Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Aldicarb, atrazine, cacodylic acid, carbofuran, etc.,

[Federal Register: July 16, 2003 (Volume 68, Number 136)]

[Proposed Rules]

[Page 41989-41996]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr16jy03-39]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0092; FRL-7301-5]

Aldicarb, Atrazine, Cacodylic acid, Carbofuran, et al.; Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This document proposes to revoke specific meat, milk, poultry, and egg tolerances for residues of the insecticides aldicarb, carbofuran, diazinon, and dimethoate; herbicides atrazine, metolachlor, and sodium acifluorfen; fungicides fenarimol, propiconazole, and thiophanate-methyl; and the defoliant cacodylic acid. EPA determined that there are no reasonable expectations of finite residues in or on meat, milk, poultry, or eggs for the aforementioned pesticide active ingredients and that these tolerances are no longer needed. Also, this document proposes to modify specific fenarimol tolerances. The regulatory actions proposed in this document contribute toward the Agency's tolerance reassessment requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q), as amended by the Food Quality Protection Act (FQPA) of 1996. By law, EPA is required by August 2006 to reassess the tolerances in existence on August 2, 1996. Because all the tolerances were previously reassessed, no reassessments are counted here toward the August 2006 review deadline.

DATES: Comments, identified by docket ID number OPP-2003-0092, must be received on or before September 15, 2003.

ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8037; e-mail address: nevola.joseph@epa.gov. SUPPLEMENTARY INFORMATION:

1. General Information

   1. 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:

      [sbull] Crop production (NAICS 111)

      [sbull] Animal production (NAICS 112)

      [sbull] Food manufacturing (NAICS 311)

      [sbull] Pesticide manufacturing (NAICS 32532)

      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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Unit II.A. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

   2. How Can I Get Copies of this Document and Other Related Information?

      1. Docket. EPA has established an official public docket for this action

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         under docket identification (ID) number OPP-2003-0092. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

      2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html , a beta site currently under development.

         An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select ``search,'' then key in the appropriate docket ID number.

         Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.

         For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

         Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the Docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

   3. How and To Whom Do I Submit Comments?

      You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked ``late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.

      1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

         i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket , and follow the online instructions for submitting comments. Once in the system, select ``search,'' and then key in docket ID number OPP-2003-0092. The system is an ``anonymous access'' system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.

         ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov, Attention: Docket ID Number OPP-2003-0092. In contrast to EPA's electronic public docket, EPA's e-mail system is not an ``anonymous access'' system. If you send an e-mail comment directly to the docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

         iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I.C.2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption.

      2. By mail. Send your comments to: Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: Docket ID Number OPP-2003-0092.

      3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1921 Jefferson

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         Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP-2003-0092. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I.B.1.

   4. How Should I Submit CBI to the Agency?

      Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

      In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

   5. What Should I Consider as I Prepare My Comments for EPA?

      You may find the following suggestions helpful for preparing your comments:

      1. Explain your views as clearly as possible.

      2. Describe any assumptions that you used.

      3. Provide copies of any technical information and/or data you used that support your views.

      4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

      5. Provide specific examples to illustrate your concerns.

      6. Offer alternative ways to improve the proposed rule or collection activity.

      7. Make sure to submit your comments by the deadline in this document.

      8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

   6. What Can I do if I Wish the Agency to Maintain a Tolerance that the Agency Proposes to Revoke?

      This proposed rule provides a comment period of 60 days for any person to state an interest in retaining a tolerance proposed for revocation. If EPA receives a comment within the 60-day period to that effect, EPA will not proceed to revoke the tolerance immediately. However, EPA will take steps to ensure the submission of any needed supporting data and will issue an order in the Federal Register under FFDCA section 408(f) if needed. The order would specify data needed and the time frames for its submission, and would require that within 90 days some person or persons notify EPA that they will submit the data. If the data are not submitted as required in the order, EPA will take appropriate action under FFDCA.

      EPA issues a final rule after considering comments that are submitted in response to this proposed rule. In addition to submitting comments in response to this proposal, you may also submit an objection at the time of the final rule. If you fail to file an objection to the final rule within the time period specified, you will have waived the right to raise any issues resolved in the final rule. After the specified time, issues resolved in the final rule cannot be raised again in any subsequent proceedings.

