Further extension of effective date of statute for residues of certain nematocides, plant regulators, defoliants, and desiccants.

Subpart C-Specific Tolerances

Further extensions of effective date of Public Law 86-139 as it affects section 408 of the Federal Food, Drug, and Cosmetic Act. Specific tolerances; general provisions.

Sesone; tolerances for residues. Captan; tolerances for residues. Heptachlor and heptachlor epoxide; tolerances for residues. Demeton; tolerances for residues. Diuron; tolerances for residues. Aramite; tolerances for residues. Monuron; tolerances for residues. Ethyl 4,4'-dichlorobenzilate; tolerances for residues.

Maneb; tolerances for residues. Malathion; tolerances for residues. Sulphenone (p-chlorophenyl phenyl sulfone); tolerances for residues.

Allethrin (allyl homolog of cinerin I); tolerances for residues. Ferbam; tolerances for residues. Zineb; tolerances for residues. Ziram; tolerances for residues. tolerances for

Chlortetracycline;

residues.

Dichlone; tolerances for residues. EPN; tolerances for residues. Methoxychlor; tolerances for residues.

Parathion or its methyl homolog;

tolerances for residues.

Chlordane; tolerances for residues. Inorganic bromides resulting from fumigation with methyl bromide; tolerances for residues. Glyodin or 2-heptadecyl glyoxalidine (base); tolerances for residues.

Calcium cyanide; tolerances for residues.

Inorganic bromides resulting from soil treatment with ethylene dibromide; tolerances for residues. Piperonyl butoxide; tolerances for residues.

Pyrethrins; tolerances for residues. Sodium 0-phenylphenate; tolerances for residues.

Hydrogen cyanide; tolerances for residues.

Endrin; tolerances for residues.

Thiram; tolerances for residues.

ing pesticides.

Lindane; tolerances for residues. Ovex; tolerances for residues.

Subpart A-Definitions and Interpretative Regulations

DEFINITIONS AND INTERPRETATIONS

§ 120.1 Definitions and interpretations. (a) Secretary, without qualification, means the Secretary of Health, Education, and Welfare.

(b) Department, without qualification, means the Department of Health, Education, and Welfare.

(c) Commissioner means the Commissioner of Food and Drugs.

(d) Pesticide Branch means the unit established within the Food and Drug Administration charged with administration of the Pesticide Residue amendment to the Federal Food, Drug, and Cosmetic Act (section 408).

(e) Raw agricultural commodities include, among other things, fresh fruits, whether or not they have been washed and colored or otherwise treated in their unpeeled natural form; vegetables in their raw or natural state, whether or not they have been stripped of their outer leaves, waxed, prepared into fresh green salads, etc.; grains, nuts, eggs, raw milk, meats, and similar agricultural produce. It does not include foods that have been processed, fabricated, or manufactured by cooking, freezing, dehydrating, or milling.

(f) Where raw agricultural commodities bearing residues that have been exempted from the requirement of a tolerance, or which are within a tolerance permitted under section 408 are used, the processed foods will not be considered unsafe within the meaning of section 406 if:

(1) The poisonous or deleterious pesticide residues have been removed to the extent possible in good manufacturing practice; and

(2) The concentration of the pesticide in the preserved or processed food when ready to eat is not greater than the tolerance permitted on the raw agricultural commodity.

(g) For the purpose of computing fees as required by § 120.33, each group of crops listed in § 120.34 (e) is counted as a single raw agricultural commodity in a petition or request for tolerances or exemption from the requirement of a tolerance for a nonsystemic pesticide. As

a general rule, when considering a petition or request with respect to a systemic pesticide (see § 120.34 (c)) crops shall not be grouped.

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

Beans.

Celery

Cherries__.

A

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

(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.

(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

(a) As a general rule, pesticide chemicals other than ferrous sulfate, sulfur, lime, lime-sulfur, potassium polysulfide, sodium carbonate, sodium chloride, and sodium polysulfide are not, for the purposes of section 408(a) of the act, generally recognized as safe for use.

(b) Upon written request, the Pesticide 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.) § 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) 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 over-all per million, the 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.

(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 O,O-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 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 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 pesticides shall not yield more than 3.5 parts per million of As2O3 on the raw agricultural commodity to which applied.

(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.

(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.