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Environmental Protection Agency § 180.3

(10) For processed foods consisting Such a tolerance is supported by res- primarily of one ingredient and sold in idue data from specific growing regions a form requiring further preparation for a raw agricultural commodity. Indi- prior to consumption (e.g., fruit juice vidual tolerances with regional reg- concentrates, dehydrated vegetables, istration are designated in separate and powdered potatoes), the processed subsections in 40 CFR 180.101 through food to be examined for residues shall 180.999, as appropriate. Additional res- be the whole processed commodity idue data which are representative of after compensating for or reconsti- the proposed use area are required to tuting to the commodity’s normal expand the geographical area of usage moisture content, unless a tolerance of a pesticide on a raw agricultural for the concentrated or dehydrated commodity having an established ‘‘tol- food form is included in this part. If erance with regional registration.’’ there exists a tolerance for a specific Persons seeking geographically broad- pesticide on the processed food in its er registration of a crop having a ‘‘tol- concentrated or dehydrated food form, erance with regional registration’’ for the purpose of determining whether should contact the appropriate EPA the food is in compliance with that tol- product manager concerning additional erance, the processed food to be exam- residue data required to expand the use ined for residues shall be the whole area. processed commodity on an ‘‘as is’’ (m) The term pesticide chemical res- basis. idue shall have the meaning specified (i) The term pesticide chemical shall in FFDCA section 201(q)(2), as amend- have the meaning specified in FFDCA ed, except as provided in § 180.4. section 201(q)(1), as amended, except as (n) The term food commodity means: provided in § 180.4. (1) Any raw agricultural commodity (j) The term negligible residue means (food or feed) as defined in section any amount of a pesticide chemical re- 201(r) of the Federal Food, Drug, and maining in or on a raw agricultural Cosmetic Act (FFDCA); and commodity or group of raw agricul- (2) Any processed food or feed as de- tural commodities that would result in fined in section 201(gg) of the FFDCA. a daily intake regarded as [36 FR 22540, Nov. 25, 1971] toxicologically insignificant on the EDITORIAL NOTE: For FEDERAL REGISTER ci- basis of scientific judgment of ade- tations affecting § 180.1, see the List of CFR quate safety data. Ordinarily this will Sections Affected, which appears in the add to the diet an amount which will Finding Aids section of the printed volume be less than 1/2,000th of the amount and at www.fdsys.gov. that has been demonstrated to have no effect from feeding studies on the most § 180.3 Tolerances for related pesticide sensitive animal species tested. Such chemicals. toxicity studies shall usually include (a) Pesticide chemicals that cause re- at least 90-day feeding studies in two lated pharmacological effects will be species of mammals. regarded, in the absence of evidence to (k) The term nonperishable raw agri- the contrary, as having an additive del- cultural commodity means any raw agri- eterious action. (For example, many cultural commodity not subject to pesticide chemicals within each of the rapid decay or deterioration that would following groups have related pharma- render it unfit for consumption. Exam- cological effects: Chlorinated organic ples are cocoa beans, coffee beans, pesticides, arsenic-containing chemi- field-dried beans, field-dried peas, cals, metallic dithiocarbamates, cho- grains, and nuts. Not included are eggs, linesterase-inhibiting pesticides.) milk, meat, poultry, fresh fruits, and (b) Tolerances established for such vegetables such as onions, parsnips, po- related pesticide chemicals may limit tatoes, and carrots. the amount of a common component (l) The term tolerance with regional (such as As2O3) that may be present, or registration means any tolerance which may limit the amount of biological ac- is established for pesticide residues re- tivity (such as cholinesterase inhibi- sulting from the use of the pesticide tion) that may be present, or may limit pursuant to a regional registration. the total amount of related pesticide

