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Proposed Rule

Chlorpropham, Linuron, Pebulate, Asulam, and Thiophanate-methyl; Proposed Tolerance Actions

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Information about this document as published in the Federal Register.

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AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

EPA is proposing to revoke certain tolerances for the herbicides linuron and pebulate and the fungicide thiophanate-methyl. Also, EPA is proposing to modify certain tolerances for the herbicides chlorpropham, linuron, asulam and the fungicide thiophanate-methyl. In addition, EPA is proposing to establish new tolerances for the herbicides chlorpropham, linuron, asulam, and the fungicide thiophanate-methyl. The regulatory actions proposed in this document are part of the Agency's reregistration program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

DATES:

Comments must be received on or before November 20, 2006.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2006-0483, 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 Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The docket telephone number is (703) 305-5805.

Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2006-0483. 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. 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 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 Drive, Arlington, VA. The hours of operation for this docket facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket facility telephone number is (703) 305-5805.

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FOR FURTHER INFORMATION CONTACT:

Jane Smith, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460-0001; telephone number: (703) 308-0048; e-mail address: smith.jane-scott@epa.gov.

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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 Start Printed Page 54954certain 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 www.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 will issue 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, modify, and establish specific tolerances for residues of the herbicides chlorpropham, linuron, pebulate, and asulam and the fungicide thiophanate-methyl 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 FQPA. The safety finding determination of “reasonable certainty of no harm” is discussed in detail in each RED and Report of the FQPA TRED for the active ingredient. REDs and TREDs recommend the implementation of certain tolerance actions, including modifications to reflect current use patterns, meet safety findings, and change commodity names and groupings in accordance with new EPA policy. Printed copies of many REDs and TREDs may be obtained from EPA's National Service Center for Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH 45242-2419, telephone 1-800-490-9198; fax 1-513-489-8695; internet at http://www.epa.gov/​ncepihom/​ and from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone 1-800-553-6847 or 703-605-6000, internet at http://www.ntis.gov. Electronic copies of REDs and TREDs are available on the internet at http://www.epa.gov/​pesticides/​reregistration/​status.htm and chlorpropham in docket number EPA-HQ-OPP-2002-0180, asulam in docket number EPA-HQ-OPP-2002-0329, linuron in docket number EPA-HQ-OPP-2002-0079, and thiophanate-methyl in dockets EPA-HQ-OPP-2002-0140, and EPA-HQ-OPP-2002-0265.

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. The evaluation of whether a tolerance is safe is a separate inquiry. EPA recommends the raising of a tolerance when data show that: 1. Lawful use (sometimes through a label change) may result in a higher residue level on the commodity; and 2. the tolerance remains safe, notwithstanding increased residue level allowed under the tolerance.

In REDs, Chapter IV on “Risk management, Reregistration, and Tolerance Reassessment” typically describes the regulatory position, FQPA assessment, cumulative safety determination, determination of safety for U.S. general population, and safety for infants and children. In particular, the human health risk assessment document which supports the RED describes risk exposure estimates and whether the Agency has concerns. In TREDs, the Agency discusses its evaluation of the dietary risk associated with the active ingredient and whether it can determine that there is a reasonable certainty (with appropriate mitigation) that no harm to any population subgroup will result from aggregate exposure.

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 are available electronically through EPA's electronic public docket and comment system, regulations.gov at http://www.regulations.gov. You may search Start Printed Page 54955for this proposed rule and for pebulate under docket number EPA-HQ-OPP-2006-0483, or for an individual chemical under its respective docket number, then click on that docket number to view its contents.

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 established or 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 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 canceled 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. Chlorpropham. A plant commodity tolerance on postharvest potato for chlorpropham is currently regulated for residues of CIPC (isopropyl m-chlorocarbanilate) and its metabolite 1-hydroxy-2-propyl 3'-chlorocarbanilate (calculated as CIPC) in 40 CFR 180.181. Because the regulated metabolite was not detected in potato following treatment with radiolabelled14 C-chlorpropham, EPA determined that the tolerance expression for plants should be expressed in terms of chlorpropham per se. Meanwhile, the current interim milk and livestock tolerances in 40 CFR 180.319 are regulated for isopropyl m-chlorocarbanilate (CIPC) residues. However, based on available ruminant data that show residues of chlorpropham and its metabolite 4-hydroxychlorpropham-O-sulfonic acid (4-HSA) in milk and edible tissues, EPA determined that the tolerance expression should be expressed in terms of the combined residues of chlorpropham and 4- hydroxychlorpropham-O-sulfonic acid (4-HSA) and recodified under 40 CFR 180.181 as permanent tolerances. Therefore, EPA is proposing to recodify plant tolerances for chlorpropham from 40 CFR 180.181(a) to (a)(1), and regulate tolerances there for residues of the plant regulator and herbicide chlorpropham (isopropyl m-chlorocarbanilate). Also, EPA is proposing to remove the interim milk and livestock tolerances (meat, fat, and meat byproducts of cattle, hog, horse, and sheep) for chlorpropham (isopropyl m-chlorocarbanilate) in 40 CFR 180.319, recodify them as permanent tolerances in 40 CFR 180.181(a)(2), and regulate tolerances there for the combined residues of the plant regulator and herbicide chlorpropham (isopropyl m-chlorocarbaniliate (CIPC)) and its metabolite 4-hydroxychlorpropham-O-sulfonic acid (4-HSA).

