Methamidophos, Oxydemeton-methyl, Profenofos, and Trichlorfon; Proposed Tolerance Actions, 28912-28920 [07-2561]

Download as PDF 28912 Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Proposed Rules ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2007–0261; FRL–8130–8] Methamidophos, Oxydemeton-methyl, Profenofos, and Trichlorfon; Proposed Tolerance Actions Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: SUMMARY: EPA is proposing to revoke certain tolerances for the insecticides methamidophos and oxydemetonmethyl. Also, EPA is proposing to modify certain tolerances for the insecticides methamidophos, oxydemeton-methyl, profenofos, and trichlorfon. In addition, EPA is proposing to establish new tolerances for the insecticides methamidophos and profenofos. The regulatory actions proposed in this document are in follow-up to the Agency’s reregistration program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and tolerance reassessment program under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q). Comments must be received on or before July 23, 2007. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2007–0261, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. Instructions: Direct your comments to docket ID number EPA–HQ–OPP–2007– 0261. EPA’s policy is that all comments received will be included in the docket without change and may be made available on-line at https:// www.regulations.gov, including any personal information provided, unless cprice-sewell on PROD1PC71 with PROPOSALS DATES: VerDate Aug<31>2005 15:44 May 22, 2007 Jkt 211001 the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The Federal regulations.gov website is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. 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. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. Docket: All documents in the docket are listed in the docket index available in regulations.gov. To access the electronic docket, go to https:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. Although listed in the index, some information is not publicly available, e.g., 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 either in the electronic docket at https:// 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 hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305–5805. FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 Ave, NW., Washington, DC 20460–0001; telephone number: (703) 308–8037; email address: nevola.joseph@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 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. B. What Should I Consider as I Prepare My Comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, 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 claimed as CBI. In addition to one complete version of the comment that includes 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. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number). E:\FR\FM\23MYP1.SGM 23MYP1 Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Proposed Rules ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/ or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. cprice-sewell on PROD1PC71 with PROPOSALS C. 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. II. Background A. What Action is the Agency Taking? EPA is proposing to revoke, remove, modify, and establish specific tolerances for residues of the insecticides VerDate Aug<31>2005 15:44 May 22, 2007 Jkt 211001 methamidophos, oxydemeton-methyl, profenofos, and trichlorfon in or on commodities listed in the regulatory text. EPA is proposing these tolerance actions to implement the tolerance recommendations made during the reregistration and tolerance reassessment processes (including follow-up on canceled or additional uses of pesticides). As part of these processes, EPA is required to determine whether each of the amended tolerances meets the safety standard of the FFDCA. The safety finding determination of ‘‘reasonable certainty of no harm’’ is discussed in detail in each Reregistration Eligibility Decision (RED) and Report of the Food Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision (TRED) for the active ingredient. REDs and TREDs recommend the implementation of certain tolerance actions, including modifications to reflect current use patterns, meet safety findings, and change commodity names and groupings in accordance with new EPA policy. Printed copies of many 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: 1 (800) 490–9198; fax: 1 (513) 489–8695; internet at https://www.epa.gov/ ncepihom/ and from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone: 1 (800) 553–6847 or (703) 605–6000; internet at https:// www.ntis.gov/. Electronic copies of REDs and TREDs are available on the internet. The methamidophos, oxydemeton-methyl, and profenofos REDs and triclorfon TRED are found at https://www.epa.gov/pesticides/ reregistration/status.htm. The selection of an individual tolerance level is based on crop field residue studies designed to produce the maximum residues under the existing or proposed product label. Generally, the level selected for a tolerance is a value slightly above the maximum residue found in such studies, provided that the tolerance is safe. The evaluation of whether a tolerance is safe is a separate inquiry. EPA recommends the raising of a tolerance when data show that: (1) Lawful use (sometimes through a label change) may result in a higher residue level on the commodity. (2) The tolerance remains safe, notwithstanding increased residue level allowed under the tolerance. In REDs, Chapter IV on ‘‘Risk management, Reregistration, and Tolerance PO 00000 Frm 00019 Fmt 4702 Sfmt 4702 28913 reassessment’’ typically describes the regulatory position, FQPA assessment, cumulative safety determination, determination of safety for U.S. general population, and safety for infants and children. In particular, the human health risk assessment document which supports the RED describes risk exposure estimates and whether the Agency has concerns. In TREDs, the Agency discusses its evaluation of the dietary risk associated with the active ingredient and whether it can determine that there is a reasonable certainty (with appropriate mitigation) that no harm to any population subgroup will result from aggregate exposure. EPA also seeks to harmonize tolerances with international standards set by the Codex Alimentarius Commission, as described in Unit III. Explanations for proposed modifications in tolerances can be found in the RED and TRED document and in more detail in the Residue Chemistry Chapter document which supports the RED and TRED. Copies of the Residue Chemistry Chapter documents are found in the Administrative Record and paper copies for methamidophos, oxydemetonmethyl, profenofos, and trichlorfon are available in the public docket for this rule. Electronic copies are available through EPA’s electronic public docket and comment system, regulations.gov at https://www.regulations.gov/. You may search for docket number EPA–HQ– OPP–2007–0261, then click on that docket number to view its contents. EPA has determined that the aggregate exposures and risks are not of concern for the above mentioned pesticide active ingredients based upon the data identified in the RED or TRED which lists the submitted studies that the Agency found acceptable. EPA has found that the tolerances that are proposed in this document to be modified, are safe; i.e., that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residues, in accordance with FFDCA section 408(b)(2)(C). (Note that changes to tolerance nomenclature do not constitute modifications of tolerances). These findings are discussed in detail in each RED or TRED. The references are available for inspection as described in this document under SUPPLEMENTARY INFORMATION. In addition, EPA is proposing to revoke certain specific tolerances because either they are no longer needed or are associated with food uses that are no longer registered under FIFRA. Those instances where E:\FR\FM\23MYP1.SGM 23MYP1 cprice-sewell on PROD1PC71 with PROPOSALS 28914 Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Proposed Rules registrations were canceled were because the registrant failed to pay the required maintenance fee and/or the registrant voluntarily requested cancellation of one or more registered uses of the pesticide. It is EPA’s general practice to propose revocation of those tolerances 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 to cover residues in or on imported commodities or domestic commodities legally treated. 1. Methamidophos. Because methamidophos is a metabolite of acephate, EPA determined that residues of methamidophos resulting from the application of acephate should be included under the tolerance regulations for methamidophos as a pesticide. Therefore, EPA is proposing to recodify the tolerances for methamidophos from 40 CFR 180.315(a) into (a)(1) for permanent tolerances for residues of methamidophos (O,Sdimethyl phosphoramidothioate) in or on food commodities as a result of the application of the insecticide methamidophos and (a)(2) for residues of methamidophos (O,S-dimethyl phosphoramidothioate) in or on food commodities as a result of the application of the insecticide acephate. Currently, 40 CFR 180.3, the section on tolerances for related pesticide chemicals, contains a paragraph (d)(8) stating that where tolerances are established for residues of O,S-dimethyl phosphoramidothioate, resulting from the use of acephate (O,S-dimethyl acetylphos-phoramidothioate) and/or O,S-dimethylphosphoramidothioate on the same agricultural commodity, the total amount of O,S-dimethylphosphoramidothioate shall not yield more residue than that permitted by the higher of the two tolerances. However, with the proposed change to include tolerances for methamidophos that result from the application of acephate under the methamidophos tolerance regulations in 40 CFR 180.315(a)(2), there is no longer a need for the related pesticide chemical regulation under 40 CFR 180.3(d)(8); and therefore, EPA is proposing to remove existing paragraph (d)(8). With the exception of uses on cotton and potatoes, EPA canceled all methamidophos FIFRA section 3 registrations and, with the exception of uses on tomatoes, all section 24(c) regional registrations (62 FR 67071, December 23, 1997) (FRL–5764–2). Because there are no active registrations for uses of either methamidophos or acephate on broccoli, cabbage, VerDate Aug<31>2005 15:44 May 22, 2007 Jkt 211001 cucumber, eggplant, and melon, the associated tolerances in 40 CFR 180.315 are no longer needed and should be revoked. Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.315 on broccoli, cabbage, cucumber, eggplant, and melon. Also, on July 31, 2002 (67 FR 49606)(FRL–7191–4), EPA published a final rule in the Federal Register in which it responded to the Canadian Horticultural Council’s comment asking that certain tolerances in 40 CFR 180.315, including those on broccoli and cabbage, not be revoked. At that time, the Agency responded that it would not revoke the tolerances on broccoli and cabbage in 40 CFR 180.315, but would follow-up to see that data requirements were met should an interested party support those tolerances for import purposes. However, in the interim period, no interested party has declared an interest and committed in writing to do the required data to support the broccoli and cabbage tolerances for import purposes. However, because there are registered acephate uses on Brussels sprouts, cauliflower, celery, and head lettuce, EPA is proposing to recodify the tolerances for Brussels sprouts, cauliflower, and lettuce from 40 CFR 180.315(a) into (a)(2) and celery from (b) into (a)(2). Also, in order to reflect active registered use of acephate on head lettuce, EPA is proposing in 40 CFR 180.315(a)(2) to revise ‘‘lettuce’’ to ‘‘lettuce, head.’’ In addition, because there is an existing tolerance for acephate use on cauliflower, which has been reassessed in the acephate RED at the same level, such that residues from metabolism to methamidophos are expected to be no greater than 0.5 parts per million (ppm), EPA is proposing to decrease the tolerance on cauliflower in 40 CFR 180.315(a)(2) from 1.0 to to 0.5 ppm. Also, this proposed level will harmonize with the Codex MRL of 0.5 mg/kg on cauliflower. At the time of the completion of the methamidophos IRED, a registrant submitted an import tolerance petition for peppers, strawberries, and squash. This petition has not been reviewed. Because there is an existing tolerance for acephate use on peppers, which in the acephate RED has been reassessed at the same level, such that residues from metabolism to methamidophos are expected to be no greater than 1.0 ppm, EPA is proposing to recodify the tolerance on pepper from 40 CFR 180.315(a) to (a)(2) at 1.0 ppm. Also, this proposed level will harmonize with the Codex MRL of 1.0 mg/kg on sweet peppers. PO 00000 Frm 00020 Fmt 4702 Sfmt 4702 Because there are registered methamidophos uses on potato, EPA is proposing to recodify the tolerance at 0.1 ppm on potato from 40 CFR 180.315(a) into (a)(1). There is a Codex MRL of 0.05 ppm on potato, but harmonization is not possible because of differences in agricultural practices. Based on available data that showed methamidophos residues as high as 0.191 ppm on cottonseed, EPA determined that the tolerance on cottonseed should be increased from 0.1 to 0.2 ppm. Therefore, the Agency is proposing to recodify the tolerance on cotton, undelinted seed from 40 CFR 180.315(a) to (a)(1) and increase the tolerance 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. Also, this proposed level will harmonize with the Codex MRL of 0.2 mg/kg on cottonseed. Based on available data that showed methamidophos residues as high as 8.03 ppm on cotton gin byproducts, EPA determined that a tolerance on cotton gin byproducts should be established at 10.0 ppm. Therefore, the Agency is proposing to establish a tolerance on cotton, gin byproducts in 40 CFR 180.315(a)(1) at 10.0 ppm. Based on available data that showed methamidophos residues as high as 1.4 ppm on tomatoes, EPA determined that the tolerance on tomato should be increased from 1.0 to 2.0 ppm. Because there are only active FIFRA section 24(c) registrations for use of methamidophos on tomatoes and no active registrations for use of acephate on tomatoes, the Agency has determined that the tolerance should be recodified as a regional tolerance. Therefore, the Agency is proposing to recodify 40 CFR 180.315(b) as (c) and the tolerance on tomato from 40 CFR 180.315(a) to (c), and increase the tolerance 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. Also, EPA is proposing to revise the tolerance expression in newly recodified 40 CFR 180.315(c), as follows: Tolerances with regional registration, as defined in 40 CFR 180.1(m), are established for residues of methamidophos (O,S-dimethyl phosphoramidothioate) in or on the following food commodities as a result of the application of the insecticide methamidophos. In addition, EPA is proposing to revise 40 CFR 180.315 by adding separate paragraphs (b) and (d), and E:\FR\FM\23MYP1.SGM 23MYP1 Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Proposed Rules cprice-sewell on PROD1PC71 with PROPOSALS reserving those sections for tolerances with section 18 emergency exemptions, and indirect or inadvertent residues, respectively. Because there are existing tolerances for use of acephate on dry and succulent beans and cranberries, which in the acephate RED have been reassessed at the same level, such that residues from metabolism to methamidophos are expected to be no greater than 1.0 ppm and 0.1 ppm, respectively, EPA is proposing to establish tolerances in 40 CFR 180.315(a)(2) for residues of methamidophos as a result from the application of acephate on bean, dry, seed at 1.0 ppm, bean, succulent at 1.0 ppm, and cranberry at 0.1 ppm. Because there is an existing tolerance for use of acephate on mint hay, which in the acephate RED has been reassessed to be increased from 15.0 to 27.0 ppm, such that residues from metabolism to methamidophos are expected to be increased from no greater than 1.0 to 2.0 ppm, EPA is proposing to establish a tolerance in 40 CFR 180.315(a)(2) for residues of methamidophos as a result from the application of acephate on mint, hay at 2.0 ppm and revise it to ‘‘peppermint, tops’’ and ‘‘spearmint, tops.’’ 2. Oxydemeton-methyl. Currently, the tolerances in 40 CFR 180.330 are expressed for residues of oxydemetonmethyl and its cholinesterase-inhibiting metabolites. Based on the Agency’s determination that only residues of oxydemeton-methyl and its metabolite oxydemeton-methyl sulfone are of concern in plants, the tolerances in 40 CFR 180.330 should be recodified for plant commodities from 40 CFR 180.330(a) to (a)(1) and animal commodities from 40 CFR 180.330(a) to (a)(2). Therefore, EPA is proposing to recodify plant tolerances in 40 CFR 180.330(a)(1) and animal tolerances in 40 CFR 180.330(a)(2) and revise the tolerance expression in 40 CFR 180.330 as follows: (a) General. (1) Tolerances are established for the combined residues of the insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)ethyl) O,O-dimethyl phosphorothioate) and its metabolite oxydemeton-methyl sulfone in or on the following food commodities. (2) Tolerances are established for the combined residues of the insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)ethyl) O,O-dimethyl phosphorothioate) and its cholinesterase-inhibiting metabolites in or on the following food commodities. Because certain registered uses have product labels which prohibit harvest within one year of application, so that there is no reasonable expectation of residues on food commodities, the Agency considers them to be nonfood uses of oxydemeton-methyl. As a result, VerDate Aug<31>2005 15:44 May 22, 2007 Jkt 211001 the tolerances in 40 CFR 180.330 for these nonfood uses are no longer needed and should be revoked for apple, apricot, grape, and plum, prune, fresh. Therefore, the Agency is proposing to revoke the tolerances in 40 CFR 180.330(a) on apple, grape, and plum, prune, fresh and in 40 CFR 180.330(c) on apricot. Because bean, lima, forage; clover, seed screenings; and sorghum milled fractions (except flour) are no longer considered by the Agency to be significant animal feed items, their tolerances in 40 CFR 180.330 are no longer needed and should be revoked. Therefore, the Agency is proposing to revoke the tolerances in 40 CFR 180.330 on bean, lima, forage; clover, seed screenings; and sorghum, milled fractions (except flour). In 1994, the technical registrant for oxydemeton-methyl (ODM) agreed not to market ODM on snap beans, field corn, popcorn, pears, and turnips but retained them on registrations with the possibility of requesting to reinstate them on marketing labels after EPA’s review of needed ODM data and completion of dietary and worker risk assessments. In a letter to the Agency dated February 4, 2004, the technical registrant requested to amend the registrations for both a technical and end-use registration and delete those uses. In the Federal Register of November 4, 2005 (70 FR 67167) (FRL– 7744–7), EPA published a notice announcing the receipt of requests for amendments to delete uses in certain pesticide registrations, including deletion for ODM use on snap beans, field corn, popcorn, pears, and turnips concerning registrations for one technical and one end use product. That notice had an effective date of December 5, 2005 and allowed the registrant to sell or distribute product under the previously approved labelling for a period of 18 months after approval of the revision. There have been no end use marketing labels for ODM use on these commodities since September 18, 1995. However, there has been one active technical registration with these uses from 1995 through the December 5, 2005 effective date that amended its label. Nevertheless, despite the allowance by EPA that existing stocks for the technical and end use registrations could be sold or distributed by the registrant for 18 months, the Agency believes that no end users have used ODM on snap beans, field corn, popcorn, pears, and turnip commodities since 1995. Therefore, EPA believes that existing stocks of end use product was exhausted years ago and that such ODM treated-snap beans, field corn, popcorn, PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 28915 pears, and turnip commodities passed through channels of trade long ago and that sufficient time has passed. Consequently, EPA is proposing to revoke the tolerances in 40 CFR 180.330 on bean, snap, succulent; bean, snap, forage; corn, grain; pear; turnip; and turnip, greens; all on the date of publication of the final rule. Based on available data that showed combined oxydemeton-methyl residues of concern as high as 0.9 ppm in or on corn forage, EPA determined that the tolerance on corn forage should be decreased from 3.0 to 1.0 ppm. Therefore, the Agency is proposing in 40 CFR 180.330 to decrease the tolerance on corn, forage to 1.0 ppm and revise it to corn, sweet, forage. No tolerance on field corn forage is needed. Based on available data that showed combined oxydemeton-methyl residues of concern as high as 9.84 ppm in or on clover hay grown for seed, EPA determined that the tolerance on clover hay grown for seed should be decreased from 11.0 to 10.0 ppm. Therefore, the Agency is proposing in 40 CFR 180.330 to decrease the tolerance on clover, hay, grown for seed to 10.0 ppm and revise it to clover, hay. Based on available data that showed combined oxydemeton-methyl residues of concern as high as 0.15 ppm in or on lima beans, 0.2 ppm in or on melons, less than 0.1 ppm in or on pumpkins, and less than 0.05 ppm in or on walnuts, EPA determined that the tolerances on lima beans, cottonseed, melons, pumpkins, and walnuts should be decreased from 0.5 to 0.2 ppm, 0.1 to 0.02 ppm, 0.3 to 0.2 ppm, 0.3 to 0.2 ppm, and 0.3 to 0.05 ppm, respectively. Therefore, the Agency is proposing in 40 CFR 180.330 to decrease the tolerances on bean, lima to 0.2 ppm, cotton, undelinted seed to 0.02 ppm, melon to 0.2 ppm, pumpkin to 0.2 ppm, and walnut to 0.05 ppm. Based on available data that showed combined oxydemeton-methyl residues of concern as high as 1.22 ppm in or on cabbage, EPA determined that the tolerance on cabbage should be increased from 1.0 to 2.0 ppm. Therefore, the Agency is proposing in 40 CFR 180.330 to increase the tolerance on cabbage 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. Also, because there is one active FIFRA section 24(c) registration for foliar use of oxydemeton-methyl on broccoli raab, EPA determined that data could be translated from cabbage and broccoli to broccoli raab, and therefore a tolerance E:\FR\FM\23MYP1.SGM 23MYP1 28916 Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Proposed Rules should be established on broccoli raab at 2.0 ppm. Therefore, EPA is proposing to establish a regional tolerance on broccoli raab in 40 CFR 180.330(c) at 2.0 ppm and revise the tolerance expression in 40 CFR 180.330(c) as follows: (c) Tolerances with regional registrations, as defined in 40 CFR 180.1(m), are established for the combined residues of the insecticide oxydemeton-methyl (S-(2(ethylsulfinyl)-ethyl) O,O-dimethyl phosphorothioate) and its metabolite oxydemeton-methyl sulfone in or on the following food commodities. cprice-sewell on PROD1PC71 with PROPOSALS Based on a poultry metabolism study at the 6x feeding level that showed no residues of toxicological concern in poultry commodities and an earlier poultry metabolism study that showed residues were present in eggs and tissues, EPA determined that egg and poultry tolerances should be established at the limit of quantitation (LOQ) of 0.01 ppm. Therefore, the Agency is proposing to establish tolerances in 40 CFR 180.330(a)(2) on egg; poultry, fat; poultry, meat; and poultry, meat byproducts at 0.01 ppm. Also, EPA is proposing to revise commodity terminology in 40 CFR 180.330 to conform to current Agency practice as follows: ‘‘alfalfa, green’’ to ‘‘alfalfa, forage;’’ ‘‘alfalfa, hay, grown for seed’’ to ‘‘alfalfa, hay;’’ ‘‘beet, sugar’’ to ‘‘beet, sugar, roots;’’ ‘‘corn, stover’’ to ‘‘corn, sweet, stover’’ (no tolerances are needed on field corn stover or popcorn stover) ‘‘mint, hay’’ to ‘‘peppermint, tops’’ and ‘‘spearmint, tops;’’ ‘‘onion, dry bulb’’ to ‘‘onion, bulb;’’ ‘‘orange, sweet’’ to ‘‘orange;’’ ‘‘sorghum, forage’’ to ‘‘sorghum, forage, forage’’ and ‘‘sorghum, grain, forage;’’ ‘‘sorghum, grain’’ to ‘‘sorghum, grain, grain.’’ There are no Codex MRLs for oxydemeton-methyl. 3. Profenofos. Currently, the tolerances in 40 CFR 180.404(a) are expressed for residues of profenofos and its metabolites converted to 4-bromo-2chlorophenyl and calculated as profenofos. Based on the Agency’s determination that only residues of profenofos per se are of toxicological concern, the tolerance expression in 40 CFR 180.404 should be revised to reflect that profenofos per se is the only regulated residue. Therefore, EPA is proposing to revise the tolerance expression in 40 CFR 180.404(a) as follows: (a) General. Tolerances are established for residues of the insecticide profenofos (O-(4bromo-2-chlorophenyl)-O-ethyl-S-propyl phosphorothioate) in or on the following food commodities. Based on available data that showed profenofos residues were as high as 1.1 ppm on cottonseed, EPA determined that the tolerance should be decreased VerDate Aug<31>2005 15:44 May 22, 2007 Jkt 211001 from 3.0 to 2.0 ppm. Therefore, the Agency is proposing to decrease the tolerance in 40 CFR 180.404 on cotton, undelinted seed to 2.0 ppm. Also, this proposed level will harmonize with the Codex MRL of 2 mg/kg on cottonseed. Based on available data that showed profenofos residues as high as 53 ppm, EPA determined that a tolerance of 55.0 ppm should be established for cotton gin byproducts. Therefore, the Agency is proposing to establish a tolerance in 40 CFR 180.404 for the residues of profenofos on cotton, gin byproducts at 55.0 ppm. 4. Trichlorfon. There are no active registrations for the use of the insecticide trichlorfon for cattle commodities in the United States. However, trichlorfon is used as a dermal pour-on application for cattle for import purposes. Based on cattle metabolism data from dermal application of trichlorfon which showed residues of trichlorfon as high as 0.2 ppm in muscle and less than 0.5 ppm in fat, EPA determined that the tolerances on cattle meat and cattle fat should be increased from 0.1 ppm to 0.2 ppm and 0.1 to 0.5 ppm, respectively. Therefore, EPA is proposing in 40 CFR 180.198 to increase the tolerances on cattle, meat to 0.2 ppm and cattle, fat to 0.5 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. Dichlorvos is a degradate of trichlorfon. However, as stated in the 2006 Dichlorvos RED, nondetectable dichlorvos residues in livestock commodities are expected as a result of trichlorfon use, and dichlorvos was not a significant metabolite in the trichlorfon dermal metabolism data. Therefore, dietary (food) exposure to dichlorvos residues resulting from use of trichlorfon is considered by the Agency to be negligible. Also, in 40 CFR 180.198, EPA is proposing to remove the ‘‘(N)’’ designation from all entries to conform to current Agency administrative practice, where the ‘‘(N)’’ designation means negligible residues. In addition, in order to conform to current Agency practice, EPA is proposing to revise 40 CFR 180.198 and establish subparts (a) through (d), recodify general tolerances under 40 CFR 180.198(a) and reserve sections (b) for tolerances with section 18 emergency exemptions, (c) for regional registrations, and (d) for indirect or inadvertent residues. There are no Codex MRLs for trichlorfon. PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 B. 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. 346a, 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. Without a tolerance or exemption, food containing pesticide residues is considered to be unsafe and therefore ‘‘adulterated’’ under section 402(a) of the FFDCA, 21 U.S.C. 342(a). Such food may not be distributed in interstate commerce (21 U.S.C. 331(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. 136 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. EPA is proposing these tolerance actions in follow-up to the tolerance recommendations made during the reregistration and tolerance reassessment processes (including follow-up on canceled or additional uses of pesticides). The safety finding determination under section 408 of the FFDCA standard is discussed in detail in each Post-FQPA 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 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 methamidophos, oxydemeton-methyl, and profenofos, and a TRED for trichlorfon, whose RED was completed prior to FQPA. REDs and TREDs contain the Agency’s evaluation of the data base for these pesticides, including requirements for additional data on the active ingredients to confirm the potential human health and environmental risk assessments associated with current product uses, and in REDs state conditions under which these uses and products will be eligible for reregistration. The REDs and TREDs recommended the establishment, E:\FR\FM\23MYP1.SGM 23MYP1 cprice-sewell on PROD1PC71 with PROPOSALS Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Proposed Rules 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 FFDCA standard of ‘‘reasonable certainty of no harm.’’ However, tolerance revocations recommended in REDs and TREDs that are proposed in this document do not need such assessment when the tolerances are no longer necessary. EPA’s general practice is to propose revocation of tolerances for residues of pesticide active ingredients on crops for which FIFRA registrations no longer exist and on which the pesticide may therefore no longer be used in the United States. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Nonetheless, EPA will establish and maintain tolerances even when corresponding domestic uses are canceled if the tolerances, which EPA refers to as ‘‘import tolerances,’’ are necessary to allow importation into the United States of food containing such pesticide residues. However, where there are no imported commodities that require these import tolerances, the Agency believes it is appropriate to revoke tolerances for unregistered pesticides in order to prevent potential misuse. Furthermore, as a general matter, the Agency believes that retention of import tolerances not needed to cover any imported food may result in unnecessary restriction on trade of pesticides and foods. Under section 408 of the FFDCA, a tolerance may only be established or maintained if EPA determines that the tolerance is safe based on a number of factors, including an assessment of the aggregate exposure to the pesticide and an assessment of the cumulative effects of such pesticide and other substances that have a common mechanism of toxicity. In doing so, EPA must consider potential contributions to such exposure from all tolerances. If the cumulative risk is such that the tolerances in aggregate are not safe, then every one of these tolerances is potentially vulnerable to revocation. Furthermore, if unneeded tolerances are included in the aggregate and cumulative risk assessments, the estimated exposure to the pesticide would be inflated. Consequently, it may be more difficult for others to obtain needed tolerances or to register needed new uses. To avoid potential trade restrictions, the Agency is proposing to revoke tolerances for residues on crops uses for which FIFRA registrations no VerDate Aug<31>2005 15:44 May 22, 2007 Jkt 211001 longer exist, unless someone expresses a need for such tolerances. Through this proposed rule, the Agency is inviting individuals who need these import tolerances to identify themselves and the tolerances that are needed to cover imported commodities. Parties interested in retention of the tolerances should be aware that additional data may be needed to support retention. These parties should be aware that, under FFDCA section 408(f), if the Agency determines that additional information is reasonably required to support the continuation of a tolerance, EPA may require that parties interested in maintaining the tolerances provide the necessary information. If the requisite information is not submitted, EPA may issue an order revoking the tolerance at issue. 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 https://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 https:// www.epa.gov/fedrgstr/. 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 pesticides 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 (c)). EPA has evaluated certain specific meat, milk, poultry, and egg tolerances proposed for revocation in this rule and has concluded that there is no reasonable expectation of finite pesticide residues of concern in or on those commodities. PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 28917 C. When do These Actions Become Effective? EPA is proposing that the actions herein become effective on the date of publication of the final rule in the Federal Register, because their associated uses have been canceled for several years. The Agency believes that existing stocks of pesticide products labeled for the uses associated with the tolerances proposed for revocation have been completely exhausted and that treated commodities have had sufficient time for passage through the channels of trade. However, if EPA is presented with information that existing stocks would still be available and that information is verified, the Agency will consider extending the expiration date of the tolerance. If you have comments regarding existing stocks and whether the effective date allows sufficient time for treated commodities to clear the channels of trade, please submit comments as described under SUPPLEMENTARY INFORMATION. Any commodities listed in this proposal treated with the pesticides subject to this proposal, and 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 the Food and Drug Administration that: 1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and 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 when the pesticide was applied to such food. III. Are the Proposed Actions Consistent with International Obligations? The tolerance actions 