U.S. Environmental Protection Agency September 2011

Identifying Priority Chemicals for Review and Assessment 

U.S. EPA, Office of Pollution Prevention and Toxics (OPPT) 

Small Meeting for Input from Key Partners & Stakeholders 

Sept. 7th, 2011 

Introduction

The OPPT Office Director provided an update on the enhanced chemicals management program 

and an overview of the Agency’s two-step process to identify priority chemicals for review and 

assessment. The primary goal is to address the highest priority chemicals to determine whether 

risk is significant and whether risk management or other action under TSCA is warranted. Step 1 

involves identifying an initial group of candidate chemicals for review by considering hazard and 

exposure factors. Step 2 utilizes additional exposure and hazard data sources to further prioritize 

chemicals selecting chemicals for assessment, including possible risk management action. The 

Agency plans to release an initial group of chemicals later this fall. This will also allow 

interested parties to provide additional information to inform EPA’s review. Following below are 

general comments from participants at a small meeting to solicit input on the process and 

surrounding specific questions on steps 1 and 2. See Attachment 1 for the list of attendees. For 

more information, please see EPA’s discussion guide, presentation slides and associated blog 

comments available at: http://blog.epa.gov/chemprioritization/. 

General Comments on Process

One commenter from industry requested clarification on the Agency’s intent to include at least 

one hazard and one exposure factor to identify priority chemicals which was confirmed. EPA 

noted that this was a change from the discussion guide, which indicated that only one criterion 

was needed to be included in the Step 1. However, the concern is for risk, so both hazard and 

exposure are needed. Another industry commenter sought more information on the criteria to 

select chemicals for assessment and how to determine relative priority. There the interest is to 

look at those that present the highest risk, where hazard is well characterized. It may also depend 

on the type of exposure information and on the number of chemicals resulting from step 1. 

An environmental group inquired as to which chemical lists would be made public after step 1 or 

just step 2. The plan is to make them both public though the timing with step 2 may also depend 

on how long assessments might also take and on the information that is made available. Another 

participant also stressed that the Agency’s website (discussion guide) makes an important point, 

that this is not intended to be exhaustive for all chemicals to meet a beyond a reasonable doubt 

standard as the worst of the worst for review. And a number of audiences and actors are 

important for this effort since the public, stakeholders and market will benefit from the 

identification of these chemicals. Relatedly, the environmental group noted that the Agency’s 

website makes a good point, that this process is not intended to review or screen all chemicals. 

Also, it’s important to keep in mind that there are multiple purposes and audiences that the full 

range of stakeholders needs to be considered as the prioritization is done. 

The environmental group participant was pleased to see the American Chemistry Council’s 

(ACC) prioritization screening approach, noting and encouraged by the commonality of criteria 
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with EPA’s process. The person noted that the ACC approach seems very rigid; there remains a 

critical need for expert judgment and flexibility. There may be factors for prioritization of certain 

chemicals that may not be appropriate for all chemicals. A numeric approach may not always be 

possible or recognize what needs to be done when information is lacking. Full information on 

both hazard and exposure may not always be possible. 

An expert on children’s health highlighted that early life exposures matter more than others. 

Those issues may arise at low doses and that effects can be lifelong. This is critical for the whole 

population and the concern is more than reproductive and developmental effects, e.g., asthma 

and respiratory effects. Neurodevelopmental effects (e.g., lead exposure) may not always 

present. The process should also consider outcomes that affect children beyond, for instance, the 

California Proposition 65 Carcinogen, Mutagen and Reproductive Toxicant (CMR) list. Further 

there are data gaps with children on hazard and exposure. The Agency should look at children’s 

environments on top of children’s products and biomonitoring data as it applies to children. 

Transparency is key to help inform us about things that matter to children and beyond what 

shows up on the National Toxicology Program (NTP). 

