Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of peanuts, tree nuts, milk, soybeans, eggs, fish, crustacea, and/or wheat when used as inert or active ingredients in pesticide products, for certain use patterns, under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996. The Agency is acting on its own initiative.
This regulation is effective on January 7, 2005.
To submit a written objection or hearing request follow the detailed instructions as provided in Unit IV. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under Docket identification (ID) number OPP–2005–0001. All documents in the docket are listed in the EDOCKET index at
Kathryn Boyle, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–6304; fax number: (703) 305–0599; e-mail address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
• Industry (NAICS code 111), e.g., Crop production
• Industry (NAICS code 32532), e.g., Pesticide manufacturing.
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
In addition to using EDOCKET
This final rule is issued under section 408 of FFDCA, 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104–170). Section 408(e) of FFDCA authorizes EPA to establish, modify, or revoke tolerances, or exemptions from the requirement of a tolerance for residues of pesticide chemicals in or on raw agricultural commodities and processed foods.
In the
One comment was received from a private citizen opposing the establishment of this exemption, particularly the animal feed-through use, but the commentor gave no reason for opposing the exemption other than a general objection to pesticides. The Agency recognizes that some individuals believe that pesticides should be banned completely. However, under the existing legal framework provided by section 408(e) of FFDCA, EPA can establish or modify pesticide tolerances or exemptions by demonstrating that the pesticide meets the safety standard imposed by that statute. The commentor has not provided the Agency with a specific rationale or additional information pertaining to the legal standards in FFDCA Section 408 for opposing the establishment of a tolerance exemption for residues of peanuts, tree nuts, milk, soybeans, eggs, fish, crustacea, and/or wheat. In the absence of any additional information of a factual nature, the Agency can not respond further to the commentor's disagreement with the Agency's decision.
A late comment was received from the Monterey Chemical Company requesting that the use patterns specified in the proposed rule be changed to include the use on bearing citrus. The requester indicated their belief that because of the washing and waxing of the harvested crop that it would be “unlikely that any residue of casein would remain on the harvested crop.” The Agency has considered the commentor's request, but believes that additional information is needed. The casein is being intentionally used as a sticking agent, that is, the casein is formulated to stick to the surface of the developing citrus fruit. The Agency simply does not know if the casein would be degraded in the environment by sunlight or by microflora, or if the casein would still be present on the surface of the fruit after washing. If the Agency were in possession of data (for example, casein-specific enzyme-linked immunosorbent assays (ELISA) wipe tests performed on citrus fruits as harvested, and as washed and waxed with detection levels of less than 10 ppm), then its ability to make a determination would increase.
While not as a result of a public comment, the Agency is also formally including the term putrescent eggs within the definition of eggs, even though putrescent eggs would not be considered as a food commodity. It is a long-standing practice of the Pesticides Program to accept the use of the term putrescent eggs as being included under the descriptor egg solids (whole). In fact, putrescent whole egg solids are a minimum risk active ingredient per 40 CFR 152.25(f)(1).
Based on the reasons set forth in the preamble to the proposed rule, and considering the comments received by the Agency in response to the proposed rule, EPA is establishing a tolerance exemption for residues of peanuts, tree nuts, milk (including casein), soybeans, eggs (including putrescent egg solids), fish, crustacea, and/or wheat when used according to the use patterns as specified by the Agency as being unlikely to result in residues of an allergen-containing material mixed-in with other (different) food commodities as a result of a pesticide application.
Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of the FFDCA, as was provided in the old FFDCA sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.
You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP–2005–0001 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before March 8, 2005.
1.
Mail your written request to: Office of the Hearing Clerk (1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. You may also deliver your request to the Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., Washington, DC 20005. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 564–6255.
2.
A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).
This final rule establishes an exemption from the tolerance requirement under section 408(e) of the FFDCA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled
This final rule establishes new tolerance exemptions in 40 CFR 180.1071. Establishing a new tolerance exemption permits expanded use of pesticide products and thus has a positive economic impact. Under section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practices and procedures, Pesticides and pests, Reporting and recordkeeping requirements.
21 U.S.C. 321(q), 346a and 371.
(a)
(1) Use in pesticide products intended to treat seeds.
(2) Use in nursery and greenhouse operations, as defined in 40 CFR 170.3, which includes seeding, potting and transplanting activities.
(3) Pre-plant and at-transplant applications.
(4) Incorporation into seedling and planting beds.
(5) Applications to cuttings and bare roots.
(6) Applications to the field that occur after the harvested crop has been removed.
(7) Soil-directed applications around and adjacent to all plants.
(8) Applications to rangelands, which is land, mostly grasslands, whose plants can provide food (i.e., forage) for grazing or browsing animals.
(9) Use in chemigation and irrigation systems (via flood, drip, or furrow application with no overhead spray applications).
(10) Application as part of a dry fertilizer on which an active ingredient is impregnated.
(11) Aerial and ground applications that occur when no above-ground harvestable food commodities are present (usually pre-bloom).
(12) Application as part of an animal feed-through product.
(13) Applications as gel and solid (non-liquid/non-spray) crack and crevice treatments that place the gel or bait directly into or on top of the cracks and crevices via a mechanism such as a syringe.
(14) Applications to the same crop from which the food commodity is derived, whether the plant fraction(s) intended for harvest are present or not, e.g., applications of peanut meal when applied to peanut plants.
(b)