Human Studies Review Board; Notice of Public Meeting, 26861-26863 [E9-13061]

Download as PDF Federal Register / Vol. 74, No. 106 / Thursday, June 4, 2009 / Notices removal and treatment of sewage from all vessels are reasonably available for the Broad and Jackson Creeks, the Fishing Bay and Porpoise Cove and Moore Creek areas, in and around Deltaville Virginia. The Commonwealth of Virginia has demonstrated that there is adequate and sufficient law enforcement capability of these regulations. The Commonwealth has also submitted data to document that local citizens, advocacy groups, and marina personnel are concerned about the adverse impacts from vessel sanitary discharges into the Broad and Jackson Creeks and Fishing Bay, and adjacent areas. In response to public meetings in May and June 2008, professional and public comments were all supportive of the decision to designate the affected areas as a no discharge zone. There were sufficient agency and environmental groups’ comments to also support these measures. A final determination on this matter will be made following the 30 day period for public comment and may result in a Virginia State prohibition of any sewage discharges from vessels in the Broad and Jackson Creeks and Fishing Bay areas. Comments and views regarding this application and EPA’s tentative determination may be filed on or before July 6, 2009. Comments or requests for information or copies of the application should be addressed to Robert Runowski, EPA Region III, Office of State and Watershed Partnerships, 1650 Arch Street, Philadelphia, PA 19103. E-mail: runowski.bob@epa.gov. Telephone: (215) 814–5385. Fax: (215) 814–2301. Dated: May 19, 2009. William C. Early, Acting Regional Administrator. [FR Doc. E9–13059 Filed 6–3–09; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–ORD–2009–0183; FRL–8913–9] Human Studies Review Board; Notice of Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The U.S. Environmental Protection Agency’s (EPA or Agency) Office of the Science Advisor (OSA) announces a public meeting of the Human Studies Review Board (HSRB) to advise the Agency on EPA’s scientific and ethical reviews of research with human subjects. VerDate Nov<24>2008 15:16 Jun 03, 2009 Jkt 217001 DATES: The public meeting will be held from June 24, 2009 from approximately 9:30 a.m. to approximately 5:30 p.m., through June 25, 2009 from approximately 8:30 a.m. to approximately 4:30 p.m. Eastern Time. Location: Holiday Inn National Airport, 2605 Jefferson Davis Highway (Crystal City), Arlington, VA 22202 (703–684–7200). Meeting Access: Seating at the meeting will be on a first-come basis. To request accommodation of a disability please contact the person listed under FOR FURTHER INFORMATION CONTACT at least 10 business days prior to the meeting, to allow EPA as much time as possible to process your request. Procedures for Providing Public Input: Interested members of the public may submit relevant written or oral comments for the HSRB to consider during the advisory process. Additional information concerning submission of relevant written or oral comments is provided in Unit I.D. of this notice. FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes further information should contact Jim Downing, EPA, Office of the Science Advisor, (8105R), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 564–2468; fax: (202) 564–2070; e-mail addresses: downing.jim@epa.gov. General information concerning the EPA HSRB can be found on the EPA Web site at https://www.epa.gov/osa/hsrb/. ADDRESSES: Submit your written comments, identified by Docket ID No. EPA–HQ–ORD–2009–0183, by one of the following methods: Internet: https://www.regulations.gov: Follow the on-line instructions for submitting comments. E-mail: ord.docket@epa.gov. Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC), ORD Docket, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Hand Delivery: The EPA/DC Public Reading Room is located in the EPA Headquarters Library, Room Number 3334 in the EPA West Building, located at 1301 Constitution Ave., NW., Washington, DC. The hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through Friday, excluding Federal holidays. Please call (202) 566– 1744 or email the ORD Docket at ord.docket@epa.gov for instructions. Updates to Public Reading Room access are available on the Web site (https:// www.epa.gov/epahome/dockets.htm). Instructions: Direct your comments to Docket ID No. EPA–HQ–ORD–2009– PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 26861 0183. EPA’s policy is that all comments received will be included in the public docket without change and may be made available online at https:// 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 https:// www.regulations.gov or e-mail. The https://www.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 https:// www.regulations.gov, your e-mail address will be automatically captured 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. SUPPLEMENTARY INFORMATION: I. Public Meeting 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 conduct or assess human studies, especially studies on substances regulated by EPA or to persons who are or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act (FFDCA) or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 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 person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Access Electronic Copies of This Document and Other Related Information? In addition to using regulations.gov, you may access this Federal Register E:\FR\FM\04JNN1.SGM 04JNN1 26862 Federal Register / Vol. 74, No. 106 / Thursday, June 4, 2009 / Notices document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https:// www.epa.gov/fedrgstr/. Docket: All documents in the docket are listed in the https:// www.regulations.gov index. 