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chemicals (such as chlorinated organic nene, and related terpenes, containing pesticides) that may be present. 65–66 percent chlorine) and (c)(1) Where tolerances for inorganic (chlorinated camphene containing 67–69 bromide in or on the same raw agricul- percent chlorine) on the same raw agri- tural commodity are set in two or cultural commodities, the total more sections in this part (example: amount of such pesticides shall not §§ 180.123 and 180.199), the overall quan- yield more residue than that permitted tity of inorganic bromide to be toler- by the larger of the two tolerances, cal- ated from use of the same pesticide in culated as a chlorinated terpene of mo- different modes of application or from lecular weight 396.6 containing 67 per- two or more pesticide chemicals for cent chlorine. which tolerances are established is the (4) Where a tolerance is established highest of the separate applicable tol- for more than one pesticide containing erances. For example, where the bro- arsenic found in, or on a raw agricul- mide tolerance on asparagus from tural commodity, the total amount of methyl bromide commodity fumigation such pesticide shall not exceed the is 100 parts per million (40 CFR 180.123) highest established tolerance cal- and on asparagus from methyl bromide culated as As2O3. soil treatment is 300 parts per million (5) Where tolerances are established (40 CFR 180.199), the overall inorganic for more than one member of the class bromide tolerance for asparagus grown of dithiocarbamates listed in para- on methyl bromide-treated soil and graph (e)(3) of this section on the same also fumigated with methyl bromide raw agricultural commodity, the total after harvest is 300 parts per million. residue of such pesticides shall not ex- (2) Where tolerances are established ceed that permitted by the highest tol- in terms of inorganic bromide residues erance established for any one member only from use of organic bromide fumi- of the class, calculated as zinc gants on raw agricutural commodities, ethylenebisdithiocarbamate. such tolerances are sufficient to pro- (6) Where tolerances are established tect the public health, and no addi- for residues of both S,S,S-tributyl tional concurrent tolerances for the or- phosphorotrithioate and tributyl ganic pesticide chemicals from such phosphorotrithioite in or on the same use are necessary. This conclusion is raw agricultural commodity, the total based on evidence of the dissipation of amount of such pesticides shall not the organic pesticide or its conversion yield more residue than that permitted to inorganic bromide residues in the by the higher of the two tolerances, food when ready to eat. calculated as S,S,S-tributyl (d)(1) Where tolerances are estab- phosphorotrithioate. lished for both calcium cyanide and hy- (7) Where tolerances are established drogen cyanide on the same raw agri- for residues of O,S-dimethyl cultural commodity, the total amount phosphoramidothioate, resulting from of such pesticides shall not yield more the use of (O,S-dimethyl residue than that permitted by the acetylphos-phoramidothioate) and/or larger of the two tolerances, calculated O,S - dimethylphosphoramidothioate on as hydrogen cyanide. the same agricultural commodity, the (2) Where tolerances are established total amount of O,S-dimethyl- for residues of both O,O-diethyl S-[2- phosphoramidothioate shall not yield (ethylthio)ethyl] phosphorodithioate more residue than that permitted by and (a mixture of O,O-diethyl the higher of the two tolerances. O-(and S-) [2-(ethylthio)ethyl] (8) Where a tolerance is established phosphorothioates) on the same raw for more than one pesticide having the agricultural commodity, the total metabolites 1-(3,4-dichlorophenyl)-3- amount of such pesticides shall not methylurea (DCPMU) and 3,4- yield more residue than that permitted dichlorophenylurea (DCPU) found in or by the larger of the two tolerances, cal- on a raw agricultural commodity, the culated as demeton. total amount of such residues shall not (3) Where tolerances are established exceed the highest established toler- for both terpene polychlorinates ance for a pesticide having these me- (chlorinated mixture of camphene, pi- tabolites.

