Identifying Priority Chem

for EPA Rev

Wendy Cleland‐Ha

The Office of Pollution Prevention 
An Agency P

“More than 30 years after Congress enacted the

Toxic Substances Control Act, it is clear that we are

not doing an adequate adequate job of assessing assessing and

managing the risks of chemicals in consumer

products, the workplace and the environment.

It is now time to revise and strengthen EPA’schemicals management and risk assessment programs.”

EPA Administrator, Lisa J

Jan 

Office of Pollution Preventio

Jan
Enhanced Chemical Mgm

• Program includes:

―Getting the information needed to

understand chemical risks.

―Increasing public access to i f n ormation

about chemicals.

―Targeting priority chemicals for action.

― EPA has released ten chemical action plans

that outline a range of risk management activities

―Regulatory and other ri ks management

actions.

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Goal of Chemical Prior

• Identify highest priority chemicals to determine whether r

significant significant and whether risk management management or other action u

is warranted.

– For hazard, begin with those chemicals with extensively revie

indicating they are carcinogens, cause reproductive/develop

concerns, or are PBTs.

– For exposure, begin with those chemicals to which children a

general popul i at on may be exposed.

• Release initial group of chemicals for priority review by late 

– Early identification will provide interested parties an opportu

provide additional relevant information to inform EPA’s revie

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Two‐Step Prioritization 

• Step 1: Identify priority chemicals for review

– Identify an initial group of candidate chemicals fo

by considering hazard and exposure priority facto

– Chemicals meeting at least one hazard and one e

factor would become part of the initial group of p

chemicals for review.

• Step 2: Select priority priority chemicals chemicals for assessm

assessm

– Use additional exposure and hazard data sources 

further prioritize the chemicals

– Select chemicals for review and assessment, inclu

possible risk management action.

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f f

Step 1 Qu

• EPA would like public input on the prioritizatio

factors:

– Chemicals identified as potentially of concern for children’s h

chemicals chemicals with reproductive reproductive or developmental developmental effects). effects).

– Chemicals identified as persistent, bioaccumulative, and toxic 

– Chemicals identified as probable or known carcinogens.

– Chemi l ca s used in children’s prod t uc s.

– Chemicals used in consumer products.

– Chemicals detected in biomonitoring programs.

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

• Should any of the factors p p ro osed by EPA not be used, and 

Office of Pollution Preventio
–

– For any additional priority criteria factors you might propose, what d

sources should be considered to identify chemicals meeting those fa

– Should any of the data sources in Table 1 not be used and why?

Step 1 Qu

• EPA would like to get public input on the data s

that the Agency intends to use to identify chem

that meet one or more of the Step 1 priority cr

f t ac ors, i l nc uding:

– Which other data sources, in addition to those listed in Table 1 below

the Agency consider in order to identify chemicals that meet the liste

Why should such data sources sources be added?Should any of the data sources in Table 1 not be used, and why?

– Should any factors or data sources receive greater weight than othe

and why?

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Table 1: Data Sources for Overall Iden

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

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 19Potential Children’s Health Concern Voluntary Children’s Chemical Evaluation Program California Proposition 65 (Safe Drinking Water and Toxic Enforcement Act of 19

 IRIS

 NTP CERHR Monographs

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 NTP CERHR Monographs
Table 1: Data Sources for Overall Iden

Children’s Product Use Washington State Children’s Safe Product Act Inventory Update Reporting (IUR, 2006)Consumer Product Use Inventory Update Reporting (IUR, 2006) National Institutes of Health (NIH) Hazardous Substances Data Bank

 Danish Consumer Product Studies

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

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Should certain data sources be considered more impo

Agency’s analysis than others? Why or why not?

Step 2 Q

• EPA would like to get public input on the data sources 

Agency i t n ends to use to f th ur er analyze the chemica

review, including:

– Should additional data sources beyond those listed in 

and 3 below be included? What sources, and why?

– Should any of the data sources listed in Tables 2 and 3 

used? Why not?

–

Office of Pollution Preventio
Table 2: Exposure and 

Uses Inventory Inventory Update Reporting Reporting (IUR) Pre‐manufacture 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 BankEnvironmental releases Toxics Release Inventory (TRI)

 National Emission Inventory (NEI) Database U.S. EPA

 Preliminary Assessment Information Rule (PAIR)

 Organization for Economic Cooperation and Development (OECD) Emissio

 NIH Hazardous Substances Data Bank

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,

Table 2: Exposure and 

General human exposures, including indoor air contaminants

 Children Children’s Total Exposure Exposure to Persistent Persistent Pesticides Pesticides and Other Persistent Persistent Org

Org

(CTEPP) Study

 Brown et al., Indoor Air, 4:123‐134, 1994.

 Daisey et al., Atmospheric Atmospheric Environment, 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‐92‐0

(NTIS PB92‐158468), 1992.

 Shah and Singh, Environmental Science & Technology, 2(12): 1381‐1388,19

 Sheldon et al., Indoor Pollutant Concentrations and Exposures, California A

Board, Contract A833‐156, Final Report, January 1992.

 Shields, et al., Indoor Air, 6:2‐17, 1996.

Office of Pollution Preventio
Table 2: Exposure and 

Environmental Exposures

 Contaminant Exposure and Effects‐Terrestrial Vertebrates database (CEE‐T

 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 Lev

 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

 N i at onal Status and Trends Program (NSTP) National Stream Quality Accounting Network (NASQAN) Surface Water and

Sediment Data U.S.G.S.

Office of Pollution Preventio
Table 2: Exposure and 

Worker Exposures

 Inventory Inventory Update Reporting Reporting and Chemical Chemical Data Reporting Reporting (IUR/CDR) (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 S bu stances D t a a B k an

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Table 3: Haz

National Library of Medicine Databases

 Biomedical Citations From PubMed

 Toxicology Toxicology Citations 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

USEPA – Office of Pesticide Programs Reregistration and Inerts Databases

USEPA – Ambient Water Quality Criteria Documents

USEPA – Drinking Water Standards Health Effects Support Documents

USEPA – ECOTOX Database

IPCS Concise International Chemical Assessment Documents (CICADs)

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