An industry representative iterated that it’s critical for EPA to have a role in the prioritization of 

chemicals and that industry can assist the Agency with potential resource challenges with greater 

prioritization. It believes that the public wants a High-Medium-Low prioritization and to avoid 

replacing chemicals that are not a concern. Importantly, it desired some clarification on how the 

Agency planned to describe the characterization that would be done and to what standard? EPA 

noted that it would summarize existing information that it believes is available, similar to what it 

has done with its action plans, and provide an opportunity for others to supplement this 

information. Following that, the Agency would conduct a more in-depth risk assessment. The 

scope of which is to be determined and based on available information. The standard would 

depend on the requisite section of TSCA where an action might be considered or taken. The 

Agency could also look at non-regulatory approaches, e.g., alternatives assessments. 

Another industry participant asked if EPA planned to post the chemicals identified in step 1 or 

whether they might be published in the Federal Register. EPA clarified that since this step would 

not involve rulemaking, that a less formal approach is appropriate. Generally, the participant 

supports the concept of identifying chemicals in need of further assessment outlined in the 

discussion guide; however, nomenclature is a concern as the list could condemn chemicals 

before the assessment has occurred. The participant suggested calling the identified chemicals a 

“candidate list” or “chemicals for review.” 

The proposed High-Medium-Low scheme was supported by another industry participant who 

also posited that the U.S. does not know what chemicals are currently in commerce. EPA 

indicated that it was not planning to reset the TSCA inventory at present, but did plan to only list 

chemicals in commerce and drawing from 2006 IUR information until more or newer 

information might be available. 

Industry noted that its approach to prioritization would be posted, that it supported integrating 

hazard and exposure information and asked what the relationship is to this effort and the TSCA 
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§5(b)(4) list. EPA explained that the 5(b)(4) list is a tool that the Agency has under TSCA, but 

that this is not the same as a chemical being added to that list. 

Another industry participant supported the combination of using hazard and exposure 

information, that language will be important in how things are described so that data-rich 

chemicals are not penalized. As a multi-layered process, it was suggested that EPA better 

describe the tiers involved and associated outputs, what lists mean and so as to minimize market 

effects. While the desire for a quick start list is understood, EPA could also undertake a larger, 

overarching effort with stakeholders. 

A state representative highlighted that a number of states (e.g., Washington, Maine, Minnesota, 

California) are involved in this issue in addition to countries internationally. Washington 

identified 300 chemicals and narrowed the list to 65. Information is pending for next year. As 

risk management actions are under development, can work on alternatives assessment 

concurrently to promote better alternatives and avoid regrettable substitutions. 

An environmental group participant suggested that flexibility to consider the broad effects 

mentioned previously in support of children’s health are important, that it is important to look at 

both hazard and exposure criteria, but to not be rigid such that chemicals must all be ready for a 

full-blown risk assessment. This, however, also depends on what chemicals are prioritized for – 

to solicit more information or for full risk assessment. There may be roles for different listings 

and actions. EPA noted that this effort also fits with its larger existing chemicals program, that 

chemicals may be prioritized appropriately for different types of action, but that this process 

would not set priorities for the entire program. 

An industry participant supported the prioritization factors outlined in the process and that the 

opportunity to submit additional information along with how the Agency communicates 

chemicals for “review” is important, both for data gathering and for later, additional analysis. 

On the issue of data gaps, an environmental group stated that it is important for industry to help 

supply hazard and exposure data if factors are to call for both and that industry not oppose 

making available or supplying information. It also supports the focus on chemicals used in 

children’s products, but that this should be as comprehensive as possible, identifying a concern 

that companies have noted they don’t know where their chemicals go and highlighting that 

biomonitoring also include umbilical cord blood monitoring. 

