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Step 1(b) Topic: Data Sources for Prioritization Factors

2011 August 5

EPA invites your thoughts on the data sources that the Agency intends to use to identify chemicals that meet one or more of the Step 1(a) prioritization factors, including:

  • Which other data sources, in addition to those listed in Table 1, should the Agency consider in order identifying 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.
  • Please discuss which data sources, if any, should receive greater consideration than others.

Editor's Note: The opinions expressed in Greenversations are those of the author. They do not reflect EPA policy, endorsement, or action, and EPA does not verify the accuracy or science of the contents of the blog.

18 Responses
  1. Rob permalink
    August 23, 2011

    Similar to my comment under 1(a) the Canadian Chemicals Management Program should be considered as a resource for identifying substances for review within the US. Their screening level hazard and exposure assessments provide a tremendous resource and could be a good starting point for fast tracking a substantial number of substances through a US assessment program since a lot of the ground work has been laid.

  2. Mike Strong permalink
    September 7, 2011

    I would think one of the main sources should be the Screening Data Sets already submitted to the EPA under the HPV program. Perhaps you should look at those first and identify if any of the HPV data already collected “red flags” any chemicals for further attention.

  3. Nelson Lawson permalink
    September 8, 2011

    We recommend that EPA be careful in using the Canadian Chemicals Management Program to prioritize chemicals for the EPA efforts. Environment Canada (EC) used a suite of computer models to estimate the persistence, biodegradability and inherent toxicity of approximately 23,000 chemicals on its Domestic Substances List. Due to lack of manpower there was no effort to check these results against published data. These classifications were published in 2005. The PCA carefully reviewed these for substances of interest to the pine chemicals industry and concluded that many of the classifications were incorrect when compared to data submitted to the USEPA under the High Production Volume Challenge program, or to other studies in our files.

  4. Derek Swick permalink
    September 8, 2011

    Below the American Petroleum Institute (API) offers ideas on the data sources EPA will use in the prioritization process.

    • The California Proposition 65 list itself is not an appropriate data source because it is largely based on the designations of other bodies. Many chemicals are listed under legal provisions that state that a chemical must be listed if it is formally identified as a carcinogen or reproductive toxicant by an “authoritative” body or if a State or federal agency formally requires it to be identified or labeled as a carcinogen or reproductive toxicant—even if other authorities have concluded differently. Thus, it is more important to consider data from the primary sources, e.g., IARC, NTP, and so forth. The California EPA Office of Environmental Health Hazard Assessment (OEHHA) Hazard Identification Materials (which is a compendium of toxicology information prepared in the process of considering chemicals for listing) may be an appropriate data source—and would be a better source than simply considering the Proposition 65 list.

    • Integrated Risk Information System (IRIS) documents should be used on a case-by-case basis, given that some are no longer current and/or are under scientific challenge.

    • EPA should consider information available from the European Chemicals Agency (ECHA), much of which is available on the ECHA website through a chemical substance search mechanism. EPA should also coordinate with ECHA and industry to leverage the work being conducted under REACH. Information developed under REACH, such as the Chemical Safety Reports, is recently generated, and is some of the most comprehensive information available in terms of exposure information.

    • EPA should consider future incoming quality information from the National Children’s Study, which is being undertaken by a consortium of the National Institutes of Health (NIH) and other federal government partners.

    • It is puzzling that ToxCast is not mentioned. EPA launched ToxCast in 2007 to develop ways to predict potential toxicity and to develop an approach for prioritizing thousands of chemicals that may need toxicity testing. EPA should carefully consider which data, approaches, tests and test results, and other information could be leveraged from ToxCast for this chemical prioritization.

    • The human biomonitoring data sources in Table 1, with the exception of the NHANES, are dated.
    o NHATS was conducted between 1970 and 1989.
    o NHEXAS was conducted in the mid 1990’s.
    o TEAM was conducted in the early 1980’s.

