[Federal Register Volume 78, Number 84 (Wednesday, May 1, 2013)]
[Notices]
[Pages 25440-25442]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10296]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: [email protected].
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
[email protected] 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 [email protected], 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 [email protected] 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
[[Page 25442]]
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]
BILLING CODE 6560-50-P