An academic participant stressed that this process not reinvent the wheel and build from others 

before it. The process should be efficient and rapid versus getting bogged down in details. There 

is a need to provide market signals with where it should go. With respect to the proposed 

industry approach, the participant reflected that it has similarities with a Dutch Quick Scan 

approach prior to the advent of REACH that put higher priority on chemicals where there was 

not data. Importantly, this approach allowed for the use of QSAR modeling where data was 

lacking and it recommended substitution, finding alternatives, for and its highest binned 

chemicals. Pollution prevention approaches that consider functional uses might also be 

incorporated into prioritization factors because functional uses may have some characteristics 

that indicate higher exposure. 
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There are multiple needs with prioritization, an industry representative stated, including 

identifying chemicals for further assessment, data needs and the need for a quick start list. This 

process can be viewed as multi-faceted whereby the Agency can identify a quick list (with a 

focus on priority) and a more comprehensive approach (including the identification of medium 

and low priorities). The proposed ACC prioritization approach/tool can be used overall. If 

insufficient information to characterize hazard is available, [with the application of the ACC 

tool] the default is high hazard. 

Addressing Questions on Steps 1 and 2

An industry representative generally supported the factors, but noted that the PBT factors depend 

on definitions, international agreements. 

A state participant supported that children’s health factors, reproductive and developmental 

effect factors, be as broad as possible from conception to development. That environmental 

toxicology include acute and chronic effects, sensitization – eyes, skin and inhalation. It 

suggested that the data for PBTs draw from the Oslo/Paris Convention (OSPAR) list as it 

includes PBTs in the environment. 

Another state representative emphasized the importance of in utero exposure factors as well as 

considering factors for chemicals that contribute to highly prevalent diseases, e.g., cardio 

vascular disease, etc. 

An environmental group participant stated that factors on the environmental/eco-side are needed 

(this is a major gap), recognizing that some carry over from PBT factors, but that it may also 

depend on the information. On children’s health, a broader set of end points and life stages 

should be incorporated. Additional sub-populations need to be included, especially labor, the 

workplace, commercial products and construction materials. Persistence and Bioaccumulation 

need a broad approach with criteria. Monitoring information can also show P & B. Chemicals 

can be ubiquitous despite PBT criteria – repeated exposure should be considered. The Agency 

should look at P and B or B and T, not necessarily all three. The Canadian system used hazard 

“or” exposure, P and T or B and T. 

An industry participant also supported including environmental effects with the prioritization 

factors, but that the objective should guide considerations with additional criteria. 

A children’s health expert clarified that there are no authoritative lists for children. To some 

degree, other lists can be shown to impact children, but doses, time periods and effects, may not 

be fully considered. EPA needs to be cognizant of such limitations and consider how this process 

can help build such information looking at indicators from a variety of sources that address a 

range of end points. De-tangling P, B or T based upon implications for children is also important, 

particularly for the prenatal period. Probable and known carcinogens are not as applicable to 

children. With ubiquity of chemicals, e.g., prevalence in bodies, where everyone’s exposed, there 

is a need to better understand effects. There is no need for hazard and exposure information if 
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something is highly toxic – need to focus on the high hazard chemicals, especially for kids. 

Action may be appropriate with a high amount of information in one area. 

Another industry participant, while agreeing that environmental factors are important and should 

be included, especially for children who may be exposed through the environment, noted that 

making judgment calls based on data in the databases may not be transparent – what criteria will 

be applied to select priorities? Need to look at recent definitions for P and B compounds, e.g., 

The Society of Environmental Toxicology and Chemistry (SETAC) Pellsten Workshop, and 

what terms mean. 

Prenatal exposures and labor/worker exposures (e.g., for workers in salons) are important, added 

an environmental group participant. 

An industry participant suggested that thinking about exposure and toxicity together might be 

useful in terms that high toxicity with chemical properties may drive/accelerate concerns with 

exposure. 

In response, an environmental group participant noted that the Canadian system did use purely 

exposure criteria that was not dependent upon hazard. The Agency should also look more 

broadly at exposures, including non-TSCA uses and aggregate exposure. Biomonitoring data 

automatically integrates multiple exposures. Jurisdictional coordination should be addressed in 

later steps. 

A state participant added that endocrine disrupting compounds should be an added factor. 

A tribal representative stressed that environmental exposures and factors targeted to 

sensitive/vulnerable populations need to consider subsistence exposures, i.e., those including 

natural resource utilizations, cultural, spiritual, traditional, dietary, etc. For instance, several 

native Alaskan populations carry some of the highest exposures to certain chemicals yet they do 

not use or are exposed to traditional consumer products or children’s products. Marine data 

sources should also be added. 

