Electronic Code of Federal Regulations

Title 40: Protection of Environment

PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD

Subpart A—Definitions and Interpretative Regulations

Subpart B—Procedural Regulations

Subpart C—Specific Tolerances

Subpart D—Exemptions From Tolerances

Subpart E—Pesticide Chemicals Not Requiring a Tolerance or an Exemption From a Tolerance

Source: 36 FR 22540, Nov. 25, 1971, unless otherwise noted.

Subpart A—Definitions and Interpretative Regulations

§180.1   Definitions and interpretations.

(a) Administrator, without qualification, means the Administrator of the Environmental Protection Agency.

(b) Agency, without qualification, means the Environmental Protection Agency.

(c) FFDCA means the Federal Food, Drug, and Cosmetic Act, as amended, 21 U.S.C. 301-392.

(d) 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.

(e) Where a raw agricultural commodity bearing a pesticide chemical residue that has been exempted from the requirement of a tolerance, or which is within a tolerance permitted under FFDCA section 408, is used in preparing a processed food, the processed food will not be considered unsafe within the meaning of FFDCA sections 402 and 408(a), despite the lack of a tolerance or exemption for the pesticide chemical residue in the processed food, if:

(1) The pesticide chemical has been used in or on the raw agricultural commodity in conformity with a tolerance under this section;

(2) The pesticide chemical residue has been removed to the extent possible in good manufacturing practice; and

(3) The concentration of the pesticide chemical residue in the processed food is not greater than the tolerance prescribed for the pesticide chemical residue on the raw agricultural commodity.

(f) For the purpose of computing fees as required by §180.33, each group of related crops listed in §180.34(e) and each crop group or subgroup listed in §180.41 is counted as a single raw agricultural commodity in a petition or request for tolerances or exemption from the requirement of a tolerance.

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

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

(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 dry bulb onions, and only the garlic cloves and onion bulbs shall be examined for pesticide residues.

(6) Where a tolerance is established on a root vegetable including tops and/or with tops, and the tops and the roots are marketed together, they shall be analyzed separately and neither the pesticide residue on the roots nor the pesticide residue on the tops shall exceed the tolerance level, except that in the case of carrots, parsnips, and rutabagas, the tops shall be removed and discarded before analyzing roots for pesticide residues.

(7) The crowns (leaves at the top of the fruit) shall be removed and discarded from pineapples before examination for pesticide residues.

(8) The term lima beans means the beans and the pod.

(9) The term peanuts means the peanut meat after removal of the hulls.

(10) For processed foods consisting primarily of one ingredient and sold in a form requiring further preparation prior to consumption (e.g., fruit juice concentrates, dehydrated vegetables, and powdered potatoes), the processed food to be examined for residues shall be the whole processed commodity after compensating for or reconstituting to the commodity's normal moisture content, unless a tolerance for the concentrated or dehydrated food form is included in this part. If there exists a tolerance for a specific pesticide on the processed food in its concentrated or dehydrated food form, for the purpose of determining whether the food is in compliance with that tolerance, the processed food to be examined for residues shall be the whole processed commodity on an “as is” basis.

(i) The term pesticide chemical shall have the meaning specified in FFDCA section 201(q)(1), as amended, except as provided in §180.4.

(j) 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.

(k) The term nonperishable raw agricultural commodity means any raw agricultural commodity not subject to rapid decay or deterioration that would render it unfit for consumption. Examples are cocoa beans, coffee beans, field-dried beans, field-dried peas, grains, and nuts. Not included are eggs, milk, meat, poultry, fresh fruits, and vegetables such as onions, parsnips, potatoes, and carrots.

(l) The term tolerance with regional registration means any tolerance which is established for pesticide residues resulting from the use of the pesticide pursuant to a regional registration. Such a tolerance is supported by residue data from specific growing regions for a raw agricultural commodity. Individual tolerances with regional registration are designated in separate subsections in 40 CFR 180.101 through 180.999, as appropriate. Additional residue data which are representative of the proposed use area are required to expand the geographical area of usage of a pesticide on a raw agricultural commodity having an established “tolerance with regional registration.” Persons seeking geographically broader registration of a crop having a “tolerance with regional registration” should contact the appropriate EPA product manager concerning additional residue data required to expand the use area.

(m) The term pesticide chemical residue shall have the meaning specified in FFDCA section 201(q)(2), as amended, except as provided in §180.4.

(n) The term food commodity means:

(1) Any raw agricultural commodity (food or feed) as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act (FFDCA); and

(2) Any processed food or feed as defined in section 201(gg) of the FFDCA.

[36 FR 22540, Nov. 25, 1971]

§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 (example: §§180.123 and 180.199), the overall quantity of inorganic bromide to be tolerated from use of the same pesticide in different modes of application or from 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 asparagus from methyl bromide commodity fumigation is 100 parts per million (40 CFR 180.123) and on asparagus from methyl bromide soil treatment is 300 parts per million (40 CFR 180.199), the overall inorganic bromide tolerance for asparagus grown on methyl bromide-treated soil and also fumigated with methyl bromide after harvest is 300 parts per million.

(2) Where tolerances are established in terms of inorganic bromide residues only from use of organic bromide fumigants on raw agricutural 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 O,O-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 65-66 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 As2O3.

(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 both as zinc ethylenebisdithiocarbamate and carbon disulfide. The tolerance based on zinc ethylenebisdithiocarbamate shall first be multiplied by 0.6 to convert it to the equivalent carbon disulfide tolerance, and then the carbon disulfide tolerance levels will be compared to determine the highest tolerance level per raw agricultural commodity.

(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 O,S-dimethyl phosphoramidothioate, resulting from the use of acephate (O,S-dimethyl acetylphos-phoramidothioate) and/or O,S - dimethylphosphoramidothioate on the same agricultural commodity, the total amount of O,S-dimethyl-phosphoramidothioate shall not yield more residue than that permitted by the higher of the two tolerances.

(8) Where a tolerance is established for more than one pesticide having the metabolites 1-(3,4-dichlorophenyl)-3-methylurea (DCPMU) and 3,4-dichlorophenylurea (DCPU) found in or on a raw agricultural commodity, the total amount of such residues shall not exceed the highest established tolerance for a pesticide having these metabolites.

(9) Where a tolerance is established for more than one pesticide having as metabolites compounds containing the benzimidazole moiety found in or on a raw agricultural commodity, the total amount of such residues shall not exceed the highest established tolerance for a pesticide having these metabolites.

(10) Where a tolerance is established for triclopyr, chloropyrifos, and chlorpyrifos-methyl having the common metabolite 3,5,6-trichloro-2-pyridinol on the same raw agricultural commodity, the total amount of such residues shall not exceed the highest established tolerance for any of the pesticides having the metabolites.

(11) Where tolerances are established for more than one pesticide having the metabolite 3,5,6-trichloro-2-pyridinol found in or on the raw agricultural commodity, the total amount of such residues shall not exceed the highest established tolerance for a pesticide having this metabolite.

(12) Where tolerances are established for residues of methomyl, resulting from the use of thiodicarb and/or methomyl on the same raw agricultural commodity, the total amount of methomyl shall not yield more residue than that permitted by the higher of the two tolerances.

(e) Except as noted in paragraphs (e)(1) and (2) of this section, 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 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:

(4) The following are members of the class of chlorinated organic pesticides:

(5) The following are members of the class of cholinesterase-inhibiting pesticides:

(6) The following pesticides are members of the class of dinitrophenols:

[41 FR 8969, Mar. 2, 1976]

§180.4   Exceptions.

The substances listed in this section are excepted from the definitions of “pesticide chemical” and “pesticide chemical residue” under FFDCA section 201(q)(3) and are therefore exempt from regulation under FFDCA section 402(a)(2)(B) and 408. These substances are subject to regulation by the Food and Drug Administration as food additives under FFDCA section 409.

