U.S. Environmental Protection Agency September 2011

Identifying Priority Chemical s for Review and Assessment U.S. EPA, Office of Pollution Prevention and Toxics (OPPT) Small Meeting for Input from Key Partners & Stakeholders Sept. 7 th , 2011

Introduction

The OPPT Office Director provid ed an update on the enhanced chemicals management program and an overview of the Agency’s two-step proce ss 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 gr oup of candidate chemicals for re view 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 ch emicals later this fall. This will also allow interested parties to provide additional informa tion to inform EPA’s review. Following below are general comments from particip ants at a small meeting to so licit 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 gu ide, presentation slides and associated blog

comments available at: http://blog.epa.gov/ch emprioritization/

.

General Comments on Process

One commenter from industry requested clarificati on 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 discussi on guide, which indicated that only one criterion was needed to be included in the Step 1. Howeve r, the concern is for risk, so both hazard and exposure are needed. Another i ndustry 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 hi ghest risk, where hazard is well ch aracterized. 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 chemi cal lists would be made public after step 1 or just step 2. The plan is to make them both publ ic 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 webs ite (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 revi ew. And a number of audiences and actors are important for this effort since the public, st akeholders and market will benefit from the

identification of these chemical s. Relatedly, the environmental group noted that the Agency’s website makes a good point, that th is process is not intended to re view 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 cons idered 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 criteriaU.S. Environmental Protection Agency September 2011

2 with EPA’s process. The person noted that the A CC approach seems very rigid; there remains a critical need for expert judgment and flexibility. There may be fact ors for prioritizat ion of certain chemicals that may not be appropriate for all ch emicals. A numeric approach may not always be possible or recognize what needs to be done wh en 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 effe cts can be lifelong. This is critical for the whole population and the concern is more than reprodu ctive and developmental effects, e.g., asthma and respiratory effects. Neurodevelopmental effects (e.g., lead exposure) may not always present. The process should also consider outc omes that affect children beyond, for instance, the California Proposition 65 Carcinogen, Mutagen a nd 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 bi omonitoring 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 th at 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-L ow prioritization and to avoid replacing chemicals that are not a concern. Importa ntly, 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 exis ting 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 c onduct a more in-depth risk assessment. The scope of which is to be determined and base d 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 planne d to post the chemicals identified in step 1 or whether they might be published in the Federal Register. EPA clarif ied that since this step would not involve rulemaking, that a less formal appro ach is appropriate. Generally, the participant supports the concept of identifying chemicals in need of further asse ssment outlined in the discussion guide; however, nomenclature is a concern as the list could condemn chemicals

before the assessment has occurre d. The participant suggested call ing the identified chemicals a

“candidate list” or “chemicals for review.”

The proposed High-Medium-Low scheme was s upported by another industry participant who also posited that the U.S. does not know wh at 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 pos ted, that it supported integrating hazard and exposure information and asked what the relationship is to this effort and the TSCAU.S. Environmental Protection Agency September 2011

3 §5(b)(4) list. EPA explained that the 5(b)(4) list is a tool th at the Agency has under TSCA, but

that this is not the same as a ch emical 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 suggest ed that EPA better

describe the tiers involved and a ssociated 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 a ddition to countries inte rnationally. Washington

identified 300 chemicals and narrowed the list to 65. Information is pending for next year. As risk management actions are under developm ent, can work on alternatives assessment concurrently to promote be tter 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, bu t to not be rigid such that ch emicals 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 asse ssment. 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 di fferent 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 th at 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 wh ere their chemicals go and highlighting that biomonitoring also include umb ilical cord blood monitoring.

An academic participant stressed that this proc ess 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 wh ere it should go. With respect to the proposed industry approach, the participant reflected that it has similar ities 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 appr oach allowed for the use of QSAR modeling where data was lacking and it recommended subs titution, 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.U.S. Environmental Protection Agency September 2011

4 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 appr oach (including the iden tification of medium and low priorities). The proposed ACC prioriti zation 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 genera lly supported the factors, but not ed that the PBT factors depend on definitions, international agreements.

A state participant supported th at 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 import ance of in utero exposure factors as well as considering factors for chemicals that contri bute to highly prevalent diseases, e.g., cardio vascular disease, etc.

An environmental group participant stated that f actors on the environmenta l/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 constructio n materials. Persistence and Bioaccumulation need a broad approach with criteria. Monitori ng information can also show P & B. Chemicals can be ubiquitous despite PBT criteria – repeat ed 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 s upported including environmental e ffects with the prioritization factors, but that the objec tive should guide c onsiderations with additional criteria.

