E7-8373. Chloroneb, Cypermethrin, Methidathion, Nitrapyrin, Oxyfluorfen, Pirimiphos-methyl, Sulfosate, Tebuthiuron, Thiabendazole, Thidiazuron, and Tribuphos; Proposed Tolerance Actions

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

EPA is proposing to revoke certain tolerances for the fungicides chloroneb and thiabendazole; the herbicide sulfosate; the defoliant thidiazuron; the insecticides cypermethrin, methidathion, and pirimiphos-methyl; and the soil microbiocide nitrapyrin. Also, EPA is proposing to modify certain tolerances for the fungicides chloroneb and thiabendazole; the herbicides oxyfluorfen and tebuthiuron; the defoliants thidiazuron and tribuphos; the insecticides cypermethrin, methidathion, and pirimiphos-methyl; and the soil microbiocide nitrapyrin. In addition, EPA is proposing to establish new tolerances for the fungicides chloroneb and thiabendazole; the herbicide oxyfluorfen; the defoliants thidiazuron and tribuphos; the insecticides cypermethrin, methidathion, and pirimiphos-methyl; and the soil microbiocide nitrapyrin. 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 2, 2007.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2007-0036, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is [phone].

Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2007-0036. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://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 http://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 http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg), 2777 S. Crystal Dr., Arlington, VA. The 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 [phone].

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: [phone]; e-mail address: [e-mail].

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).

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 fungicides chloroneb and thiabendazole; the herbicides oxyfluorfen, sulfosate, and tebuthiuron; the defoliants thidiazuron and tribuphos; the insecticides cypermethrin, methidathion, and pirimiphos-methyl; and the soil microbiocide nitrapyrin 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 [phone]; fax [phone]; internet at http://www.epa.gov/​ncepihom/​ and from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone [phone] or [phone]; internet at http://www.ntis.gov/​. Electronic copies of REDs and TREDs are available on the internet for chloroneb, cypermethrin, nitrapyrin, oxyfluorfen, tebuthiuron, and thidiazuron in public dockets EPA-HQ-OPP-2004-0369, EPA-HQ-OPP-2005-0293, EPA-HQ-OPP-2004-0283, EPA-HQ-OPP-2002-0255, EPA-HQ-OPP-2002-0146, and EPA-HQ-OPP-2004-0382, respectively, at http://www.regulations.gov/​ and for methidathion, pirimiphos-methyl, thiabendazole, and tribuphos at http://www.epa.gov/​pesticides/​reregistration/​status.htm. A RED for sulfosate was not needed because it was registered after November 1, 1984 and not subject to reregistration eligibility, and because its tolerances were reassessed at the time of the addition of a tolerance for a new use, as described below in Unit II.A., a TRED document was no longer needed for the purpose of tolerance reassessment.

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:

• Lawful use (sometimes through a label change) may result in a higher residue level on the commodity; and
• 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 chloroneb, cypermethrin, nitrapyrin, tebuthiuron, and thidiazuron can be found under their respective public docket numbers, identified in Unit II.A. Paper copies for methidathion, oxyfluorfen, pirimiphos-methyl, thiabendazole, and tribuphos 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 http://www.regulations.gov/​. You may search for docket number EPA-HQ-OPP-2007-0036, 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 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. Chloroneb. Currently, chloroneb tolerances are set forth in 40 CFR 180.257(a) for residues of chloroneb and its metabolite 2,5-dichloro-4-methoxyphenol, calculated as chloroneb. The Agency determined, as described in the Residue Chemistry Chapter document, that residues of concern include the conjugate of 2,5-dichloro-4-methoxyphenol. Therefore, EPA is proposing to revise the tolerance expression to include the conjugated as well as free metabolite in 40 CFR 180.257(a) as follows:

Tolerances are established for residues of the fungicide chloroneb (1,4-dichloro-2,5-dimethoxybenzene) and its metabolite 2,5-dichloro-4-methoxyphenol (free and conjugated), calculated as chloroneb, in or on the following raw agricultural commodities.

Also, in 40 CFR 180.257(a), 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.

The tolerance in 40 CFR 180.257(a) for chloroneb residues of concern in or on cotton, forage should be revoked because the Agency no longer considers this commodity to be a significant livestock feed item, and therefore, is no longer needed. Consequently, EPA is proposing to revoke the tolerance in 40 CFR 180.257(a) on cotton, forage.

Based on available data from beans, undelinted cottonseed, soybeans, sugarbeet roots and sugarbeet tops that showed combined chloroneb residues of concern at <0.1 ppm, EPA determined that these tolerances should be increased from 0.1 ppm and set at the limit of quantitation (LOQ) of 0.2 ppm. Therefore, the Agency is proposing in 40 CFR 180.257(a) to increase the tolerances to 0.2 ppm for the following: Bean and revise to bean, dry, seed and bean, succulent; beet, sugar, roots; beet, sugar, tops; cotton, undelinted seed; and soybean and revise to soybean, seed. The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

Based on the translation of available data from cowpea forage and soybean forage that showed combined chloroneb residues of concern as high as <2.0 ppm, EPA determined that the expected residues on cowpea hay and soybean hay would be <2.0 ppm and tolerances on cowpea hay and soybean hay should be established at 2.0 ppm. Therefore, the Agency is proposing in 40 CFR 180.257(a) to establish tolerances on cowpea, hay and soybean, hay, each at 2.0 ppm.

Based on cotton metabolism data that showed combined chloroneb residues of concern from cottonseed treatment were as high as 0.256 ppm on cotton gin byproducts, EPA determined that a tolerance on cotton gin byproducts should be established at 1.0 ppm. Therefore, the Agency is proposing in 40 CFR 180.257(a) to establish a tolerance on cotton, gin byproducts at 1.0 ppm.

In addition, EPA is proposing to revise commodity terminology in newly recodified 40 CFR 180.257(a) to conform to current Agency practice as follows: “bean, forage” to “cowpea, forage.”

There are no Codex MRLs for chloroneb.

2. Cypermethrin. Based on available cattle exaggerated feeding data (0.83x and 2.8x maximum theoretical dietary burden or MTDB) for cypermethrin, EPA calculated that the maximum expected residues in muscle, fat, kidney, liver, whole milk and milk cream at 1x MTDB to be 0.084 ppm, 0.699 ppm, 0.025 ppm, <0.0036 ppm, 0.084 ppm, and 0.378 ppm, respectively. Therefore, the Agency determined that tolerances for the meat of cattle, goats, horses and sheep should be increased from 0.05 to 0.2 ppm in order to harmonize with Codex, and tolerances for the fat of cattle, goats, horses, and sheep should be increased from 0.05 to 1.0 ppm. In addition, the Agency determined that the tolerance level in 40 CFR 180.418(a)(2) for zeta-cypermethrin on milk fat (reflecting 0.10 in whole milk) at 2.5 ppm (based on a slightly higher theoretical dietary burden for cattle than cypermethrin) is also appropriate for cypermethrin and therefore the tolerance on milk should be revised to milk fat and increased from 0.05 to 2.5 ppm. Consequently, EPA is proposing to increase the tolerances in 40 CFR 180.418(a)(1) on cattle, meat; goat, meat; horse, meat; and sheep, meat to 0.2 ppm; cattle, fat; goat, fat; horse, fat; and sheep, fat to 1.0 ppm; and milk to 2.5 ppm and revise the commodity terminology to milk, fat (reflecting 0.10 in whole milk). The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

Based on available cattle exaggerated feeding data and a 10-fold lower MTDB of cypermethrin for swine in comparison with cattle, EPA calculated that the maximum expected residues in muscle, fat, kidney, and liver of swine at 1x MTDB to be 0.0084 ppm, 0.0699 ppm, 0.0025 ppm, and <0.00036 ppm, respectively. Therefore, the tolerances on hog fat should be increased from 0.05 to 0.1 ppm in 40 CFR 180.418(a)(1) and decreased from 1.0 to 0.1 ppm in 40 CFR 180.418(a)(2). Consequently, EPA is proposing to increase the tolerance in 40 CFR 180.418(a)(1) on hog, fat to 0.1 ppm and decrease the tolerance on hog, fat in 40 CFR 180.418(a)(2) to 0.1 ppm. Also, while the Agency determined that the tolerance on hog meat is adequate at 0.05 ppm in 40 CFR 180.418(a)(1), it believes that it should be decreased from 0.2 to 0.05 ppm in 40 CFR 180.418(a)(2). Consequently, EPA is proposing to decrease the tolerance on hog, meat in 40 CFR 180.418(a)(2) to 0.05 ppm. In addition, because the Agency expects cypermethrin residues on kidney and liver to be below the livestock method LOQ of 0.05 ppm, it believes that there is no reasonable expectation of detecting finite residues of cypermethrin or zeta-cypermethrin residues in or on hog, meat byproducts and therefore the tolerances are no longer needed under 40 CFR 180.6(a)(3). Consequently, the Agency is proposing to revoke the tolerances on hog, meat byproducts in both 40 CFR 180.418(a)(1) and (a)(2). The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

Based on available poultry exaggerated feeding data (14.3x MTDB) of cypermethrin, EPA calculated that the maximum expected residues in kidney, liver, and muscle of poultry at 1x MTDB is each at <0.0007 ppm, which is below the livestock method LOQ of 0.05 ppm and LOD of 0.01 ppm, 0.02 ppm in poultry fat, and 0.0086 ppm in egg. Therefore, EPA determined that there is no reasonable expectation of detecting finite residues of cypermethrin in poultry meat or meat byproducts and the poultry meat byproducts tolerance in 180.418(a)(2) is no longer needed under 40 CFR 180.6(a)(3). However, the Agency believes that tolerances of 0.05 ppm should be established on egg, poultry fat, and poultry meat in order to harmonize with Codex. Consequently, the Agency is proposing to revoke the tolerances in 40 CFR 180.418(a)(2) on poultry, meat byproducts and establish tolerances in 40 CFR 180.418(a)(1) on egg; poultry, fat; and poultry, meat at 0.05 ppm.

