Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Bromoxynil, diclofop-methyl, dicofol, diquat, etridiazole, et al.,

[Federal Register: August 4, 2004 (Volume 69, Number 149)]

[Proposed Rules]

[Page 47051-47068]

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

[DOCID:fr04au04-28]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0154; FRL-7368-7]

Bromoxynil, Diclofop-methyl, Dicofol, Diquat, Etridiazole, et al.; Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to revoke certain tolerances for the herbicides bromoxynil, diclofop-methyl, and paraquat; the fungicides etridiazole (terrazole) and iprodione; the miticides dicofol and propargite; and the plant growth regulator and herbicide diquat. Also, EPA is proposing to remove duplicate tolerances for the herbicides bromoxynil and picloram; the fumigant phosphine; the fungicide iprodione; the miticides dicofol and propargite; and the insecticides fenbutatin-oxide and hydramethylnon. In addition, EPA is proposing to modify certain tolerances for the insecticide hydramethylnon; the herbicides bromoxynil, paraquat, and triclopyr; the fungicides etridiazole, folpet, iprodione, and triphenyltin hydroxide (TPTH); the miticides dicofol and propargite; and the plant growth regulator and herbicide diquat. Moreover, EPA is proposing to establish new tolerances for the herbicides bromoxynil, paraquat, and picloram; the fungicides etridiazole, folpet, and TPTH; the miticides dicofol and propargite; the insecticide fenbutatin-oxide; and the plant growth regulator and herbicide diquat. The regulatory actions proposed in this document are part of the Agency's reregistration program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the tolerance reassessment requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q), as amended by the Food Quality Protection Act (FQPA) of 1996. By law, EPA is required by August 2006 to reassess the tolerances in existence on August 2, 1996. No tolerance reassessments will be counted at the time of a final rule because tolerances in existence at FQPA that are associated with actions proposed herein were previously counted as reassessed at the time of the completed Registration Eligibility Decision (RED), Report on FQPA Tolerance Reassessment Progress and Interim Risk Management Decision (TRED), or Federal Register action.

DATES: Comments must be received on or before October 4, 2004.

ADDRESSES: Submit your comments, identified by docket ID number OPP- 2004-0154, by one of the following methods:

Federal eRulemaking Portal: http://www.regulations.gov/.

Follow the on-line instructions for submitting comments.

Agency Website: http://www.epa.gov/edocket/. EDOCKET,

EPA's electronic public docket and comment system, is EPA's preferred method for receiving comments. Follow

[[Page 47052]]

the on-line instructions for submitting comments.

E-mail: Comments may be sent by e-mail to opp-docket@epa.gov, Attention: Docket ID Number OPP-2004-0154.

Mail: Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001, Attention: Docket ID Number OPP-2004-0154.

Hand Delivery: Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1801 South Bell St., Arlington, VA, Attention: Docket ID Number OPP-2004-0154. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

Instructions: Direct your comments to docket ID number OPP-2004- 0154. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.epa.gov/edocket/, 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 EDOCKET, regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov websites are ``anonymous access'' systems, 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 EDOCKET or regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public 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. For additional information about EPA's public docket visit EDOCKET on-line or see the Federal Register of May 31, 2002 (67 FR 38102) (FRL-7181-7).

Docket: All documents in the docket are listed in the EDOCKET index at http://www.epa.gov/edocket/. Although listed in the index, some

information is not publicly available, i.e., 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 electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 South Bell St., Arlington, VA. This Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Special Review and Reregistration Division (7508C), 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 111)

      Animal production (NAICS 112)

      Food manufacturing (NAICS 311)

      Pesticide manufacturing (NAICS 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 IIA. 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. How Can I Access Electronic Copies of This Document and Other Related Information?

      In addition to using EDOCKET (http://www.epa.gov/edocket/), you may

      access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180

      is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

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

      Submitting CBI. Do not submit this information to EPA through EDOCKET, 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.

      Tips for preparing your comments. When submitting comments, remember to:

      i. Identify the rulemaking by docket 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.