In addition, based on ruminant feeding data and the calculated maximum theoretical dietary burden (MTDB) estimates, EPA determined that tolerances on the meat of cattle, hog, horse and sheep should be increased in 40 CFR 180.181(a)(2) from 0.05 to 0.06 ppm, the limit of quantitation (LOQ), and a tolerance for goat meat should be established at 0.06 ppm. Also, based on exaggerated feeding study data that showed combined residues of concern in kidney at about 0.3 ppm, the Agency determined that tolerances for kidney of cattle, hog, horse, and sheep should be separated from their existing meat byproduct tolerances at 0.05 ppm and in 40 CFR 180.181(a)(2) increased to 0.30 ppm, and a tolerance for goat kidney should be established at 0.30 ppm. However, because combined residues of concern in liver were shown to be near the LOQ (0.06 ppm), the Agency determined that tolerances for meat byproduct, except kidney of cattle, hog, horse, and sheep should be increased in 40 CFR 180.181(a)(2) from 0.05 to 0.06 pm, and a tolerance for goat, meat byproducts, except kidney should be established at 0.06 ppm. In addition, based on ruminant feeding data that showed combined residues of concern in fat at 0.17 ppm, the Agency determined that tolerances for the fat of cattle, hog, horse, and sheep should be increased from 0.05 to 0.20 ppm, and a tolerance for goat fat should be established at 0.20 ppm. Moreover, based on ruminant feeding data and the MTDB estimates that showed combined residues of concern to be 0.25 ppm, the Agency determined that the tolerance for milk should be increased from 0.05 to 0.30 ppm. Therefore, EPA is proposing to increase tolerances in newly recodified 40 CFR 180.181(a)(2) for the combined residues of chlorpropham and 4-hydroxychlorpropham-O-sulfonic acid (4-HSA) as follows: Milk from 0.05 to 0.30 ppm; cattle, fat; hog, fat; horse, fat; and sheep, fat from 0.05 to 0.20 ppm; cattle, meat; hog, meat; horse, meat; and sheep, meat from 0.05 to 0.06 ppm; cattle, meat byproducts, except kidney; hog, meat byproducts, except kidney; horse, meat byproducts, except kidney; and sheep, meat byproducts, except kidney from 0.05 to 0.06 ppm, and cattle, kidney; hog, kidney; horse, kidney; and sheep, kidney from 0.05 to 0.30 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 establish tolerances in newly recodified 40 CFR 180.181(a)(2) for the combined residues of chlorpropham and 4-hydroxychlorpropham-O-sulfonic acid (4-HSA) as follows: Goat, fat at 0.20 ppm; goat, kidney at 0.30 ppm; goat, meat at 0.06 ppm; and goat, meat byproducts,except kidney at 0.06 ppm.

Based on available potato field trial data that show residues of chlorpropham as high as 24.0 ppm, the Agency determined that the tolerance in newly recodified 40 CFR 180.181(a)(1) should be decreased from 50.0 to 30.0 ppm. Therefore, EPA is proposing to decrease the tolerance in newly recodified 40 CFR 180.181(a)(1) on potato, postharvest from 50.0 to 30.0 ppm.

Based on an available potato processing data that show an average concentration factor of chlorpropham residues at 3x and a highest average field trial (HAFT) whole potato residue of 12.0 ppm, the Agency determined that residues would be 36 ppm and a tolerance should be established on potato, wet peel at 40 ppm. (Residues did not concentrate in potato granules, flakes, or chips). Therefore, EPA is proposing to establish a tolerance in newly recodified 40 CFR 180.181(a)(1) on potato, wet peel at 40.0 ppm.

Since the chlorpropham TRED, the spinach tolerance in 40 CFR 180.319 was revoked by final rule published in the Federal Register on July 23, 2004 (69 FR 43918) (FRL-7358-6), which included tolerance actions on a number Start Printed Page 54956of pesticide active ingredients including chlorpropham.

2. Linuron. According to the TRED, the tolerance expression, which is currently expressed as “residues of the herbicide linuron (3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea)” in 40 CFR 180.184(a) and (c), should be modified to include metabolites that can be converted to 3,4-dichloroaniline that are of toxicological concern. Consequently, EPA is proposing the tolerance expression in 40 CFR 180.184(a) and (c) read as follows:

(a) General. Tolerances are established for the combined residues of the herbicide linuron (3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea) and its metabolites convertible to 3,4-dichloroaniline, calculated as linuron, in or on the following food commodities:

* * * * *

(c) Tolerances with regional registrations. Tolerances with regional registrations, as defined in § 180.1(n), are established for the combined residues of the herbicide linuron (3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea) and its metabolites convertible to 3,4-dichloroaniline, calculated as linuron, in or on the following food commodities:

The feeding of treated soybean forage or hay to livestock is prohibited as stated on registration labels and therefore the tolerances are no longer needed. Consequently, EPA is proposing to revoke the tolerances in 40 CFR 180.184(a) for residues of the herbicide linuron and its metabolites convertible to 3,4-dichloroaniline, calculated as linuron, in or on soybean, forage and soybean, hay.

Based on field trial data that indicate linuron residues of concern in or on field corn stover are as high as 5.5 ppm, the Agency determined that a tolerance of 6.0 ppm is appropriate. Therefore, EPA is proposing to increase the tolerance in 40 CFR 180.184(a) for residues of the herbicide linuron and its metabolites convertible to 3,4-dichloroaniline, calculated as linuron, in or on corn, field, stover from 1.0 to 6.0 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.