Based on available field trial data that showed cypermethrin residues as high as 3.4 ppm in or on head lettuce, EPA determined that the tolerance should be decreased from 10.0 to 4.0 ppm. Also, since the use of zeta-cypermethrin on head lettuce is covered by the tolerance on leafy vegetables except Brassica, the Agency has determined that the tolerance on head lettuce is no longer needed in 40 CFR 180.418(a)(2). Therefore, the Agency is proposing in 40 CFR 180.418(a)(1) to decrease the tolerance on lettuce, head to 4.0 ppm and revoke the tolerance on lettuce, head in 40 CFR 180.418(a)(2).

Based on data that showed cypermethrin residues as high as 8.84 ppm in or on cotton gin byproducts, EPA determined that a tolerance on cotton gin byproducts should be established at 11.0 ppm. Therefore, the Agency is proposing in 40 CFR 180.418(a)(1) to establish a tolerance on cotton, gin byproducts at 11.0 ppm.

Because the tolerance expired on June 30, 2005, EPA is proposing to remove the entry for the time-limited tolerance on mustard seed from 40 CFR 180.418(b).

In addition, EPA is proposing to revise commodity terminology to conform to current Agency practice as follows: in 40 CFR 180.418(a)(1), “onion, dry bulb” to “onion, bulb;” and in 40 CFR 180.418(a)(2), “dried, shelled pea and bean, except soybean (Crop subgroup 6C)” to “pea and bean, dried shelled, except soybean, subgroup 6C;” “edible podded legume vegetables (Crop subgroup 6A)” to “vegetable, legume, edible podded, subgroup 6A;” “leafy vegetables except Brassica” to “vegetable, leafy, except brassica, group 4;” “onion, dry bulb” to “onion, bulb;” “sorghum, forage” to “sorghum, grain, forage;” “sorghum, grain” to “sorghum, grain, grain;” “succulent, shelled pea and bean (Crop subgroup 6B)” to “pea and bean, succulent shelled, subgroup 6B;” and “vegetable, fruiting, except cucurbits (Crop group 8)” to “vegetable, fruiting, group 8.” Because there is an existing tolerance on grass forage, in this case via a group tolerance, there is no need to include sorghum, forage, forage in the revision of the commodity terminology for sorghum forage.

In the Federal Register of December 13, 2006 (71 FR 74802) (FRL-8064-3), EPA published a direct final rule which finalized certain pesticide tolerance nomenclature changes. In both 40 CFR 180.418(a)(1) and (a)(2), the changes from “Brassica leafy” to “Vegetable, brassica, leafy group 5” were not correct because there are existing tolerances for subgroup 5A and therefore the terminology “Brassica, leafy” should have been changed so as to denote subgroup 5B. Therefore, EPA is proposing to revise “Vegetable, brassica, leafy group 5” (formerly “Brassica, leafy”) to “Brassica, leafy greens, subgroup 5B” in both 40 CFR 180.418(a)(1) and (2).

The proposed tolerance actions herein for cypermethrin and zeta-cypermethrin, to implement the recommendations of the cypermethrin RED, reflect use patterns in the U.S. which support a different tolerance than the Codex value on Brassica vegetables, cottonseed, head lettuce, and milk because of differences in good agricultural practices and determination of secondary residue levels in livestock commodities. However, compatibility exists for bulb onions and meat byproducts, and will exist between the proposed reassessed U.S. tolerances and Codex MRLs for cypermethrin residues in or on egg, poultry meat; and meat of cattle, goats, horses, and sheep.

3. Methidathion. Because residues of methidathion in or on pecans and walnut at 0.05 ppm and peach at 0.05 ppm are covered by the existing group tolerance on nut (0.05 ppm) and stone fruit (0.05 ppm), respectively, EPA determined that these individual tolerances are no longer needed, and therefore should be revoked. Consequently, EPA is proposing to revoke the tolerances in 40 CFR 180.298(a) on peach, pecan, and walnut.

Based on available data that showed residues of methidathion as high as 3.6 ppm in or on oranges, EPA determined that the tolerance on citrus fruit (except mandarins) should be increased from 2.0 to 4.0 ppm. Therefore, the Agency is proposing in 40 CFR 180.298(a) to revise the tolerance on fruit, citrus (except mandarins) to fruit, citrus, group 10, except tangerine and increase the tolerance to 4.0 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

Also, based on available data that showed residues of methidathion concentrate an average of 118x in oil processed from methidathion-treated oranges, EPA determined that a tolerance on citrus oil should be established at 420.0 ppm. Therefore, the Agency is proposing in 40 CFR 180.298(a) to establish a tolerance on citrus, oil at 420.0 ppm.

The methidathion IRED recommended both recodifying the tolerances for alfalfa, alfalfa hay, grass, and grass hay (revising grass and grass hay to timothy and timothy hay) from 40 CFR 180.298(a) into (c) as regional tolerances and decreasing them from 12.0 to 5.0 ppm because section 24(c) FIFRA registrations had existed which allowed application to alfalfa and grass intended for haying, green chopping or grazing to be fed to livestock provided that the registrations were revised to impose a 21-day pre-harvest interval (PHI) and limited the amount of active ingredient per acre to timothy or timothy/alfalfa stands to 1 pound per cutting. From available data that showed residues of methidathion ranged from 0.13 to 25.0 ppm up to 12 days post-application and field trial data which demonstrated that residues of methidathion decline rapidly with time, EPA calculated that residues would be <5.0 ppm with a 21-day PHI. However, while currently existing section 24(c) FIFRA registrations for use of methidathion on timothy and timothy hay have a 21-day PHI, a rate up to 1 lb. per acre per cutting, and a restriction against the grazing or harvesting of treated timothy and timothy hay for feeding to any animal that may enter the human food chain, one registration in Idaho that expires on December 31, 2007 does not specify a restriction against treated hay, seed, or seed screenings from entering the human food chain (unlike the other registrations). Therefore, the Agency believes that the grass and grass hay tolerances would no longer be needed shortly after December 31, 2007; i.e., after the Idaho registration expires. Consequently, EPA is proposing to recodify the tolerances on grass and grass, hay from 40 CFR 180.298(a) to (c), revise their commodity terminology to timothy, forage and timothy, hay, respectively, decrease the tolerances from 12.0 to 5.0 ppm, and revoke them with an expiration/revocation date of March 31, 2008.

In addition, section 24(c) FIFRA registrations exist for methidathion use on alfalfa grown for seed production, a non-food/non-feed use (that include restrictions against grazing/feeding on alfalfa, including seed, seed screenings and hay for human consumption or animal feed). However, while one of those registrations (for use on alfalfa with a 21-day PHI and rate up to 1 lb. per acre per cutting in Idaho that expires on December 31, 2007) has a restriction against the grazing or harvesting of treated alfalfa for feeding to any animal that may enter the human food chain, it does not specify a restriction against treated hay, seed, or seed screenings from entering the human food chain. Therefore, the Agency believes that the alfalfa and alfalfa hay tolerances would no longer be needed shortly after December 31, 2007. Consequently, EPA is proposing to recodify the tolerances on alfalfa and alfalfa, hay from 40 CFR 180.298(a) to (c), decrease them to 5.0 ppm, revoke them with an expiration/revocation date of March 31, 2008, and revise the commodity terminology for alfalfa to alfalfa, forage.

Also, EPA is proposing to revise commodity terminology in 40 CFR 180.298(a) to conform to current Agency practice as follows: “fruit, pome” to “fruit, pome, group 11;” “fruit, stone” to “fruit, stone, group 12;” “nut” to “nut, tree, group 14;” and “sorghum, forage” to “sorghum, grain, forage” and “sorghum, forage, forage;” “sorghum, grain” to “sorghum, grain, grain.”