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. In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the E:\FR\FM\23MYP1.SGM 23MYP1 28918 Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Proposed Rules cprice-sewell on PROD1PC71 with PROPOSALS international Maximum Residue Limits (MRLs) established by the Codex Alimentarius Commission, as required by section 408(b)(4) of the FFDCA. The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standardssetting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, section 408(b)(4) of FFDCA requires that EPA explain the reasons for departing from the Codex level in a notice published for public comment. EPA’s effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual REDs and TREDs, and in the Residue Chemistry document which supports the RED and TRED, as mentioned in Unit II.A. Specific tolerance actions in this rule and how they compare to Codex MRLs (if any) are discussed in Unit II.A. IV. Statutory and Executive Order Reviews In this proposed rule, EPA is proposing to establish tolerances under FFDCA section 408(e), and also modify and revoke specific tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions (e.g., 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 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 VerDate Aug<31>2005 15:44 May 22, 2007 Jkt 211001 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 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 proposed rule, the Agency hereby certifies that this proposed action will not have a significant negative 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 of this proposed rule). Furthermore, for the pesticide named in this proposed rule, the Agency knows of no extraordinary circumstances that exist as to the present proposal that would change the 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 PO 00000 Frm 00024 Fmt 4702 Sfmt 4702 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 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: May 16, 2007. Debra Edwards, Director, Office of Pesticide Programs. Therefore, it is proposed that 40 CFR chapter I be amended as follows: E:\FR\FM\23MYP1.SGM 23MYP1 Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Proposed Rules PART 180—[AMENDED] Commodity 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. §180.3 Lettuce, head .................. Pepper ............................ Peppermint, tops ............ Spearmint, tops .............. 1.0 1.0 2.0 2.0 [Amended] 2. Section 180.3 is amended by removing paragraph (d)(8) and redesignationg paragraphs (d)(9) through (d)(14) as paragraphs (d)(8) through (d)(13). 3. Section 180.198 is revised to read as follows: §180.198 Trichlorfon; tolerances for residues. (a) General. Tolerances are established for residues of the insecticide trichlorfon (dimethyl (2,2,2trichloro-1-hydroxyethyl) phosphonate) in or on the following food commodities: Commodity 0.2 0.1 are no U.S. registrations for cattle commodities as of June 24, 1999. (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent residues. [Reserved] 4. Section 180.315 is revised to read as follows: §180.315 Methamidophos; tolerances for residues. (a) General. (1) Tolerances are established for residues of methamidophos (O,S-dimethyl phosphoramidothioate) in or on the following food commodities as a result of the application of the insecticide methamidophos. Parts per million Cotton, gin byproducts ... Cotton, undelinted seed Potato ............................. 10.0 0.2 0.1 (2) Tolerances are established for residues of methamidophos (O,Sdimethyl phosphoramidothioate) in or on the following food commodities as a result of the application of the insecticide acephate. Commodity Parts per million Bean, dry, seed .............. Bean, succulent .............. Brussels sprouts ............. Cauliflower ...................... Celery ............................. Cranberry ........................ VerDate Aug<31>2005 Commodity Parts per million Tomato 2.0 (d) Indirect or inadvertent residues. [Reserved] 5. Section 180.330 is revised to read 0.5 as follows: 1There Commodity (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. Tolerances with regional registration, as defined in 180.1(m), are established for residues of methamidophos (O,S-dimethyl phosphoramidothioate) in or on the following food commodities as a result of the application of the insecticide methamidophos. Parts per million Cattle, fat 1 ..................... Cattle, meat 1 ................. Cattle, meat byproducts 1 cprice-sewell on PROD1PC71 with PROPOSALS Parts per million 15:44 May 22, 2007 1.0 1.0 1.0 0.5 1.0 0.1 Jkt 211001 §180.330 S-(2-(Ethylsulfinyl)ethyl) O,Odimethyl phosphorothioate; tolerances for residues. (a) General. (1) Tolerances are established for the combined residues of the insecticide oxydemeton-methyl (S(2-(ethylsulfinyl)-ethyl) O,O-dimethyl phosphorothioate) and its metabolite oxydemeton-methyl sulfone in or on the following food commodities: Commodity Parts per million Alfalfa, forage ................. Alfalfa, hay ...................... Bean, lima ....................... Beet, sugar, roots ........... Beet, sugar, tops ............ Broccoli ........................... Brussels sprouts ............. Cabbage ......................... Cauliflower ...................... Clover, forage ................. Clover, hay ..................... Corn, sweet, forage ........ Corn, sweet, kernel plus cob with husks removed ......................... Corn, sweet, stover ........ Cotton, undelinted seed Cucumber ....................... Eggplant .......................... Filbert .............................. Grapefruit ........................ Lemon ............................. Lettuce, head .................. Melon .............................. Onion, bulb ..................... Orange ............................ Pepper ............................ Peppermint, tops ............ Pumpkin .......................... Safflower, seed ............... Sorghum, forage, forage Sorghum, grain, forage ... PO 00000 Frm 00025 Fmt 4702 Sfmt 4702 5.0 11.0 0.2 0.3 0.5 1.0 1.0 2.0 1.0 5.0 10.0 1.0 Commodity 28919 Parts per million Sorghum, grain, grain ..... Spearmint, tops .............. Squash, summer ............ Squash, winter ................ Strawberry ...................... Walnut ............................. 0.75 12.5 1.0 0.3 2.0 0.05 (2) Tolerances are established for the combined residues of the insecticide oxydemeton-methyl (S-(2(ethylsulfinyl)-ethyl) O,O-dimethyl phosphorothioate) and its cholinesterase-inhibiting metabolites in or on the following food commodities. Commodity Parts per million Cattle, fat ........................ Cattle, meat .................... Cattle, meat byproducts Egg ................................. Goat, fat .......................... Goat, meat ...................... Goat, meat byproducts ... Hog, fat ........................... Hog, meat ....................... Hog, meat byproducts .... Horse, fat ........................ Horse, meat .................... Horse, meat byproducts Milk ................................. Poultry, fat ...................... Poultry, meat .................. Poultry, meat byproducts Sheep, fat ....................... Sheep, meat ................... Sheep, meat byproducts 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. Tolerances with regional registrations, as defined in 180.1(m), are established for the combined residues of the insecticide oxydemeton-methyl (S(2-(ethylsulfinyl)-ethyl) O,O-dimethyl phosphorothioate) and its metabolite oxydemeton-methyl sulfone in or on the following food commodities: Commodity Parts per million Broccoli raab ................... 0.5 3.0 0.02 1.0 1.0 0.05 1.0 1.0 2.0 0.2 0.05 1.0 0.75 12.5 0.2 1.0 2.0 2.0 2.0 (d) Indirect or inadvertent residues. [Reserved] 6. Section 180.404, paragraph (a) is revised to read as follows: §180.404 Profenofos; tolerances for residues. (a) General. Tolerances are established for residues of the insecticide profenofos (O-(4-bromo-2chlorophenyl)-O-ethyl-S-propyl phosphorothioate) in or on the following food commodities: Commodity Cattle, fat ........................ E:\FR\FM\23MYP1.SGM 23MYP1 Parts per million 0.05 28920 Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Proposed Rules Commodity Parts per million Cattle, meat .................... Cattle, meat byproducts Cotton, gin byproducts ... Cotton, undelinted seed Goat, fat .......................... Goat, meat ...................... Goat, meat byproducts ... Horse, fat ........................ Horse, meat .................... Horse, meat byproducts Milk ................................. Sheep, fat ....................... Sheep, meat ................... Sheep, meat byproducts * * * * 0.05 0.05 55.0 2.0 0.05 0.05 0.05 0.05 0.05 0.05 0.01 0.05 0.05 0.05 * FR Doc. 07–2561 Filed 5–22–07; 8:45 am BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2006–0766; FRL–8126–1] [RIN 2070–AJ28] Pesticide Tolerance Crop Grouping Program; Proposed Expansion Environmental Protection Agency (EPA). ACTION: Proposed rule. cprice-sewell on PROD1PC71 with PROPOSALS AGENCY: SUMMARY: EPA is proposing revisions to its pesticide tolerance crop grouping regulations, which allow establishment of tolerances for multiple related crops, based on data from a representative set of crops. The present revision would create a new crop group for edible fungi (mushrooms), expand existing crop groups by adding new commodities, establish new crop subgroups, and revise the representative crops in some groups. Additionally, EPA is revising the generic crop group regulation to add a subsection explaining how the Agency will implement revisions to crop groups. EPA expects these revisions to promote greater use of crop groupings for tolerance-setting purposes and, in particular, will assist in retaining or making available pesticides for minor crop uses. This is the first in a series of planned crop group updates expected to be proposed over the next several years. DATES: Comments must be received on or before July 23, 2007. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2006–0766, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. VerDate Aug<31>2005 15:44 May 22, 2007 Jkt 211001 • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is (703) 305– 5805. Instructions: Direct your comments to docket ID number EPA–HQ–OPP–2006– 0766. EPA’s policy is that all comments received will be included in the docket without change and may be made available on-line at https:// www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The Federal regulations.gov website is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. 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. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. Docket: All documents in the docket are listed in the docket index. Although listed in the index, some information is not publicly available, e.g., 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 either in the PO 00000 Frm 00026 Fmt 4702 Sfmt 4702 electronic docket at https:// www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305–5805. FOR FURTHER INFORMATION CONTACT: ` Rame Cromwell, Field and External Affairs Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–9068; fax number: (703) 305–5884; e-mail address: cromwell.rame@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. What Should I Consider as I Prepare My Comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through www.regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI E:\FR\FM\23MYP1.SGM 23MYP1