    At Step 1(b), EPA’s Discussion Guide includes only a table of data sources “for each of the Action Plan prioritization factors.” There is no information on how the Agency will use the data to do evaluation/assessment. The next step (2) begins with “After identifying a group of chemicals for priority review,” with no explanation of the methods or approach EPA would use to get from the data sources in 1(b) to the group of chemicals for priority review in Step 2. How EPA will use these data in conjunction with the prioritization factors is really the heart of the matter, but EPA’s Discussion Guide is virtually silent on this important issue. Please refer to our comments on step 2, which address use of data sources. Also please refer to API’s comments under Step 1(a).

  5. Richard Denison permalink
    September 13, 2011

    Avoiding paralysis by analysis: EPA proposes a sensible approach to identifying chemicals of concern

    Last week, the Environmental Protection Agency (EPA) held stakeholder meetings to get public input into the criteria it will use to identify additional chemicals of concern beyond the 11 chemicals or chemical classes it has already identified. EPA used these meetings (as well as this online forum open until September 14) as an opportunity for the public to respond to a “discussion guide” it issued in August that sets forth draft criteria and identifies data sources it intends to use to look for chemicals that meet the criteria.

    EDF and the Safer Chemicals Healthy Families coalition strongly support EPA in this endeavor – both for what it is, and for what it is not.

    The word “action” was for many years virtually missing from the EPA chemicals program’s vocabulary. (I guess you could say the program was kinda “missing in action.”) Of the more than 60,000 chemicals on the market at the time TSCA was adopted in 1976, fewer than two percent have received any substantive, data-informed review. So it is a welcome development that EPA is actually looking at chemicals in commerce – despite the lack of a mandate to do so under the Toxic Substances Control Act (TSCA) – and, for those posing concerns, initiating at least those limited actions allowed by TSCA.

    For the chemicals of concern EPA identifies, it expects to develop “chemical action plans” similar to those it has developed for the first 11 noted above. These plans identify “a range of actions … 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.”

    That’s the purpose of the criteria EPA is now proposing to formalize. Equally important is what EPA’s purpose is not. As EPA states on its website:

    “EPA’s goal is to identify priority chemicals for near-term evaluation, not to screen and prioritize the entire TSCA Inventory of approximately 84,000 chemicals.” (emphasis added)

    EPA has been clear that the latter task – a comprehensive review and ranking of all chemicals in commerce – is beyond its current authority and resources, and that any such effort – to the extent it is desired – must await TSCA reform.

    Clarity as to the more limited purpose of EPA’s current initiative is important to note for two reasons. First, it means that EPA is not claiming that chemicals it identifies as priorities are necessarily those that have somehow been shown to pose the greatest risk in comparison to all other chemicals. Rather, they are chemicals for which there is sufficient evidence or reason for concern that they warrant further scrutiny. And, of course, in order to actually regulate the production or use of such chemicals, EPA would have to meet the very high burdens imposed on it under TSCA.

    Second, some in industry have been arguing that EPA cannot even name a chemical of concern unless it first shows it is at the top of the list, identified though some kind of comprehensive ranking system that is applied to all chemicals in commerce. That approach is indeed awfully close to what ACC has proposed as its “comprehensive” prioritization tool, about which I’ll have more to say in my next post.

    This impression is amplified by ACC’s invoking of the Canadian approach to prioritization to support its tool. What ACC fails to mention is that Canada’s approach – which entailed a review of all 23,000 chemicals on Canada’s equivalent to the TSCA Inventory – was mandated by statute in amendments to the Canadian Environmental Protection Act (CEPA) adopted in 1999.

    Moreover, Canadian agencies were given seven years and a major infusion of new resources to complete just the first phase of its process. With 84,000 chemicals on the TSCA Inventory … well, I’ll let you do the math to guesstimate how long and how many resources it would take for EPA to carry out the same approach. Without the authority and the resources, well, that’s just a recipe for paralysis by analysis.

    So, what is EPA’s proposal?

    While the EPA description of its proposal is merely a “discussion guide” and more detail will be needed to fully comprehend it, the agency proposes to utilize a basic set of criteria about which there is little controversy at least at the 30,000-foot level. We are pleased to see an emphasis on chemicals that can adversely affect children’s health, on PBTs (persistent, bioaccumulative and toxic chemicals), and on chemicals detected in biomonitoring.

