-1, 9004-98-2, 68920-66-1, 61804-34-0, 61791-28-4, 71060-57-6, 26468-86-0, 31726-34-8, 52609-19-5, 61791-20-6, 68155-01-1, 69013-19-0, 69364-63-2, 70879-83-3, 78330-19-5, 97953-22-5, 157627-86-6, 34398-05-5, 72905-87-4, 84133-50-6, 61702-78-1, 27306-79-2, 169107-21-5, 61791-13-7, 39587-22-9, 85422-93-1; 68154-98-3, 61725-89-1, 68002-96-0, 68154-97-2, 68439-51-0, 68551-13-3, 68603-25-8, 68937-66-6, 68987-81-5, 69227-21-0, 70750-27-5, 103818-93-5, 166736-08-9, 120313-48-6, 68213-24-1, 68458-88-8, 68551-14-4, 69013-18-9, 69227-22-1, 72854-13-8, 73049-34-0, 78330-23-1, 37311-02-7, 64366-70-7, 37251-67-5, 9087-53-0, 196823-11-7, 57679-21-7, 111905-54-5, 61827-84-7, 172588-43-1)

Surfactants, related adjuvants of surfactants
Alkyl (C8-C18) sulfate and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts

Surfactant


N,N-Bis-?-ethyl-?-hydroxypoly(oxy-1,2-ethanediyl) C8-C18 saturated and unsaturated alkylamines; the poly(oxy-1,2-ethanediyl) content is 2-60 moles (CAS Reg. Nos. 10213-78-2, 25307-17-9, 26635-92-7, 26635-93-8, 288259-52-9, 58253-49-9, 61790-82-7, 61791-14-8, 61791-24-0, 61791-26-2, 61791-31-9, 61791-44-4, 68155-33-9, 68155-39-5, 68155-40-8,70955-14-5, 73246-96-5)
Not to exceed 25% in herbicide formulations and 10% in insecticide and fungicide formulationsSurfactants, related adjuvants of surfactants


N,N-Bis-?-ethyl-?-hydroxypoly(oxy-1,2-ethanediyl/oxy(methyl-1,2-ethanediyl) C8-C18 saturated and unsaturated alkylamines; the poly(oxy-1,2-ethanediyl/oxy(methyl-1,2-ethanediyl) content is 2-60 moles (CAS Reg. Nos. 68213-26-3, 68153-97-9, 75601-76-2)
Not to exceed 25% in herbicide formulations and 10% in insecticide and fungicide formulationsSurfactants, related adjuvants of surfactants
Ascorbyl palmitate

Preservative
Attapulgite-type clay

Solid diluent, carrier
Barium sulfate (CAS Reg. No. 7727-43-7)

Carrier, density control agent
Benzoic acid

Preservative for formulations
2-Bromo-2-nitro-1,3-propanediol (CAS Reg. No. 52-51-7)0.04% or less by weight of the total pesticide formulationIn-can preservative
Butane

Propellant


n-Butanol (CAS Reg. No. 71-36-3)


Solvent for blended emulsifiers
Butylated hydroxyanisole

Antioxidant
Butylated hydroxytoluene

Do.
Calcium carbonate

Solid diluent, carrier
Calcium chloride

Stabilizer
Calcium silicate, hydrated calcium silicate

Anticaking agent, solid diluent, carrier
Calcium stearate (CAS Reg. No. 1592-23-0)

Stabilizer, component of plastic animal tag
Calcium sulfate

Solid diluent, carrier
Carbon black (CAS Reg. No. 1333-86-4)

Colorant/pigment in animal tag
Carrageenan, conforming to 21 CFR 172.620Minimum molecular weight (in amu): 100,000Thickener
Cyclohexanone

Solvent, cosolvent
D&C Green No. 6

Dye, coloring agent
D&C Red No. 17

Do.
D&C Violet No. 2

Do.
Dialkyl (C8-C18) dimethylammonium chlorideNot more than 0.2% in silica hydrated silicaFlocculating agent in the manufacture of silica hydrated silica for use as a solid diluent, carrier
Diatomite (diatomaceous earth)

