[Federal Register Volume 76, Number 59 (Monday, March 28, 2011)]
[Notices]
[Pages 17121-17123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7198]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2011-0124; FRL-9287-1]


Human Studies Review Board (HSRB); Notification of a Public 
Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) Office of the 
Science Advisor (OSA) announces a public meeting of the 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 April 13-14, 2011, from 
approximately 8:30 a.m. to approximately 5 p.m. Eastern Time.

ADDRESSES: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2011-0124, 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#155a47513b517a767e7061557065743b727a63"><span class="__cf_email__" data-cfemail="b8f7eafc96fcd7dbd3ddccf8ddc8d996dfd7ce">[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" class="__cf_email__" data-cfemail="ed829f89c389828e868899ad889d8cc38a829b">[email protected]</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-
2011-0124. 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

[[Page 17122]]

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#096d667e6760676e27636064496c7968276e667f"><span class="__cf_email__" data-cfemail="30545f475e595e571e5a595d705540511e575f46">[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#503b3c35393231333b35227e3c257d313e3e103520317e373f26"><span class="__cf_email__" data-cfemail="e883848d818a898b838d9ac6849dc5898686a88d9889c68f879e">[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:
    Location: Holiday Inn National Airport, 2650 Jefferson Davis 
Highway, Arlington, VA 22202.
    Meeting access: 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 ten 
business days prior to the meeting using the information under FOR 
FURTHER INFORMATION CONTACT, so that appropriate arrangements can be 
made.
    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.

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 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" class="__cf_email__" data-cfemail="513e23357f353e323a3425113421307f363e27">[email protected]</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 the end of March 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 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-2011-0124 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, April 6, 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 
email) to Jim Downing or Lu-Ann Kleibacker, under FOR FURTHER 
INFORMATION CONTACT, no later than noon, Eastern Time, Wednesday, April 
6, 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

[[Page 17123]]

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, Wednesday, April 6, 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 Sec.  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 April 13 and 14, 2011, 
EPA's Human Studies Review Board will consider scientific and ethical 
issues surrounding these topics:
    a. The report of a completed scenario monograph and study reports 
from the Agricultural Handler Exposure Task Force (AHETF) measuring the 
dermal and inhalation exposure of professional agricultural workers 
applying liquid spray pesticides to tree or trellis crops using open 
cab airblast equipment.
    b. The report of a completed scenario monograph and study report 
from the Antimicrobial Exposure Assessment Task Force II (AEATF) in 
which the dermal and inhalation exposure of professional janitorial 
workers was monitored as they applied a liquid antimicrobial product to 
indoor surfaces using a trigger spray bottle and wipes or ready-to-use 
wipes.
    c. A published report by Gulson et al (2010) of an intentional 
exposure human study measuring dermal absorption of zinc oxides 
contained in sunscreen.
    d. A reevaluation of an intentional human dosing study with 
chlorpyrifos (Kisicki) previously reviewed by the HSRB; pertinent new 
information from the sponsor has been made available.
    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: March 23, 2011.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2011-7198 Filed 3-25-11; 8:45 am]
BILLING CODE 6560-50-P


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