[Federal Register Volume 75, Number 193 (Wednesday, October 6, 2010)]
[Notices]
[Pages 61748-61750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25126]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2010-0797' FRL-9211-1]


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 October 27-28, 2010, from 
approximately 11 a.m. on October 27, 2010 to approximately 5:30 p.m. on 
October 28, 2010, Eastern Time.
    Location: 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 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 section 
I., under subsection D., ``SUPPLEMENTARY INFORMATION'' of this notice.

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#45212a322b2c2b226b2f2c28052035246b222a33"><span class="__cf_email__" data-cfemail="6f0b001801060108410506022f0a1f0e41080019">[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#f09b9c95999291939b9582de9c85dd919e9eb0958091de979f86"><span class="__cf_email__" data-cfemail="fb90979e92999a98909e89d5978ed69a9595bb9e8b9ad59c948d">[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/.

ADDRESSES: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2010-0797, 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#1f706d7b317b707c747a6b5f7a6f7e31787069"><span class="__cf_email__" data-cfemail="79160b1d571d161a121c0d391c0918571e160f">[email protected]</span></a>.
    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 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#e58a9781cb818a868e8091a5809584cb828a93"><span class="__cf_email__" data-cfemail="7d120f195319121e1618093d180d1c531a120b">[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-
2010-0797. 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://

[[Page 61749]]

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 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 Ave., NW., Washington, DC 20460. 
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 e-
mail the ORD Docket at <a href="/cdn-cgi/l/email-protection#5c332e387238333f3739281c392c3d723b332a"><span class="__cf_email__" data-cfemail="0f607d6b216b606c646a7b4f6a7f6e21686079">[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 early October 2010. 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-2010-0797 in the subject line 
on the first page of your request.
    1. Oral comments. Requests to present oral comments will be 
accepted up to Thursday, October 21, 2010. 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, FOR FURTHER INFORMATION 
CONTACT, no later than noon, Eastern Time, Thursday, October 21, 2010, 
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, October 21, 2010. 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 Kleibacher listed under FOR FURTHER INFORMATION 
CONTACT. There is no limit on the length of written comments for 
consideration by the HSRB.

E. Background

    1. Topics for discussion. At its meeting on October 27-28, 2010 
EPA's Human Studies Review Board will

[[Page 61750]]

consider scientific and ethical issues surrounding these topics:
    a. A proposal for new research to be conducted by Carroll-Loye 
Biological Research to evaluate in the field the repellent efficacy 
against mosquitoes of a registered product containing 16% para-methane-
3,8-diol and 2% lemongrass oil. EPA requests the advice of the HSRB 
concerning whether, if the protocol 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 
efficacy of the tested material in repelling mosquitoes, 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 applicators who 
use backpack sprayers or hand gun sprayers to apply pesticides in 
utility rights-of-way. 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 apply pesticides in utility rights-of-way with backpack 
sprayers or hand gun sprayers, and to meet the applicable requirements 
of 40 CFR part 26, subparts K and L.
    c. A revised 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 in water-soluble packaging. This 
scenario was previously reviewed favorably by the HSRB in June 2009, 
but has since been revised to use different surrogate chemicals. These 
changes forced other revisions in turn; the proposed changes, taken 
together, are significant enough to warrant a new review by the HSRB. 
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 in water-soluble packaging, 
and to meet the applicable requirements of 40 CFR part 26, subparts K 
and L.
    d. The report of a completed scenario monograph and study report 
from the Antimicrobial Exposure Assessment Task Force II (AEATF-II) in 
which the dermal and inhalation exposure of professional janitorial 
workers was monitored as they applied liquid antimicrobial products to 
indoor floors using a bucket and mop. 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 professional 
janitorial workers who apply antimicrobial floor-cleaning products with 
mops, 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: September 29, 2010.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2010-25126 Filed 10-5-10; 8:45 am]
BILLING CODE 6560-50-P


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