Request for Information and Citations on Methods for Cumulative Risk Assessment, 25440-25442 [2013-10296]
Download as PDF
25440
Federal Register / Vol. 78, No. 84 / Wednesday, May 1, 2013 / Notices
III. Summary of Public Comments
Received and Agency Response to
Comments
During the public comment period
provided, EPA received no comments in
response to the February 20, 2013
Federal Register notice announcing the
Agency’s receipt of the requests for
voluntary cancellations of products
listed in Table 1 and Table 2 of Unit II.
IV. Cancellation Order
Pursuant to FIFRA section 6(f), EPA
hereby approves the requested
cancellations of the registrations
identified in Table 1 and Table 2 of Unit
II. Accordingly, the Agency hereby
orders that the product registrations
identified in Table 1 and Table 2 of Unit
II. are canceled. The effective date of the
cancellation of the products listed in
Table 1 of this notice is May 1, 2013.
The effective date of cancellation of the
products listed in Table 2 is December
31, 2014. Any distribution, sale, or use
of existing stocks of the products
identified in Table 1 and Table 2 of Unit
II. in a manner inconsistent with any of
the provisions for disposition of existing
stocks set forth in Unit VI. will be a
violation of FIFRA.
wreier-aviles on DSK5TPTVN1PROD with NOTICES
V. What is the Agency’s authority for
taking this action?
Section 6(f)(1) of FIFRA provides that
a registrant of a pesticide product may
at any time request that any of its
pesticide registrations be canceled or
amended to terminate one or more uses.
FIFRA further provides that, before
acting on the request, EPA must publish
a notice of receipt of any such request
in the Federal Register. Thereafter,
following the public comment period,
the EPA Administrator may approve
such a request. The notice of receipt for
this action was published for comment
in the Federal Register issue of
February 20, 2013 (78 FR 11881) (FRL–
9378–9). The comment period closed on
March 22, 2013.
VI. Provisions for Disposition of
Existing Stocks
Existing stocks are those stocks of
registered pesticide products which are
currently in the United States and
which were packaged, labeled, and
released for shipment prior to the
effective date of the cancellation action.
The existing stocks provisions for the
products subject to this order are as
follows.
1. For Products 007173–00283 and
007173–00285 identified in Table 1:
Because the Agency has identified
significant potential risk concerns
associated with these pesticide
products, EPA prohibits the sale or
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14:21 Apr 30, 2013
Jkt 229001
distribution of existing stocks by the
registrant, except for export consistent
with FIFRA section 17 or for proper
disposal. Persons other than the
registrant will be allowed to sell or
distribute existing stocks of products,
until such stocks are exhausted. Users
will be allowed to use existing stocks
regardless of the date of purchase until
such stocks are exhausted, provided that
such use is consistent with the terms of
the previously approved labeling on, or
that accompanied, the canceled product.
2. For all other products identified in
Table 1: The registrants may continue to
sell and distribute existing stocks of
products listed in Table 1 of Unit II.
until May 1, 2014, which is 1 year after
the publication of the Cancellation
Order in the Federal Register.
Thereafter, the registrants are prohibited
from selling or distributing products
listed in Table 1, except for export in
accordance with FIFRA section 17, or
proper disposal. Persons other than the
registrants may sell, distribute, or use
existing stocks of products listed in
Table 1 of Unit II. until existing stocks
are exhausted, provided that such sale,
distribution, or use is consistent with
the terms of the previously approved
labeling on, or that accompanied, the
canceled products.
3. For all products listed in Table 2:
After December 31, 2014, registrants are
prohibited from selling or distributing
existing stocks of products containing
ODM. After December 31, 2016, persons
other than registrants are prohibited
from selling or distributing existing
stocks of products containing ODM.
After December 31, 2016, existing stocks
of products containing ODM already in
the possession of end users can be used
legally until they are exhausted,
provided that such use complies with
the EPA-approved label and labeling of
the affected product.
List of Subjects
Environmental protection, Pesticides
and pests.
Dated: April 23, 2013.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division,
Office of Pesticide Programs.
[FR Doc. 2013–10188 Filed 4–30–13; 8:45 am]
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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
Office of the Science Advisor,
Environmental Protection Agency
(EPA).