In order to conform to current Agency practice, EPA is proposing to revise the commodity terminology in 40 CFR 180.184 for corn, grain (inc. pop) at 0.25 ppm into corn, field, grain and corn, pop, grain. However, because there are no active U.S. registrations for linuron residues of concern on popcorn, and therefore a tolerance is no longer needed, EPA is proposing to revoke the newly revised tolerance in 40 CFR 180.184(a) on corn, pop, grain. In addition, based on field trial data that indicate linuron residues of concern in or on corn grain as high as 0.06 ppm, the Agency determined that the corn, field, grain tolerance should be decreased from 0.25 to 0.1 ppm. Therefore, EPA is proposing to decrease the newly revised tolerance in 40 CFR 180.184(a) for the combined residues of the linuron and its metabolites convertible to 3,4-dichloroaniline, calculated as linuron, in or on corn, field, grain from 0.25 to 0.1 ppm.

Ruminant feeding data at an exaggerated level (6.9x) show that linuron residues of concern expected at a 1x feeding level are 0.16 ppm in fat, 0.07 ppm in meat, 1.9 ppm in liver and kidney, and 0.05 ppm (LOQ) in milk. Based on these expected residue levels, the Agency determined that the fat tolerances of cattle, goat, horse and sheep should be decreased from 1.0 to 0.2 ppm; meat tolerances of cattle, goat, horse and sheep should be decreased from 1.0 to 0.1 ppm; meat byproduct tolerances of cattle, goat, horse, and sheep should be separated into tolerances for meat byproducts, except kidney and liver, and decreased from 1.0 to 0.1 ppm, kidney of cattle, goat, horse, and sheep, which should be established separately and increased from 1.0 to 2.0 ppm, and liver of cattle, goat, horse, and sheep, which should be established separately and increased from 1.0 to 2.0 ppm; and a tolerance for milk should be established at 0.05 ppm. Therefore, EPA is proposing to decrease tolerances from 1.0 ppm in 40 CFR 180.184(a) to the following: Cattle, fat; goat, fat; horse, fat; and sheep, fat; each at 0.2 ppm; cattle, meat; cattle, meat byproducts, except kidney and liver; goat, meat; goat, meat byproducts, except kidney and liver; horse, meat; horse, meat byproducts, except, kidney and liver; sheep, meat and sheep, meat byproducts, except kidney and liver; each at 0.1 ppm. Also, EPA is proposing to established separate tolerances and increase them from 1.0 in 40 CFR 180.184(a) as follows: Cattle, kidney; cattle, liver; goat, kidney; goat, liver; horse, kidney; horse, liver; sheep, kidney; and sheep, liver; each at 2.0 ppm. In addition, EPA is proposing to establish a tolerance in 40 CFR 180.184(a) on milk at 0.05 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 ruminant feeding data and an estimated dietary burden in swine that is much less than that for beef and dairy cattle, the Agency calculated likely linuron residues of concern to be 0.007 ppm in hog fat, 0.003 ppm in hog meat, and 0.08 ppm in hog liver and kidney, and therefore tolerances should be decreased from 1.0 ppm to 0.05 ppm, 0.05 ppm, and 0.1 ppm for hog fat, meat, and meat byproducts, respectively. Therefore, EPA is proposing to decrease tolerances in 40 CFR 180.184(a) for the combined residues of linuron and its metabolites convertible to 3,4-dichloroaniline, calculated as linuron, in or on hog, fat and hog, meat from 1.0 to 0.05 ppm; and hog, meat byproducts from 1.0 to 0.1 ppm.

Based on field trial data, the Agency determined that linuron residues of concern were non-detectable (<0.05 ppm) in or on parsnips. Therefore, EPA is proposing to decrease the tolerance in 40 CFR 180.184(a) for the combined residues of linuron and its metabolites convertible to 3,4-dichloroaniline, calculated as linuron, in or on parsnip (with or without tops) from 0.5 to 0.05 ppm and revise the commodity terminology into parsnip, roots and parsnip, tops.

The Linuron TRED reassessed the tolerance on cottonseed and recommended that it should be decreased from 0.25 to 0.05 ppm and be recodified from 40 CFR 80.184(a) to (c) as a regional tolerance, with use restricted to east of the Rocky Mountains. Since completion of the Linuron TRED, EPA has reviewed additional cotton field trial data from all cotton growing regions of the U.S. that indicate linuron residues of concern ranged from <0.05 to 0.244 ppm in or on undelinted cottonseed and that linuron did not concentrate in the processed fractions of cottonseed (meal, refined oil, and hulls). The Agency determined that the number of cottonseed field trials met geographical representation guidelines in accordance with OPPTS Harmonized Guideline 860.1500 (which is available at http://www.epa.gov/​opptsfrs/​publications/​OPPTS_​Harmonized/​860_​Residue_​Chemistry_​Test_​Guidelines/​Series/​) for use of linuron on cotton both east and west of the Rocky Mountains. Based on these data, the Agency determined that the current tolerance for cotton, undelinted seed at 0.25 ppm is appropriate and should be maintained in 40 CFR 180.184(a), and separate tolerances are not needed on cotton meal, refined oil and hulls.

Since completion of the Linuron TRED, the registrant has adequately Start Printed Page 54957responded to the deficiencies for cotton gin byproducts and has provided sufficient information with regard to the type of equipment used for harvesting the cotton commodities as well as justification for hand harvesting some cotton gin byproduct samples. Based on more recent cotton storage stability and field trial data reflecting all cotton growing regions of the U.S. submitted in response to the TRED that show linuron residues of concern in or on stripper cotton gin byproducts as high as 3.32 ppm, the Agency determined that a tolerance should be established for cotton gin byproducts in 40 CFR 180.184(a) at 5.0 ppm. Therefore, EPA is proposing to establish a tolerance in 40 CFR 180.184(a) for the combined residues of linuron and its metabolites convertible to 3,4-dichloroaniline, calculated as linuron, in or on cotton, gin byproducts at 5.0 ppm.

