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such as onions, parsnips, potatoes, and carrots. (Sec. 701, 52 Stat. 1055, as amended; 21 U.S.C. 371) (36 FR 22540, Nov. 25, 1971, as amended at 38 FR 3511, Feb. 7, 1973] § 180.2 Pesticide chemicals considered
safe. (a) As a general rule, pesticide chemi. cals other than benzaldehyde (when used as a bee repellant in the harvesting of honey), ferrous sulfate, lime, lime-sulfur, potassium polysulfide, sodium carbonate, sodium chloride, sodium polysulfide, and sulfur, and, when used postharvest as fungicides, citric acid, fumaric acid, oil of lemon, oil of orange, sodium benzoate, and sodium propionate are not for the purposes of section 408(a) of the act generally recognized as safe for use.
(b) Upon written request, the Pesticides Tolerance Division will advise interested persons whether a pesticide chemical should be considered as poisonous or deleterious, or one not generally recognized by qualified experts as safe.
(c) The training and experience necessary to qualify experts to evaluate the safety of pesticide chemicals for the purposes of section 408(a) are essen. tially the same as training and experi. ence necessary to qualify experts to serve on advisory Committees prescribed by section 408 (g). (See $ 180.11.) (Sec. 701, 52 Stat. 1055, as amended; 21 0.8.0. 371) | 180.3 Tolerances for related pesticide
chemicals. (a) Pesticide chemicals that cause related pharmacological effects will be regarded, in the absence of evidence to the contrary, as having an additive deleterious action. (For example, many pesticide chemicals within each of the following groups have related pharmacological effects: Chlorinated organic pesticides, arsenic-containing chemicals, metallic dithiocarbamates, cholinesterase-inhibiting pesticides.)
(b) Tolerances established for such related pesticide chemicals may limit the amount of a common component (such as As2O3) that may be present, or may limit the amount of biological activity (such as cholinesterase inhibition) that may be present, or may limit the total amount of related pesticide chemicals (such as chlorinated organic pesticides) that may be present.
(c) (1) Where tolerances for inorganic bromide in or on the same raw agricultural commodity are set in two or more sections in this part, the overall quantity of inorganic bromide to be tolerated from use of two or more pesticide chemicals for which tolerances are established is the highest of the separate applicable tolerances. For example, where the bromide tolerance on lima beans from ethylene dibromide soil treatment is 5 parts per million and on lima beans from methyl bromide fumigation is 50 parts per million, the overall inorganic bromide tolerance for lima beans grown on ethylene dibromide treated soil and also fumigated with methyl bromide after harvest is 50 parts per million.
(2) Where tolerances are established in terms of inorganic bromide residues only from use of organic bromide fumigants on raw agricultural commodities, such tolerances are sufficient to protect the public health and no additional concurrent tolerances for the organic pesticide chemicals from such use are necessary. This conclusion is based on evidence of the dissipation of the organic pesticide or its conversion to inorganic bromide residues in the food when ready to eat.
(d) (1) Where tolerances are established for both calcium cyanide and hydrogen cyanide on the same raw agricultural commodity, the total amount of such pesticides shall not yield more residue than that permitted by the larger of the two tolerances, calculated as hydrogen cyanide.
(2) Where tolerances are established for residues of both 0,0-diethyl S-[2(ethylthio) ethyl) phosphorodithioate and demeton (a mixture of 0,0-diethyl O-(and S-) (2-(ethylthio) ethyl) phosphorothioates) on the same raw agricultural commodity, the total amount of such pesticides shall not yield more residue than that permitted by the larger of the two tolerances, calculated as demeton.
(3) Where tolerances are established for both terpene polychlorinates (chlorinated mixture of camphene, pinene, and related terpenes, containing 65-66 percent chlorine) and toxaphene (chlorinated camphene containing 67–69 percent chlorine) on the same raw agricultural commodities, the total amount of such pesticides shall not yield more residue than that permitted by the larger of the two tolerances, calculated as a
chlorinated terpene of molecular weight 396.6 containing 67 percent chlorine.
(4) Where a tolerance is established for more than one pesticide containing arsenic found in, or on a raw agricultural commodity, the total amount of such pesticide shall not exceed the highest established tolerance calculated As Os.
(5) Where tolerances are established for more than one member of the class of dithiocarbamates listed in paragraph (e) (3) of this section on the same raw agricultural commodity, the total residue of such pesticides shall not exceed that permitted by the highest tolerance established for any one member of the class, calculated as zinc ethylenebisdithiocarbamate.