    EPA also identifies a list of sources of information it would use initially to identify chemicals meeting each of the criteria, and then additional sources it would use to refine the list, conduct reviews of the selected chemicals and initiate risk assessment and risk management actions as warranted. Again, the sources EPA identifies are pretty straightforward.

    The idea, according to EPA, is to generate and make public an additional list of chemicals of concern this fall, and then to proceed on to identify more chemicals over time using the same criteria. Release of that list would provide all parties with an opportunity to provide more information to the agency.

    What else is needed?

    We generally support EPA’s approach and believe it strikes the right balance between clarity and transparency and avoiding paralysis by analysis. Nonetheless, we offer the following 10 additional suggestions for improvement:

    1. Cast a wide net in Step 1: EPA need not and should not limit the sources it relies on in Step 1 to a small number, as it suggests it will do, especially if those sources are intended to identify the longer list from which a subset will be selected for further review and action.
    o Many of the sources EPA plans to use in Step 2 could identify chemicals that might otherwise be missed in Step 1. For example, databases of chemical releases to or presence in air, water, fish, sediment, etc. should supplement the human biomonitoring data sources identified for use in Step 1.
    o While an exhaustive search of all possible data sources is not warranted especially to develop a “starter list,” EPA should be able to efficiently conduct searches of multiple data sources by relying on its own and others’ integrated databases and portals, such as:
     ToxRefDB: EPA’s own Toxicity Reference Database captures thousands of in vivo animal toxicity studies on hundreds of chemicals.
     ExpoCastDB: EPA’s Exposure Database includes studies where chemicals were measured in environmental and biological media, including air, house dust and food, and human biological fluids and tissues.
     The OECD’s eChem Portal: The Portal consolidates chemical data from many different international and national programs across OECD member countries.
     European Union classification databases and lists, including ESIS (the European chemical Substances Information System), which includes lists of chemicals classified using criteria developed under the Globally Harmonized System (GHS) for Classification and Labeling as carcinogens, mutagens, reproductive toxicants, aquatic toxicants, PBTs, etc.

    2. EPA should not preclude using published, peer-reviewed literature as a primary source of information to identify priority chemicals: While reliability and data quality always need to be considered in any weight-of-the-evidence approach, there is no a priori reason to exclude such information, any more than to exclude industry-generated data that populate many of the databases just noted.

    3. Add criteria for environmental hazard and exposure: EPA’s proposed criteria are heavily weighted toward human health and need to be balanced by adding criteria that address both hazards to wildlife and ecosystems and environmental release and exposures.

    4. Expand health effects of prenatal and postnatal concern for children’s health: Reproductive and developmental toxicity are appropriate focuses, but need to be supplemented with an additional explicit focus on neurodevelopmental effects, a major concern for many chemicals for which early life exposure may occur.

    5. Expand the scope of exposure considerations for children: While EPA articulates a broad concern for children’s health, its main focus on products intended for use by children is far too limited. Children may be directly exposed to products used in the home whether or not they use them. And exposures that occur in utero via transfer of chemicals from pregnant women or through breast feeding may be just as or more important than children’s product exposures.

    6. Consider a broader range of vulnerable subpopulations: While a focus on children’s health is warranted, EPA also needs to consider chemical exposures of workers and other subpopulations (e.g., environmental justice communities) who may be more susceptible or disproportionately exposed relative to the general population. For workers, this focus should extend beyond chemical or product manufacturing workplaces to include exposures to chemicals in industrial or commercial products or materials they use (e.g., building materials, automotive products) or manage after their use (e.g., product and material recycling, disposal).

    7. Consider aggregate exposure to chemicals: In making prioritization decisions, EPA should factor in the range of sources and uses of a chemical that contribute to overall exposure, not just those uses that fall under its TSCA jurisdiction. While legal issues would need to be addressed if and when EPA decided that regulatory action would be needed, it makes no sense for EPA to ignore at this stage uses or sources of a chemical that may contribute substantially to overall exposure. Just as EPA’s proposed reliance on biomonitoring data represents a measure of exposure integrated across all sources, so too should its consideration of other exposure information sources.