(a) Inert ingredients in food packaging treated with a pesticide, when such inert ingredients are the components of the food packaging material (e.g. paper and paperboard, coatings, adhesives, and polymers).

(b) [Reserved]

[63 FR 10720, Mar. 4, 1998, as amended at 73 FR 54976, Sept. 24, 2008]

§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 changes in the chemical itself, prior to introduction of the raw agricultural commodity into interstate commerce.

§180.6   Pesticide tolerances regarding milk, eggs, meat, and/or poultry; statement of policy.

(a) When establishing tolerances for pesticide residues in or on raw agricultural commodities, consideration is always given to possible residues of those pesticide chemicals or their conversion products entering the diet of man through the ingestion of milk, eggs, meat, and/or poultry produced by animals fed agricultural products bearing such pesticide residues. In each instance an evaluation of all available data will result in a conclusion either:

(1) That finite residues will actually be incurred in these foods from feed use of the raw agricultural commodity including its byproducts; or

(2) That it is not possible to establish with certainty whether finite residues will be incurred, but there is a reasonable expectation of finite residues; or

(3) That it is not possible to establish with certainty whether finite residues will be incurred, but there is no reasonable expectation of finite residues.

(b) When the data show that finite residues will actually be incurred in milk, eggs, meat, and/or poultry, a tolerance will be established on the raw agricultural commodity used as feed provided that tolerances can be established at the same time, on the basis of the toxicological and other data available, for the finite residues incurred in milk, eggs, meat, and/or poultry. When it is not possible to determine with certainty whether finite residues will be incurred in milk, eggs, meat, and/or poultry but there is a reasonable expectation of finite residues in light of data reflecting exaggerated pesticides levels in feeding studies, a tolerance will be established on the raw agricultural commodity provided that appropriate tolerances can be established at the same time, on the basis of the toxicological and other data available, for the finite residues likely to be incurred in these foods through the feed use of the raw agricultural commodity or its byproducts. When it is not possible to determine with certainty whether finite residues will be incurred in milk, eggs, meat, and/or poultry but there is no reasonable expectation of finite residues in light of data such as those reflecting exaggerated pesticide levels in feeding studies and those elucidating the biochemistry of the pesticide chemical in the animal, a tolerance may be established on the raw agricultural commodity without the necessity of a tolerance on food products derived from the animal.

(c) The principles outlined in paragraphs (a) and (b) of this section will also be followed with respect to tolerances for residues which will actually be incurred or are reasonably to be expected in milk, eggs, meat, and/or poultry by the use of pesticides directly on the animal or administered purposely in the feed or drinking water.

(d) Tolerances contemplated by paragraphs (a) and (b) of this section will in addition to toxicological considerations be conditioned on the availability of a practicable analytical method to determine the pesticide residue; that is, the method must be sensitive and reliable at the tolerance level or in special cases at a higher level where such level is deemed satisfactory and safe in light of the toxicity of the pesticide residue and of the unlikelihood of such residue exceeding the tolerance. The analytical methods to be used for enforcement purposes will be those set forth in the “Pesticide Analytical Manual” (see §180.101(c)). The sensitivities of these methods are expressed in that manual.

Subpart B—Procedural Regulations

§180.7   Petitions proposing tolerances or exemptions for pesticide residues in or on raw agricultural commodities or processed foods.

(a) Petitions to be filed with the Agency under the provisions of FFDCA section 408(d) shall be submitted in duplicate. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petition shall be accompanied by an advance deposit for fees described in §180.33. The petition shall state the petitioner's mail address to which notice of objection under FFDCA section 408(g)(2) may be sent. The petition must be signed by the petitioner or by his attorney or agent, or (if a corporation) by an authorized official.

(b) Petitions shall include the following information:

(1) An informative summary of the petition and of the data, information, and arguments submitted or cited in support of the petition. Both a paper and electronic copy of the summary should be submitted. The electronic copy should be formatted according to the Office of Pesticide Programs' current standard for electronic data submission as specified at http://www.epa.gov/pesticides/regulating/registering/submissions/index.htm.

(2) A statement that the petitioner agrees that such summary or any information it contains may be published as a part of the notice of filing of the petition to be published under FFDCA section 408(d)(3) and as a part of a proposed or final regulation issued under FFDCA section 408.

(3) The name, chemical identity, and composition of the pesticide chemical residue and of the pesticide chemical that produces the residue.

(4) Data showing the recommended amount, frequency, method, and time of application of the pesticide chemical.

(5) Full reports of tests and investigations made with respect to the safety of the pesticide chemical, including full information as to the methods and controls used in conducting those tests and investigations.

(6) Full reports of tests and investigations made with respect to the nature and amount of the pesticide chemical residue that is likely to remain in or on the food, including a description of the analytical methods used. (See §180.34 for further information about residue tests.)

(7) Proposed tolerances for the pesticide chemical residue if tolerances are proposed.

(8) Practicable methods for removing any amount of the residue that would exceed any proposed tolerance.

(9) A practical method for detecting and measuring the levels of the pesticide chemical residue in or on the food, or for exemptions, a statement why such a method is not needed.

(10) If the petition relates to a tolerance for a processed food, reports of investigations conducted using the processing method(s) used to produce that food.

(11) Such information as the Administrator may require to make the determination under FFDCA section 408(b)(2)(C).

(12) Such information as the Administrator may require on whether the pesticide chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects.

(13) Information regarding exposure to the pesticide chemical residue due to any tolerance or exemption already granted for such residue.

(14) Information concerning any maximum residue level established by the Codex Alimentarius Commission for the pesticide chemical residue addressed in the petition. If a Codex maximum residue level has been established for the pesticide chemical residue and the petitioner does not propose that this level be adopted, a statement explaining the reasons for this departure from the Codex level.

(15) Such other data and information as the Administrator requires by regulation to support the petition.

(16) Reasonable grounds in support of the petition.

(c) The data specified under paragraphs (b)(1) through (b)(16) of this section should be on separate sheets or sets of sheets, suitably identified. If such data have already been submitted with an earlier application, the present petition may incorporate it by reference to the earlier one.

(d) Except as noted in paragraph (e) of this section, a petition shall not be accepted for filing if any of the data prescribed by FFDCA section 408(d) are lacking or are not set forth so as to be readily understood. The availability to the public of information provided to, or otherwise obtained by, the Agency under this part shall be governed by part 2 of this chapter. The Administrator shall make the full text of the summary referenced in paragraph (b)(1) of this section available to the public in the public docket at http://www.regulations.gov no later than publication in the Federal Register of the notice of the petition filing.

(e) The Administrator shall notify the petitioner within 15 days after its receipt of acceptance or nonacceptance of a petition, and if not accepted the reasons therefor. If petitioner desires, the petitioner may supplement a deficient petition after notification as to deficiencies. If the petitioner does not wish to supplement or explain the petition and requests in writing that it be filed as submitted, the petition shall be filed and the petitioner so notified.

(f) A notice of the filing of a petition for a pesticide chemical residue tolerance that the Administrator determines has met the requirements of paragraph (b) of this section shall be published in the Federal Register by the Administrator within 30 days after such determination. The notice shall state the name of the pesticide chemical residue and the commodities for which a tolerance is sought and announce the availability of a description of the analytical methods available to the Administrator for the detection and measurement of the pesticide chemical residue with respect to which the petition is filed or shall set forth the petitioner's statement of why such a method is not needed. The notice shall explicitly reference the specific docket identification number in the public docket at http://www.regulations.gov where the full text of the summary required in paragraph (b) of this section is located, and refer interested parties to this document for further information on the petition. The full text of the summary may be omitted from the notice.

(g) The Administrator may request a sample of the pesticide chemical at any time while a petition is under consideration. The Administrator shall specify in its request for a sample of the pesticide chemical, a quantity which it deems adequate to permit tests of analytical methods used to determine residues of the pesticide chemical and of methods proposed by the petitioner for removing any residues of the chemical that exceed the tolerance proposed.

