U.S. Environmental Protection Agency August 2011



### Discussion Guide: Background and Discussion Questions for

Identifying Priority Chemical s 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 unde r 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 Di scussion Questions for Input (b) Data Sources for Prioritization Fa ctors and Discussion Questions for Input Step 2: Select Specifi c 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 priori ty 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 woul d afford all interested parties the opportunity to bring additional relevant information on those chemicals to the Agen cy’s attention in order to further inform the review. In order to take risk management acti ons on a chemical substance under various sections of TSCA, the Agency would have to make the appropriate find ings required by the specific provisions of the statute.

Identification of some chemicals as priority ch emicals for review does not mean that EPA would not consider other chemicals for risk assessmen t and potential risk management action. EPA will consider other chemicals if warranted by av ailable 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 chemi cals for review will likely be well-characterized for hazard and have information indicating expos ure potential, EPA will continue to use its TSCA information collection, te sting, and subpoena authorities, including sections 4, 8, and 11(c) of TSCA, to develop needed information on additional chemicals th at currently have less robust hazard or exposure databases.U.S. Environmental Protection Agency August 2011

2 

### 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 gr oup 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 tw o 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 us ing a broader range of da ta 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 ch emicals, the Agency may repeat this two-step process to select subsequent chem icals for review and assessment.U.S. Environmental Protection Agency August 2011

3 Step 1: Identify Priority Chemicals for Review

(a) Prioritization Factors and Di scussion Questions for Input

To identify candidate chemicals for review, EPA intends to consider risk-based prioritization factors consistent with the criteria used in se lecting 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 Agen cy has begun to implement, from voluntary phase-outs and alternatives assess ments in cooperation with indus try and other stakeholders, to the development of test rules to require the development of a dditional data under section 4 of TSCA, to controls or use rest rictions under sections 5 or 6 of TSCA. These factors are:

 Chemicals identified as potentially of concer n for children’s health (e.g., chemicals with reproductive or developmental effects).

 Chemicals identified as persistent, bioaccumulative, and toxic (PBT).

 Chemicals identified as pr obable 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, a nd carcinogens are among the Agency’s highest hazard-based priorities, while use in children’s pr oducts or other consumer products or detection in biomonitoring programs suggest a potential fo r exposures to the gene ral 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 pestic ide, food additive, cosmetic, pharmaceutical, or other use specifically excluded from TSCA regulation).

Chemicals meeting one or more of these Action Pl an prioritization factors would become part of the initial group of priority chemicals for review.

EPA would like to get public input on th ese prioritization factors, including:

 What other factors, if any, should the Agency add, and why?

 Please discuss which prioritization fa ctors, if any, should receive greater consideration than others.

(b) Data Sources for Prioritization Fa ctors and Discussion Questions for Input

EPA would like to get public input on the dat a 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 th ose listed in Table 1 below, should the Agency consider in order to identify chem icals that meet the listed factors? Why should such data sources be added?

 For any additional priority criteria fact ors 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

4  Please discuss which data sources, if any, should receive greater consideration than others.

For each of the Action Plan prioritizati on 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 childrenU.S. Environmental Protection Agency August 2011

5 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

sourcesU.S. Environmental Protection Agency August 2011

6 Step 2: Select Priority Chemicals For Assessment

Data Sources for Further Analysis and Discussion Questions for Input

After identifying a group of chemicals for prio rity 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 fo r further assessment, including possible risk assessment and risk management action.

EPA would like to get public inpu t 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 id entified below in Tables 2 and 3. Table 2 lists exposure and use-related information data s ources. 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 Ch emical 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 Coopera tion and Development (OECD) Emission Scenario Documents NIH Hazardous Substances Data BankU.S. Environmental Protection Agency August 2011

7 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 da ta 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 A 833-156, Final Report, January 1992. Shields, et al., Indoor Air , 6:2-17, 1996.

Worker exposures Inventory Update Reporting and Ch emical 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-Terre strial Vertebrates database (CEETV) EPA Environmental Monitoring and Assessment Program (EMAP) EPA’s Databases on Monitoring and Assessing Water Quality List of Drinking Water Contaminan ts 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 Wate r 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.U.S. Environmental Protection Agency August 2011

8 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, search ing 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/waterscien ce/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