An environmental group representative suggested that the list might include community 

exposures beyond the four federal biomonitoring programs, noted there are State and Tribal 

monitoring programs not listed. 

An industry participant noted that the hazard may not match the exposure route, supporting 

consideration of use patterns in combination with hazard. Also noted that the focus should be on 

TSCA-relevant exposures for prioritization, keeping in mind what TSCA can address. The 

Agency should also consider criteria for data quality and [criteria] if there might be a need to 

deselect chemicals that were selected. 

Another industry participant suggested that volume used for children’s products, not just 

production volume alone, should be used to understand potential for exposure in the 

environment. 
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Production volume is useful with the caveat of life cycle stages and intensity of exposure at 

points in time, clarified an environmental group participant. Children’s exposures may be more 

related to products not intended for their use. Here, there is agreement with the proposed 

approach in the ACC paper and that there is a need to interpret this more broadly. Indirect 

exposures, e.g. contamination of house dust and soil, are good examples. There is a need to 

further refine the product approach for ubiquity, dispersion, use exposures or elsewhere. A 

colleague added that an eco-toxicity factor married with environmental monitoring should be 

added. 

An industry participant thought that focusing on children’s products might be better with the 

second step. The first step should have more scientific criteria for all chemicals, while the second 

tier, could be more qualitative. 

There’s a need to look at children’s environments, pre-natal, homes, schools, day care, food, etc., 

as a way to organize, and link factors to data sources, a children’s health expert added. 

Determine what you are trying to measure, then look to best available data sources, and then 

expand to other lesser sources. 

An industry participant also noted that the more factors that are added to the first pass, could also 

hamper timing. Suggested starting simply, building momentum for an entire program. Using a 

multi-layered approach can get the effort moving quicker. With a process that treats chemicals 

on an equal basis, the public will understand the refinement process and that there won’t be 

shortcuts taken. 

Data Sources

An academic participant observed that there is only biomonitoring data for about 200 chemicals. 

Surrogates for exposure should also be considered, e.g., liquid form, dispersive. There is a need 

to broaden the net for the first screen. 

A state participant supported the factors with the addition of environmental effects, and wanted 

to be mindful of not overburdening the process. 

Environmental group participants suggested looking at EPA’s National Center for Computational 

Toxicology (NCCT) databases such as ToxCast, ToxRefDB, and ExpoCast. It was also 

suggested that while it may need to limit the number of criteria, EPA should cast a broad net and 

not limit the data sources, that it look at integrated databases at EPA, the OECD’s eChemPortal, 

REACH IT, the EU list for Classification on CMRs and PBTs. With regard to the second step, 

it’s not entirely clear how the data sources in the second step will be used to expand on the first 

step. Need to document work and show why EPA relied on certain information. Where there’s 

published, peer reviewed literature, it should be considered. EPA clarified that step 1 factors are 

intended to identify highest priority chemicals for focus while step 2 may get more at exposure 

component. The environmental group participants identified that exposure data sources from 

Step 2 should be companions to the biomonitoring data. 
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A tribal participant suggested looking at the NOAA marine mammal exposures database and that 

phytoremediation databases under CERCLA might also be used to screen how contaminants are 

entering food and other natural resources. 

An industry participant supported using the eChemPortal. It contains over 600,000 data records, 

HPV and REACH (ECHA) information with 5400 data sets. The Agency should look to 

Canada’s approach that looked at the greatest potential for exposure, considering hazard and 

information from their high concern list. 

An academic participant stated that we shouldn’t let chemicals fall to the bottom is we don’t 

have exposure (versus knowing that there is not a lot of exposure). Exposure is important for 

children and it’s important to note that data sources, e.g., table 1 in the Discussion Guide, do not 

necessarily identify or take into account children’s health concerns. Need more children’s data 

sources. 

An industry participant stated that VCCEP shouldn’t be used because it is exposure based and 

not hazard based. 