The proposed tolerance actions herein for methidathion, to implement the recommendations of the methidathion RED, reflect use patterns in the U.S. which support a different tolerance than the Codex value on citrus fruits (except tangerines), as well as tolerances on pome fruit, stone fruit, tangerines (mandarins), and safflower seeds, which are to be maintained at their existing levels. However, compatibility with Codex MRLs exists for U.S. tolerances on globe artichokes, grain sorghum, pecans, sunflower seeds, and walnuts.

4. Nitrapyrin. Based on ruminant and poultry data feeding the maximum theoretical dietary burden of 6-chloropicolinic acid, EPA determined that there is no reasonable expectation of finite residues of nitrapyrin's metabolite 6-chloropicolinic acid, free or conjugated, in any livestock or poultry commodities. (Because 6-chloropicolinic acid is the only residue expected in crops treated with nitrapyrin, it was appropriate to feed 6-chloropicolinic acid instead of nitrapyrin). Therefore, tolerances on the fat, meat, and meat byproducts of cattle, goats, hogs, horses, sheep, and poultry are no longer needed under 40 CFR 180.6(a)(3). Consequently, the Agency is proposing to revoke the tolerances in 40 CFR 180.350 for the combined residues of nitrapyrin and 6-chloropicolinic acid in or on cattle, fat; cattle, meat; cattle, meat byproducts; goat, fat; goat, meat; goat, meat byproducts; hog, fat; hog, meat; hog, meat byproducts; horse, fat; horse, meat; horse, meat byproducts; sheep, fat; sheep, meat; and sheep, meat byproducts; poultry, fat; poultry, meat; and poultry, meat byproducts.

Based on available data showing combined nitrapyrin and 6-chloropicolinic acid residues as high as 0.315 ppm on sorghum forage, EPA determined that the tolerance for sorghum forage should be increased from 0.1 to 0.5 ppm. Therefore, EPA is proposing to increase the tolerance in 40 CFR 180.350(a) on sorghum, forage to 0.5 ppm and revise it to “sorghum, forage, forage” and “sorghum, grain, forage.” The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

Based on available data showing combined nitrapyrin and 6-chloropicolinic acid residues as high as 0.35 ppm on wheat grain, 1.436 ppm on wheat forage, and 4.8 ppm on wheat straw, EPA determined that the tolerances for wheat grain, forage, and straw should be increased from 0.1 to 0.5 ppm, 0.5 to 2.0 ppm and 0.5 to 6.0 ppm, respectively. Therefore, EPA is proposing to increase the tolerances in 40 CFR 180.350(a) on wheat, grain to 0.5 ppm, wheat, forage to 2.0 ppm, and wheat, straw to 6.0 ppm. The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

Based on field trial data that supported an increased tolerance for wheat grain from 0.1 to 0.5 ppm and processing data that showed concentration of 6-chloropicolinic acid in wheat bran by 5.5x and wheat shorts by 2.2x, but not in flour (nitrapyrin was not detectable in any processed wheat product), EPA determined that tolerances should be established for wheat bran at 3.0 ppm and wheat milled byproducts, except flour at 2.0 ppm. Therefore, the Agency is proposing to establish tolerances in 40 CFR 180.350(a) for combined residues of nitrapyrin and its metabolite 6-chloropicolinic acid in or on wheat, bran at 3.0 ppm, and wheat, milled byproducts, except flour at 2.0 ppm.

Based on field trial data that supported a tolerance of 0.1 ppm for corn grain and processing data that showed concentration of 6-chloropicolinic acid in field corn screenings and grits after both dry and wet milling by 1.4x and 1.45x, respectively, but not in sweet corn fractions processed from sweet corn, EPA determined that a tolerance should be established for field corn milled byproducts at 0.2 ppm. Therefore, the Agency is proposing to establish a tolerance in 40 CFR 180.350(a) for combined residues of nitrapyrin and its metabolite 6-chloropicolinic acid in or on corn, field, milled byproducts at 0.2 ppm.

Also, in 40 CFR 180.350(a), 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 40 CFR 180.350(a), EPA is proposing to revise the commodity terminology for “corn, forage” to “corn, field, forage” and “corn, sweet, forage;” “corn, grain” to “corn, field, grain” and “corn, pop, grain;” “corn, stover” to “corn, field, stover,” “corn, pop, stover,” and “corn, sweet, stover;” and “sorghum, grain” to “sorghum, grain, grain.”

There are no Codex MRLs for nitrapyrin.

5. Oxyfluorfen. Based on available data that showed residues of oxyfluorfen as high as 0.03 ppm in or on mint hay, EPA determined that the tolerance on mint hay (peppermint and spearmint) should be decreased from 0.1 to 0.05 ppm. Therefore, the Agency is proposing in 40 CFR 180.381(a) to revise the commodity terminology for mint hay into separate tolerances on peppermint, tops and spearmint, tops and decrease each tolerance to 0.05 ppm.

Based on available exaggerated (5x to 7x MTDB) cattle feeding data that showed residues of oxyfluorfen as high as <0.003 ppm in milk, 0.007 ppm in fat, <0.003 ppm in meat, <0.003 ppm in kidney, and <0.003 ppm in liver, EPA expected residues below the LOQ (0.01 ppm) in milk, fat, meat, and meat byproducts at the 1x MTDB for cattle. The Agency determined that the tolerances on milk and the fat, meat and meat byproducts of cattle, goats, hogs, horses, and sheep should be set at the LOQ and decreased from 0.05 to 0.01 ppm. Therefore, EPA is proposing in 40 CFR 180.381(a) to decrease the tolerances on milk; cattle, fat; cattle, meat; cattle, meat byproducts; goat, fat; goat, meat; goat, meat byproducts; hog, fat; hog, meat; hog, meat byproducts; horse, fat; horse, meat; horse, meat byproducts; sheep, fat; sheep, meat; and sheep, meat byproducts to 0.01 ppm.

Based on available exaggerated (2.0x MTDB) poultry feeding data that showed residues of oxyfluorfen as high as 0.024 ppm in eggs, 0.163 ppm in fat, 0.004 ppm in meat, and 0.006 ppm in liver, EPA expected residues of 0.012 ppm in egg, 0.082 ppm in fat, 0.002 ppm in meat, and 0.003 ppm in liver at the 1x MTDB for poultry. The Agency determined that the tolerances should be decreased on egg from 0.05 to 0.03 ppm, meat and meat byproducts from 0.05 to 0.01 ppm, and increased on fat from 0.05 to 0.2 ppm. Therefore, EPA is proposing in 40 CFR 180.381(a) to decrease the tolerances on egg to 0.03 ppm, poultry, meat to 0.01 ppm, poultry, meat byproducts to 0.01 ppm, and increase the tolerance on poultry, fat 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.

Based on available data that showed oxyfluorfen residues from use of oxyfluorfen on grass grown for seed in Oregon and Washington were not detectable (<0.03 ppm) in or on grass forage, hay, and seed screenings, EPA determined that the reassessed animal commodity tolerances are adequate to cover any residue contribution from regional registration uses of oxyfluorfen on grasses grown for seed and tolerances should be established on grass forage, hay, and seed screenings at 0.05 ppm. Therefore, the Agency is proposing to establish tolerances in 40 CFR 180.381(c) on grass, forage; grass, hay; and grass, seed screenings; each at 0.05 ppm.

In addition, EPA is proposing to revise commodity terminology in 40 CFR 180.381 to conform to current Agency practice as follows: “banana (including plantain)” to “banana;” “coffee, bean” to “coffee, bean, green;” “corn, grain” to “corn, field, grain” and “corn, pop, grain;” “onion, dry bulb” to “onion, bulb;” “taro, corm and leaves” to “taro, corm” and “taro, leaves. Moreover, it should be noted that use of oxyfluorfen on plantains is covered by the existing tolerance at 0.05 ppm for banana under 40 CFR 180.1(g), and there is no need to establish a separate tolerance on plantains at 0.05 ppm. Also, because use of oxyfluorfen on garlic is covered by the existing tolerance at 0.05 ppm for onion bulb under 40 CFR 180.1(g), there is no need to establish a separate tolerance on garlic at 0.05 ppm as had been recommended in the RED.

There are no Codex MRLs for oxyfluorfen.

6. Pirimiphos-methyl. Currently, pirimiphos-methyl tolerances are established in 40 CFR 180.409 and expressed for the combined residues of the insecticide parent and metabolite O-(2-ethylamino-6-methyl-pyrimidin-4-yl) O,O-dimethyl phosphorothioate and, in free and conjugated form, the metabolites 2-diethylamino-6-methyl-pyrimidin-4-ol, 2-ethylamino-6-methyl-pyrimidin-4-ol, and 2-amino-6-methyl-pyrimidin-4-ol. However, because EPA has determined that the endpoint chosen for dietary risk assessment is cholinesterase inhibition, the non-cholinesterase-inhibiting hydroxypyrimidine metabolites no longer need to be included for the purpose of tolerance regulation. Also, in an effort to harmonize with Codex, the Agency determined that the residue to be regulated in commodities is pirimiphos-methyl per se. Therefore, EPA is proposing in 40 CFR 180.409(a) to revise the tolerance expression to residues of pirimiphos-methyl per se as follows:

Tolerances are established for residues of the insecticide pirimiphos-methyl (O-(2-diethylamino-6-methyl-4-pyrimidinyl) O,O-dimethyl phosphorothioate) in or on the following raw agricultural commodities.