Because use of linuron on potatoes and celery is restricted to east of the Rocky Mountains, and use on wheat is restricted to the states of Idaho, Oregon, and Washington, the Agency determined that tolerances on celery, potato, and the forage, grain, hay, and straw of wheat should be recodified as regional registrations. Also, based on field trial data that indicate linuron residues of concern were as high as 0.42 ppm in or on celery, nondetectable (<0.05 ppm) in or on all but one sample (0.07 ppm) of potato, <0.03 ppm in or on wheat grain, and as high as 2.0 ppm in or on wheat straw, the Agency determined that the tolerance should remain at 0.5 ppm on celery, be decreased from 1.0 to 0.2 ppm on potato and 0.25 to 0.05 ppm on wheat, grain, and increased from 0.5 to 2.0 ppm on wheat straw. However, while tolerances for wheat forage and hay have been reassessed, additional data are anticipated in 2007 in response to the 2002 Linuron TRED. Therefore, EPA is proposing to recodify tolerances on celery, potato, and the forage, grain, hay, and straw of wheat from 40 CFR 180.184(a) to (c) and maintain or modify their tolerance levels for combined residues of linuron and its metabolites convertible to 3,4-dichloroaniline, calculated as linuron, as follows: Celery; wheat, forage; and wheat, hay; each maintained at 0.5 ppm; potato decreased from 1.0 to 0.2 ppm; wheat, grain decreased from 0.25 to 0.05 ppm; and wheat, straw increased from 0.5 to 2.0 ppm. The Agency determined that the increased tolerance is safe; i.e. there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

Interregional Research Project number 4 (IR-4) has submitted petitions (PP 8E5027 and PP 8E5028) requesting the establishment of tolerances on celeriac and rhubarb based on use directions and data translated from carrots and celery, respectively. Based on field trial data that show linuron residues of concern for carrot samples treated at 0.75x were as high as 0.56 ppm and celery samples treated at 1x were as high as 0.42 ppm, the Agency determined that tolerances should be established at 1.0 ppm on celeriac and 0.5 ppm on rhubarb. Therefore, EPA is proposing to establish tolerances in 40 CFR 180.184(a) for the combined residues of linuron and its metabolites convertible to 3,4-dichloroaniline, calculated as linuron, in or on celeriac at 1.0 ppm and rhubarb at 0.5 ppm.

Although additional data are anticipated in 2007 in response to the TRED, tolerances associated with sorghum and sweet corn have been reassessed at the current tolerance levels. The Agency determined that the tolerances are safe; i.e. there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. EPA is proposing to maintain the tolerance and revise commodity terminology in 40 CFR 180.184(a) to conform to current Agency practice as follows: “Sorghum, forage” to “sorghum, grain, forage” at 1.0 ppm; “corn, fresh (inc. kernel plus cob with husks removed)” to “corn, sweet, kernel plus cob with husks removed” at 0.25 ppm; and “soybean, (dry or succulent)” to “soybean, seed” at 1.0 ppm and “soybean, vegetable” at 1.0 ppm.

3. Pebulate. The last U.S. registration for the pesticide active ingredient pebulate (S-propyl butylethylthiocarbamate) was canceled on October 24, 2003, due to non-payment of registration fees and a notice was published in the Federal Register on November 6, 2003 (68 FR 62785) (FRL-7331-3). Therefore, the tolerances are no longer needed and EPA is proposing to revoke the tolerances in 40 CFR 180.238 for residues of S-propyl butylethylthiocarbamate in or on beet, sugar, roots; beet, sugar, tops; and tomato.

4. Asulam. The tolerance expression in 40 CFR 180.360 currently regulates asulam (methyl sulfanilylcarbamate) per se. Because an adequate enforcement method is available for the determination of combined residues of asulam and all metabolites containing the sulfanilamide moiety, the Agency recommended in the asulam TRED that the tolerance expression be revised to include metabolites containing the sulfanilamide moiety. Therefore, EPA is proposing the tolerance expression in 40 CFR 180.360 read as follows:

“(a) General. Tolerances are established for the combined residues of asulam (methyl sulfanilylcarbamate) and its metabolites containing the sulfanilamide moiety in or on the following food commodities:”

Based on sugarcane field trial data that showed asulam residues of concern as high as 0.213 ppm and a correction for a 70% loss of residues during storage, the Agency calculated that maximum residues should be 0.71 ppm and determined that the tolerance on sugarcane should be increased from 0.1 to 1.0 ppm. Therefore, EPA is proposing to increase the tolerance in 40 CFR 180.360(a) for the combined residues of asulam and its metabolites containing the sulfanilamide moiety in or on sugarcane, cane from 0.1 to 1.0 ppm. The Agency determined that the increased tolerance is safe; i.e. there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

Based on an available sugarcane processing data that show an average concentration factor of asulam residues at 48x and a HAFT residue value that when corrected for a 70% loss in storage is expected to be 0.557 ppm (0.167 ppm/0.3), the Agency calculated that residues would be about 26.7 ppm and determined that a tolerance should be established on sugarcane, molasses at 30.0 ppm. Therefore, EPA is proposing to establish a tolerance in 40 CFR 180.360(a) for the combined residues of asulam and its metabolites containing the sulfanilamide moiety in or on sugarcane, molasses at 30 ppm.