    8. Don’t exclude chemicals with high hazard or high exposure for which data gaps leave uncertainty as to risk: Where strong evidence of high hazard or pervasive or high exposures exists, EPA should be able to prioritize such a chemical. This is critical if the limited data gaps are to be addressed – otherwise, EPA will simply continue to look at the same data-rich chemicals over and over again. Chemicals with high hazard or high exposure for which there is concern about the other parameter need to be prioritized at a minimum for data development to determine the level of risk they pose. (I’ll have more to say about ACC’s insistence that only chemicals with affirmative evidence of both high hazard and high exposure should be identified as priorities.)

    9. Go beyond the TSCA Inventory Update Reporting (IUR) data on use and exposure wherever possible: As we’ve blogged about repeatedly in the past, and as EPA has forthrightly acknowledged in finalizing major enhancements to its chemical information reporting system, chemical use information available to EPA through the IUR are woefully incomplete and limited. To the extent possible, EPA should look for other sources of such information to identify priority chemicals, and certainly should not exclude high hazard chemicals on the basis of such information. That was a common mistake EPA made in its earlier, ill-fated ChAMP initiative.

    10. Provide more clarity as to how EPA intends to proceed from Step 1 to Step 2: This is an area where EPA discussion guide is particularly lacking in detail and needs to be clarified.

  6. Jane Wishneff permalink
    September 13, 2011

    IFRA North America believes that the data sources relied upon by EPA in identifying priority chemicals must be valid and authoritative. Additionally, existing hazard and exposure information should be leveraged in EPA’s prioritization of chemicals in commerce, including data and information from other mandatory and voluntary regulatory programs such as the European Union’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), Canada’s Chemical Management Plan, the U.S. High Production Volume (HPV) challenge, and the Organization for Economic Cooperation and Development (OECD) eChemPortal.

    IFRA North America is, however, concerned with the inclusion of State governmental bodies or lists as sources of data that the Agency intends to use to prioritize chemicals (i.e. California Proposition 65, Washington State Children’s Safe Product Act). Reliance on these State programs indicates EPA’s tacit approval of the criteria by which a State has developed their list. This puts the EPA in a somewhat difficult position of either justifying the inclusion of a State’s list, or justifying why a particular list was not included. In addition, many State lists or programs have not been developed through an appropriate stakeholder process.

  7. September 14, 2011

    Please see the ECHA dissemination website for information on registered substanes. http://apps.echa.europa.eu/registered/registered-sub.aspx#phasein

  8. Kathleen Roberts permalink
    September 14, 2011

    The North American Metals Council (NAMC) is pleased to submit input to Step 1(b) — Data Sources for Prioritization Factors in the U.S. Environmental Protection Agency’s (EPA) “Discussion Guide: Background and Discussion Questions for Identifying Priority Chemicals for Review and Assessment” (Discussion Guide).

    Toxic Release Inventory (TRI) Persistent, Bioaccumulative, and Toxic (PBT) Rule Is Not Appropriate Data Source

    EPA has long recognized that metals and metal substances must be assessed differently than organic chemicals. Thus, as noted in EPA’s Framework for Metals Risk Assessment:

    The purpose of this document is to present key guiding principles based on the unique attributes of metals (as differentiated from organic and organometallic compounds) and to describe how these metals-specific attributes and principles may then be applied in the context of existing EPA risk assessment guidance and practices. While organic compounds, for example, undergo bioaccumulation, there are unique properties, issues, and processes within these principles that assessors need to consider when evaluating metal compounds. Furthermore, the latest scientific data on bioaccumulation do not currently support the use of bioconcentration factors and bioaccumulation factors when applied as generic threshold criteria for the hazard potential of metals.

    As EPA notes elsewhere in the Framework for Metals Risk Assessment, this last point applies specifically to the question of whether a substance should be classified as a PBT chemical for purposes of human and ecological risk assessments.