(h) The Administrator shall determine, in accordance with the Act, whether to issue an order that establishes, modifies, or revokes a tolerance regulation (whether or not in accord with the action proposed by the petitioner), whether to publish a proposed tolerance regulation and request public comment thereon under §180.29, or whether to deny the petition. The Administrator shall publish in the Federal Register such order or proposed regulation. After receiving comments on any proposed regulation, the Administrator may issue an order that establishes, modifies, or revokes a tolerance regulation. An order published under this section shall describe briefly how to submit objections and requests for a hearing under part 178 of this chapter. A regulation issued under this section shall be effective on the date of publication in the Federal Register unless otherwise provided in the regulation.

[70 FR 33360, June 8, 2005, as amended at 73 FR 75600, Dec. 12, 2008]

§180.8   Withdrawal of petitions without prejudice.

In some cases the Administrator will notify the petitioner that the petition, while technically complete, is inadequate to justify the establishment of a tolerance or the tolerance requested by petitioner. This may be due to the fact that the data are not sufficiently clear or complete. In such cases, the petitioner may withdraw the petition pending its clarification or the obtaining of additional data. This withdrawal may be without prejudice to a future filing. A deposit for fees as specified in §180.33 shall accompany the resubmission of the petition.

[70 FR 33361, June 8, 2005]

§180.9   Substantive amendments to petitions.

After a petition has been filed, the petitioner may submit additional information or data in support thereof, but in such cases the petition will be given a new filing date.

[70 FR 33361, June 8, 2005]

§180.29   Establishment, modification, and revocation of tolerance on initiative of Administrator.

(a) Upon the Administrator's own initiative, the Administrator may propose, under FFDCA section 408(e), the issuance of a regulation establishing a tolerance for a pesticide chemical or exempting it from the necessity of a tolerance, or a regulation modifying or revoking an existing tolerance or exemption.

(b) The Administrator shall provide a period of not less than 60 days for persons to comment on the proposed regulation, except that a shorter period for comment may be provided if the Administrator for good cause finds that it would be in the public interest to do so and states the reasons for the finding in the notice of proposed rulemaking.

(c) After reviewing any timely comments received, the Administrator may by order establish, modify, or revoke a tolerance regulation, which order and regulation shall be published in the Federal Register. An order published under this section shall state that persons may submit objections and requests for a hearing in the manner described in part 178 of this chapter.

(d) Any final regulation issued under this section shall be effective on the date of publication in the Federal Register unless otherwise provided in the regulation.

[70 FR 33361, June 8, 2005]

§180.30   Judicial review.

(a) Under FFDCA section 408(h), judicial review is available in the United States Courts of Appeal as to the following actions:

(1) Regulations establishing general procedures and requirements under FFDCA section 408(e)(1)(C).

(2) Orders issued under FFDCA section 408(f)(1)(C) requiring the submission of data.

(3) Orders issued under FFDCA section 408(g)(2)(C) ruling on objections to establishment, modification, or revocation of a tolerance or exemption under FFDCA section 408(d)(4), or any regulation that is the subject of such an order. The underlying action here is Agency disposition of a petition seeking the establishment, modification, or revocation of a tolerance or exemption.

(4) Orders issued under FFDCA section 408(g)(2)(C) ruling on objections to the denial of a petition under FFDCA section 408(d)(4).

(5) Orders issued under FFDCA section 408(g)(2)(C) ruling on objections to the establishment, modification, suspension, or revocation of a tolerance or exemption under FFDCA section 408(e)(1)(A) or (e)(1)(B). The underlying action here is the establishment, modification, suspension, or revocation of a tolerance or exemption upon the initiative of EPA including EPA actions pursuant to FFDCA sections 408(b)(2)(B)(v), 408(b)(2)(E)(ii), 408(d)(4)(C)(ii), 408(l)(4), and 408(q)(1).

(6) Orders issued under FFDCA section 408(g)(2)(C) ruling on objections to the revocation or modification of a tolerance or exemption under FFDCA section 408(f)(2) for noncompliance with requirements for the submission of data.

(7) Orders issued under FFDCA section 408(g)(2)(C) ruling on objections to rules issued under FFDCA sections 408(n)(3) and 408(d) or (e) regarding determinations pertaining to State authority to establish regulatory limits on pesticide chemical residues.

(8) Orders issued under FFDCA section 408(g)(2)(C) ruling on objections to orders issued under FFDCA section 408(n)(5)(C) authorizing States to establish regulatory limits not identical to certain tolerances or exemptions.

(b) Any issue as to which review is or was obtainable under paragraph (a) of this section shall not be the subject of judicial review under any other provision of law. In part, this means that, for the Agency actions subject to the objection procedure in FFDCA section 408(g)(2), judicial review is not available unless an adversely affected party exhausts these objection procedures, and any petition procedures preliminary thereto.

[70 FR 33362, June 8, 2005]

§180.31   Temporary tolerances.

(a) A temporary tolerance (or exemption from a tolerance) established under the authority of FFDCA section 408(r) shall be deemed to be a tolerance (or exemption from the requirement of a tolerance) for the purposes of FFDCA section 408(a)(1) or (a)(2) and for the purposes of §180.30.

(b) A request for a temporary tolerance or a temporary exemption from a tolerance by a person who has obtained or is seeking an experimental permit for a pesticide chemical under the Federal Insecticide, Fungicide, and Rodenticide Act shall be accompanied by such data as are available on subjects outlined in §180.7(b) and an advance deposit to cover fees as provided in §180.33.

(c) To obtain a temporary tolerance, a requestor must comply with the petition procedures specified in FFDCA section 408(d) and §180.7 except as provided in this section.

(d) A temporary tolerance or exemption from a tolerance may be issued for a period designed to allow the orderly marketing of the raw agricultural commodities produced while testing a pesticide chemical under an experimental permit issued under authority of the Federal Insecticide, Fungicide, and Rodenticide Act if the Administrator concludes that the safety standard in FFDCA section 408(b)(2) or (c), as applicable, is met. Subject to the requirements of FFDCA section 408(e), a temporary tolerance or exemption from a tolerance may be revoked if the experimental permit is revoked, or may be revoked at any time if it develops that the application for a temporary tolerance contains a misstatement of a material fact or that new scientific data or experience with the pesticide chemical indicates that it does not meet the safety standard in FFDCA section 408(b)(2) or (c), as applicable.

(e) Conditions under which a temporary tolerance is established shall include:

(1) A limitation on the amount of the chemical to be used on the designated crops permitted under the experimental permit.

(2) A limitation for the use of the chemical on the designated crops to bona fide experimental use by qualified persons as indicated in the experimental permit.

(3) A requirement that the person or firm which obtains the experimental permit for which the temporary tolerance is established will immediately inform the Environmental Protection Agency of any reports on findings from the experimental use that have a bearing on safety.

(4) A requirement that the person or firm which obtained the experimental permit for which the temporary tolerance is established will keep records of production, distribution, and performance for a period of 2 years and, on request, at any reasonable time, make these records available to any authorized officer or employee of the Environmental Protection Agency.

[70 FR 33362, June 8, 2005]

§180.32   Procedure for modifying and revoking tolerances or exemptions from tolerances.

(a) The Administrator on his/her own initiative may propose the issuance of a regulation modifying or revoking a tolerance for a pesticide chemical residue on raw agricultural commodities or processed foods or modifying or revoking an exemption from tolerance for such residue.