Based on available exaggerated (4x to 40x MTDB) cattle feeding data from which EPA determined that detectable residues are not reasonably expected in meat, and residues calculated at 1x MTDB would be expected at 0.01 ppm in fat, and <0.01 ppm in both kidney and liver, the Agency determined that tolerances should be decreased and set at the LOQ of 0.02 ppm for residues in the fat and meat byproducts of ruminants and fat in poultry. Because the tolerances on kidney and liver of cattle, goats, hogs, horses, and sheep should be decreased from 2.0 to 0.02 ppm and tolerances on meat byproducts of cattle, goats, hogs, horses, and sheep should be decreased from 0.2 to 0.02 ppm, residues in or on liver and kidney will be covered by the reassessed tolerances on meat byproducts and separate tolerances on kidney and liver are no longer needed and should be revoked. Therefore, EPA is proposing in 40 CFR 180.409(a) to revoke the separate tolerances on cattle, kidney; cattle, liver; goat, kidney; goat, liver; hog, kidney; hog, liver; horse, kidney; horse, liver; sheep, kidney; and sheep, liver; and decrease the tolerances on cattle, fat; cattle, meat byproducts; goat, fat; goat, meat byproducts; hog, fat; hog, meat byproducts; horse, fat; horse, meat byproducts; poultry, fat; sheep, fat; and sheep, meat byproducts to 0.02 ppm.

Based on the cattle feeding data, with current registrations, the tolerance for cattle meat can be classified under 40 CFR 180.6(a)(3); i.e. there is no reasonable expectation of finite residues, and therefore was recommended by the Agency in the pirimiphos-methyl RED to be revoked. In the Federal Register of July 31, 2002 (67 FR 49606) (FRL-7191-4), EPA published a rule which finalized certain tolerance actions for a number of pesticide active ingredients, including pirimiphos-methyl. In a response to a comment from Schering-Plough Animal Health Corporation on cattle tolerances and pending registration of a pour-on product, the Agency announced that it would not take action on revoking the tolerance for cattle meat at that time. However, since then, the pending registration application for a pour-on product formulation was withdrawn by Schering-Plough Animal Health Corporation. Currently, there are still active ear tag registrations. The Agency has determined that the use of impregnated materials (ear tags) on non-lactating dairy cattle and beef cattle does not contribute to significant secondary residues in livestock (calculated contribution is a dietary equivalent to <0.01 ppm, which is less than the dietary LOQ of 0.02 ppm). Therefore, under 40 CFR 180.6(a)(3), EPA is proposing to revoke the tolerance in 40 CFR 180.409 on cattle, meat.

While there is a Codex MRL for pirimiphos-methyl on meat at 0.01 mg/kg, EPA notes that the definition of “meat” under Codex is different than in U.S. tolerances and Codex has not established pirimiphos-methyl MRLs for fat or meat byproducts.

Based on available processing data that showed residues of pirimiphos-methyl with an average concentration factor of 3.8x in aspirated grain fractions of corn and a highest average field trial (HAFT) of 4.87 ppm in or on corn grain, EPA determined that a tolerance should be established at 20.0 ppm. Therefore, EPA is proposing to establish a tolerance in 40 CFR 180.409(a) on grain, aspirated fractions at 20.0 ppm.

In addition, EPA is proposing to revise commodity terminology in 40 CFR 180.409 to conform to current Agency practice as follows: “corn” to “corn, field, grain” and “corn, pop, grain.”

7. Sulfosate. Because sulfosate was registered after November 1, 1984, it was not subject to eligibility for reregistration under FIFRA and therefore a RED was not needed. Existing tolerances were reassessed according to the FQPA standard when new tolerances were established on September 11, 1998 (63 FR 48597)(FRL-6026-6) and therefore a TRED was not needed. However, the last U.S. registrations for the herbicide sulfosate (sulfonium, trimethyl-salt with N- (phosphonomethyl)glycine (1:1)) were canceled on October 15, 2004, due to non-payment of registration maintenance fees, and a notice was published in the Federal Register on October 27, 2004 (69 FR 62666)(FRL-7683-7). Therefore, the tolerances are no longer needed. In the Federal Register notice of October 27, 2004 (69 FR 62666), EPA stated that cancellation orders generally permit registrants to continue to sell and distribute existing stocks of the canceled products until January 15, 2005. However, during follow-up communication, the registrant informed the Agency that it did not produce sulfosate after 2002 and sold the remaining existing stocks of sulfosate in 2003. Nor is the registrant supporting the import tolerance on banana. Therefore, the Agency believes that end users have had sufficient time to exhaust existing stocks and for treated commodities to have cleared the channels of trade.

Consequently, EPA is proposing to revoke tolerances in 40 CFR 180.489 on the following: Almond, hulls (of which no more than 0.30 ppm is trimethylsulfonium (TMS)); banana (imported only); cattle, fat; cattle, kidney; cattle, meat byproducts, except kidney; cattle, meat; corn, field, forage; corn, field and pop, grain (of which no more than 0.10 ppm is TMS); corn, field and pop, stover (of which no more than 0.20 ppm is TMS); corn, sweet, forage (of which no more than 5.0 ppm is TMS); corn, sweet, kernel plus cob with husks removed (of which no more than 0.10 ppm is TMS); corn, sweet, stover (of which no more than 65 ppm is TMS); cotton, gin byproducts (of which no more than 35 ppm is TMS); cotton, undelinted seed (of which no more than 10 ppm is TMS); crop group 2: Leaves of root and tuber vegetables (human food or animal feed (except radish) group (of which no more than 0.20 ppm is TMS); crop group 8: Vegetable, fruiting (except cucurbits) group; crop subgroup 1-A: Root vegetables (except radish) subgroup (of which no more than 0.10 ppm is TMS); crop subgroup 1-C: Tuberous and corm vegetables subgroup (of which no more than 0.50 ppm is TMS); crop subgroup 6-A: Edible-podded legume vegetables subgroup (of which no more than 0.3 ppm is TMS); crop subgroup 6-B: Succulent shelled pea and bean subgroup (of which no more than 0.1 ppm is TMS); crop subgroup 6C: Dried shelled pea and bean (except soybean and animal feed) subgroup (of which no more than 1.5 ppm is TMS); egg; fruit, citrus, group 10; fruit, pome, group 11; fruit, stone, group 12; goat, fat; goat, kidney; goat, meat byproducts, except kidney; goat, meat; grain, aspirated fractions (of which no more than 720 ppm is TMS); grape; grape, raisin (of which no more than 0.05 ppm is TMS); hog, fat; hog, kidney; hog, meat byproducts, except kidney; hog, meat; horse, fat; horse, kidney; horse, meat byproducts, except kidney; horse, meat; milk; nut, tree, group 14; pistachio; poultry, fat; poultry, meat byproducts; poultry, meat; prune (of which no more than 0.05 ppm is TMS); radish, roots (of which no more than 15 ppm is TMS); radish, tops (of which no more than 8.0 ppm is TMS); sheep, fat; sheep, kidney; sheep, meat byproducts, except kidney; sheep, meat; sorghum, grain, forage (of which no more than 0.10 ppm is TMS); sorghum, grain, grain (of which no more than 15 ppm is TMS); sorghum, grain, stover (of which no more than 60 ppm is TMS); soybean, forage (of which no more than 1 ppm is TMS); soybean, hay (of which no more than 2 ppm is TMS); soybean, hulls (of which no more than 25 ppm is TMS); soybean, seed (of which no more than 13 ppm is TMS); wheat, bran (of which no more than 6.0 ppm is TMS); wheat, forage (of which no more than 30 ppm is TMS); wheat, grain (of which no more than 2.5 ppm is TMS); wheat, hay (of which no more than 0.50 ppm is TMS); wheat shorts (of which no more than 0.5 ppm is TMS); wheat, shorts (of which no more than 5.0 ppm is TMS); wheat, straw (of which no more than 0.5 ppm is TMS); and wheat, straw (of which no more than 40 ppm is TMS).

8. Tebuthiuron. Currently, the tolerance expression in 40 CFR 180.390 regulates for the herbicide tebuthiuron and its metabolites containing the dimethylethyl thiadiazole moiety. Because the Agency has determined that the residues of concern in plants are tebuthiuron and its metabolites N-(5-(2-hydroxy-1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N,N′-dimethylurea, N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N-methylurea, and N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N′-hydroxymethyl-N-methylurea, EPA is proposing to revise the tolerance expression for plant commodities from 40 CFR 180.390 to 180.390(a)(1) with tolerances established for the combined residues of tebuthiuron (N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N,N′-dimethylurea) and its metabolites N-(5-(2-hydroxy-1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N,N′-dimethylurea, N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N-methylurea, and N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N′-hydroxymethyl-N-methylurea.

