[Federal Register Volume 78, Number 84 (Wednesday, May 1, 2013)]
[Notices]
[Pages 25440-25442]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10296]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2013-0292; FRL-9807-5]


Request for Information and Citations on Methods for Cumulative 
Risk Assessment

AGENCY: Office of the Science Advisor, Environmental Protection Agency 
(EPA).

ACTION: Notice.

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SUMMARY: The United States Environmental Protection Agency (EPA) is 
requesting information and citations on approaches and methods for the 
planning, analysis, assessment, and characterization of cumulative 
risks to human populations and the environment. The EPA is developing 
guidelines for the assessment of cumulative risk as defined and 
characterized in the EPA 2003 publication Framework for Cumulative Risk 
Assessment, ``An analysis, characterization, and possible 
quantification of the combined risks to health or the environment from 
multiple agents or stressors'' using scientifically defensible 
approaches and methods. The Guidelines will assist agency programs and 
regions in the assessment of risk and in decision making, including the 
planning and development of regulations and permits. This notice 
solicits information and citations pertaining to approaches and methods 
that can be used to plan and conduct cumulative risk assessments (CRA). 
Published background information regarding cumulative risk can be found 
at http://www.epa.gov/raf/publications/pdfs/frmwrk_cum_risk_assmnt.pdf or from the person listed under FOR FURTHER INFORMATION 
CONTACT.

DATES: Information and citations may be submitted on or before Friday, 
June 28, 2013.

ADDRESSES: Submit your information, identified by Docket ID No. EPA-HQ-
ORD-2013-0292, by one of the following methods:
    Internet: http://www.regulations.gov: Follow the Web site 
instructions for submitting information.
    Email: ORD.Docket@epa.gov.
    Mail: Environmental Protection Agency, EPA Docket Center EPA/DC, 
ORD Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW., Washington, 
DC 20460.
    Hand Delivery: The EPA/DC Public Reading Room is located in the EPA 
Headquarters Library, Room Number 3334 in the EPA West Building, 
located at 1301 Constitution Avenue NW.,

[[Page 25441]]

Washington, DC 20460. The Public Reading Room hours of operation are 
8:30 a.m. to 4:30 p.m. Eastern Time, Monday through Friday, excluding 
Federal holidays. Please call (202) 566-1744 or email the ORD Docket at 
ord.docket@epa.gov for instructions. Updates to Public Reading Room 
access are available online at http://www.epa.gov/epahome/dockets.htm.
    Instructions: Direct your information and citations to Docket ID 
No. EPA-HQ-ORD-2013-0292. The Agency's policy is that all submissions 
received will be included in the public docket without change and will 
be made available online at http://www.regulations.gov, including any 
personal information provided, unless the information includes data 
claimed to be Confidential Business Information (CBI) or other 
information the disclosure of which is restricted by statute. Do not 
submit information that you consider to be CBI or otherwise protected 
through http://www.regulations.gov or email. The http://www.regulations.gov Web site is an ``anonymous access'' system, which 
means the EPA will not know your identity or contact information unless 
you provide it in the body of your submission to the docket. If you 
send an email with information directly to the EPA without going 
through http://www.regulations.gov, your email address will be 
automatically captured and included as part of the information that is 
placed in the public docket and made available on the Internet. If you 
submit information electronically, the EPA recommends that you include 
your name and other contact information in the body of your submission 
and with any disk or CD-ROM you submit. If the EPA cannot read your 
information due to technical difficulties and cannot contact you for 
clarification, the EPA may not be able to consider your information. 
Electronic files should avoid the use of special characters, any form 
of encryption, and be free of any defects or viruses.

FOR FURTHER INFORMATION CONTACT: Any members of the public who wish to 
receive further information about submitting information on methods for 
cumulative risk assessment should contact Lawrence Martin at telephone 
number (202) 564-6497 or email address martin.lawrence@epa.gov, mailing 
address Environmental Protection Agency, Office of the Science Advisor, 
Mail Code 8105R, 1200 Pennsylvania Avenue NW., Washington, DC 20460.

