U.S. Environmental Protection Agency
August 2011
Discussion Guide: Background and Discussion Questions for
Identifying Priority Chemicals for Review and Assessment
This discussion guide is intended to be used to help structure public input during the September
2011 webinar and discussion forum addressing the prioritization factors and data sources EPA
plans to use to identify priority chemicals for review and assessment under the Toxic Substances
Control Act (TSCA). This effort is part of EPA's comprehensive approach to enhance the
Agency's current chemicals management program.
This discussion guide provides the following information:
Goal of Prioritization
Two-Step Process for Identifying Chemicals
Step 1: Identify Priority Chemicals for Review
(a)	Prioritization Factors and Discussion Questions for Input
(b)	Data Sources for Prioritization Factors and Discussion Questions for
Input
Step 2: Select Specific Chemicals for Assessment
Data Sources for Further Analysis and Discussion Questions for Input
Goal of Prioritization
EPA intends to identify priority chemicals for review and possible risk management action under
TSCA. Identification of a chemical as a priority chemical for review would not itself constitute a
finding by the Agency that the chemical presents a risk to human health or the environment.
Rather, identification of a chemical as a priority chemical would indicate only that the Agency
intends to review it on a priority basis. The Agency believes that identifying these chemicals
early in the review process would afford all interested parties the opportunity to bring additional
relevant information on those chemicals to the Agency's attention in order to further inform the
review. In order to take risk management actions on a chemical substance under various sections
of TSCA, the Agency would have to make the appropriate findings required by the specific
provisions of the statute.
Identification of some chemicals as priority chemicals for review does not mean that EPA would
not consider other chemicals for risk assessment and potential risk management action. EPA will
consider other chemicals if warranted by available information. In addition, EPA may
subsequently identify other priority chemicals for review in addition to this initial group. Further,
while the chemicals identified as priority chemicals for review will likely be well-characterized
for hazard and have information indicating exposure potential, EPA will continue to use its
TSCA information collection, testing, and subpoena authorities, including sections 4, 8, and
11(c) of TSCA, to develop needed information on additional chemicals that currently have less
robust hazard or exposure databases.

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U.S. Environmental Protection Agency
August 2011
Two-Step Process
EPA is planning to use a two-step process to identify priority chemicals for review and
assessment.
In Step 1, EPA plans to identify an initial group of priority chemicals for review by using a
specific set of data sources to identify chemicals that meet one of more of the Action Plan
priority factors.
EPA is seeking public input on two related aspects of Step 1:
(a) Prioritization Factors; and (b) Data Sources for Prioritization Factors.
In Step 2, EPA intends to refine that group by using a broader range of data sources to further
analyze and select specific chemicals from the initial group for further assessment.
EPA is seeking input on the Data Sources for Further Analysis to be used in Step 2.
As EPA works through the initial set of priority chemicals, the Agency may repeat this two-step
process to select subsequent chemicals for review and assessment.
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U.S. Environmental Protection Agency
August 2011
Step 1: Identify Priority Chemicals for Review
(a)	Prioritization Factors and Discussion Questions for Input
To identify candidate chemicals for review, EPA intends to consider risk-based prioritization
factors consistent with the criteria used in selecting the initial chemicals on which EPA prepared
chemical Action Plans from December 2009 through April 2011. The Action Plans for these
chemicals identified a range of actions the Agency has begun to implement, from voluntary
phase-outs and alternatives assessments in cooperation with industry and other stakeholders, to
the development of test rules to require the development of additional data under section 4 of
TSCA, to controls or use restrictions under sections 5 or 6 of TSCA. These factors are:
	Chemicals identified as potentially of concern for children's health (e.g., chemicals with
reproductive or developmental effects).
	Chemicals identified as persistent, bioaccumulative, and toxic (PBT).
	Chemicals identified as probable or known carcinogens.
	Chemicals used in children's products.
	Chemicals used in consumer products.
	Chemicals detected in biomonitoring programs.
Children's health issues, PBT chemicals, and carcinogens are among the Agency's highest
hazard-based priorities, while use in children's products or other consumer products or detection
in biomonitoring programs suggest a potential for exposures to the general population, including
vulnerable populations such as children. Of course, the uses of interest must be subject to TSCA
(i.e., the chemical is not used only as a pesticide, food additive, cosmetic, pharmaceutical, or
other use specifically excluded from TSCA regulation).
Chemicals meeting one or more of these Action Plan prioritization factors would become part of
the initial group of priority chemicals for review.