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(9) Where a tolerance is established 100 to determine the percentage of the for more than one pesticide having as permitted amount of residue present. metabolites compounds containing the (iii) Add the percentages so obtained benzimidazole moiety found in or on a for all residues present. raw agricultural commodity, the total (iv) The sum of the percentages shall amount of such residues shall not ex- not exceed 100 percent. ceed the highest established tolerance (2) Where residues from two or more for a pesticide having these metabo- chemicals in the same class are present lites. in or on a raw agricultural commodity (10) Where a tolerance is established and there are available methods that for triclopyr, chloropyrifos, and permit quantitative determinations of -methyl having the com- one or more, but not all, of the resi- mon metabolite 3,5,6-trichloro-2- dues, the amounts of such residues as pyridinol on the same raw agricultural may be determinable shall be deducted commodity, the total amount of such from the total amount of residues residues shall not exceed the highest present and the remainder shall have established tolerance for any of the the same tolerance as that for the pesticides having the metabolites. chemical having the lowest numerical (11) Where tolerances are established tolerance in that class. The quantity of for more than one pesticide having the combined residues that are within the metabolite 3,5,6-trichloro-2-pyridinol tolerance may be determined as fol- found in or on the raw agricultural lows: commodity, the total amount of such (i) Determine the quantity of each residues shall not exceed the highest determinable residue present. established tolerance for a pesticide (ii) Deduct the amounts of such resi- having this metabolite. dues from the total amount of residues (12) Where tolerances are established present and consider the remainder to for residues of , resulting have the same tolerance as that for the from the use of thiodicarb and/or chemical having the lowest numerical methomyl on the same raw agricul- tolerance in that class. tural commodity, the total amount of (iii) Divide the quantity of each de- methomyl shall not yield more residue terminable residue by the tolerance than that permitted by the higher of that would apply if it occurred alone the two tolerances. and the quantity of the remaining res- idue by the tolerance for the chemical (e) Except as noted in paragraphs having the lowest numerical tolerance (e)(1) and (2) of this section, where resi- in that class and multiply by 100 to de- dues from two or more chemicals in the termine the percentage of the per- same class are present in or on a raw mitted amount of residue present. agricultural commodity the tolerance (iv) Add the percentages so obtained for the total of such residues shall be for all residues present. the same as that for the chemical hav- (v) The sum of the percentages shall ing the lowest numerical tolerance in not exceed 100 percent. this class, unless a higher tolerance (3) The following pesticides are mem- level is specifically provided for the bers of the class of dithiocarbamates: combined residues by a regulation in this part. A mixture of 5.2 parts by weight of ammoni- (1) Where residues from two or more ates of [ethylenebis (dithiocarbamato)] chemicals in the same class are present zinc with 1 part by weight ethylenebis [dithiocarbamic acid] bimolecular and in or on a raw agricultural commodity trimolecular cyclic anhydrosulfides and and there are available methods that disulfides. permit quantitative determination of 2-Chloroallyl diethyldithiocarbamate. each residue, the quantity of combined Coordination product of zinc ion and maneb residues that are within the tolerance containing 20 percent manganese, 2.5 per- may be determined as follows: cent zinc, and 77.5 percent (i) Determine the quantity of each ethylenebisdithiocarbamate. Ferbam. residue present. Maneb. (ii) Divide the quantity of each res- Manganous dimethyldithiocarbamate. idue by the tolerance that would apply Sodium dimethyldithiocarbamate. if it occurred alone, and multiply by Thiram.

