Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: p-chlorophenoxyacetic acid, glyphosate, difenzoquat, and hexazinone,
[Federal Register: September 27, 2006 (Volume 71, Number 187)]
[Rules and Regulations]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
p-Chlorophenoxyacetic acid, Glyphosate, Difenzoquat, and Hexazinone; Tolerance Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: EPA is revoking certain tolerances for the plant growth regulator p-chlorophenoxyacetic acid and the herbicide hexazinone. Also, EPA is modifying certain tolerances for the plant growth regulator p-chlorophenoxyacetic acid and the herbicides glyphosate, difenzoquat, and hexazinone. In addition, EPA is establishing new tolerances for the herbicides difenzoquat and hexazinone.
DATES: This regulation is effective September 27, 2006. Objections and requests for hearings must be received on or before November 27, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2006-0036. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business
Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available
in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Jane Smith, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-0048; e-mail address: firstname.lastname@example.org.
Does this Action Apply to Me?
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:
Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.
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 FOR FURTHER INFORMATION CONTACT.
How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you may access this ``Federal Register'' document
electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr .
Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, as amended by 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. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0036 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 November 27, 2006.
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0036, by one of the following methods.
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.
What Action is the Agency Taking?
In the Federal Register of June 7, 2006 (71 FR 32899) (FRL-8062-7), EPA issued a proposed rule to revoke, remove, modify, and establish certain tolerances and/or tolerance exemptions for residues of the plant growth regulator p-chlorophenoxyacetic acid and the herbicides glyphosate, difenzoquat, and hexazinone. The proposal of June 7, 2006 also provided a 60-day comment period which invited public comment for consideration and for support of tolerance retention under FFDCA standards. EPA is revoking, removing, modifying, and establishing specific tolerances for residues of the plant growth regulator p- chlorophenoxyacetic acid and the herbicides glyphosate, difenzoquat, and hexazinone in or on commodities listed in the regulatory text.
EPA is finalizing these tolerance actions in order to implement the tolerance recommendations made during the reregistration and tolerance reassessment processes (including follow-up on canceled or additional uses of pesticides). As part of reregistration and when taking action on tolerances and exemptions, EPA is required to determine whether each of the amended tolerances or exemptions meets the safety standards under FQPA. The safety finding determination of ``reasonable certainty of no harm'' is found in detail in each RED and TRED for the active ingredient. REDs and TREDs recommend certain tolerance actions to be implemented to reflect current use patterns, to meet safety findings, and change commodity names and groupings in accordance with new EPA policy. Printed copies of REDs and TREDs may be obtained from EPA's National Service Center for Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH 45242-2419; telephone number: 1-800-490- 9198; fax number: 1-513-489-8695; Internet address: http://www.epa.gov/ncepihom and from the National Technical Information Service (NTIS),
5285 Port Royal Rd., Springfield, VA 22161; telephone number: 1-800- 553-6847 or (703) 605-6000; Internet address: http://www.ntis.gov.
Electronic copies of REDs and TREDs are available on the internet at http://www.epa.gov/pesticides/reregistration/status.htm.
In this final rule, EPA is revoking certain tolerances and tolerance exemptions because these specific tolerances and exemptions correspond to uses no longer current or registered under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in the United States. The tolerances revoked by this final rule are no longer necessary to cover residues of the relevant pesticides in or on domestically treated commodities or commodities treated outside but imported into the United States. It is EPA's general practice to revoke those tolerances and tolerance exemptions for residues of pesticide active ingredients on crop uses for which there are no active registrations under FIFRA, unless any person in comments on the proposal indicates a need for the tolerance or tolerance exemption to cover residues in or on imported commodities or domestic commodities legally treated.
EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Thus, it is EPA's policy to issue a final rule revoking those tolerances for residues of pesticide chemicals for which there are no active registrations under FIFRA, unless any person commenting on the proposal demonstrates a need for the tolerance to cover residues in or on imported commodities or domestic commodities legally treated.
Generally, EPA will proceed with the revocation of these tolerances on the grounds discussed in Unit II.A. if one of the following conditions applies:
-- Prior to EPA's issuance of a FFDCA section 408(f) order requesting additional data or issuance of a FFDCA section 408(d) or (e) order revoking the tolerances on other grounds, commenters retract the comment identifying a need for the tolerance to be retained.
-- EPA independently verifies that the tolerance is no longer needed.
-- The tolerance is not supported by data that demonstrate that the tolerance meets the requirements under FQPA.
This final rule does not revoke those tolerances for which EPA received comments stating a need for the tolerance to be retained. In response to the proposal published in the Federal Register of June 7, 2006, EPA received three comments during the 60-day public comment period, as follows:
Comment. A comment was received from a private citizen that expressed concern with pesticide residues in general and that animals should eat quality foods. The individual stated that pesticide residue levels should be zero. Agency response. The private citizen's comment did not take issue with the Agency's conclusion that certain tolerances should be revoked. It is EPA's general practice to propose revocation of tolerances for residues of pesticide active ingredients on crop uses for which FIFRA registrations no longer exist. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States.
Hexazinone. Comment. A comment was received from DuPont Crop Protection who requested that the current regional tolerances on sugarcane, cane and sugarcane molasses in 40 CFR 180.396(c), which excludes use of hexazinone on sugarcane in Florida, be codified as general tolerances. The commenter stated that two of DuPont Crop Protection's registrations for use of hexazinone on sugarcane in Florida are currently active.
