[Federal Register: November 6, 2006 (Volume 71, Number 214)]
[Notices]
[Page 64951-64952]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06no06-30]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-8240-4]
Notice of an Expert Panel Workshop on the State-of-the-Science
Approaches for Observational Exposure Measurement Studies
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of meeting.
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SUMMARY: The Environmental Protection Agency (EPA) is announcing that
Eastern Research Group, Inc. (ERG), an EPA contractor, will convene a
panel of experts and organize and conduct a meeting to gather
information on the most up-to-date methods, approaches, and ethical
standards for designing and implementing observational exposure
measurement studies. EPA expects to use the information from the
workshop in the preparation of a document on the state-of-the-science
approaches for observational exposure measurement studies. The meeting
will include sessions for discussion by the panel and time will be set
aside for public comment. The meeting is open to the public to attend
as observers.
Observers who wish to make oral comments during the comment periods
may sign up on the Eastern Research Group, Inc.'s online registration
page. Time slots for comments will be limited to 5-minutes and
observers will be scheduled to speak in the order in which they
register. The public may also use a separate process to send written
comments regarding the planned document electronically to the project
Web site at http://www.epa.gov/nerl/sots/. or by e-mail to the EPA technical contact at Fortmann.roy@epa.gov. The charge to the panel and
background materials are available primarily via the Internet on the
National Exposure Research Laboratory's (NERL's) home page under the
Featured Links at http://www.epa.gov/nerl/sots/.
DATES: The workshop will begin on November 28, 2006, at 8:30 a.m. and
end at 4 p.m. on November 29, 2006 (Eastern Time). The oral public
comment sessions will begin on November 28, 2006, at approximately 10
a.m. and on November 29, 2006 at approximately 1 p.m.
ADDRESSES: The workshop will be held at the Hilton Durham at 3800
Hillsborough Rd., Durham, NC 27705. The EPA contractor, Eastern
Research Group, Inc., is organizing, convening, and conducting the
workshop. Members of the public may attend the workshop as observers.
To attend the workshop, register by November 21, 2006, by accessing the
online registration page at https://www2.ergweb.com/projects/conferences/exposure/register-exposure.htm
, via telephone by calling
Eastern Research Group, Inc. at 781-674-7374, or sending an e-mail to
meetings@erg.com (subject line: Observational Studies). Registration
will also be available at the site of the meeting, as space allows.
There will be time set aside each day to present brief (no longer than
five minutes) oral comments from the public. Please let Eastern
Research Group, Inc. know if you wish to make comments during the
observer comment period. Space is limited, and registrations will be
accepted on a first-come, first-served basis. Observers may also submit
written comments regarding the planned document electronically to the
project Web site at http://www.epa.gov/nerl/sots/ or by e-mail to the EPA technical contact at Fortmann.roy@epa.gov.
FOR FURTHER INFORMATION CONTACT: Questions regarding registration and
logistics for the workshop should be directed to Eastern Research
Group, Inc., 110 Hartwell Avenue, Lexington, MA 02421-3136; telephone:
781-674-7374; facsimile: 781-674-2906; e-mail
[[Page 64952]]
meetings@erg.com, subject line: Observational Studies. If you need
technical information about the planned document, please contact Roy
Fortmann, National Exposure Research Laboratory (NERL); telephone: 919-
541-1021; facsimile: 919-541-0905; e-mail Fortmann.roy@epa.gov.
SUPPLEMENTARY INFORMATION:
Information About the Workshop and Planned Document
Observational exposure measurement studies are performed by
researchers both within and outside of EPA to measure people's contact
with chemicals in their everyday environments during their normal daily
activities. These studies involve measurements of chemicals in
environmental media (e.g., air, water, food, soil, and dust);
collection of information about the voluntary study participants, their
homes, their work environments, and their activities; and analysis of
voluntary human samples such as blood or urine to determine the amounts
of contact. These observational studies do not involve any additional
contact with the chemicals being studied by the people who volunteer to
participate in the studies. EPA's observational studies generally
collect information that is critical to meeting the goal of improving
public health. In these studies, EPA identifies the chemicals that
people are coming in contact with; the concentrations of those
chemicals; the most important sources of chemicals in people's lives;
and when, where, how often, and why people come into contact with
chemicals in the environment. The information collected in
observational studies can be used to better understand potential risks
and health effects from chemicals in the environment and to develop
risk mitigation strategies and methods.
EPA strives to follow the most up-to-date approaches in designing
and performing observational studies. These approaches are developed by
experts in both academia and various Federal agencies. The approaches
evolve over time to meet changing and more stringent ethical standards
and study requirements. EPA wants to ensure that the observational
studies conducted by the Agency for measuring people's contact with
environmental chemicals continue to be based on the most up-to-date
sound science and the highest ethical standards. Therefore, there is a
need to evaluate the latest approaches and ensure that EPA is using the
state-of-the-science approaches. In this project, EPA intends to review
and evaluate the latest methods, techniques, ethical standards, and
approaches for design and implementation of observational exposure
measurement studies and compile a set of state-of-the-science
approaches in a single document. Examples of study elements for which
state-of-the-science approaches will be evaluated and compiled in the
document include identification of community groups and interactions
with communities during the scoping and planning of studies,
participant recruitment methods, informed consent procedures,
identification and reporting unanticipated results, communication of
study results, etc. EPA expects that the final document will be used by
EPA researchers and others in the scientific community to design and
perform observational exposure measurement studies.
Researchers in NERL intend to work with the public and experts from
outside of the Agency to evaluate and compile the state-of-the-science
approaches. The Workshop announced in this Notice is expected to bring
together experts in the areas of human exposure science, community
research, ethics, children's health, and other relevant disciplines to
discuss and compile information that EPA can use to develop a draft
document. EPA has asked the Panel to provide recommendations on the
content of the document, sources of information for the document, and
an evaluation of the state-of-the-science for approaches for specific
elements of the design and implementation of observational exposure
measurement studies. Using information gathered at the Workshop, EPA
plans to develop a draft document, tentatively titled ``State-of-the-
Science Approaches for Observational Exposure Measurement Studies.''
When completed, EPA expects to release the draft document as an
external review document for public comment. EPA also expects to hire a
contractor to conduct an independent external scientific peer review of
the draft document. Availability of the document for public comment and
the schedule and location of the independent external peer review will
be announced in the Federal Register.
Dated: October 31, 2006.
Lawrence W. Reiter,
Director, National Exposure Research Laboratory.
[FR Doc. E6-18655 Filed 11-3-06; 8:45 am]
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