(b) Any person may file with the Administrator a petition proposing the issuance of a regulation modifying or revoking a tolerance or exemption from a tolerance for a pesticide chemical residue. The petition shall furnish reasonable grounds for the action sought. Reasonable grounds shall include an explanation showing wherein the person has a substantial interest in such tolerance or exemption from tolerance and an assertion of facts (supported by data if available) showing that new uses for the pesticide chemical have been developed or old uses abandoned, that new data are available as to toxicity of the chemical, or that experience with the application of the tolerance or exemption from tolerance may justify its modification or revocation. Evidence that a person has registered or has submitted an application for the registration of a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act will be regarded as evidence that the person has a substantial interest in a tolerance or exemption from the requirement of a tolerance for a pesticide chemical that consists in whole or in part of the pesticide. New data should be furnished in the form specified in §180.7(b) for submitting petitions, as applicable.

(c) The procedures for completing action on an Administrator initiated proposal or a petition shall be those specified in §§180.29 and 180.7, as applicable.

[70 FR 33362, June 8, 2005]

§180.33   Fees.

(a) Each petition for the establishment of a new tolerance or a tolerance higher than already established, shall be accompanied by a fee of $80,950, plus $2,025 for each raw agricultural commodity more than nine on which the establishment of a tolerance is requested, except as provided in paragraphs (b), (d), and (h) of this section.

(b) Each petition for the establishment of a tolerance at a lower numerical level or levels than a tolerance already established for the same pesticide chemical, or for the establishment of a tolerance on additional raw agricultural commodities at the same numerical level as a tolerance already established for the same pesticide chemical, shall be accompanied by a fee of $18,500 plus $1,225 for each raw agricultural commodity on which a tolerance is requested.

(c) Each petition for an exemption from the requirement of a tolerance or repeal of an exemption shall be accompanied by a fee of $14,925.

(d) Each petition or request for a temporary tolerance or a temporary exemption from the requirement of a tolerance shall be accompanied by a fee of $32,325 except as provided in paragraph (e) of this section. A petition or request to renew or extend such temporary tolerance or temporary exemption shall be accompanied by a fee of $4,600.

(e) A petition or request for a temporary tolerance for a pesticide chemical which has a tolerance for other uses at the same numerical level or a higher numerical level shall be accompanied by a fee of $16,075, plus $1,225 for each raw agricultural commodity on which the temporary tolerance is sought.

(f) Each petition for revocation of a tolerance shall be accompanied by a fee of $10,125. Such fee is not required when, in connection with the change sought under this paragraph, a petition is filed for the establishment of new tolerances to take the place of those sought to be revoked and a fee is paid as required by paragraph (a) of this section.

(g) If a petition or a request is not accepted for processing because it is technically incomplete, the fee, less $2,025 for handling and initial review, shall be returned. If a petition is withdrawn by the petitioner after initial processing, but before significant Agency scientific review has begun, the fee, less $2,025 for handling and initial review, shall be returned. If an unacceptable or withdrawn petition is resubmitted, it shall be accompanied by the fee that would be required if it were being submitted for the first time.

(h) Each petition for a crop group tolerance, regardless of the number of raw agricultural commodities involved, shall be accompanied by a fee equal to the fee required by the analogous category for a single tolerance that is not a crop group tolerance, i.e., paragraphs (a) through (f) of this section, without a charge for each commodity where that would otherwise apply.

(i) Objections under section 408(d)(5) of the Act shall be accompanied by a filing fee of $4,050.

(j) The person who files a petition for judicial review of an order under section 408(h) of the Act shall pay the costs of preparing the record on which the order is based unless the person has no financial interest in the petition for judicial review.

(k) No fee under this section will be imposed on the Interregional Research Project Number 4 (IR-4 Program).

(l) The Administrator may waive or refund part or all of any fee imposed by this section if the Administrator determines in his or her sole discretion that such a waiver or refund will promote the public interest or that payment of the fee would work an unreasonable hardship on the person on whom the fee is imposed. A request for waiver or refund of a fee shall be submitted to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b). A fee of $2,025 shall accompany every request for a waiver or refund, as specified in paragraph (m) of this section, except that the fee under this paragraph shall not be imposed on any person who has no financial interest in any action requested by such person under paragraphs (a) through (j) of this section. The fee for requesting a waiver or refund shall be refunded if the request is granted.

(m) All deposits and fees required by the regulations in this part shall be paid by money order, bank draft, or certified check drawn to the order of the Environmental Protection Agency. All deposits and fees shall be forwarded to the Environmental Protection Agency, Headquarters Accounting Operations Branch, Office of Pesticide Programs (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. The payments should be specifically labeled “Tolerance Petition Fees” and should be accompanied only by a copy of the letter or petition requesting the tolerance. The actual letter or petition, along with supporting data, shall be forwarded within 30 days of payment to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b). A petition will not be accepted for processing until the required fees have been submitted. A petition for which a waiver of fees has been requested will not be accepted for processing until the fee has been waived or, if the waiver has been denied, the proper fee is submitted after notice of denial. A request for waiver or refund will not be accepted after scientific review has begun on a petition.

(n) This fee schedule will be changed annually by the same percentage as the percent change in the Federal General Schedule (GS) pay scale. In addition, processing costs and fees will periodically be reviewed and changes will be made to the schedule as necessary. When automatic adjustments are made based on the GS pay scale, the new fee schedule will be published in the Federal Register as a final rule to become effective 30 days or more after publication, as specified in the rule. When changes are made based on periodic reviews, the changes will be subject to public comment.

(o) No fee required by this section shall be levied during the period beginning on October 1, 2003, and ending September 30, 2008.

[68 FR 24371, May 7, 2003, as amended at 69 FR 12544, Mar. 17, 2004; 70 FR 33363, June 8, 2005; 71 FR 35547, June 21, 2006]

§180.34   Tests on the amount of residue remaining.

(a) Data in a petition on the amount of residue remaining in or on a raw agricultural commodity should establish the residue that may remain when the pesticide chemical is applied according to directions registered under the Federal Insecticide, Fungicide, and Rodenticide Act, or according to directions contained in an application for registration. These data should establish the residues that may remain under conditions most likely to result in high residues on the commodity.

(b) The petition should establish the reliability of the residue data reported in it. Sufficient information should be submitted about the analytical method to permit competent analysts to apply it successfully.

(c) If the pesticide chemical is absorbed into a living plant or animal when applied (is systemic), residue data may be needed on each plant or animal on which a tolerance or exemption is requested.

(d) If the pesticide chemical is not absorbed into the living plant or animal when applied (is not systemic), it may be possible to make a reliable estimate of the residues to be expected on each commodity in a group of related commodities on the basis of less data than would be required for each commodity in the group, considered separately.

(e) Each of the following groups of crops lists raw agricultural commodities that are considered to be related for the purpose of paragraph (d) of this section. Commodities not listed in this paragraph are not considered to be related for the purpose of paragraph (d) of this section.

(1) Apples, crabapples, pears, quinces.

(2) Avocados, papayas.

(3) Blackberries, boysenberries, dewberries, loganberries, raspberries.

(4) Blueberries, currants, gooseberries, huckleberries.

(5) Cherries, plums, prunes.

(6) Oranges, citrus citron, grapefruit, kumquats, lemons, limes, tangelos, tangerines.

(7) Mangoes, persimmons.

(8) Peaches, apricots, nectarines.

(9) Beans, peas, soybeans (each in dry form).

(10) Beans, peas, soybeans (each in succulent form).

(11) Broccoli, brussels sprouts, cauliflower, kohlrabi.

(12) Cantaloups, honeydew melons, muskmelons, pumpkins, watermelons, winter squash.

(13) Carrots, garden beets, sugar beets, horseradish, parsnips, radishes, rutabagas, salsify roots, turnips.

(14) Celery, fennel.

(15) Cucumbers, summer squash.

(16) Lettuce, endive (escarole), Chinese cabbage, salsify tops.

(17) Onions, garlic, leeks, shallots (green, or in dry bulb form).

(18) Potatoes, Jerusalem-artichokes, sweetpotatoes, yams.

