E6-18655. 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.

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 [e-mail]. 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 [e-mail] (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 [e-mail].

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: [phone]; facsimile: 781-674-2906; e-mail [e-mail], subject line: Observational Studies. If you need technical information about the planned document, please contact Roy Fortmann, National Exposure Research Laboratory (NERL); telephone: [phone]; facsimile: 919-541-0905; e-mail [e-mail].

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.