(6) Where tolerances are established for residues of both S,s,s-tributyl phosphorotrithioate and tributyl phosphorotrithioite in or on the same raw agricultural commodity, the total amount of such pesticides shall not yield more residue than that permitted by the higher of the two tolerances, calculated as S,S,S-tributyl phosphorotrithioate.
(7) Where tolerances are established for residues of a-naphthaleneacetamide and/or a-naphthaleneacetic acid in or on the same raw agricultural commodity, the total amount of such pesticides shall not yield more residue than that permitted by the higher of the two tolerances, calculated as a-naphthaleneacetic acid.
(e) Except as noted in subparagraphs (1) and (2) of this paragraph, where residues from two or more chemicals in the same class are present in or on a raw agricultural commodity the tolerance for the total of such residues shall be the same as that for the chemical having the lowest numerical tolerance in this class, unless a higher tolerance level is specifically provided for the combined residues by a regulation in this part.
(1) Where residues from two or more chemicals in the same class are present in or on a raw agricultural commodity and there are available methods that permit quantitative determination of each residue, the quantity of combined residues that are within the tolerance may be determined as follows:
(1) Determine the quantity of each residue present.
(ii) Divide the quantity of each residue by the tolerance that would apply if it occurred alone, and multiply by 100
to determine the percentage of the permitted amount of residue present.
(iii) Add the percentages so obtained for all residues present.
(iv) The sum of the percentages shall not exceed 100 percent.
(2) Where residues from two or more chemicals in the same class are present in or on a raw agricultural commodity and there are available methods that permit quantitative determinations of one or more, but not all, of the residues, the amounts of such residues as may be determinable shall be deducted from the total amount of residues present and the remainder shall have the same tolerance as that for the chemical having the lowest numerical tolerance in that class. The quantity of combined residues that are within the tolerance may be determined as follows:
(i) Determine the quantity of each determinable residue present.
(ii) Deduct the amounts of such residues from the total amount of residues present and consider the remainder to have the same tolerance as that for the chemical having the lowest numerical tolerance in that class.
(iii) Divide the quantity of each determinable residue by the tolerance that would apply if it occurred alone and the quantity of the remaining residue by the tolerance for the chemical having the lowest numerical tolerance in that class and multiply by 100 to determine the percentage of the permitted amount of residue present.
(iv) Add the percentages so obtained for all residues present.
(v) The sum of the percentages shall not exceed 100 percent.
(3) The following pesticides are members of the class of dithiocarbamates:
A mixture of 5.2 parts by weight of ammoniates of (ethylenebis (dithlocarbamato) | zinc with 1 part by weight ethylenebis (dithiocarbamic acid) bimolecular and trimolecular cyclic anhydrosulfides and disul. Ades.
Coordination product of zinc ion and maneb containing 20 percent manganese, 2.5 percent zinc, and 77.5 percent ethylenebisdithiocarbamate.
(4) The following are members of the class of chlorinated organic pesticides:
1,1 - Bis(p-chlorophenyl) - 2,2,2-trichloroethanol.
Chlorbensido (p-chlorobenzyl p-chlorophenyl sulfide).
Chlorobenzllate (ethyl 4,4'-dichlorobenzil. ate).
p-Chlorophenyl-2,4,5-trichlorophenyl sul. fide.
2,4-D (2,4-dichlorophenoxyacetic acid).
1.1 - Dichloro - 2,2 - bis(p - ethylphenyl) ethane,
Dodecachlorooctahydro - 1,3,4 - metheno 2H-cyclobuta(cdpentalene.
Endosulfan (6,7,8,9,10,10-hexachloro-1,5,5a, 6,9,9a - hexahydro - 6,9 - methano - 2,4,3 benzodloxathiepin-3-oxide).
Endosulfan sulfate (6,7,8,9,10,10-hexacloro1,5,5a,6,9,98 - hexahydro - 6,9 - methano - 2, 4,3-benzodioxathiepin-3,3-dioxide).
Heptachlor (1,4,5,6,7,8,8-heptachloro-3a,4,7, 7a-tetrahydro-4,7-methanoindene).
Heptachlor epoxide (1,4,5,6,7,8,8-hepta. chloro - 2,3 - epoxy - 2,3,38,4,7,7a-hexahydro4,7-methanoindene).