EPA would like to get public input on these prioritization factors, including:
	What other factors, if any, should the Agency add, and why?
	Please discuss which prioritization factors, if any, should receive greater
consideration than others.
(b)	Data Sources for Prioritization Factors and Discussion Questions for Input
EPA would like to get public input on the data sources that the Agency intends to use to
identify chemicals that meet one or more of the Step 1 (a) priority criteria factors, including:
	Which other data sources, in addition to those listed in Table 1 below, should the
Agency consider in order to identify chemicals that meet the listed factors? Why
should such data sources be added?
	For any additional priority criteria factors you might propose, what data sources
should be considered to identify chemicals meeting those factors?
	Please explain your concerns or comments, if any, relating to the data sources
featured in Table 1.
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U.S. Environmental Protection Agency	August 2011
 Please discuss which data sources, if any, should receive greater consideration than
others.
For each of the Action Plan prioritization factors, these data sources are:
Table 1
Data Sources for Overall Identification of Priority Chemicals
l-'aclor
Data Sources
Definition
PBT
TRI PBT Rule
Great Lakes Binational Toxics Strategy
Canadian Categorization
EPA Region 5 PBT Identification
Project (Syracuse Research Corp.)
Chemicals proposed to UNECE
LRTAP POPs and Stockholm
Convention on POPs
P, B, and T as defined in the
specific data source
Carcinogenicity
Integrated Risk Information Svstem
(IRIS)
International Agencv for Research on
Cancer (IARC)
National Toxicology Program (NTP)
California Proposition 65 (Safe
Drinking Water and Toxic Enforcement
Act of 1986)
IRIS: A or Bl, or known or
likely to be carcinogenic to
humans
IARC: 1 or 2A
NTP: known or reasonably
anticipated to be carcinogenic
to humans
CA: Known to the state to
cause cancer
Potential
Children's Health
Concern
Voluntary Children's Chemical
Evaluation Program
California Proposition 65 (Safe
Drinking Water and Toxic Enforcement
Act of 1986)
IRIS
NTP CERHR Monographs
VCCEP: Named in program
CA: Known to the state to
cause reproductive toxicity
IRIS: Non-cancer RfD or RfC
is based on repro/dev effects
NTP: "Some concern,"
"concern," or "serious
concern" for effects on fetuses,
infants, or children at current
human exposures; or effects on
offspring from exposure of
pregnant women; or repro
effects in exposed adults
Children's Product
Use
Washington State Children's Safe
Product Act
Inventory Update Reporting (IUR.
2006)
WA: Listed in the Children's
Safe Products - Reporting rule
IUR: Any report that used in
products intended for use by
children
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U.S. Environmental Protection Agency
August 2011
l-'sictor
Sources
Dcl'iii il ion
Consumer Product
Use
Iii\ eiHoi'N Update ReDOiliivj, (ILR,
1LR: Any report of
"consumer/commercial" use
Others: Identified as being in
consumer product
2006)
National Institutes of Health (N1H)
Hazardous Substances Data Bank
Danish Consumer Product Studies
Human
Biomonitoring
National Health and Nutrition
Examination Survev (NHANES)
National Human Adipose Tissue
Survev (NHATS)
National Human Exposure Assessment
Survev (NHEXAS)
Total Exposure Assessment
Methodology
Reported in any of the data
sources
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U.S. Environmental Protection Agency
Step 2: Select Priority Chemicals For Assessment
August 2011
Data Sources for Further Analysis and Discussion Questions for Input
After identifying a group of chemicals for priority review, the second step of EPA's planned
process is to use information from additional exposure and hazard data sources to further analyze
the chemicals to select specific chemicals for further assessment, including possible risk
assessment and risk management action.
EPA would like to get public input on the data sources that the Agency intends to use in this
further analysis, including:
	Should additional data sources beyond those listed in Tables 2 and 3 below be
included? What sources, and why?
	Please explain your concerns or comments, if any, relating to the data sources
featured in Tables 2 and 3.
	Please discuss which data sources, if any, should receive greater consideration for
analysis than others.
EPA is planning to use the particular sources identified below in Tables 2 and 3. Table 2 lists
exposure and use-related information data sources. Table 3 lists hazard data sources.
