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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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. 

 
U.S. Environmental Protection Agency August 2011

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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. 
U.S. Environmental Protection Agency August 2011

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 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 

Factor 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 System 

(IRIS)

International Agency for Research on 

Cancer (IARC)

National Toxicology Program (NTP)

California Proposition 65 (Safe 

Drinking Water and Toxic Enforcement 

Act of 1986)

IRIS: A or B1, 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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Factor Data Sources Definition 

Consumer Product 

Use 

Inventory Update Reporting (IUR, 

2006)

National Institutes of Health (NIH) 

Hazardous Substances Data Bank

Danish Consumer Product Studies

IUR: Any report of 

“consumer/commercial” use 

Others: Identified as being in 

consumer product 

Human 

Biomonitoring 

National Health and Nutrition 

Examination Survey (NHANES)

National Human Adipose Tissue 

Survey (NHATS) 

National Human Exposure Assessment 

Survey (NHEXAS) 

Total Exposure Assessment 

Methodology

Reported in any of the data 

sources 

 
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Step 2: Select Priority Chemicals For Assessment 

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 

Exposure Data Sources for Screening Priority Chemicals for Assessment 

Exposure and Use Information 

Data Type 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 (SIDS) Documents

National Institutes of Health (NIH) Household Product Database

NIH Hazardous Substances Data Bank

Environmental 

releases 

Toxics Release Inventory (TRI)

National Emission Inventory (NEI) 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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Exposure and Use Information 

Data Type Data Source 

General human 

exposures, 

including indoor 

air contaminants 

Children’s Total Exposure to Persistent Pesticides and Other Persistent 

Organic Pollutants (CTEPP) Study 

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 (CEETV)

EPA Environmental Monitoring and Assessment Program (EMAP)

EPA’s Databases on Monitoring and Assessing Water Quality

List of Drinking Water Contaminants and their Maximum Contaminant 

Levels (MCLs)

National Air Quality System (AQS) U.S. EPA

National Contaminant Occurrence Database (NCOD) U.S. EPA

Current National Recommended Water Quality Criteria U.S. EPA

National Water-Quality Assessment Program (USGS NAWQA)

EPA Fish Tissue Studies

National Sediment Inventory (NSI) Tissue Data

National Status and Trends Program (NSTP)

National Stream Quality Accounting Network (NASQAN) Surface Water 

and Sediment Data U.S.G.S.

 
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Table 3 

Hazard Data Sources for Screening Priority Chemicals for Assessment 

 Hazard Information (Data on all toxicological endpoints) 

Providers/ Data 

Source Description 

National Library of 

Medicine Databases 

http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp 

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://www.syrres.com/esc/tscats.htm

USEPA - Office of 

Pesticide Programs 

http://www.epa.gov/pesticides/reregistration/status.htm

http://www.epa.gov/opprd001/inerts/decisiondoc_a2k.html 

USEPA - Ambient 

Water Quality Criteria 

Documents 

http://www.epa.gov/waterscience/criteria/wqcriteria.html

USEPA - Drinking 

Water Standards 

Health Effects Support 

Documents 

http://www.epa.gov/safewater/standards.html

USEPA - ECOTOX 

Database http://www.epa.gov/ecotox

IPCS Concise 

International Chemical 

Assessment 

Documents (CICADs) 

http://www.inchem.org/pages/cicads.html