An industry participant suggested that EPA keep the process simple and stressed the need for 

predictability with the approach so that business knows where its chemicals might end up. 

Ultimately want a flexible approach. Mentioned the 2006 IUR for product and exposure data and 

using modeling software, QSARs if lacking tox data. 

Another industry participant stated that OECD portal and other sites are appropriated but 

cautioned that care be taken in expanding datasets, hazard and toxicity can be universal, but 

exposure with products should be based on U.S.-centric. Cautioned on using the Danish data on 

consumer products. Moving beyond data sets, need to make sure that data quality is maintained. 

Industry identified that the age of the databases needs to be considered – e.g., NHANES vs 

NHATS. Need to ensure data quality reviews were done. VCCEP results should be included in 

this effort. Industry proposed that this dialogue continue on process and as we work toward 

solutions, the continued provision of information. 

It was also suggested by industry that EPA look at Safety Data Sheets with REACH as they 

contain a lot of exposure/use information. EPA should also ask for information similar to what 

Canada did with narrow timelines. Industry has information from its Global Product Stewardship 

initiative and information system. 

An industry participant also recommended drawing from the Chemical Data Reporting (CDR) 

rule for use information. Downstream users are looking to provide more information as well. 

Noted the HSDB is very old. 

A state representative flagged that states have information that may be of use from sampling 

children’s products and conducting biomonitoring in specific regions. An extended dialogue 

could be of useful so long as it does not lead to paralysis by analysis. Another state participant 
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noted the National Children’s Study as a source of potential information. EPA should also have 

flexibility to get information wherever it exists subject to QA/QC, added another state. 

A tribal participant said that CERCLIS Tribal contaminant studies could be another data source. 

An environmental group said that EPA should invite data on chemicals at both stages in the 

process from the public and that there could be additional consideration to how chemicals are 

properly characterized and not demonized. 

EPA thanked all participants for their constructive comments, thoughtful input and a productive 

meeting. 

 
U.S. Environmental Protection Agency September 2011

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ATTACHMENT 1 

Attendees List 

Sarah Brozena, American Chemistry Council 

Christina Franz, American Chemistry Council 

Connie Deford, Dow Chemical Company 

Richard Sedlak, American Cleaning Institute 

Julie Froehlicher, Proctor & Gamble Company 

Laura Madden, Consumer Specialty Products Association 

Doug Fratz, Consumer Specialty Products Association 

Suzanne Hagen, U.S. Henkel 

John Shanahan, Grocery Manufacturers Association 

Bill Greggs, Grocery Manufacturers Association 

James Cooper, National Petroleum Refiners Association 

Dan Newton, The Society of Chemical Manufacturers and Affiliates 

Beth Bosley, Boron Specialties 

Amy D Kyle, UC Berkeley, CHPAC Representative 

Joel Tickner, University of Massachusetts Lowell 

Richard Denison, Environmental Defense Fund 

Jennifer McPartland, Environmental Defense Fund 

Allison Tracy, Environmental Defense Fund 

Andy Igrejas, Safer Chemicals Healthy Families 

Daryl Ditz, Center for International Environmental Law 

Daniel Rosenberg, Natural Resources Defense Council 

Jason Rano, Environmental Working Group 

Ken Zarker, Washington Department of Ecology 

Kathy Kinsey, Marland Department of the Environment 

Peggy Harris, California Department of Toxic Substance Control 

Cathy O’Dell, Minnesota Pollution Control Agency 

Nancy Rice, Minnesota Pollution Control Agency 

Fred Corey, Aroostook Band of Micmacs 

EPA Participants: 

Wendy Cleland-Hamnett, Office of Pollution Prevention and Toxics 

Barbara Cunningham, Office of Pollution Prevention and Toxics 

Jeffrey Morris, Office of Pollution Prevention and Toxics 

Maria Doa, Chemical Control Division 

Oscar Hernandez, Risk Assessment Division 

Neil Patel, Economics, Exposure and Technology Division 

John Shoaff, Environmental Assistance Division 

Susan Sharkey, Chemical Control Division 

Mary Dominiak, Chemical Control Division