FIFRA Scientific Advisory Panel; Notice of Public Meeting, 26287-26290 [2011-11027]

Download as PDF Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Notices Revision to FR Notice Published 04/15/2011: Correction to the Review Period from 05/08/2011 to 05/16/2011. EIS No. 20110119, Final EIS, USFS, CA, Kings River Experimental Watershed Forest Health and Research Project, Implementation, Sierra National Forest, High Sierra Ranger District, Fresno County, CA, Review Period Ends: 05/16/2011, Contact: Judi Tapia 559–297–0706 Ext. 4938. Revision to FR Notice Published 04/15/2011: Correction to the Review Period from 05/09/2011 to 05/16/2011. Dated: May 3, 2011. Robert W. Hargrove, Director, NEPA Compliance Division, Office of Federal Activities. [FR Doc. 2011–11118 Filed 5–5–11; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2011–0399; FRL– 8872–8] FIFRA Scientific Advisory Panel; Notice of Public Meeting Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: There will be a 4-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 the Re-Evaluation of Human Health Effects of Atrazine: Review of NonCancer Effects, Drinking Water Monitoring Frequency, and Cancer Epidemiology. SUMMARY: The meeting will be held on July 26–29, 2011, from approximately 8:30 a.m. to 5 p.m. Comments. The Agency encourages that written comments be submitted by July 12, 2011 and requests for oral comments be submitted by July 19, 2011. 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 12, 2011 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 20, 2011. Webcast. This meeting may be webcast. Please refer to the FIFRA SAP’s emcdonald on DSK2BSOYB1PROD with NOTICES DATES: VerDate Mar<15>2010 17:26 May 05, 2011 Jkt 223001 Web site, 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–2011–0399, 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 (703) 305–5805. Instructions: Direct your comments to docket ID number EPA–HQ–OPP–2011– 0399. 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- PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 26287 mail. The regulations.gov Web site 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 (703) 305–5805. 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: Joseph Bailey, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (202) 564–2045; fax number: (202) 564– 8382; e-mail address: bailey.joseph@epa.gov. SUPPLEMENTARY INFORMATION: E:\FR\FM\06MYN1.SGM 06MYN1 26288 Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Notices 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. emcdonald on DSK2BSOYB1PROD with NOTICES 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–2011–0399 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 12, 2011, to provide FIFRA SAP the time necessary to consider and review the written comments. Written comments VerDate Mar<15>2010 17:26 May 05, 2011 Jkt 223001 are accepted until the date of the meeting, but anyone submitting written comments after July 12, 2011should contact the DFO listed under FOR FURTHER INFORMATION CONTACT. Anyone submitting written comments at the meeting should bring 30 copies for distribution to the FIFRA SAP. 2. Oral comments. The Agency encourages that each individual or group wishing to make brief oral comments to the FIFRA SAP submit their request to the DFO listed under FOR FURTHER INFORMATION CONTACT no later than July 19, 2011, 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 firstcome 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: Risk assessment, environmental epidemiology, exposure assessment (particularly pesticide applicators), mammary gland development, mode of action analysis (particularly those with MOA framework experience), frameworks to evaluate human relevance, prostate development, pharmacokinetics, physiologicallybased pharmacokinetic modeling, neuroendocrinology, hormone-mediated health effects, HPA axis (corticosterone), reproductive/developmental biology and environmental sampling and statistical modeling. Nominees should PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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 20, 2011. 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 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 candidate’s financial disclosure E:\FR\FM\06MYN1.SGM 06MYN1 Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Notices 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 Web site at http://epa.gov/scipoly/sap or may be obtained from the OPP Regulatory Public Docket at http:// www.regulations.gov. emcdonald on DSK2BSOYB1PROD with NOTICES 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 EPA is undertaking a re-evaluation of the human health effects of atrazine. The human health re-evaluation has involved three SAP meetings in 2010 and one in 2011. The first meeting was VerDate Mar<15>2010 17:26 May 05, 2011 Jkt 223001 held in February 2010 during which the Agency presented its preliminary reviews of several atrazine epidemiology studies on birth outcomes and described a project plan to evaluate atrazine epidemiology data from the Agricultural Health Study (http:// aghealth.nci.nih.gov/). The second meeting in April 2010 SAP meeting focused on: 1. A preliminary review of experimental toxicology studies from laboratory mammals and in vitro studies and