ACTION: Notice.
AGENCY:
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 https://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: https://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.,
E:\FR\FM\01MYN1.SGM
01MYN1
Federal Register / Vol. 78, No. 84 / Wednesday, May 1, 2013 / Notices
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 https://
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 https://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 https://
www.regulations.gov or email. The
https://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 https://
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.
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.
wreier-aviles on DSK5TPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
14:21 Apr 30, 2013
Jkt 229001
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 https://
www.regulations.gov, or you may access
this Federal Register document via the
EPA’s internet site under the ‘‘Federal
Register’’ listings at https://
www.epa.gov/fedrgstr.
Docket: All documents in the docket
are listed in the https://
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 https://
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 https://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
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
25441
that support the information you
provide. Methods published in the peerreviewed 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 Agencywide 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 https://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) (https://
www.nap.edu/
catalog.php?record_id=2125#toc) and
the Presidential-Congressional
E:\FR\FM\01MYN1.SGM
01MYN1
25442
Federal Register / Vol. 78, No. 84 / Wednesday, May 1, 2013 / Notices
wreier-aviles on DSK5TPTVN1PROD with NOTICES
Commission on Risk Assessment
(https://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 https://
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 multichemical/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 nonchemical stressors, and that address any
of the following characteristics: multistressor, 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,
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14:21 Apr 30, 2013
Jkt 229001
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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FEDERAL DEPOSIT INSURANCE
CORPORATION
FDIC Advisory Committee on
Economic Inclusion (ComE–IN); Notice
of Meeting
Federal Deposit Insurance
Corporation (FDIC).
ACTION: Notice of Open Meeting.
AGENCY:
SUMMARY: In accordance with the
Federal Advisory Committee Act, notice
is hereby given of a meeting of the FDIC
Advisory Committee on Economic
Inclusion, which will be held in
Washington, DC. The Advisory
Committee will provide advice and
recommendations on initiatives to
expand access to banking services by
underserved populations.
DATES: Thursday, May 16, 2013, from
9:00 a.m. to 3:15 p.m.
ADDRESSES: The meeting will be held in
the FDIC Board Room on the sixth floor
of the FDIC Building located at 550 17th
Street NW., Washington, DC.
FOR FURTHER INFORMATION CONTACT:
Requests for further information
concerning the meeting may be directed
to Mr. Robert E. Feldman, Committee
Management Officer of the FDIC, at
(202) 898–7043.
SUPPLEMENTARY INFORMATION:
Agenda: The agenda will be focused
on savings initiatives, safe accounts and
bank prepaid cards, and an update on
mobile financial services and economic
inclusion. The agenda may be subject to
change. Any changes to the agenda will
be announced at the beginning of the
meeting.
Type of Meeting: The meeting will be
open to the public, limited only by the
space available on a first-come, firstserved basis. For security reasons,
members of the public will be subject to
security screening procedures and must
present a valid photo identification to
enter the building. The FDIC will
provide attendees with auxiliary aids
(e.g., sign language interpretation)
required for this meeting. Those
attendees needing such assistance
should call (703) 562–6067 (Voice or
TTY) at least two days before the
meeting to make necessary
arrangements. Written statements may
be filed with the committee before or
after the meeting. This ComE–IN
meeting will be Webcast live via the
Internet at: https://www.vodium.com/
goto/fdic/advisorycommittee.asp. This
service is free and available to anyone
with the following systems
requirements: https://www.vodium.com/
home/sysreq.html. Adobe Flash Player
is required to view these presentations.
E:\FR\FM\01MYN1.SGM
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Agencies
[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]
-----------------------------------------------------------------------
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 https://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: https://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 https://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 https://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 https://www.regulations.gov or email. The https://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 https://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 https://www.regulations.gov, or you may access this
Federal Register document via the EPA's internet site under the
``Federal Register'' listings at https://www.epa.gov/fedrgstr.
Docket: All documents in the docket are listed in the https://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 https://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 https://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 https://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) (https://www.nap.edu/catalog.php?record_id=2125#toc) and the Presidential-
Congressional
[[Page 25442]]
Commission on Risk Assessment (https://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 https://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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