2. Background

   1. What Action is the Agency Taking?

      EPA is proposing to revoke specific meat, milk, poultry, and egg tolerances for residues of the insecticides aldicarb, carbofuran, diazinon, and dimethoate; herbicides atrazine, metolachlor, and sodium acifluorfen; fungicides fenarimol, propiconazole, and thiophanate- methyl; and the defoliant cacodylic acid because the Agency has concluded that there is no reasonable expectation of finite residues in or on the commodities associated with those tolerances, and therefore these tolerances are no longer needed. Also, EPA is proposing to modify specific fenarimol tolerances.

      The determinations that there are no reasonable expectations of finite residues for the tolerances listed in this document were made based on feeding studies submitted since the time that the tolerances were originally established. These feeding studies used exaggerated amounts of the compound and did not show measurable residues of the pesticides tested. The Agency originally made the determination that there is no reasonable expectation of finite residues for the pesticide active ingredient/commodity combinations listed in this proposal in memoranda of March 6, 2002; March 25, 2002; April 21, 2002; July 1, 2002; and July 23, 2002. Because there was no expectation of finite residues, in subsequent memoranda of May 3, 2002; June 3, 2002; July 11, 2002; and July 23, 2002, the Agency declared these tolerances as safe and counted these tolerances toward meeting the tolerance reassessment requirements listed in FFDCA section 408(q). Copies of these memoranda can be found in the public docket for this proposed rule. Because EPA determined that there is no reasonable expectation of finite residues, under 40 CFR 180.6 the tolerances are no longer needed under the FFDCA and can be proposed for revocation.

      1. Aldicarb. Based on available ruminant feeding and storage stability data, EPA determined that there is no reasonable expectation of finite residues of aldicarb and its carbamate metabolites in milk and livestock commodities. The associated tolerances are no longer needed under 40 CFR 180.6(a)(3). Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.269 for the combined residues of the insecticide and nematocide aldicarb (2-methyl-2- (methylthio)propionaldehyde O-(methylcarbamoyl) oxime and its cholinesterase-inhibiting metabolites 2-methyl 2-(methylsulfinyl) propionaldehyde O-(methylcarbamoyl) oxime and 2-methyl-2- (methylsulfonyl) propionaldehyde O-(methylcarbamoyl) oxime in or on the following: cattle, fat; cattle, meat; cattle meat byproducts; goat, fat; goat, meat; goat, meat byproducts; hog, fat; hog, meat; hog, meat byproducts; horse, fat; horse, meat; horse, meat byproducts; and sheep, fat; sheep, meat; sheep, meat byproducts; and milk.

      2. Atrazine. Based on available ruminant and poultry feeding data, EPA determined that there is no reasonable expectation of finite residues of atrazine in fat, meat, and meat byproducts of hogs and poultry; and eggs. These tolerances are no longer needed under 40 CFR 180.6(a)(3). Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.220 for residues of the herbicide atrazine in or on hog, fat; hog, meat; hog, meat byproducts; poultry, fat; poultry, meat; poultry, meat byproducts; and egg.

      3. Cacodylic acid (dimethylarsinic acid). Arsenic is ubiquitous and abundant in the environment. Studies show that arsenicals are methylated in animals to potentially significant levels of dimethyl arsonate. Also, available

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         data show that background levels of dimethyl arsonate (cacodylate) found in beef tissues and milk may substantially exceed those incurred from the maximum theoretical dietary burden from ingestion of feed stuffs derived from raw agricultural commodities treated with cacodylic acid at the maximum supported use rates. Based on all these data, EPA determined that tolerances for residues of cacodylic acid in beef tissues and milk are no longer needed under 40 CFR 180.6(a)(3). Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.311 for residues of the defoliant cacodylic acid (dimethylarsinic acid), expressed as As2 O3, in or on cattle, fat; cattle, kidney; cattle, liver; cattle, meat; and cattle meat byproducts (except kidney and liver).