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   4. What Can I do if I Wish the Agency to Maintain a Tolerance That the Agency Proposes to Revoke?

      This proposed rule provides a comment period of 60 days for any person to state an interest in retaining a tolerance proposed for revocation. If EPA receives a comment within the 60-day period to that effect, EPA will not proceed to revoke the tolerance immediately. However, EPA will take steps to ensure the submission of any needed supporting data and will issue an order in the Federal Register under FFDCA section 408(f) if needed. The order would specify data needed and the time frames for its submission, and would require that within 90 days some person or persons notify EPA that they will submit the data. If the data are not submitted as required in the order, EPA will take appropriate action under FFDCA.

      EPA issues a final rule after considering comments that are submitted in response to this proposed rule. In addition to submitting comments in response to this proposal, you may also submit an objection at the time of the final rule. If you fail to file an objection to the final rule within the time period specified, you will have waived the right to raise any issues resolved in the final rule. After the specified time, issues resolved in the final rule cannot be raised again in any subsequent proceedings.

2. Background

   1. What Action is the Agency Taking?

   EPA is proposing to revoke, remove, modify, and establish specific tolerances for residues of the insecticides fenbutatin-oxide and hydramethylnon, the herbicides bromoxynil, diclofop-methyl, paraquat, picloram, and triclopyr; the fumigant phosphine; the fungicides etridiazole, folpet, iprodione, and triphenyltin hydroxide (TPTH); the miticides dicofol and propargite, and the plant growth regulator and herbicide diquat 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 the reregistration and tolerance reassessment processes, EPA is required to determine whether each of the amended tolerances meets the safety standards under the FQPA. The safety finding determination of ``reasonable certainty of no harm'' is found in detail in each RED and Report on FQPA Tolerance Reassessment Progress and Interim Risk Management Decision (TRED) for the active ingredient. REDs and TREDs propose certain tolerance actions to be implemented to reflect current use patterns, to meet safety findings and change commodity names and groupings in accordance with new EPA policy. Printed copies of the 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.

   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 hard copies are available in the public docket for this rule, while electronic copies are available through EPA's electronic public docket and comment system, EPA Dockets at http://www.epa.gov/edocket/. You may search for docket number OPP-2004-0154 then click on

   that docket number to view its contents.

   EPA has determined that the aggregate acute exposure and risk and the aggregate chronic exposure and risk are not of concern for the above mentioned pesticide active ingredients based upon the target data base required for reregistration, the current guidelines for conducting acceptable studies to generate such data, published scientific literature, and the data identified in the RED or TRED which lists the submitted studies that the Agency found acceptable.

   With respect to the tolerances that are proposed in this document to be raised, EPA has found that these tolerances are safe in accordance with FFDCA section 408(b)(2)(A), and 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). These findings are found in detail in each RED. The references are available for inspection as described in this document under SUPPLEMENTARY INFORMATION.

   In addition, EPA is proposing to revoke certain tolerances because these pesticides are not registered under FIFRA for uses on the commodities. The registrations for these pesticide chemicals were canceled 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. Bromoxynil. Because flax straw is no longer a regulated feed item, the tolerance for bromoxynil residue is no longer needed. Therefore, EPA is proposing to revoke the tolerance in 40 CFR 180.324(a)(1) for ``flax, straw.'' Also, EPA is proposing to remove the commodity tolerances in 40 CFR 180.324(a)(1) for residues of bromoxynil in or on ``corn, stover'' which was previously termed corn, fodder (dry) in the RED; ``corn, fodder (green);'' and ``corn, grain'' because these tolerances are no longer needed since their uses are covered by the existing tolerances for corn, field, stover and corn, grain, field. In addition, EPA is proposing to remove the duplicate tolerance for ``corn, field, stover'' because that use is covered by the remaining tolerance for corn, field, stover. Further, based on field trial data that indicate residues of bromoxynil as high as 0.14 ppm in or on corn stover, the Agency determined that the tolerance for corn, field, stover should be increased to 0.2 ppm and a tolerance should be established for corn, pop, stover at 0.2 ppm. Therefore, EPA is also proposing in 40 CFR 180.324(a)(1) to increase the tolerance for ``corn, field, stover'' from 0.1 to 0.2 ppm and establish a tolerance for residues of bromoxynil in or on ``corn, pop, stover'' at 0.2 ppm.

