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<p>I am wondering if the following notice applies to pharmaceuticals. Exposure and risk assessments to "multiple chemicals" should include drugs found in the environment, considering what we know.<br>
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[Federal Register: March 31, 2006 (Volume 71, Number 62)]<br>
[Notices] <br>
[Page 16306-16307]<br>
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]<br>
[DOCID:fr31mr06-66] <br>
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<br>
ENVIRONMENTAL PROTECTION AGENCY<br>
<br>
[FRL-8052-5; Docket ID No. EPA-HQ-ORD-2006-0223]<br>
<br>
<br>
Considerations for Developing Alternative Health Risk Assessment <br>
Approaches for Addressing Multiple Chemicals, Exposures and Effects; <br>
External Review Draft<br>
<br>
AGENCY: Environmental Protection Agency (EPA).<br>
<br>
ACTION: Notice of public comment period.<br>
<br>
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<br>
SUMMARY: EPA is announcing a 45-day public comment period for the draft <br>
document titled, ``Considerations for Developing Alternative Health <br>
Risk Assessment Approaches for Addressing Multiple Chemicals, Exposures <br>
and Effects'' (EPA/600/R-06/013A). The draft document was prepared by <br>
the National Center for Environmental Assessment (NCEA) within EPA's <br>
Office of Research and Development.<br>
EPA is releasing this draft document solely for the purpose of pre-<br>
dissemination peer review under applicable information quality <br>
guidelines. This document has not been formally disseminated by EPA. It <br>
does not represent and should not be construed to represent any Agency <br>
policy or determination. EPA will consider any public comments <br>
submitted in accordance with this notice when revising the document.<br>
<br>
DATES: The 45-day public comment period begins March 31, 2006, and ends <br>
May 15, 2006. Technical comments should be in writing and must be <br>
received by EPA by May 15, 2006.<br>
<br>
ADDRESSES: The draft document, ``Considerations for Developing <br>
Alternative Health Risk Assessment Approaches for Addressing Multiple <br>
Chemicals, Exposures and Effects,'' is available primarily via the <br>
Internet on the NCEA home page under the Recent Additions and the Data <br>
and Publications menus at <a href="http://www.epa.gov/ncea">http://www.epa.gov/ncea</a>.<br>
<br>
A limited number of paper copies are available from Ms. Donna <br>
Tucker, Technical Information Manager, NCEA-Cincinnati; telephone: 513-<br>
569-7257; facsimile: 513-569-7916; e-mail: tucker.donna@epa.gov. If you <br>
are requesting a paper copy, please provide your name, your mailing <br>
address, and the document title, ``Considerations for Developing <br>
Alternative Health Risk Assessment Approaches for Addressing Multiple <br>
Chemicals, Exposures and Effects,'' and its EPA publication number, <br>
EPA/600/R-06/013A.<br>
Comments may be submitted electronically via <a href="http://www.regulations.gov">http://www.regulations.gov</a><br>
, by mail, by facsimile, or by hand delivery/<br>
<br>
courier. Please follow the detailed instructions provided in the <br>
SUPPLEMENTARY INFORMATION section of this notice.<br>
<br>
FOR FURTHER INFORMATION CONTACT: For information on the public comment <br>
period, contact the Office of Environmental Information Docket; <br>
telephone: 202-566-1752; facsimile: 202-566-1753; or e-mail: <br>
ORD.Docket@epa.gov.<br>
<br>
For technical information, contact Linda K. Teuschler, NCEA-<br>
Cincinnati; telephone: 513-569-7573; facsimile: 513-487-2539; or e-<br>
mail: teuschler.linda@epa.gov.<br>
<br>
SUPPLEMENTARY INFORMATION:<br>
<br>
I. Information About the Document<br>
<br>
In EPA's 2003 ``Framework for Cumulative Risk Assessment,'' <br>
cumulative risk assessment is defined as the evaluation of risks from <br>
exposures to multiple chemicals and other stressors, and having a <br>
population focus rather than a source-to-receptor focus. Several <br>
reports and environmental justice concerns published over the past 11 <br>
years have highlighted the importance of estimating cumulative risks. <br>
EPA has published several guidance documents dealing with specific <br>
aspects of cumulative risk, such as chemical mixture risk assessment, <br>
planning and scoping, stakeholder involvement, and the toxicity from a <br>
mixture of pesticides sharing a common mode of action. This draft <br>
document is one contribution to EPA's efforts to address issues related <br>
to cumulative health risk assessment.<br>
Existing EPA guidance addresses some of the combination aspects of <br>
cumulative risk, but none addresses all of the multiples included in <br>
this report, such as consideration of the composite impact of multiple <br>
health effects. Among the distinctive new approaches are those for <br>
grouping chemicals based on exposure characteristics and toxic <br>
endpoints, multi-route combination of relative potency factors, <br>
integration of categorical regression modeling of multiple effects with <br>
additivity approaches, and the emphasis on the iteration and <br>
collaboration between exposure assessment and dose-response assessment <br>
to ensure compatible and relevant information. Major findings and <br>
conclusions in this document are as follows:<br>
This draft report provides a set of approaches that deal <br>