         Furthermore, in order to conform to current Agency practice, in 40 CFR 180.311, EPA is proposing to revise the tolerance commodity terminology for ``cottonseed'' to ``cotton, undelinted seed.''

      4. Carbofuran. Based on available dairy cattle feeding data, EPA determined that there is no reasonable expectation of finite residues of carbofuran and its metabolites in fat, meat, and meat byproducts of cattle, goats, hogs, horses and sheep. These tolerances are no longer needed under 40 CFR 180.6(a)(3). Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.254 for the combined residues of the insecticide carbofuran (2,3-dihydro-2,2-dimethyl-7-benzofuranyl-N- methylcarbamate), its carbamate metabolite 2,3-dihydro-2,2-dimethyl-3- hydroxy-7-benzofuranyl-N-methylcarbamate, and its phenolic metabolites 2,3-dihydro-2, 2-dimethyl-7-benzofuranol, 2,3-dihydro-2,2-dimethyl-3,- oxo-7-benzofuranol and 2,3-dihydro-2,2-dimethyl-3,7-benzofurandiol in or on the following commodities: Cattle, fat; cattle, meat; cattle meat byproducts; goats, fat; goats, meat; goats, meat byproducts; hogs, fat; hogs, meat; hogs, meat byproducts; horses, fat; horses, meat; horses, meat byproducts; sheep, fat; sheep, meat; and sheep, meat byproducts.

      5. Diazinon. Based on available cattle dermal treatment and feeding data, EPA determined that there is no reasonable expectation of finite residues in or on meat and meat byproducts from the registered uses of cattle ear tags or from consumption of diazinon-treated feed items by cattle. These tolerances are no longer needed under 40 CFR 180.6(a)(3). A tolerance for milk is not required as long as the ear tag labels maintain that use is for beef cattle and non-lactating dairy cattle, only. Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.153 for residues of the insecticide diazinon in or on cattle, meat (fat basis) (PRE-S appli) and cattle, meat byproducts (fat basis) (PRE- S appli).

      6. Dimethoate. Metabolism and feeding studies in ruminants and poultry showed no detectable residues of dimethoate in muscle, fat, kidney, liver, milk, and egg samples. However, residues of omethoate, its oxygen analog, were found in liver and egg whites samples and residues of dimethoate carboxylic acid were found in liver, egg whites, and milk samples. Based on these available ruminant and poultry metabolism and feeding data, EPA determined that there is no reasonable expectation of finite residues of concern in meat, fat, and kidney of livestock (ruminants and poultry) from ingestion of dimethoate treated crop and feed items. These tolerances are no longer needed under 40 CFR 180.6(a)(3). Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.204 for total residues of the insecticide dimethoate (O,O- dimethyl S-(N-methylcarbamoylmethyl) phosphorodithioate) including its oxygen analog (O,O-dimethyl S-(N-methylcarbamoylmethyl) phosphorothioate) in or on the following commodities: Cattle, fat; cattle, meat; goat, fat; goat, meat; hog, fat; hog, meat; horse, fat; horse, meat; poultry, fat; poultry, meat; sheep, fat; and sheep, meat. Use of dimethoate on other commodities, including food and feed commodities, will be addressed in the ``Report on FQPA Tolerance Reassessment Progress and Interim Risk Management Decision'' (IRED), which EPA will complete in the near future.

         Also, EPA is proposing in 40 CFR 180.204 to remove the ``(N)'' designation from all entries to conform to current Agency administrative practice (``(N)'' designation means negligible residues).

      7. Fenarimol. Fenarimol tolerances were reassessed according to the FQPA standard in the August 2002 ``Report of the FQPA Tolerance Reassessment Progress and Risk Management Decision (TRED) for Fenarimol.'' 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 monitoring data for apples). Of the currently registered uses of fenarimol, wet apple pomace is the only commodity considered a livestock feed item. (Dry apple pomace is no longer considered a significant feed item). For cattle, goats, horses, and sheep, the Agency concluded from monitoring, feeding, and metabolism data that tolerances for liver should be effectively decreased from 0.1 to 0.05 parts per million (ppm) and tolerances for meat byproducts should be increased from 0.01 to 0.05 ppm based on the highest residue found on an organ tissue; i.e., liver. Because both liver and meat byproduct tolerances were reassessed at the same level (0.05 ppm) for cattle, goats, horses, and sheep, the Agency recommended covering residues in liver by the reassessed tolerances for meat byproducts, revising each commodity terminology to ``meat byproducts, except kidney,'' and revoking existing liver tolerances at 0.1 ppm since they are no longer needed. EPA issued a finding in this TRED that these revised tolerances are safe, as required by section 408 of FFDCA.