Also, because the Agency has determined that the residues of concern in fat, meat, kidney, and liver are tebuthiuron and its metabolites N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N-methylurea, N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)urea, 2-dimethylethyl-5-amino-1,3,4-thiadiazole, and N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N′-hydroxymethyl-N-methylurea, EPA is proposing to revise the tolerance expression for these animal commodities from 40 CFR 180.390 to 180.390(a)(2) with tolerances established for the combined residues of tebuthiuron (N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N,N′-dimethylurea) and its metabolites N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N-methylurea, N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)urea, 2-dimethylethyl-5-amino-1,3,4-thiadiazole, and N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N′-hydroxymethyl-N-methylurea.

In addition, because the Agency has determined that the residues of concern in milk are tebuthiuron and its metabolites N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N-methylurea, N-(5-(2-hydroxy-1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N-methylurea, N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)urea, N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N′-hydroxymethyl-N-methylurea, and N-(5-(2-hydroxy-1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N′-hydroxymethyl-N-methylurea, EPA is proposing to revise the tolerance expression for milk from 40 CFR 180.390 to 180.390(a)(3) with a tolerance established for the combined residues of tebuthiuron (N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N,N′-dimethylurea) and its metabolites N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N-methylurea, N-(5-(2-hydroxy-1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N-methylurea, N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)urea, N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N′-hydroxymethyl-N-methylurea, and N-(5-(2-hydroxy-1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N′-hydroxymethyl-N-methylurea.

Based on the MTDB for beef cattle and available exaggerated ruminant feeding data (2.07x), combined tebuthiuron residues of concern in the milk, fat, meat, kidney, and liver of cattle were expected by the Agency at 1x to be as high as 0.57 ppm, 0.39 ppm, 0.67 ppm, 1.66 ppm, and 3.44 ppm, respectively. Therefore, tolerances on the fat and meat of cattle, goats, horses, and sheep should be decreased from 2.0 to 1.0 ppm; tolerances on meat byproducts of cattle, goats, horses, and sheep should be increased from 2.0 to 5.0 ppm; and tolerance on milk should be increased from 0.3 to 0.8 ppm. Consequently, EPA is proposing in 40 CFR 180.390(a)(2) to decrease tolerances on cattle, fat; cattle, meat; goat, fat; goat, meat; horse, fat; horse, meat; sheep, fat; and sheep, meat to 1.0 ppm; and increase tolerances on cattle, meat byproducts; goat, meat byproducts; horse, meat byproducts; and sheep, meat byproducts to 5.0 ppm. Also, EPA is proposing in 40 CFR 180.390(a)(3) to increase the tolerance on milk to 0.8 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.

Also, EPA is proposing to revise 40 CFR 180.390 by adding separate paragraphs (b), (c), and (d), and reserving those sections for tolerances with section 18 emergency exemptions, regional registrations, and indirect or inadvertent residues, respectively.

There are no Codex MRLs for tebuthiuron.

9. Thiabendazole. Currently, thiabendazole tolerances are established in 40 CFR 180.242(a)(1) and expressed for residues of the fungicide thiabendazole (2-(4-thiazolyl)benzimidazole in or on plant commodities. However, EPA has determined that for the purpose of tolerance regulation that its metabolite benzimidazole (free and conjugated) should be included as a residue of concern in or on plant commodities. Therefore, EPA is proposing in 40 CFR 180.242(a)(1) to revise the tolerance expression as follows:

Tolerances are established for the combined residues of the fungicide thiabendazole (2-(4-thiazolyl)benzimidazole) and its metabolite benzimidazole (free and conjugated) in or on the following raw agricultural commodities.

Currently, thiabendazole tolerances are established in 40 CFR 180.242(a)(2) and expressed for combined residues of thiabendazole and its metabolite 5-hydroxythiabendazole in or on animal commodities. However, EPA has determined that for the purpose of tolerance regulation that its metabolites 5-hydroxythiabendazole (free and conjugated) and benzimidazole should be included as residues of concern in animal commodities. Therefore, EPA is proposing in 40 CFR 180.242(a)(2) to revise the tolerance expression as follows:

Tolerances are established for the combined residues of thiabendazole (2-(4-thiazolyl)benzimidazole) and its metabolites 5-hydroxythiabendazole (free and conjugated) and benzimidazole in or on the following raw agricultural commodities.

Currently, time-limited thiabendazole tolerances for emergency exemptions are established in 40 CFR 180.242(b) and expressed for residues of thiabendazole. However, EPA has determined that for the purpose of tolerance regulation that its metabolite benzimidazole (free and conjugated) should be included as a residue of concern in plant commodities. Therefore, EPA is proposing in 40 CFR 180.242(b) to revise the tolerance expression as follows:

Time-limited tolerances are established for the combined residues of thiabendazole (2-(4-thiazolyl)benzimidazole) and its metabolite benzimidazole (free and conjugated), in connection with use of the pesticide under section 18 emergency exemptions granted by EPA. The tolerances are specified in the following table. The tolerances will expire on the dates specified in the table.

Because thiabendazole residues of concern on postharvest banana pulp will be covered by the tolerance in 40 CFR 180.242(a)(1) on banana, postharvest at 3.0 ppm, a separate tolerance on postharvest banana pulp at 0.4 ppm is no longer needed, and therefore that tolerance on postharvest banana pulp should be revoked. Furthermore, currently, the Agency considers the raw agricultural commodity to be the whole banana and not just the pulp. Therefore, EPA is proposing to revoke the tolerance in 40 CFR 180.242(a)(1) for thiabendazole residues of concern in or on banana, pulp, postharvest.

Because there have been no registered uses of thiabendazole for squash since 1993 and rice since 1999, the tolerances on hubbard squash, rice hulls, rice rough, and rice straw are no longer needed. Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.242(a)(1) for thiabendazole residues of concern in or on squash, hubbard; rice, hulls; rice, rough; and rice, straw.

Based on available processing data that showed residues of thiabendazole do not concentrate in any regulated processed commodity of potato (granules/flakes, chips, or wet peel) or wheat (bran, flour, middlings, shorts, germ), the Agency determined that the tolerances on processing waste of potato and milled fractions (excluding flour) of wheat are no longer needed. Therefore, EPA is proposing to revoke tolerances in 40 CFR 180.242(a)(1) on potato, processing waste (pre- & post-H) and wheat, milled fractions (except flour).

Based on available processing data that showed residues of thiabendazole concentrated in dried citrus pulp by a factor of 1.6x and a HAFT of 5.2 ppm for whole citrus fruits, EPA expected residues of 8.3 ppm, which is below the current and reassessed tolerance of 10.0 ppm on whole citrus fruit. Therefore, the dried citrus pulp tolerance is no longer needed. Consequently, EPA is proposing to revoke the tolerance in 40 CFR 180.242(a)(1) on citrus, dried pulp, postharvest.

Based on the MTDB for poultry and available exaggerated (125x MTDB) poultry feeding data which showed combined thiabendazole residues of concern in poultry tissues at <0.109 ppm and in egg yolks at 0.065 ppm, the Agency expects residues to be <0.027 ppm in poultry tissues and 0.015 ppm in eggs. Because these levels are below the combined LOQs of 0.3 ppm in tissues and 0.15 ppm in eggs for the enforcement method, the Agency concluded that there is no reasonable expectation of finding finite thiabendazole residues of concern in poultry tissues and eggs resulting from the feeding of thiabendazole treated crops to poultry. Therefore, tolerances on poultry and eggs are no longer needed. Consequently, under 40 CFR 180.6(a)(3), EPA is proposing to revoke tolerances in 40 CFR 180.242(a)(2) on poultry; poultry, meat byproducts; poultry, meat; and egg.

Based on the MTDB for beef cattle and swine and available exaggerated ruminant feeding data (1.9x and 6.7x MTDB in fat and muscle, respectively), combined thiabendazole residues of concern in the fat and meat of cattle were as high as 0.030 and 0.023 ppm, respectively. Because each of these levels is below the combined LOQ (0.1 ppm for each analyte), the Agency concluded that there is no reasonable expectation of finding finite thiabendazole residues of concern in the fat and meat of cattle, goats, hogs, horses, and sheep resulting from the feeding of thiabendazole treated crops to livestock. Therefore, tolerances on the fat of cattle, goats, hogs, horses, and sheep are no longer needed. Consequently, under 40 CFR 180.6(a)(3), EPA is proposing to revoke tolerances in 40 CFR 180.242(a)(2) on cattle, fat; goat, fat; hog, fat; horse, fat; and sheep, fat.