Agencies

[Federal Register Volume 72, Number 99 (Wednesday, May 23, 2007)]
[Proposed Rules]
[Pages 28912-28920]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-2561]



[[Page 28912]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0261; FRL-8130-8]


Methamidophos, Oxydemeton-methyl, Profenofos, and Trichlorfon; 
Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke certain tolerances for the 
insecticides methamidophos and oxydemeton-methyl. Also, EPA is 
proposing to modify certain tolerances for the insecticides 
methamidophos, oxydemeton-methyl, profenofos, and trichlorfon. In 
addition, EPA is proposing to establish new tolerances for the 
insecticides methamidophos and profenofos. The regulatory actions 
proposed in this document are in follow-up to the Agency's 
reregistration program under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), and tolerance reassessment program under the 
Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q).

DATES: Comments must be received on or before July 23, 2007.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2007-0261, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
      Mail: Office of Pesticide Programs (OPP) Regulatory 
Public Docket (7502P), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
      Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.
     Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0261. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
https://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access'' 
system, which means EPA will not know your identity or contact 
information unless you provide it in the body of your comment. If you 
send an e-mail comment directly to EPA without going through 
regulations.gov, your e-mail address will be automatically captured and 
included as part of the comment that is placed in the docket and made 
available on the Internet. If you submit an electronic comment, EPA 
recommends that you include your name and other contact information in 
the body of your comment and with any disk or CD-ROM you submit. 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. Electronic files should avoid the use of special characters, 
any form of encryption, and be free of any defects or viruses.
     Docket: All documents in the docket are listed in the docket index 
available in regulations.gov. To access the electronic docket, go to 
https://www.regulations.gov, select ``Advanced Search,'' then ``Docket 
Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov web 
site to view the docket index or access available documents. Although 
listed in the index, some information is not publicly available, e.g., 
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 either in the 
electronic docket at https://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 
hours of operation of this Docket Facility are from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Docket 
Facility telephone number is (703) 305-5805.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 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.

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

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD ROM that you mail to EPA, 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 claimed as CBI. In addition to one 
complete version of the comment that includes 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. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).

[[Page 28913]]

    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

C. 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.

II. Background

A. What Action is the Agency Taking?

    EPA is proposing to revoke, remove, modify, and establish specific 
tolerances for residues of the insecticides methamidophos, oxydemeton-
methyl, profenofos, and trichlorfon in or on commodities listed in the 
regulatory text.
    EPA is proposing these tolerance actions to implement the tolerance 
recommendations made during the reregistration and tolerance 
reassessment processes (including follow-up on canceled or additional 
uses of pesticides). As part of these processes, EPA is required to 
determine whether each of the amended tolerances meets the safety 
standard of the FFDCA. The safety finding determination of ``reasonable 
certainty of no harm'' is discussed in detail in each Reregistration 
Eligibility Decision (RED) and Report of the Food Quality Protection 
Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision 
(TRED) for the active ingredient. REDs and TREDs recommend the 
implementation of certain tolerance actions, including modifications to 
reflect current use patterns, meet safety findings, and change 
commodity names and groupings in accordance with new EPA policy. 
Printed copies of many 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: 1 (800) 490-9198; 
fax: 1 (513) 489-8695; internet at https://www.epa.gov/ncepihom/ and 
from the National Technical Information Service (NTIS), 5285 Port Royal 
Road, Springfield, VA 22161, telephone: 1 (800) 553-6847 or (703) 605-
6000; internet at https://www.ntis.gov/. Electronic copies of REDs and 
TREDs are available on the internet. The methamidophos, oxydemeton-
methyl, and profenofos REDs and triclorfon TRED are found at https://
www.epa.gov/pesticides/reregistration/status.htm.
    The selection of an individual tolerance level is based on crop 
field residue studies designed to produce the maximum residues under 
the existing or proposed product label. Generally, the level selected 
for a tolerance is a value slightly above the maximum residue found in 
such studies, provided that the tolerance is safe. The evaluation of 
whether a tolerance is safe is a separate inquiry. EPA recommends the 
raising of a tolerance when data show that:
    (1) Lawful use (sometimes through a label change) may result in a 
higher residue level on the commodity.
    (2) The tolerance remains safe, notwithstanding increased residue 
level allowed under the tolerance. In REDs, Chapter IV on ``Risk 
management, Reregistration, and Tolerance reassessment'' typically 
describes the regulatory position, FQPA assessment, cumulative safety 
determination, determination of safety for U.S. general population, and 
safety for infants and children. In particular, the human health risk 
assessment document which supports the RED describes risk exposure 
estimates and whether the Agency has concerns. In TREDs, the Agency 
discusses its evaluation of the dietary risk associated with the active 
ingredient and whether it can determine that there is a reasonable 
certainty (with appropriate mitigation) that no harm to any population 
subgroup will result from aggregate exposure. EPA also seeks to 
harmonize tolerances with international standards set by the Codex 
Alimentarius Commission, as described in Unit III.
    Explanations for proposed modifications in tolerances can be found 
in the RED and TRED document and in more detail in the Residue 
Chemistry Chapter document which supports the RED and TRED. Copies of 
the Residue Chemistry Chapter documents are found in the Administrative 
Record and paper copies for methamidophos, oxydemeton-methyl, 
profenofos, and trichlorfon are available in the public docket for this 
rule. Electronic copies are available through EPA's electronic public 
docket and comment system, regulations.gov at https://
www.regulations.gov/. You may search for docket number EPA-HQ-OPP-2007-
0261, then click on that docket number to view its contents.
    EPA has determined that the aggregate exposures and risks are not 
of concern for the above mentioned pesticide active ingredients based 
upon the data identified in the RED or TRED which lists the submitted 
studies that the Agency found acceptable.
    EPA has found that the tolerances that are proposed in this 
document to be modified, are safe; i.e., that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residues, in accordance 
with FFDCA section 408(b)(2)(C). (Note that changes to tolerance 
nomenclature do not constitute modifications of tolerances). These 
findings are discussed in detail in each RED or TRED. The references 
are available for inspection as described in this document under 
SUPPLEMENTARY INFORMATION.
    In addition, EPA is proposing to revoke certain specific tolerances 
because either they are no longer needed or are associated with food 
uses that are no longer registered under FIFRA. Those instances where

[[Page 28914]]