(19) Spinach, beet tops, collards, dandelion, kale, mustard greens, parsley, Swiss chard, turnip tops, watercress.

(20) Tomatoes, eggplants, peppers, pimentos.

(21) Pecans, almonds, brazil nuts, bush nuts, butternuts, chestnuts, filberts, hazelnuts, hickory nuts, walnuts.

(22) Field corn, popcorn, sweet corn (each in grain form).

(23) Milo, sorghum (each in grain form).

(24) Wheat, barley, oats, rice, rye (each in grain form).

(25) Alfalfa, Bermuda grass, bluegrass, brome grass, clovers, cowpea hay, fescue, lespedeza, lupines, orchard grass, peanut hay, peavine hay, rye grass, soybean hay, sudan grass, timothy, and vetch.

(26) Corn forage, sorghum forage.

(27) Sugarcane, cane sorghum.

[36 FR 22540, Nov. 25, 1971, as amended at 39 FR 28286, Aug. 6, 1974; 39 FR 28977, Aug. 13, 1974; 40 FR 6972, Feb. 18, 1975; 45 FR 82928, Dec. 17, 1980; 48 FR 29860, June 29, 1983; 60 FR 26635, May 17, 1995; 73 FR 75600, Dec. 12, 2008]

§180.35   Tests for potentiation.

Experiments have shown that certain cholinesterase-inhibiting pesticides when fed together to test animals are more toxic than the sum of their individual toxicities when fed separately. One substance potentiates the toxicity of the other. Important toxicological interactions also have been observed between pesticides and other substances. Wherever there is reason to believe that a pesticide chemical for which a tolerance is proposed may interact with other pesticide chemicals or other substances to which man is exposed, it may be necessary to require special experimental data regarding potentiation capacities to evaluate the safety of the proposed tolerance. This necessarily will be determined on a case-by-case basis.

§180.40   Tolerances for crop groups.

(a) Group or subgroup tolerances may be established as a result of:

(1) A petition from a person who has submitted an application for the registration of a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act.

(2) On the initiative of the Administrator.

(3) A petition by an interested person.

(b) The tables in §180.41 are to be used in conjunction with this section for the establishment of crop group tolerances. Each table in §180.41 lists a group of raw agricultural commodities that are considered to be related for the purposes of this section. Refer also to §180.1(g) for a listing of commodities for which established tolerances may be applied to certain other related and similar commodities.

(c) When there is an established or proposed tolerance for all of the representative commodities for a specific group or subgroup of related commodities, a tolerance may be established for all commodities in the associated group or subgroup. Tolerances may be established for a crop group or, alternatively, tolerances may be established for one or more of the subgroups of a crop group.

(d) The representative crops are given as an indication of the minimum residue chemistry data base acceptable to the Agency for the purposes of establishing a group tolerance. The Agency may, at its discretion, allow group tolerances when data on suitable substitutes for the representative crops are available (e.g., limes instead of lemons).

(e) Since a group tolerance reflects maximum residues likely to occur on all individual crops within a group, the proposed or registered patterns of use for all crops in the group or subgroup must be similar before a group tolerance is established. The pattern of use consists of the amount of pesticide applied, the number of times applied, the timing of the first application, the interval between applications, and the interval between the last application and harvest. The pattern of use will also include the type of application; for example, soil or foliar application, or application by ground or aerial equipment. Additionally, since a group tolerance reflects maximum residues likely to occur on all individual foods within a group, food processing practices must be similar for all crops in the group or subgroup if the processing practice has the potential to result in residues in a processed commodity at a higher concentration than the raw agricultural commodity.

(f)(1) General. EPA will not establish a crop group for a pesticide unless all tolerances made necessary by the presence of pesticide residues in the crop group commodities have been issued or are being issued simultaneously with the crop group tolerance. For purposes of paragraph (f)(1):

(i) Necessary tolerances for residues resulting from crop group tolerances include:

(A) Tolerances for processed food, including processed animal feed, to the extent needed under FFDCA section 408(a)(2).

(B) Tolerances for raw commodities not covered by the crop group tolerance that are derivative of commodities in the group.

(C) Tolerances for meat, milk, or egg products that may contain residues as a result of livestock's consumption of animal feed containing pesticide residues to the extent needed under §180.6(b).

(ii) Notwithstanding the foregoing, a tolerance is not considered necessary for processed food, derivative raw commodities, or meat, milk, and eggs if the precursor raw commodities are grown solely for sale as raw commodities and are completely segregated from commodities grown for the purpose of producing processed foods, derivative raw commodities, and commodities, or fractions thereof, that are used as animal feed.

(2) Processed commodity and related raw commodity crop group tolerances. EPA may establish crop group tolerances for processed commodities or fractions of commodities (e.g., bran and flour from the Cereal Grains Group), including processed fractions used as animal feed (e.g., pomace from the Pome Fruit Group), produced from crops in the crop groups in §180.41. EPA may establish crop group tolerances for raw commodities or fractions of commodities, including fractions used as animal feed, derived from commodities covered by the crop groups in §180.41 (e.g., aspirated grain dust associated with the Cereal Grains Group). Crop group tolerances on processed foods and derivative raw commodities may be based on data on representative commodities for associated crop group. Paragraphs (c), (d), (e), (g), and (h) of §180.40 apply to group tolerances authorized by paragraph (f)(2).

(3) Representative crops. Unless indicated otherwise in §§180.40 and 180.41, the processed food and feed forms of the representative crops for a crop group are considered to be representative of the processed food and feed forms and any derivative raw commodities not covered by the crop group, that are produced from any of the raw agricultural commodities covered by the crop group tolerance. Additionally, unless indicated otherwise in §§180.40 and 180.41, representative commodities for such crop groups are selected taking into consideration whether their use as animal feed will result in residues in or on meat, milk, and/or eggs at a level representative of the residues that would result from use of the other commodities or byproducts in the crop group as an animal feed.

(4) Data. Processing data on representative crops are required prior to establishment of a group tolerance if the processing of the representative commodity has the potential to result in residues in a processed commodity at a higher concentration than in the representative commodity. Residue data are required on raw commodities derived from the crops in the crop group tolerance but not directly covered by the tolerance. Animal feeding studies with a representative crop are required if the representative crop is used as a significant animal feed.

(g) If maximum residues (tolerances) for the representative crops vary by more than a factor of 5 from the maximum value observed for any crop in the group, a group or subgroup tolerance will ordinarily not be established. In this case individual crop tolerances, rather than group tolerances, will normally be established.

(h) Alternatively, a commodity with a residue level significantly higher or lower than the other commodities in a group may be excluded from the group tolerance (e.g., cereal grains, except corn). In this case an individual tolerance at the appropriate level for the unique commodity would be established, if necessary. The alternative approach of excluding a commodity with a significantly higher or lower residue level will not be used to establish a tolerance for a commodity subgroup. Most subgroups have only two representative commodities; to exclude one such commodity and its related residue data would likely provide insufficient residue information to support the remainder of the subgroup. Residue data from crops additional to those representative crops in a grouping may be required for systemic pesticides.

(i) The commodities included in the groups will be updated periodically either at the initiative of the Agency or at the request of an interested party. Persons interested in updating this section should contact the Registration Division of the Office of Pesticide Programs.

(j) When EPA amends a crop group in a manner that expands or contracts the commodities that are covered by the group, EPA will initially retain the pre-existing as well as the revised crop group in the CFR. The revised crop group will have the same number as the pre-existing crop group; however, the revised crop group number will be followed by a hyphen and the final two digits of the year in which it was established (e.g., if Crop Group 1 is amended in 2007, the revised group will be designated as Crop Group 1-07). If the pre-existing crop group had crop subgroups, these subgroups will be numbered in a similar fashion in the revised crop group. The name of the revised crop group will not be changed from the pre-existing crop group unless the revision so changes the composition of the crop group that the pre-existing name is no longer accurate. Once a revised crop group is established, EPA will no longer establish tolerances under the pre-existing crop group. At appropriate times, EPA will amend tolerances for crop groups that have been superseded by revised crop groups to conform the pre-existing crop group to the revised crop group. Once all of the tolerances for the pre-existing crop group have been updated, the pre-existing crop group will be removed from the CFR.