The proposed changes to include the metabolite benzimidazole in the tolerance expression for thiabendazole when finalized could make U.S. tolerances and Codex MRLs incompatible because the Codex MRLs for thiabendazole are currently expressed in terms of the parent for plant commodities and sum of the parent and 5-hydroxythiabendazole for animal commodities. Because of the lack of Codex MRLs on the meat of goats, hogs, horses, and sheep; proposed change in the tolerance expression for animal commodities, and data that show no reasonable expectation of finding finite thiabendazole residues of concern in the meat of cattle, goats, hogs, horses, and sheep, the Agency determined that the meat tolerances of goats, hogs, horses, and sheep are no longer needed and therefore should be revoked. Consequently, under 40 CFR 180.6(a)(3), EPA is proposing to revoke tolerances in 40 CFR 180.242(a)(2) on goat, meat; hog, meat; horse, meat; and sheep, meat. However, despite the expected difference in tolerance expression and undetectable residues, EPA is maintaining the tolerance on cattle meat at 0.1 ppm in order to harmonize as closely as possible with the Codex MRL of 0.1 mg/kg.

Based on available ruminant feeding data (1x MTDB) that showed combined thiabendazole residues of concern as high as 0.028 ppm in milk, which is below the combined LOQ of 0.1 ppm for the enforcement method, EPA determined that the tolerances on milk should be decreased from 0.4 to 0.1 ppm. Therefore, the Agency is proposing to decrease the tolerance in 40 CFR 180.242(a)(2) on milk to 0.1 ppm.

Based on available exaggerated (1.9x MTDB) ruminant feeding data that showed combined thiabendazole residues of concern as high as 0.28 ppm in liver and 0.687 ppm in kidney, EPA expected residues of 0.15 ppm in liver and 0.36 ppm in kidney at the 1x MTDB for beef cattle. The Agency determined that the tolerance for meat byproducts of cattle, goats, horses, and sheep should be increased from 0.1 to 0.4 ppm. Therefore, EPA is proposing to increase the tolerances in 40 CFR 180.242(a)(2) on cattle, meat byproducts; goat, meat byproducts; horse, meat byproducts; and sheep, meat byproducts to 0.4 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

Based on available exaggerated ruminant feeding data and 14.7x MTDB for swine that showed combined thiabendazole residues of concern as high as 0.28 ppm in liver and 0.687 ppm in kidney, the Agency determined that the tolerance for combined thiabendazole residues of concern on hog meat byproducts should be increased from 0.1 ppm and set at the combined LOQ of 0.3 ppm for the analytes in the enforcement method. Therefore, EPA is proposing to increase the tolerance in 40 CFR 180.242(a)(2) on hog, meat byproducts to 0.3 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

Based on available data showing combined thiabendazole residues of concern as high as <0.022 ppm on sweet potatoes grown from treated seed roots, EPA determined that the postharvest tolerance for sweet potato from treated seed should be increased from 0.02 to 0.05 ppm. Therefore, EPA is proposing to increase the tolerance in 40 CFR 180.242(a)(1) on sweet potato (post-H to sweet potato intended only for use as seed) to 0.05 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

Based on available data that showed combined thiabendazole residues of concern as high as 5.0 ppm in or on pears and a HAFT for 3.4 ppm for apples, EPA determined that the tolerances on apples and pears should be decreased from 10.0 to 5.0 ppm and combined into a group tolerance. Therefore, the Agency is proposing to decrease the tolerances in 40 CFR 180.242(a)(1) on apple, postharvest and pear, postharvest and combine them into a group tolerance for fruit, pome, group 11, postharvest at 5.0 ppm.

Based on available processing data that showed residues of thiabendazole concentrated in wet apple pomace by a factor of 3.5x and a HAFT of 3.4 ppm for apples, EPA expected combined residues of 11.9 ppm in wet apple pomace. Therefore, the Agency determined that a tolerance on wet apple pomace should be established at 12.0 ppm. Consequently, EPA is proposing to establish a tolerance in 40 CFR 180.242(a)(1) on apple, wet pomace at 12.0 ppm.

Based on available processing data that showed residues of thiabendazole concentrated in citrus oil by an average factor of 2.4x and a HAFT of 5.2 ppm for whole citrus fruits, EPA expected combined residues of 12.5 ppm in citrus oil. Therefore, the Agency determined that a tolerance on citrus oil should be established at 15.0 ppm. Consequently, EPA is proposing to establish a tolerance in 40 CFR 180.242(a)(1) on citrus, oil at 15.0 ppm.

In addition, EPA is proposing to revise commodity terminology in 40 CFR 180.242(a)(1) to conform to current Agency practice as follows: “fruit, citrus, postharvest” to “fruit, citrus, group 10, postharvest.”

Currently, there is an active registration for thiabendazole use on sugar beets. The registrant does not intend to support the sugar beet tolerances. Consequently, EPA will not take action to revoke the sugar beet tolerances in 40 CFR 180.242 at this time, but will follow-up with the registrant on amending the registration in order to delete the sugarbeet use and address the tolerances in a future publication in the Federal Register.

10. Thidiazuron. Based on available processing data that show thidiazuron residues on cottonseed hulls concentrated slightly by a factor of 1.4x, EPA expects residues not to exceed the current recommended raw agricultural commodity tolerance of 0.3 ppm for cottonseed. Therefore, the tolerance on cottonseed hulls is no longer needed. Consequently, EPA is proposing to revoke the tolerance in 40 CFR 180.403(a) on cotton, hulls.

Cottonseed meal is a common feeding source for poultry. A cottonseed meal processing study at 5x application rate showed that thidiazuron residues were less than the LOQ (<0.05 ppm) and did not concentrate, and EPA determined that there is no reasonable expectation of finite residues in poultry and eggs. Therefore, the tolerances on poultry fat, meat, meat byproducts, and egg are no longer needed under 40 CFR 180.6(a)(3). Consequently, the Agency is proposing to revoke the tolerances in 40 CFR 180.403 for the combined residues of thidiazuron and its aniline containing metabolites in or on poultry, fat; poultry, meat; poultry, meat byproducts; and egg.

Based on available data showing thidiazuron residues were as high as 0.21 ppm on cottonseed, EPA determined that the tolerance should be decreased from 0.4 to 0.3 ppm. Therefore, the Agency is proposing to decrease the tolerance in 40 CFR 180.403(a) on cotton, undelinted seed to 0.3 ppm.

Pending storage stability and raw data to validate the ruminant feeding study, EPA determined that the tolerances for thidiazuron and its metabolites of concern are not expected to exceed 0.4 ppm for fat, meat, and meat byproducts, and therefore should be increased from 0.2 to 0.4 ppm. Therefore, the Agency is proposing to increase the tolerances in 40 CFR 180.403(a) on cattle, fat; cattle, meat; cattle, meat byproducts; goat, fat; goat, meat; goat, meat byproducts; hog, fat; hog, meat; hog, meat byproducts; horse, fat; horse, meat; horse, meat byproducts; sheep, fat; sheep, meat; and sheep, meat byproducts to 0.4 ppm. The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pestcide chemical residue.

Based on available data that showed thidiazuron residues as high as 22.12 ppm, EPA determined that a tolerance of 24.0 ppm should be established for cotton gin byproducts. Therefore, the Agency is proposing to establish a tolerance in 40 CFR 180.403(a) for the combined residues of thidiazuron and its aniline containing metabolites in or on cotton, gin byproducts at 24.0 ppm.

There are no Codex MRLs for thidiazuron.

11. Tribuphos. EPA is proposing to remove the “negligible residue” designation from all entries in 40 CFR 180.272 to conform to current Agency administrative practice.

Based on the MTDB for cattle and available exaggerated ruminant feeding data (2.7x MTDB), tribuphos residues in milk and fat were expected by the Agency at 1x to be as high as 0.008 ppm and 0.13 ppm, respectively. Therefore, the Agency determined that the tolerance on milk should be increased from 0.002 ppm to the LOQ (0.01 ppm), and that tolerances on the fat of cattle, goats, and sheep should be increased from 0.02 to 0.15 ppm and tolerances on the fat of hogs and horses should be established at 0.15 ppm. Therefore, EPA is proposing in 40 CFR 180.272 to increase tolerances on cattle, fat; goat, fat; and sheep, fat to 0.15 ppm; and establish tolerances on hog, fat and horse, fat at 0.15 ppm. Also, EPA is proposing in 40 CFR 180.272 to increase the tolerance on milk to 0.01 ppm. The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

Based on the MTDB for cattle and available exaggerated ruminant feeding data (2.7x MTDB), tribuphos residues in meat and liver were expected by the Agency at 1x to be as high as 0.015 ppm and 0.019 ppm, respectively. Therefore, the Agency determined that the tolerances on meat and meat byproducts of hogs and horses should all be established at 0.02 ppm. Therefore, EPA is proposing in 40 CFR 180.272 to establish tolerances on hog, meat; hog, meat byproducts; horse, meat; and horse, meat byproducts at 0.02 ppm.