registrations were canceled were because the registrant failed to pay 
the required maintenance fee and/or the registrant voluntarily 
requested cancellation of one or more registered uses of the pesticide. 
It is EPA's general practice to propose revocation of those tolerances 
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 to cover 
residues in or on imported commodities or domestic commodities legally 
treated.
    1. Methamidophos. Because methamidophos is a metabolite of 
acephate, EPA determined that residues of methamidophos resulting from 
the application of acephate should be included under the tolerance 
regulations for methamidophos as a pesticide. Therefore, EPA is 
proposing to recodify the tolerances for methamidophos from 40 CFR 
180.315(a) into (a)(1) for permanent tolerances for residues of 
methamidophos (O,S-dimethyl phosphoramidothioate) in or on food 
commodities as a result of the application of the insecticide 
methamidophos and (a)(2) for residues of methamidophos (O,S-dimethyl 
phosphoramidothioate) in or on food commodities as a result of the 
application of the insecticide acephate.
    Currently, 40 CFR 180.3, the section on tolerances for related 
pesticide chemicals, contains a paragraph (d)(8) stating that where 
tolerances are established for residues of O,S-dimethyl 
phosphoramidothioate, resulting from the use of acephate (O,S-dimethyl 
acetylphos-phoramidothioate) and/or O,S-dimethylphosphoramidothioate on 
the same agricultural commodity, the total amount of O,S-dimethyl-
phosphoramidothioate shall not yield more residue than that permitted 
by the higher of the two tolerances. However, with the proposed change 
to include tolerances for methamidophos that result from the 
application of acephate under the methamidophos tolerance regulations 
in 40 CFR 180.315(a)(2), there is no longer a need for the related 
pesticide chemical regulation under 40 CFR 180.3(d)(8); and therefore, 
EPA is proposing to remove existing paragraph (d)(8).
    With the exception of uses on cotton and potatoes, EPA canceled all 
methamidophos FIFRA section 3 registrations and, with the exception of 
uses on tomatoes, all section 24(c) regional registrations (62 FR 
67071, December 23, 1997) (FRL-5764-2). Because there are no active 
registrations for uses of either methamidophos or acephate on broccoli, 
cabbage, cucumber, eggplant, and melon, the associated tolerances in 40 
CFR 180.315 are no longer needed and should be revoked. Therefore, EPA 
is proposing to revoke the tolerances in 40 CFR 180.315 on broccoli, 
cabbage, cucumber, eggplant, and melon. Also, on July 31, 2002 (67 FR 
49606)(FRL-7191-4), EPA published a final rule in the Federal Register 
in which it responded to the Canadian Horticultural Council's comment 
asking that certain tolerances in 40 CFR 180.315, including those on 
broccoli and cabbage, not be revoked. At that time, the Agency 
responded that it would not revoke the tolerances on broccoli and 
cabbage in 40 CFR 180.315, but would follow-up to see that data 
requirements were met should an interested party support those 
tolerances for import purposes. However, in the interim period, no 
interested party has declared an interest and committed in writing to 
do the required data to support the broccoli and cabbage tolerances for 
import purposes.
    However, because there are registered acephate uses on Brussels 
sprouts, cauliflower, celery, and head lettuce, EPA is proposing to 
recodify the tolerances for Brussels sprouts, cauliflower, and lettuce 
from 40 CFR 180.315(a) into (a)(2) and celery from (b) into (a)(2). 
Also, in order to reflect active registered use of acephate on head 
lettuce, EPA is proposing in 40 CFR 180.315(a)(2) to revise ``lettuce'' 
to ``lettuce, head.'' In addition, because there is an existing 
tolerance for acephate use on cauliflower, which has been reassessed in 
the acephate RED at the same level, such that residues from metabolism 
to methamidophos are expected to be no greater than 0.5 parts per 
million (ppm), EPA is proposing to decrease the tolerance on 
cauliflower in 40 CFR 180.315(a)(2) from 1.0 to to 0.5 ppm. Also, this 
proposed level will harmonize with the Codex MRL of 0.5 mg/kg on 
cauliflower.
    At the time of the completion of the methamidophos IRED, a 
registrant submitted an import tolerance petition for peppers, 
strawberries, and squash. This petition has not been reviewed. Because 
there is an existing tolerance for acephate use on peppers, which in 
the acephate RED has been reassessed at the same level, such that 
residues from metabolism to methamidophos are expected to be no greater 
than 1.0 ppm, EPA is proposing to recodify the tolerance on pepper from 
40 CFR 180.315(a) to (a)(2) at 1.0 ppm. Also, this proposed level will 
harmonize with the Codex MRL of 1.0 mg/kg on sweet peppers.
    Because there are registered methamidophos uses on potato, EPA is 
proposing to recodify the tolerance at 0.1 ppm on potato from 40 CFR 
180.315(a) into (a)(1). There is a Codex MRL of 0.05 ppm on potato, but 
harmonization is not possible because of differences in agricultural 
practices.
    Based on available data that showed methamidophos residues as high 
as 0.191 ppm on cottonseed, EPA determined that the tolerance on 
cottonseed should be increased from 0.1 to 0.2 ppm. Therefore, the 
Agency is proposing to recodify the tolerance on cotton, undelinted 
seed from 40 CFR 180.315(a) to (a)(1) and increase the tolerance 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. Also, this proposed level 
will harmonize with the Codex MRL of 0.2 mg/kg on cottonseed.
    Based on available data that showed methamidophos residues as high 
as 8.03 ppm on cotton gin byproducts, EPA determined that a tolerance 
on cotton gin byproducts should be established at 10.0 ppm. Therefore, 
the Agency is proposing to establish a tolerance on cotton, gin 
byproducts in 40 CFR 180.315(a)(1) at 10.0 ppm.
    Based on available data that showed methamidophos residues as high 
as 1.4 ppm on tomatoes, EPA determined that the tolerance on tomato 
should be increased from 1.0 to 2.0 ppm. Because there are only active 
FIFRA section 24(c) registrations for use of methamidophos on tomatoes 
and no active registrations for use of acephate on tomatoes, the Agency 
has determined that the tolerance should be recodified as a regional 
tolerance. Therefore, the Agency is proposing to recodify 40 CFR 
180.315(b) as (c) and the tolerance on tomato from 40 CFR 180.315(a) to 
(c), and increase the tolerance 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. Also, EPA is proposing to revise the tolerance 
expression in newly recodified 40 CFR 180.315(c), as follows:
    Tolerances with regional registration, as defined in 40 CFR 
180.1(m), are established for residues of methamidophos (O,S-dimethyl 
phosphoramidothioate) in or on the following food commodities as a 
result of the application of the insecticide methamidophos.
    In addition, EPA is proposing to revise 40 CFR 180.315 by adding 
separate paragraphs (b) and (d), and

[[Page 28915]]

reserving those sections for tolerances with section 18 emergency 
exemptions, and indirect or inadvertent residues, respectively.
    Because there are existing tolerances for use of acephate on dry 
and succulent beans and cranberries, which in the acephate RED have 
been reassessed at the same level, such that residues from metabolism 
to methamidophos are expected to be no greater than 1.0 ppm and 0.1 
ppm, respectively, EPA is proposing to establish tolerances in 40 CFR 
180.315(a)(2) for residues of methamidophos as a result from the 
application of acephate on bean, dry, seed at 1.0 ppm, bean, succulent 
at 1.0 ppm, and cranberry at 0.1 ppm.
    Because there is an existing tolerance for use of acephate on mint 
hay, which in the acephate RED has been reassessed to be increased from 
15.0 to 27.0 ppm, such that residues from metabolism to methamidophos 
are expected to be increased from no greater than 1.0 to 2.0 ppm, EPA 
is proposing to establish a tolerance in 40 CFR 180.315(a)(2) for 
residues of methamidophos as a result from the application of acephate 
on mint, hay at 2.0 ppm and revise it to ``peppermint, tops'' and 
``spearmint, tops.''
    2. Oxydemeton-methyl. Currently, the tolerances in 40 CFR 180.330 
are expressed for residues of oxydemeton-methyl and its cholinesterase-
inhibiting metabolites. Based on the Agency's determination that only 
residues of oxydemeton-methyl and its metabolite oxydemeton-methyl 
sulfone are of concern in plants, the tolerances in 40 CFR 180.330 
should be recodified for plant commodities from 40 CFR 180.330(a) to 
(a)(1) and animal commodities from 40 CFR 180.330(a) to (a)(2). 
Therefore, EPA is proposing to recodify plant tolerances in 40 CFR 
180.330(a)(1) and animal tolerances in 40 CFR 180.330(a)(2) and revise 
the tolerance expression in 40 CFR 180.330 as follows:
    (a) General. (1) Tolerances are established for the combined 
residues of the insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)-
ethyl) O,O-dimethyl phosphorothioate) and its metabolite oxydemeton-
methyl sulfone in or on the following food commodities.
    (2) Tolerances are established for the combined residues of the 
insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)-ethyl) O,O-
dimethyl phosphorothioate) and its cholinesterase-inhibiting 
metabolites in or on the following food commodities.
    Because certain registered uses have product labels which prohibit 
harvest within one year of application, so that there is no reasonable 
expectation of residues on food commodities, the Agency considers them 
to be nonfood uses of oxydemeton-methyl. As a result, the tolerances in 
40 CFR 180.330 for these nonfood uses are no longer needed and should 
be revoked for apple, apricot, grape, and plum, prune, fresh. 
Therefore, the Agency is proposing to revoke the tolerances in 40 CFR 
180.330(a) on apple, grape, and plum, prune, fresh and in 40 CFR 
180.330(c) on apricot.
    Because bean, lima, forage; clover, seed screenings; and sorghum 
milled fractions (except flour) are no longer considered by the Agency 
to be significant animal feed items, their tolerances in 40 CFR 180.330 
are no longer needed and should be revoked. Therefore, the Agency is 
proposing to revoke the tolerances in 40 CFR 180.330 on bean, lima, 
forage; clover, seed screenings; and sorghum, milled fractions (except 
flour).
    In 1994, the technical registrant for oxydemeton-methyl (ODM) 
agreed not to market ODM on snap beans, field corn, popcorn, pears, and 
turnips but retained them on registrations with the possibility of 
requesting to reinstate them on marketing labels after EPA's review of 
needed ODM data and completion of dietary and worker risk assessments. 
In a letter to the Agency dated February 4, 2004, the technical 
registrant requested to amend the registrations for both a technical 
and end-use registration and delete those uses. In the Federal Register 
of November 4, 2005 (70 FR 67167) (FRL-7744-7), EPA published a notice 
announcing the receipt of requests for amendments to delete uses in 
certain pesticide registrations, including deletion for ODM use on snap 
beans, field corn, popcorn, pears, and turnips concerning registrations 
for one technical and one end use product. That notice had an effective 
date of December 5, 2005 and allowed the registrant to sell or 
distribute product under the previously approved labelling for a period 
of 18 months after approval of the revision. There have been no end use 
marketing labels for ODM use on these commodities since September 18, 
1995. However, there has been one active technical registration with 
these uses from 1995 through the December 5, 2005 effective date that 
amended its label. Nevertheless, despite the allowance by EPA that 
existing stocks for the technical and end use registrations could be 
sold or distributed by the registrant for 18 months, the Agency 
believes that no end users have used ODM on snap beans, field corn, 
popcorn, pears, and turnip commodities since 1995. Therefore, EPA 
believes that existing stocks of end use product was exhausted years 
ago and that such ODM treated-snap beans, field corn, popcorn, pears, 
and turnip commodities passed through channels of trade long ago and 
that sufficient time has passed. Consequently, EPA is proposing to 
revoke the tolerances in 40 CFR 180.330 on bean, snap, succulent; bean, 
snap, forage; corn, grain; pear; turnip; and turnip, greens; all on the 
date of publication of the final rule.
    Based on available data that showed combined oxydemeton-methyl 
residues of concern as high as 0.9 ppm in or on corn forage, EPA 
determined that the tolerance on corn forage should be decreased from 
3.0 to 1.0 ppm. Therefore, the Agency is proposing in 40 CFR 180.330 to 
decrease the tolerance on corn, forage to 1.0 ppm and revise it to 
corn, sweet, forage. No tolerance on field corn forage is needed.
    Based on available data that showed combined oxydemeton-methyl 
residues of concern as high as 9.84 ppm in or on clover hay grown for 
seed, EPA determined that the tolerance on clover hay grown for seed 
should be decreased from 11.0 to 10.0 ppm. Therefore, the Agency is 
proposing in 40 CFR 180.330 to decrease the tolerance on clover, hay, 
grown for seed to 10.0 ppm and revise it to clover, hay.
    Based on available data that showed combined oxydemeton-methyl 
residues of concern as high as 0.15 ppm in or on lima beans, 0.2 ppm in 
or on melons, less than 0.1 ppm in or on pumpkins, and less than 0.05 
ppm in or on walnuts, EPA determined that the tolerances on lima beans, 
cottonseed, melons, pumpkins, and walnuts should be decreased from 0.5 
to 0.2 ppm, 0.1 to 0.02 ppm, 0.3 to 0.2 ppm, 0.3 to 0.2 ppm, and 0.3 to 
0.05 ppm, respectively. Therefore, the Agency is proposing in 40 CFR 
180.330 to decrease the tolerances on bean, lima to 0.2 ppm, cotton, 
undelinted seed to 0.02 ppm, melon to 0.2 ppm, pumpkin to 0.2 ppm, and 
walnut to 0.05 ppm.
    Based on available data that showed combined oxydemeton-methyl 
residues of concern as high as 1.22 ppm in or on cabbage, EPA 
determined that the tolerance on cabbage should be increased from 1.0 
to 2.0 ppm. Therefore, the Agency is proposing in 40 CFR 180.330 to 
increase the tolerance on cabbage 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. Also, because there is one active FIFRA 
section 24(c) registration for foliar use of oxydemeton-methyl on 
broccoli raab, EPA determined that data could be translated from 
cabbage and broccoli to broccoli raab, and therefore a tolerance