         Therefore, EPA is proposing to revoke the separate tolerances in 40 CFR 180.421 for residues of the fungicide fenarimol in or on cattle, liver; goat, liver; horse, liver; and sheep, liver. Also, EPA is proposing in 40 CFR 180.421 to increase the tolerances for the meat byproducts of cattle, goats, horses, and sheep, each from 0.01 to 0.05 ppm, and to revise their commodity terminologies to cattle, meat byproducts, except kidney; goat, meat byproducts, except kidney; horse, meat byproducts, except kidney; and sheep, meat byproducts, except kidney.

         Expected fenarimol residues in muscle, fat and kidney are calculated from the 28-day data to be less than or near the enforcement method's limit of detection (0.003 ppm). Therefore, the Agency concluded 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). While EPA reassessed fenarimol tolerances for cattle, goats, horses, and sheep in the TRED, including meat, kidney, and fat tolerances at 0.01 ppm, the method limit of quantitation, the Agency will address them in a Federal Register document to be published in the near future.

         In addition, the fenarimol tolerance for milk (0.003 ppm) should be revoked because residues in milk for dairy cattle are predicted to be significantly less than the enforcement method's limit of detection (0.001 ppm). Based on the available data, EPA determined that there is no reasonable expectation of finite residues of fenarimol in milk and that the tolerance is no longer needed under 40 CFR 180.6(a)(3). Therefore, EPA is proposing to revoke the tolerance

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         in 40 CFR 180.421 for residues of the fungicide fenarimol in milk.

         Moreover, EPA determined that there is no reasonable expectation of residue transfer to livestock commodities via consumption of fenarimol- treated crop and feed items because no feed items for poultry and hogs are associated with active fenarimol registrations. The tolerances for eggs, poultry, and hogs are no longer needed and should be revoked. Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.421 for residues of the fungicide fenarimol in or on the following commodities: Hog, fat; hog, kidney; hog, liver; hog, meat; hog, meat byproducts; poultry, fat; poultry, meat; poultry, meat byproducts; and egg.

         Furthermore, in order to conform to current Agency practice, in 40 CFR 180.421, EPA is proposing to revise the tolerance commodity terminology for ``pecans'' to ``pecan.''

      8. Metolachlor. Based on available ruminant feeding data and the maximum theoretical dietary burden for swine, EPA determined that there is no reasonable expectation of finite residues of metolachlor and its metabolites in fat, kidney, liver, meat, and meat byproducts of hogs. These tolerances are no longer needed under 40 CFR 180.6(a)(3). Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.368 for the combined residues (free and bound) of the herbicide metolachlor

         [2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1- methylethyl)acetamide] and its metabolites, determined as the derivatives, 2-[(2-ethyl-6-methylphenyl)amino]-1-propanol and 4-(2- ethyl-6-methylphenyl)-2-hydroxy-5- methyl-3-morpholinone, each expressed as the parent compound, in or on hog, fat; hog, kidney; hog, liver; hog, meat; and hog, meat byproducts, except kidney and liver.

      9. Propiconazole. Based on available poultry metabolism and feeding data, EPA determined that there is no reasonable expectation of finite residues of propiconazole and its metabolites (determined as 2,4- dichlorobenzoic acid) in poultry muscle, liver, fat, and egg samples from hens fed 10X the maximum theoretical dietary burden for poultry. These tolerances are no longer needed under 40 CFR 180.6(a)(3). Therefore, EPA is proposing to revoke tolerances in 40 CFR 180.434 for the combined residues of the fungicide 1-[[2-(2,4-dichlorophenyl)-4- propyl-1,3-dioxolan-2-yl] methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4-dichlorobenzoic acid and expressed as parent compound in or on poultry, fat; poultry, kidney; poultry, liver; poultry, meat; poultry, meat byproducts, except kidney and liver; and egg.

