Considerations for Developing Alternative Health Risk Assessment Approaches for Addressing Multiple Chemicals, Exposures and Effects; External Review Draft, 16306-16307 [E6-4746]

Download as PDF 16306 Federal Register / Vol. 71, No. 62 / Friday, March 31, 2006 / Notices Drinking Water Advisory Council Working Group on Public Education, U.S. Environmental Protection Agency, Office of Ground Water and Drinking Water, Drinking Water Protection Division (Mail Code 4606M), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. Please contact Elizabeth McDermott at mcdermott.elizabeth@epa.gov or call 202–564–1603 to receive additional details. SUPPLEMENTARY INFORMATION: dsatterwhite on PROD1PC76 with NOTICES Background: The charge for the Working Group on the Public Education Requirements of the Lead and Copper Rule (WGPE) is to (1) Review the current public education requirements on lead in drinking water to find and define the need for improvements and make recommendations to the full NDWAC accordingly; (2) develop language for communicating the risk of lead in drinking water and a suggested response to the public; and (3) define the delivery means to the public. The NDWAC established a target date of May 2006 to complete these tasks. The WGPE is comprised of 16 members from drinking water industries, stakeholder organizations, State and local officials, public health officials, environmental organizations, and risk communication experts. Public Comment: An opportunity for public comment will be provided during the WGPE meeting. Oral statements will be limited to five minutes; it is preferred that only one person present the statement on behalf of a group or organization. Written comments may be provided at the meeting or may be sent by mail to Elizabeth McDermott, Designated Federal Officer for the WGPE, at the mail or e-mail address listed in the FOR FURTHER INFORMATION CONTACT section of this notice. Special Accommodations: For information on access or services for individuals with disabilities, please contact Elizabeth McDermott at 202– 564–1603 or mcdermott.elizabeth@epa.gov. To request accommodation of a disability, please contact Elizabeth McDermott, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request. Dated: March 24, 2006. Cynthia C. Dougherty, Director, Office of Ground Water and Drinking Water. [FR Doc. E6–4681 Filed 3–30–06; 8:45 am] BILLING CODE 6560–50–P VerDate Aug<31>2005 16:35 Mar 30, 2006 Jkt 208001 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 Environmental Protection Agency (EPA). ACTION: Notice of public comment period. AGENCY: 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 predissemination 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 https://www.epa.gov/ncea. A limited number of paper copies are available from Ms. Donna Tucker, Technical Information Manager, NCEACincinnati; telephone: 513–569–7257; facsimile: 513–569–7916; e-mail: tucker.donna@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 https:// PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 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@epa.gov. For technical information, contact Linda K. Teuschler, NCEA-Cincinnati; telephone: 513–569–7573; facsimile: 513–487–2539; or e-mail: teuschler.linda@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 E:\FR\FM\31MRN1.SGM 31MRN1 Federal Register / Vol. 71, No. 62 / Friday, March 31, 2006 / Notices 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. dsatterwhite on PROD1PC76 with NOTICES II. How to Submit Technical Comments to https://www.regulations.gov Submit your comments, identified by Docket ID No. EPA–HQ–ORD–2006– 0223 by one of the following methods: • https://www.regulations.gov: Follow the on-line instructions for submitting comments. • E-mail: ORD.Docket@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 email: ORD.Docket@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. VerDate Aug<31>2005 16:35 Mar 30, 2006 Jkt 208001 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 https:// 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 https:// www.regulations.gov or e-mail. The https://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 https:// 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 https:// www.epa.gov/epahome/dockets.htm. Docket: All documents in the docket are listed in the https:// 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 https:// 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 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 16307 ENVIRONMENTAL PROTECTION AGENCY [Docket No. EPA–RO4–SFUND–2006–0289, FRL–8052–4] Davis Refining Superfund Site Tallahassee, Leon County, FL Notice of Proposed Settlement Environmental Protection Agency. ACTION: Notice of Proposed Settlement. AGENCY: SUMMARY: Under section 122(h)(1) of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), the United States Environmental Protection Agency is proposing to enter into a settlement for the partial reimbursement of past response costs concerning the Davis Refining Superfund Site in Tallahassee, Leon County, Florida. DATES: The Agency will consider public comments on the proposed settlement until May 1, 2006. The Agency will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. ADDRESSES: Copies of the proposed settlement are available from Ms. Paula V. Batchelor. Submit your comments, identified by Docket ID No. EPA–RO4– SFUND–2006–0289 or Site name Davis Refining, by one of the following methods: • https://www.regulations.gov: Follow the on-line instructions for submitting comments. • E-mail: Batchelor.Paula@epa.gov. • Fax: 404/562–8842. Mail: Ms. Paula V. Batchelor, U.S. EPA Region 4, WMD–SEIMB, 61 Forsyth Street, SW., Atlanta, Georgia 30303. ‘‘In addition, please mail a copy of your comments on the information collection provisions to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attn: Desk Officer for EPA, 725 17th St., NW., Washington, DC 20503.’’ Instructions: Direct your comments to Docket ID No. EPA–R04–SFUND–2006– 0289. EPA’s policy is that all comments received will be included in the public docket without change and may be made available online at https:// 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 E:\FR\FM\31MRN1.SGM 31MRN1

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 62 (Friday, March 31, 2006)]
[Notices]
[Pages 16306-16307]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-4746]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2006-
0223 by one of the following methods:
     https://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
     E-mail: ORD.Docket@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@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 
https://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 https://
www.regulations.gov or e-mail. The https://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 https://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 https://www.epa.gov/
epahome/dockets.htm.
    Docket: All documents in the docket are listed in the https://
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 https://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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