[[Page 28916]]

should be established on broccoli raab at 2.0 ppm. Therefore, EPA is 
proposing to establish a regional tolerance on broccoli raab in 40 CFR 
180.330(c) at 2.0 ppm and revise the tolerance expression in 40 CFR 
180.330(c) as follows:
    (c) Tolerances with regional registrations, as defined in 40 CFR 
180.1(m), are established for the combined residues of the 
insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)-ethyl) O,O-
dimethyl phosphorothioate) and its metabolite oxydemeton-methyl 
sulfone in or on the following food commodities.
    Based on a poultry metabolism study at the 6x feeding level that 
showed no residues of toxicological concern in poultry commodities and 
an earlier poultry metabolism study that showed residues were present 
in eggs and tissues, EPA determined that egg and poultry tolerances 
should be established at the limit of quantitation (LOQ) of 0.01 ppm. 
Therefore, the Agency is proposing to establish tolerances in 40 CFR 
180.330(a)(2) on egg; poultry, fat; poultry, meat; and poultry, meat 
byproducts at 0.01 ppm.
    Also, EPA is proposing to revise commodity terminology in 40 CFR 
180.330 to conform to current Agency practice as follows: ``alfalfa, 
green'' to ``alfalfa, forage;'' ``alfalfa, hay, grown for seed'' to 
``alfalfa, hay;'' ``beet, sugar'' to ``beet, sugar, roots;'' ``corn, 
stover'' to ``corn, sweet, stover'' (no tolerances are needed on field 
corn stover or popcorn stover) ``mint, hay'' to ``peppermint, tops'' 
and ``spearmint, tops;'' ``onion, dry bulb'' to ``onion, bulb;'' 
``orange, sweet'' to ``orange;'' ``sorghum, forage'' to ``sorghum, 
forage, forage'' and ``sorghum, grain, forage;'' ``sorghum, grain'' to 
``sorghum, grain, grain.''
    There are no Codex MRLs for oxydemeton-methyl.
    3. Profenofos. Currently, the tolerances in 40 CFR 180.404(a) are 
expressed for residues of profenofos and its metabolites converted to 
4-bromo-2-chlorophenyl and calculated as profenofos. Based on the 
Agency's determination that only residues of profenofos per se are of 
toxicological concern, the tolerance expression in 40 CFR 180.404 
should be revised to reflect that profenofos per se is the only 
regulated residue. Therefore, EPA is proposing to revise the tolerance 
expression in 40 CFR 180.404(a) as follows:
    (a) General. Tolerances are established for residues of the 
insecticide profenofos (O-(4-bromo-2-chlorophenyl)-O-ethyl-S-propyl 
phosphorothioate) in or on the following food commodities.
     Based on available data that showed profenofos residues were as 
high as 1.1 ppm on cottonseed, EPA determined that the tolerance should 
be decreased from 3.0 to 2.0 ppm. Therefore, the Agency is proposing to 
decrease the tolerance in 40 CFR 180.404 on cotton, undelinted seed to 
2.0 ppm. Also, this proposed level will harmonize with the Codex MRL of 
2 mg/kg on cottonseed.
    Based on available data that showed profenofos residues as high as 
53 ppm, EPA determined that a tolerance of 55.0 ppm should be 
established for cotton gin byproducts. Therefore, the Agency is 
proposing to establish a tolerance in 40 CFR 180.404 for the residues 
of profenofos on cotton, gin byproducts at 55.0 ppm.
    4. Trichlorfon. There are no active registrations for the use of 
the insecticide trichlorfon for cattle commodities in the United 
States. However, trichlorfon is used as a dermal pour-on application 
for cattle for import purposes. Based on cattle metabolism data from 
dermal application of trichlorfon which showed residues of trichlorfon 
as high as 0.2 ppm in muscle and less than 0.5 ppm in fat, EPA 
determined that the tolerances on cattle meat and cattle fat should be 
increased from 0.1 ppm to 0.2 ppm and 0.1 to 0.5 ppm, respectively. 
Therefore, EPA is proposing in 40 CFR 180.198 to increase the 
tolerances on cattle, meat to 0.2 ppm and cattle, fat to 0.5 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. Dichlorvos is a degradate 
of trichlorfon. However, as stated in the 2006 Dichlorvos RED, non-
detectable dichlorvos residues in livestock commodities are expected as 
a result of trichlorfon use, and dichlorvos was not a significant 
metabolite in the trichlorfon dermal metabolism data. Therefore, 
dietary (food) exposure to dichlorvos residues resulting from use of 
trichlorfon is considered by the Agency to be negligible.
    Also, in 40 CFR 180.198, EPA is proposing to remove the ``(N)'' 
designation from all entries to conform to current Agency 
administrative practice, where the ``(N)'' designation means negligible 
residues. In addition, in order to conform to current Agency practice, 
EPA is proposing to revise 40 CFR 180.198 and establish subparts (a) 
through (d), recodify general tolerances under 40 CFR 180.198(a) and 
reserve sections (b) for tolerances with section 18 emergency 
exemptions, (c) for regional registrations, and (d) for indirect or 
inadvertent residues.
    There are no Codex MRLs for trichlorfon.

B. 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. 346a, 
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. Without a tolerance or exemption, food containing 
pesticide residues is considered to be unsafe and therefore 
``adulterated'' under section 402(a) of the FFDCA, 21 U.S.C. 342(a). 
Such food may not be distributed in interstate commerce (21 U.S.C. 
331(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. 136 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.
    EPA is proposing these tolerance actions in follow-up to the 
tolerance recommendations made during the reregistration and tolerance 
reassessment processes (including follow-up on canceled or additional 
uses of pesticides). The safety finding determination under section 408 
of the FFDCA standard is discussed in detail in each Post-FQPA 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 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 methamidophos, oxydemeton-methyl, 
and profenofos, and a TRED for trichlorfon, whose RED was completed 
prior to FQPA. REDs and TREDs contain the Agency's evaluation of the 
data base for these pesticides, including requirements for additional 
data on the active ingredients to confirm the potential human health 
and environmental risk assessments associated with current product 
uses, and in REDs state conditions under which these uses and products 
will be eligible for reregistration. The REDs and TREDs recommended the 
establishment,

[[Page 28917]]

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 
FFDCA standard of ``reasonable certainty of no harm.'' However, 
tolerance revocations recommended in REDs and TREDs that are proposed 
in this document do not need such assessment when the tolerances are no 
longer necessary.
    EPA's general practice is to propose revocation of tolerances for 
residues of pesticide active ingredients on crops for which FIFRA 
registrations no longer exist and on which the pesticide may therefore 
no longer be used in the United States. EPA has historically been 
concerned that retention of tolerances that are not necessary to cover 
residues in or on legally treated foods may encourage misuse of 
pesticides within the United States. Nonetheless, EPA will establish 
and maintain tolerances even when corresponding domestic uses are 
canceled if the tolerances, which EPA refers to as ``import 
tolerances,'' are necessary to allow importation into the United States 
of food containing such pesticide residues. However, where there are no 
imported commodities that require these import tolerances, the Agency 
believes it is appropriate to revoke tolerances for unregistered 
pesticides in order to prevent potential misuse.
    Furthermore, as a general matter, the Agency believes that 
retention of import tolerances not needed to cover any imported food 
may result in unnecessary restriction on trade of pesticides and foods. 
Under section 408 of the FFDCA, a tolerance may only be established or 
maintained if EPA determines that the tolerance is safe based on a 
number of factors, including an assessment of the aggregate exposure to 
the pesticide and an assessment of the cumulative effects of such 
pesticide and other substances that have a common mechanism of 
toxicity. In doing so, EPA must consider potential contributions to 
such exposure from all tolerances. If the cumulative risk is such that 
the tolerances in aggregate are not safe, then every one of these 
tolerances is potentially vulnerable to revocation. Furthermore, if 
unneeded tolerances are included in the aggregate and cumulative risk 
assessments, the estimated exposure to the pesticide would be inflated. 
Consequently, it may be more difficult for others to obtain needed 
tolerances or to register needed new uses. To avoid potential trade 
restrictions, the Agency is proposing to revoke tolerances for residues 
on crops uses for which FIFRA registrations no longer exist, unless 
someone expresses a need for such tolerances. Through this proposed 
rule, the Agency is inviting individuals who need these import 
tolerances to identify themselves and the tolerances that are needed to 
cover imported commodities.
    Parties interested in retention of the tolerances should be aware 
that additional data may be needed to support retention. These parties 
should be aware that, under FFDCA section 408(f), if the Agency 
determines that additional information is reasonably required to 
support the continuation of a tolerance, EPA may require that parties 
interested in maintaining the tolerances provide the necessary 
information. If the requisite information is not submitted, EPA may 
issue an order revoking the tolerance at issue.
    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 https://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 https://
www.epa.gov/fedrgstr/.
    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 pesticides 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 (c)).
    EPA has evaluated certain specific meat, milk, poultry, and egg 
tolerances proposed for revocation in this rule and has concluded that 
there is no reasonable expectation of finite pesticide residues of 
concern in or on those commodities.