Based on a 1.2x exaggerated feeding data, animal metabolism data, and a ruminant diet of containing 10% molasses, a livestock feed item, the Agency determined that because the anticipated residues of asulam and sulfanilamide containing metabolites in milk are <0.025 ppm, in or on fat, liver, and muscle are <0.05 ppm, and kidney is 0.12 ppm, that tolerances should be established in milk, and on the fat and meat of cattle, goats, hogs, horses, and sheep at 0.05 ppm, and meat byproducts of cattle, goats, hogs, horses, and sheep at 0.2 ppm. Therefore, EPA is proposing to establish tolerances in 40 CFR 180.360(a) for the combined residues of asulam and its metabolites containing the sulfanilamide moiety in or on commodities, as follows: Cattle, fat; cattle, meat; goat, fat; goat, meat; hog, fat; hog, meat; horse, fat; horse, meat; sheep, fat; and sheep, meat at 0.05 ppm; and cattle, meat byproducts; goat, meat byproducts; hog, meat byproducts; horse, meat byproducts; and sheep meat Start Printed Page 54958byproducts at 0.2 ppm; and milk at 0.05 ppm.

5. Thiophanate-methyl. Currently, the tolerances for thiophanate-methyl are expressed in 40 CFR 180.371(a) in terms of thiophanate-methyl (dimethyl [(1,2-phenylene)-bis(iminocarbonothioyl)] bis(carbamate)), its oxygen analogue dimethyl-4,4-o-phenylene bis(allophonate), and its benzimidazole-containing metabolites (calculated as thiophanate-methyl); and in 180.371(b) and (c) in terms of thiophanate-methyl and its metabolite methyl 2-benzimidazoyl carbamate (MBC). However, the Agency no longer considers the metabolite allophanate to be a residue of concern and has determined that residues of concern for plant and animal commodities for tolerance enforcement consists of the parent and its metabolite methyl 2-benzimidazoyl carbamate. Therefore, EPA is proposing to amend the tolerance expression in 40 CFR 180.371(a), (b) and (c) so as to regulate tolerances for the combined residues of thiophanate-methyl (dimethyl [(1,2-phenylene) bis(iminocarbonothioyl)] bis(carbamate)) and its metabolite methyl 2-benzimidazoyl carbamate, calculated as thiophanate-methyl, in or on food commodities.

CODEX alimentarius commission maximum residues limits (MRLs) for thiophanate-methyl are currently expressed as methyl 2-benzimidazoyl carbamate (carbendazim), which is incompatible with the revised U.S. tolerance definition that will include both thiophanate-methyl and methyl 2-benzimidazoyl carbamate. EPA has determined that residues of concern for plant and animal commodities for tolerance enforcement consists of the parent and its metabolite methyl 2-benzimidazoyl carbamate based on the metabolism of thiophanate-methyl in/on apples, sugar beets, wheat, lima beans, and in ruminants and poultry.

EPA no longer considers dry apple pomace, banana pulp, bean forage and hay, and peanut forage to be significant animal feed items, and therefore, tolerances are no longer needed. (A listing of significant food and feed commodities is found in Table 1. - Raw Agricultural and Processed Commodities and Feedstuffs Derived from Crops of the Residue Chemistry Test Guideline OPPTS 860.1000 dated August 1996, available at http://www.epa.gov/​opptsfrs/​publications/​OPPTS_​Harmonized/​860_​Residue_​Chemistry_​Test_​Guidelines/​Series/​). Currently, there is a tolerance in 40 CFR 180.371 on peanut (forage and hay). Based on field trial data that show thiophanate-methyl residues of concern as high as 3.76 ppm, the Agency determined that the tolerance on peanut hay should be decreased from 15.0 to 5.0 ppm. In addition, thiophanate-methyl registrations were approved by EPA to be amended to delete use on celery by request of the registrant in 1997. Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.371(a) on apple, dry pomace; banana, pulp; bean (forage and hay), and celery, and revise the commodity terminology from peanut (forage and hay) into separate tolerances for peanut, forage and peanut, hay, and revoke peanut forage, and decrease peanut, hay from 15.0 to 5.0 ppm.

Based on available exaggerated (10x) poultry feeding data, EPA determined that there is no reasonable expectation of finite thiophanate-methyl residues of concern in poultry commodities and therefore, the tolerance for egg (the only existing poultry commodity tolerance) is no longer needed under 40 CFR 180.6(a)(3). Therefore, EPA is proposing to revoke the tolerance in 40 CFR 180.371 for egg.

Based on the available ruminant feeding study, the Agency determined that thiophanate-methyl residues of concern in milk and animal tissues were at the combined Limit of Quantitions (LOQs) and therefore the tolerances for the fat and meat of cattle, goat, horse, and sheep should be increased from 0.10 (N) to 0.15 ppm, meat byproducts, except kidney and liver of cattle, goat, and sheep should be increased from 0.10 (N) to 0.15 ppm, meat byproducts, except liver of horse should be increased from 0.10 (N) to 0.15 ppm, and kidney of cattle, goat, and sheep should be decreased from 0.2 to 0.15 ppm, and therefore the separate meat byproduct tolerances should be combined at 0.15 ppm for cattle, goat, horse, and sheep, and milk from 1.0 to 0.15 ppm, and milk decreased from 1.0 to 0.15 ppm. Consequently, EPA is proposing to remove the “(N)” designation from all entries in 40 CFR 180.371 to conform to current Agency administrative practice (“(N)” designation means negligible residues), and to increase the tolerances in 40 CFR 180.371 for the combined residues of thophanate-methyl and methyl 2-benzimidazoyl carbamate in or on cattle, fat; cattle, meat; goat, fat; goat, meat; horse, fat; horse, meat; sheep, fat; and sheep, meat from 0.1(N) to 0.15 ppm, and remove individual meat byproduct commodity tolerances of a given animal and combine them into a single tolerance for meat byproducts for that animal in 40 CFR 180.371 for the combined residues of thiophanate-methyl and methyl 2-benzimidazoyl carbamate in or on the cattle, meat byproducts; goat, meat byproducts; horse, meat byproducts; and sheep, meat byproducts at 0.15 ppm, and decrease milk from from 1.0 to 0.15 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 show thiophanate-methyl residues of concern as high as 16.25 ppm in or on tart and sweet cherries, 6.22 ppm on strawberries, less than the LOQ (<0.1 ppm) on wheat, the Agency determined that the tolerances should be increased on cherries from 15.0 to 20.0 ppm, on strawberries from 5.0 to 7.0 ppm, and on wheat grain from 0.05 to 0.1 ppm. Therefore, EPA is proposing to increase the tolerances in 40 CFR 180.371(a) for the combined residues of thiophanate-methyl and methyl 2-benzimidazoyl carbamate in or on cherry, postharvest from 15.0 to 20.0 ppm, strawberry from 5.0 to 7.0 ppm, and on wheat, grain from 0.05 to 0.1 ppm. The Agency determined that the increased tolerances are safe; i.e. there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

