Proposed Tolerance Actions: Mancozeb, Maneb, Metiram, and Thiram

Federal Register: September 16, 2009 (Volume 74, Number 178)

Proposed Rules

Page 47507-47517

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

DOCID:fr16se09-17

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180

EPA-HQ-OPP-2009-0431; FRL-8431-4

Mancozeb, Maneb, Metiram, and Thiram; Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to revoke certain tolerances for the fungicides mancozeb and maneb. Also, EPA is proposing to modify certain tolerances for the fungicides mancozeb, maneb, metiram, and thiram. In addition, EPA is proposing to establish new tolerances for the fungicides mancozeb, maneb, and metiram. 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 November 16, 2009.

ADDRESSES: Submit your comments, identified by docket identification

(ID) number EPA-HQ-OPP-2009-0431, 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 Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays).

Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

Instructions: Direct your comments to docket ID number EPA-HQ-OPP- 2009-0431. 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 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 at http://www.regulations.gov. 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 Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Pesticide Re-evaluation

Division (7508P), Office of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460- 0001; telephone number: (703) 308-8037; e-mail address: nevola.joseph@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. Does this Action Apply to Me?

      You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer.

      Potentially

      Page 47508

      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.

   2. 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.

   3. 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 timeframes 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 proposed rule, you may also submit an objection at the time of the final rule. If you fail to file an objection to the final rule within the time period specified, you will have waived the right to raise any issues resolved in the final rule.

      After the specified time, issues resolved in the final rule cannot be raised again in any subsequent proceedings.

2. Background

   1. What Action is the Agency Taking?

   EPA is proposing to revoke, modify, and establish specific tolerances for residues of the fungicides mancozeb, maneb, metiram, and thiram 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 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 number: 1-800-490- 9198; fax number: 1-513-489-8695; Internet at http://www.epa.gov/ ncepihom and from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161; telephone number: 1-800- 553-6847 or (703) 605-6000; Internet at http://www.ntis.gov. Electronic copies of REDs and TREDs are available on the Internet in public dockets; REDs for mancozeb (EPA-HQ-OPP-2005-0176), maneb (EPA-HQ-OPP- 2005-0178), metiram (EPA-HQ-OPP-2005-0177), and thiram (EPA-HQ-OPP- 2004-0183), at http://www.regulations.gov and also at http:// www.epa.gov/pesticides/reregistration/status.htm.

   The selection of an individual tolerance level is based on crop field residue studies designed to produce the maximum residues under the existing or proposed product label. Generally, the level selected for a tolerance is a value slightly above the maximum residue found in such studies, provided that the tolerance is safe. The evaluation of whether a tolerance is safe is a separate inquiry. EPA recommends the raising of a tolerance when data show that: 1. Lawful use (sometimes through a label change) may result in a higher residue level on the commodity. 2. The tolerance remains safe, notwithstanding increased residue level allowed under the tolerance.

   In REDs, Chapter IV on ``Risk management, Reregistration, and Tolerance reassessment'' typically describes the regulatory position, FQPA assessment, cumulative safety determination, determination of safety for U.S. general population, and safety for infants and children. In particular,

   Page 47509

   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 and exemptions and/or establishments of tolerances and exemptions for mancozeb, maneb, metiram, and thiram 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 electronic copies for mancozeb, maneb, and metiram can be found under their respective public docket ID numbers, identified in Unit II.A.

   Electronic copies of support documents for thiram are available in public docket EPA-HQ-OPP-2004-0183. An electronic copy of the Residue

   Chemistry Chapter for thiram is available in the public docket for this proposed 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 this proposed rule under docket

   ID number EPA-HQ-OPP-2009-0431, then click on that docket ID 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 legally treated domestic commodities. 1. Mancozeb. Currently, tolerances for mancozeb are established in 40 CFR 180.176(a) for residues of the fungicide mancozeb, a coordination product of zinc ion and maneb (manganese ethylenebisdithiocarbamate) and calculated as zinc ethylenebisdithiocarbamate (zineb). Mancozeb is a member of the class of dithiocarbamates, whose decomposition releases carbon disulfide

   (CS2). In order to allow harmonization of U.S. tolerances with Codex

   Maximum Residue Limits (MRLs), the Agency determined that for the purpose of tolerance enforcement, residues of mancozeb should be calculated as carbon disulfide. Therefore, EPA is proposing to revise the introductory text containing the tolerance expression in 40 CFR 180.176(a) to read as follows:

   Tolerances are established for residues of mancozeb (a coordination product of zinc ion and maneb (manganese ethylenebisdithiocarbamate)), including its metabolites and degradates, in or on the commodities in the table in this paragraph.

   Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only those mancozeb residues convertible to and expressed in terms of the degradate carbon disulfide.

   Also, the Agency determined that the change in tolerance expression should also apply to the other dithiocarbamates that are determined by the carbon disulfide common moiety and have current tolerances. (That document is available in the docket for this proposed rule). Currently, according to 40 CFR 180.3(d)(5), total dithiocarbamate residue on the same raw agricultural commodity shall not exceed that permitted by the highest tolerance for any one member of the class, calculated as zinc ethylenebisdithiocarbamate (zineb). Therefore, in the interim, until all tolerance expressions can be changed for dithiocarbamates with the carbon disulfide moiety and current tolerances, EPA is proposing to revise the text in 40 CFR 180.3(d)(5) by adding carbon disulfide as part of the calculated residues, to read as follows:

   Where tolerances are established for more than one member of the class of dithiocarbamates listed in paragraph (e)(3) of this section on the same raw agricultural commodity, the total residue of such pesticides shall not exceed that permitted by the highest tolerance established for any one member of the class, calculated as zinc ethylenebisdithiocarbamate and carbon disulfide.

   Oat bran is no longer considered to be a significant food/feed item by the Agency, and therefore is no longer regulated as a commodity in accordance with ``Table 1. Raw Agricultural and Processed Commodities and Feedstuffs Derived from Crops,'' which is found in Residue

   Chemistry Test Guidelines OPPTS 860.1000 dated August 1996, available at http://www.epa.gov/opptsfrs/home/guidelin.htm; consequently, the

   Agency has determined that the tolerance for mancozeb on oat, bran at 20 ppm is no longer needed. Therefore, EPA is proposing to revoke the tolerance in 40 CFR 180.176(a) on oat, bran.

   Based on available field trial data that showed mancozeb residues on apples as high as 0.55 parts per million (ppm) and on pears as high as 0.13 ppm (for a pre-bloom treatment schedule), and 0.65 ppm (for an extended treatment schedule), EPA determined that the tolerances should be decreased from 7.0 ppm and 10.0 ppm, respectively, to 1 ppm, which when converted to carbon disulfide equivalents using a rounded conversion factor of 0.6X (based on relative molecular weights) is calculated as 0.6 ppm. The Agency determined that data for apple should be translated to crabapple because the registered use patterns

   (application method, maximal single application rate, maximal seasonal rate, and preharvest interval) associated with given formulations for mancozeb are identical for crabapple and apple, and data for pear should be translated to quince because the registered use patterns associated with given formulations for mancozeb are identical for quince and pear, and therefore the tolerances on crabapple and quince should each be decreased from 10.0 ppm to 0.6 ppm. Consequently, EPA is proposing to decrease the tolerances in 40 CFR 180.176(a) on apple, crabapple, pear, and quince, each to 0.6 ppm.

   Based on available field trial data that showed mancozeb residues as high as

   Page 47510

   1.0 ppm in or on bananas harvested 0 days following the last foliar application at 1.3X the maximum single application rate and for bagged and unbagged bananas as high as 0.13 ppm and 1.18 ppm, respectively, on whole banana fruit including peel harvested 0 days following the last foliar application at 1X the maximum single application rate, and to harmonize with a Codex MRL of 2 expressed as milligrams (mg) carbon disulfide/kilogram (kg) for dithiocarbamates, EPA determined that the tolerance should be decreased from 4.0 ppm to 2 ppm. Therefore, EPA is proposing to decrease the tolerance in 40 CFR 180.176(a) on banana to 2 ppm. In addition, because banana pulp is covered by the tolerance for banana at the proposed level, a separate tolerance for the obsolete commodity term banana, pulp is no longer needed and should be revoked.

   Consequently, EPA is proposing to revoke the tolerance in 40 CFR 180.176(a) on banana, pulp.

   Based on available field trial data that showed mancozeb residues as high as 1.5 ppm and 99.5 ppm for sugar beet roots and tops, respectively, EPA determined that tolerances should be set at 2 ppm and 100 ppm, respectively, which when converted to carbon disulfide equivalents using a rounded conversion factor of 0.6X are calculated as 1.2 ppm and 60 ppm, respectively. Also, based on available processing data that showed mancozeb residues concentrated 3X in sugar beet dried pulp and a highest average field trial (HAFT) of