Table 2
F.xposure Data Sources for Screening Priority Chemicals for Assessment
Kxposure and I se
nformalion
Data Tvpc
Data Source
Uses
Inventory Update Reporting and Chemical Data Reporting (IUR/CDR)
Premanufacture Notice (PMN) Database (confidential)
High Production Volume (HPV) Challenge Submissions
Screening Information Data Sets (S1DS) Documents
National Institutes of Health (NIH) Household Product Database
NIH Hazardous Substances Data Bank
Environmental
releases
Toxics Release Inventory (TRI)
National Emission Inventory (NED Database U.S. EPA
Preliminary Assessment Information Reporting (PAIR)
Organization for Economic Cooperation and Development (OECD)
Emission Scenario Documents
NIH Hazardous Substances Data Bank
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U.S. Environmental Protection Agency
August 2011
Kxposurc ;iii(I I so
11 r<>riii:ilioii
Type
Source
General human
exposures,
including indoor
air contaminants
(_ lukircii s i oltil i.Nposiii'c So Pcrsi si en i Pesticides ;nid Oilier E 'ci's  si ci"! 1
Organic Pollutants (CTEPP) Studv
Brown et al., Indoor Air, 4:123-134, 1994.
Daisey et al., Atmospheric Environment, 28 (22): 3557-3562, 1994.
Kelly et al., Environmental Science & Technology, 28(8): 378A-387A,
1994.
NOPES Final Report, EPA/600/3-90/003 (NTIS PB90-152224), January
1990.
Samfield, M.M. Indoor air quality data base for organic compounds. Govt.
Reports Announcements & Index (GRA&I), Issue 12. EPA-600-R-92-025
(NTIS PB92-158468), 1992.
Shah and Singh, Environmental Science & Technology, 2(12): 1381-1388,
1988.
Sheldon et al., Indoor Pollutant Concentrations and Exposures, California
Air Resources Board, Contract A833-156, Final Report, January 1992.
Shields, et al., Indoor Air, 6:2-17, 1996.
Worker exposures
Inventory Update Reporting and Chemical Data Reporting (IUR/CDR)
National Occupational Exposure Survey (NOES)
Occupational Safety and Health Administration (OSHA) monitoring
studies
Preliminary Assessment Information Reporting (PAIR)
OECD Emission Scenario Documents
NIH Hazardous Substances Data Bank
Environmental
exposures
Contaminant Exposure and Effects-Terrestrial Vertebrates database (CEE-
IV)
EPA Environmental Monitoring and Assessment Program (EMAP)
EPA's Databases on Monitoring and Assessing Water Oualitv
List of Drinking Water Contaminants and their Maximum Contaminant
Levels (MCLs)
National Air Oualitv Svstem (AOS) U.S. EPA
National Contaminant Occurrence Database (NCOD) U.S. EPA
Current National Recommended Water Oualitv Criteria U.S. EPA
National Water-Oualitv Assessment Program (USGS NAWOA)
EPA Fish Tissue Studies
National Sediment Inventory (NS1) Tissue Data
National Status and Trends Program (NSTP)
National Stream Oualitv Accounting Network (N A SO AN) Surface Water
and Sediment Data U.S.G.S.
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U.S. Environmental Protection Agency	August 2011
Table 3
Hazard Data Sources for Screening Priority Chemicals for Assessment
Hazard Information (l)a 1 a on all loxicological endpoinls)
Providers/ Data
Source
Description
National Library of
Medicine Databases
http://chem. sis.nlm.nih.gov/chemidDlus/chemidheavv.isp
Accessed through ChemID Plus, searching on a chemical name or ID
produces results that are linked to all NLM databases, including:
Biomedical Citations From PubMed
Toxicology Citations From PubMed
Registry of Toxic Effects of Chemical Substances (RTECS)
NLM TOXLINE on TOXNET
Agency for Toxic Substances and Disease Registry (ATSDR)
Medical Management Guidelines
ATSDR Public Health Statements
ATSDR Toxicological Profiles
ATSDR ToxFAQS
TSCATS
The Toxic Substance Control Act Test Submission Database
http://vvvvvv.svrres.com/esc/tscats.htm
USEPA - Office of
Pesticide Programs
http://www.epa.gov/pesticides/reregistration/status.htm
http://www.epa.gov/opprdOO 1 /inerts/decisiondoc a2k.html
USEPA - Ambient
Water Quality Criteria
Documents
http://vvvvvv.epa. gov/vvatersci ence/criteri a/ vvq criteri a. html

USEPA - Drinking
Water Standards
Health Effects Support
Documents
http://vvvvvv.epa. gov/safevvater/standards.html
USEPA - ECOTOX
Database
http ://vvvvvv. epa. gov/ecotox
IPCS Concise
International Chemical
Assessment
Documents (CICADs)
http://vvvvvv.inchem.org/pages/cicads.html
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