[Pharmwaste] (no subject)

Tue Apr 4 15:04:17 EDT 2006

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.

[Federal Register: March 31, 2006 (Volume 71, Number 62)]
[Notices]
[Page 16306-16307]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr06-66]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8052-5; Docket ID No. EPA-HQ-ORD-2006-0223]

Considerations for Developing Alternative Health Risk Assessment
Approaches for Addressing Multiple Chemicals, Exposures and Effects;
External Review Draft

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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SUMMARY: EPA is announcing a 45-day public comment period for the draft
document titled, ``Considerations for Developing Alternative Health
Risk Assessment Approaches for Addressing Multiple Chemicals, Exposures
and Effects'' (EPA/600/R-06/013A). The draft document was prepared by
the National Center for Environmental Assessment (NCEA) within EPA's
Office of Research and Development.
    EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality
guidelines. This document has not been formally disseminated by EPA. It
does not represent and should not be construed to represent any Agency
policy or determination. EPA will consider any public comments
submitted in accordance with this notice when revising the document.

DATES: The 45-day public comment period begins March 31, 2006, and ends
May 15, 2006. Technical comments should be in writing and must be
received by EPA by May 15, 2006.

ADDRESSES: The draft document, ``Considerations for Developing
Alternative Health Risk Assessment Approaches for Addressing Multiple
Chemicals, Exposures and Effects,'' is available primarily via the
Internet on the NCEA home page under the Recent Additions and the Data
and Publications menus at http://www.epa.gov/ncea.

    A limited number of paper copies are available from Ms. Donna
Tucker, Technical Information Manager, NCEA-Cincinnati; telephone: 513-
569-7257; facsimile: 513-569-7916; e-mail: tucker.donna at epa.gov. If you
are requesting a paper copy, please provide your name, your mailing
address, and the document title, ``Considerations for Developing
Alternative Health Risk Assessment Approaches for Addressing Multiple
Chemicals, Exposures and Effects,'' and its EPA publication number,
EPA/600/R-06/013A.
    Comments may be submitted electronically via http://www.regulations.gov
, by mail, by facsimile, or by hand delivery/

courier. Please follow the detailed instructions provided in the
SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Office of Environmental Information Docket;
telephone: 202-566-1752; facsimile: 202-566-1753; or e-mail:
ORD.Docket at epa.gov.

    For technical information, contact Linda K. Teuschler, NCEA-
Cincinnati; telephone: 513-569-7573; facsimile: 513-487-2539; or e-
mail: teuschler.linda at epa.gov.

SUPPLEMENTARY INFORMATION:

I. Information About the Document

    In EPA's 2003 ``Framework for Cumulative Risk Assessment,''
cumulative risk assessment is defined as the evaluation of risks from
exposures to multiple chemicals and other stressors, and having a
population focus rather than a source-to-receptor focus. Several
reports and environmental justice concerns published over the past 11
years have highlighted the importance of estimating cumulative risks.
EPA has published several guidance documents dealing with specific
aspects of cumulative risk, such as chemical mixture risk assessment,
planning and scoping, stakeholder involvement, and the toxicity from a
mixture of pesticides sharing a common mode of action. This draft
document is one contribution to EPA's efforts to address issues related
to cumulative health risk assessment.
    Existing EPA guidance addresses some of the combination aspects of
cumulative risk, but none addresses all of the multiples included in
this report, such as consideration of the composite impact of multiple
health effects. Among the distinctive new approaches are those for
grouping chemicals based on exposure characteristics and toxic
endpoints, multi-route combination of relative potency factors,
integration of categorical regression modeling of multiple effects with
additivity approaches, and the emphasis on the iteration and
collaboration between exposure assessment and dose-response assessment
to ensure compatible and relevant information. Major findings and
conclusions in this document are as follows:
     This draft report provides a set of approaches that deal
with certain complications in cumulative risk assessment, specifically
those caused by multiple chemicals, exposures and effects, including
toxicological interactions and environmental

[[Page 16307]]

transformations of mixture component chemicals.
     The scope is focused on the evaluation of health risks
from exposures to multiple chemicals, including multiple exposure
routes and times as well as multiple health endpoints.
     Areas of cumulative health risk assessment emphasized in
this report can often be performed with existing information.
     Exposure and toxicity characterizations of mixtures are
strongly dependent on mixture composition (chemicals and
concentrations) and timing of exposures and health effects.
     Qualitative and semiquantitative approaches provided can
simplify the number of potential combinations of chemicals, exposures,
and effects to make the cumulative health risk assessment more
feasible.

II. How to Submit Technical Comments to http://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2006-
0223 by one of the following methods:
     http://www.regulations.gov: Follow the on-line

instructions for submitting comments.
     E-mail: ORD.Docket at epa.gov.
     Fax: 202-566-1753.
     Mail: Office of Environmental Information Docket (Mail
Code: 2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460. The phone number is 202-566-1752;
facsimile: 202-566-1753.
     Hand Delivery: The Office of Environmental Information
(OEI) Docket in the EPA Headquarters Docket Center, Room B102, EPA West
Building, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket
Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is 202-566-1744, and the telephone number for the
OEI Docket is 202-566-1752; facsimile: 202-566-1753; or e-mail:
ORD.Docket at epa.gov. Such deliveries are only accepted during the

Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    If you provide comments in writing, please submit one unbound
original with pages numbered consecutively, and three copies of the
comments. For attachments, provide an index, number pages consecutively
with the comments, and submit an unbound original and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2006-0223. 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 whose
disclosure 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://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. For additional information about EPA's public
docket visit the EPA Docket Center homepage at
http://www.epa.gov/epahome/dockets.htm
.

    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 OEI Docket in the

EPA Headquarters Docket Center.

    Dated: March 27, 2006.
Peter W. Preuss,
Director, National Center for Environmental Assessment.
 [FR Doc. E6-4746 Filed 3-30-06; 8:45 am]

BILLING CODE 6560-50-P
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