Solid diluent, carrier
Diethanolamine salts of alkyl (C8-C24) benzenesulfonic acid (CAS Reg. Nos. 26545-53-9 and 68953-97-9)Not to exceed 7% of pesticide formulationSurfactants, related adjuvants of surfactants
Diethylphthalate

Solvent, cosolvent
1,1-Difluoroethane (CAS Reg. No. 75-37-6)For aerosol pesticide formulations used for insect control in food- and feed-handling establishments and animalsAerosol propellant
Dimethyl ether (CAS Reg. No. 115-10-6)

Propellant
Dimethylaminopropylamine, isopropylamine, ethanolamine, and triethanolamine salts of alkyl (C8-C24) benzenesulfonic acid (CAS Reg. Nos. 26264-05-1, 27323-41-7, 55470-69-4, 68411-31-4, 68584-24-7, 68584-25-8, 68648-81-7, 68648-96-4, 68649-00-3, 68910-32-7, 68953-93-5, 90194-42-6, 90194-53-9, 90218-35-2, 157966-96-6, 319926-68-6, 877677-48-0, 1093628-27-3)

Surfactants, related adjuvants of surfactants
3,6-Dimethyl-4-octyne-3,6-diolNot more than 2.5% of pesticide formulationSurfactants, related adjuvants of surfactants
Dimethylpolysiloxane (CAS Reg. No. 9016-00-6)

Defoaming agent
Dipropylene glycol monomethyl ether

Surfactants, related adjuvants of surfactants
Epoxidized soybean oil (CAS Reg. No. 8013-07-8)

Stabilizer, plasticizer, component animal tag
Ethyl alcohol

Solvent, cosolvent
Ethyl maltol (CAS Reg. No.4940-11-8)Not more than 0.2 % of the pesticide formulationOdor masking agent
Ethylene oxide adducts of 2,4,7,9-tetramethyl-5-decynediol, the ethylene oxide content averages 3.5, 10 or 30 moles (CAS Reg. No. 9014-85-1)

Surfactants, related adjuvants of surfactants
2-Ethyl-1-hexanolNot more than 2.5% of pesticide formulationSolvent, adjuvant of surfactants
FD&C Blue No. 1

Dye, coloring agent
FD&C Yellow No. 6 Aluminum Lake (CAS Reg. No. 15790-07-5)Not more than 2% by weight of pesticide formulationPigment in animal tag and similar slow-release devices
D-glucopyranose, oligomeric, C10-16-alkyl glycosides (CAS Reg. No. 110615-47-9)

Surfactant
Glycerol monooleate

Surfactants, related adjuvants of surfactants
Glyceryl monostearate

Emulsifier
Glyceryl tris-12-hydroxystearate

Flow control agent
Graphite

Solid diluent, carrier


n-Hexyl alcohol (CAS Reg. No. 111-27-3)


Solvent, cosolvent
2-(2?-Hydroxy-5?-methylphenyl)benzotriazole (CAS Reg. No. 2440-22-4)Not more than 0.5% by weight of pesticide formulationUltraviolet light absorber/stabilizer in animal tag and similar slow-release devices
Iron oxide (CAS Reg. No. 1309-37-1)

Colorant in pesticide formulations for animal tags
Isopropyl myristate, CAS Reg. No. 110-27-0

Solvent
Kaolinite-type clay

Solid diluent, carrier
Kerosene, U.S.P. reagent

Solvent, cosolvent
Lactic acid

Solvent
Lactic acid, 2-ethylhexyl ester (CAS Reg. No. 6283-86-9)

Solvent
Lactic acid, 2-ethylhexyl ester, (2S)- (CAS Reg. No. 186817-80-1)

Solvent
Lactic acid, n-propyl ester, (S); (CAS Reg. No. 53651-69-7)

Solvent
Lignin (CAS Reg. No. 9005-53-2)

Surfactant, related adjuvants of surfactants
Lignin, alkali (CAS Reg. No. 8068-05-1)

Do.
Lignin, alkali, oxidized, sodium salt (CAS Reg. No. 68201-23-0)

Do.
Lignin alkali reaction products with disodium sulfite and formaldehyde (CAS Reg. No. 105859-97-0)

Do.
Lignin alkali reaction products with formaldehyde and sodium bisulfite (CAS Reg. No. 68512-35-6)

