§ 180.40 - Tolerances for crop groups.

§ 180.40 Tolerances for crop groups.

Cross Reference

Link to an amendment published at 85 FR 70984, Nov. 6, 2020.

(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)

(1) 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

(2) Where the revised crop group

will have

has 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.

(3) Where EPA amends a crop group by creating one or more different crop groups, the revised crop groups will have different numbers and names (e.g., the amendment of Crop Group 19 through the creation of Crop Groups 25 and 26). The pre-existing crop group will be amended to identify the revised crop group(s).

(4) 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; 85 FR 70984, Nov. 6, 2020]