SUPPLEMENTARY INFORMATION:

A. Does this information request apply to me?

    The purpose of the CRA Guidelines is to delineate CRA methods that 
will support informed decision-making at EPA. This request also may be 
of interest to persons involved with the design, formulation, and 
conduct of risk assessments more generally. Since many and various 
entities may also be interested, the EPA has not attempted to describe 
all the specific entities that may be interested in this request. If 
you have any questions regarding the applicability of this request, 
please consult Lawrence Martin listed under FOR FURTHER INFORMATION 
CONTACT.

B. How can I access electronic copies of this document and other 
related information?

    You may use http://www.regulations.gov, or you may access this 
Federal Register document via the EPA's internet site under the 
``Federal Register'' listings at http://www.epa.gov/fedrgstr.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some 
information may not be 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 at http://www.regulations.gov or in hard copy at the ORD 
Docket, EPA/DC Public Reading Room. The EPA/DC Public Reading Room is 
located in the EPA Headquarters Library, Room Number 3334 in the EPA 
West Building, located at 1301 Constitution Avenue NW., Washington, DC 
20460; its hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Time, 
Monday through Friday, excluding federal holidays. Please call (202) 
566-1744, or email the ORD Docket at ord.docket@epa.gov for 
instructions. Updates regarding the Public Reading Room access are 
available at http://www.epa.gov/epahome/dockets.htm.

C. What should I consider as I prepare my information for the EPA?

    You may find the following suggestions helpful for preparing your 
information:
    1. Explain the information you are providing as clearly as 
possible.
    2. Describe any assumptions that you used.
    3. Provide copies or citations for any technical information and/or 
data used that support the information you provide. Methods published 
in the peer-reviewed literature are preferred and are more readily 
useful.
    4. Provide specific examples.
    5. To ensure proper receipt by the EPA, be sure to identify the 
docket ID number assigned to this action in the subject line on the 
first page of your response. You may also provide the name, date and 
Federal Register citation.
    Responses to this request are voluntary. This notice does not 
obligate the U.S. Government to award a contract or otherwise pay for 
the information provided in response to this request. The U.S. 
Government reserves the right to use information provided by 
respondents for any purpose deemed necessary and legally appropriate. 
Respondents are advised that the U.S. Government is under no obligation 
to acknowledge receipt of the information received or provide feedback 
to respondents with respect to any information submitted.

D. Background

    Former EPA Administrator Carol Browner transmitted the EPA Science 
Policy Council's Guidance on Cumulative Risk Assessment, Part 1, 
Planning and Scoping in a memo dated July 3, 1997. Administrator 
Browner wrote: ``Today, we are providing guidance for all EPA offices 
on cumulative risk assessment. This guidance directs each office to 
take into account cumulative risk issues in scoping and planning major 
risk assessments and to consider a broader scope that integrates 
multiple sources, effects, pathways, stressors and populations for 
cumulative risk analyses in all cases for which relevant data are 
available. This assures a more consistent and scientifically complete 
Agency-wide approach to cumulative risk assessments in order to better 
protect public health and the environment.'' Subsequently, the EPA Risk 
Assessment Forum was charged to complete comprehensive guidelines for 
the assessment of cumulative risks. In May 2003, the RAF released the 
Framework for Cumulative Risk Assessment (EPA/630/P-02/001F), available 
to download from the internet at http://www.epa.gov/raf/publications/pdfs/frmwrk_cum_risk_assmnt.pdf. The 2003 CRA Framework was the 
EPA's first step toward development of the CRA Guidelines. The foreword 
to the Framework notes that the National Research Council (NRC) (http://www.nap.edu/catalog.php?record_id=2125#toc) and the Presidential-
Congressional