      10. Sodium acifluorfen. Label restrictions prohibit use of sodium acifluorfen-treated peanut and soybean forage or hay for feed and grazing livestock on these treated crops. There is no reasonable expectation of residues being transferred to livestock commodities via consumption of feed items derived from crops treated with sodium acifluorfen according to current use directions. Based on the registered food/feed use patterns, EPA determined that there is no reasonable expectation of finite residues of sodium acifluorfen and its metabolites in kidney and liver of cattle, goats, hogs, horses, and sheep; fat, meat, and meat byproducts of poultry; eggs, and milk. These tolerances are no longer needed under 40 CFR 180.6(a)(3). Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.383 for 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) in or on the following commodities: Cattle, kidney; cattle, liver; goat, kidney; goat, liver; hog, kidney; hog, liver; horse, kidney; horse, liver; poultry, fat; poultry, meat; poultry, meat byproducts; sheep, kidney; sheep, liver; egg; and milk.

      11. Thiophanate-methyl. Based on available ruminant and poultry feeding data, EPA determined that there is no reasonable expectation of finite residues of thiophanate-methyl, its oxygen analogue, and benzimidazole metabolites in fat, liver, meat, and meat byproducts of hogs and poultry. These tolerances are no longer needed under 40 CFR 180.6(a)(3). Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.371 for residues of the fungicide thiophanate-methyl (dimethyl[(1,2-phenylene)-bis(iminocarbonothioyl)] bis [carbamate]), its oxygen analogue dimethyl-4,4-o-phenylene bis(allophonate), and its benzimidazole-containing metabolites (calculated as thiophanate-methyl) in or on hog, fat; hog, liver; hog, meat; hog, meat byproducts, except liver; poultry, fat; poultry, liver; poultry, meat; and poultry, meat byproducts, except liver.

   2. What is the Agency's Authority for Taking this Action?

      A ``tolerance'' represents the maximum level for residues of pesticide chemicals legally allowed in or on raw agricultural commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 301 et seq., as amended by the FQPA of 1996, Public Law 104-170, authorizes the establishment of tolerances, exemptions from tolerance requirements, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods (21 U.S.C. 346(a)). Without a tolerance or exemption, food containing pesticide residues is considered to be unsafe and therefore ``adulterated'' under section 402(a) of the FFDCA. Such food may not be distributed in interstate commerce (21 U.S.C. 331(a) and 342(a)). For a food-use pesticide to be sold and distributed, the pesticide must not only have appropriate tolerances under the FFDCA, but also must be registered under FIFRA (7 U.S.C. et seq.). Food-use pesticides not registered in the United States must have tolerances in order for commodities treated with those pesticides to be imported into the United States.

      When EPA establishes tolerances for pesticide residues in or on raw agricultural commodities, consideration must be given to the possible residues of those chemicals in meat, milk, poultry, and/or eggs produced by animals that are fed agricultural products (for example, grain or hay) containing pesticide residues (40 CFR 180.6). When considering this possibility, EPA can conclude that:

      1. Finite residues will exist in meat, milk, poultry and/or eggs.

      2. There is a reasonable expectation that finite residues will exist.

      3. There is a reasonable expectation that finite residues will not exist. If there is no reasonable expectation of finite pesticide residues in or on meat, milk, poultry, or eggs, tolerances do not need to be established for these commodities (40 CFR 180.6(b) and 40 CFR 180.6(c)).

      EPA has evaluated the meat, milk, poultry, and egg tolerances proposed for revocation in this proposed rule and has concluded that there is no reasonable expectation of finite residues of the listed pesticide active ingredients in or on those commodities.

      Regarding the proposed modification of fenarimol tolerances, EPA is required to determine wheter each of the amended tolerances meets the safety standards under the FQPA. A safety finding determination is found in detail in the August 2002 TRED for fenarimol. An electronic copy of the TRED for fenarimol is available on EPA's website at http://www.epa.gov/pesticides/reregistration/status.htm .

