[Code of Federal Regulations] [Title 40, Volume 22] [Revised as of July 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 40CFR180.930] [Page 534-540] TITLE 40--PROTECTION OF ENVIRONMENT CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PART 180_TOLERANCES AND EXEMPTIONS FROM TOLERANCES FOR PESTICIDE CHEMICALS IN FOOD--Table of Contents Subpart D_Exemptions From Tolerances Sec. 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 ingredients Limits Uses ------------------------------------------------------------------------ Acetic acid (CAS Reg. No. 64- Not more than Catalyst 19-7). 0.5% of pesticide formulation. Acetic anhydride............. ................ Solvent, cosolvent, stabilizer Acetyl tributyl citrate (CAS ................ Component of plastic Reg. No. 77-90-7). animal tags Acetylated lanolin alcohol... ................ Moisturizer Alkanoic and alkenoic acids, ................ Emulsifiers mono- and diesters of [alpha]-hydro-[omega]- hydroxypoly(oxyethylene) with molecular weight (in amu) range of 200 to 6,000. Alkyl (C8-C24) ................ Surfactants, benzenesulfonic acid and its emulsifier, related ammonium, calcium, adjuvants of magnesium, potassium, surfactants sodium, and zinc salts. [alpha]-Alkyl (C9-C18)- ................ Solvent, cosolvent, [omega]-hydroxy surfactant, and poly(oxyethylene): the related adjuvants of poly(oxyethylene) content surfactants averages 2-20 moles. [alpha]-Alkyl (C12- C15)- ................ Solvent, cosolvent, [omega]- surfactant, and hydroxypoly(oxyethylene/ related adjuvants of oxypropylene) hetero polymer surfactants in which the oxyethylene content is 8-13 moles and the oxypropylene content is 7-30 moles. [alpha]-Alkyl (C8-C10) ................ Do. hydroxypoly(oxypropylene) block polymer with polyoxyethylene; polyoxypropylene content averages 3 moles and polyoxyethylene content averages 5-12 moles. [alpha]-Alkyl (C6-C14)- ................ Surfactants, related [omega]- adjuvants of hydroxypoly(oxypropylene) surfactants block copolymer with polyoxyethylene; polyoxypropylene content is 1-3 moles; polyoxyethylene content is 7-9 moles; average molecular weight (in amu) approximately 635. [alpha]-alkyl (C12-C15)- Not to exceed Surfactant [omega]-hydroxypoly 20% of (oxypropylene)poly pesticide (oxyethylene)copolymers formulations (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. 68551-13-3. [alpha]-(p- Alkylphenyl)- ................ Do. [omega]-hydroxypoly (oxyethylene) produced by the condensation of 1 mole of alkylphenol (alkyl is a mixture of propylene tetramer and pentamer isomers and averages C13) with 6 moles of ethylene oxide. Alkyl (C8-C18) sulfate and ................ Do. its ammonium, calcium, magnesium, potassium, sodium, and zinc salts. Amine salts of alkyl (C8-C24) ................ Do. benzenesulfonic acid (butylamine; dimethylamino propylamine; mono- and diisopropyl- amine; and mono- , di-, and triethanolamine). Ascorbyl palmitate........... ................ Preservative Attapulgite-type clay........ ................ Solid diluent, carrier Barium sulfate (CAS Reg. No. ................ Carrier, density 7727-43-7). control agent Benzoic acid................. ................ Preservative for formulations Butane....................... ................ Propellant n-Butanol (CAS Reg. No. 71-36- ................ Solvent for blended 3). emulsifiers Butylated hydroxyanisole..... ................ Antioxidant Butylated hydroxytoluene..... ................ Do. [[Page 535]] [alpha]-(p-tert- Butylphenyl)- ................ Surfactants, related [omega]-hydroxypoly adjuvants of (oxyethylene) mixture of surfactants dihydrogen phosphate and monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, monoethanolamine, potassium, sodium, and zinc salts of the phosphate esters; the poly(oxyethylene) content averages 4-12 moles. Calcium carbonate............ ................ Solid diluent, carrier Calcium chloride............. ................ Stabilizer Calcium silicate, hydrated ................ Anticaking agent, solid calcium silicate. diluent, carrier Calcium stearate (CAS Reg. ................ Stabilizer, component No. 1592-23-0). of plastic animal tag Calcium sulfate.............. ................ Solid diluent, carrier Calcium and sodium salts of ................ Surfactants, related certain sulfonated petroleum adjuvants of fractions (mahogany soaps); surfactants calcium salt molecular weight (in amu) 790-1,020, sodium salt molecular weight (in amu) 400-500. Carbon black (CAS Reg. No. ................ Colorant/pigment in 1333-86-4). animal tag Carnauba wax (CAS Reg. No. ................ Binder 8015-86-9). Carrageenan, conforming to 21 Minimum Thickener CFR 172.620. molecular weight (in amu): 100,000. Cumene (isopropylbenzene).... ................ Solvent, cosolvent Cyclohexanone................ ................ Do. D&C Green No. 6.............. ................ Dye, coloring agent D&C Red No. 17............... ................ Do. D&C Violet No. 2............. ................ Do. Diacetyl tartaric acid esters ................ Emulsifier of mono- and diglycerides of edible fatty acids. Dialkyl (C8-C18) Not more than Flocculating agent in dimethylammonium chloride. 0.2% in silica the manufacture of hydrated silica. silica hydrated silica for use as a solid diluent, carrier Diatomite (diatomaceous ................ Solid diluent, carrier earth). Dibutyltin dilaurate (CAS ................ Component of plastic Reg. No. 77-58-7). slow release tag Dichlorodifluoromethane...... ................ Propellant Diethylphthalate............. ................ Solvent, cosolvent 1,1-Difluoroethane (CAS Reg. For aerosol Aerosol propellant No. 75-37-6). pesticide formulations used for insect control in food- and feed- handling establishments and animals. Dimethyl ether (CAS Reg. No. ................ Propellant 115-10-6). 3,6-Dimethyl-4-octyne-3,6- Not more than Surfactants, related diol. 2.5% of adjuvants of pesticide surfactants formulation. Dimethylpolysiloxane (CAS ................ Defoaming agent Reg. No. 9016-00-6). [alpha]-(o,p-Dinonylphenyl)- ................ Surfactants, related [omega]-hydroxypoly adjuvants of (oxyethylene) mixture of surfactants dihydrogen phosphate and monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, monoethanolamine, 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 moles. [alpha]-(o,p-Dinonylphenyl)- ................ Do. [omega]-hydroxypoly (oxyethylene), produced by the condensation of 1 mole of dinonylphenol (nonyl group is a propylene trimer isomer) with an average of 4- 14 moles of ethylene oxide. Dipropylene glycol monomethyl ................ Do. ether. Dodecylbenzenesulfonic acid, ................ Do. amine salts. [alpha]-(p-Dodecylphenyl)- ................ Surfactants, emulsifier [omega]-hydroxypoly (oxyethylene) produced by the condensation of 1 mole of dodecylphenol (dodecyl group is a propylene tetramer isomer) with an average of 4-14 or 30-70 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- 14 or 30-70 moles. Epoxidized soybean oil (CAS ................ Stabilizer, Reg. No. 8013-07-8). plasticizer, component animal tag [[Page 536]] Ethyl alcohol................ ................ Solvent, cosolvent Ethylene oxide adducts of ................ Surfactants, related 2,4,7,9-tetramethyl-5- adjuvants of decynediol, the ethylene surfactants oxide content averages 3.5, 10, or 30 moles. 2-Ethyl-1-hexanol............ Not more than Solvent, adjuvant of 2.5% of surfactants pesticide formulation. Ethyl vinyl acetate (CAS Reg. ................ Component of plastic No. 24937-78-8). slow release tag FD&C Blue No. 1.............. ................ Dye, coloring agent FD&C Yellow No. 6 Aluminum Not more than 2% Pigment in animal tag Lake (CAS Reg. No. 15790-07- by weight of and similar slow- 5). pesticide release devices formulation. Glycerol (glycerin).......... Meets Solvent and thickener specifications of Food Chemicals Codex. Glycerol monooleate.......... ................ Surfactants, related adjuvants of surfactants Glyceryl monostearate........ ................ Emulsifier Glyceryl tris-12- ................ Flow control agent hydroxystearate. Graphite..................... ................ Solid diluent, carrier n-Hexyl alcohol (CAS Reg. No. ................ Solvent, cosolvent 111-27-3). 2-(2[min]-Hydroxy-5[min]- Not more than Ultraviolet light methylphenyl)benzotriazole 0.5% by weight absorber/stabilizer in (CAS Reg. No. 2440-22-4). of pesticide animal tag and similar formulation. slow-release devices Iron oxide (CAS Reg. No. 1309- ................ Colorant in pesticide 37-1). formulations for animal tags Isopropyl alcohol............ ................ Solvent, cosolvent 4,4[min]- Not to exceed 1% Stabilizer, component Isopropylidenediphenol alkyl of polymer. animal tag (C12-C15) phosphites (CAS Reg. No. 92908-32-2). Isopropyl myristate, CAS Reg. ................ Solvent No. 110-27-0. Kaolinite-type clay.......... ................ Solid diluent, carrier Kerosene, U.S.P. reagent..... ................ Solvent, cosolvent Lactic acid.................. ................ Solvent Lactic acid, n-propyl ester, ................ Solvent (S); (CAS Reg. No. 53651-69- 7). [alpha]-Lauryl-[omega]- ................ Emulsifier hydroxypoly(oxyethylene), average molecular weight (in amu) of 600. [alpha]-Lauryl-[omega]- ................ Surfactants, related hydroxypoly(oxyethylene) adjuvants of sulfate, sodium salt; the surfactants poly(oxyethylene) content is 3-4 moles. Lignosulfonate: ammonium, ................ Surfactants, related calcium, magnesium, adjuvants of potassium, sodium, and zinc surfactants salts. d-Limonene (CAS Reg. No. 5989- ................ Solvent, fragrance 27-5). Magnesium carbonate.......... ................ Solid diluent, carrier Magnesium silicate, hydrated ................ Do. magnesium silicate. Manganous oxide.............. ................ Do. Methyl alcohol............... ................ Solvent, cosolvent Methyl n-amyl ketone (CAS ................ Solvent, cosolvent Reg. No. 110-43-0). [alpha]-(Methylene (4- ................ Surfactants, related (1,1,3,3-tetramethylbutyl)-o- adjuvants of phenylene) bis-[omega]- surfactants hydroxypoly(oxyethylene) having 6-7.5 moles of ethylene oxide per hydroxyl group. Methyl esters of higher fatty ................ Antidusting agent acids conforming to 21 CFR 573.640. Methyl-p-hydroxybenzoate Meets Preservative (Methyl paraben). specifications of Food Chemicals Codex; not to exceed 0.1% in formulations. Methyl isobutyl ketone....... ................ Solvent, cosolvent 2-[Methyl ................ Water repellant agent [(perfluoroalkyl)alkyl(C2- C8)sulfonyl] amino]alkyl(C2- C8) acrylate--alkyl(C2-C8) methacrylates-N- methylolacrylamide copolymer. Mineral oil, U.S.P., or ................ Solvent, diluent conforming to 21 CFR 172.878 or 178.3620(a), (b). Mono-, di-, and Not to exceed Dispersing-wetting trimethylnaphthalenesulfonic 0.006% in final agent in dip vat acids-formaldehyde formulation. operations for large condensates, sodium salts. animals, such as cattle Montmorillonite-type clay.... ................ Solid diluent, carrier Naphthalenesulfonic acid and ................ Surfactants, related its sodium salt. adjuvants of surfactants Nitrile rubber modified ................ Component of plastic acrylonitrile methylacrylate slow release tag (CAS Reg. No. 27012-62-0) conforming to 21 CFR 177.1480. [[Page 537]] Nonyl, decyl, and undecyl ................ Surfactant 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). [alpha]-(p-Nonylphenyl)- ................ Surfactants, related [omega]- adjuvants of hydroxypoly(oxyethylene) surfactants mixture of dihydrogen phosphate and monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, monoethanolamine, 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 moles. [alpha]-(p-Nonylphenyl)- ................ Surfactants, [omega]- emulsifier, related hydroxypoly(oxyethylene) adjuvants of produced by the condensation surfactants. 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. [alpha]-(p-Nonylphenyl)- ................ Surfactants, related [omega]- adjuvants of hydroxypoly(oxyethylene) surfactants sulfate, and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts; the nonyl group is a propylene trimer isomer and the poly(oxyethylene) content averages 4 moles. [alpha]-(p-Nonylphenyl)- ................ Surfactants, related [omega]- adjuvants of hydroxypoly(oxyethylene) surfactants sulfate, and its ammonium, calcium, magnesium, monoethanolamine, potassium, sodium, and zinc salts; the nonyl group is a propylene trimer isomer and the poly(oxyethylene) content averages 4-14 or 30-90 moles of ethyiene oxide. Octadecyl 3,5-di-tert-butyl-4- Not more than Thermal stabilizer/ hydroxyhydro cinnamate (CAS 0.5% by weight antioxidant in animal Reg. No. 2082-79-3). of pesticide tag and similar slow- formulation. release devices Octyl and decyl glucosides ................ Do. 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. Octyl epoxytallate (CAS Reg. ................ Plasticizer, component No. 61788-72-5). animal tag Oleic acid, conforming to 21 ................ Defoaming agent CFR 172.862 (CAS Reg. No. 112-80-1). [alpha]-Oleoyl-[omega]- ................ Emulsifier hydroxypoly(oxyethylene), average molecular weight (in amu) of 600. [alpha]-Oleoyl-[omega]- ................ Emulsifier, defoaming (oleyloxy)poly(oxyethylene) agent derived from [alpha]-hydro- [omega]- hydroxypoly(oxyethylene), molecular weight (in amu) 600. Oxidized pine lignin, sodium Maximum of 2% of Surfactant, related salt (CAS Reg. No. 68201-23- formulation. adjuvant of surfactant 0). Paraformaldehyde............. Not more than 2% Preservative for of pesticide formulation formulation. Petroleum hydrocarbons, ................ Solvent, diluent light, odorless, conforming to 21 CFR 172.884 or 178.3650. Petroleum hydrocarbons, ................ Do. synthetic isoparaffinic, conforming to 21 CFR 172.882 or 178.3530. Phenol....................... ................ Solvent, cosolvent Pine lignin.................. ................ Adsorbent [alpha]-Pinene............... Not more than 2% Stabilizer of formulation by weight. Polyethylene (CAS Reg. No. ................ Component of plastic 9002-88-4) conforming to 21 slow release tag CFR 172.615. [[Page 538]] Polyethylene esters of fatty ................ Surfactants, related acids, conforming to 21 CFR adjuvants of 172.854. surfactants Polyethylene glycol [[alpha]- ................ Surfactants, related hydro-[omega]- adjuvants of hydroxypoly(oxyethylene)]; surfactants mean molecular weight (in amu) 194 to 9,500 conforms to 21 CFR 178.3750. Polyglyceryl phthalate esters ................ Do. of coconut oil fatty acids. Poly(methylene-p-tert- ................ Do. butylphenoxy)poly(oxyethylen e) ethanol; the poly(oxyethylene) content averages 4-12 moles. Poly(methylene-p- ................ Do. nonylphenoxy)poly(oxyethylen e) ethanol; the poly(oxyethylene) content averages 4-12 moles. Poly(methylene-p- ................ Do. nonylphenoxy)poly(oxypropyle ne) propanol; the poly(oxypropylene) content averages 4-12 moles. Potassium hydroxide.......... Meeting Food Neutralizer Chemicals, Codex specifications. Propane...................... ................ Propellant n-Propanol................... ................ Solvent, for blended emulsifiers 2-Propenoic acid, 2-methyl-, ................ Encapsulating polymer with ethyl 2- agent,dispensers, propenoate and methyl 2- resins, fibers and methyl-2-propenoate, beads ammonium salt (CAS Registration No. 55989-05- 4), minimum number average molecular weight (in amu), 18,900. Propylene glycol............. ................ Solvent, cosolvent Propylene glycol monomethyl ................ Deactivator, emmolient ether. Propyl gallate............... ................ Antioxidant Propyl p-hydroxybenzoate Meets Preservative (Propyl paraben). specifications of Food Chemicals Codex; not to exceed 0.1% in formulations. Pyrophylite.................. ................ Solid diluent, carrier Rhodamine B.................. Expires December Dye for use in ear tags 27, 2004.. only Secondary alkyl (C11-C15) ................ Surfactant poly(oxyethylene) acetate, sodium salt; the ethylene oxide content averages 5 moles. Silica, hydrated silica...... ................ Anticaking agent, solid diluent, carrier Silica aerogel (finely ................ Component of powdered microcellular antifoaming agent silica foam having a minimum silica content of 89.5%). Soapstone.................... ................ Solid diluent Sodium benzoate (CAS Reg. No. ................ Anticaking agent/ 532-32-1). stabilizer/ preservative Sodium ................ Not more than 0.5% of butylnaphthalenesulfonate. pesticide formulation Sodium ................ Surfactants, related diisobutylnaphthalenesulfona adjuvants of te. surfactants Sodium dioctylsulfosuccinate. ................ Do. Sodium hydroxide............. ................ Neutralizer Sodium ................ Surfactants, related isopropylisohexylnaphthalene adjuvants of sulfonate. surfactants Sodium ................ Do. isopropylnaphthalenesulfonat e. Sodium monoalkyl and diakyl ................ Do. (C8-C13) phenoxybenzenedisulfonate mixtures containing not less than 70% of the monoalkylated product. Sodium mono- and ................ Do. dimethylnaphthalenesulfonate , molecular weight (in amu) 245-260. Sodium mono-, di-, and ................ Solvent, cosolvent tributylnaphthalenesulfonate stabilizer s. Sodium N-oleoyl-N-methyl Not more than 1% Surfactant taurine. of pesticide formulations. Sodium starch glycolate (CAS Granular and Disintegrant Reg. No. 9063-38-1). tableted products only; not to exceed 8% of the formulated product. Sodium sulfate............... ................ Solid diluent, carrier [[Page 539]] Sorbitan fatty acid esters ................ Buffering agent; (fatty acids limited to C12, corrosion inhibition 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. Sorbitol..................... ................ Antidusting agent. Soy protein, isolated........ Expires May 24, Adhesive 2005.. Stearic acid (CAS Reg. No. 57- ................ Lubricant, component 11-4). animal tag [alpha]-Stearoyl-[omega]- ................ Emulsifier hydroxypoly(oxyethylene), average molecular weight (in amu) of 600. [alpha]-Stearoyl-[omega]- ................ Surfactants; related hydroxypoly(oxyethylene); adjuvants of the poly(oxyethylene) surfactants 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. Sulfur (CAS Reg. No. 7704-34- ................ Stabilizer 9). Talc......................... ................ Do. Tall oil; fatty acids not ................ Surfactants, related less than 58%, rosin acids adjuvants of not more than 44%, surfactants unsaponifiables not more than 8%. Tartrazine................... ................ Dye, coloring agent [alpha]-[p-(1,1,3,3- ................ Surfactants, related Tetramethylbutyl)phenyl]- adjuvants of [omega]- surfactants hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p (1,1,3,3- tetramethylbutyl)phenol with a range of 1-14 or 30-70 moles of ethylene oxide: if a blend of products is used, the average range number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range of 1-14 or 30-70. [alpha]-[p-(1,1,3,3- ................ Surfactants, related Tetramethylbutyl)phenyl]- adjuvants of [omega]- surfactants hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-(1,1,-3,3- tetramethylbutyl) phenol with an average of 4-14 or 30-70 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- 14 or 30-70. 2,4,7,9-Tetramethyl-5-decyne- Not more than Do. 4.7-diol. 2.5% of pesticide formulation. Titanium dioxide (CAS Reg. ................ Pigment/colorant in No. 13463-67-7). pesticide formulations for animal tag Toluenesulfonic acid and its ................ Do. ammonium, calcium, magnesium, potassium, sodium, and zinc salts. Triacetin (glyceryl ................ Solvent, cosolvent triacetate). Tri-tert-butylphenol ................ Dispersing agent polyglycol ether (molecular weight (in amu) 746). 1,1,1-Trichloroethane........ ................ Solvent, cosolvent Trichlorofluoromethane....... ................ Propellant Tridecylpoly(oxyethylene) ................ Surfactants, related acetate sodiums salt; where adjuvants of the ethylene oxide content surfactants averages 6-7 moles. Triethylene glycol diacetate For use on beef Solvent (CAS Reg. No. 111-21-7). cattle only. Trisodium phosphate.......... ................ Precipitant, buffer, filler Wheat shorts................. Expires May 24, Solid diluent 2005.. Wood rosin acid, potassium ................ Surfactants, related salts, conforming to 21 CFR adjuvants of 178.3870. surfactants Xylene....................... ................ Solvent, cosolvent Xylenesulfonic acid and its ................ Surfactants, related ammonium, calcium, adjuvants of magnesium, potassium, surfactants sodium, and zinc salts. Zinc oxide................... ................ Solid diluent, carrier Zinc stearate, conforming to ................ Water repellant, 21 CFR 182.5994 and 582.5994. dessicant, and coating agent. Zinc stearate (CAS Reg. No. ................ Water repellant, 557-05-1). desiccant, and coating agent; stabilizer, component of plastic animal tag Zinc sulfate (basic and ................ Water repellant, monohydrate). dessicant, and coating agent ------------------------------------------------------------------------ [[Page 540]] [69 FR 23130, Apr. 28, 2004, as amended at 69 FR 29894, May 26, 2004; 69 FR 34949, June 23, 2004]