Also, the commenter requested that EPA not revoke the tolerances in 40 CFR 180.396 for fat of cattle, goats, hogs, horses, and sheep, and meat and meat byproducts of hogs because later this year it will submit grass residue data to support a revised zero-day forage/grazing restriction (current labels show a 60-day restriction which is not considered to be practical by the Agency). The commenter stated that it expects increased residues warranting a revision of existing tolerances for both grass and hay as livestock feed commodities.
In addition, the commenter stated that an analysis on current hexazinone registrations for use on cattle feed commodities conducted by the Florida Department of Agriculture and Consumer Services in 2005 may show that tolerances for hexazinone on meat, meat byproducts, and in milk may be exceeded based on a maximum theoretical dietary burden.
Agency response. Since the time of the 2002 hexazinone TRED, EPA agrees that the Agency did approve two registrations submitted by DuPont Crop Protection for use of hexazinone on sugarcane in Florida. Based on these registrations, EPA believes that since there are no regional sugarcane registrations that specifically exclude hexazinone use in Florida; therefore, these tolerances need not be codified as regional. Since this regulatory action was not in the original Federal Register proposal, recodifying the sugarcane, cane and sugarcane molasses tolerances from 40 CFR 180.396(c) to (a) as general tolerances will need to be proposed separately in a future action. Moreover, in its comment, DuPont Crop Protection did not take issue with the Agency's proposal to modify the sugarcane tolerances. Available data indicate combined residues of hexazinone and its regulated metabolites were Comment. A comment was received from Monsanto Company generally agreeing with the proposed tolerance changes to glyphosate in 40 CFR 180.364. Monsanto also wanted to alert the Agency of the recent changes in the CODEX Maximum Residue Limits (MRLs) for glyphosate finalized by the CODEX Alimentarious Commission in July of 2006. Monsanto provided a detailed list of suggested changes to the U.S. tolerance regulation for glyphosate (concerning cereal, grains, cotton seed, meat byproducts, kiwifruit, and rapeseed) to achieve better alignment with the newly established CODEX MRLs. Monsanto did note two modifications that should be made in 40 CFR 180.364:
--To alphabetize the commodity cacao beans.
--Add the term ``except corn forage'' to the Crop group 16 forage, fodder, and straw tolerance to eliminate a conflict with the individual tolerance for ``corn, field, forage''.
Agency response. The Agency appreciates the support of Monsanto and the alert concerning the changes in the CODEX MRLs. Since the CODEX MRLs were adopted during the comment period of the proposal, any tolerance modifications made in attempt to harmonize with CODEX will need to be proposed separately for comment. The Agency will address the CODEX harmonization in a future proposal and consider Monsanto's detailed recommendations for CODEX harmonization of tolerances for glyphosate at that time. Consequently, the Agency is not taking action on the tolerances in 40 CFR 180.364 on kiwifruit, and cattle and hog liver as proposed. EPA agrees with alphabetizing cacao bean and revising the crop group 16 to include the term ``except corn forage'' in 40 CFR 180.364.
EPA is revising commodity terminology in 40 CFR 180.364 to conform to current Agency practice as follows: Hop, dried cone to hop, dried cones; wheat, milling fractions, (except flour) to wheat, bran; wheat, middlings; and wheat, shorts; grain, cereal, stover and straw, group to grain, cereal, forage, fodder and straw, group 16, except corn forage; vegetable, bulb, group to vegetable, bulb, group 3; vegetable, foliage of legume except soybean, subgroup 7A to vegetable, foliage of legume, subgroup 7A, except soybean; vegetable, fruiting, group to vegetable, fruiting, group 8; vegetable, leafy, group to vegetable, leafy, group 4; and vegetable, leaves of root and tuber, group (except sugar beet tops) to vegetable, leaves of root and tuber, group 2, except sugar beet tops.
The RED recommended that alfalfa (fresh and hay), clover and other non-grass animal feeds be consolidated in the corresponding crop group ``animal feed, nongrass, group 18'' at 100 ppm. Since the RED was published, the ``animal feed, nongrass, group 18'' was established; however, due to changes in the use patterns and grazing intervals the corresponding tolerance level is 400 ppm. Also, the existing and conflicting tolerances for ``alfalfa, hay'' (400 ppm) and ``alfalfa, forage'' (175 ppm), respectively, should be removed since the existing tolerance on ``animal feed, nongrass, group 18'' (400 ppm) covers these animal feed items. This was originally proposed by the EPA June 18, 2003 (68 FR 36472) (FRL-7308-8). Therefore, EPA is removing the tolerances in 40 CFR 180.364 on alfalfa, forage at 175 ppm and alfalfa, hay at 400 ppm, because they are no longer needed and their commodity uses are covered by the existing group tolerance.
No comments were received by the Agency concerning the following.
p-Chlorophenoxyacetic acid. The Agency canceled the last registered use for p-chlorophenoxyacetic acid on tomato in May 1995. Therefore, the Agency is revoking the tolerance in 40 CFR 180.202(a)(1) for combined residues of the plant regulator p-chlorophenoxyacetic acid and its metabolite p-chlorophenol in or on tomato, removing paragraph (a)(1), and recodifying existing paragraph (a)(2) as paragraph (a).
Based on the available data that indicate combined residues of p- chlorophenoxyacetic acid and its metabolite p-chlorophenol in or on mung bean sprouts will not exceed 0.2 ppm, the Agency determined that the tolerance should be lowered to 0.2 ppm. Therefore, EPA is decreasing the tolerance for combined residues of the plant regulator p-chlorophenoxyacetic acid and its metabolite p-chlorophenol to inhibit embryonic root development in or on bean, mung, sprouts from 2.0 to 0.2 ppm in newly recodified 40 CFR 180.202(a).
Difenzoquat. Based on available field trial data that indicate residues of difenzoquat were non-detectable (