Source: https://www.federalregister.gov/documents/2006/09/15/E6-15258/endosulfan-fenarimol-imazalil-oryzalin-sodium-acifluorfen-trifluralin-and-ziram-tolerance-actions
Timestamp: 2017-10-19 02:35:42
Document Index: 93159647

Matched Legal Cases: ['art 178', 'art 180', 'art 178', 'art 178', 'art 178', 'art 2', 'art 7', '§\u2009180', '§\u2009180', '§\u2009180', '§\u2009180', '§\u2009180']

Federal Register :: Endosulfan, Fenarimol, Imazalil, Oryzalin, Sodium Acifluorfen, Trifluralin, and Ziram; Tolerance Actions
Endosulfan, Fenarimol, Imazalil, Oryzalin, Sodium Acifluorfen, Trifluralin, and Ziram; Tolerance Actions
A Rule by the Environmental Protection Agency on 09/15/2006
This regulation is effective September 15, 2006. However, certain regulatory actions will not occur until the date specified in the regulatory text. Objections and requests for hearings must be received on or before November 14, 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).
71 FR 54423
54423-54434 (12 pages)
EPA-HQ-OPP-2005-0459
FRL-8077-9
E6-15258
https://www.federalregister.gov/d/E6-15258 https://www.federalregister.gov/d/E6-15258
EPA is revoking certain tolerances for the insecticide endosulfan; the fungicides fenarimol, imazalil, and ziram; and the herbicide trifluralin. Also, EPA is modifying certain tolerances for the insecticide endosulfan, the fungicides fenarimol and imazalil, and the herbicides sodium acifluorfen and trifluralin. EPA is not modifying tolerances for ziram. In addition, EPA is establishing new tolerances for the insecticide endosulfan, the fungicides fenarimol and imazalil, and the herbicides oryzalin and trifluralin. The regulatory actions in this document are part of the Agency's reregistration program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2005-0459. 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.
Kendra Tyler, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-0125; e-mail address: tyler.kendra@epa.gov.
Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.Start Printed Page 54424
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.
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 the docket ID number EPA-HQ-OPP-2005-0459 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 14, 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-2005-0459, by one of the following methods.
In the Federal Register of April 26, 2006 (71 FR 24615) (FRL-7771-9), EPA issued a proposed rule to revoke, modify, and establish certain tolerances and tolerance exemptions for residues of endosulfan, fenarimol, imazalil, oryzalin, sodium acifluorfen, trifluralin, and ziram. The proposal 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/or establishing specific tolerances for residues of the insectcide endosulfan; the fungicides fenarimol, imazalil, and ziram; and the herbicides oryzalin, sodium acifluorfen, and trifluralin in or on commodities listed in the regulatory text of this document.
EPA is finalizing these tolerance actions in order to implement the tolerance recommendations made during the reregistration and when taking action on tolerances and exemptions (including follow-up on canceled or additional uses of pesticides). As part of the reregistration and tolerance reassessment processes, EPA is required to determine whether each of the amended tolerances 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 to 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 the specific tolerances and exemptions correspond to uses no longer current or registered under 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 independently verifies that the tolerance is no longer needed.Start Printed Page 54425
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 proposed rule of April 26, 2006, EPA received one comment during the 60-day public comment period, as follows:
Comment by private citizen. A private citizen stated that only zero tolerances should be acceptable. In addition, the commenter expressed a concern for pesticide use in general and their possible toxic effects on plants, wildlife, and humans.
Agency response. The private citizen's comments did not take issue with any of the Agency's specific conclusions to modify, revoke, or establish certain tolerances. Also, the commenter did not refer to any specific scientific studies which pertained to the reregistration of any active ingredient, or Agency decision document which pertained to the reregistration eligibility of any active ingredient.
Section 4 of FIFRA directs EPA to make decisions about the future use of older pesticides. Under the pesticide reregistration program, EPA examines health and safety data for pesticide active ingredients initially registered before November 1, 1984, and determines whether they are eligible for reregistration to ensure that they meet current scientific and regulatory standards. During reregistration, EPA considers the human health and ecological effects of pesticides and addresses actions to reduce risks that are of concern.
Of the 613 cases subject to reregistration, about 40% have been canceled for various reasons, including request for voluntary cancellation by the registrant, cancellation by EPA because required fees were not paid, or cancellation by EPA because unacceptable risk existed that could not be reduced by other actions, such as voluntary cancellation of selected uses or changes in the way the pesticide is used.
Reducing pesticide risks is an important aspect of the reregistration program. In developing REDs, EPA works with stakeholders, pesticide registrants, growers and other pesticide users, environmental and public health interests, the States, the U.S. Department of Agriculture (USDA), other Federal agencies, and others to develop voluntary measures or regulatory controls needed to effectively reduce risks of concern. Such options include voluntary cancellation of pesticide products or deletion of uses, declaring certain uses ineligible or not yet eligible, restricting use of products to certified applicators, limiting the amount or frequency of use, improving use directions and precautions, adding more protective clothing and equipment requirements, requiring special packaging or engineering controls, requiring no-treatment buffer zones, employing environmental and ecological safeguards, and other measures.
Also, for all pesticides with food uses, EPA is reassessing tolerances (pesticide residue limits in food) to ensure that they met the safety standard of FFDCA section 408, 21 U.S.C. 346a, as amended by FQPA. Under FFDCA, EPA must make a determination that pesticide residues remaining in or on food are safe; that is, that there is reasonable certainty that no harm will result from aggregate exposure to the pesticide residue from dietary and other sources. EPA has integrated reregistration and tolerance reassessment to most effectively accomplish the goals of both programs.
At the end of the reregistration process, after EPA has issued a RED and declared a pesticide reregistration case eligible for reregistration, individual end-use products that contain pesticide active ingredients included in the case still must be reregistered. During this product reregistration, EPA sends registrants a Data Call-In (DCI) notice requesting any product specific data and specific revised labelling needed to complete reregistration for each of the individual pesticide products covered by the RED. Based on the results of EPA's review of these data and labelling, products found to meet FIFRA and FFDCA standards may be reregistered.
Therefore, EPA believes that the tolerance actions in the proposed rule of April 26, 2006, should be implemented and made final as expressed in this final rule.
No comments were received by the Agency specific to endosulfan, fenarimol, imazalil, oryzalin, and sodium acifluorfen.
1. Endosulfan. Currently, the tolerance expression for residues is defined in terms of endosulfan and its metabolite endosulfan sulfate in 40 CFR 180.182. Because the tolerance expression should reflect the alpha- and beta- isomers of the parent compound, EPA is modifying the tolerance expression in 40 CFR 180.182 in order to specify the alpha- and beta- isomers of the parent. Also, EPA is removing the “(N)” designation from all entries to conform to current Agency administrative practice (“N” designation means negligible residues).