Based on available data (where sites had a 7-day PHI, with the exception of one site with a 9-day PHI) that showed tribuphos residues as high as 36.39 ppm, EPA determined that a tolerance of 40.0 ppm should be established for cotton gin byproducts. Therefore, the Agency is proposing to establish a tolerance in 40 CFR 180.272 on cotton, gin byproducts at 40.0 ppm.

There are no Codex MRLs for tribuphos.

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 chloroneb, cypermethrin, methidathion, nitrapyrin, oxyfluorfen, pirimiphos-methyl, thiabendazole, thidiazuron, and tribuphos, and a TRED for tebuthiuron, whose RED was completed prior to FQPA. A RED for sulfosate was not needed because it was registered after November 1, 1984 and not subject to reregistration eligibility, and its tolerances were reassessed prior to completion of a TRED, such that a TRED for sulfosate was no longer needed because EPA made a safety finding which reassessed its tolerances according to the FFDCA standard, maintaining them when new tolerances were established as noted in Unit II.A. 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, 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 http://www.epa.gov/​. On the Home Page select “Laws, Regulations, and Dockets,” then select Regulations and Proposed Rules and then look up the entry for this document under “Federal Register—Environmental Documents.” You can also go directly to the “Federal Register” listings at http://www.epa.gov/​fedrgstr/​.

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?

With the exception of revocation of regional tolerances for methidathion on alfalfa forage, alfalfa hay, timothy forage, and timothy hay for which EPA is proposing specific expiration/revocation dates, the Agency is proposing that the actions herein become effective on the date of publication of the final rule in the Federal Register. With the exception of the revocation of these four regional tolerances for methidathion, 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. EPA is proposing an expiration/revocation date of March 31, 2008 for the methidathion tolerances on alfalfa forage, alfalfa hay, timothy forage, and timothy hay. The Agency believes that, because their regional registrations expire on December 31, 2007, the revocation date of March 31, 2008 allows sufficient time for passage of treated commodities 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 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, FFDCA section 408(b)(4) 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 “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: April 17, 2007.

Debra Edwards,

Director, Office of Pesticide Programs.

Therefore, it is proposed that 40 CFR chapter I be amended as follows:

PART 180

—AMENDED

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

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

2. Section 180.242 is amended as follows:

i. Paragraphs (a)(1) and (2) are revised.

ii. The introductory text to paragraph (b) is revised to read as follows:

§180.242

Thiabendazole; tolerances for residues.

(a) General. (1) Tolerances are established for the combined residues of the fungicide thiabendazole (2-(4-thiazolyl)benzimidazole) and its metabolite benzimidazole (free and conjugated) in or on the following raw agricultural commodities:

Commodity	Parts per million
Apple, wet pomace	12.0
Avocado1	10.0
Banana, postharvest	3.0
Bean, dry, seed	0.1
Beet, sugar, dried pulp	3.5
Beet, sugar, roots	0.25
Beet, sugar, tops	10.0
Cantaloupe1	15.0
Carrot, roots, postharvest	10.0
Citrus, oil	15.0
Fruit, citrus, group 10, postharvest	10.0
Fruit, pome, group 11, postharvest	5.0
Mango	10.0
Mushroom	40.0
Papaya, postharvest	5.0
Potato, postharvest	10.0
Soybean	0.1
Strawberry1	5.0
Sweet potato (POST-H to sweet potato intended only for use as seed)	0.05
Wheat, grain	1.0
Wheat, straw	1.0
1 There are no U.S. registrations on the indicated commodity.

(2) Tolerances are established for the combined residues of thiabendazole (2-(4-thiazolyl)benzimidazole) and its metabolites 5-hydroxythiabendazole (free and conjugated) and benzimidazole in or on the following raw agricultural commodities:

Commodity	Parts per million
Cattle, meat	0.1
Cattle, meat byproducts	0.4
Goat, meat byproducts	0.4
Hog, meat byproducts	0.3
Horse, meat byproducts	0.4
Milk	0.1
Sheep, meat byproducts	0.4

(b) Section 18 emergency exemptions. Time-limited tolerances are established for the combined residues of thiabendazole (2-(4-thiazolyl)benzimidazole) and its metabolite benzimidazole (free and conjugated), in connection with use of the pesticide under section 18 emergency exemptions granted by EPA. The tolerances are specified in the following table. The tolerances will expire on the dates specified in the table.

3. Section 180.257 is amended by revising paragraph (a) to read as follows:

§180.257

Chloroneb; tolerances for residues.

(a) General. Tolerances are established for residues of the fungicide chloroneb (1,4-dichloro-2,5-dimethoxybenzene) and its metabolite 2,5-dichloro-4-methoxyphenol (free and conjugated), calculated as chloroneb, in or on the following raw agricultural commodities:

Commodity	Parts per million
Bean, dry, seed	0.2
Bean, succulent	0.2
Beet, sugar, roots	0.2
Beet, sugar, tops	0.2
Cowpea, forage	2.0
Cowpea, hay	2.0
Cattle, fat	0.2
Cattle, meat	0.2
Cattle, meat byproducts	0.2
Cotton, gin byproducts	1.0
Cotton, undelinted seed	0.2
Goat, fat	0.2
Goat, meat	0.2
Goat, meat byproducts	0.2
Hog, fat	0.2
Hog, meat	0.2
Hog, meat byproducts	0.2
Horse, fat	0.2
Horse, meat	0.2
Horse, meat byproducts	0.2
Milk	0.05
Sheep, fat	0.2
Sheep, meat	0.2
Sheep, meat byproducts	0.2
Soybean, forage	2.0
Soybean, hay	2.0
Soybean, seed	0.2

* * * * *

4. Section 180.272 is amended by revising the table in paragraph (a) to read as follows:

§180.272

Tribuphos; tolerances for residues.

(a) General. * * *

Commodity	Parts per million
Cattle, fat	0.15
Cattle, meat	0.02
Cattle, meat byproducts	0.02
Cotton, gin byproducts	40.0
Cotton, undelinted seed	4.0
Goat, fat	0.15
Goat, meat	0.02
Goat, meat byproducts	0.02
Hog, fat	0.15
Hog, meat	0.02
Hog, meat byproducts	0.02
Horse, fat	0.15
Horse, meat	0.02
Horse, meat byproducts	0.02
Milk	0.01
Sheep, fat	0.15
Sheep, meat	0.02
Sheep, meat byproducts	0.02

5. Section 180.298 is amended by revising the tables in paragraphs (a) and (c) to read as follows:

§180.298

Methidathion; tolerances for residues.

(a) General. * * *

Commodity	Parts per million
Almond, hulls	6.0
Artichoke, globe	0.05
Citrus, oil	420.0
Cotton, undelinted seed	0.2
Fruit, citrus, group 10, except tangerine	4.0
Fruit, pome, group 11	0.05
Fruit, stone, group 12	0.05
Mango	0.05
Nut, tree, group 14	0.05
Olive	0.05
Safflower, seed	0.5
Sorghum, forage, forage	2.0
Sorghum, grain, forage	2.0
Sorghum, grain, grain	0.2
Sorghum, grain, stover	2.0
Sunflower, seed	0.5
Tangerine	6.0

(c) * * *

Commodity	Parts per million	Expiration/Revocation Date
Alfalfa, forage	5.0	3/31/2008
Alfalfa, hay	5.0	3/31/2008
Kiwifruit	0.1	None
Longan	0.1	None
Starfruit	0.1	None
Sugar apple	0.2	None
Timothy, forage	5.0	3/31/2008
Timothy, hay	5.0	3/31/2008

6. Section 180.350 is amended by revising the table in paragraph (a) to read as follows:

§180.350

Nitrapyrin; tolerances for residues.

(a) General. * * *

Commodity	Parts per million
Corn, field, forage	1.0
Corn, field, grain	0.1
Corn, field, milled byproducts	0.2
Corn, field, stover	1.0
Corn, pop, grain	0.1
Corn, pop, stover	1.0
Corn, sweet, forage	1.0
Corn, sweet, kernel plus cob with husks removed	0.1
Corn, sweet, stover	1.0
Sorghum, forage, forage	0.5
Sorghum, grain, forage	0.5
Sorghum, grain, grain	0.1
Sorghum, grain, stover	0.5
Wheat, bran	3.0
Wheat, forage	2.0
Wheat, grain	0.5
Wheat, milled byproducts, except flour	2.0
Wheat, straw	6.0

7. Section 180.381 is amended by revising the tables in paragraphs (a) and (c) to read as follows:

§180.381

Oxyfluorfen; tolerances for residues.