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   3. When do These Actions Become Effective?

      EPA is proposing that these actions become effective on the day of publication of the final rule in the Federal Register.

      The Agency has determined that most of the tolerances herein proposed for revocation are no longer needed, based on no reasonable expectation of finite pesticide residues. Therefore, the Agency believes that this revocation date allows users to continue utilizing existing pesticide stocks and that commodities treated with these pesticides in a manner that is lawful under FIFRA will continue to clear the channels of trade since there is no reasonable expectation of finite residues. Also, because fenarimol tolerances for liver, when revised would become duplicates covered by revised ``meat byproduct, except kidney'' tolerances, they are no longer needed as separate liver tolerances.

      In addition, because the modifications to increase specific fenarimol tolerances proposed herein are safe, as required by section 408 of FFDCA, the Agency believes that these modifications become effective on the day of publication of the final rule in the Federal Register.

      If you have comments regarding the effective date, please submit comments as described under SUPPLEMENTARY INFORMATION.

   4. What Is the Contribution to Tolerance Reassessment?

      By law, EPA is required by August 2006 to reassess the tolerances in existence on August 2, 1996. As of July 2, 2003, EPA has reassessed over 6,510 tolerances. This document proposes to revoke a total of 105 tolerances, all of which were previously counted as reassessed. Therefore, none are counted in a final rule toward the August 2006 review deadline of FFDCA section 408(q), as amended by FQPA in 1996.

3. Are The Proposed Actions Consistent with International Obligations?

   The tolerance revocations in this proposal are not discriminatory and are designed to ensure that both domestically produced and imported foods meet the food safety standards established by the FFDCA. The same food safety standards apply to domestically produced and imported foods.

   EPA is working to ensure that the U.S. tolerance reassessment program under FQPA does not disrupt international trade. EPA considers Codex Maximum Residue Limits (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. It is EPA's policy to harmonize U.S. tolerances with Codex MRLs to the extent possible, provided that the MRLs achieve the level of protection required under FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual Reregistration Eligibility Decision documents. 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, and 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/ .

4. Statutory and Executive Order Reviews

   In this proposed rule, EPA is proposing to revoke and modify specific tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions (i.e., 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 proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed 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 proposed 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 104-113, 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 raising of tolerance levels or revocations of tolerances 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 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 these analyses, and the fact that there is no reasonable expectation that residues of the pesticides listed in this proposed rule will be found on the commodities discussed in this proposed rule (so that the lack of the tolerance could not prevent sale of the commodity), I certify that this action will not have a significant economic impact on a substantial number of small entities. Furthermore, for the pesticides named in this proposed rule, the Agency knows of no extraordinary circumstances that exist as to the present proposed revocations that would change EPA's previous analysis. Any comments about the Agency's determination should be submitted to the EPA along with comments on the proposal, and will be addressed prior to issuing a final rule. 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

   [[Page 41995]]

   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 proposed 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 the FFDCA. For these same reasons, the Agency has determined that this proposed 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 proposed 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 proposed rule.

   List of Subjects in 40 CFR Part 180

   Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

   Dated: June 17, 2003. Martha Monell, Acting Director, Office of Pesticide Programs.

   Therefore, it is proposed that 40 CFR part 180 be amended as follows:

   PART 180--[AMENDED]

   1. The authority citation for part 180 continues to read as follows:

      Authority: 21 U.S.C. 321(q), 346(a) and 371.

      Sec. 180.153 [Amended]

   2. Section 180.153 is amended by removing the entries for cattle, meat (fat basis) (PRE-S appli) and cattle, meat byproducts (fat basis) (PRE-S appli) from the table in paragraph (a)(1).

      Sec. 180.204 [Amended]

   3. Section 180.204 is amended by removing the entries for cattle, fat; cattle, meat; goat, fat; goat, meat; hog, fat; hog, meat; horse, fat; horse, meat; poultry, fat; poultry, meat; sheep, fat; and sheep, meat from the table in paragraph (a), and by also removing from the table in paragraph (a) the ``(N)'' designation from any entry where it appears.

