Proposed Tolerance Actions: Ametryn, Amitraz, Ammonium Soap Salts of Higher Fatty Acids, Bitertanol, Coppers, et al.

Federal Register: May 13, 2009 (Volume 74, Number 91)

Proposed Rules

Page 22478-22490

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

DOCID:fr13my09-16

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180

EPA-HQ-OPP-2009-0251; FRL-8412-3

Ametryn, Amitraz, Ammonium Soap Salts of Higher Fatty Acids

(C8-C18saturated; C8-C12 unsaturated), Bitertanol, Coppers, et al.; Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to revoke certain tolerances/tolerance exemptions for the fungicides pentachloronitrobenzene and triadimenol, the herbicides ametryn, fluazifop-P-butyl, and prometryn; the insecticides amitraz and mineral oil; the defoliant/desiccant sodium chlorate; and the fungicide/algicide/herbicide coppers. Also, EPA is proposing to modify certain tolerances for the fungicide bitertanol and the insecticide malathion. In addition, EPA is proposing to establish new tolerances/tolerance exemptions for the fungicides coppers and pentachloronitrobenzene; the herbicide prometryn; the insecticide malathion; and the defoliant/desiccant sodium chlorate; and revise the tolerance expression for the ammonium salts of higher fatty acids

(ammonium soap salts). 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 13, 2009.

ADDRESSES: Submit your comments, identified by docket identification

(ID) number EPA-HQ-OPP-2009-0251, 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

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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- 2009-0251. 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, Special Review and

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

Environmental Protection Agency, 1200 Pennsylvania Ave, NW.,

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

SUPPLEMENTARY INFORMATION:

1. General Information

   1. Does this Action Apply to Me?

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

      Potentially affected entities may include, but are not limited to:

      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 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

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      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/tolerance exemptions for residues of the fungicides bitertanol, pentachloronitrobenzene, and triadimenol; the herbicides ametryn, fluazifop-P-butyl, and prometryn; the insecticides amitraz, malathion, and mineral oil; the defoliant/desiccant sodium chlorate; and the fungicide/algicide/herbicide coppers; and revise the tolerance expression for the ammonium salts of higher fatty acids (ammonium soap salts) 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 ametryn (EPA-HQ-OPP-2004-0411), coppers (EPA-HQ-OPP- 2005-0558), malathion (EPA-HQ-OPP-2004-0348), aliphatic solvents

   (mineral oil) (EPA-HQ-OPP-2006-0284), pentachloronitrobenzene (EPA-HQ-

   OPP-2004-0202), and inorganic chlorates (sodium chlorate)(EPA-HQ-OPP- 2005-0507), and TREDs for amitraz (EPA-HQ-OPP-2004-0048), bitertanol

   (EPA-HQ-OPP-2005-0491), fluazifop-P-butyl (EPA-HQ-OPP-2004-0347), and triadimenol (EPA-HQ-OPP-2006-0038), at http://www.regulations.gov and

   REDs for soap salts (includes ammonium salts of higher fatty acids) and prometryn 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:

   Lawful use (sometimes through a label change) may result in a higher residue level on the commodity.

   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 and exemptions and/or establishments of tolerances and exemptions for bitertanol, coppers, malathion, pentachloronitrobenzene, prometryn, and sodium chlorate 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 bitertanol, coppers (included in revised Human Health Chapter), malathion, pentachloronitrobenzene, and sodium chlorate (included in the HED

   Chapter of the RED) can be found under their respective public docket

   ID numbers, identified in Unit II.A. Electronic copies of support documents for soap salts (including the revised Human Health Assessment

   Scoping Document in Support of Registration Review) are available in public docket EPA-HQ-OPP-2008-0519. An electronic copy of the Residue

   Chemistry Chapter for prometryn 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-2009-0251, 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.

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   1. Ametryn. In the Federal Register notice of December 19, 2007 (72

   FR 71898) (FRL-8343-9), EPA issued a notice regarding EPA's announcement on the receipt of requests from the registrant to voluntarily cancel specific registrations, which would terminate the last ametryn uses for banana and sweet corn. EPA approved cancellation of the registration by issuing a cancellation order with the close of the comment period, made it effective on June 16, 2008, and permitted the registrant for the canceled registration to sell and distribute existing stocks until June 16, 2009. Also, EPA permitted persons other than the registrant to sell, distribute, and conforming to the EPA- approved label and labeling of the products, use existing ametryn pesticide stocks on banana and sweet corn until they are exhausted. The

   Agency believes that end users will have had sufficient time to exhaust those existing stocks and for ametryn treated banana and sweet corn commodities to have cleared the channels of trade by June 16, 2010.

   Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.258(a) on banana; corn, sweet, forage; corn, sweet, kernel plus cob with husks removed; and corn, sweet, stover; each with an expiration/ revocation date of June 16, 2010.

   There are no Codex Maximum Residue Limits (MRLs) for ametryn. 2. Amitraz. EPA approved cancellation of the last registration for use of amitraz on pears by issuing a cancellation order on May 3, 2006

   (71 FR 26083) (FRL-8059-5), and permitted the registrants for the canceled registrations to sell and distribute existing stocks for 18 months (i.e., until November 3, 2007). Also, EPA permitted persons other than the registrant to sell, distribute, and conforming to the

   EPA-approved label and labeling of the products, use existing amitraz pesticide stocks on pears until they are exhausted. The Agency believes that end users have had sufficient time to exhaust those existing stocks and for amitraz treated pear commodities to have cleared the channels of trade. Therefore, EPA is proposing to revoke the tolerance in 40 CFR 180.287(a) on pear.

   There are Codex MRLs for amitraz, including one on pome fruits at 0.5 milligrams/kilogram (mg/kg). 3. Ammonium salts of higher fatty acids (C8-

   C18saturated; C8-C12unsaturated).

   Currently, there is an exemption from a tolerance in 40 CFR 180.1284 for ammonium salts of higher fatty acids (C8-C18 saturated; C8-C12unsaturated) residues in or on all food commodities when applied for the suppression and control of a wide variety of grasses and weeds. However, since 1993, there are existing product labels for the ammonium salts with instructions for use in agricultural settings as a deer repellent to growing crops and orchards with fruit present. Ammonium salts of fatty acids (ammonium soap salts) have low acute toxicity by oral, dermal, or inhalation routes of exposure. Due to the lack of effects at high doses in the available studies, the nature of the fatty acids and their ubiquity in nature, and the unlikelihood of prolonged human exposure via the oral route due to the use patterns, the Agency continues to believe that it is appropriate to waive all generic mammalian toxicity data requirements for the soap salts. Therefore, the Agency determined that the introductory text in 40 CFR 180.1284 should be revised from its current form where it is limited to herbicide uses to be broad enough to cover all the use patterns that exist for currently registered products. Consequently, EPA is proposing to revise the introductory text containing the tolerance expression in 40 CFR 180.1284 to read as follows: ``Ammonium salts of C8-C18saturated and

   C8-C12unsaturated higher fatty acids are exempted from the requirement of a tolerance for residues in or on all food commodities when used in accordance with good agricultural practice.''

   There are no Codex MRLs for soap salts, including ammonium soap salts. 4. Bitertanol, [beta]-((1,1''-biphenyl)-4-yloxy)-[alpha]-(1,1- dimethylethyl)-1H-1,2,4-triazole-1-ethanol. There have been no U.S. registrations for bitertanol, a fungicide, since 1992. Based on available foreign data that showed residues of bitertanol, [beta]-

   ((1,1''-biphenyl)-4-yloxy)-[alpha]-(1,1-dimethylethyl)-1H-1,2,4- triazole-1-ethanol, as high as 0.76 parts per million (ppm) in or on the green peel and 0.36 ppm in or on the green fruit of treated unbagged bananas (washed and unwashed samples) at an exaggerated application rate of 2X (0.26 lb active ingredient per acre per application) the current application rate, the Agency believes residues would be as high as 0.38 ppm at the current application rate (0.13 pounds active ingredient per acre per application). Although intended for use on bagged bananas (where residues were 8-

   C18saturated; C8-C12unsaturated); exemption from the requirement of a tolerance.

   Ammonium salts of C8-C18saturated and

   C8-C12unsaturated higher fatty acids are exempted from the requirement of a tolerance for residues in or on all food commodities when used in accordance with good agricultural practice.

   FR Doc. E9-11172 Filed 5-12-09; 8:45 am

   BILLING CODE 6560-50-S