Crop field trials conducted in North Dakota on canola seed samples in 2001 demonstrate the combined residues thiophanate-methyl and methyl 2-benzimidazoyl carbamate were below the LOQ (<0.14 ppm) at the 1x rate of application (1.4 lb ai/acre) after 38 days. These data indicate the tolerance on canola seeds should be increased from 0.1 to 0.2 ppm with a regional registration restricted to Minnesota, North Dakota, and Montana (East of Interstate 15). Therefore, EPA is proposing to increase a tolerance in 40 CFR 180.371(c) for the combined residues of thiophanate-methyl and methyl 2-benzimidazoyl carbamate in or on canola, seed from 0.1 to 0.2 ppm. The Agency determined that the increased tolerance is safe; i.e. there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

Based on available field trial data that indicates that thiophanate-methyl residues of concern were less than 2.0 ppm in or on apples, less than the combined LOQs (<0.1 ppm each) in or on almond nutmeat and as high as 0.49 ppm in or on almond hulls, <0.1 ppm in or on pecans and peanut nutmeat, as high as 0.19 ppm in or on dry beans (as high as 1.43 on snap beans), as high as 2.55 ppm in or on peaches, and less than 0.5 ppm in or on plums, the Agency determined that established Start Printed Page 54959tolerances for thiophanate-methyl and methyl 2-benzimidazoyl carbamate should be decreased for apples; almonds; almond, hulls; dry beans, peaches, peanuts, pecans, and plums. Therefore, EPA is proposing to decrease the tolerances in 40 CFR 180.371(a) for the combined residues of thiophanate-methyl and methyl 2-benzimidazoyl carbamate in or on apple, postharvest from 7.0 to 2.0 ppm; almond from 0.2(N) to 0.1 ppm; almond, hulls from 1.0 to 0.5 ppm; dry beans from 2.0 to 0.2 ppm, and revise the commodity terminology from bean (snap and dry) to bean, dry, seed at 0.2 ppm and bean, snap, succulent (which will be maintained at 2.0 ppm); peach, postharvest from 15.0 to 3.0 ppm; peanut from 0.2(N) to 0.1 ppm; pecans from 0.2 to 0.1 ppm, and revise the commodity terminology from pecans to pecan; and plum, postharvest from 15.0 to 0.5 ppm.

In accordance with 40 CFR 180.1(h), residues in or on nectarines are covered by the reassessed tolerance on peaches, and therefore the tolerance on postharvest nectarines is no longer needed. Therefore, EPA is proposing to remove the tolerance in 40 CFR 180.371(a) on nectarine, postharvest.

Based on plum processing data from plums treated at 10x that show thiophanate-methyl residues of concern do not concentrate in prunes, the Agency determined that the tolerance on plum, prune, postharvest is no longer needed since residues in or on prunes would be covered by the reassessed tolerance on plum, postharvest at 0.5 ppm. Therefore, EPA is proposing to remove the tolerance in 40 CFR 180.371(a) on plum, prune, postharvest.

Based on field trial data that show thiophanate-methyl residues of concern in or on dry bulb onions as high as 0.30 ppm, the Agency determined that the tolerance for onion, dry should be decreased from 3.00 to 0.5 ppm and residues on garlic are covered by the bulb onion tolerance in accordance with 40 CFR 180.1(h). EPA is proposing to decrease the tolerance in 40 CFR 180.371 for the combined residues of thiophanate-methyl and methyl 2-benzimidazoyl carbamate in or on onion, dry from 3.00 to 0.5 ppm, and revise the term to onion, bulb.

Based upon a HAFT residue level of 0.2 ppm in or on soybeans and the observed 6.5x concentration factor for hulls, the Agency determined that a separate tolerance should be established on soybean hulls at 1.5 ppm. Therefore, EPA is proposing to establish a tolerance in 40 CFR 180.371(a) for the combined residues of thiophanate-methyl and methyl 2-benzimidazoyl carbamate in or on soybean, hulls at 1.5 ppm.

The available field trial residue data in or on cucumbers, melons, pumpkins, and squash are adequate to support a cucurbit vegetable group tolerance at 1.0 ppm. Because a crop group tolerance covers all of the cucurbit vegetables, individual tolerances are no longer needed. Therefore, EPA is proposing in 40 CFR 180.371(a) to remove the individual tolerances on cucumber, melon, pumpkin, and squash at 1.0 ppm and combine them into a crop group tolerance on vegetable, cucurbit, group 9 at 1.0 ppm.