      Sec. 180.220 [Amended]

   4. Section 180.220 is amended by removing the entries for egg; hog, fat; hog, meat byproducts; hog, meat; poultry, fat; poultry, meat byproducts; and poultry, meat from the table in paragraph (a)(1).

      Sec. 180.254 [Amended]

   5. Section 180.254 is amended by removing the entries for cattle, fat; cattle, meat; cattle, meat byproducts; goat, fat; goat, meat; goat, meat byproducts; hog, fat; hog, meat; hog, meat byproducts; horse, fat; horse, meat; horse, meat byproducts; sheep, fat; sheep, meat; and sheep, meat byproducts from the table in paragraph (a).

      Sec. 180.269 [Amended]

   6. Section 180.269 is amended by removing the entries for cattle, fat; cattle, meat byproducts; cattle, meat; goat, fat; goat, meat byproducts; goat, meat; hog, fat; hog, meat byproducts; hog, meat; horse, fat; horse, meat byproducts; horse, meat; sheep, fat; sheep, meat byproducts; sheep, meat; and milk from the table in paragraph (a).

   7. Section 180.311 is revised to read as follows:

      Sec. 180.311 Cacodylic acid; tolerances for residues.

      (a) General. Tolerances are established for residues of the defoliant cacodylic acid (dimethylarsinic acid), expressed as As2 O3, in or on the following raw agricultural commodity as follows:

      Commodity

      Parts per million

      Cotton, undelinted seed..............................

      2.8

      (b) Section 18 emergency exemptions. [Reserved]

      (c) Tolerances with regional registrations. [Reserved]

      (d) Indirect or inadvertent residues. [Reserved]

      Sec. 180.368 [Amended]

   8. Section 180.368 is amended by removing the entries for hog, fat; hog, kidney; hog, liver; hog, meat; and hog, meat byproducts, except kidney and liver from the table in paragraph (a).

      Sec. 180.371 [Amended]

   9. Section 180.371 is amended by removing the entries for hog, fat; hog, liver; hog, meat byproducts, except liver; hog, meat; poultry, fat; poultry, liver; poultry, meat byproducts, except liver; and poultry, meat from the table in paragraph (a).

   10. Section 180.383 is amended by revising the table in paragraph (a) to read as follows:

       Sec. 180.383 Sodium salt of acifluorfen; tolerances for residues.

       (a) * * *

       Commodity

       Parts per million

       Peanut...............................................

       0.1 Rice, grain..........................................

       0.1 Rice, straw..........................................

       0.1 Soybean..............................................

       0.1 Strawberry...........................................

       0.05

       * * * * *

   11. Section 180.421 is amended by revising the table in paragraph (a)(1) to read as follows:

       Sec. 180.421 Fenarimol; tolerances for residues.

       (a) General. (1) * * *

       Commodity

       Parts per million

       Apple................................................

       0.1 Apple, dry pomace....................................

       2.0 Apple, wet pomace....................................

       2.0 Cattle, fat..........................................

       0.1 Cattle, kidney.......................................

       0.1 Cattle, meat.........................................

       0.01 Cattle, meat byproducts, except kidney...............

       0.05 Goat, fat............................................

       0.1 Goat, kidney.........................................

       0.1 Goat, meat...........................................

       0.01 Goat, meat byproducts, except kidney.................

       0.05 Horse, fat...........................................

       0.1 Horse, kidney........................................

       0.1 Horse, meat..........................................

       0.01 Horse, meat byproducts, except kidney................

       0.05 Pear.................................................

       0.1 Pecan................................................

       0.1 Sheep, fat...........................................

       0.1 Sheep, kidney........................................

       0.1 Sheep, meat..........................................

       0.01 Sheep, meat byproducts, except kidney................

       0.05

       * * * * *

       [[Page 41996]]

       Sec. 180.434 [Amended]

   12. Section 180.434 is amended by removing the entries for poultry, fat; poultry, kidney; poultry, liver; poultry, meat byproducts, except kidney and liver; poultry, meat; and egg from the table in paragraph (a).

       [FR Doc. 03-17730 Filed 7-15-03; 8:45 am]

       BILLING CODE 6560-50-S