Do.
Lignosulfonic acid (CAS Reg. No. 8062-15-5)

Do.
Lignosulfonic acid, ammonium calcium salt (CAS Reg. No. 12710-04-2)

Do.
Lignosulfonic acid, ammonium magnesium salt (CAS Reg. No. 123175-37-1)

Do.
Lignosulfonic acid, ammonium salt (CAS Reg. No. 8061-53-8)

Do.
Lignosulfonic acid, ammonium sodium salt (CAS Reg. No. 166798-73-8)

Do.
Lignosulfonic acid, calcium magnesium salt (CAS Reg. No. 55598-86-2)

Do.
Lignosulfonic acid, calcium salt (CAS Reg. No. 8061-52-7)

Do.
Lignosulfonic acid, calcium sodium salt (CAS Reg. No. 37325-33-0)

Do.
Lignosulfonic acid, ethoxylated, sodium salt (CAS Reg. No. 68611-14-3)

Do.
Lignosulfonic acid, magnesium salt (CAS Reg. No. 8061-54-9)

Do.
Lignosulfonic acid, potassium salt (CAS Reg. No. 37314-65-1)

Do.
Lignosulfonic acid, sodium salt (CAS Reg. No. 8061-51-6)

Do.
Lignosulfonic acid, sodium salt, oxidized (CAS Reg. No. 68855-41-4)

Do.
Lignosulfonic acid, sodium salt, polymer with formaldehyde and phenol (CAS Reg. No. 37207-89-9)

Do.
Lignosulfonic acid, sodium salt, sulfomethylated (CAS Reg. No. 68512-34-5)

Do.
Lignosulfonic acid, zinc salt (CAS Reg. No. 57866-49-6)

Do.
d-Limonene (CAS Reg. No. 5989-27-5)

Solvent, fragrance
Magnesium carbonate

Solid diluent, carrier
Magnesium silicate, hydrated magnesium silicate

Do.
Methyl alcohol

Solvent, cosolvent
Methyl n-amyl ketone (CAS Reg. No. 110-43-0)

Solvent, cosolvent
Methyl esters of higher fatty acids conforming to 21 CFR 573.640

Antidusting agent
Methyl-p-hydroxybenzoate (Methyl paraben)Meets specifications of Food Chemicals Codex; not to exceed 0.1% in formulationsPreservative
Methyl isobutyl ketone

Solvent, cosolvent
Mineral oil, U.S.P., or conforming to 21 CFR 172.878 or 178.3620(a), (b)

Solvent, diluent
Montmorillonite-type clay

Solid diluent, carrier
Nonyl, decyl, and undecyl glycoside mixture with a mixture of nonyl, decyl, and undecyl oligosaccharides and related reaction products (primarily decanol and undecanol) produced as an aqueous-based liquid (50 to 65% solids) from the reaction of primary alcohols (containing 15 to 20% secondary alcohol isomers) in a ratio of 20% C9, 40% C10, and 40% C11 with carbohydrates (average glucose to alkyl chain ratio 1.3 to 1.8)

Surfactant
?-(p-nonylphenol)-?-hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, potassium, sodium, and zinc salts of the phosphate esters; the nonyl group is a propylene trimer isomer and the poly(oxyethylene) content averages 4-14 or 30 moles (CAS Reg. Nos. 51811-79-1, 59139-23-0, 67922-57-0, 68412-53-3, 68553-97-9, 68954-84-7, 99821-14-4, 152143-22-1, 51609-41-7, 37340-60-6, 106151-63-7, 68584-47-4, 52503-15-8, 68458-49-1)Not to exceed 7% of pesticide formulation. Expires May 17, 2012Surfactants, related adjuvants of surfactants
?-(p-nonylphenol)-?-hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts the nonyl group is propylene trimer isomer and the poly(oxyethylene) content averages 4 moles (CAS Reg Nos. 9014-90-8, 9051-57-4, 9081-17-8, 68649-55-8, 68891-33-8)Not to exceed 7% of pesticide formulation. Expires May 17, 2012Surfactants, related adjuvants of surfactants
?-(p-Nonylphenyl)-?-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of nonylphenol (nonyl group is a propylene trimer isomer) with an average of 4-15 or 30-90 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range of 4-15 or 30-90 moles