Because no active registrations exist for use of endosulfan on artichoke, globe; beet, sugar, roots; raspberry; safflower, seed; and sunflower, seed, the tolerances are no longer needed. Therefore, EPA is revoking the tolerances in 40 CFR 180.182(a)(1) on artichoke, globe; beet, sugar, roots; raspberry; safflower, seed; and sunflower, seed.
Based on available data on almond that show combined endosulfan residues of concern are non-detectable (<0.1 parts per million (ppm) for each residue of concern) in or on almond kernels, the Agency has determined that the tolerance on almond should be increased to 0.3 ppm, the combined limits of detection. Therefore, EPA is increasing the tolerance in 40 CFR 180.182(a)(1) for combined endosulfan residues of concern in or on almond from 0.2 to 0.3 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Based on available data on the grain and straw of barley and wheat that show combined endosulfan residues of concern as high as 0.30, 0.30, 0.35, and 0.38 ppm in or on barley grain, wheat grain, barley straw, and wheat straw, respectively, the Agency has determined that the tolerances on barley and wheat grain should be increased to 0.3 ppm and tolerances on barley and wheat straw should be increased to 0.4 ppm. Therefore, EPA is increasing the tolerances in 40 CFR 180.182(a)(1) for combined endosulfan residues of concern in or on barley, grain and wheat, grain from 0.1 to 0.3 ppm, and barley, straw and wheat, straw from 0.2 to 0.4 ppm. The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Based on available data on blueberry that show combined endosulfan residues of concern are non-detectable (<0.1 ppm), the Agency has determined that the tolerance on blueberry should be increased to 0.3 ppm, the combined limits of detection. Therefore, EPA is increasing the tolerance in 40 CFR 180.182(a)(1) for combined endosulfan residues of concern in or on blueberry from 0.1 to 0.3 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.Start Printed Page 54426
Based on available data on broccoli that show combined endosulfan residues of concern as high as 2.41 ppm, the Agency has determined that the tolerance on broccoli should be increased to 3.0 ppm. Therefore, EPA is increasing the tolerance in 40 CFR 180.182(a)(1) for combined endosulfan residues of concern in or on broccoli from 2.0 to 3.0 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Based on available data that show combined endosulfan residues of concern as high as 3.1 ppm on cabbage with wrapper leaves, the Agency has determined that the tolerance on cabbage should be increased to 4.0 ppm. Therefore, EPA is increasing the tolerance in 40 CFR 180.182(a)(1) for combined endosulfan residues of concern in or on cabbage from 2.0 to 4.0 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Based on available data on celery that show combined endosulfan residues of concern as high as 7.0 ppm, the Agency has determined that the tolerance on celery should be increased to 8.0 ppm. Therefore, EPA is increasing the tolerance in 40 CFR 180.182(a)(1) for combined endosulfan residues of concern in or on celery from 2.0 to 8.0 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Based on available data that show combined endosulfan residues of concern as high as 10.11 ppm in or on head lettuce with wrapper leaves and 5.72 ppm in or on leaf lettuce, the Agency has determined that the existing tolerance on lettuce should be split into separate tolerances for head lettuce and leaf lettuce, and increased to 11.0 ppm and 6.0 ppm, respectively. Therefore, EPA is separating the tolerance in 40 CFR 180.182(a)(1) on lettuce into lettuce, head and lettuce, leaf and increasing them for combined endosulfan residues of concern from 2.0 to 11.0 and 6.0 ppm, respectively. The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Based on available data on oat grain, oat straw, rye grain, and rye straw that show combined endosulfan residues of concern as high as 0.30, 0.32, 0.30, and 0.30 ppm, respectively, the Agency has determined that the tolerances on oat grain, oat straw, rye grain, and rye straw should be increased to 0.3, 0.4, 0.3, and 0.3 ppm, respectively. Therefore, EPA is increasing the tolerances in 40 CFR 180.182(a)(1) for combined endosulfan residues of concern in or on oat, grain from 0.1 to 0.3 ppm; oat, straw from 0.2 to 0.4 ppm; rye, grain from 0.1 to 0.3 ppm; and rye, straw from 0.2 to 0.3 ppm. The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Available ruminant metabolism data indicate that combined endosulfan residues of concern at 1.1x and 1.7x the maximum dietary burden for beef and dairy cattle, respectively were detected at 0.78 ppm in milk, 12 ppm in fat, 0.85 ppm in kidney, 4.6 ppm in liver, and 2.0 ppm in muscle. The Agency determined that separate tolerances for liver should be established and that the tolerances for meat byproducts should be revised to meat byproducts, except liver and the appropriate tolerances for fat, meat byproducts (except liver), liver, and meat of cattle, goats, hogs, horses, and sheep should be increased to 13.0, 1.0, 5.0, and 2.0 ppm, respectively. Also, the Agency determined that the tolerance for milk fat should be increased to 2.0 ppm. Therefore, EPA is increasing the commodity tolerances in 40 CFR 180.182(a)(1) for combined endosulfan residues of concern in or on cattle, fat; goat, fat; hog, fat; horse, fat; and sheep, fat from 0.2 to 13.0 ppm; cattle, meat byproducts, except liver; goat, meat byproducts, except liver; hog, meat byproducts, except liver; horse, meat byproducts, except liver; and sheep, meat byproducts, except liver, from 0.2 to 1.0 ppm; cattle, meat; goat, meat; hog, meat; horse, meat; and sheep, meat from 0.2 to 2.0 ppm; milk, fat from 0.5 to 2.0 ppm; and establish tolerances at 5.0 ppm for cattle, liver; goat, liver; hog, liver; horse, liver; and sheep, liver. The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Based on available data on cantaloupes, cucumbers, and summer squash that show combined endosulfan residues of concern as high as 0.76, 0.66, and 0.25 ppm, respectively, the Agency has determined that the tolerances on melon, cucumber, and summer squash should be decreased to 1.0 ppm. Also, the available data for melon, cucumber, and summer squash may be translated to pumpkin and winter squash. Therefore, EPA is combining the individual tolerances in 40 CFR 180.182(a)(1) on cucumber, melon, pumpkin, squash, summer; and squash, winter into vegetable, cucurbit, group 9 and decreasing the tolerance for combined endosulfan residues of concern from 2.0 to 1.0 ppm.
Based on available data on tomato that show combined endosulfan residues of concern as high as 0.97 ppm, respectively, the Agency has determined that the tolerance on tomato should be decreased to 1.0 ppm. Also, the available data for tomato may be translated to eggplant. Therefore, EPA is decreasing the tolerances in 40 CFR 180.182(a)(1) for combined endosulfan residues of concern in or on eggplant from 2.0 to 1.0 ppm and tomato from 2.0 to 1.0 ppm.
