Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Propanil, phenmedipham, triallate, and MCPA,

[Federal Register: September 27, 2006 (Volume 71, Number 187)]

[Proposed Rules]

[Page 56425-56433]

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

[DOCID:fr27se06-35]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0586; FRL-8089-5]

Propanil, Phenmedipham, Triallate, and MCPA; Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to revoke certain tolerances for herbicides propanil, triallate, and MCPA. Also, EPA is proposing to modify certain tolerances for the herbicides propanil, phenmedipham, triallate, and MCPA. In addition, EPA is proposing to establish tolerances for the herbicides propanil, phenmedipham, triallate, and MCPA.

DATES: Comments must be received on or before November 27, 2006.

ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2006-0586, 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 Building), 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- 2006-0586. 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

[[Page 56426]]

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 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 Building), 2777 S. Crystal Drive, 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 telephone number is (703) 3057-5805.

FOR FURTHER INFORMATION CONTACT: Jane Smith, Special Review and Reregistration Division (7805P), 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 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 Federal Food, Drug, and Cosmetic Act (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 herbicides propanil, phenmedipham, triallate, and MCPA 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 Food Quality Protection Act (FQPA). The safety finding determination of ``reasonable certainty of no harm'' is discussed in detail in each

   [[Page 56427]]

   Reregistration Eligibility Decision (RED) and Report of the FQPA Tolerance Reassessment Progress and Risk Management Decision (TRED) for the active ingredients. 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 452427-2419, 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 propanil, phenmedipham, triallate, and MCPA at the internet at http://www.epa.gov/pesticides/reregistration/status.htm and in public dockets

   EPA-HQ-OPP-2003-0348 and EPA-HQ-OPP-2002-0033 (propanil); EPA-HQ-OPP- 2004-0384 (phenmedipham); and EPA-HQ-OPP-2004-0156 and EPA-HQ-OPP-2004- 0239 (MCPA) 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 are available in the public docket for this proposed rule, while electronic copies are available through EPA's electronic public docket and comment system, regulations.gov at http://www.regulations.gov. You may search for docket ID number EPA-HQ-OPP-

   006-0586, 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.

   With respect to the tolerances that are proposed in this document to be modified, unless technical (e.g., commodity tolerance nomenclature revision), 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 discussed 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 specific tolerances because either they are no longer needed or are associated with food uses that are no longer registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 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. Propanil. Currently, in 40 CFR 180.274 (a)(1) and (2), tolerances are established for the combined residues of propanil and its metabolites (calculated as propanil) in or on both raw agricultural commodities (RACs) and processed foods and feeds. EPA is proposing to revise the tolerance expression to specify the residues of concern and combine the RACs and processed foods and feed tolerances in accordance with FFDCA 408 as amended by FQPA (1996) in 40 CFR 180.274(a) to read as follows: Tolerances are established for the combined residues of the herbicide propanil (3', 4'-dichloropropionanilide) and its metabolites convertible to 3, 4-dichloroaniline (3, 4-DCA).

   Tolerances currently exist for rice milling fractions and rice polishings. Rice milling fractions are no longer considered a significant animal feed item as delineated in ``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/[fxsp0 ]opptsfrs/publications/[fxsp0]OPPTS--Harmonized/[fxsp0]860--

   Residue--[fxsp0]Chemistry--Test--[fxsp0]Guidelines/Series. Therefore, EPA is proposing to remove the tolerances in 40 CFR 180.274(a) for the combined residues of propanil in or on rice milling fractions and rice, polishings at 10 parts per million (ppm).

   The registered uses on barley, oat, and wheat (small grains) have been voluntarily cancelled (68 FR 68901, December 10, 2003) (FRL-7332- 5), (68 FR 38328, June 27, 2003) (FRL-7310-6). In the absence of registered uses, the tolerances associated with the small grains should be revoked. Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.274(a) for the combined propanil residues of concern in or on barley, straw; oat, straw; and wheat, straw at 0.75 ppm; barley, grain at .2 ppm; oat, grain at .2 ppm; wheat, grain at 0.2 ppm.

   Two studies depicting the magnitude of regulated propanil residues in or on rice, grain exceeded the established tolerance of 2 ppm in or on treated rice, grain samples demonstrating residues ranging from 0.03 ppm to 8.7 ppm. Based on these data, EPA determined the tolerance should be 10 ppm on rice, grain. Therefore, EPA is proposing to increase the tolerance in 40 CFR 180.274(a) for the combined propanil residues of concern in or on rice, grain from 2 ppm to 10 ppm. The Agency determined that the increased tolerance is safe; i.e. there is a reasonable certainty that no harm will result from

   [[Page 56428]]

   aggregate exposure to the pesticide chemical residue.

   A rice processing study showed no concentration of residues in polished rice and average concentration factors of 3.5x for rice, hulls and 4.6x for rice, bran. The highest average field trial (HAFT) propanil residues found in rice were 8.7 ppm. Based on this HAFT and the observed concentration factors, the maximum expected residues are 30.45 ppm in or on rice, hulls (8.7 x 3.5) and 40.02 ppm in or on rice, bran (8.7 x 4.6). These expected residues are higher in the processed commodities than the reassessed tolerance of 10 ppm for rice, grain. Based on these data, EPA has determined that the tolerances should be 30 ppm on rice, hulls and 40 ppm on rice, bran. Therefore, EPA is proposing to increase tolerances in 40 CFR 180.274(a) for the combined propanil residues of concern in or on rice, hulls from 10 to 30 ppm and rice, bran from 10 to 40 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. The potential for secondary transfer of propanil residues to animal commodities exists because the herbicide is registered for use on rice, which may be used as animal feed. Based on a maximum theoretical dietary burden (x) and using the residues levels found in dairy cattle and milk fed 15 ppm (0.75x) resulted in residues of: 0.035 ppm in milk, 0.31 ppm in liver, 0.77 ppm in kidney,