C. When do These Actions Become Effective?

    EPA is proposing that the actions herein become effective on the 
date of publication of the final rule in the Federal Register, because 
their associated uses have been canceled for several years. The Agency 
believes that existing stocks of pesticide products labeled for the 
uses associated with the tolerances proposed for revocation have been 
completely exhausted and that treated commodities have had sufficient 
time for passage through the channels of trade. However, if EPA is 
presented with information that existing stocks would still be 
available and that information is verified, the Agency will consider 
extending the expiration date of the tolerance. If you have comments 
regarding existing stocks and whether the effective date allows 
sufficient time for treated commodities to clear the channels of trade, 
please submit comments as described under SUPPLEMENTARY INFORMATION.
    Any commodities listed in this proposal treated with the pesticides 
subject to this proposal, and 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 the Food and Drug 
Administration that:
    1. The residue is present as the result of an application or use of 
the pesticide at a time and in a manner that was lawful under FIFRA, 
and
    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 when the 
pesticide was applied to such food.

III. Are the Proposed Actions Consistent with International 
Obligations?

     The tolerance actions 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.
    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the

[[Page 28918]]

international Maximum Residue Limits (MRLs) established by the Codex 
Alimentarius Commission, as required by section 408(b)(4) of the FFDCA. 
The Codex Alimentarius is a joint U.N. Food and Agriculture 
Organization/World Health Organization food standards program, and it 
is recognized as an international food safety standards-setting 
organization in trade agreements to which the United States is a party. 
EPA may establish a tolerance that is different from a Codex MRL; 
however, section 408(b)(4) of FFDCA requires that EPA explain the 
reasons for departing from the Codex level in a notice published for 
public comment. EPA's effort to harmonize with Codex MRLs is summarized 
in the tolerance reassessment section of individual REDs and TREDs, and 
in the Residue Chemistry document which supports the RED and TRED, as 
mentioned in Unit II.A. Specific tolerance actions in this rule and how 
they compare to Codex MRLs (if any) are discussed in Unit II.A.

IV. Statutory and Executive Order Reviews

    In this proposed rule, EPA is proposing to establish tolerances 
under FFDCA section 408(e), and also modify and revoke specific 
tolerances established under FFDCA section 408. The Office of 
Management and Budget (OMB) has exempted these types of actions (e.g., 
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 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 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 
proposed rule, the Agency hereby certifies that this proposed action 
will not have a significant negative 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 of this proposed rule). 
Furthermore, for the pesticide named in this proposed rule, the Agency 
knows of no extraordinary circumstances that exist as to the present 
proposal that would change the 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 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 [ld]quo;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: May 16, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

[[Page 28919]]

PART 180--[AMENDED]

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

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


Sec. 180.3  [Amended]

    2. Section 180.3 is amended by removing paragraph (d)(8) and 
redesignationg paragraphs (d)(9) through (d)(14) as paragraphs (d)(8) 
through (d)(13).
    3. Section 180.198 is revised to read as follows:


Sec. 180.198  Trichlorfon; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide trichlorfon (dimethyl (2,2,2-trichloro-1-hydroxyethyl) 
phosphonate) in or on the following food commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Cattle, fat \1\......................................                0.5
Cattle, meat \1\.....................................                0.2
Cattle, meat byproducts \1\..........................                0.1
------------------------------------------------------------------------
\1\There are no U.S. registrations for cattle commodities as of June 24,
  1999.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
    4. Section 180.315 is revised to read as follows:


Sec. 180.315  Methamidophos; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
methamidophos (O,S-dimethyl phosphoramidothioate) in or on the 
following food commodities as a result of the application of the 
insecticide methamidophos.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Cotton, gin byproducts...............................               10.0
Cotton, undelinted seed..............................                0.2
Potato...............................................                0.1
------------------------------------------------------------------------

    (2) Tolerances are established for residues of methamidophos (O,S-
dimethyl phosphoramidothioate) in or on the following food commodities 
as a result of the application of the insecticide acephate.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Bean, dry, seed......................................                1.0
Bean, succulent......................................                1.0
Brussels sprouts.....................................                1.0
Cauliflower..........................................                0.5
Celery...............................................                1.0
Cranberry............................................                0.1
Lettuce, head........................................                1.0
Pepper...............................................                1.0
Peppermint, tops.....................................                2.0
Spearmint, tops......................................                2.0
------------------------------------------------------------------------

     (b) Section 18 emergency exemptions. [Reserved]
     (c) Tolerances with regional registrations. Tolerances with 
regional registration, as defined in 180.1(m), are established for 
residues of methamidophos (O,S-dimethyl phosphoramidothioate) in or on 
the following food commodities as a result of the application of the 
insecticide methamidophos.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Tomato                                                               2.0
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]
    5. Section 180.330 is revised to read as follows:


Sec. 180.330  S-(2-(Ethylsulfinyl)ethyl) O,O-dimethyl phosphorothioate; 
tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of the insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)-
ethyl) O,O-dimethyl phosphorothioate) and its metabolite oxydemeton-
methyl sulfone in or on the following food commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Alfalfa, forage......................................                5.0
Alfalfa, hay.........................................               11.0
Bean, lima...........................................                0.2
Beet, sugar, roots...................................                0.3
Beet, sugar, tops....................................                0.5
Broccoli.............................................                1.0
Brussels sprouts.....................................                1.0
Cabbage..............................................                2.0
Cauliflower..........................................                1.0
Clover, forage.......................................                5.0
Clover, hay..........................................               10.0
Corn, sweet, forage..................................                1.0
Corn, sweet, kernel plus cob with husks removed......                0.5
Corn, sweet, stover..................................                3.0
Cotton, undelinted seed..............................               0.02
Cucumber.............................................                1.0
Eggplant.............................................                1.0
Filbert..............................................               0.05
Grapefruit...........................................                1.0
Lemon................................................                1.0
Lettuce, head........................................                2.0
Melon................................................                0.2
Onion, bulb..........................................               0.05
Orange...............................................                1.0
Pepper...............................................               0.75
Peppermint, tops.....................................               12.5
Pumpkin..............................................                0.2
Safflower, seed......................................                1.0
Sorghum, forage, forage..............................                2.0
Sorghum, grain, forage...............................                2.0
Sorghum, grain, grain................................               0.75
Spearmint, tops......................................               12.5
Squash, summer.......................................                1.0
Squash, winter.......................................                0.3
Strawberry...........................................                2.0
Walnut...............................................               0.05
------------------------------------------------------------------------

     (2) Tolerances are established for the combined residues of the 
insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)-ethyl) O,O-dimethyl 
phosphorothioate) and its cholinesterase-inhibiting metabolites in or 
on the following food commodities.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Cattle, fat..........................................               0.01
Cattle, meat.........................................               0.01
Cattle, meat byproducts..............................               0.01
Egg..................................................               0.01
Goat, fat............................................               0.01
Goat, meat...........................................               0.01
Goat, meat byproducts................................               0.01
Hog, fat.............................................               0.01
Hog, meat............................................               0.01
Hog, meat byproducts.................................               0.01
Horse, fat...........................................               0.01
Horse, meat..........................................               0.01
Horse, meat byproducts...............................               0.01
Milk.................................................               0.01
Poultry, fat.........................................               0.01
Poultry, meat........................................               0.01
Poultry, meat byproducts.............................               0.01
Sheep, fat...........................................               0.01
Sheep, meat..........................................               0.01
Sheep, meat byproducts...............................               0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with 
regional registrations, as defined in 180.1(m), are established for the 
combined residues of the insecticide oxydemeton-methyl (S-(2-
(ethylsulfinyl)-ethyl) O,O-dimethyl phosphorothioate) and its 
metabolite oxydemeton-methyl sulfone in or on the following food 
commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Broccoli raab........................................                2.0
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]
    6. Section 180.404, paragraph (a) is revised to read as follows:


Sec. 180.404  Profenofos; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide profenofos (O-(4-bromo-2-chlorophenyl)-O-ethyl-S-propyl 
phosphorothioate) in or on the following food commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Cattle, fat..........................................               0.05

[[Page 28920]]

 
Cattle, meat.........................................               0.05
Cattle, meat byproducts..............................               0.05
Cotton, gin byproducts...............................               55.0
Cotton, undelinted seed..............................                2.0
Goat, fat............................................               0.05
Goat, meat...........................................               0.05
Goat, meat byproducts................................               0.05
Horse, fat...........................................               0.05
Horse, meat..........................................               0.05
Horse, meat byproducts...............................               0.05
Milk.................................................               0.01
Sheep, fat...........................................               0.05
Sheep, meat..........................................               0.05
Sheep, meat byproducts...............................               0.05
------------------------------------------------------------------------

* * * * *

FR Doc. 07-2561 Filed 5-22-07; 8:45 am
BILLING CODE 6560-50-S
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