(k) Establishment of a tolerance does not substitute for the additional need to register the pesticide under a companion law, the Federal Insecticide, Fungicide, and Rodenticide Act. The Registration Division of the Office of Pesticide Programs should be contacted concerning procedures for registration of new uses of a pesticide.

[60 FR 26635, May 17, 1995, as amended at 70 FR 33363, June 8, 2005; 72 FR 69155, Dec. 7, 2007; 75 FR 56014, Sept. 15, 2010; 81 FR 26476, May 3, 2016]

§180.41   Crop group tables.

(a) The tables in this section are to be used in conjunction with §180.40 to establish crop group tolerances.

(b) Commodities not listed are not considered as included in the groups for the purposes of paragraph (b), and individual tolerances must be established. Miscellaneous commodities intentionally not included in any group include globe artichoke, hops, peanut, and water chestnut.

(c) Each group is identified by a group name and consists of a list of representative commodities followed by a list of all commodity members for the group. If the group includes subgroups, each subgroup lists the subgroup name, the representative commodity or commodities, and the member commodities for the subgroup. Subgroups, which are a subset of their associated crop group, are established for some but not all crops groups.

(1) Crop Group 1: Root and Tuber Vegetables Group.

(i) Representative commodities. Carrot, potato, radish, and sugar beet.

(ii) Table. The following table 1 lists all the commodities included in Crop Group 1 and identifies the related crop subgroups.

(iii) Table. The following table 2 identifies the crop subgroups for Crop Group 1, specifies the representative commodity(ies) for each subgroup, and lists all the commodities included in each subgroup.

(2) Crop Group 2. Leaves of Root and Tuber Vegetables (Human Food or Animal Feed) Group (Human Food or Animal Feed) Group.

(i) Representative commodities. Turnip and garden beet or sugar beet.

(ii) Commodities. The following is a list of all the commodities included in Crop Group 2:

(3) Crop Group 3. Bulb Vegetables (Allium spp.) Group.

(i) Representative commodities. Onion, green; and onion, dry bulb.

(ii) Commodities. The following is a list of all the commodities in Crop Group 3.

(4) Crop Group 3-07. Bulb Vegetable Group.

(i) Representative Commodities. Onion, bulb and onion, green.

(ii) Table. The following Table 1 lists all the commodities listed in Crop Group 3-07 and identifies the related crop subgroups.

(iii) Table. The following Table 2 identifies the crop subgroups for Crop Group 3-07, specifies the representative commodities for each subgroup and lists all the commodities included in each subgroup.

(5) Crop Group 4. Leafy Vegetables (Except Brassica Vegetables) Group.

(i) Representative commodities. Celery, head lettuce, leaf lettuce, and spinach (Spinacia oleracea).

(ii) Table. The following table 1 lists all the commodities included in Crop Group 4 and identifies the related crop subgroups.

(iii) Table. The following table 2 identifies the crop subgroups for Crop Group 4, specifies the representative commodities for each subgroup, and lists all the commodities included in each subgroup.

(6) Crop Group 4-16. Leafy Vegetable Group.

(i) Representative commodities. Head lettuce, leaf lettuce, mustard greens, and spinach.

(ii) Commodities. The following Table 1 lists all commodities included in Crop Group 4-16.

(iii) Crop subgroups. The following Table 2 identifies the crop subgroups for Crop Group 4-16, specifies the representative commodities for each subgroup, and lists all the commodities included in each subgroup.

(7) Crop Group 5. Brassica (Cole) Leafy Vegetables Group.

(i) Representative commodities. Broccoli or cauliflower; cabbage; and mustard greens.

(ii) Table. The following table 1 lists all the commodities included in Crop Group 5 and identifies the related crop subgroups.

(iii) Table. The following table 2 identifies the crop subgroups for Crop Group 5, specifies the representative commodity(ies) for each subgroup, and lists all the commodities included in each subgroup.

(8) Crop Group 5-16. Brassica Head and Stem Vegetable Group.

(i) Representative commodities. Broccoli or cauliflower and cabbage.

(ii) Commodities. The following List 1 contains all commodities included in Crop Group 5-16.

(9) Crop Group 6. Legume Vegetables (Succulent or Dried) Group.

(i) Representative commodities. Bean (Phaseolus spp.; one succulent cultivar and one dried cultivar); pea (Pisum spp.; one succulent cultivar and one dried cultivar); and soybean.

(ii) Table. The following table 1 lists all the commodities included in Crop Group 6 and identifies the related crop subgroups.

(iii) Table. The following table 2 identifies the crop subgroups for Crop Group 6, specifies the representative commodities for each subgroup, and lists all the commodities included in each subgroup.

(10) Crop Group 7. Foliage of Legume Vegetables Group.

(i) Representative commodities. Any cultivar of bean (Phaseolus spp.), field pea (Pisum spp.), and soybean.

(ii) Table. The following table 1 lists the commodities included in Crop Group 7.

(iii) Table. The following table 2 identifies the crop subgroup for Crop Group 7 and specifies the representative commodities for the subgroup, and lists all the commodities included in the subgroup.

(11) Crop Group 8. Fruiting Vegetables Group.

(i) Representative commodities. Tomato, bell pepper, and one cultivar of non-bell pepper.

(ii) Commodities. The following is a list of all the commodities included in Crop Group 8:

(12) Crop Group 8-10. Fruiting Vegetable Group.

(i) Representative commodities. Tomato, standard size, and one cultivar of small tomato; bell pepper and one cultivar of small nonbell pepper.

(ii) Commodities. The following is a list of all commodities included in the Crop group 8-10.

(iii) Table. The following Table 2 identifies the crop subgroups for Crop Group 8-10, specifies the representative commodities for each subgroup and lists all the commodities included in each subgroup.

(13) Crop Group 9. Cucurbit Vegetables Group.

(i) Representative commodities. Cucumber, muskmelon, and summer squash.

(ii) Table. The following table 1 lists all the commodities included in Crop Group 9 and identifies the related subgroups.

(iii) Table. The following table 2 identifies the crop subgroups for Crop Group 9, specifies the representative commodities for each subgroup, and lists all the commodities included in each subgroup.

(14) Crop Group 10. Citrus Fruit Group.

(i) Representative commodities. Sweet orange; lemon and grapefruit.

(ii) Commodities. The following is a list of all the commodities in Crop Group 10:

(15) Crop Group 10-10. Citrus Fruit Group.

(i) Representative commodities. Orange or Tangerine/Mandarin, Lemon or Lime, and Grapefruit.

(ii) Commodities. The following is a list of all the commodities in Crop Group 10-10.

(iii) Table. The following Table 2 identifies the crop subgroups for Crop Group 10-10, specifies the representative commodities for each subgroup and lists all the commodities included in each subgroup.

(16) Crop Group 11: Pome Fruits Group.

(i) Representative commodities. Apple and pear.

(ii) Commodities. The following is a list of all the commodities included in Crop Group 11:

(17) Crop group 11-10. Pome Fruit Group.

(i) Representative commodities. Apple and Pear

(ii) Commodities. The following is a list of all the commodities in Crop Group 11-10.

(18) Crop Group 12. Stone Fruits Group.

(i) Representative commodities. Sweet cherry or tart cherry; peach; and plum or fresh prune (Prunus domestica, Prunus spp.)

(ii) Commodities. The following is a list of all the commodities included in Crop Group 12:

(19) Crop Group 12-12: Stone Fruit Group.