EPA is proposing to revise commodity terminology in 40 CFR 180.371(a) to conform to current Agency practice as follows: “Sugar beet, roots” to “beet, sugar, roots;” “sugar beet, tops” to “beet, sugar, tops;” “soybean” to “soybean, seed;” and “sugarcane, seed piece treatment PRE-H” to “sugarcane, seed piece treatment” and in 40 CFR 180.371(b) from “cotton” to “cotton, undelinted seed.”

The Agency will address the tolerance in § 180.371 on sugarcane, seed piece treatment in a future Federal Register notice.

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 (RACs) 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 RACs 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 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 was required to determine whether each of the amended tolerances meets the safety standard of the FQPA. The safety finding determination 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 pebulate and thiophanate-methyl and TREDs for chlorpropham, linuron, and asulam, which had REDs completed prior to FQPA. REDs and TREDs contain the Agency's evaluation of the data base for these pesticides, including requirements for additional data on the active ingredients to confirm the potential human health and environmental risk assessments associated with current product uses, and in REDs state conditions under which these uses and products will be eligible for reregistration. The REDs and TREDs recommended the establishment, modification, and/or revocation of specific tolerances. RED and TRED recommendations such as establishing or modifying tolerances, and in some cases revoking tolerances, are the result of assessment under the FQPA standard of “reasonable certainty of no harm.” However, tolerance revocations recommended in REDs and TREDs that are 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. 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 Start Printed Page 54960imported 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.

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

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

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

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

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

C. When do These Actions Become Effective?

EPA is proposing that these revocations, modifications, establishment of tolerances, and commodity terminology revisions become effective on the date of publication of the final rule in the Federal Register. For this rule, proposed revocations will affect tolerances for uses which have been canceled for many years or are no longer needed. The Agency believes that treated commodities have had sufficient time for passage through the channels of trade. However, if EPA is presented with information that existing stocks would still be available and that information is verified, the Agency will consider extending the expiration date of the tolerance. If you have comments regarding existing stocks and whether the effective date allows sufficient time for treated commodities to clear the channels of trade, please submit comments as described under SUPPLEMENTARY INFORMATION.

Any commodities listed in this proposal treated with the pesticides subject to this proposal, and in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by FQPA. Under this section, any residues of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration that:

1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA.

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.

D. What is the Contribution to Tolerance Reassessment?

By law, EPA was required by August 3, 2006, to reassess the tolerances in existence on August 2, 1996. Regarding tolerances mentioned in this proposed rule, tolerances in existence as of August 2, 1996, were previously counted as reassessed at the time of the signature completion of a Post-FQPA RED or TRED for each active ingredient. Therefore, no further tolerance reassessments would be counted toward the August 2006 review deadline.

III. Are the Proposed Actions Consistent with International Obligations?

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

The tolerance action in the proposal apply equally to domestically-produced and import foods. In making its tolerance decisions, the Agency seeks to harmonize 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 Alimentarium Comission, as required by section 408(b)(4) of the Federal Food, Drug, and Cosmetic Act. The Codex Alimentarium is a joint UN food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safty standards-setting organization in trade agreements to which the United States is a party. EPA also considers MRLs established in Canada and Mexico.

EPA's effort to harmonize MRLs is summarized in the tolerance reassessment section of individual RED documents. EPA has developed guidance concerning submissions for import tolerance support (June 1, 2000, 65 FR 35069) (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.

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. Start Printed Page 54961The Office of Management and Budget (OMB) has exempted these types of actions (i.e., establishment and modification of a tolerance and tolerance revocation for which extraordinary circumstances do not exist) from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this 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 EPA's previous analysis. Any comments about the Agency's determination should be submitted to 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.

Start List of Subjects

List of Subjects in 40 CFR Part 180

End List of Subjects Start Signature

Dated: August 29, 2006.

James Jones,

Director, Office of Pesticide Programs.

End Signature

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

Start Part

PART 180

—[AMENDED]End Part

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

Start Authority

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

End Authority

2. In § 180.181 the section heading and paragraph (a) are revised to read as follows:

Chlorpropham; tolerances for residues.

(a)(1) General. Tolerances are established for residues of the plant regulator and herbicide chlorpropham (isopropyl m-chlorocarbaniliate (CIPC)) in or on the following food commodities:

CommodityParts per million
Potato, postharvest30
Start Printed Page 54962
Potato, wet peel40

(2) Tolerances are established for the combined residues of the plant regulator and herbicide chlorpropham (isopropyl m-chlorocarbaniliate (CIPC)) and its metabolite 4-hydroxychlorpropham-O-sulfonic acid (4-HSA) in or on the following food commodities:

CommodityParts per million
Cattle, fat0.20
Cattle, kidney0.30
Cattle. meat0.06
Cattle, meat byproducts, except kidney0.06
Goat, fat0.20
Goat, kidney0.30
Goat, meat0.06
Goat, meat byproducts, except kidney0.06
Hog, fat0.20
Hog, kidney0.30
Hog, meat0.06
Hog, meat byproducts, except kidney0.06
Horse, fat0.20
Horse, kidney0.30
Horse, meat0.06
Horse, meat byproducts, except kidney0.06
Milk0.3
Sheep, fat0.20
Sheep, kidney0.30
Sheep, meat0.06
Sheep, meat byproducts, except kidney0.06
* * * * *

3. In § 180.184 paragraphs (a) and (c) are revised to read as follows:

Linuron; tolerances for residues.

(a) General. Tolerances are established for the combined residues of the herbicide linuron (3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea) and its metabolites convertible to 3,4-dichloroaniline, calculated as linuron, in or on the following food commodities:

CommodityParts per million
Asparagus7.0
Carrot, roots1.0
Cattle, fat0.2
Cattle, kidney2.0
Cattle, liver2.0
Cattle, meat0.1
Cattle, meat byproducts, except kidney and liver0.1
Celeriac1.0
Corn, field, forage1.0
Corn, field, grain0.1
Corn, field, stover6.0
Corn, sweet, forage1.0
Corn, sweet, kernel plus cob with husks removed0.25
Corn, sweet, stover1.0
Cotton, gin byproducts5.0
Cotton, undelinted seed0.25
Goat, fat0.2
Goat, kidney2.0
Goat, liver2.0
Goat, meat0.1
Goat, meat byproducts, except kidney and liver0.1
Hog, fat0.05
Hog, meat0.05
Hog, meat byproducts0.1
Horse, fat0.2
Horse, kidney2.0
Horse, liver2.0
Horse, meat0.1
Horse, meat byproducts, except kidney and liver0.1
Milk0.05
Parsnip, roots0.05
Parsnip, tops0.05
Start Printed Page 54963
Rhubarb0.5
Sheep, fat0.2
Sheep, kidney2.0
Sheep, liver2.0
Sheep, meat0.1
Sheep, meat byproducts, except kidney and liver0.1
Sorghum, grain, forage1.0
Sorghum, grain, grain0.25
Sorghum, grain, stover1.0
Soybean, seed1.0
Soybean, vegetable1.0
* * * * *

(c) Tolerances with regional registrations. Tolerances with regional registrations, as defined in § 180.1(n), are established for the combined residues of the herbicide linuron (3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea) and its metabolites convertible to 3,4-dichloroaniline, calculated as linuron, in or on the following food commodities:

CommodityParts per million
Celery0.5
Parsley, leaves0.25
Potato0.2
Wheat, forage0.5
Wheat, grain0.05
Wheat, hay0.5
Wheat, straw2.0
* * * * *
[Amended]

4. Section 180.238 is removed.

[Amended]

5. Section 180.319 is amended by removing from the table the entry for isopropyl m-chlorocarbanilate (CIPC).

6 In § 180.360 paragraph (a) is revised to read as follows:

Asulam; tolerances for residues.

(a) General. Tolerances are established for the combined residues of asulam (methyl sulfanilylcarbamate) and its metabolites containing the sulfanilamide moiety in or on the following food commodities:

CommodityParts per million
Cattle, fat0.05
Cattle, meat0.05
Cattle, meat byproducts0.2
Goat, fat0.05
Goat, meat0.05
Goat, meat byproducts0.2
Hog, fat0.05
Hog, meat0.05
Hog, meat byproducts0.2
Horse, fat0.05
Horse, meat0.05
Horse, meat byproducts0.2
Milk0.05
Sheep, fat0.05
Sheep, meat0.05
Sheep, meat byproducts0.2
Sugarcane, cane1.0
Sugarcane, molasses30
* * * * *

7 In § 180.371 paragraphs (a), (b), and (c) are revised to read as follows:

Thiophanate-methyl; tolerances for residues.

(a) General. Tolerances are established for the combined residues of thiophanate-methyl (dimethyl [(1,2-phenylene) bis (iminocarbonothioyl)] bis(carbamate)) and its metabolite methyl 2-benzimidazoyl carbamate, calculated as thiophanate-methyl in or on the following commodities:

CommodityParts per million
Almond0.1
Almond, hulls0.5
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Apple, postharvest2.0
Apricot, postharvest15.0
Banana2.0
Bean, dry, seed0.2
Bean, snap, succulent2.0
Beet, sugar, roots0.2
Beet, sugar, tops15.0
Cattle, fat0.15
Cattle, meat0.15
Cattle, meat byproducts0.15
Cherry, postharvest20.0
Goat, fat0.15
Goat, meat0.15
Goat, meat byproducts0.15
Grape5.0
Horse, fat0.15
Horse, meat0.15
Horse, meat byproducts0.15
Milk1.5
Onion, bulb0.5
Onion, green3.0
Peach, postharvest3.0
Peanut0.1
Peanut, hay5.0
Pecan0.1
Pistachio0.1
Pear3.0
Plum, postharvest0.5
Potato0.1
Sheep, fat0.15
Sheep, meat0.15
Sheep, meat byproducts0.15
Soybean, seed0.2
Soybean, hulls1.5
Strawberry7.0
Sugarcane, seed piece treatment0.1
Vegetable, cucurbit, group 91.0
Wheat, grain0.1
Wheat, hay0.1
Wheat, straw0.1

(b) Section 18 emergency exemptions. Time-limited tolerances are established for the combined residues of thiophanate-methyl (dimethyl [(1,2-phenylene) bis (iminocarbonothioyl)] bis(carbamate)) and its metabolite methyl 2-benzimidazoyl carbamate, calculated as thiophanate-methyl, in or on the following commodities:

CommodityParts per millionExpiration/revocation date
Blueberry1.56/30/07
Citrus0.56/30/07
Cotton, gin byproducts5.012/31/07
Cotton, undelinted seed0.0512/31/07
Mushroom0.0112/31/07
Vegetable, fruiting, group 80.512/31/08

(c) Tolerances with regional registrations. Tolerances with regional registration, as defined in 180.1(n), are established for the combined residues of thiophanate-methyl (dimethyl [(1,2-phenylene) bis (iminocarbonothioyl)] bis(carbamate)) and its metabolite methyl 2-benzimidazoyl carbamate, calculated as thiophanate-methyl, in or on the following commodities:

CommodityParts per million
Canola, seed0.2
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* * * * *
End Supplemental Information

[FR Doc. E6-15471 Filed 9-19-06; 8:45 am]

BILLING CODE 6560-50-S