Hexachlorophene (2,2'-methylenebis(3,4,6trichlorophenol)) and its monosodium salt.
Ovex (p-chlorophenyl p-chlorobenzenesulfonate).
Sesone (sodium 2,4-dichlorophenoxyethyl sulfate, SES).
Sulphenone (p-chlorophenyl phenyl sulfone).
Terpene polychlorinates (chlorinated misture of camphene, pinene, and related terpenes 65–66 percent chlorine).
Tetradilon (2,4,5,4'-tetrachlorodiphenyl sulfone).
Toxapbene (chlorinated camphene).
(5) The following are members of the class of cholinesterase-inhibiting pesticides:
Aldicarb (2-methyl-2-(methylthio) propionaldehyde 0-(methylcarbamoyl) oxime) an its chlorinesterase-inhibiting metabolites 2methyl - 2 - (methylsulfinyl)propionaldehydo O-(methylcarbamoyl) oxime and 2-methyl-2(methylsulfonyl) propionaldehyde 0-(methylcarbamoyl)oxime.
Carbaryl (1-naphthyi N-methylcarbamate).
Carbofuran (2,3-dihydro-2,2-dimethyl-7benzofuranyl N-methylcarbamate).
Carbofuran metabolite (2,3-dihydro-2,2-dimethyl-3-hydroxy-7-benzofuranyi N-methylcarbamate).
Carbophenothion(S-[(p-chlorophenylthio) methyl) 0,0-diethyl phosphorodithioate) and its cholinesterase-inhibiting metabolites.
2-Chloro-1-(2,4,6-trichlorophenyl) vinyl dimethyl phosphate.
2-Chloro-1-(2,4-dichlorophenyl) vinyl diethyl phosphate.
Coumaphos (0,0-diethyl 0-3-chloro-4. methyl-2-oxo-2H-1-benzopyran-7-yi phosran-7-yl phosphate). phorothioate).
Coumaphos oxygen analog (0,0-diethyl 0-3-chloro-4-methyl-2-0X0-2H-1-benzopy
Dialifor (S-(2-chloro-1-phthallmidoethyl) 0,0-diethyl phosphorodithioate).
Dialifor oxygen analog (S-(2-chloro-lphthalimidoethyl) 0,0-diethyl phosphorothloate).
Demeton (a mixture of 0,0-diethyl 0(and s-) (2-(ethylthio) ethyl) phosphorotibioates).
2,2-Dichlorovinyl dimethyl phosphate.
0,0-Diethyl s-[2-(ethylthio) ethyll phosphorodithioate and its cholinesterase-inhibiting metabolites.
0,0-Diethyl 0-(2-diethylamino-6-methyl4-pyrimidinyl) phosphorothioate and its oxygen analog diethyl 2-diethylamino-6-methyl4-pyrimidinyl phosphate.
0,0-Diethyl 0-(2-1sopropyl-4-methyl-6pyrimidinyl) phosphorothioate.
0,0-Diethyl 0-1p-(methylsulinyl) phenyl] phosphorotbloato and its cholinesterase-inbibiting metabolites.
Diethyl 2-pyrazinyl phosphate. 0,0-Diethyl 0-2-pyrazinyl phosphorothioate.
S-(0,0-Dllsopropyl phosphorodithioate) of N-(2-mercaptoethyl) benzenesulfonamide.
S-(0,0-Duisopropyl phosphorothioate) of N-(2-mercaptoethyl) benzenesulfonamide.
Dimethoate (0,0-dimethyl S-(N-methylcarbamoylmethyl) phosphorodithioate).
Dimethoate oxygen analog (0,0-dimethyl S-(N-methylcarbamoylmethyl) phosphorothioate).
0,0-Dimethyl 0-p-(dimethylsulfamoyl) phenyl phosphate.
0,0-Dimethyl 0-p-(dimethylsulfamoyl) phenyl phosphorothioate.
0,0-Dimethyl 0-[4-(methylthio)-m-tolyij phosphorothioate and its cholinesterase-inalbiting metabolites.
0,0-Dimethyl S-14-0X0-1,2,3-benzotriazin3-(4H)-ylmethyl) phosphorodithioate.
Dimethyl phosphate of a-methylbenzyl 3hydroxy-cis-crotonate.
Dimethyl phosphate of 3-hydroxy-N-methyl-cis-crotonamide.
