Coppers Risk Assessments; Notice of Availability and Risk Reduction Options

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of EPA's risk assessments and related documents for copper-containing pesticides, hereon referred to as coppers, and opens a public comment period on these documents. The public is encouraged to suggest risk management ideas or proposals to address the risks identified. EPA is developing a Reregistration Eligibility Decision (RED) for coppers through a modified, 4-Phase public participation process that the Agency uses to involve the public in developing pesticide reregistration and tolerance reassessment decisions. Through these programs, EPA is ensuring that all pesticides meet current health and safety standards.

DATES:

Comments must be received on or before March 27, 2006.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2005-0558, by one of the following methods:

• http://www.regulations.gov/ . Follow the on-line instructions for submitting comments.
• E-mail: opp-docket@epa.gov.
• 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.

Hand Delivery: Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-2005-0558. The docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the docket facility is (703) 305-5805. 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 EPA -HQ-OPP-2005-0558. EPA's policy is that all comments received will be included in the public 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 captured automatically 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. Those who intend to submit electronic files should avoid the use of special characters, any form of encryption, and ensure the files are free of any defects or viruses. For additional information about EPA's public docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/docket.htm/ .

Docket: All documents in the docket are listed in the regulation.gov index. 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, will be publicly available only in hard copy. Publicly available docket materials are available either electronically at http://www.regulations.gov/ or in hard copy at the Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. The docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the docket facility is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT:

Rosanna Louie, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, D.C. 20460-0001; telephone number: (703) 308-0037; fax number: (703) 308-8005; e-mail address: louie.rosanna@epa.gov.

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 www.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 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 releasing for public comment its human health and environmental fate and effects risk assessments and related documents for copper pesticides, and soliciting public comment including additional use information and risk management ideas or proposals. Copper pesticides are extensively used on a wide range of agricultural crops, and for other conventional and antimicrobial uses. EPA developed the risk assessments and risk characterization for coppers through a modified version of its public 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 Food Quality Protection Act of 1996 (FQPA).

-Coppers are used on a variety of agricultural sites, including food (fruits, vegetables and nuts) and ornamental crops to manage fungal diseases, and on aquatic sites as an herbicide, algaecide and molluscicide. These chemicals are also used in antimicrobial applications as an anti-foulant, wood preservative, and bactericide. Both conventional and antimicrobial uses of copper are addressed in the human health risk assessment. However, the ecological risk assessment only addresses conventional uses; the Agency will address antimicrobial applications of coppers in a separate document at a later date. The Agency's ecological risk assessment identified risks of concern due to high estimates of copper exposure to the environment and other information. Because limited information is available on actual use and usage of copper pesticides, many conservative assumptions were made in the ecological exposure assessment. The ecological assessment presents current maximum labeled application and use rates; however, it is expected that actual usage may be less and the Agency is interested in receiving actual use pattern information to help refine the risk assessment.

-Through this notice, EPA is providing an opportunity for interested parties to provide risk management proposals or otherwise comment on risk management for coppers. Such comments and input could address, for example, the availability of additional data to further refine the risk assessments, or could address the Agency's risk assessment methodologies and assumptions as applied to this specific pesticide. EPA is seeking public comment for data refinement or mitigation proposals for risk estimates of concern identified in EPA's risk assessments. In particular, the Agency is seeking refined use information for all conventional uses of copper that may help to refine ecological exposure estimates, such as: current use rates on its respective crops; timing and locations of applications; and equipment used. Mitigation proposals for current use patterns will be helpful if new information does not refine risk estimates.

-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, and policies. 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 coppers, 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, the Agency is tailoring its public participation process to be commensurate with the level of risk, extent of use, complexity of the issues, and degree of public concern associated with each pesticide. For coppers, a modified, 4-Phase process with 1 comment period and ample opportunity for public consultation seems appropriate in view of the risk issues. However, if as a result of comments received during this comment period EPA finds that additional issues warranting further discussion are raised, the Agency may consider an additional comment period, as needed.

-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 coppers. 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) of FIFRA as amended directs that, after submission of all data concerning a pesticide active ingredient, “the Administrator shall determine whether pesticides containing such active ingredient are eligible for reregistration,” before calling in product-specific data on individual end-use products and either reregistering products or taking other “appropriate regulatory action.”

-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.

List of Subjects

• -Environmental protection
• Pesticides and pests