E6-1106. FIFRA Scientific Advisory Panel; Notice of Rescheduled Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The February 14 - 16, 2006, Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) meeting to consider the Review of Worker Exposure Assessment Methods has been rescheduled.

DATES:

The meeting will now be held on April 4 - 6, 2006, from 8:30 a.m. to approximately 5 p.m., eastern time.

Comments: For the deadlines for the submission of requests to present oral comments and submission of written comments, see Unit I.C. of the SUPPLEMENTARY INFORMATION.

Nominations: Nominations of scientific experts to serve as ad hoc members of the FIFRA SAP for this meeting should be provided on or before February 13, 2006.

Special accommodations: For information on access or services for individuals with disabilities, and to request accommodation of a disability, please contact the Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT at least 10 business 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 Holiday Inn Rosslyn at Key Bridge, 1900 North Fort Myer Drive, Arlington, VA 22209. The telephone number for the Holiday Inn Rosslyn at Key Bridge is [phone].

Comments: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2005-0471, by one of the following methods:

• http://www.regulations.gov/​. Follow the on-line instructions for submitting comments.
• E-mail: [e-mail].
• 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-2005-0471. 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 [phone]. 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-2005-0471. 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. Electronic files should avoid the use of special characters, any form of encryption, and be 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 [phone].

Nominations, requests to present oral comments, and special accommodations: See Unit I.C. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:

Myrta R. Christian, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 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 preparing and submitting comments, remember to use these tips:

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1. Identify the document by docket 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.

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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-2005-0471 in the subject line on the first page of your request.

1. Oral comments. Oral comments presented at the meetings should not be repetitive of previously submitted oral or written comments. Although requests to present oral comments are accepted until the date of the meeting (unless otherwise stated), to the extent that time permits, interested persons may be permitted by the Chair of FIFRA SAP to present oral comments at the meeting. Each individual or group wishing to make brief oral comments to FIFRA SAP is strongly advised to submit their request to the DFO listed under FOR FURTHER INFORMATION CONTACT no later than noon, eastern time, March 28, 2006, in order to be included on the meeting agenda. 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 FIFRA SAP at the meeting.

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2. Written comments. Although written comments will be accepted until the date of the meeting (unless otherwise stated), the Agency encourages that written comments be submitted, using the instructions in ADDRESSES, no later than noon, eastern time, March 21, 2006, to provide FIFRA SAP the time necessary to consider and review the written comments. It is requested that persons submitting comments directly to the docket also notify the DFO listed under FOR FURTHER INFORMATION CONTAC T. There is no limit on the extent of written comments for consideration by FIFRA SAP. Persons wishing to submit written comments at the meeting should bring 30 copies.

3. Seating at the meeting. Seating at the meeting will be on a first-come basis. Individuals requiring special accommodations at this meeting, including wheelchair access and assistance for the hearing impaired, should contact the DFO at least 10 business days prior to the meeting using the information under FOR FURTHER INFORMATION CONTACT so that appropriate arrangements can be made.

4. Request for nominations of prospective candidates for service as ad hoc members of the FIFRA SAP for this meeting. As part of a broader process for developing a pool of candidates for each meeting, the FIFRA SAP staff routinely solicit the stakeholder community for nominations of prospective candidates for service as ad hoc members of the FIFRA SAP. Any interested person or organization may nominate qualified individuals to be considered as prospective candidates for a specific meeting. Individuals nominated for this meeting should have expertise in one or more of the following areas: Occupational exposure assessment, occupational exposure monitoring, agricultural practices (especially hand labor practices), statistics, and risk assessment. Nominees should be scientists who have sufficient professional qualifications, including training and experience, to be capable of providing expert comments on the scientific issues for this meeting. Nominees should be identified by name, occupation, position, address, and telephone number. Nominations should be provided to the DFO listed under FOR FURTHER INFORMATION CONTACT on or before [insert date 12 days after date of publication in the Federal Register]. The Agency will consider all nominations of prospective candidates for this meeting that are received on or before this date. However, final selection of ad hoc members for this meeting is a discretionary function of the Agency.

