E9-24229. FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

There will be an informational meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to present the approach to re-evaluate atrazine.

DATES:

The meeting will be held on November 3, 2009 from approximately 9 a.m. to 12 p.m.

Comments. The Agency encourages that written comments be submitted by October 23, 2009 and requests for oral comments be submitted by October 27, 2009. However, written comments and requests to make oral comments may be submitted until the date of the meeting, but anyone submitting written comments after October 23, 2009 should contact the Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT. For additional instructions, see Unit I.C. of the SUPPLEMENTARY INFORMATION.

Special accommodations. For information on access or services for individuals with disabilities, and to request accommodation of a disability, please contact the DFO listed under FOR FURTHER INFORMATION CONTACT at least 10 days prior to the meeting to give EPA as much time as possible to process your request.

ADDRESSES:

The meeting will be held at the Environmental Protection Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202.

Comments. Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2009-0759, 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 Facility '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-2009-0759. If your comments contain any information that you consider to be CBI or otherwise protected, please contact the DFO listed under FOR FURTHER INFORMATION CONTACT to obtain special instructions before submitting your comments. 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 at http://www.regulations.gov. 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].

Requests to present oral comments, and requests for special accommodations. Submit requests for special seating accommodations, or requests to present oral comments to the DFO listed under FOR FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT:

Joseph E. Bailey, DFO, Office of Science Coordination and Policy (7201M), 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. This action may, however, be of interest to persons who are or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act (FFDCA), FIFRA, and the Food Quality Protection Act of 1996 (FQPA). Since other entities may also 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 DFO listed under FOR FURTHER INFORMATION CONTACT.

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

When submitting comments, remember to:

1. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

2. 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.

3. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

4. Describe any assumptions and provide any technical information and/or data that you used.

5. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

6. Provide specific examples to illustrate your concerns and suggest alternatives.

7. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

8. Make sure to submit your comments by the comment period deadline identified.

C. How May I Participate in this Meeting?

You may participate in this meeting by following the instructions in this unit. To ensure proper receipt by EPA, it is imperative that you identify docket ID number EPA-HQ-OPP-2009-0759 in the subject line on the first page of your request.

1. Written comments. The Agency encourages that written comments be submitted, using the instructions in ADDRESSES, no later than October 23, 2009, to provide FIFRA SAP the time necessary to consider and review the written comments. Written comments are accepted until the date of the meeting, but anyone submitting written comments after October 23, 2009 should contact the DFO listed under FOR FURTHER INFORMATION CONTACT. Anyone submitting written comments at the meeting should bring 30 copies for distribution to FIFRA SAP.

2. Oral comments. The Agency encourages that each individual or group wishing to make brief oral comments to FIFRA SAP submit their request to the DFO listed under FOR FURTHER INFORMATION CONTACT no later than October 27, 2009, in order to be included on the meeting agenda. Requests to present oral comments will be accepted until the date of the meeting and, to the extent that time permits, the Chair of FIFRA SAP may permit the presentation of oral comments at the meeting by interested persons who have not previously requested time. The request should identify the name of the individual making the presentation, the organization (if any) the individual will represent, and any requirements for audiovisual equipment (e.g., overhead projector, 35 mm projector, chalkboard). Oral comments before FIFRA SAP are limited to approximately 5 minutes unless prior arrangements have been made. In addition, each speaker should bring 30 copies of his or her comments and presentation slides for distribution to the FIFRA SAP at the meeting.

3. Seating at the meeting. Seating at the meeting will be open and on a first-come basis.

II. Background

A. Purpose of FIFRA SAP

FIFRA SAP serves as the primary scientific peer review mechanism of EPA’s Office of Prevention, Pesticides and Toxic Substances (OPPTS) and is structured to provide scientific advice, information and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on health and the environment. FIFRA SAP is a Federal advisory committee established in 1975 under FIFRA that operates in accordance with requirements of the Federal Advisory Committee Act. FIFRA SAP is composed of a permanent panel consisting of seven members who are appointed by the EPA Administrator from nominees provided by the National Institutes of Health and the National Science Foundation. FIFRA, as amended by FQPA, established a Science Review Board consisting of at least 60 scientists who are available to the SAP on an ad hoc basis to assist in reviews conducted by the SAP. As a peer review mechanism, FIFRA SAP provides comments, evaluations and recommendations to improve the effectiveness and quality of analyses made by Agency scientists. Members of FIFRA SAP are scientists who have sufficient professional qualifications, including training and experience, to provide expert advice and recommendation to the Agency.