(a) General. * * *

Commodity	Parts per million
Almond, hulls	0.1
Artichoke, globe	0.05
Avocado	0.05
Banana	0.05
Broccoli	0.05
Cabbage	0.05
Cattle, fat	0.01
Cattle, meat	0.01
Cattle, meat byproducts	0.01
Cauliflower	0.05
Cocoa bean, dried bean	0.05
Coffee, bean, green	0.05
Corn, field, grain	0.05
Corn, pop, grain	0.05
Cotton, undelinted seed	0.05
Date	0.05
Egg	0.03
Feijoa	0.05
Fig	0.05
Fruit, pome, group 11	0.05
Fruit, stone, group 12	0.05
Goat, fat	0.01
Goat, meat	0.01
Goat, meat byproducts	0.01
Grape	0.05
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
Horseradish	0.05
Kiwifruit	0.05
Milk	0.01
Nut, tree, group 14	0.05
Olive	0.05
Onion, bulb	0.05
Peppermint, tops	0.05
Persimmon	0.05
Pistachio	0.05
Pomegranate	0.05
Poultry, fat	0.2
Poultry, meat	0.01
Poultry, meat byproducts	0.01
Sheep, fat	0.01
Sheep, meat	0.01
Sheep, meat byproducts	0.01
Soybean	0.05
Spearmint, tops	0.05

(c) * * *

Commodity	Parts per million
Blackberry	0.05
Chickpea, seed	0.05
Grass, forage	0.05
Grass, hay	0.05
Grass, seed screenings	0.05
Guava	0.05
Papaya	0.05
Raspberry	0.05
Taro, corm	0.05
Taro, leaves	0.05

8. Section 180.390 is revised to read as follows:

§180.390

Tebuthiuron; tolerances for residues.

(a) General. (1) Tolerances are established for the combined residues of the herbicide tebuthiuron (N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N, N′-dimethylurea) and its metabolites N-(5-(2-hydroxy-1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N,N′-dimethylurea, N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N-methylurea, and N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N′-hydroxymethyl-N-methylurea in or on the following raw agricultural commodities:

Commodity	Parts per million
Grass, forage	10.0
Grass, hay	10.0

(2) Tolerances are established for the combined residues of the herbicide tebuthiuron (N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N,N′-dimethylurea) and its metabolites N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N-methylurea, N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)urea, 2-dimethylethyl-5-amino-1,3,4-thiadiazole, and N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N′-hydroxymethyl-N-methylurea in or on the following raw agricultural commodities:

Commodity	Parts per million
Cattle, fat	1.0
Cattle, meat	1.0
Cattle, meat byproducts	5.0
Goat, fat	1.0
Goat, meat	1.0
Goat, meat byproducts	5.0
Horse, fat	1.0
Horse, meat	1.0
Horse, meat byproducts	5.0
Sheep, fat	1.0
Sheep, meat	1.0
Sheep, meat byproducts	5.0

(3) A tolerance is established for the combined residues of the herbicide tebuthiuron (N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N,N′-dimethylurea) and its metabolites N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N-methylurea, N-(5-(2-hydroxy-1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N-methylurea, N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)urea, N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N′-hydroxymethyl-N-methylurea, and N-(5-(2-hydroxy-1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N′-hydroxymethyl-N-methylurea in or on the following raw agricultural commodities:

Commodity	Parts per million
Milk	0.8

(b) Section 18 emergency exemptions. [Reserved]

(c) Tolerances with regional registrations. [Reserved]

(d) Indirect or inadvertent residues. [Reserved]

9. Section 180.403 is amended by revising the table in paragraph (a) to read as follows:

§180.403

Thidiazuron; tolerances for residues.

(a) General. * * *

Commodity	Parts per million
Cattle, fat	0.4
Cattle, meat	0.4
Cattle, meat byproducts	0.4
Cotton, gin byproducts	24.0
Cotton, undelinted seed	0.3
Goat, fat	0.4
Goat, meat	0.4
Goat, meat byproducts	0.4
Hog, fat	0.4
Hog, meat	0.4
Hog, meat byproducts	0.4
Horse, fat	0.4
Horse, meat	0.4
Horse, meat byproducts	0.4
Milk	0.05
Sheep, fat	0.4
Sheep, meat	0.4
Sheep, meat byproducts	0.4

10. Section 180.409 is amended by revising paragraph (a) to read as follows:

§180.409

Pirimiphos-methyl; tolerances for residues.

(a) General. Tolerances are established for residues of the insecticide pirimiphos-methyl (O-(2-diethylamino-6-methyl-4-pyrimidinyl) O,O-dimethyl phosphorothioate) in or on the following raw agricultural commodities:

Commodity	Parts per million
Cattle, fat	0.02
Cattle, meat byproducts	0.02
Corn, field, grain	8.0
Corn, pop, grain	8.0
Goat, fat	0.02
Goat, meat byproducts	0.02
Grain, aspirated fractions	20.0
Hog, fat	0.02
Hog, meat byproducts	0.02
Horse, fat	0.02
Horse, meat byproducts	0.02
Poultry, fat	0.02
Sheep, fat	0.02
Sheep, meat byproducts	0.02
Sorghum, grain, grain	8.0

* * * * *

11. Section 180.418 is amended by revising the tables in paragraphs (a)(1), (a)(2), and (b) to read as follows:

§180.418

Cypermethrin and an isomer zeta-cypermethrin; tolerances for residues.

(a) General. (1) * * *

Commodity	Parts per million
Brassica, head and stem, subgroup 5A	2.0
Brassica, leafy greens, subgroup 5B	14.0
Cattle, fat	1.0
Cattle, meat	0.2
Cattle, meat byproducts	0.05
Cotton, gin byproducts	11.0
Cotton, undelinted seed	0.5
Egg	0.05
Goat, fat	1.0
Goat, meat	0.2
Goat, meat byproducts	0.05
Hog, fat	0.1
Hog, meat	0.05
Horse, fat	1.0
Horse, meat	0.2
Horse, meat byproducts	0.05
Lettuce, head	4.0
Milk, fat (reflecting 0.10 in whole milk)	2.5
Onion, bulb	0.1
Onion, green	6.0
Pecan	0.05
Poultry, fat	0.05
Poultry, meat	0.05
Sheep, fat	1.0
Sheep, meat	0.2
Sheep, meat byproducts	0.05

(2) * * *

Commodity	Parts per million
Alfalfa, hay	15.00
Alfalfa, forage	5.00
Alfalfa, seed	0.50
Almond, hulls	6
Animal feed, nongrass, group 18, forage	8
Animal feed, nongrass, group 18, hay	40
Beet, sugar, roots	0.05
Beet, sugar, tops	0.20
Berry, group 13	0.8
Brassica, head and stem, subgroup 5A	2.00
Brassica, leafy greens, subgroup 5B	14.00
Cabbage	2.00
Cattle, fat	1.00
Cattle, meat	0.2
Cattle, meat byproducts	0.05
Cilantro, leaves	10
Corn, field, forage	0.20
Corn, field, grain	0.05
Corn, field, stover	3.00
Corn, pop, grain	0.05
Corn, pop, stover	3.00
Corn, sweet, forage	15.00
Corn, sweet, kernel plus cob with husks removed	0.05
Corn, sweet, stover	15.00
Cotton, undelinted seed	0.5
Egg	0.05
Food/feed items (other than those covered by a higher tolerance as a result of use on growing crops) in food/feed handling establishments	0.05
Fruit, pome, group 11	2
Fruit, stone, group 12	1
Goat, fat	1.00
Goat, meat	0.2
Goat, meat byproducts	0.05
Grain, aspirated fractions	10.0
Grape	2
Grass, forage, group 17	10
Grass, hay, group 17	35
Hog, fat	0.1
Hog, meat	0.05
Horse, fat	1.00
Horse, meat	0.2
Horse, meat byproducts	0.05
Milk, fat (reflecting 0.10 in whole milk)	2.50
Nut, tree, group 14	0.05
Onion, bulb	0.10
Onion, green	3.00
Pea and bean, dried shelled, except soybean, subgroup 6C	0.05
Pea and bean, succulent shelled, subgroup 6B	0.1
Peanut	0.05
Pecan	0.05
Poultry, fat	0.05
Poultry, meat	0.05
Rapeseed	0.2
Rice, grain	1.50
Rice, hulls	6.00
Rice, straw	2.00
Sheep, fat	1.00
Sheep, meat	0.2
Sheep, meat byproducts	0.05
Sorghum, grain, forage	0.1
Sorghum, grain, grain	0.5
Sorghum, grain, stover	5.0
Soybean, seed	0.05
Sugarcane, cane	0.60
Sunflower	0.2
Sunflower, refined oil	0.5
Turnip, greens	14
Vegetable, cucurbit, group 9	0.2
Vegetable, fruiting, group 8	0.2
Vegetable, leafy, except brassica, group 4	10.00
Vegetable, legume, edible podded, subgroup 6A	0.5
Vegetable, root and tuber, group 1, except sugar beet	0.1
Wheat, forage	3.0
Wheat, grain	0.2
Wheat, hay	6.0
Wheat, straw	7.0

(b) * * *

Commodity	Parts per million	Expiration/Revocation Date
Flax, meal	0.2	6/30/2008
Flax, seed	0.2	6/30/2008

§180.489

[Removed]

12. Section 180.489 is removed.