with certain complications in cumulative risk assessment, specifically <br>
those caused by multiple chemicals, exposures and effects, including <br>
toxicological interactions and environmental<br>
<br>
[[Page 16307]]<br>
<br>
transformations of mixture component chemicals.<br>
The scope is focused on the evaluation of health risks <br>
from exposures to multiple chemicals, including multiple exposure <br>
routes and times as well as multiple health endpoints.<br>
Areas of cumulative health risk assessment emphasized in <br>
this report can often be performed with existing information.<br>
Exposure and toxicity characterizations of mixtures are <br>
strongly dependent on mixture composition (chemicals and <br>
concentrations) and timing of exposures and health effects.<br>
Qualitative and semiquantitative approaches provided can <br>
simplify the number of potential combinations of chemicals, exposures, <br>
and effects to make the cumulative health risk assessment more <br>
feasible.<br>
<br>
II. How to Submit Technical Comments to <a href="http://www.regulations.gov">http://www.regulations.gov</a><br>
<br>
<br>
Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2006-<br>
0223 by one of the following methods:<br>
<a href="http://www.regulations.gov:">http://www.regulations.gov:</a> Follow the on-line <br>
<br>
instructions for submitting comments.<br>
E-mail: ORD.Docket@epa.gov.<br>
Fax: 202-566-1753.<br>
Mail: Office of Environmental Information Docket (Mail <br>
Code: 2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania <br>
Ave., NW., Washington, DC 20460. The phone number is 202-566-1752; <br>
facsimile: 202-566-1753.<br>
Hand Delivery: The Office of Environmental Information <br>
(OEI) Docket in the EPA Headquarters Docket Center, Room B102, EPA West <br>
Building, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket <br>
Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday <br>
through Friday, excluding legal holidays. The telephone number for the <br>
Public Reading Room is 202-566-1744, and the telephone number for the <br>
OEI Docket is 202-566-1752; facsimile: 202-566-1753; or e-mail: <br>
ORD.Docket@epa.gov. Such deliveries are only accepted during the <br>
<br>
Docket's normal hours of operation, and special arrangements should be <br>
made for deliveries of boxed information.<br>
If you provide comments in writing, please submit one unbound <br>
original with pages numbered consecutively, and three copies of the <br>
comments. For attachments, provide an index, number pages consecutively <br>
with the comments, and submit an unbound original and three copies.<br>
Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-<br>
2006-0223. EPA's policy is that all comments received will be included <br>
in the public docket without change and may be made available online at <br>
<a href="http://www.regulations.gov">http://www.regulations.gov</a>, including any personal information <br>
<br>
provided, unless the comment includes information claimed to be <br>
Confidential Business Information (CBI) or other information whose <br>
disclosure is restricted by statute. Do not submit information that you <br>
consider to be CBI or otherwise protected through <a href="http://www.regulations.gov">http://www.regulations.gov</a> or e-mail. The <a href="http://www.regulations.gov">http://www.regulations.gov</a> Web site <br>
<br>
is an ``anonymous access'' system, which means EPA will not know your <br>
identity or contact information unless you provide it in the body of <br>
your comment. If you send an e-mail comment directly to EPA without <br>
going through <a href="http://www.regulations.gov">http://www.regulations.gov</a>, your e-mail address will be <br>
<br>
automatically captured and included as part of the comment that is <br>
placed in the public docket and made available on the Internet. If you <br>
submit an electronic comment, EPA recommends that you include your name <br>
and other contact information in the body of your comment and with any <br>
disk or CD-ROM you submit. If EPA cannot read your comment due to <br>
technical difficulties and cannot contact you for clarification, EPA <br>
may not be able to consider your comment. Electronic files should avoid <br>
the use of special characters, any form of encryption, and be free of <br>
any defects or viruses. For additional information about EPA's public <br>
docket visit the EPA Docket Center homepage at <a href="http://www.epa.gov/epahome/dockets.htm">http://www.epa.gov/epahome/dockets.htm</a><br>
.<br>
<br>
Docket: All documents in the docket are listed in the <a href="http://www.regulations.gov">http://www.regulations.gov</a><br>
index. Although listed in the index, some <br>
<br>
information is not publicly available, e.g., CBI or other information <br>
whose disclosure is restricted by statute. Certain other material, such <br>
as copyrighted material, will be publicly available only in hard copy. <br>
Publicly available docket materials are available either electronically <br>
in <a href="http://www.regulations.gov">http://www.regulations.gov</a> or in hard copy at the OEI Docket in the <br>
<br>
EPA Headquarters Docket Center.<br>
<br>
Dated: March 27, 2006.<br>
Peter W. Preuss,<br>
Director, National Center for Environmental Assessment.<br>
[FR Doc. E6-4746 Filed 3-30-06; 8:45 am]<br>
<br>
BILLING CODE 6560-50-P</body></html>