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Zineb. (2-methyl-2-(methylthio) Ziram. propionaldehyde O- (methylcarbamoyl)oxime) and its (4) The following are members of the chlorinesterase-inhibiting metabolites 2- class of chlorinated organic pesticides: methyl-2-(methylsulfinyl)propionaldehyde . O-(methycarbamoyl) oxime and 2-methyl- BHC (benzene hexachloride). 2-(methylsulfonyl)propionaldehyde O- (methylcarbamoyl)oxime. 1,1-Bis(p-chlorophenyl)-2,2,2- 4-tert-Butyl-2-chlorophenyl methyl methyl trichloroethanol. phosphoramidate. Chlorbenside (p-chlorobenzyl p-chlorophenyl S-[(tert-Butylthio)methyl] O,O-diethyl sulfide). phosphorodithioate and its cholinesterase- . inhibiting metabolites. Chlorobenzilate (ethyl 4,4′- (1-naphthyl N-methylcarbamate). dichlorobenzilate). (2,3,-dihydro-2,2-dimethyl-7- p-Chlorophenoxyacetic acid. benzofuranyl-N-methylcarbamate). p-Chlorophenyl-2,4,5-trichlorophenyl sulfide. Carbofuran metabolite (2,3-dihydro-2,2-di- 2,4-D (2,4-dichlorophenoxyacetic acid). methyl-3-hydroxy-7-benofuranyl N- DDD (TDE). methylcarbamate). DDT. (S-[(p-chlorophenyl) 1,1-Dichloro-2,2-bis(p-ethylphenyl) ethane. thiolmethyl] O,O-diethyl 2,6-Dichloro-4-nitroaniline. phosphorodithioate) and its cholinesterase- 2,4-Dichlorophenyl p-nitrophenyl ether. inhibiting metabolites. . Chlorpyrifos (O,O-diethyl O-(3,5,6-trichloro- Dodecachlorooctahydro-1,3,4-metheno-2H- 2-pyridyl)phosphorothioate). cyclobuta[cd]pentalene. Chlorpyrifos-methyl (O,O-dimethyl-O-(3,5,6- (6,7,8,9,10,10-hexachloro-1,5,5a, trichloro-2-pyridyl) phosphorothioate. 6,9,9a-hexahydro-6,9-methano-2,4,3- 2-Chloro-1-(2,4,5-trichlorophenyl)vinyl di- benzodioxathiepin-3-oxide). methyl phosphate. Endosulfan sulfate (6,7,8,9,10,10-hexachloro- 2-Chloro-1-(2,4-dichlorophenyl) vinyl diethyl 1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3- phosphate. benzodioxathiepin-3,3-dioxide). (O,O-diethyl O-3-chloro-4-meth- (1,4,5,6,7,8,8-heptachlor-3a,4,7, 7a- yl-2-oxo-2H-1-benzopyran-7-yl phosran-7-yl tetrahydro-4,7-methanoindene). phosphate). Heptachlor epoxide (1,4,5,6,7,8,8-heptachloro- Coumaphos oxygen analog (O,O-diethyl O-3- 2,3-epoxy-2,3,3a,4,7,7a-hexahydro-4,7- chloro-4-methyl-2-oxo-2H-1- methanoindene). benzopyphorothioate). Hexachlorophene (2,2′-methylenebis(3,4,6- Dialifor (S-(2-chloro-1-phthalimidoethyl) trichlorophenol) and its monosodium salt. O,O-diethyl phosphorodithioate). Isopropyl 4,4′-dichlorobenzilate. Dialifor oxygen analog (S-(2-chloro-1- . phthalimidoethyl) O,O-diethyl . phosphorothioate). Ovex (p-chlorophenyl p- Demeton (a mixture of O,O-diethyl O-(and S) chlorobenzenesulfonate). [2-ethylthio)ethyl] phosphorothioates). Sesone (sodium 2,4-dichlorophenoxyethyl Ethiolate (S-ethyl diethylthiocarbamate). sulfate, SES). 2,2-Dichlorovinyl dimethyl phosphate. Sodium 2,4-dichlorophenoxyacetate. O,O-Diethyl S-[2-(ethylthio)ethyl] Sodium trichloroacetate. phosphorodithioate and its cholinesterase- Sulphenone (p-chlorophenyl phenyl sulfone). inhibiting metabolites. Terpene polychlorinates (chlorinated mix- O,O-Diethyl O-(2-diethylamino-6-methyl-4- ture of camphene, pinene, and related pyrimidinyl) phosphorothioate and its oxy- terpenes 65-66 percent chlorine). gen analog diethyl 2-diethylamino-6-meth- 2,3,5,6-Tetrachloronitrobenzene. yl-4-pyrimidinyl phosphate. (2,4,5,4′-tetrachlorodiphenyl O,O-Diethyl O-(2-isoprophyl-4-methyl-6- sulfone). pyrimidinyl) phosphorothioate. Toxaphene (chlorinated camphene). O,O-Diethyl O-[p-(methylsulfinyl)phenyl] Trichlorobenzoic acid. phosphorothioate and its cholinesterase-in- Trichlorobenzyl chloride. hibiting metabolites. Diethyl 2-pyrazinyl phosphate. (5) The following are members of the O,O-Diethyl O-2-pyrazinyl phosphorothioate. class of cholinesterase-inhibiting pes- S-(O,O-Diisopropyl phosphorodithioate) of N- ticides: (2-mercaptoethyl) benzenesulfonamide S-(O,O-Diisopropyl phosphorodithioate) of N- Acephate (O,S-dimethyl acetyl- (2-mercaptoethyl) benzenesulfonamide phosphoramidothioate) and its cholin- 2-(Dimethylamino)-5.6-dimethyl-4- esterase-inhibiting metabolite O,S-di- pyrimidinyl dimethylcarbamate and its methyl phosphoramidothioate. metabolites 5,6-dimethyl-2-