A children’s health expert clarified that ther e are no authoritative lists for children. To some degree, other lists can be shown to impact child ren, 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 indicat ors from a variety of sources that address a range of end points. De-tangling P, B or T base d 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., prev alence in bodies, where everyone’s exposed, there

is a need to better understand effects. There is no need for hazard and exposure information ifU.S. Environmental Protection Agency September 2011

5 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 database s may not be transparent – what criteria will be applied to select priorities ? Need to look at recent defini tions 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/wor ker 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 chemi cal 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. Ju risdictional coordination should be addressed in later steps.

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

A tribal representative stresse d that environmental exposures and factors targeted to sensitive/vulnerable populations need to consid er subsistence exposures, i.e., those including natural resource utilizations, cultural, spiritual, traditional, dietary, etc. For instance, several native Alaskan populations carry some of the high est 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 sugges ted 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 wi th hazard. Also noted that the focus should be on TSCA-relevant exposures for prioritization, k eeping in mind what TS CA can address. The Agency should also consider criteria for data qua lity and [criteria] if there might be a need to

deselect chemicals that were selected.

Another industry participant suggested that volume used for childre n’s products, not just production volume alone, should be used to understand potential for exposure in the

environment.U.S. Environmental Protection Agency September 2011

6 Production volume is useful with the caveat of li fe 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 ubiqui ty, dispersion, use exposur es 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 scien tific criteria for all chemicals, while the second tier, could be more qualitative.

There’s a need to look at childre n’s environments, pre-natal, home s, schools, day care, food, etc., as a way to organize, and link factors to da ta sources, a children’s health expert added. Determine what you are trying to measure, then l ook to best available data sources, and then expand to other lesser sources.

An industry participant also noted that the more f actors that are added to th e first pass, could also hamper timing. Suggested starting simply, buildi ng 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 pr ocess 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 fo r the first screen.

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

to be mindful of not ove rburdening the process.

Environmental group participants suggested looki ng at EPA’s National Center for Computational Toxicology (NCCT) databases such as ToxCas t, 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 integr ated databases at EPA, the OECD’s eChemPortal,
REACH IT, the EU list for Classi fication 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 EP A relied on certain information. Where there’s published, peer reviewed literature, it should be considered. EPA clar ified that step 1 factors are intended to identify highest prior ity 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.U.S. Environmental Protection Agency September 2011

7 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 othe r natural resources.

An industry participant supported using the eChemPortal. It cont ains over 600,000 data records, HPV and REACH (ECHA) information with 5 400 data sets. The Agency should look to Canada’s approach that looked at the greatest potential for ex posure, 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 exposu re). 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 conc erns. Need more children’s data

sources.

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

not hazard based.

An industry participant suggested that EPA keep the process s imple 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 data sets, 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 we re done. VCCEP results should be included in this effort. Industry proposed that this dialogu e continue on process and as we work toward solutions, the continued provision of information.

It was also suggested by industr y that EPA look at Safety Data Sheets with REACH as they contain a lot of exposure/use information. EPA s hould also ask for information similar to what Canada did with narrow timelines. Industry has in formation from its Global Product Stewardship initiative and information system.

An industry participant also recommended draw ing 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 participantU.S. Environmental Protection Agency September 2011

8 noted the National Children’s Study as a source of potential information. EPA should also have flexibility to get information wherever it ex ists 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 inv ite 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 constr uctive comments, thoughtful input and a productive meeting.U.S. Environmental Protection Agency September 2011

9 ATTACHMENT 1

Attendees List

Sarah Brozena, American Chemistry Council Christina Franz, Americ an Chemistry Council Connie Deford, Dow Chemical Company Richard Sedlak, American Cleaning Institute Julie Froehlicher, Proctor & Gamble Company Laura Madden, Consumer Speci alty Products Association Doug Fratz, Consumer Specia lty Products Association Suzanne Hagen, U.S. Henkel John Shanahan, Grocery Manufacturers Association Bill Greggs, Grocery Manufacturers Association James Cooper, National Petrol eum 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 Po llution Prevention and Toxics Maria Doa, Chemical Control Division Oscar Hernandez, Risk Assessment Division Neil Patel, Economics, Expos ure and Technology Division John Shoaff, Environmenta l Assistance Division Susan Sharkey, Chemical Control Division Mary Dominiak, Chemical Control Division