B. Public Meeting

Atrazine is currently one of the most widely used agricultural pesticides in the United States, with approximately 70 million pounds of active ingredient applied domestically per year. First registered for use in December 1958, its primary uses are on corn and sugarcane, and to a lesser extent, on residential lawns in the Southeast. Consistent with the requirements of FIFRA and FFDCA, EPA and its predecessor agencies have required extensive evaluation of the potential adverse effects of atrazine over the years. Based on these extensive evaluations, most recently in 2003, EPA had determined that atrazine can be used with a reasonable certainty of no harm to human health if the product is used according to the label. Nonetheless, concerns have been raised recently about the health impacts of atrazine. Since 2003, there have been many studies of its ability to cause health effects. In order to evaluate this new science, EPA is launching a year long, comprehensive scientific re-evaluation of the potential human health impacts of atrazine by using information about atrazine’s mode of action and by carefully considering the potential for cancer and non-cancer effects based on the available data from laboratory animal and human epidemiology studies.

The Agency relies on transparency and sound science, including independent scientific peer review, to inform its regulatory decisions. The Agency’s 2003 evaluation of atrazine provided a detailed evaluation of the mode of action and human health effects of atrazine. Through a series of SAP meetings, EPA’s evaluation of the new scientific evidence available since that time will be described in the context of how it is similar to or differs from that available for the last atrazine assessment, and how this new evidence does or does not affect the Agency’s human health risk assessment of atrazine.

In the kick-off meeting to be held on November 3, 2009, the Panel members and public will be informed about EPA’s plans for three subsequent SAP meetings to be held in February, April and September, 2010.

In February 2010 the Agency will present its proposed approach for incorporating epidemiology and human incident data in the risk assessment. It will also present its evaluations of the human epidemiology studies which use an ecological design that have been published since the last atrazine assessment. The SAP will be asked to comment on the soundness of the scientific approach.

At the April 2010 meeting, EPA will present its evaluation of non-cancer effects based on an evaluation of studies used in past assessments, as well as those that have been published since then. The Agency will also present new data on alternative modes of action not considered in the 2003 evaluation as well as EPA’s plans for sampling frequency and monitoring of community water systems. The SAP will be asked to comment about the soundness of the scientific approach.

In September 2010, EPA will discuss its evaluation of cancer effects, based on an evaluation of studies used in past assessments, as well as those that have been published since then, including new findings from the Agricultural Health Study anticipated in 2010. EPA will also present any changes to its plans for monitoring community water systems based on its analysis and the SAP’s guidance from the April meeting. Further, any new scientific developments related to the Agency’s evaluation of non-cancer effects or setting the FQPA safety factor which may have become available since the April meeting will also be presented. The SAP will be asked to comment about the soundness of the scientific approach.

At the end of this year-long effort, the Agency will determine if the current risk assessment for atrazine should be revised and whether or not the Agency’s current regulatory position and community water system monitoring requirements should be changed.

C. FIFRA SAP Documents and Meeting Minutes

EPA's background paper, related supporting materials, FIFRA SAP panel members, and the meeting agenda will be available by mid-October for the November 3, 2009 meeting. In addition, the Agency may provide additional background documents as the materials become available. You may obtain electronic copies of these documents, and certain other related documents that might be available electronically, at http://www.regulations.gov and the FIFRA SAP homepage at http://www.epa.gov/​scipoly/​sap.

FIFRA SAP will prepare meeting minutes summarizing its recommendations to the Agency approximately 90 days after the meeting. The meeting minutes will be posted on the FIFRA SAP website or may be obtained from the OPP Regulatory Public Docket at http://www.regulations.gov.

List of Subjects

• Environmental protection
• Pesticides and pests

Dated: September 30, 2009.

Frank Sanders,

Director, Office of Science Coordination and Policy.