Based on available data on sweet potatoes that show combined endosulfan residues of concern are non-detectable (<0.05 ppm), the Agency has determined that the tolerance on sweet potato should be decreased to 0.15 ppm. Therefore, EPA is decreasing the tolerance in 40 CFR 180.182(a)(1) for combined endosulfan residues of concern in or on sweet potato, roots from 0.2 to 0.15 ppm.
Based on available data on apple that show combined endosulfan residues of concern as high as 0.84 ppm, the Agency has determined that the tolerance on apple should be decreased to 1.0 ppm. This level is also compatible with CODEX Alimentarius Commission Maximum Residue Limits (MRLs) for endosulfan residues on pome fruits. Therefore, EPA is decreasing the tolerance in 40 CFR 180.182(a)(1) for combined endosulfan residues of concern in or on apple from 2.0 to 1.0 ppm.
Apple processing data indicate that combined endosulfan residues of concern concentrate by 6x in wet apple pomace. Based on the highest average field trial (HAFT) combined residues of 0.77 ppm in or on apples, combined residues as high as 4.62 ppm would be expected. Therefore, EPA is establishing a tolerance in 40 CFR 180.182(a)(1) for combined endosulfan residues of concern in or on apple, wet pomace at 5.0 ppm.
Based on available data on pineapple that show combined endosulfan residues of concern as high as 0.5 ppm, the Agency has determined that the tolerance on pineapple should be decreased to 1.0 ppm. Therefore, EPA is decreasing the tolerance in 40 CFR 180.182(a)(1) for combined endosulfan residues of concern in or on pineapple from 2.0 to 1.0 ppm.
Based on processing data that indicate combined endosulfan residues of Start Printed Page 54427concern concentrate 7x in peel and 41x in bran processed from whole pineapple and a HAFT combined residues of 0.44 ppm for in or on pineapple, residues as high as 18.04 ppm would be expected and the Agency determined that a tolerance for pineapple process residue (also known as wet bran) should be established at 20.0 ppm. Although, the RED and Residue Chemistry Chapters have tables which inadvertently are listed as 18 ppm; the text within the RED and Residue Chemistry Chapter both state that 20.0 ppm is appropriate. Therefore, EPA is establishing a tolerance in 40 CFR 180.182(a)(1) for combined endosulfan residues of concern in or on pineapple, process residue at 20.0 ppm.
Based on available data on sweet corn that show combined endosulfan residues of concern as high as 12.0 ppm in or on sweet corn forage and 13.92 ppm in or on sweet corn stover, the Agency has determined that tolerances should be established at 12.0 and 14.0 ppm, respectively. Therefore, EPA is establishing tolerances in 40 CFR 180.182(a)(1) for combined endosulfan residues of concern in or on corn, sweet, forage at 12.0 ppm and corn, sweet, stover at 14.0 ppm.
Based on available data on cotton gin byproducts that show combined endosulfan residues of concern as high as 27.5 ppm, the Agency has determined that a tolerance on cotton gin byproducts should be established at 30.0 ppm. Therefore, EPA is establishing a tolerance in 40 CFR 180.182(a)(1) for combined endosulfan residues of concern in or on cotton, gin byproducts at 30.0 ppm.
Based on the translation of data from carrot and potato, the Agency determined that a tolerance should be established for turnip roots at 0.2 ppm. Therefore, EPA is establishing a tolerance in 40 CFR 180.182(a)(1) for combined endosulfan residues of concern in or on turnip, roots at 0.2 ppm.
EPA is revising commodity terminology in 40 CFR 180.182 to conform to current Agency practice as follows: Cherry to cherry, sweet and cherry, tart; pecans to pecan; filbert to hazelnut; and turnip, greens to turnip, tops.
Some U.S. tolerances for endosulfan (such as on broccoli, cabbage, celery, lettuce head, lettuce leaf, pineapple, the vegetable curcurbit group, and wheat grain) may be incompatible with the CODEX MRLs because of differences in registrations or good agricultural practices.
2. Fenarimol. Because dry apple pomace, grape pomace (wet and dry), and raisin waste are no longer considered to be significant livestock feed items, the tolerances are no longer needed. Therefore, EPA is revoking the tolerances in 40 CFR 180.421(a)(1) for residues of the fungicide fenarimol in or on apple, dry pomace; and in 40 CFR 180.421(a)(2) for residues of the fungicide fenarimol and its metabolites in or on grape pomace (wet and dry) and grape, raisin, waste.
Based on available grape processing data, the Agency determined that combined residues of fenarimol and its metabolites marginally concentrated in juice and raisins. However, calculations using the anticipated residue for grape with the processing factors, show that the anticipated combined residues for the grape processed commodities (juice and raisin) are each less than the reassessed tolerance for grape (0.1 ppm). The tolerances for grape juice at 0.6 ppm and raisins at 0.6 ppm are no longer needed. Therefore, EPA is revoking the tolerances in 40 CFR 180.421(a)(2) for residues of the fungicide fenarimol and its metabolites in or on grape, juice and grape, raisin.
The Agency extrapolated data from a 28-day ruminant feeding study of exaggerated dietary burdens to the 1x feeding rate, and examined the expected impact of the average theoretical dietary burden from wet apple pomace (calculated using Food and Drug Administration (FDA) monitoring data for apples). Of the currently registered uses of fenarimol, wet apple pomace is the only commodity considered a livestock feed item. For cattle, goats, horses, and sheep, the Agency concluded from monitoring, feeding, and metabolism data that expected fenarimol residues in muscle, fat, and kidney are calculated to be less than or near the enforcement method's limit of detection (0.003 ppm). Therefore, the Agency determined that for muscle, fat, and kidney of ruminants it is not possible to establish with certainty whether finite residues will be incurred, but there is a reasonable expectation of finite residues under 40 CFR 180.6(a)(2). For cattle, goats, horses, and sheep, EPA reassessed meat, kidney, and fat tolerances at 0.01 ppm, the method limit of quantitation. Therefore, EPA is decreasing the tolerances in 40 CFR 180.421(a)(1) for residues of the fungicide fenarimol in or on cattle, fat; cattle, kidney; goat, fat; goat, kidney; horse, fat; horse, kidney; sheep, fat; and sheep, kidney; each from 0.1 to 0.01 ppm, and maintaining the tolerances at 0.01 ppm for cattle, meat; goat, meat; horse, meat; and sheep, meat.
Based on field trial data that show residues of fenarimol per se were non-detectable (less than 0.002 ppm, the method limit of detection) in pecan nut meat samples from six trials and in one trial were detected at 0.02 ppm, the Agency determined that the tolerance should be decreased from 0.1 to 0.02 ppm. Therefore, EPA is decreasing the tolerance in 40 CFR 180.421(a)(1) for residues of fenarimol in or on pecan from 0.1 to 0.02 ppm.
