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tolerances for negligible residues, each group listed in § 120.34(f) is counted as a single commodity without regard as to whether or not the pesticide is systemic.

(h) Tolerances and exemptions established for pesticide chemicals in or on the general category of raw agricultural A

Beans..

Celery-
Cherries.

Citrus fruits.

Melons__

Onions..

Onions (dry bulbs only). Turnip tops or turnip greens.

commodities listed in column A apply to the corresponding specific raw agricultural commodities listed in column B. However, a tolerance or exemption for a specific commodity in column B does not apply to the general category in column A.

B

Green beans, lima beans, navy beans, red kidney beans, snap beans, wax beans, cowpeas, blackeyed peas.

Anise (fresh leaves and stalks only), celery.
Sour cherries, sweet cherries.

Grapefruit, lemons, limes, oranges, tangelos, tangerines, citrus citron, kumquats, and hybrids of these.

Cantaloups, casabas, crenshaws, honeydew melons, honey balls, muskmelons, Persian melons, and hybrids of these, watermelons and their hybrids.

Dry bulb onions, green onions, garlic, leeks, shallots, spring onions.

Garlic, onions (dry bulb only).

Broccoli raab (raab, raab salad), turnip tops (turnip greens).

(i) Unless otherwise specified, tolerances and exemptions established under the regulations in this part apply to residues from only preharvest application of the chemical.

(j) Unless otherwise specified in this paragraph or in tolerance regulations prescribed in this part for specific pesticide chemicals, the raw agricultural commodity to be examined for pesticide residues shall consist of the whole raw agricultural commodity.

(1) The raw agricultural commodity bananas, when examined for pesticide residues, shall not include any crown tissue or stalk.

(2) Shell shall be removed and discarded from nuts before examination for pesticide residues.

(3) Caps (hulls) shall be removed and discarded from strawberries before examination for pesticide residues.

(4) Stems shall be removed and discarded from melons before examination for pesticide residues.

(5) Roots, stems, and outer sheaths (or husks) shall be removed and discarded from garlic bulbs, and only the garlic cloves shall be examined for pesticide residues.

(6) Where a tolerance is established on a root vegetable including tops or with tops, and the tops and the roots are marketed together, they shall be analyzed separately and neither the pesticide residues on the roots nor the pesticide residues on the tops shall exceed the tolerance level.

(7) The crowns (leaves at the top of

the fruit) shall be removed and discarded from pineapples before examination for pesticide residues.

(k) The term "pesticide chemical," as defined in § 201(q) of the act, means any substance which, alone, in chemical combination, or in formulation with one or more other substances, is an "economic poison" within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135-135k) and as defined in § 362.2 of regulations for its enforcement (7 C.F.R. 362.2), as now in force or as hereafter amended, and which is used in the production, storage, or transportation of raw agricultural

commodities.

(1) The term "negligible residue" means any amount of a pesticide chemical remaining in or on a raw agricultural commodity or group of raw agricultural commodities that would result in a daily intake regarded as toxicologically insignificant on the basis of scientific judgment of adequate safety data. Ordinarily this will add to the diet an amount which will be less than 1/2,000th of the amount that has been demonstrated to have no effect from feeding studies on the most sensitive animal species tested. Such toxicity studies shall usually include at least 90-day feeding studies in two species of mammals.

(Sec. 701, 52 Stat. 1055, as amended; 21 U.S.C. 371) [27 F.R. 12092, Dec. 6, 1962, as amended at 28 F.R. 7473, July 23, 1963, 29 F.R. 1802, Feb. 6, 1964, 29 F.R. 7597, June 13, 1964; 32 F.R. 13571, Sept. 28, 1967]

§ 120.2 Pesticide chemicals considered

safe.

(a) As a general rule, pesticide chemicals 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 benzonate, 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 Petitions Control Branch 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 essentially the same as training and experience necessary to qualify experts to serve on advisory committees prescribed by section 408(g). (See § 120.11.)

(Sec. 701, 52 Stat. 1055, as amended; 21 U.S.C. 371) [27 F.R. 12092, Dec. 6, 1962, as amended at 29 F.R. 7597, June 13, 1964, 30 F.R. 11916, Sept. 17, 1965]

§ 120.3 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 over-all 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 over-all 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 O,O-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 percent-66 percent chlorine) and toxaphene (chlorinated camphene containing 67 percent-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 toler

ances, 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 pesticides shall not yield more than 3.5 parts per million of As2Os on the raw agricultural commodity to which applied.

(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.

(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:

(i) 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 or 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 (dithiocarbamato)] zinc with 1 part by weight ethylenebis [dithiocarbamic acid] bimolecular and trimolecular cyclic anhydrosulfides and disulfides.

Coordination product of zinc ion and maneb containing 20 percent manganese, 2.5 percent zinc, and 77.5 percent ethylenebisdithiocarbamate.

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Cite this Code CFR

thus: 21 CFR 120.1

Title 21-Food and Drugs

(This book contains Parts 120 to 129)

Part

CHAPTER I-Food and Drug Administration, Department of Health, Education, and Welfare (continued)

120

CROSS REFERENCES: Compliance with the Federal Food, Drug, and Cosmetic Act required of the Agricultural Research Service, Department of Agriculture: See Animals and Animal Products, 9 CFR Part 326.

Federal Trade Commission: See Commercial Practices, 16 CFR Chapter I.

Bureau of Customs, Department of the Treasury: See Customs Duties, 19 CFR Chapter I.

Internal Revenue Service, Department of the Treasury: See Internal Revenue, 26 CFR Chapter I. Intoxicating Liquors, 27 CFR Chapter I.

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