The selection of scientists to serve on the FIFRA SAP is based on the function of the panel and the expertise needed to address the Agency's charge to the panel. No interested scientists shall be ineligible to serve by reason of their membership on any other advisory committee to a Federal department or agency or their employment by a Federal department or agency (except the EPA). Other factors considered during the selection process include availability of the potential panel member to fully participate in the panel's reviews, absence of any conflicts of interest or appearance of lack of impartiality, independence with respect to the matters under review, and lack of bias. Though financial conflicts of interest, the appearance of lack of impartiality, lack of independence, and bias may result in disqualification, the absence of such concerns does not assure that a candidate will be selected to serve on the FIFRA SAP. Numerous qualified candidates are identified for each panel. Therefore, selection decisions involve carefully weighing a number of factors including the candidates' areas of expertise and professional qualifications and achieving an overall balance of different scientific perspectives on the panel. In order to have the collective breadth of experience needed to address the Agency's charge for this meeting, the Agency anticipates selecting approximately 12 ad hoc scientists.

If a prospective candidate for service on the FIFRA SAP is considered for participation in a particular session, the candidate is subject to the provisions of 5 CFR part 2634, Executive Branch Financial Disclosure, as supplemented by the EPA in 5 CFR part 6401. As such, the FIFRA SAP candidate is required to submit a Confidential Financial Disclosure Form for Special Government Employees Serving on Federal Advisory Committees at the U.S. Environmental Protection Agency (EPA Form 3110-48 5-02) which shall fully disclose, among other financial interests, the candidate's employment, stocks and bonds, and where applicable, sources of research support. The EPA will evaluate the candidate's financial disclosure form to assess that there are no financial conflicts of interest, no appearance of lack of impartiality and no prior involvement with the development of the documents under consideration (including previous scientific peer review) before the candidate is considered further for service on the FIFRA SAP.

Those who are selected from the pool of prospective candidates will be asked to attend the public meetings and to participate in the discussion of key issues and assumptions at these meetings. In addition, they will be asked to review and to help finalize the meeting minutes. The list of FIFRA SAP members participating at this meeting will be posted on the FIFRA SAP web site or may be obtained by contacting the PIRIB at the address or telephone number listed under ADDRESSES.

II. Background

A. Purpose of the FIFRA SAP

Amendments to FIFRA enacted November 28, 1975 (7 U.S.C. 136w(d)), include a requirement under section 25(d) of FIFRA that notices of intent to cancel or reclassify pesticide registrations pursuant to section 6(b)(2) of FIFRA, as well as proposed and final forms of regulations pursuant to section 25(a) of FIFRA, be submitted to a SAP prior to being made public or issued to a registrant. In accordance with section 25(d) of FIFRA, the FIFRA SAP is to have an opportunity to comment on the health and environmental impact of such actions. The FIFRA SAP also shall make comments, evaluations, and recommendations for operating guidelines to improve the effectiveness and quality of analyses made by Agency scientists. Members are scientists who have sufficient professional qualifications, including training and experience, to be capable of providing expert comments as to the impact on health and the environment of regulatory actions under sections 6(b) and 25(a) of FIFRA. The Deputy Administrator appoints seven individuals to serve on the FIFRA SAP for staggered terms of 4 years, based on recommendations from the National Institutes of Health and the National Science Foundation.

Section 104 of FQPA (Public Law 104-170) established the FQPA Science Review Board (SRB). These scientists shall be available to the FIFRA SAP on an ad hoc basis to assist in reviews conducted by the FIFRA SAP.

