Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Chlorophenoxyacetic acid, etc.,

[Federal Register: June 7, 2006 (Volume 71, Number 109)]

[Proposed Rules]

[Page 32899-32909]

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

[DOCID:fr07jn06-36]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0036; FRL-8062-7]

p-Chlorophenoxyacetic acid, Glyphosate, Difenzoquat, and Hexazinone; Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to revoke certain tolerances for the plant growth regulator p-chlorophenoxyacetic acid and the herbicide hexazinone. Also, EPA is proposing to modify certain tolerances for the plant growth regulator p-chlorophenoxyacetic acid and the herbicides glyphosate, difenzoquat, and hexazinone. In addition, EPA is proposing to establish new tolerances for the herbicides difenzoquat and hexazinone. 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 that were in existence on August 2, 1996. No tolerance reassessments will be counted at the time of a final rule because tolerances in existence on August 2, 1996 that are associated with actions proposed herein were previously counted as reassessed at the time of the completed Reregistration Eligibility Decision (RED), Report of the FQPA Tolerance Reassessment Progress and Risk Management Decision (TRED), or Federal Register action.

DATES: Comments must be received on or before August 7, 2006.

ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2006-0036. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (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 Building), 2777 S. Crystal Drive, Arlington, VA. The 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: 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.

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 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. 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 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

      [[Page 32900]]

      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 plant growth regulator p- chlorophenoxyacetic acid and the herbicides glyphosate, difenzoquat, and hexazinone 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 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, P.O. Box 42419, Cincinnati, OH 45242-2419, telephone 1-00-490-9198; fax 1-513-489-8695; internet at http://www.epa.gov/ncepihom/ and from the National

    Technical Information Service, 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 for glyphosate at http://www.epa.gov/pesticides/

    reregistration/status.htm, and p-chlorophenoxyacetic acid, difenzoquat, and hexazinone in public dockets EPA-HQ-OPP-2003-0124, EPA-HQ-OPP-2002- 0097, and EPA-HQ-OPP-2002-0188, respectively, at http://www.regulations.gov .

    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 paper copies for difenzoquat and hexazinone can be found under their respective public docket numbers, identified above. Paper copies for p-chlorophenoxyacetic acid and glyphosate are available in the public docket for this rule. Electronic copies are available through EPA's electronic public docket and comment system, regulations.gov at http://www.regulations.gov/. You may search for this

    rule under docket number EPA-HQ-OPP-2006-0036, 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. p-Chlorophenoxyacetic acid. The Agency canceled the last registered uses for p-chlorophenoxyacetic acid on tomato in May 1995. Therefore, the Agency is proposing to revoke the tolerance in 40 CFR 180.202(a)(1) for combined residues of the plant regulator p- chlorophenoxyacetic acid and its metabolite p-chlorophenol in or on tomato, remove paragraph (a)(1), and recodify existing paragraph (a)(2) as paragraph (a).

      Based on the available data that indicate combined residues of p- chlorophenoxyacetic acid and its metabolite p-chlorophenol in or on mung bean sprouts will not exceed 0.2 ppm, the Agency determined that the tolerance should be lowered to 0.2 ppm. Therefore, EPA is proposing to decrease the tolerance for combined residues of the plant regulator p-chlorophenoxyacetic acid and its metabolite p-chlorophenol to inhibit embryonic root development in or on bean, mung, sprouts from 2.0 to 0.2 ppm in newly recodified 40 CFR 180.202(a).

    2. Glyphosate. A RED was completed on glyphosate in September 1993 before the passage of the FQPA. On April 11, 1997 (62 FR 17723) (FRL- 5598-6) EPA published a notice in the Federal Register which established new uses for glyphosate. Existing tolerances for glyphosate in 40 CFR 180.364 were

      [[Page 32901]]

      considered by the Agency to be reassessed at that time. Although the glyphosate RED recommended revocation of tolerances based on no registered uses for the following food commodities; bread fruit, canistel, cherimoya, cacao bean, date, marmaladebox (formerly genip), jaboticaba, jackfruit, persimmon, sapote (black and white), soursop, and tamarind at 0.2 ppm and coconut at 0.1 ppm; these food uses are currently active and have existed for years since the RED. Canistel, cacao bean, jackfruit, and sapote have existed since 2003; bread fruit, cherimoya, marmaladebox, jaboticaba, soursop, and tamarind since 2000, and persimmon and dates since 1998. Therefore, EPA will maintain these tolerances in 40 CFR 180.364.

      Data on glyphosate residues in or on both tea leaves and instant tea were available at the time of the RED. Nevertheless, instant tea was also recommended for revocation in the RED because the Agency at that time did not consider it to be a significant item in the daily dietary risk assessment of the population of the United States from pesticide use on that processed commodity. However, instant tea is now considered to be a processed commodity according to the ``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/

      publications/ OPPTS--Harmonized/ 860--Residue--Chemistry-- Test-- Guidelines/Series/. As stated above, existing tolerances for glyphosate in 40 CFR 180.364, including instant tea, were reassessed at the time of new use approvals on (April 11, 1997, 62 FR 17723). Therefore, EPA will maintain the tolerance on ``tea, instant'' in 40 CFR 180.364.

      In the RED, it was recommended that tolerances be established for potato chips, granules, flakes and processed potato waste; however, the quality of the data for potato chips, granules and processed potato waste was in question. In 1996 new residue data on potatoes and processed potato foods and feeds were provided to the Agency. These data indicated that at the 10x rate residues were

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