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(formylmethylamino)-4-pyrimidinyl 1-Methoxycarbonyl-1-propen-2-yl dimethyl dimethylcarbamate and 5,6-dimethyl-2- phosphate and its beta isomer. (methylamino)-4-pyrimidinyl m-(1-Methylbutyl)phenyl methylcarbamate. dimethylcarbamate (both calculated as Methyl . parent). (1,2-dibromo-2,2-dichloroethyl di- (O,O-dimethyl S-(N-methyl- methyl phosphate). carbamoylmethyl) phosphorodithioate). (methyl N′,N′-dimethyl-N- Dimethoate oxygen analog (O,O-dimethyl S- [(methylcarbamoyl)oxy]-1- (N-methylcarbamoylmethyl) thiooxamimidate) phosphorothioate). Parathion. O,O-Dimethyl O-p-(dimethylsulfamoyl) (O,O-diethyl S-(ethylthio)methyl phenyl phosphate. phosphorodithioate) and its cholinesterase- O,O-Dimethyl O-p-(dimethylsulfamoyl) inhibiting metabolites. phenyl phosphorothioate. (S-(6-chloro-3-mercaptomethyl)-2- 3,5-Dimethyl-4-(methylthio) phenyl benzoxazolinone) O,O-diethyl methylcarbamate. phosphorodithioate). O,O-Dimethyl S-[4-oxo-1,2,3-benzotriazin-3- (2-chloro-2-diethylcarbamoyl- (4H)-ylmethyl] phosphorodithioate. 1-methylvinyl dimethyl phosphate) includ- Dimethyl phosphate of 3-hydroxy-N,N-di- ing all of its related cholinesterase-inhib- methyl-cis-crotonamide. iting compounds. Dimethyl phosphate of 3-hydroxy-N-methyl- Pirimiphos-methyl O-[2-diethylamino-6- cis-crotonamide. methyl-pyrimidinyl) O,O-dimethyl Dimethyl phosphate of a-methylbenzyl 3-hy- phosphorothioate droxy-cis-crotonate. Ronnel. O,O-Dimethyl 2,2,2-trichloro-1-hydroxyethyl (octamethylpyrophosphoramide). phosphonate. . O,O-Dimethyl phosphorodithioate, S-ester O,O,O′,O′-Tetramethyl O,O′-sulfinyldi-p- with 4-(mercaptomethyl)-2-methozy-D2- phenylene phosphorothioate. 1,3,4-thiadiazolin-5-one. O,O,O′,O′-Tetramethyl O,O′-thiodi-p-phen- (2,3-p-dioxanedithiol S,S-bis (O,O- ylene phosphorothioate. diethylphosphorodithioate)) containing ap- Tributyl phosphorotritlioite. proximately 70 percent cis and trans iso- S,S,S-Tributyl phosphorothrithioate. mers and approximately 30 percent related 3,4,5-Trimethylphenyl methylcarbamate and compounds. its isomer 2,3,5-trimethylphenyl EPN. methylcarbamate. Ethephon ((2- - chloroethyl) phosphonic acid). (6) The following pesticides are mem- . bers of the class of dinitrophenols: Ethion oxygen analog (S- 2,4-Dinitro-6-octylphenyl crotonate and 2,6- [[(diethoxyphosphinothioyl)thio] methyl] dinitro-4-octylphenyl crotonate, mixture O,O-diethyl phosphorothioate). of. O- Ethyl O-[4-(methylthio) phenyl] S-propyl 4,6-Dinitro-o-cresol and its sodium salt. phosphorodithioate and its cholinesterase- Dinoseb (2-sec-butyl-4,6-dinitrophenol) and inhibiting metabolites. its alkanolamine, ammonium, and sodium O-Ethyl S,S-dipropylphosphorodithioate. salts. Ethyl 3-methyl-4-(methylthio)phenyl (1- methylethyl) phosphoramidate and its cho- [41 FR 8969, Mar. 2, 1976] linesterase-inhibiting metabolites. EDITORIAL NOTE: For FEDERAL REGISTER ci- O-Ethyl S-phenyl ethylphosphonodithioate. tations affecting § 180.3, see the List of CFR -Ethyl -phenyl ethylphosphonothiolate. O S Sections Affected, which appears in the m-(1-Ethylpropyl)phenyl methylcarbamate. Finding Aids section of the printed volume S-[2-Ethylsulfinyl)ethyl] O,O-dimethyl and at www.fdsys.gov. phosphorothioate and its cholinesterase-in- hibiting metabolites, (primarily S-[2- § 180.4 Exceptions. (ethyl-sulfonyl)ethyl] O,O-dimethyl phosphorothioate). The substances listed in this section (O,O-dimethyl O-[3-methyl-4- are excepted from the definitions of (methylthio)phenyl]phosphorothioate and ‘‘pesticide chemical’’ and ‘‘pesticide its cholinesterase-inhibiting metabolites. chemical residue’’ under FFDCA sec- . tion 201(q)(3) and are therefore exempt N-(Mercaptomethyl)phthalimide S-(O,O-di- from regulation under FFDCA section methyl phosphorodithioate). N-(Mercaptomethyl)phthalimide S-(O,O-di- 402(a)(2)(B) and 408. These substances methyl phosphorothioate). are subject to regulation by the Food Methomyl (S-methyl N- and Drug Administration as food addi- [(methylcarbamoyl)oxy]thioacetimidate). tives under FFDCA section 409.

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