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Commission on Risk Assessment (http://www.riskworld.com/Nreports/1996/risk_rpt/Rr6me001.htm) assign importance to understanding risk from 
multiple stressors, and that EPA had begun to address approaches to 
CRA. The NRC and EPA's Science Advisory Board have provided consistent 
recommendations that encourage better integrated, multi-stressor 
approaches to understanding risks to human health and the environment. 
For example, in Science & Decisions 2009, the NRC recommends that EPA 
develop CRA tools (see pg. 236). ``EPA is increasingly asked to address 
broader public-health and environmental-health questions involving 
multiple exposures, complex mixtures, and vulnerability of exposed 
populations--issues that stakeholder groups . . . often consider to be 
inadequately captured by current risk assessments. There is a need for 
cumulative risk assessments . . .'' (Science and Decisions; available 
to download from the internet at http://www.nap.edu/catalog.php?record_id=12209.

E. Request for Information and Citations on Cumulative Risk Assessment 
Methods

    To date, CRA experience at EPA has been principally in the 
application of CRA screening and chemical additivity methods for 
aggregating risk from multiple exposures and/or toxicity pathways. 
These have been conducted by EPA programs and regions. This limited 
application of CRA has substantiated the value of multi-chemical/
stressor assessments in an environmental risk assessment context, but 
illustrates a more limited application than that recommended by the 
NRC, or discussed in the 2003 CRA Framework. EPA requests information 
on and citations for CRA methods that have been employed to date and 
approaches that could assist EPA in the development of improved CRA 
methods. Methods and information published in the peer-reviewed 
literature are preferred and would be more readily useful. Information 
and citations are also being requested for existing, on-going 
cumulative risk assessments that incorporate the assessment of multiple 
chemical or non-chemical stressors, and that address any of the 
following characteristics: multi-stressor, multi-media, multi-receptor, 
including assessment of a vulnerable population, both human and 
environmental health considerations, or socio-economic stressors. EPA 
also requests information on examples where CRA has been successfully 
used for decision making at the local, state, national, or 
international levels, including a description of the circumstances 
leading to the use of CRA methods in those examples.
    More specifically, information and citations are sought for the 
following purposes:
    1. Methods for CRA planning, scoping and problem formulation to 
ensure that the scope of a CRA is tractable and also adequately 
addresses the key concerns of a specified environmental problem. This 
includes methods that could be used for the following: evaluating 
population vulnerabilities that are either perceived or empirically 
demonstrated as important elements of a CRA; involving the spectrum of 
interested/affected parties in formulating the problem for assessment 
or decision; considering stakeholder objectives and integrating them 
into an analysis; identifying the most influential stressors that need 
to be considered in a CRA; and developing conceptual models that link 
stressors and health outcomes.
    2. Methods to identify and quantify population vulnerabilities 
(risk factors) and buffers (protective factors) that may influence 
exposures, dose-response or risk/hazard posed by environmental 
contaminant exposures, and methods to integrate population 
vulnerabilities and buffers into a CRA. Vulnerabilities could include 
factors leading to differential exposures, differential responses, 
preparedness and resiliency within a population.
    3. Methods for integrating chemical, physical, biological and 
socio-economic stressors within a CRA, including quantifying and 
integrating ``exposure'' and ``dose-response'' for disparate stressors, 
and grouping of chemical and nonchemical stressors for combined (or 
integrated) risk analysis.
    4. Methods for characterizing integrated risks posed by disparate 
stressors in a CRA context. These could include methods and/or study 
data from epidemiology, toxicology, ecology, health economics, chemical 
mixtures risk assessment, social sciences, dose response modeling and 
statistics (among others); and may also include addressing spatial and 
temporal scales.
    5. Methods to integrate ecological and human health exposures and 
health effects in a CRA.
    6. Approaches for addressing stakeholder participation, engagement 
and risk communication when conducting a CRA.

    Date: April 22, 2013.
Glenn Paulson,
Science Advisor.
[FR Doc. 2013-10296 Filed 4-30-13; 8:45 am]
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