E7-18860. N-methyl Carbamate Revised Cumulative Risk Assessment; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of EPA's revised cumulative risk assessment for the N-methyl carbamate group of pesticides, and opens a public comment period on this document and other support documents. As required by the Food Quality Protection Act (FQPA), a cumulative risk assessment, which evaluates exposures based on a common mechanism of toxicity, was conducted to evaluate the risk from food, drinking water, residential, and other non-occupational exposures resulting from registered uses of N-methyl carbamate pesticides. The N-methyl carbamate group includes aldicarb, carbaryl, carbofuran, formetanate HCl, methiocarb, methomyl, oxamyl, pirimicarb, propoxur, and thiodicarb.

DATES:

Comments must be received on or before November 26, 2007.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2007-0935, 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'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 [phone].

Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2007-0935. 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 in regulations.gov. To access the electronic docket, go to http://www.regulations.gov, select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. 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 [phone].

FOR FURTHER INFORMATION CONTACT:

Neil Anderson, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. 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.

II. Background

A. What Action is the Agency Taking?

EPA is making available the completed cumulative risk assessment for the N-methyl carbamate pesticides. The Agency developed this risk assessment as part of its ongoing process for making pesticide reregistration eligibility and tolerance reassessment decisions. Through these programs, EPA is ensuring that pesticides meet current standards under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA), as amended by the FQPA.

Section 408(b)(2)(D)(v) of the FFDCA directs the Agency to consider available information on the cumulative risk from substances sharing a common mechanism of toxicity. The Agency determined in 2004 that the N-methyl carbamate pesticides share a common mechanism of toxicity, cholinesterase inhibition. The N-methyl carbamates have been among EPA's highest priority pesticides for review under FQPA.

In developing the N-methyl carbamate cumulative risk assessment, EPA employed the methodologies utilized in earlier cumulative risk assessments (i.e., the organophosphate pesticides) and consulted with the FIFRA Scientific Advisory Panel numerous times, seeking expert review, advice, and recommendations at each major step of the process. The Agency also met with several of its advisory committees to obtain input from a broad spectrum of stakeholders representing the pesticide industry, environmental and public interest groups, growers, academia, and others, including other federal and state regulatory agencies. EPA issued the Estimation of Cumulative Risk from N-methyl Carbamate Pesticides: Preliminary Assessment in August 2005. The N-methyl Carbamate Revised Cumulative Risk Assessment is considered an addendum to the August 2005 assessment, and includes improvements and refinements in assessing the cumulative risks of the N-methyl carbamate pesticides. The previous versions of the N-methyl carbamate cumulative risk assessment may be accessed on the EPA website at http://www.epa.gov/​pesticides/​cumulative.

EPA has concluded that, with the adoption of the risk mitigation measures evaluated in the N-methyl carbamate cumulative risk assessment, all of the N-methyl carbamate pesticide tolerances assessed in this risk assessment meet the safety standard set forth in section 408(b)(2)(a) of the FFDCA. For those tolerances, this conclusion terminates the tolerance reassessment process under section 408(q) of the FFDCA. For all of the chemicals, to the extent that the safety determination for these uses based on the cumulative risk assessment was the only remaining issue to complete the reregistration eligibility determination for a particular chemical under section 4(g)(2)(A) of FIFRA, the Agency now considers that determination (consistent with the risk mitigation measures described in the cumulative assessment) to be complete. As noted in the Introduction to the cumulative risk assessment, certain tolerances and uses were omitted from the risk assessment because EPA had previously determined that these uses or tolerances did not meet the safety standards based on their individual, aggregate risks or should be canceled for other reasons. These tolerances and uses are identified in Appendix II.A of the cumulative risk assessment. The cumulative assessment does not change the Agency's determination with respect to those uses. Should any risk mitigation measures identified in the assessment not subsequently be implemented, EPA will revise the assessment as necessary to take those residues into account.

In June 2006, the Agency determined that 144 of the N-methyl carbamate tolerances were insignificant contributors to the overall dietary exposure to the N-methyl carbamates. The uses associated with these 144 tolerances make an insignificant contribution to the overall N-methyl carbamate cumulative risk. Therefore, EPA counted these tolerances as reassessed before the final N-methyl carbamate cumulative assessment was issued. That determination is not changed by the assessment the Agency is now issuing. As noted in the previous paragraph above, EPA has now determined that those tolerances assessed in the N-methyl carbamate cumulative risk assessment meet the FFDCA safety standard and that no further dietary risk mitigation is necessary for any of the pesticides involved in the cumulative risk assessment other than the mitigation measures identified in the individual chemical or cumulative assessments.

EPA is providing an opportunity, through this notice, for interested parties to provide comments and input on the Agency's completed cumulative risk assessment for the N-methyl carbamate pesticides. Such comments and input could address the Agency's risk assessment methodologies and assumptions as applied to this cumulative assessment.

The Agency will consider all comments received, and make changes, if appropriate, to the N-methyl carbamate cumulative risk assessment.

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation, and enforcement of environmental laws, regulations, andpolicies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical, unusually high exposure to N-methyl carbamate pesticides, compared to the general population.

EPA is applying the principles of public participation to all pesticides undergoing reregistration and tolerance reassessment. The Agency's Pesticide Tolerance Reassessment and Reregistration; Public Participation Process, published in the Federal Register on May 14, 2004, (69 FR 26819) (FRL-7357-9) explains that in conducting these programs, EPA is tailoring its public participation process to be commensurate with the level of risk, extent of use, complexity of issues, and degree of public concern associated with each pesticide. The N-methyl carbamate pesticides have had extensive opportunities for public comment as part of their reregistration and tolerance reassessment process.

Comments should be limited to issues raised within the N-methyl carbamate cumulative risk assessment and associated documents. Failure to comment on any such issues as part of this opportunity will not limit a commenter's opportunity to participate in any later notice and comment processes on this matter. All comments should be submitted using the methods in ADDRESSES, and must be received by EPA on or before the closing date. Comments will become part of the Agency Docket for the N-methyl carbamate cumulative risk assessment. Comments received after the close of the comment period will be marked <<late.'' EPA is not required to consider these late comments.

B. What is the Agency's Authority for Taking this Action?

Section 4(g)(2)(A) of FIFRA, as amended, requires the Administrator to make “a determination as to the eligibility for reregistration (i) for all active ingredients subject to reregistration under this section for which tolerances or exemptions from tolerances are required under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), not later than the last date for tolerance reassessment established under section 408(q)(1)(C) of that Act (21 U.S.C. 346a((q)(1)(C))...''

Section 408(q) of the FFDCA, 21 U.S.C. 346a(q), requires EPA to review tolerances and exemptions for pesticide residues in effect as of August 2, 1996, to determine whether the tolerance or exemption meets the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review is to be completed by August 3, 2006. A tolerance or exemption meets the requirements of section 408(b)(2) or (c)(2), respectively, if “the Administrator determines the pesticide chemical residue is safe,'' i.e., “that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' 21 U.S.C. 346a(b)(2)(A), and (c)(2)(A). In making this safety finding, FFDCA requires the Administrator to consider, among other factors, “available information concerning the cumulative effects of such residues and other substances that have a common mechanism of toxicity...'' 21 U.S.C. 346a(b)(2)(D)(v), and (c)(2)(B).

List of Subjects

• Environmental protection
• Pesticides and pests

Dated: September 19, 2007.

Peter Caulkins,

Acting Director, Special Review and Reregistration Division, Office of Pesticide Programs.