B. Public Meeting

The FIFRA SAP will meet to consider the Review of Worker Exposure Assessment Methods. The Agency issued its first occupational exposure testing guidelines in the early 1980s. These guidelines were intended to standardize the methodology used to conduct the studies necessary to allow the Agency to determine the potential exposures, and consequently, risks associated with the activities surrounding pesticide exposures. These activities included handling pesticides (i.e., mixing, loading and applying) as well as exposures resulting from working in fields following pesticide applications (e.g., harvesting, thinning, weeding). In the early 1990s, the Pesticide Handlers Exposure Database was constructed in order to estimate exposures resulting from mixing/loading/applying pesticides. The studies assembled for use in this database were taken from published literature as well as from industry-generated studies. This database has been used as the main source for estimating occupational exposures to workers handling pesticides for both registration and reregistration actions. In 1995, in order to develop a similar database, which could be used to address fieldworker exposures, the Agency issued a Data Call-In Notice (DCI) for post-application farmworker exposure data. As a result of this DCI, every pesticide registrant who manufactured products that could lead to post-application farmworker exposures needed to generate data that could be used to quantify exposures to their products.

In response to the issuance of the 1995 DCI, most major pesticide registrants consolidated their efforts and formed the Agricultural Reentry Task Force (ARTF). For more details, see http://www.exposuretf.com. The ARTF has generated the vast majority of the post-application farmworker exposure monitoring data since that time. It follows that the bulk of the data that have been generated by ARTF include exposure monitoring studies for a variety of hand-labor practices in a range of crops.

The purpose of this meeting of the FIFRA Science Advisory Panel (SAP) is to evaluate certain methodologies used to generate exposure studies and how the Agency uses these and other studies to conduct occupational exposure assessments. Three key issues have been identified by the Agency as the focus of this review. These include:

• Hand exposure methods. Based upon review of the data, it appears that the hands are important contributors to overall exposures levels. In most monitoring studies used by the Agency, a wash technique, which is based on methods described in the scientific literature, is generally utilized to measure exposure to the hands. The goal of this evaluation is to identify issues associated with the use of this technique and to make recommendations with regard to how these data should be interpreted for exposure assessment purposes based on factors such as chemical properties and exposure duration.
• Predictive capability of exposure monitoring techniques. Most exposure data that are currently available are based on the use of passive dosimetry techniques (e.g., whole-body dosimeters and handwash). These data quantify the residues that result on the surface of the skin after completing a job task of some sort. The purpose of this evaluation is to characterize the performance of passive dosimetry as a predictive tool for risk assessment purposes (e.g., through comparison with biological monitoring data and other possible analyses).
• Clustering of hand labor tasks for exposure assessment purposes. The crops in the United States that require hand labor for successful production are extremely varied and range from field crops such as lettuce (e.g., harvest is a key labor requirement) to tree fruit such as apples (e.g., thinning and harvest are key labor requirements). Based on the currently available data and a need to address exposures related to hand labor across agriculture, the Agency has created clusters or groups that represent categories of exposures that are believed to be similar for assessment purposes. These categories allow the Agency to develop risk estimates for a wide range of crops and were defined based on agronomic and ergonomic similarities in crops and workers, respectively. The purpose of this evaluation is to characterize the methods used to define a representative cluster and analyze the monitoring data that pertains to that group, which are then used for exposure assessment purposes. An example based on vineyard and trellis crops will be used for illustrative purposes.

C. FIFRA SAP Documents and Meeting Minutes

EPA's position paper, charge/questions to FIFRA SAP, FIFRA SAP composition (i.e., members and consultants for this meeting), and the meeting agenda will be available by March 2006. 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, from the regulation.gov Web site and the FIFRA SAP homepage at http://www.epa.gov/​scipoly/​sap.

The FIFRA SAP will prepare meeting minutes summarizing its recommendations to the Agency in approximately 90 days after the meeting. The meeting minutes will be posted on the FIFRA SAP web site or may be obtained by contacting the PIRIB at the address or telephone number listed under ADDRESSES.

List of Subjects

• Environmental protection
• Pesticides and pests

Dated: January 24, 2006.

Clifford J. Gabriel,

Director, Office of Science Coordination and Policy.