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 VerDate Mar<15>2010 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] BILLING CODE 6560–50–P PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 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, VerDate Mar<15>2010 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] BILLING CODE 6560–50–P PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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 01MYN1

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]
BILLING CODE 6560-50-P