[Federal Register Volume 71, Number 214 (Monday, November 6, 2006)]
[Notices]
[Pages 64951-64952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18655]


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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 [email protected]. 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 
[email protected] (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 [email protected].

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]]

[email protected], 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 [email protected].

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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