(i) Representative commodities. Sweet cherry or Tart cherry; Peach; and Plum or Prune plum.

(ii) Commodities. The following Table 1 is a list of all commodities included in Crop Group 12-12.

(iii) Crop subgroups. The following Table 2 identifies the crop subgroups for Crop Group 12-12, specifies the representative commodities for each subgroup, and lists all the commodities included in each subgroup.

(20) Crop Group 13. Berries Group.

(i) Representative commodities. Any one blackberry or any one raspberry; and blueberry.

(ii) Table. The following table 1 lists all the commodities included in Crop Group 13 and identifies the related subgroups.

(iii) Table. The following table 2 identifies the crop subgroups for Crop Group 13, specifies the representative commodities for each subgroup, and lists all the commodities included in each subgroup.

(21) Crop Group 13-07. Berry and Small Fruit Crop Group

(i) Representative commodities. Any one blackberry or any one raspberry; highbush blueberry; elderberry or mulberry; grape; fuzzy kiwifruit, and strawberry.

(ii) Table. The following Table 1 lists all the commodities listed in Crop Group 13-07 and identifies the related crop subgroups.

(iii) Table. The following Table 2 identifies the crop subgroups for Crop Group 13-07, specifies the representative commodities for each subgroup and lists all the commodities included in each subgroup.

(22) Crop Group 14. Tree Nuts Group.

(i) Representative commodities. Almond and pecan.

(ii) Commodities. The following is a list of all the commodities included in Crop Group 14:

(23) Crop Group 14-12. Tree Nut Group.

(i) Representative commodities. Almond and Pecan.

(ii) Commodities. The following is a list of all commodities included in Crop Group 14-12.

(24) Crop Group 15. Cereal Grains Group.

(i) Representative commodities. Corn (fresh sweet corn and dried field corn), rice, sorghum, and wheat.

(ii) Commodities. The following is a list of all the commodities included in Crop Group 15:

(25) Crop Group 16. Forage, Fodder and Straw of Cereal Grains Group.

(i) Representative commodities. Corn, wheat, and any other cereal grain crop.

(ii) Commodities. The commodities included in Crop Group 16 are: Forage, fodder, stover, and straw of all commodities included in the group cereal grains group. EPA may establish separate group tolerances on forage, fodder, hay, stover, or straw, if data on the representative commodities indicate differences in the levels of residues on forage, fodder, stover, or straw.

(26) Crop Group 17. Grass Forage, Fodder, and Hay Group.

(i) Representative commodities. Bermuda grass; bluegrass; and bromegrass or fescue.

(ii) Commodities. The commodities included in Crop Group 17 are: Forage, fodder, stover, and hay of any grass, Gramineae/Poaceae family (either green or cured) except sugarcane and those included in the cereal grains group, that will be fed to or grazed by livestock, all pasture and range grasses and grasses grown for hay or silage. EPA may establish separate group tolerances on forage, fodder, stover, or hay, if data on the representative commodities indicate differences in the levels of residues on forage, fodder, stover, or hay.

(27) Crop Group 18. Nongrass Animal Feeds (Forage, Fodder, Straw, and Hay) Group.

(i) Representative commodities. Alfalfa and clover (Trifolium spp.)

(ii) Commodities. EPA may establish separate group tolerances on forage, fodder, straw, or hay, if data on the representative commodities indicate differences in the levels of residues on forage, fodder, straw, or hay. The following is a list of all the commodities included in Crop Group 18:

(28) Crop Group 19. Herbs and Spices Group.

(i) Representative commodities. Basil (fresh and dried); black pepper; chive; and celery seed or dill seed.

(ii) Table. The following table 1 lists all the commodities included in Crop Group 19 and identifies the related subgroups.

(iii) Table. The following table 2 identifies the crop subgroups for Crop Group 19, specifies the representative commodities for each subgroup, and lists all the commodities included in each subgroup.

(29) Crop Group 20. Oilseed Group.

(i) Representative commodities. Rapeseed (canola varieties only); sunflower, seed and cottonseed.

(ii) Table. The following Table 1 lists all the commodities listed in Crop Group 20 and identifies the related crop subgroups and includes cultivars and/or varieties of these commodities.

(iii) Table. The following Table 2 identifies the crop subgroups for Crop Group 20, specifies the representative commodities for each subgroup and lists all the commodities included in each subgroup.

(30) Crop Group 21. Edible fungi Group.

(i) Representative commodities. White button mushroom and any one oyster mushroom or any Shiitake mushroom.

(ii) Table. The following is a list of all the commodities in Crop Group 21. There are no related subgroups.

(31) Crop Group 22. Stalk, Stem and Leaf Petiole Vegetable Group.

(i) Representative commodities. Asparagus and celery.

(ii) Commodities. The following Table 1 lists all commodities included in Crop Group 22.

(iii) Crop subgroups. The following Table 2 identifies the crop subgroups for Crop Group 22, specifies the representative commodities for each subgroup, and lists all the commodities included in each subgroup.

(32) Crop Group 23. Tropical and Subtropical Fruit, Edible Peel Group.

(i) Representative commodities. Date, fig, guava, and olive.

(ii) Commodities. The following Table 1 lists all commodities included in Crop Group 23.

(iii) Table. The following Table 2 identifies the crop subgroups for Crop Group 23, specifies the representative commodities for each subgroup, and lists all the commodities included in each subgroup.

(33) Crop Group 24. Tropical and Subtropical Fruit, Inedible Peel Group.

(i) Representative commodities. Atemoya or sugar apple, avocado, banana or pomegranate, dragon fruit, lychee, passionfruit, pineapple, and prickly pear, fruit.

(ii) Commodities. The following Table 1 lists all commodities included in Crop Group 24.

(iii) Table. The following Table 2 identifies the crop subgroups for Crop Group 24, specifies the representative commodities for each subgroup, and lists all the commodities included in each subgroup.

[60 FR 26635, May 17, 1995, as amended at 72 FR 69156, 69157, Dec. 7, 2007; 73 FR 52, Jan. 2, 2008; 75 FR 76289, Dec. 8, 2010; 77 FR 50620, Aug. 22, 2012; 81 FR 26477, May 3, 2016]

Subpart C—Specific Tolerances

§180.101   Specific tolerances; general provisions.

(a) The tolerances established for pesticide chemicals in this subpart C apply to residues resulting from their application prior to harvest or slaughter, unless otherwise stated. Tolerances are expressed in terms of parts by weight of the pesticide chemical per one million parts by weight of the raw agricultural commodity.

(b) The poisonous and deleterious substances for which tolerances are established by the regulations in this subpart C are named by their common names wherever practicable, otherwise by their chemical names.

(c) The analytical methods to be used for determining whether pesticide residues, including negligible residues, in or on raw agricultural commodities are in compliance with the tolerances established in this part 180 are identified among the methods contained or referenced in the Food and Drug Administration's “Pesticide Analytical Manual” which is available from the Food and Drug Administration, Department of Health, Education, and Welfare, 200 C Street SW., Washington, DC 20204.

§180.103   Captan; tolerances for residues.

(a)(1) General. Tolerances are established for residues of the fungicide, captan (N-trichloromethylthio-4-cyclohexene-1,2-dicarboximide) in or on the following commodities:

(2) Tolerances are established for the combined residues of the fungicide, captan (N-trichloromethylthio-4-cyclohexene-1,2-dicarboximide) and its metabolite 1,2,3,6-tetrahydrophthalimide (THPI), measured at THPI, in or on the following commodities:

(b) Section 18 emergency exemptions. [Reserved]

(c) Tolerances with regional registrations. [Reserved]

(d) Indirect or inadvertent residues. [Reserved]

[72 FR 52016, Sept. 12, 2007]

§180.106   Diuron; tolerances for residues.