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, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in https:// www.regulations.gov or in hard copy at the ORD Docket, EPA/DC, Public Reading Room. The EPA/DC Public Reading Room is located in the EPA Headquarters Library, Room Number 3334 in the EPA West Building, located at 1301 Constitution Ave., NW., Washington, DC. The hours of operation are 8:30 a.m. to 4:30 p.m. EST, Monday through Friday, excluding Federal holidays. Please call (202) 566–1744 or email the ORD Docket at ord.docket@epa.gov for instructions. Updates to Public Reading Room access are available on the Web site (https:// www.epa.gov/epahome/dockets.htm). EPA’s position paper(s), charge/ questions to the HSRB, and the meeting agenda will be available by early June 2009. 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 regulations.gov website and the EPA HSRB website at https://www.epa.gov/ osa/hsrb/. For questions on document availability or if you do not have access to the Internet, consult the person listed under FOR FURTHER INFORMATION. C. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: a. Explain your views as clearly as possible. b. Describe any assumptions that you used. c. Provide copies of any technical information and/or data you used that support your views. d. Provide specific examples to illustrate your concerns and suggest alternatives. e. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. VerDate Nov<24>2008 15:16 Jun 03, 2009 Jkt 217001 You may also provide the name, date, and Federal Register citation. D. How May I Participate in This Meeting? You may participate in this meeting by following the instructions in this section. To ensure proper receipt by EPA, it is imperative that you identify docket ID number EPA–HQ–ORD–2009– 0183 in the subject line on the first page of your request. a. Oral comments. Requests to present oral comments will be accepted up to June 17, 2009. To the extent that time permits, interested persons who have not pre-registered may be permitted by the Chair of the HSRB to present oral comments at the meeting. Each individual or group wishing to make brief oral comments to the HSRB is strongly advised to submit their request (preferably via e-mail) to the person listed under FOR FURTHER INFORMATION CONTACT no later than noon, Eastern time, June 17, 2009 in order to be included on the meeting agenda and to provide sufficient time for the HSRB Chair and HSRB Designated Federal Officer (DFO) to review the agenda to provide an appropriate public comment period. 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, LCD projector, chalkboard). Oral comments before the HSRB are limited to five minutes per individual or organization. Please note that this limit applies to the cumulative time used by all individuals appearing either as part of, or on behalf of an organization. While it is our intent to hear a full range of oral comments on the science and ethics issues under discussion, it is not our intent to permit organizations to expand these time limitations by having numerous individuals sign up separately to speak on their behalf. If additional time is available, there may be flexibility in time for public comments. Each speaker should bring 25 copies of his or her comments and presentation slides for distribution to the HSRB at the meeting. b. Written comments. Although you may submit written comments at any time, for the HSRB to have the best opportunity to review and consider your comments as it deliberates on its report, you should submit your comments at least five business days prior to the beginning of the meeting. If you submit comments after this date, those comments will be provided to the Board members, but you should recognize that the Board members may not have adequate time to consider those PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 comments prior to making a decision. Thus, if you plan to submit written comments, the Agency strongly encourages you to submit such comments no later than noon, Eastern Time, June 17, 2009. You should submit your comments using the instructions in Unit I.C. of this notice. In addition, the Agency also requests that person(s) submitting comments directly to the docket also provide a copy of their comments to the person listed under FOR FURTHER INFORMATION CONTACT. There is no limit on the length of written comments for consideration by the HSRB. E. Background A. Topics for Discussion The HSRB is a Federal advisory committee operating in accordance with the Federal Advisory Committee Act (FACA) 5 U.S.C. App. 2 section 9. The HSRB provides advice, information, and recommendations to EPA on issues related to scientific and ethical aspects of human subjects research. The major objectives of the HSRB are to provide advice and recommendations on: (1) Research proposals and protocols; (2) reports of completed research with human subjects; and (3) how to strengthen EPA’s programs for protection of human subjects of research. The HSRB reports to the EPA Administrator through EPA’s Science Advisor. The June 24–25, 2009 meeting of the Human Studies Review Board will address scientific and ethical issues surrounding: • Four unpublished reports of research completed before enactment of the 2006 expanded EPA Regulation 40 CFR part 26 (Protection of Human Subjects rule) on the organophosphate pesticide chlorpyrifos: a. A study by Coulston et al. (1972) of the subacute oral toxicity of chlorpyrifos to adult male prisoners. b. A study by Nolan et al. (1982) of the metabolism and excretion of chlorpyrifos and cholinesterase activity in adult males after a single oral or dermal exposure. c. A study by Honeycutt and DeGeare (1993) monitoring the Acetylcholinesterase activity and urinary metabolites of chlorpyrifos in agricultural workers who re-entered chlorpyrifos-treated citrus groves. d. A study by Kisicki et al. (1999) of the acute oral toxicity of chlorpyrifos to adult male and female volunteers. • A proposal for new research to be conducted by Carroll-Loye Biological Research to evaluate the repellent efficacy to biting flies in the field of two E:\FR\FM\04JNN1.SGM 04JNN1 