FDA monitoring data for apples during the period 1996-1999 showed non-detectable (less than 0.003 ppm, the method limit of detection) residues of fenarimol per se on apples. Based on the HAFT residue of 0.059 ppm for apples and a concentration factor of 3.7-fold for wet pomace, the maximum expected residue in wet pomace is 0.22 ppm and the Agency determined that a tolerance of 0.3 ppm on wet apple pomace is appropriate. Therefore, EPA is decreasing the tolerance in 40 CFR 180.421(a)(1) for residues of fenarimol in or on apple, wet pomace from 2.0 to 0.3 ppm.
FDA monitoring data for grapes during the period 1996-1999 showed non-detectable (less than 0.003 ppm, the method limit of detection) residues of fenarimol per se on grapes. Based on field trial data that indicate residues as high as 0.042 ppm for fenarimol and 0.073 for its metabolites in or on grapes harvested after 30 days following the last of 4 applications, the Agency determined that a tolerance of 0.1 ppm on grapes is appropriate. However, since the August 2002 fenarimol TRED the registrant, Gowan Company has requested that the Agency shorten the pre-harvest interval (PHI) from 30 days to 21 days on grapes. Based on the grape residue data submitted reflecting the 21 day PHI, the decrease in the tolerance reflected in the August 2002 TRED is appropriate at 0.1 ppm in or on grapes with a PHI of 21 days. However, EPA concluded that residues be expressed as fenarimol parent only, rather than the combined residues of fenarimol and its metabolites because parent only would be an adequate indicator of misuse and would harmonize with the CODEX MRLs. Therefore, EPA is decreasing the tolerance for residues of fenarimol and its metabolites in or on grape from 0.2 to 0.1 ppm.
Currently, a tolerance in 40 CFR 180.421(a)(2) for combined residues of fenarimol and its metabolites in or on banana exists at 0.5 ppm where not more than 0.25 ppm shall be present in the pulp after peel is removed. Fenarimol is presently not registered for use on banana in the United States. Based on foreign field trial data that indicate residues of fenarimol as high as 0.19 ppm and 0.075 ppm for its Start Printed Page 54428metabolites, the Agency determined that a tolerance of 0.25 ppm is appropriate for whole banana. It is current Agency practice to establish a tolerance on the whole commodity (including peel after removing and discarding crown tissue and stalk). Therefore, EPA is revising the tolerance commodity terminology in 40 CFR 180.421(a)(2) from banana (Not more than 0.25 ppm shall be present in the pulp after peel is removed) to banana and decreasing the tolerance from 0.5 to 0.25 ppm.
Currently, tolerances in 40 CFR 180.421(a)(1) are expressed in terms of residues of fenarimol, while tolerances in 40 CFR 180.421(a)(2) are expressed in terms of combined residues of fenarimol and specific metabolites (calculated as fenarimol). As stated in the October 2001 Fenarimol Product and Residue Chemistry Chapter, EPA concluded that for enforcement purposes, the tolerances for plant commodities should be expressed in terms of parent only; i.e., residues of fenarimol per se would be an adequate indicator of misuse. The tolerances for banana, cherry, grape are currently regulated under 40 CFR 180.421(a)(2), which has been recodified to 40 CFR 180.421(a). Also, in order to conform to Agency commodity terminology, the current commodity term for cherry should be changed to cherry, sweet and cherry, tart, both at 1.0 ppm. Therefore, EPA is reclassifying the tolerances for residues of fenarimol and it metabolites in or on banana at 0.25 ppm, cherry at 1.0 ppm, and grape at 0.1 ppm. EPA is combining tolerances in 40 CFR 180.421(a)(2) with tolerances in 40 CFR 180.421(a)(1) to create a single paragraph, 40 CFR 180.421(a), for residues of fenarimol. Also, EPA is revising the tolerance in 40 CFR 180.421(a) for residues of fenarimol in/on cherry to “cherry, sweet” and “cherry, tart” at 1.0 ppm.
Some U.S. tolerances for fenarimol (such as on banana, cattle kidney, grape, and wheat grain) and the CODEX MRLs may be incompatible because of differences in registrations or good agricultural practices.
Since the Agency's proposed rule of April 26, 2006, EPA published a final rule in the Federal Register on June 7, 2006 (71 FR 32841) (FRL-8061-4) as a follow-up to a notice of filing of a pesticide petition published on August 31, 2005 (70 FR 51802) (FRL-7733-1). The final rule of June 7, 2006, established a tolerance for fenarimol in 40 CFR 180.421 on filbert at 0.02 ppm, which is reflected in the regulatory text of this document, as “hazelnut,” the current commodity terminology.
3. Imazalil. Tolerances for residues in livestock commodities are currently expressed as the combined residues of imazalil, 1-[2-(2,4-dichlorophenyl)-2-(2-propenyloxy)ethyl]-1 H-imidazole, and its metabolites, 1-(2,4-dichlorophenyl)-2-(1 H-imidazole-1-yl)-1-ethanol and 3-[1-(2,4-dichlorophenyl)-2-(1 H-imidazole-1-yl)ethoxyl]-1,2-propane diol. EPA has found that any metabolite containing the 2,4-dichlorophenyl moiety is of toxicological concern and must be included in the tolerance expression along with the parent compound imazalil. In order to account for the 2,4-dichlorophenyl group moiety toxicological concerns, the total toxic residues for imazalil will be adjusted using the ratios of imazalil and the marker metabolites (FK772 and FK284) that were found to account for a high percentage of the total toxic residues in the livestock metabolism studies rather than the currently regulated metabolites. Metabolites (FK772 and FK284), with their parent compound, should serve as marker compounds which should be used to determine residue values for the dietary risk assessment. Therefore, EPA is revising the tolerance expression for livestock commodities for imazalil in 40 CFR 180.413 (a)(2) to regulate imazalil, 3-[2-(2,4-dichlorophenyl)-2-(2,3-dihydroxypropoxy)ethyl]-2,4-imidazolidinedione (FK772), and 3-[2-(2,4-dichlorophenyl)-2-(hydroxy)]-2,4-imidazolidinedione (FK284).
Because a tolerance exists for combined imazalil residues of concern on whole banana at 3.0 ppm and whole bananas are defined as the peel and the pulp after discarding the crown tissue and stalk, the tolerance on banana pulp at 0.2 ppm is no longer necessary. Therefore, the Agency is revoking the tolerance in 40 CFR 180.413(a)(1) for the combined imazalil residues of concern in or on banana, pulp and revising the tolerance commodity terminology from banana (whole) to banana.
Because dried citrus is no longer considered to be a significant feed item for hogs, and because there are no other hog feeding commodities associated with existing imazalil tolerances, there is no reasonable expectation of finite residues of imazalil in hog tissues. Therefore, the Agency believes that tolerances on hog fat, hog liver, hog meat, and hog meat byproduct are no longer needed. Hence, the EPA is revoking, in 40 CFR 180.413(a)(2), tolerances for combined imazalil residues of concern in or on the following: Hog, fat; hog, liver; hog, meat; and hog, meat byproducts.
In the tolerance summary table for both the imazalil TRED and Residue Chemistry Chapter, the recommendation to revoke horse fat was an inadvertent entry. There is no basis for revocation of horse fat listed in either document. Consequently, the Agency has revised the Imazalil Residue Chemistry Chapter accordingly and the horse, fat tolerance in 40 CFR 180.413(a)(2) will be maintained.
Cattle feeding data show that combined imazalil residues of concern ranged as high as just slightly greater than 0.05 ppm in milk at an exaggerated 5x feeding level, and therefore, the tolerance for milk should be increased from 0.01 to 0.02 ppm. Consequently, EPA is increasing the tolerance in 40 CFR 180.413(a)(2) for combined imazalil residues of concern in milk to 0.02 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Also, the cattle feeding data show that combined imazalil residues of concern ranged as high as 14.7 ppm in liver at an exaggerated 70x feeding level, and therefore, the liver tolerances of cattle, goats, horse, and sheep should be decreased from 0.5 to 0.2 ppm. In addition, because exaggerated feeding data show combined imazalil regulated residues were highest in liver and the tolerance for meat byproducts should be equivalent to the level which is highest for either meat or any individual organ for which residues were measured, tolerances for the meat byproducts of cattle, goats, horses, and sheep should each be increased from 0.01 to 0.2 ppm. Therefore, EPA is increasing the tolerances in 40 CFR 180.413(a)(2) for cattle, meat byproducts; goat, meat byproducts; horse, meat byproducts; and sheep, meat byproducts from 0.01 to 0.2 ppm. The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. However, because increasing these meat byproduct tolerances to 0.2 ppm would cover their respective animal liver commodities, separate tolerances at 0.2 ppm in 40 CFR 180.413(a)(2) for cattle, liver; goat, liver; horse, liver; and sheep, liver are not needed. Therefore, EPA is removing tolerances in 40 CFR 180.413(a)(2) for cattle, liver; goat, liver; horse, liver; and sheep, liver rather than modifying them because these commodities would be covered.
Based on grain data that indicate the regulated residues of imazalil in or on barley grain and wheat grain are above the limit of quantitation (LOQ) of 0.08 ppm, the Agency determined to increase the tolerances for barley grain and wheat grain, each to 0.1 ppm. Therefore, the Agency is increasing, in 40 CFR Start Printed Page 54429180.413(a)(1), tolerances for residues of imazalil in or on barley, grain and wheat, grain. from 0.05 to 0.1 ppm. The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Based on residue data that indicate levels of imazalil and its metabolite in citrus oil as high as 187 ppm, the Agency determined that a tolerance of 200 ppm is warranted for citrus oil. Citrus oils are not considered ready-to-eat and are used primarily as a minor ingredient in chewing gums, baked goods, gelatins, and puddings. The dilution factor for citrus oil (238x) in its conversion to ready-to-eat form exceeds the average concentration factor (28x based on oranges) from the raw agricultural commodity (RAC) to the oil by a factor of 8.5. As consumed, the concentration of imazalil and its metabolite, expressed as imazalil equivalents, are expected to be less than the concentration in the RAC (whole fruit). Therefore, EPA is increasing the tolerance in 40 CFR 180.413(a)(1), for residues of imazalil in citrus oil from 25.0 to 200.0 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Because the Agency now considers barley hay and wheat hay to be RACs, tolerances are warranted. Based on residue data for forage and straw of barley and wheat that indicate residues of concern as high as 0.12 ppm for spring barley straw and 0.24 ppm for winter wheat straw (each after a 2x correction factor for storage stability), and by translating available data for barley forage and straw to barley hay and available data for wheat forage and straw to wheat hay, EPA determined that tolerances on hay should be established at 0.5 ppm. Therefore, EPA is establishing separate tolerances in 40 CFR 180.413(a)(1) for residues of imazalil in or on barley, hay and wheat, hay at 0.5 ppm each.
4. Oryzalin. In order to conform to current Agency practice, EPA is revising the commodity terminology in 40 CFR 180.304(a) for small fruit at 0.05 ppm into individual tolerances for berry, group 13; cranberry; grape; and strawberry; each at 0.05 ppm. Also, EPA is revising commodity terminology to conform to current Agency practice as follows: Fruit, citrus to fruit, citrus, group 10; fruit, pome to fruit, pome, group 11; and fruit, stone to fruit, stone, group 12.
In addition, in order to conform to current Agency practice, EPA is recodifying the regional tolerances for guava and papaya from 40 CFR 180.304(b) to (c), and establishing and reserving sections for emergency exemptions in 40 CFR 180.304(b) and indirect or inadvertent residues in 40 CFR 180.304(d).
5. Sodium acifluorfen. Tolerances for sodium acifluorfen are currently expressed as the combined residues of the herbicide sodium salt of acifluorfen (sodium 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoic acid) and its metabolites (the corresponding acid, methyl ester, and amino analogues). Typically, the salt form of an acid is expressed with the suffix “ate,” and therefore a salt of nitrobenzoic acid should be termed a nitrobenzoate. While the tolerance expression for sodium acifluorfen in 40 CFR 180.383 is appropriate, EPA is revising only the name of the sodium salt of acifluorfen in the tolerance expression from sodium 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoic acid to sodium 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate.
Based on field trial data that indicate residues of sodium acifluorfen in or on rice straw as high as 0.124 ppm, the Agency determined that the tolerance for rice, straw should be increased to 0.2 ppm. Therefore, EPA is increasing the tolerance for rice, straw in 40 CFR 180.383 from 0.1 to 0.2 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
In order to conform to current Agency practice in 40 CFR 180.383, EPA is revising commodity terminology for soybean to soybean, seed.
Comment. A comment was received by the Agency from Steve McMaster of Dow AgroSciences (DAS) pertaining to the chemical trifluralin. The Agency proposed revocation of the tolerance for the commodity mung bean sprouts because there are no active registrations for the commodity. DAS pointed out that there is an active registration for mung bean sprouts on a supplemental label for a triflualin product. DAS also asks that the Agency review residue chemistry data that was submitted in November 1998 and January 2005 in support of the mung bean tolerance. They would like to maintain the tolerance for bean, mung, sprouts at 2.0 ppm.
Agency Response. Because there is an active registration for mung bean sprouts, EPA re-evaluated and reassessed the safety of trifluralin, taking into account the mung bean sprout tolerance. With the addition of the mung bean sprout tolerance, EPA has determined that tolerances for trifluralin remain safe.
6. Trifluralin. Because there have been no active registered uses for trifluralin on upland cress since 1989, and therefore the tolerances are no longer needed, EPA is revoking the tolerances in 40 CFR 180.207 for residues of trifluralin in or on cress, upland.
Because adequate residue data exists for field corn grain and data may be bridged from wheat and sorghum processing studies to barley, sorghum, and wheat, the Agency has determined that the commodity group for grain, crops, except corn, sweet and rice is inappropriate and should be revoked concomitant with the establishment of individual tolerances for barley grain and sorghum grain. No active registrations have existed on oats since cancellation of a soil treatment for oats in May 2001, and therefore an oat grain tolerance is not needed. Separate tolerances already exist for corn and wheat grain. Based on translating available residue data from wheat and sorghum processing studies which showed that trifluralin residues were non-detectable (<0.01 ppm) in or on wheat grain and sorghum grain, the Agency determined that the tolerances for barley grain and sorghum grain should each be established at 0.05 ppm (the enforcement method LOQ). Therefore, EPA is revoking the group tolerance in 40 CFR 180.207 for grain, crop, except corn, sweet and rice grain at 0.05 ppm and establishing individual tolerances for barley, grain and sorghum, grain, grain each at 0.05 ppm.
In order to conform to current Agency practice, the obsolete commodity definition for legume, forage should be revised to vegetable, foliage of legume, group 7 and alfalfa, forage. Based on field residue data that indicate residues of trifluralin as high as 2.2 ppm on alfalfa forage, the Agency determined that the appropriate tolerance should be increased from 0.05 to 3.0 ppm. Therefore, EPA is revising the commodity tolerance for legume, forage in 40 CFR 180.207 at 0.05 ppm into vegetable, foliage of legume, group 7 at 0.05 ppm and an individual tolerance for alfalfa, forage, increasing the tolerance for alfalfa, forage from 0.05 to 3.0 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.Start Printed Page 54430
Because celery data will be translated to endive, and because residue data are not available on all of the representative commodities from crop group 4, the Agency determined that the commodity group for vegetable, leafy should be revised to vegetable, leaves of root and tuber, group 2 and vegetable, brassica, leafy group 5 with separate tolerances for celery and endive. Therefore, EPA is removing the commodity group in 40 CFR 180.207 for vegetable, leafy, except brassica and replacing it with separate tolerances for celery; endive; vegetable, leaves of root and tuber, group 2; and vegetable, brassica, leafy group 5 at 0.05 ppm.
In order to conform to current Agency practice, the obsolete commodity definition for vegetables, root (exc. carrots) should be revised to vegetable, root and tuber, group 1, except carrot and vegetable, bulb, group 3. Based on available trifluralin residue data for the representative commodities from each group (residues on radishes as high as 0.026 ppm; residues on green onions as high as 0.016 ppm), EPA determined that a tolerance of 0.05 ppm is appropriate for each group. Therefore, EPA is revising the commodity tolerance for vegetable, root (exc. carrot) in 40 CFR 180.207 at 0.05 ppm to vegetable, root and tuber, group 1, except carrot and vegetable, bulb, group 3, each at 0.05 ppm.
In addition, the commodity group, “vegetable, seed and pod,” is obsolete. The commodity term has been revised to “vegetable, legume group 6.” Because of this terminology change, a separate tolerance is being established for okra which is not included in the newly revised “vegetable, crop group 6.” Based on the available data for okra and selected members of crop group 6, a tolerance of 0.05 ppm would be appropriate for each. Therefore, EPA is revising the commodity tolerance in 40 CFR 180.207 for vegetables, seed and pod at 0.05 ppm to vegetable, legume, group 6 and okra each at 0.05 ppm.
Based on data that indicate residues of trifluralin in or on alfalfa hay as high as 1.6 ppm, the Agency determined that the alfalfa hay tolerance should be increased to 2.0 ppm. Therefore, EPA is increasing the tolerance in 40 CFR 180.207 for residues of trifluralin in or on alfalfa, hay from 0.2 to 2.0 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Based on data that indicate residues of trifluralin in or on peanut hay as high as 0.014 ppm, the Agency determined that a tolerance should be established for peanut hay at 0.05 ppm. Therefore, EPA is establishing a tolerance in 40 CFR 180.207 for residues of trifluralin in or on peanut, hay at 0.05 ppm.
The available mustard seed data indicate residues of concern are non-detectable (<0.01 ppm). Tree nut field trial data and weight of evidence for trifluralin residues in tree nut indicate residues of trifluralin are non-detectable (<0.01 ppm) in almond hulls. Based on these data supporting each commodity, the Agency determined that tolerances should be established for mustard seed and almond hulls each at 0.05 ppm, the enforcement method LOQ. Therefore, EPA is establishing tolerances in 40 CFR 180.207 for residues of trifluralin in or on mustard, seed and almond, hulls each at 0.05 ppm.
Available data show that residues of trifluralin in or on cotton gin byproducts are warranted at 0.05 ppm. Therefore, EPA is establishing a tolerance in 40 CFR 180.207 for residues of trifluralin in or on cotton, gin byproducts at 0.05 ppm.
EPA is revising commodity terminology in 40 CFR 180.207 to conform to current Agency practice as follows: Hop to hop, dried cones; and sorghum, forage to sorghum, grain, forage.
i. Comment. A comment was received by the Agency from VJP Consulting, Inc., on behalf of the Ziram Task Force (ZTF). The comment states that the crop commodity quince may be a commodity of interest in the future, and VJP Consulting, Inc., asks that the tolerance for ziram residues in/on quince not be revoked, as proposed. ZTF requested that residue data for apples and pears could support the quince tolerance.
ii. Comment. A comment was also received from VJP Consulting, Inc., on behalf of Taminco, a member of the ZTF consortium. Taminco has requested that the tolerances for residues of ziram in/on onion and melon not be revoked. The commenter stated that ziram is registered and used on these crops outside the United States, and import tolerances are needed.
Agency Response. The Agency is not addressing tolerances for quince, onion, and melon in this final rule, but will address the tolerances in a future Federal Register document.
7. Ziram. Because the associated commodity registrations have not been active since 1991 and the tolerances are no longer needed, EPA is revoking, in 40 CFR 180.116, tolerances for residues of ziram in or on the following: Broccoli; brussel sprouts; carrot, roots; collards; gooseberry; kale; kohlrabi; lettuce; loganberry; peanut; pea; radish, roots; radish, tops; raspberry; rutabaga, roots; rutabaga, tops; spinach; turnip, greens; and turnip, roots.
Because registrations for the ziram use on eggplant and the use on pepper have not been active since 1994, and the tolerances are no longer needed, EPA is revoking, in 40 CFR 180.116, tolerances for residues of ziram in or on the following: Eggplant and pepper.
Because registrations for ziram use on bean, celery, cranberry, cucumber, pumpkin, and squash have not been active since 1995, and the tolerances are no longer needed, EPA is revoking, in 40 CFR 180.116, tolerances for residues of ziram in or on the following: Bean, celery, cranberry, cucumber, pumpkin, squash, and squash, summer.
The last U.S. registration for beet, garden, roots; beet, garden, tops; cabbage; and cauliflower was cancelled due to non-payment of the year 2005 maintenance fee as announced in a Federal Register notice published on August 3, 2005 (70 FR 44637) (FRL-7726-4). The Agency permitted the sale and distribution of existing stocks until January 15, 2006. The Agency believes that there is sufficient time for end users to exhaust those existing stocks and treated commodities to clear the channels of trade by January 15, 2007. Therefore, EPA is revoking the tolerances in 40 CFR 180.116 for ziram residues in or on beet, garden, roots; beet, garden, tops; cabbage; and cauliflower; each with an expiration/revocation date of January 15, 2007.
Active ziram registrations currently exist for blackberry. However, ziram tolerances at 7.0 ppm on boysenberry, dewberry, and youngberry are no longer needed because their uses are covered by the existing tolerance at 7.0 ppm on blackberry. Therefore, EPA is revoking the tolerances in 40 CFR 180.116 for boysenberry, dewberry, and youngberry.
In accordance with 40 CFR 180.1(h) which indicates that the tolerance for peach also covers the use in or on nectarines, the tolerance on nectarine is no longer needed. Therefore, EPA is removing the tolerance in 40 CFR 180.116 for residues of ziram in or on nectarine.
Also, while the ziram RED recommends revocation for the tolerance on strawberry, active registrations associated with the commodity use currently exist, and therefore the tolerance will not be proposed for revocation at this time. The Agency intends to follow up with the registrants and expects to propose revocation in a future Federal Register document.
In order to conform to current Agency practice in 40 CFR 180.116, EPA is revising the commodity terminology Start Printed Page 54431cherries to cherry, sweet, and cherry, tart.
The Agency will address other tolerance actions for ziram in a future Federal Register document.
EPA may issue a regulation establishing, modifying, or revoking a tolerance under FFDCA section 408(e). In this final rule, EPA is establishing, modifying, and revoking tolerances to implement the tolerance recommendations made during the reregistration and tolerance reassessment processes, and as follow-up on canceled uses of pesticides. As part of these processes, EPA is required to determine whether each of the amended tolerances meets the safety standards under FQPA. The safety finding determination is found in detail in each RED and TRED for the active ingredient. REDs and TREDs recommend the implementation of certain tolerance actions, including modifications to reflect current use patterns, to meet safety findings, and to change commodity names and groupings in accordance with new EPA policy. Printed and electronic copies of the REDs and TREDs are available as provided in Unit II.A.
EPA has issued post-FQPA REDs for endosulfan, imazalil, sodium acifluorfen, and ziram, and TREDs for oryzalin and trifluralin. The imazalil RED was completed after its TRED, and fenarimol had no RED because it was registered after November 1, 1984, and not subject to reregistration. Also, EPA issued a RED prior to FQPA for oryzalin and trifluralin and made a safety finding which reassessed their tolerances according to the FQPA standard, maintaining them when new tolerances were established as noted in Unit II.A. REDs and TREDs contain the Agency's evaluation of the database for these pesticides, including statements regarding additional data on the active ingredients that may be needed to confirm the potential human health and environmental risk assessments associated with current product uses, and REDs state conditions under which these uses and products will be eligible for reregistration. The REDs and TREDs recommended the establishment, modification, and/or revocation of specific tolerances. RED and TRED recommendations such as establishing or modifying tolerances, and in some cases revoking tolerances, are the result of assessment under the FQPA standard of “reasonable certainty of no harm.” However, tolerance revocations recommended in REDs and TREDs that are made final in this document do not need such assessment when the tolerances are no longer necessary.
When EPA establishes tolerances for pesticide residues in or on RACs, the Agency gives consideration to possible pesticide residues in meat, milk, poultry, and/or eggs produced by animals that are fed agricultural products (for example, grain or hay) containing pesticides residues (40 CFR 180.6). If there is no reasonable expectation of finite pesticide residues in or on meat, milk, poultry, or eggs, then tolerances do not need to be established for these commodities (40 CFR 180.6(b) and (c)).
With the exception of certain tolerances for ziram for which EPA is revoking certain tolerances with specific expiration/revocation dates, the Agency is revoking, modifying, establishing tolerances, and revising specific commodity terminologies effective on the date of publication of this final rule in the Federal Register. With the exception of ziram, the Agency believes that existing stocks of pesticide products labeled for the uses associated with the revoked tolerances have been completely exhausted and that treated commodities have cleared the channels of trade. EPA is revoking certain ziram tolerances with an expiration/revocation date of January 15, 2007. The Agency believes that this revocation date allows users to exhaust stocks and allows sufficient time for passage of treated commodities through the channels of trade.
Any commodities listed in the regulatory text of this document that are treated with the pesticides subject to this final rule, and that are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by FQPA. Under this section, any residues of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of FDA that:
2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance.
Evidence to show that food was lawfully treated may include records that verify the dates that the pesticide was applied to such food.
EPA considers CODEX MRLs in setting U.S. tolerances and in reassessing them. MRLs are established by the CODEX Committee on Pesticide Residues, a committee within the CODEX Alimentarius Commission, an international organization formed to promote the coordination of international food standards. When possible, EPA seeks to harmonize U.S. tolerances with CODEX MRLs. EPA may establish a tolerance that is different from a CODEX MRL; however, FFDCA section 408(b)(4) requires that EPA explain in a Federal Register document the reasons for departing from the CODEX level. EPA's effort to harmonize with CODEX MRLs is summarized in the tolerance reassessment section of individual REDs. EPA has developed guidance concerning submissions for import tolerance support (65 FR 35069, June 1, 2000) (FRL-6559-3). This guidance will be made available to interested persons. Electronic copies are available on the Internet at http://www.epa.gov. On the Home Page select “Laws, Regulations, & Dockets” then select “Regulations and Proposed Rules” and then look up the entry for this document under “Federal Register—Environmental Documents.” You can also go directly to the “Federal Register” listings at http://www.epa.gov/​fedrgstr.
In this final rule EPA establishes tolerances under FFDCA section 408(e), and also modifies and revokes specific Start Printed Page 54432tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions (i.e., establishment and modification of a tolerance and tolerance revocation for which extraordinary circumstances do not exist) from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-13, section 12(d) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether establishment of tolerances, exemptions from tolerances, raising of tolerance levels, expansion of exemptions, or revocations might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. These analyses for tolerance establishments and modifications, and for tolerance revocations were published on May 4, 1981 (46 FR 24950) and on December 17, 1997 (62 FR 66020), respectively, and were provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticides listed in this final rule, the Agency hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities. In a memorandum dated May 25, 2001, EPA determined that eight conditions must all be satisfied in order for an import tolerance or tolerance exemption revocation to adversely affect a significant number of small entity importers, and that there is a negligible joint probability of all eight conditions holding simultaneously with respect to any particular revocation. (This Agency document is available in the docket for this final rule). Furthermore, for the pesticides named in this final rule, the Agency knows of no extraordinary circumstances that exist as to the present revocations that would change EPA's previous analysis. 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 Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the 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.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.
Almond 0.11 None
Apple 7.01 None
Apricot 7.01 None
Beet, garden, roots 7.01 1/15/07
Beet, garden, tops 7.01 1/15/07
Blackberry 7.01 None
Blueberry 7.01 None
Cabbage 7.0 1/15/07
Cauliflower 7.0 1/15/07
Cherry, sweet 7.01 None
Cherry, tart 7.01 None
Melon 7.0 None
Onion 7.0 None
Pear 7.01 None
Quince 7.01 None
Tomato 7.01 None
1 See footnote to § 180.114.
3. Section 180.182 is amended by revising paragraph (a) to read as follows:
§ 180.182
(a) General. (1) Tolerances are established for the combined residues of the insecticide endosulfan, 6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-benzodioxathiepin-3-oxide (alpha and beta isomers), and its metabolite endosulfan sulfate, 6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-benzodioxathiepin-3,3-dioxide, in or on the following food commodities:
Alfalfa, fresh 0.3
Alfalfa, hay 1.0
Almond 0.3
Almond, hulls 1.0
Apricot 2.0
Barley, straw 0.4
Blueberry 0.3
Brussels sprouts 2.0
Cabbage 4.0
Carrot, roots 0.2
Cattle, fat 13.0
Cattle, liver 5.0
Cattle, meat 2.0
Cattle, meat byproducts, except liver 1.0
Celery 8.0
Collards 2.0
Corn, sweet, kernel plus cob with husks removed 0.2
Corn, sweet, stover 14.0
Cotton, gin byproducts 30.0
Goat, fat 13.0
Goat, liver 5.0
Goat, meat 2.0
Goat, meat byproducts, except liver 1.0
Hog, fat 13.0
Hog, liver 5.0
Hog, meat 2.0
Hog, meat byproducts, except liver 1.0
Horse, fat 13.0
Horse, liver 5.0
Horse, meat 2.0
Horse, meat byproducts, except liver 1.0
Lettuce, head 11.0
Lettuce, leaf 6.0
Milk, fat 2.0
Mustard, seed 0.2
Nut, macadamia 0.2
Oat, straw 0.4
Pea, succulent 2.0
Pineapple, process residue 20.0
Plum, prune 2.0
Rapeseed, seed 0.2
Sheep, fat 13.0
Sheep, liver 5.0
Sheep, meat 2.0
Sheep, meat byproducts, except liver 1.0
Sugarcane, cane 0.5
Sweet potato, roots 0.15
(2) A tolerances of 24 parts per million (ppm) is established for the combined residues of the insecticide endosulfan, 6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-benzodioxathiepin-3-oxide (alpha and beta isomers), and its metabolite endosulfan sulfate, 6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-benzodioxathiepin-3,3-dioxide, in or on dried tea (reflecting less than 0.1 ppm residues in beverage tea) resulting from application of the insecticide to growing tea.
4. Section 180.207 is amended by revising paragraph (a) to read as follows:
§ 180.207
(a) General. Tolerances are established for residues of the herbicide and plant growth regulator trifluralin, alpha, alpha, alpha-trifluoro-2,6-dinitro-N, N-dipropyl-p-toluidine, in or on the following raw agricultural commodities:
Almond, hulls 0.05
Bean, mung, sprouts 2.0
Fruit, citrus, group 10 0.05
Peanut, hay 0.05
Peppermint oil 2.0
Peppermint, tops 0.05
Spearmint oil 2.0
Spearmint, tops 0.05
Vegetable, brassica, leafy group 5 0.05
Vegetable, bulb, group 3 0.05
Vegetable, foliage of legume, group 7 0.05
Vegetable, leaves of root and tuber, group 2 0.05
Vegetable, legume, group 6 0.05
Vegetable, root and tuber, group 1, except carrot 0.05
5. Section 180.304 is revised to read as follows:
§ 180.304
(a) General. Tolerances are established for residues of the herbicide oryzalin, 3,5-dinitro-N4, N4-dipropylsulfanilamide, in or on the following raw agricultural commodities:
Berry, group 13 0.05
Kiwifruit 0.05
Olive 0.05
Pomegranate 0.05
(c) Tolerances with regional registrations. Tolerances with regional registration, as defined in § 180.1(n), are established for residues of oryzalin, 3,5-dinitro-N4, N4-dipropylsulfanilamide, in or on the following raw agricultural commodities:
Papaya 0.05
6. Section 180.383 is amended by revising paragraph (a) to read as follows:
(a) General. Tolerances are established for combined residues of the herbicide sodium salt of acifluorfen, sodium 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate, and its metabolites (the corresponding acid, methyl ester, and amino analogues) in or on the following raw agricultural commodities:
Rice, straw 0.2
7. Section 180.413 is amended by revising paragraph (a) to read as follows:
(a) General. (1) Tolerances are established for the combined residues of the fungicide imazalil, 1-[2-(2,4-dichlorophenyl)-2-(2-propenyloxy)ethyl]-1 H-imidazole, and its metabolite, 1-(2,4-dichlorophenyl)-2-(1 H-imidazole-1-yl)-1-ethanol, in or on the following food commodities:
Citrus, dried pulp 25.0
Citrus, oil 200.0
Fruit, citrus, postharvest 10.0
(2) Tolerances are established for the combined residues of the fungicide imazalil, 1-[2-(2,4-dichlorophenyl)-2-(2-propenyloxy)ethyl]-1 H-imidazole, and its metabolites, 3-[2-(2,4-dichlorophenyl)-2-(2,3-dihydroxypropoxy)ethyl]-2,4-imidazolidinedione (FK772) and 3-[2-(2,4-dichlorophenyl)-2-(hydroxy)]-2,4-imidazolidinedione (FK284), in or on the following food commodities:
8. Section 180.421 is amended by revising paragraph (a) to read as follows:
(a) General. Tolerances are established for residues of the fungicide fenarimol, alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol, in or on the following raw agricultural commodities:
Apple, wet pomace 0.3
Cattle, kidney 0.01
Goat, kidney 0.01
Grape 0.1.
Hazelnut 0.02
Horse, kidney 0.01
Pecan 0.02
Sheep, kidney 0.01
[FR Doc. E6-15258 Filed 9-14-06; 8:45 am]