(a) General. Tolerances are established for the combined residues of the herbicide diuron, 3-(3,4-dichlorophenyl)-1,1-dimethylurea and its metabolites convertible to 3,4-dichloroaniline in or on food commodities, as follows:

(b) Section 18 emergency exemptions. [Reserved]

(c) Tolerances with regional registrations. Tolerances with a regional registration as defined in §180.1(l) are established for the combined residues of the herbicide diuron (3-(3,4-dichlorophenyl)-1,1-dimethylurea and its metabolites convertible to 3,4-dichloroaniline) in or on the raw agricultural commodities:

(d) Indirect or inadvertent residues. [Reserved]

[63 FR 2164, Jan. 14, 1998, as amended at 63 FR 57072, Oct. 26, 1998; 64 FR 41305, July 30, 1999; 66 FR 28671, May 24, 2001; 67 FR 46883, July 17, 2002; 69 FR 71717, Dec. 10, 2004; 72 FR 32540, June 13, 2007; 72 FR 35666, June 29, 2007; 73 FR 54958, Sept. 24, 2008; 76 FR 34885, June 15, 2011]

§180.107   Triflumezopyrim; tolerance for residues.

(a) General. Tolerances are established for residues of the insecticide triflumezopyrim, including its metabolites and degradates, in or on the following food commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only triflumezopyrim (2,4-dioxo-1-(5-pyrimidinylmethyl)-3-[3-(trifluoromethyl)phenyl]-2H-pyrido[1,2-a] pyrimidinium inner salt) in or on the commodity.

(b) Section 18 emergency exemptions. [Reserved]

(c) Tolerances with regional registrations. [Reserved]

(d) Indirect or inadvertent residues. [Reserved]

[82 FR 48005, Oct. 16, 2017]

§180.108   Acephate; tolerances for residues.

(a) General. (1) Tolerances are established for residues of acephate, O,S-dimethyl acetyl phosphoramidothioate, including its metabolites and degradates other than methamidophos, in or on the commodities in the following table. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only acephate, O,S-dimethyl acetyl phosphoramidothioate, in or on the commodity.

(2) A tolerance of 0.02 ppm is established for residues of acephate, O,S-dimethyl acetyl phosphoramidothioate, including its metabolites and degradates other than methamidophos, in or on all food items (other than those already covered by a higher tolerance as a result of use on growing crops) in food handling establishments where food and food products are held, processed, prepared and served, including food service, manufacturing and processing establishments, such as restaurants, cafeterias, supermarkets, bakeries, breweries, dairies, meat slaughtering and packing plants, and canneries, where application of acephate shall be limited solely to spot and/or crack and crevice treatment (a coarse, low-pressure spray shall be used to avoid atomization or splashing of the spray for spot treatments; equipment capable of delivering a pin-stream of insecticide shall be used for crack and crevice treatments). Spray concentration shall be limited to a maximum of 1.0 percent active ingredient. Contamination of food or food-contact surfaces shall be avoided. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only acephate, O,S-dimethyl acetyl phosphoramidothioate, in or on the commodity.

(3) Tolerances are established for residues of methamidophos, O,S-dimethyl phosphoramidothioate, including its metabolites and degradates, in or on the commodities in the following table as a result of the application of acephate. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only methamidophos, O,S-dimethyl phosphoramidothioate, in or on the commodity.

(b) Section 18 emergency exemptions. [Reserved]

(c) Tolerances with regional registrations. A tolerance with a regional registration is established for residues of acephate, O,S-dimethyl acetyl phosphoramidothioate, including its metabolites and degradates other than methamidophos, in or on the commodity in the following table. Compliance with the tolerance level specified in this paragraph is to be determined by measuring only acephate, O,S-dimethyl acetyl phosphoramidothioate, in or on the commodity.

(d) Indirect or inadvertent residues. [Reserved]

[63 FR 13542, Mar. 20, 1998, as amended at 67 FR 49615, July 31, 2002; 73 FR 5108, Jan. 29, 2008; 75 FR 60237, Sept. 29, 2010; 81 FR 34905, June 1, 2016]

§180.109   Fenpicoxamid; Tolerances for residues.

(a) General. Tolerances are established for residues of fenpicoxamid including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels for fenpicoxamid is to be determined by measuring only fenpicoxamid ([[4-methoxy-2-[[[(3S,7R,8R,9S)-9-methyl-8-(2-methyl-1-oxopropoxy)-2,6-dioxo-7-(phenylmethyl)-1,5-dioxonan-3-yl]amino]carbonyl]-3-pyridinyl]oxy]methyl 2-methylpropanoate) in or on the commodity.

(b) Section 18 emergency exemptions. [Reserved]

(c) Tolerances with regional registrations. [Reserved]

(d) Indirect or inadvertent residues. [Reserved]

[82 FR 48000, Oct. 16, 2017]

§180.111   Malathion; tolerances for residues.

(a) General. (1) Tolerances are established for residues of the insecticide malathion (O,O-dimethyl dithiophosphate of diethyl mercaptosuccinate) in or on the following food commodities:

(2) Tolerances are established for the combined residues of the insecticide malathion (O,O-dimethyl dithiophosphate of diethyl mercaptosuccinate) and its metabolite, malaoxon (O,O-dimethyl thiophosphate of diethyl mercaptosuccinate), in or on the following food commodities:

(3) Tolerances are established for residues of the insecticide malathion (O,O-dimethyl dithiophosphate of diethyl mercaptosuccinate), in or on the following food commodities:

(4) Malathion may be safely used in accordance with the following conditions:

(i) It is incorporated into paper trays in amounts not exceeding 100 milligrams per square foot.

(ii) Treated paper trays are intended for use only in the drying of grape (raisins).

(iii) Total residues of malathion resulting from drying of grape on treated trays and from application to grape before harvest shall not exceed 12 parts per million on processed ready-to-eat raisins.

(5) Residues of malathion in safflower, refined oil from application to the growing safflower plant shall not exceed 0.6 parts per million.

(6) Malathion may be safely used for the control of insects during the drying of grape (raisins) in compliance with paragraph (a)(4) of this section by incorporation into paper trays in amounts not exceeding 100 milligrams per square foot.

(7) Malathion (O,O-dimethyl dithiophosphate of diethyl mercaptosuccinate) may be safely used in feed in accordance with the following conditions.

(i) A tolerance of 50 parts per million is established for residues of malathion in citrus, dried pulp for cattle feed, when present as the result of the application of the pesticide to bagged citrus pulp during storage. Whether or not tolerances for residues of malathion on the fresh fruit have been established under section 408 of the Act, the total residue of malathion in the citrus, dried pulp shall not exceed 50 parts per million.

(ii) A tolerance of 10 parts per million is established for malathion in nonmedicated cattle feed concentrate blocks resulting from its application as a pesticide to paper used in packaging the nonmedicated cattle feed concentrate blocks.

(b) Section 18 emergency exemptions. [Reserved]

(c) Tolerances with regional registrations. [Reserved]

(d) Indirect or inadvertent residues. [Reserved]

[43 FR 22974, May 30, 1978, as amended at 43 FR 45584, Oct. 3, 1978; 44 FR 38844, July 3, 1979; 45 FR 76145, Nov. 18, 1980; 47 FR 42738, Sept. 29, 1982; 47 FR 55226, Dec. 8, 1982; 52 FR 45183, Nov. 25, 1987; 62 FR 66023, 66025, Dec. 17, 1997; 65 FR 33694, May 24, 2000; 72 FR 35665, June 29, 2007; 73 FR 54959, Sept. 24, 2008; 74 FR 47455, Sept. 16, 2009; 75 FR 60238, Sept. 29, 2010]

§180.114   Ferbam; tolerances for residues.

(a) General. Tolerances are established for residues of the fungicide ferbam (ferric dimethyldithiocarbamate), calculated as carbon disulfide, in or on the following food commodities: