2010-10231. FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

There will be a 3-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review a set of scientific issues related to review of SHEDs-Multimedia version 4, Peer consult on PBPK Modeling, and a SHEDS-PBPK Permethrin study.

DATES:

The meeting will be held on July 20-22, 2010, from 9 a.m. to approximately 5:30 p.m.

Comments. The Agency encourages that written comments be submitted by July 8, 2010 and requests for oral comments be submitted by July 15, 2010. However, written comments and requests to make oral comments may be submitted until the date of the meeting, but anyone submitting written comments after July 8, 2010 should contact the Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT. For additional instructions, see Unit I.C. of the SUPPLEMENTARY INFORMATION.

Nominations. Nominations of candidates to serve as ad hoc members of FIFRA SAP for this meeting should be provided on or before May 14, 2010.

Webcasting. This meeting may be webcast. Please refer to the FIFRA SAP’s website, http://www.epa.gov/​scipoly/​SAP/​ for information on how to access the webcast. Please note that the webcast is a supplementary public process provided only for convenience. If difficulties arise resulting in webcasting outages, the meeting will continue as planned.

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-2010-0383, 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-2010-0383. 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].

Nominations, requests to present oral comments, and requests for special accommodations. Submit nominations to serve as ad hoc members of FIFRA SAP, requests for special seating accommodations, or requests to present oral comments to the DFO listed under FOR FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT:

Sharlene R. Matten, 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-2010-0383 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 July 8, 2010, 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 July 15, 2010 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 July 15, 2010, 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.

4. Request for nominations to serve as ad hoc members of FIFRA SAP for this meeting. As part of a broader process for developing a pool of candidates for each meeting, FIFRA SAP staff routinely solicits the stakeholder community for nominations of prospective candidates for service as ad hoc members of 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: pesticide exposure, general statistics, exposure modeling, dose modeling, 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 May 14, 2010. 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 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. Although 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 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 12-15 ad hoc scientists.

FIFRA SAP members are subject to the provisions of 5 CFR part 2634, Executive Branch Financial Disclosure, as supplemented by the EPA in 5 CFR part 6401. In anticipation of this requirement, prospective candidates for service on the FIFRA SAP will be asked to submit confidential financial information 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 candidates financial disclosure form to assess whether there are financial conflicts of interest, appearance of a lack of impartiality or any prior involvement with the development of the documents under consideration (including previous scientific peer review) before the candidate is considered further for service on 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 website at http://epa.gov/​scipoly/​sap or may be obtained from the OPP Regulatory Public Docket at http://www.regulations.gov.

II. Background

A. Purpose of FIFRA SAP

FIFRA SAP serves as the primary scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 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

The Food Quality Protection Act (FQPA) amended laws under which EPA evaluates the safety of pesticide residues in food. Section 408(b)(2)(D)(v) and (vi) of the Federal Food, Drug, and Cosmetic Act (FFDCA) as amended by FQPA, specifies that, when determining the safety of a pesticide chemical, EPA shall consider aggregate exposure (i.e.,total dietary (food and water), residential, and other non- occupational) and available information concerning the cumulative effects to human health that may result from exposure to other substances that have a common mechanism of toxicity. Aggregate assessments account for multiple sources and routes of exposure for a single chemical. FQPA-mandated cumulative assessments combine exposures and doses to two or more chemicals that share a common mechanism of toxicity.

EPA's Office of Pesticide Programs (OPP) and Office of Research and Development (ORD) have been conducting collaborative science to inform the Agency's anticipated pyrethroid cumulative risk assessment (CRA). This FIFRA SAP review is part of the Agency's ongoing process to enhance probabilistic exposure, dose, and risk assessments, and OPP's ongoing efforts to consider available probabilistic exposure and dose models to address FQPA. Through a coordinated multi-disciplinary effort, ORD and OPP scientists have developed new approaches for Commulative Risk Assessment (CRA) which are incorporated into ORD's SHEDS-Multimedia (Stochastic Human Exposure and Dose Simulation) computer model and software. SHEDS-Multimedia (http://www.epa.gov/​heasd/​products/​ sheds_multimedia/sheds_mm.html) is a physically-based, probabilistic model that predicts for user-specified population cohorts exposures incurred via eating contaminated foods or drinking water, inhaling contaminated air, touching contaminated surface residues, and ingesting residues from hand-to-mouth or object-to-mouth activities. It can simulate aggregate or cumulative exposures over time via multiple routes of exposure (dietary & non-dietary residential) for multiple types of chemicals & scenarios. To do this, it combines information on chemical usage, human activity data (e.g., from Consolidated Human Activity Database (CHAD; www.epa.gov/​chadnet1) time/activity diary surveys and videography studies), environmental residues and concentrations, and exposure factors to generate time series of exposure for simulated individuals. One-stage or two-stage Monte Carlo simulation is used to produce distributions of exposure for various population cohorts (e.g., age/gender groups) that reflect the variability and/or uncertainty in the input parameters.

While the core of SHEDS-Multimedia is the concentration-to-exposure module, there are various options (e.g., built-in simple source-to-concentration module, user-entered time series from other models or field study measurements) for obtaining concentration inputs. SHEDS-Multimedia also includes a simple built-in pharmacokinetic (PK) model. In addition, SHEDS-Multimedia exposure outputs can be used as inputs to more sophisticated physiologically-based pharmacokinetic (PBPK) models which can, in turn, be used to model and estimate tissue burden and urinary concentrations of chemicals through class-oriented approaches. The combined exposure- and dose- modeled outputs will be compared against real-world biomonitoring data, and will be integrated with corresponding effects research.

An earlier version of the SHEDS-Multimedia model (version 3) was originally presented to the SAP for review in August 2007 (http://www.epa.gov/​scipoly/​SAP/​meetings/​2007/​081407_​mtg.htm). In that version, only the aggregate residential module of SHEDS-Multimedia was operational, and then only for post-application exposures (i.e., pesticide applicators were not considered). In that 2007 meeting, the SAP reviewed the aggregate residential (post-application only) version of SHEDS-Multimedia (version 3), as well as conceptual plans for the SHEDS dietary module and for the PBPK modeling.

This July 2010 SAP will focus on work conducted by ORD and OPP scientists since 2007 on these models, and will consist of:

(i) A formal review of SHEDS-Multimedia version 4 which now includes dietary as well as both applicator and post-application residential exposures, and allows for cumulative as well as aggregate assessments;

(ii) A peer consult on refinements to the PBPK models and how SHEDS outputs are introduced into and used by PBPK models; and

(iii) Demonstration of the application of linked SHEDS-PBPK models with a permethrin case study.

The methods and models reviewed by this SAP will provide new science and data that will inform the CRA for pyrethroids and support future cumulative risk assessments. The overall goal of this SAP is to review these individual and linked state-of-the-science exposure and dose assessment tools with a permethrin case study to support the Agency's pyrethroid CRA.

The purpose of this review is to request input from the SAP on this updated version of the models and related software. Specifically, the FIFRA SAP Panel at this meeting will be asked to review:

(i) The dietary module of SHEDS-Multimedia version 4, including algorithms, inputs, and results illustrated with a permethrin case study;

(ii) The residential module of SHEDS-Multimedia version 4, including algorithms, inputs, and results illustrated with a permethrin case study;

(iii) The SHEDS-Multimedia version 4 aggregate (dietary and residential modules combined) permethrin case study, including algorithms, inputs, and results;

(iv) Update on PBPK modeling since the 2007 SAP, and approaches for and results of linking SHEDS-Multimedia with PBPK models, illustrated with a permethrin case study; and

(v) Plans for a mini-cumulative (2-3 chemicals) cumulative pyrethroids assessment, including proposed methodologies using linked SHEDS-Multimedia and PBPK models.

Review of the SHEDS-Multimedia model (both dietary and residential modules) will include review of: The approaches, methodology, and algorithms used in SHEDS; annotated SHEDS SAS code; the SHEDS Graphical User Interface (GUI) and its ease of use; and technical and user manuals. The Panel will be asked to focus on non- chemical-specific default inputs at this SAP meeting. While a permethrin case study is being presented for model illustration and evaluation purposes, the Panel will not be asked to assess permethrin outputs.

Overall, the science and products being reviewed in this SAP provide exposure and risk assessors within and outside the Agency with an externally peer-reviewed physically-based, probabilistic human exposure model for multimedia, multi-route/pathway chemicals. In addition, the issues associated with refinements to PBPK models and how SHEDS outputs are linked to and used by PBPK models will be discussed both in general and by a demonstration of the application of linked SHEDS-PBPK models to a permethrin case study. It is anticipated that the review of this material by the SAP will assist ORD and OPP in both producing a plan for applying these tools to inform any future pyrethroids CRA and a generalizable approach that can be applied to other chemicals in the future.

C. FIFRA SAP Documents and Meeting Minutes

EPA's background paper, related supporting materials, charge/questions to FIFRA SAP, FIFRA SAP composition (i.e., members and ad hoc members for this meeting), and the meeting agenda will be available by late June. 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: April 27, 2010.

Frank Sanders,

Director, Office of Science Coordination and Policy.