recent advancements in understanding atrazine’s mode of action along with; 2. Statistical and modeling approaches for evaluating monitoring frequency in community water systems (CWS). The September 2010 meeting built on the scientific analysis and SAP feedback from the April meeting. Specifically, the Agency presented scientific analyses on an empirical approach for estimating internal dosimetry, and calculation of benchmark dose estimates for purposes of deriving points of departure. In addition, EPA presented a general strategy for designing a monitoring study to characterize drinking water exposures and discussed different methods for analyzing and interpreting monitoring data collected at different sampling frequencies. The September 2010 meeting also provided proposals for updating the critical durations of exposure based on the new science, and a preliminary evaluation of potential susceptibility of the young. In addition, the September 2010 meeting included evaluation of non-cancer epidemiology studies, a weight of the evidence evaluation of the non-cancer epidemiology studies with experimental laboratory studies, and a proposal to use the non-cancer epidemiology studies qualitatively in evaluating the human relevance of experimental toxicology findings. The July 2011 SAP meeting will build on the scientific analyses and SAP feedback from the previous three SAP meetings by proposing a conceptual framework for the evaluation of atrazine human health non-cancer effects. This proposed conceptual framework will integrate information on mode of action and adverse outcome pathways, potentially susceptible lifestages/ subpopulations, drinking water exposure, internal dosimetry, and water monitoring sampling uncertainty. The Agency will solicit comment on the overall integrative approach proposed for atrazine along with technical considerations for each scientific component. To illustrate the conceptual framework, a case study will be PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 26289 provided that demonstrates an approach for estimating non-cancer risk to atrazine based on an internal dose metric for temporally, spatially, and demographically explicit information. The Agency will use feedback received from the SAP at the July 2011 meeting as it completes the scientific analysis for determining whether or not adjustments may be necessary in the sampling frequency of CWS monitoring. The evaluation of non-cancer effects will include studies available up through April 29, 2010. In the 2003 Interim Reregistration Eligibility Decision (IRED) for atrazine, the Agency noted that it would convene another SAP meeting concerning atrazine and its possible association with carcinogenic effects, particularly as new information from the National Cancer Institute’s (NCI) Agricultural Health Study (AHS) is made available. The Agency believes it is appropriate at this time to re-evaluate the cancer epidemiology literature on atrazine in a SAP meeting; EPA notes that the evidence of atrazine carcinogenicity based upon experimental animal data were evaluated by the SAP in April 2010. As such, at the July 2011 meeting, the Agency will provide a preliminary review of cancer epidemiology studies and a draft weight of the evidence (WOE) analysis on cancer that integrates mode of action, experimental toxicology information, and epidemiology. This draft WOE analysis will follow the Draft Framework for Incorporating Epidemiologic and Human Incident Data in Health Risk Assessment, which was reviewed by the SAP in February 2010. The Agency will include epidemiological studies on the cancer effects of atrazine available up through April 29, 2010. The Agricultural Health Study is anticipated to be published in spring 2011 and will be part of this review given that this study is considered to be a pivotal line of evidence. At the February 2010 SAP, the Agency presented a proposed plan for a collaborative project with investigators from the AHS to evaluate approaches for estimating exposure to pesticide applicators. At the July 2011 meeting, the Agency will discuss the status of the collaborative project (which includes a case study involving atrazine) and solicit comment from the Panel on the overall direction of the project and the methods development aspects of this effort. This project is part of a larger effort by OPP to improve the incorporation of epidemiology in human health risk assessment. The feedback from the SAP may not be used for atrazine risk assessment per se but E:\FR\FM\06MYN1.SGM 06MYN1 26290 Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Notices will inform EPA’s continued efforts to improve risk assessment approaches and methodologies. The public teleconference will be conducted by telephone only. ADDRESSES: 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 Web site 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, 2011. Frank Sanders, Director, Office of Science Coordination and Policy. [FR Doc. 2011–11027 Filed 5–5–11; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–9302–7] Science Advisory Board Staff Office; Notification of a Public Teleconference of the Chartered Science Advisory Board Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: The EPA Science Advisory Board (SAB) Staff Office announces a public teleconference of the chartered SAB on June 6, 2011 to conduct a quality review of a draft SAB report entitled ‘‘SAB Review of EPA’s Reanalysis of Key Issues Related to Dioxin Toxicity and Response to NAS Comments.’’ emcdonald on DSK2BSOYB1PROD with NOTICES SUMMARY: The public teleconference will be held on June 6, 2011, from 12 p.m. to 4 p.m. (Eastern Time). DATES: VerDate Mar<15>2010 17:26 May 05, 2011 Jkt 223001 Any member of the public wishing to obtain general information concerning the public teleconference may contact Ms. Stephanie Sanzone, Designated Federal Officer (DFO), EPA Science Advisory Board via e-mail at sanzone.stephanie@epa.gov, telephone/ voice mail (202) 564–2067, or fax (202) 565–2098. General information concerning the EPA Science Advisory Board can be found on the EPA Web site at http://www.epa.gov/sab. FOR FURTHER INFORMATION CONTACT: C. FIFRA SAP Documents and Meeting Minutes The SAB was established pursuant to the Environmental Research, Development, and Demonstration Authorization Act (ERDAA), codified at 42 U.S.C. 4365, to provide independent scientific and technical advice to the EPA Administrator on the technical basis for Agency positions and regulations. The SAB is a Federal Advisory Committee chartered under the Federal Advisory Committee Act (FACA), 5 U.S.C., App. 2. Pursuant to FACA and EPA policy, notice is hereby given that the SAB will hold a public teleconference to conduct a quality review of a draft report entitled ‘‘SAB Review of EPA’s Reanalysis of Key Issues Related to Dioxin Toxicity and Response to NAS Comments.’’ The SAB will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies. Background: The SAB was asked to review and provide advice to EPA on a draft report, entitled ‘‘EPA’s Reanalysis of Key Issues Related to Dioxin Toxicity and Response to NAS Comments.’’ To conduct this review, the SAB Staff Office requested public nominations of experts (73 FR 61114) and formed the ad hoc SAB Dioxin Review Panel. The Panel held face-to-face public meetings on July 13–15, 2010 (75 FR 28805) and October 27–29, 2010 (75 FR 57779), and follow-up public teleconference meetings on March 1 and March 2, 2011 (76 FR 6784) to review EPA’s draft document. The SAB will conduct a quality review of the Panel’s draft report, ‘‘SAB Review of EPA’s Reanalysis of Key Issues Related to Dioxin Toxicity and Response to NAS Comments.’’ Background information about this SAB advisory activity can be found on the SAB Web site at http:// yosemite.epa.gov/sab/sabproduct.nsf/ fedrgstr_activites/ Dioxin%20Reasst%20-%2020082011?OpenDocument. Availability of Meeting Materials: The agenda and other materials in support of the teleconference will be placed on the SUPPLEMENTARY INFORMATION: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 SAB Web site at http://www.epa.gov/sab in advance of the teleconference. Procedures for Providing Public Input: Public comment for consideration by EPA’s federal advisory committees and panels has a different purpose from public comment provided to EPA program offices. Therefore, the process for submitting comments to a federal advisory committee is different from the process used to submit comments to an EPA program office. Federal advisory committees and panels, including scientific advisory committees, provide independent advice to EPA. Members of the public can submit comments for a federal advisory committee to consider as it develops advice for EPA. Input from the public to the SAB will have the most impact if it provides specific scientific or technical information or analysis for SAB panels to consider or if it relates to the clarity or accuracy of the technical information. Members of the public wishing to provide comment should contact the Designated Federal Officer directly. Oral Statements: Individuals or groups requesting an oral presentation will be limited to five minutes. Those interested in being placed on the public speakers list for the June 6, 2011, teleconference should contact Ms. Sanzone at the contact information provided above no later than May 27, 2011. Written Statements: Written statements should be supplied to the DFO via e-mail at the contact information noted above by May 27, 2011, for the teleconference so that the information may be made available to the Panel members for their consideration. Written statements should be supplied in one of the following electronic formats: Adobe Acrobat PDF, MS Word, MS PowerPoint, or Rich Text files in IBM– PC/Windows 98/2000/XP format. It is the SAB Staff Office general policy to post written comments on the Web page for the advisory meeting or teleconference. Submitters are requested to provide an unsigned version of each document because the SAB Staff Office does not publish documents with signatures on its Web sites. Members of the public should be aware that their personal contact information, if included in any written comments, may be posted to the SAB Web site. Copyrighted material will not be posted without explicit permission of the copyright holder. Accessibility: For information on access or services for individuals with disabilities, please contact Ms. Sanzone at (202) 564–2067 or sanzone.stephanie@epa.gov. To request accommodation of a disability, please E:\FR\FM\06MYN1.SGM 06MYN1

Agencies

[Federal Register Volume 76, Number 88 (Friday, May 6, 2011)]
[Notices]
[Pages 26287-26290]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11027]


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ENVIRONMENTAL PROTECTION AGENCY

 [EPA-HQ-OPP-2011-0399; FRL- 8872-8]


FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 4-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 the Re-
Evaluation of Human Health Effects of Atrazine: Review of Non-Cancer 
Effects, Drinking Water Monitoring Frequency, and Cancer Epidemiology.

DATES: The meeting will be held on July 26-29, 2011, from approximately 
8:30 a.m. to 5 p.m.
    Comments. The Agency encourages that written comments be submitted 
by July 12, 2011 and requests for oral comments be submitted by July 
19, 2011. 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 12, 2011 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 20, 
2011.
    Webcast. This meeting may be webcast. Please refer to the FIFRA 
SAP's Web site, 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-2011-0399, 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 (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2011-0399. 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 Web site 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 (703) 305-5805.
    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: Joseph Bailey, DFO, Office of Science 
Coordination and Policy (7201M), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(202) 564-2045; fax number: (202) 564-8382; e-mail address: 
bailey.joseph@epa.gov.

SUPPLEMENTARY INFORMATION:

[[Page 26288]]

 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-2011-0399 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 12, 
2011, 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 12, 
2011should contact the DFO listed under FOR FURTHER INFORMATION 
CONTACT. Anyone submitting written comments at the meeting should bring 
30 copies for distribution to the FIFRA SAP.
    2. Oral comments. The Agency encourages that each individual or 
group wishing to make brief oral comments to the FIFRA SAP submit their 
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no 
later than July 19, 2011, 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: Risk assessment, environmental epidemiology, exposure assessment 
(particularly pesticide applicators), mammary gland development, mode 
of action analysis (particularly those with MOA framework experience), 
frameworks to evaluate human relevance, prostate development, 
pharmacokinetics, physiologically-based pharmacokinetic modeling, 
neuroendocrinology, hormone-mediated health effects, HPA axis 
(corticosterone), reproductive/developmental biology and environmental 
sampling and statistical modeling. 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 20, 2011. 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 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 candidate's financial disclosure

[[Page 26289]]

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 Web site 
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

    EPA is undertaking a re-evaluation of the human health effects of 
atrazine. The human health re-evaluation has involved three SAP 
meetings in 2010 and one in 2011. The first meeting was held in 
February 2010 during which the Agency presented its preliminary reviews 
of several atrazine epidemiology studies on birth outcomes and 
described a project plan to evaluate atrazine epidemiology data from 
the Agricultural Health Study (http://aghealth.nci.nih.gov/). The 
second meeting in April 2010 SAP meeting focused on:
    1. A preliminary review of experimental toxicology studies from 
laboratory mammals and in vitro studies and recent advancements in 
understanding atrazine's mode of action along with;
    2. Statistical and modeling approaches for evaluating monitoring 
frequency in community water systems (CWS). The September 2010 meeting 
built on the scientific analysis and SAP feedback from the April 
meeting. Specifically, the Agency presented scientific analyses on an 
empirical approach for estimating internal dosimetry, and calculation 
of benchmark dose estimates for purposes of deriving points of 
departure. In addition, EPA presented a general strategy for designing 
a monitoring study to characterize drinking water exposures and 
discussed different methods for analyzing and interpreting monitoring 
data collected at different sampling frequencies. The September 2010 
meeting also provided proposals for updating the critical durations of 
exposure based on the new science, and a preliminary evaluation of 
potential susceptibility of the young. In addition, the September 2010 
meeting included evaluation of non-cancer epidemiology studies, a 
weight of the evidence evaluation of the non-cancer epidemiology 
studies with experimental laboratory studies, and a proposal to use the 
non-cancer epidemiology studies qualitatively in evaluating the human 
relevance of experimental toxicology findings.
    The July 2011 SAP meeting will build on the scientific analyses and 
SAP feedback from the previous three SAP meetings by proposing a 
conceptual framework for the evaluation of atrazine human health non-
cancer effects. This proposed conceptual framework will integrate 
information on mode of action and adverse outcome pathways, potentially 
susceptible lifestages/subpopulations, drinking water exposure, 
internal dosimetry, and water monitoring sampling uncertainty. The 
Agency will solicit comment on the overall integrative approach 
proposed for atrazine along with technical considerations for each 
scientific component. To illustrate the conceptual framework, a case 
study will be provided that demonstrates an approach for estimating 
non-cancer risk to atrazine based on an internal dose metric for 
temporally, spatially, and demographically explicit information. The 
Agency will use feedback received from the SAP at the July 2011 meeting 
as it completes the scientific analysis for determining whether or not 
adjustments may be necessary in the sampling frequency of CWS 
monitoring. The evaluation of non-cancer effects will include studies 
available up through April 29, 2010.
    In the 2003 Interim Reregistration Eligibility Decision (IRED) for 
atrazine, the Agency noted that it would convene another SAP meeting 
concerning atrazine and its possible association with carcinogenic 
effects, particularly as new information from the National Cancer 
Institute's (NCI) Agricultural Health Study (AHS) is made available. 
The Agency believes it is appropriate at this time to re-evaluate the 
cancer epidemiology literature on atrazine in a SAP meeting; EPA notes 
that the evidence of atrazine carcinogenicity based upon experimental 
animal data were evaluated by the SAP in April 2010. As such, at the 
July 2011 meeting, the Agency will provide a preliminary review of 
cancer epidemiology studies and a draft weight of the evidence (WOE) 
analysis on cancer that integrates mode of action, experimental 
toxicology information, and epidemiology. This draft WOE analysis will 
follow the Draft Framework for Incorporating Epidemiologic and Human 
Incident Data in Health Risk Assessment, which was reviewed by the SAP 
in February 2010. The Agency will include epidemiological studies on 
the cancer effects of atrazine available up through April 29, 2010. The 
Agricultural Health Study is anticipated to be published in spring 2011 
and will be part of this review given that this study is considered to 
be a pivotal line of evidence.
    At the February 2010 SAP, the Agency presented a proposed plan for 
a collaborative project with investigators from the AHS to evaluate 
approaches for estimating exposure to pesticide applicators. At the 
July 2011 meeting, the Agency will discuss the status of the 
collaborative project (which includes a case study involving atrazine) 
and solicit comment from the Panel on the overall direction of the 
project and the methods development aspects of this effort. This 
project is part of a larger effort by OPP to improve the incorporation 
of epidemiology in human health risk assessment. The feedback from the 
SAP may not be used for atrazine risk assessment per se but

[[Page 26290]]

will inform EPA's continued efforts to improve risk assessment 
approaches and methodologies.

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 Web site 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, 2011.
 Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. 2011-11027 Filed 5-5-11; 8:45 am]
BILLING CODE 6560-50-P