   Because the time-limited tolerances in 40 CFR 180.324(b) for timothy, hay and timothy, forage have expiration/revocation dates that have since passed, EPA is proposing to remove the existing paragraph and table, and reserve the section.

   Based on field trial data that indicate residues of bromoxynil in or on alfalfa hay as high as 0.38 ppm, the Agency determined that the tolerance for alfalfa hay should be increased to 0.5 ppm. Therefore, EPA is proposing to revise the commodity tolerance ``alfalfa, seedling''in 40 CFR 180.324(a)(1) at 0.1

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   parts per million (ppm) to ``alfalfa, forage,'' and ``alfalfa, hay'' and maintain the tolerance for alfalfa, forage at 0.1 ppm, while increasing the tolerance for alfalfa, hay to 0.5 ppm.

   Based on field trial data that indicate residues of bromoxynil in or on grass forage and hay as high as 2.9 and 2.4 ppm, respectively, the Agency determined that the tolerances for grass forage and hay should be increased to 3.0 ppm. Therefore, EPA is proposing to revise the commodity terminologies ``canarygrass, annual, seed'' and ``grass, canary, annual, straw'' in 40 CFR 180.324(a)(1) to ``grass, forage'' and ``grass, hay,'' respectively, and increase the tolerance for each from 0.1 ppm to 3.0 ppm.

   Based on field trial data that indicate residues of bromoxynil in or on barley straw as high as 3.9 ppm, and translating barley data to oat straw, the Agency determined that the tolerances for barley straw and oat straw should be increased to 4.0 ppm. Therefore, EPA is proposing to increase the tolerances in 40 CFR 180.324(a)(1) for residues of bromoxynil in or on ``barley, straw'' from 0.1 to 4.0 ppm, and ``oat, straw'' from 0.1 to 4.0 ppm.

   Based on field trial data that indicate residues of bromoxynil in or on wheat forage and straw as high as 0.6 and 1.2 ppm, respectively, and translating wheat data to rye, the Agency determined that the tolerances for both rye and wheat forage should be increased to 1.0 ppm, and both rye and wheat straw should be increased to 2.0 ppm. Therefore, EPA is proposing to increase the tolerances in 40 CFR 180.324(a)(1) for residues of bromoxynil in or on ``rye, forage'' from 0.1 to 1.0 ppm; ``rye, straw'' from 0.1 to 2.0 ppm; ``wheat, forage'' from 0.1 to 1.0 ppm; and ``wheat, straw'' from 0.1 to 2.0 ppm.

   Based on field trial data that indicate residues of bromoxynil in or on barley forage, and translating barley data to oat, the Agency determined that the tolerance for oat forage should be increased to 0.3 ppm. Therefore, EPA is proposing to increase the tolerance in 40 CFR 180.324(a)(1) for residues of bromoxynil in or on ``oat, forage'' from 0.1 to 0.3 ppm.

   Based on field trial data that indicate residues of bromoxynil in or on sorghum forage and stover as high as 0.29 and 0.14 ppm, respectively, the Agency determined that the tolerances for sorghum forage and stover should be increased to 0.5 and 0.2 ppm, respectively. Therefore, EPA is proposing to increase the tolerance in 40 CFR 180.324(a)(1) for residues of bromoxynil in or on``sorghum, forage'' from 0.1 to 0.5 ppm and revise the commodity terminology to ``sorghum, grain, forage;''and ``sorghum, grain, stover'' from 0.1 to 0.2 ppm.

   Based on field trial data that indicate residues of bromoxynil in or on grain of barley, corn, sorghum, and wheat at