Dimethyl phosphate of 3-hydroxy-N,N-di. methyl-cis-crotonamide.
0,0-Dimethyl 2,2,3-trichloro-1-hydroxyethyl phosphonate. 4-thiadiazolin-5-one.
0,0-Dimethyl phosphorodithioate, s-ester with 4-(mercaptomethyl)-2-methoxy-1*-1,3,
Dioxathion (2,3-p-dioxanedithiol S,S-bis (0,0-diethylphosphorodithloate)) containing approximately 70 percent cis and trans isomers and approximately 30 percent related compounds.
Ethephon ((2- - chloroethyl) phosphonic acid).
Ethion oxygen analog (S-1/(diethoxyphosphinothioyl)thio) methyl]0,0-diethyl phosphorothioate).
O-Ethyl S,S-dipropylphosphorodithioate. O-Ethyl S-phenyl ethylphosphonodithloate.
O-Ethyl s-phenyl ethylphosphonothiolate.
m - (1 - Ethylpropyl) phenyl methylcarbamate.
S-[2-(Ethylsulfinyl) ethyl] 0,0-dimethyl phosphorothioate and its cholinesterase-inhibiting metabolites, (primarily S-[2-(ethylsulfonyl)ethyl] 0,0-dimethyl phosphorothioate).
N-(Mercaptomethyl) phthallmide S-(0,0dimethyl phosphorodithloate).
N-(Mercaptomethyl)phthallmide S-(0,0dimethyl phosphorothioate).
Methomyl (S-methyl N-[(methylcarbamoyl) oxy]thloacetimidate).
1-Methoxycarbonyl-1-propen-2-yl dimethyl phosphate and its beta Isomer.
m-(1-Methylbutyl) phenyl methylcarbamate.
Naled (1,2-dibromo-2,2-dichloroethyl dimethyl phosphate).
Phorate (0,0-diethyl s-(ethylthio)methyl phosphorodithioate) and its cholinesteraseInhibiting metabolites.
Phosalone (S-(6-chloro-3-mercaptomethyl) - 2 - benzoxazolinone) 0,0 - diethyl phosphorodithioate).
Phosphamidon (2-chloro-2-diethylcarbamoyl-1-methylvinyl dimethyl phosphate) including all of its related cholinesterase-inhibiting compounds.
4-tert-Butyl-2-chlorophenyl methyl methyl phosphoramidate.
0,0,0',0'-Tetramethyl 0,0'-sulfinyldi-pphenylene phosphorothioate.
0,0,0",0'-Tetramethyl 0,0'-thiodi-pphenylene phosphorothioate.
3,4,5-Trimethylphenyl methylcarbamate and
its isomer 2,3,5-trimethylphenyl methylcarbamate.
(6) The following pesticides are members of the class of dinitrophenols:
Binapacryl (2-sec-butyl-4,5-dinitrophenyl. 3-methyl-2-butenoate) and its metabolite 2sec-butyl-4,6-dinitrophenol.
2,4-Dinitro-6-octylphenyl crotonate and 2,6-dinitro-4-octylphenyl crotonate, mixture of.
Dinoseb (2-sec-butyl-4,6-dinitrophenol) and its alkanolamine, ammonium, and sodium salts. [36 F.R. 22540, Nov. 25, 1971; 36 F.R. 24803, Dec. 23, 1971, as amended at 37 FR 4912, 4913, Mar. 7, 1972; 37 FR 6579, Mar. 31, 1972; 37 FR 11724, June 13, 1972; 37 FR 21995, Oct. 18, 1972; 37 FR 22982, Oct. 27, 1972; 37 FR 24900, Nov. 22, 1972; 37 FR 26009, Dec. 7, 1972) $ 180.4 Certification of usefulness and
residue estimate. The time period for the Agency's consideration of a petition will not begin to run until the Administrator of the Environmental Protection Agency certifies that the pesticide chemical involved is useful and gives an opinion whether the tolerance proposed by the petitioner reasonably reflects the amount of residue likely to result when the pesticide chemical is used in the manner proposed. The tolerance thereafter established ordinarily will not exceed that figure which the Administrator of the Environmental Protection Agency states, in his opinion, reasonably reflects the amounts of residue likely to result. § 180.5 Zero tolerances.
