[Federal Register Volume 76, Number 8 (Wednesday, January 12, 2011)]
[Notices]
[Pages 2107-2109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-625]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2011-0970; FRL-9252-3]


Human Studies Review Board; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The U.S. Environmental Protection Agency (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: This public meeting will be held on January 26, 2011, from 
approximately 8:30 a.m. to approximately 5 p.m. Eastern Time. The 
meeting will be held at the Environmental Protection Agency, Conference 
Center--Lobby Level, One Potomac Yard (South Bldg.), 2777 S.

[[Page 2108]]

Crystal Drive, Arlington, VA 22202. Seating at the meeting will be on a 
first-come basis. To request accommodation of a disability, please 
contact the persons listed under FOR FURTHER INFORMATION CONTACT at 
least 10 business days prior to the meeting to allow EPA adequate time 
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 section 
I. ``Public Meeting,'' under subsection D. ``How may I participate in 
this meeting?'' of this notice.

ADDRESSES: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2011-0970, by one of the following methods:
    Internet: http://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
    E-mail: <a href="/cdn-cgi/l/email-protection#751a07115b111a161e1001351005145b121a03"><span class="__cf_email__" data-cfemail="c7a8b5a3e9a3a8a4aca2b387a2b7a6e9a0a8b1">[email protected]</span></a>.
    Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC), 
ORD Docket, Mailcode: 28221T, 1200 Pennsylvania Avenue, 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 Avenue, NW., Washington, DC 20460. 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 e-mail the ORD Docket at <a href="/cdn-cgi/l/email-protection#cca3bea8e2a8a3afa7a9b88ca9bcade2aba3ba"><span class="__cf_email__" data-cfemail="0e617c6a206a616d656b7a4e6b7e6f20696178">[email protected]</span></a> for instructions. 
Updates to Public Reading Room access are available on the Web site 
(http://www.epa.gov/epahome/dockets.htm).
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2011-0970. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available online 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 the 
disclosure of which is restricted by statute. Do not submit information 
that you consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.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 http://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.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to 
receive further information should contact Jim Downing at telephone 
number: (202) 564-2468; fax: (202) 564-2070; e-mail address: 
<a href="/cdn-cgi/l/email-protection#f89c978f9691969fd6929195b89d8899d69f978e"><span class="__cf_email__" data-cfemail="37535840595e5950195d5e5a7752475619505841">[email protected]</span></a>, or Lu-Ann Kleibacker at telephone number: (202) 
564-7189; fax: 202-564-2070; e-mail address: <a href="/cdn-cgi/l/email-protection#dfb4b3bab6bdbebcb4baadf1b3aaf2beb1b19fbaafbef1b8b0a9"><span class="__cf_email__" data-cfemail="eb80878e82898a88808e99c5879ec68a8585ab8e9b8ac58c849d">[email protected]</span></a>; 
mailing address: Environmental Protection Agency, Office of the Science 
Advisor (8105R), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. 
General information concerning the EPA HSRB can be found on the EPA Web 
site at http://www.epa.gov/osa/hsrb/.

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 particular 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 Jim Downing or Lu-Ann Kleibacker 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 document electronically through the EPA Internet under the 
``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
    Docket: All documents in the docket are listed in the http://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 http://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 Avenue NW., Washington, DC 
20460. The hours of operation are 8:30 am to 4:30 p.m. EST, Monday 
through Friday, excluding Federal holidays. Please call (202) 566-1744 
or e-mail the ORD Docket at <a href="/cdn-cgi/l/email-protection#f19e8395df959e929a9485b1948190df969e87"><span class="__cf_email__" data-cfemail="117e63753f757e727a7465517461703f767e67">[email protected]</span></a> for instructions. 
Updates to Public Reading Room access are available on the Web site 
(http://www.epa.gov/epahome/dockets.htm). EPA's position paper(s), 
charge/questions to the HSRB, and the meeting agenda will be available 
by mid January 2011. 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 Web site and the EPA HSRB Web site at http://www.epa.gov/osa/hsrb/. For questions on document availability, or if 
you do not have access to the Internet, consult either Jim Downing or 
Lu-Ann Kleibacker listed under FOR FURTHER INFORMATION CONTACT.

C. What should I consider as I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data that you 
used to support your views.
    4. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    5. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject

[[Page 2109]]

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-2011-0970 in the subject line 
on the first page of your request.
    1. Oral comments. Requests to present oral comments will be 
accepted up to Wednesday, January 19, 2011. 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 Jim Downing or Lu-Ann Kleibacker, under FOR FURTHER 
INFORMATION CONTACT, no later than noon, Eastern Time, Wednesday, 
January 19, 2011, in order to be included on the meeting agenda and to 
provide sufficient time for the HSRB Chair and HSRB Designated Federal 
Official (DFO) to review the meeting agenda to provide an appropriate 
public comment period. The request should identify the name of the 
individual making the presentation and the organization (if any) the 
individual will represent. Oral comments before the HSRB are generally 
limited to five minutes per individual or organization. Please note 
that this includes 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 the time 
limitations by having numerous individuals sign up separately to speak 
on their behalf. If additional time is available, further public 
comments may be possible.
    2. Written comments. Submit your written comments prior to the 
meeting. 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 this 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, January 19, 2011. You should submit your 
comments using the instructions in section I., under subsection C., 
``What should I consider as I prepare my comments for EPA?'' In 
addition, the Agency also requests that persons submitting comments 
directly to the docket also provide a copy of their comments to Jim 
Downing or Lu-Ann Kleibacker listed under FOR FURTHER INFORMATION 
CONTACT. There is no limit on the length of written comments for 
consideration by the HSRB.

E. Background

    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.
    1. Topics for discussion. At its meeting on January 26, 2011, EPA's 
Human Studies Review Board will consider scientific and ethical issues 
surrounding these topics:

--A scenario design and associated protocol from the Agricultural 
Handler Exposure Task Force (AHETF) describing proposed research to 
monitor exposure of workers who mix and load pesticides formulated as 
wettable powders. EPA requests the advice of the HSRB concerning 
whether, if it is revised as suggested in EPA's review and if it is 
performed as described, this research is likely to generate 
scientifically reliable data, useful for assessing the exposure of 
those who mix and load pesticides formulated as wettable powders, and 
to meet the applicable requirements of 40 CFR part 26, subparts K and 
L.
--The report of a completed scenario monograph and study reports of 
five field studies from the Agricultural Handler Exposure Task Force 
(AHETF) measuring the dermal and inhalation exposure of workers 
applying liquid spray pesticides to tree or trellis crops using closed 
cab airblast equipment. The studies were conducted in five states in 
the U.S. where closed cab airblast equipment is commonly used in 
production agriculture. EPA seeks the advice of the HSRB on the 
scientific soundness of this completed research and on its 
appropriateness for use in estimating the exposure of workers who apply 
liquid spray pesticides using closed cab airblast equipment, and on 
whether available information supports a determination that the study 
was conducted in substantial compliance with subparts K and L of 40 CFR 
part 26.

    2. 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 http://www.epa.gov/osa/hsrb/ and http://www.regulations.gov. In addition, 
information concerning a Board meeting report, if applicable, can be 
found at http://www.epa.gov/osa/hsrb/ or from the person listed under 
FOR FURTHER INFORMATION CONTACT.

    Dated: January 7, 2011.
Fred S. Hauchman,
Acting EPA Science Advisor.
[FR Doc. 2011-625 Filed 1-11-11; 8:45 am]
BILLING CODE 6560-50-P


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