Federal Register / Vol. 74, No. 106 / Thursday, June 4, 2009 / Notices registered products containing 20% picaridin. • The report of a completed laboratory study conducted by ICR, Inc., to evaluate the repellent efficacy to stable flies of two registered products containing 20% picaridin. • A new scenario design and associated protocol for field studies at five sites from the Agricultural Handlers Exposure Task Force (AHETF), describing proposed research to monitor exposure of professional pesticide handlers who mix and load pesticides formulated as wettable powders in water-soluble packaging. In addition, the Board will be reviewing its draft February 17, 2009 meeting report for subsequent Board approval. Finally, the HSRB may also discuss planning for future HSRB meetings. B. Meeting Minutes and Reports Minutes of the meeting, summarizing the matters discussed and recommendations, if any, made by the advisory committee regarding such matters will be released within 90 calendar days of the meeting. Such minutes will be available at https:// www.epa.gov/osa/hsrb/ and https:// www.regulations.gov. In addition, information concerning a Board meeting report, if applicable, can be found at https://www.epa.gov/osa/hsrb/ or from the person listed under FOR FURTHER INFORMATION. Dated: May 29, 2009. Kevin Teichman, EPA Acting Science Advisor. [FR Doc. E9–13061 Filed 6–3–09; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–8913–4] Proposed Settlement Agreement AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of proposed settlement agreement; request for public comment. SUMMARY: In accordance with section 113(g) of the Clean Air Act, as amended (‘‘Act’’), 42 U.S.C. 7413(g), notice is hereby given of a proposed settlement agreement to address a lawsuit filed by American Petroleum Institute (API) in the United States Court of Appeals for the District of Columbia Circuit: American Petroleum Institute v. EPA, No. 06–1321 (D.C. Cir.). API filed a petition for review of an EPA rule promulgating regulations requiring new VerDate Nov<24>2008 15:16 Jun 03, 2009 Jkt 217001 source performance standards for new stationary compression ignition internal combustion engines. Under the terms of the proposed settlement agreement, EPA agrees to propose revisions to the new source performance standards and to issue guidance specifying particular standards applicable under the regulations. DATES: Written comments on the proposed settlement agreement must be received by July 6, 2009. ADDRESSES: Submit your comments, identified by Docket ID number EPA– HQ–OGC–2009–0354, Online at https:// www.regulations.gov (EPA’s preferred method); by e-mail to oei.docket@epa.gov; by mail to EPA Docket Center, Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; or by hand delivery or courier to EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on a disk or CD– ROM should be formatted in Word or ASCII file, avoiding the use of special characters and any form of encryption, and may be mailed to the mailing address above. FOR FURTHER INFORMATION CONTACT: Michael Horowitz, Air and Radiation Law Office (2344A), Office of General Counsel, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone: (202) 564–5583; fax number (202) 564–5603; e-mail address: horowitz.michael@epa.gov. SUPPLEMENTARY INFORMATION: I. Additional Information About the Proposed Settlement Agreement This proposed settlement agreement would potentially resolve a petition for judicial review filed by API for review of a rule promulgating new source performance standards for new stationary compression ignition internal combustion engines. Under the terms of the proposed settlement agreement, EPA agrees to propose, no later than one year after execution of the settlement agreement, revisions to the new source performance standards. The proposed revisions would allow owners and operators more options in operating and maintaining their engines, but would require more testing for sources using the additional options. The proposal would also clarify certain provisions of the existing regulations and make minor modifications unrelated to the stringency of the standards. After considering any comment reviewed, PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 26863 EPA agrees to sign a final rule within one year of the publication of the proposal. If the relevant provisions of the final rule are in substantial conformance with the revisions in the draft agreement, then API agrees to the dismissal of its petition for review. Additionally, based on API concerns that the regulations are not sufficiently clear regarding the not-to-exceed standards and multiples applicable to engines subject to the regulations, EPA agrees to issue guidance specifying the not-to-exceed standards and multiples applicable to such engines. For a period of thirty (30) days following the date of publication of this notice, the Agency will accept written comments relating to the proposed settlement agreement from persons who were not named as parties or intervenors to the litigation in question. EPA or the Department of Justice may withdraw or withhold consent to the proposed settlement agreement if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act. Unless EPA or the Department of Justice determines, based on any comment submitted, that consent to this settlement agreement should be withdrawn, the terms of the agreement will be affirmed. II. Additional Information About Commenting on the Proposed Settlement Agreement A. How Can I Get a Copy of the Settlement Agreement? The official public docket for this action (identified by Docket ID No. EPA–HQ–OGC–2009–0354) contains a copy of the proposed settlement agreement. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OEI Docket is (202) 566– 1752. An electronic version of the public docket is available through https:// www.regulations.gov. You may use the https://www.regulations.gov to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the E:\FR\FM\04JNN1.SGM 04JNN1

Agencies

[Federal Register Volume 74, Number 106 (Thursday, June 4, 2009)]
[Notices]
[Pages 26861-26863]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13061]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2009-0183; FRL-8913-9]


Human Studies Review Board; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The U.S. Environmental Protection Agency's (EPA or Agency) 
Office of the Science Advisor (OSA) announces a public meeting of the 
Human Studies Review Board (HSRB) to advise the Agency on EPA's 
scientific and ethical reviews of research with human subjects.

DATES: The public meeting will be held from June 24, 2009 from 
approximately 9:30 a.m. to approximately 5:30 p.m., through June 25, 
2009 from approximately 8:30 a.m. to approximately 4:30 p.m. Eastern 
Time.
    Location: Holiday Inn National Airport, 2605 Jefferson Davis 
Highway (Crystal City), Arlington, VA 22202 (703-684-7200).
    Meeting Access: Seating at the meeting will be on a first-come 
basis. To request accommodation of a disability please contact the 
person listed under FOR FURTHER INFORMATION CONTACT at least 10 
business days prior to the meeting, to allow EPA as much time as 
possible to process your request.
    Procedures for Providing Public Input: Interested members of the 
public may submit relevant written or oral comments for the HSRB to 
consider during the advisory process. Additional information concerning 
submission of relevant written or oral comments is provided in Unit 
I.D. of this notice.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes 
further information should contact Jim Downing, EPA, Office of the 
Science Advisor, (8105R), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 
564-2468; fax: (202) 564-2070; e-mail addresses: downing.jim@epa.gov. 
General information concerning the EPA HSRB can be found on the EPA Web 
site at https://www.epa.gov/osa/hsrb/.

ADDRESSES: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2009-0183, by one of the following methods:
    Internet: https://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
    E-mail: ord.docket@epa.gov.
    Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC), 
ORD Docket, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, 
DC 20460.
    Hand Delivery: The EPA/DC Public Reading Room is located in the EPA 
Headquarters Library, Room Number 3334 in the EPA West Building, 
located at 1301 Constitution Ave., NW., Washington, DC. The hours of 
operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through 
Friday, excluding Federal holidays. Please call (202) 566-1744 or email 
the ORD Docket at ord.docket@epa.gov for instructions. Updates to 
Public Reading Room access are available on the Web site (https://www.epa.gov/epahome/dockets.htm).
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2009-0183. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available online at 
https://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 https://www.regulations.gov or e-mail. The https://www.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 https://www.regulations.gov, your e-mail address will be 
automatically captured 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.

SUPPLEMENTARY INFORMATION: 

I. Public Meeting

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 conduct or assess human studies, 
especially studies on substances regulated by EPA or to persons who are 
or may be required to conduct testing of chemical substances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA) or the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA). 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 person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of This Document and Other 
Related Information?

    In addition to using regulations.gov, you may access this Federal 
Register

[[Page 26862]]

document electronically through the EPA Internet under the ``Federal 
Register'' listings at https://www.epa.gov/fedrgstr/.
    Docket: All documents in the docket are listed in the https://www.regulations.gov index. 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, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in https://www.regulations.gov or in hard copy at the ORD Docket, EPA/
DC, Public Reading Room. The EPA/DC Public Reading Room is located in 
the EPA Headquarters Library, Room Number 3334 in the EPA West 
Building, located at 1301 Constitution Ave., NW., Washington, DC. The 
hours of operation are 8:30 a.m. to 4:30 p.m. EST, Monday through 
Friday, excluding Federal holidays. Please call (202) 566-1744 or email 
the ORD Docket at ord.docket@epa.gov for instructions. Updates to 
Public Reading Room access are available on the Web site (https://www.epa.gov/epahome/dockets.htm).
    EPA's position paper(s), charge/questions to the HSRB, and the 
meeting agenda will be available by early June 2009. 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 regulations.gov website and the EPA HSRB 
website at https://www.epa.gov/osa/hsrb/. For questions on document 
availability or if you do not have access to the Internet, consult the 
person listed under FOR FURTHER INFORMATION.

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

    You may find the following suggestions helpful for preparing your 
comments:
    a. Explain your views as clearly as possible.
    b. Describe any assumptions that you used.
    c. Provide copies of any technical information and/or data you used 
that support your views.
    d. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    e. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

D. How May I Participate in This Meeting?

    You may participate in this meeting by following the instructions 
in this section. To ensure proper receipt by EPA, it is imperative that 
you identify docket ID number EPA-HQ-ORD-2009-0183 in the subject line 
on the first page of your request.
    a. Oral comments. Requests to present oral comments will be 
accepted up to June 17, 2009. To the extent that time permits, 
interested persons who have not pre-registered may be permitted by the 
Chair of the HSRB to present oral comments at the meeting. Each 
individual or group wishing to make brief oral comments to the HSRB is 
strongly advised to submit their request (preferably via e-mail) to the 
person listed under FOR FURTHER INFORMATION CONTACT no later than noon, 
Eastern time, June 17, 2009 in order to be included on the meeting 
agenda and to provide sufficient time for the HSRB Chair and HSRB 
Designated Federal Officer (DFO) to review the agenda to provide an 
appropriate public comment period. 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, LCD projector, chalkboard). Oral 
comments before the HSRB are limited to five minutes per individual or 
organization. Please note that this limit applies to the cumulative 
time used by all individuals appearing either as part of, or on behalf 
of an organization. While it is our intent to hear a full range of oral 
comments on the science and ethics issues under discussion, it is not 
our intent to permit organizations to expand these time limitations by 
having numerous individuals sign up separately to speak on their 
behalf. If additional time is available, there may be flexibility in 
time for public comments. Each speaker should bring 25 copies of his or 
her comments and presentation slides for distribution to the HSRB at 
the meeting.
    b. Written comments. Although you may submit written comments at 
any time, for the HSRB to have the best opportunity to review and 
consider your comments as it deliberates on its report, you should 
submit your comments at least five business days prior to the beginning 
of the meeting. If you submit comments after this date, those comments 
will be provided to the Board members, but you should recognize that 
the Board members may not have adequate time to consider those comments 
prior to making a decision. Thus, if you plan to submit written 
comments, the Agency strongly encourages you to submit such comments no 
later than noon, Eastern Time, June 17, 2009. You should submit your 
comments using the instructions in Unit I.C. of this notice. In 
addition, the Agency also requests that person(s) submitting comments 
directly to the docket also provide a copy of their comments to the 
person listed under FOR FURTHER INFORMATION CONTACT. There is no limit 
on the length of written comments for consideration by the HSRB.

E. Background

A. Topics for Discussion
    The HSRB is a Federal advisory committee operating in accordance 
with the Federal Advisory Committee Act (FACA) 5 U.S.C. App. 2 section 
9. The HSRB provides advice, information, and recommendations to EPA on 
issues related to scientific and ethical aspects of human subjects 
research. The major objectives of the HSRB are to provide advice and 
recommendations on: (1) Research proposals and protocols; (2) reports 
of completed research with human subjects; and (3) how to strengthen 
EPA's programs for protection of human subjects of research. The HSRB 
reports to the EPA Administrator through EPA's Science Advisor.
    The June 24-25, 2009 meeting of the Human Studies Review Board will 
address scientific and ethical issues surrounding:
     Four unpublished reports of research completed before 
enactment of the 2006 expanded EPA Regulation 40 CFR part 26 
(Protection of Human Subjects rule) on the organophosphate pesticide 
chlorpyrifos:
    a. A study by Coulston et al. (1972) of the subacute oral toxicity 
of chlorpyrifos to adult male prisoners.
    b. A study by Nolan et al. (1982) of the metabolism and excretion 
of chlorpyrifos and cholinesterase activity in adult males after a 
single oral or dermal exposure.
    c. A study by Honeycutt and DeGeare (1993) monitoring the 
Acetylcholinesterase activity and urinary metabolites of chlorpyrifos 
in agricultural workers who re-entered chlorpyrifos-treated citrus 
groves.
    d. A study by Kisicki et al. (1999) of the acute oral toxicity of 
chlorpyrifos to adult male and female volunteers.
     A proposal for new research to be conducted by Carroll-
Loye Biological Research to evaluate the repellent efficacy to biting 
flies in the field of two

[[Page 26863]]

registered products containing 20% picaridin.
     The report of a completed laboratory study conducted by 
ICR, Inc., to evaluate the repellent efficacy to stable flies of two 
registered products containing 20% picaridin.
     A new scenario design and associated protocol for field 
studies at five sites from the Agricultural Handlers Exposure Task 
Force (AHETF), describing proposed research to monitor exposure of 
professional pesticide handlers who mix and load pesticides formulated 
as wettable powders in water-soluble packaging.
    In addition, the Board will be reviewing its draft February 17, 
2009 meeting report for subsequent Board approval. Finally, the HSRB 
may also discuss planning for future HSRB meetings.
B. Meeting Minutes and Reports
    Minutes of the meeting, summarizing the matters discussed and 
recommendations, if any, made by the advisory committee regarding such 
matters will be released within 90 calendar days of the meeting. Such 
minutes will be available at https://www.epa.gov/osa/hsrb/ and https://www.regulations.gov. In addition, information concerning a Board 
meeting report, if applicable, can be found at https://www.epa.gov/osa/hsrb/ or from the person listed under FOR FURTHER INFORMATION.

    Dated: May 29, 2009.
Kevin Teichman,
EPA Acting Science Advisor.
[FR Doc. E9-13061 Filed 6-3-09; 8:45 am]
BILLING CODE 6560-50-P
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