A zero tolerance means that no amount of the pesticide chemical may remain on the raw agricultural commodity when it is offered for shipment. A zero tolerance for a pesticide chemical in or on a raw agricultural commodity may be established because, among other reasons:
(a) A safe level of the pesticide chemical in the diet of two different species of warm-blooded animals has not been reliably determined.
(b) The chemical is carcinogenic to or has other alarming physiological effects upon one or more of the species of the test animals used, when fed in the diet of such animals.
(c) The pesticide chemical is toxic, but is normally used at times when, or in such manner that, fruit, vegetables, or other raw agricultural commodities will not bear or contain it.
(d) All residue of the pesticide chemical is normally removed through good agricultural practice such as washing or
brushing or through weathering or other ing exaggerated pesticide levels in feedchanges in the chemical itself, prior to ing studies and those elucidating the introduction of the raw agricultural biochemistry of the pesticide chemical commodity into Interstate commerce. in the animal, a tolerance may be estab8 180.6 Pesticide tolerances regarding
lished on the raw agricultural commodity milk, eggs, meat, and/or poultry;
without the necessity of a tolerance on statement of policy.
food products derived from the animal.
(c) The principles outlined in par&(a) When establishing tolerances for
graphs (a) and (b) of this section will pesticide residues in or on raw agricul
also be followed with respect to tolertural commodities, consideration is al
ances for residues which will actually ways given to possible residues of those
be incurred or are reasonably to be expesticide chemicals or their conversion
pected in milk, eggs, meat, and/or poulproducts entering the diet of man
try by the use of pesticides directly on through the ingestion of milk, eggs, meat, the animal or administered purposely in and/or poultry produced by animals fed
the feed or drinking water. agricultural products bearing such pesti- (d) Tolerances contemplated by paracide residues. In each instance an evalu- graphs (a) and (b) of this section will ation of all available data will result in a
in addition to toxicological consideraconclusion either:
tions be conditioned on the availability (1) That finite residues will actually
of a practicable analytical method to be incurred in these foods from feed use
determine the pesticide residue; that is, of the raw agricultural commodity in
the method must be sensitive and reliable cluding its byproducts; or
at the tolerance level or in special cases (2) That it is not possible to establish with certainty whether finite residues
at a higher level where such level is will be incurred, but there is a reasonable
deemed satisfactory and safe in light of expectation of finite residues; or
the toxicity of the pesticide residue and (3) That it is not possible to establish of the unlikelihood of such residue exwith certainty whether finite residues ceeding the tolerance. The analytical will be incurred, but there is no reason- methods to be used for enforcement purable expectation of finite residues.
poses will be those set forth in the "Pes(b) When the data show that finite
ticide Analytical Manual” (see § 180.101 residues will actually be incurred in milk,
(c)). The sensitivities of these methods eggs, meat, and/or poultry, a tolerance
are expressed in that manual. will be established on the raw agricul
(Sec. 701(a), 68 Stat. 511 et seq.; 21 U.S.O. tural commodity used as feed provided
371(a)). that tolerances can be established at the same time, on the basis of the toxicologi- Subpart B— Procedural Regulations cal and other data available, for the
PROCEDURE FOR FILING PETITIONS finite residues incurred in milk, eggs, meat, and/or poultry. When it is not pos
$ 180.7 Petitions proposing tolerances sible to determine with certainty whether or exemptions for pesticide residues finite residues will be incurred in milk,
raw agricultural com
modities. eggs, meat, and/or poultry but there is a reasonable expectation of finite resi- (a) Petitions to be filed with the dues in light of data reflecting exagger- Agency under the provisions of section ated pesticides levels in feeding studies, 408(d) shall be submitted in duplicate to a tolerance will be established on the
the Pesticides Tolerance Division. If any raw agricultural commodity provided
part of the material submitted is in a that appropriate tolerances can be established at the same time, on the basis of
foreign language, it shall be accompanied the toxicological and other data avail
by an accurate and complete English able, for the finite residues likely to be
translation. The petition shall be acincurred in these foods through the feed companied by an advance deposit for use of the raw agricultural commodity fees described in § 180.33. The petition or its byproducts. When it is not pos- shall state petitioner's mail address to sible to determine with certainty whether which notice of objection under section finite residues will be incurred in milk, 408(d) (5) may be sent. eggs, meat, and/or poultry but there is (b) Petitions shall include the followno reasonable expectation of finite resi- ing data and be submitted in the followdues in light of data such as those reflect- ing form: