
[Federal Register Volume 76, Number 187 (Tuesday, September 27, 2011)]
[Notices]
[Pages 59697-59699]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24816]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2011-0693; FRL-9472-4]


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 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 October 19-20, 2011, from 
approximately 9 a.m. to approximately 5:30 p.m. Eastern Time. Comments 
may be submitted on or before Wednesday, October 12, 2011.

ADDRESSES: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2011-0693, by one of the following methods:
    Internet: http://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 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 ord.docket@epa.gov 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-
2011-0693. 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 
electronic storage media 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: 
downing.jim@epa.gov, or Lu-Ann Kleibacker at telephone number: (202) 
564-7189; fax: 202-564-2070; e-mail address: kleibacker.lu-ann@epa.gov; 
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: The meeting will be held at the 
Environmental Protection Agency, Conference Center--Lobby Level, One 
Potomac Yard (South Bldg.) 2777 S. Crystal Drive, 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). This 
notice might also be of special interest to participants of studies 
involving human subjects, or representatives of study participants or 
experts on community engagement. Since many 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/.

[[Page 59698]]

    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. 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 (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 first of October 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-2011-0693 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, October 12, 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, 
October 12, 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, Wednesday, October 12, 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 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 October 19 and 20, 
2011, EPA's Human Studies Review Board will consider scientific and 
ethical issues surrounding these topics:
    a. A new scenario design and associated protocol from the 
Antimicrobials Exposure Assessment Task Force II (AEATF-II), describing 
proposed research to monitor the dermal and inhalation of workers while 
pouring liquid antimicrobial pesticide products from both conventional 
and reduced-splash containers. 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 pour liquid antimicrobial pesticide products from 
conventional and reduced-splash containers, and to meet the applicable 
requirements of 40 CFR part 26, subparts K and L.
    b. A new scenario design and associated protocol from the 
Agricultural Handler Exposure Task Force (AHETF) describing proposed 
research to measure dermal and inhalation exposure to workers who load 
liquid pesticides with closed system equipment. 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

[[Page 59699]]

described, this research is likely to generate scientifically reliable 
data, useful for assessing the exposure of those who load liquid 
pesticides with closed system equipment, and to meet the applicable 
requirements of 40 CFR part 26, subparts K and L.
    c. The unpublished report of the completed Carroll-Loye Biological 
Research, Inc. study No. Mas-003 to evaluate in the field the repellent 
efficacy against mosquitoes of a product containing 16% para-methane-
3,8-diol and 2% lemongrass oil. The protocol for this study was 
reviewed favorably by the HSRB at their meeting in October 2010. EPA 
seeks the advice of the HSRB on the scientific soundness of this 
completed study for use to estimate the duration of complete protection 
against mosquitoes provided by the tested repellent, 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.
    d. A published report by Moiemen et al. (2010) of an intentional 
exposure human study measuring dermal absorption of silver from the use 
of nanosilver-containing wound dressings to treat major burns. EPA 
seeks the advice of the HSRB on the scientific soundness of this 
completed study for use in support of an assessment of the absorption 
of nanosilver particles through the skin, and on whether there is 
adequate information to determine that the study was conducted in 
substantial compliance with procedures at least as protective as those 
in subparts A-L of EPA's regulation at 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 regarding the Board's Final meeting report, will be found 
at http://www.epa.gov/osa/hsrb/ or from the person listed under FOR 
FURTHER INFORMATION CONTACT.

    Dated: September 21, 2011.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2011-24816 Filed 9-26-11; 8:45 am]
BILLING CODE 6560-50-P