    Despite EPA’s clear position that PBT should not be applied to metals, the TRI office continues to list lead as a “TRI” PBT substance. Because the TRI office’s listing runs counter to EPA’s scientific views, the term “TRI” has been inserted in front of the PBT designation in an attempt to avoid confusion. Because the TRI listing of lead is not based on EPA’s Framework for Metals Risk Assessment, NAMC does not believe it should be used to identify lead as a PBT substance.

    EPA Should Not Include the List of Chemicals Proposed for Listing under the Convention on Long-range Transboundary Air Pollution (LRTAP) or the Protocol on Persistent Organic Pollutants (POP)

    NAMC does not support the inclusion of chemicals proposed for listing in LRTAP or POPs. EPA cannot rely on a list of chemicals that have not yet undergone scientific review and evaluation under those programs.

    Proposition 65 (Prop 65) Is Not an Appropriate Data Source

    Rather than referencing Prop 65 chemical lists, the data source list would be more defensible if it relied upon underlying studies/sources supporting the Prop 65 listing itself, including National Toxicology Program (NTP) studies, International Agency for Research on Cancer (IARC) determinations, and related “primary source” determinations.

    Washington State Children’s Safe Product Act List Is an Inappropriate Data Source

    The Washington State Children’s Safe Product List is a list of chemicals for which manufacturers must report by August 2012. This reporting obligation is not intended to prejudge whether a chemical has been used in children’s products, so its inclusion as a data source is inappropriate.

  9. Paul Dugard permalink
    September 14, 2011

    Carcinogenicity:
    IRIS classifications A and B1 are explicit, as is the newer “carcinogenic to humans” (“known” is not used). “Likely” is more problematic, covering a range that includes the older B1and B2 down to somewhere in the “C” (possible) class. It is necessary to review the “narrative” that accompanies “likely” to establish the true level of concern. For IRIS, potency can be considered also.
    IARC classification follows an arcane scheme and anything below “1” may be suspect. NTP may also follow an IARC classification. Proposition 65 listing often relies on an “authoritative body” such as IARC or NTP and should not be used to add weight to other listings. Prop 65 listing may not consider “relevance to humans” and is generally unsuitable for prioritization purposes.

    Children’s Health Concerns:
    Chemicals chosen for the VCCEP pilot are small in number (23) and they were not selected for pre-existing concerns for children’s health. The Federal Register notice that established the VCCEP pilot (65 Fed. Reg. 81702 (Dec 26, 2000)) states: “Identification for the VCCEP also does not mean that EPA has made or will make a determination that any uses of the chemical pose significant risks to children’s health.” Chemicals were selected because they were data-rich and were part of biomonitoring programs with no presumption of concern for children’s exposures. VCCEP listing should be dropped as an identifier for prioritization. The recent report of the Office of the Inspector General regarding VCCEP concluded that the chemicals chosen for the pilot were not of primary concern for children’s health.

    Consumer Product Use:
    Is the Danish Consumer Products Studies list relevant to the US?

    Human Biomonitoring:
    To imagine that detection of a chemical in biomonitoring studies is, in itself, indicative of an exposure of concern is naïve in the extreme. The chemicals selected for biomonitoring are, overwhelmingly, well-tested, comprehensively regulated materials. Analytical techniques are capable of detecting levels in biomonotoring that are far below levels of concern. Thus using detection in biomonitoring for prioritizing chemicals in Step 1 will lead to selection of chemicals of low priority for action under TSCA.

  10. Barbara Losey permalink
    September 14, 2011

    Please see APERC comments posted under item 1A.

  11. Sarah E. Amick permalink
    September 14, 2011

    The Rubber Manufacturers Association (RMA) thanks EPA for the opportunity to provide comments on EPA’s “Discussion Guide: Background and Discussion Questions for Identifying Priority Chemicals for Review and Assessment.” RMA supports EPA’s goal of prioritization chemicals for review under TSCA. We are pleased that EPA’s Discussion Draft provides a table of possible data sources for overall identification of priority chemicals in Step 1, and a table of possible data sources for further analysis in Step 2.