Surfactants, emulsifier, related adjuvants of surfactants.
Octadecyl 3,5-di-tert-butyl-4-hydroxyhydro cinnamate (CAS Reg. No. 2082-79-3)Not more than 0.5% by weight of pesticide formulationThermal stabilizer/antioxidant in animal tag and similar slow-release devices
1-Octanal (CAS Reg. No. 124-13-0)Not more than 0.2% of the pesticide formulationOdor masking agent
Octyl and decyl glucosides mixture with a mixture of octyl and decyl oligosaccharides and related reaction products (primarily n-decanol) produced as an aqueous-based liquid (68-72% solids) from the reaction of straight chain alcohols (C8(45%), C10) with anhydrous glucose

Thermal stabilizer/antioxidant in animal tag and similar slow-release devices
Octyl epoxytallate (CAS Reg. No. 61788-72-5)

Plasticizer, component animal tag
Oleic acid, conforming to 21 CFR 172.862 (CAS Reg. No. 112-80-1)

Defoaming agent
?-Oleoyl-?-hydroxypoly(oxyethylene), average molecular weight (in amu) of 600

Emulsifier
?-Oleoyl-?-(oleyloxy)poly(oxyethylene) derived from ?-hydro-?-hydroxypoly(oxyethylene), molecular weight (in amu) 600

Emulsifier, defoaming agent
Petroleum hydrocarbons, light, odorless, conforming to 21 CFR 172.884 or 178.3650

Solvent, diluent
Petroleum hydrocarbons, synthetic isoparaffinic, conforming to 21 CFR 172.882 or 178.3530

Do.
Phenol

Solvent, cosolvent
?-PineneNot more than 2% of formulation by weightStabilizer
Polyethylene (CAS Reg. No. 9002-88-4) conforming to 21 CFR 172.615

Component of plastic slow release tag
Polyethylene glycol [?-hydro-?-hydroxypoly(oxyethylene)]; mean molecular weight (in amu) 194 to 9,500 conforms to 21 CFR 178.3750

Surfactants, related adjuvants of surfactants
Potassium hydroxideMeeting Food Chemicals, Codex specificationsNeutralizer
Propane

Propellant
1,2,3-Propanetriol, homopolymer diisooctadecanoate (CAS Reg. No. 63705-03-3)

Emulsifier


n-Propanol


Solvent, for blended emulsifiers
2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt (CAS Registration No. 55989-05-4), minimum number average molecular weight (in amu), 18,900.

Encapsulating agent,dispensers, resins, fibers and beads
Propylene glycol

Solvent, cosolvent
Propylene glycol monomethyl ether

Deactivator, emmolient
Propyl gallate

Antioxidant
Propyl p-hydroxybenzoate (Propyl paraben)Meets specifications of Food Chemicals Codex; not to exceed 0.1% in formulationsPreservative
Pyrophylite

Solid diluent, carrier
Silica, hydrated silica

Anticaking agent, solid diluent, carrier
Silica aerogel (finely powdered microcellular silica foam having a minimum silica content of 89.5%)

Component of antifoaming agent
Soapstone

Solid diluent
Sodium alkyl naphthalenesulfonates (CAS Reg. Nos. 68909-83-1, 68909-84-2, 68909-82-0, 27213-90-7, 26264-58-4, 27178-87-6, 111163-74-7, 908356-16-1, 25417-20-3, 25638-17-9, 145578-88-7, 1322-93-6, 1323-19-9, 7403-47-6, 68442-09-1, 127646-44-0, 908356-18-3)Limited to no more than 30% by weight in pesticide end-use productsSurfactants, related adjuvants of surfactants
Sodium 1,4-dihexyl sulfosuccinate (CAS Reg. No. 3006-15-3)

Surfactants, related adjuvants of surfactants
Sodium 1,4-diisobutyl sulfosuccinate (CAS Reg. No. 127-39-9)

Surfactants, related adjuvants of surfactants
Sodium dioctylsulfosuccinate

Surfactants, related adjuvants of surfactants
Sodium 1,4-dipentyl sulfosuccinate (CAS Reg. No. 922-80-5)

Surfactants, related adjuvants of surfactants
Sodium hydroxide

Neutralizer
Sodium monoalkyl and dialkyl (C6-C16) phenoxy benzenedisulfonates and related acids (CAS Reg. Nos. 147732-59-0, 147732-60-3, 169662-22-0, 70191-75-2, 36445-71-3, 39354-74-0, 70146-13-3, 119345-03-8, 149119-20-0, 149119-19-7, 119345-04-9, 28519-02-0, 25167-32-2, 30260-73-2, 65143-89-7, 70191-76-3)Not to exceed 20% in pesticide formulationsSurfactants, related adjuvants of surfactants
Sodium N-oleoyl-N-methyl taurine (CAS Reg. No. 137-20-2)

Surfactants, related adjuvants of surfactants
Sodium starch glycolate (CAS Reg. No. 9063-38-1)Granular and tableted products only; not to exceed 8% of the formulated productDisintegrant
Sodium sulfate

Solid diluent, carrier
Sorbitan fatty acid esters (fatty acids limited to C12, C14, C16, and C18 containing minor amounts of associated fatty acids) and poly(oxyethylene) derivatives of sorbitan fatty acid esters; the poly(oxyethylene) content averages 16-20 moles

Buffering agent; corrosion inhibition
Sorbitol

Antidusting agent.
Stearic acid (CAS Reg. No. 57-11-4)

Lubricant, component animal tag
?-Stearoyl-?-hydroxypoly(oxyethylene), average molecular weight (in amu) of 600

Emulsifier
?-Stearoyl-?-hydroxypoly(oxyethylene); the poly(oxyethylene) content averages 8, 9, or 40 moles; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be 8, 9, or 40

Surfactants; related adjuvants of surfactants
Sulfite liquors and cooking liquors, spent, oxidized (CAS Reg. No. 68514-09-0)

Surfactant, related adjuvants of surfactants
Sulfur (CAS Reg. No. 7704-34-9)

Stabilizer
Talc

Do.
Tall oil; fatty acids not less than 58%, rosin acids not more than 44%, unsaponifiables not more than 8%

Surfactants, related adjuvants of surfactants
Tartrazine

Dye, coloring agent
2,4,7,9-Tetramethyl-5-decyne-4.7-diolNot more than 2.5% of pesticide formulationSurfactants, related adjuvants of surfactants
Titanium dioxide (CAS Reg. No. 13463-67-7)

Pigment/colorant in pesticide formulations for animal tag
Toluenesulfonic acid and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts

Do.
Triacetin (glyceryl triacetate)

Solvent, cosolvent
Trisodium phosphate

Precipitant, buffer, filler
Xylene

Solvent, cosolvent
Xylenesulfonic acid and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts

Surfactants, related adjuvants of surfactants
Zinc oxide

Solid diluent, carrier
Zinc stearate, conforming to 21 CFR 182.5994 and 582.5994

Water repellant, dessicant, and coating agent.
Zinc stearate (CAS Reg. No. 557-05-1)

Water repellant, desiccant, and coating agent; stabilizer, component of plastic animal tag
Zinc sulfate (basic and monohydrate)

Water repellant, dessicant, and coating agent


[69 FR 23130, Apr. 28, 2004, as amended at 69 FR 29894, May 26, 2004; 69 FR 34949, June 23, 2004; 69 FR 58070, Sept. 29, 2004; 69 FR 58304, Sept. 30, 2004; 70 FR 37692, June 30, 2005; 70 FR 43312, July 27, 2005; 70 FR 44496, Aug. 3, 2005; 70 FR 51628, Aug. 31, 2005; 70 FR 54286, Sept. 14, 2005; 70 FR 55296, Sept. 21, 2005; 70 FR 67910, Nov. 9, 2005; 70 FR 55733, Sept. 23, 2005; 71 FR 14415, Mar. 22, 2006; 71 FR 30811, May 31, 2006; 71 FR 45422, Aug. 9, 2006; 74 FR 28623, June 17, 2009; 74 FR 37578, 37597, 37605, 37612, July 29, 2009; 74 FR 38935, 38943, 38970, Aug. 5, 2009; 75 FR 8504, Feb. 25, 2010; 75 FR 19268, Apr. 14, 2010; 75 FR 27443, May 17, 2010; 75 FR 34049, June 16, 2010]

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