    EPA has asked for public input on the data sources that the Agency intends to use in Steps 1 and 2. To assure the prioritization processes are valid, RMA strongly recommends that the data sources EPA plans to use in both Step 1 and Step 2 be credible, widely recognized, scientifically based and open to the public. RMA is not opposed to the inclusion of additional data sources so long as they are credible, widely recognized, scientifically based and open to the public. EPA should exclude any data sources that do not fit these qualifications.

  12. Filipa Rio permalink
    September 20, 2011

    We support EPA for initiating the Prioritization Stakeholder Dialog and proposing a process to identify priority chemicals for review and assessment. Further, we support EPA in recognizing the need for a systematic process for prioritizing chemicals, as prioritization is a critical and necessary first step in any chemical management program. In light of EPA’s goal to increase transparency, we encourage EPA to invite a public notice and comment period when the initial list of priority chemicals is determined later this Fall. Doing so would provide the public with an opportunity to better-inform EPA’s decision on chemical prioritization and its process.

    EPA has not yet explained how it is going to use the prioritization factors and data sources (e.g., what models, assumptions, analysis, etc. it will use) outlined in steps 1 and 2 of the discussion document. How the factors and data sources are used is as important as what the data sources are, particularly in Step 2, which EPA says will be used to select specific chemicals for further assessment, including possible risk assessment and risk management actions. It is critical that EPA establish a solid framework for the analysis up front, and then use it to assess chemicals in batches on a well-communicated schedule with opportunity for public input. The methodology used must be scientifically sound, transparent, properly documented, and consistent.

    Along those lines, we support EPA for this important first step, and recommend continued stakeholder dialog and transparency as this process moves forward.

  13. Laura Madden permalink
    September 21, 2011

    The American Cleaning Institute®, Consumer Specialty Products Association and Grocery Manufacturers Association (hereinafter referred to as the Downstream Coalition) are the leading trade associations representing downstream users of chemical substances used in household and commercial products. Our member companies are committed to manufacturing and marketing safe, innovative and sustainable products that provide essential benefits to consumers while protecting human health and the environment.

    The Downstream Coalition appreciates being a part of EPA’s discussion regarding prioritization factors and data sources it plans to use to identify candidate chemicals for review and assessment under the Toxic Substances Control Act (TSCA). We are committed to providing substantive comments and continuing to assist EPA in strengthening its current chemicals management program.

    EPA has requested input on the data sources for Step 1 prioritization factors. The Downstream Coalition was pleased to see the Canadian Categorization as a data source for PBTs. The Agency should capitalize on work done by Environment Canada to use both hazard and exposure potential to set both health and environmental priorities. In fact, we recommend that EPA focus its consideration on the approximately 500 chemicals identified as High Priority in the Canadian program.

    EPA should leverage existing hazard and exposure information from other mandatory and voluntary programs to inform prioritization. Examples would include the European Union’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), the U.S. High Production Volume Challenge, the Organization for Economic Cooperation and Development (OECD), HPV information and the eChemPortal. Each of these is a current, available data source that would provide EPA with a wealth of hazard data to better inform the prioritization process.

    The Downstream Coalition would like to caution EPA about using consumer product use information from other countries. Consumer product formulations and use patterns are typically very different from the way in which U.S. consumer products are formulated and used.

    While the National Health and Nutrition Examination Survey (NHANES) is a well recognized and authoritative source for biomonitoring information, the other surveys (i.e., NHATS, NHEXAS and TEAM) are dated and less informative of current biomonitoring evidence in the US population. We recommend EPA strike the NHATS, NHEXAS and TEAM sources from Table 1.

    The EPA should be careful not to rely on lists that represent potential hazard and exposure factors as defined by other authorities that do not include a formalized scientific process. A list(s) that is derivative (i.e., based on other lists) is not based on objective criteria or on a review of original information on the chemicals. In addition, the Washington State Children’s Safe Product Act Reporting Rule only seeks information about whether a listed compound is used in children’s products. Initial reporting on that list is not due until 2012, making it premature to assume that compounds on the list are actually used in children’s products. Similarly, concerns have been raised on the California Proposition 65 list as an appropriate data source for chemicals that are listed by the Labor Code mechanism, because it is based on the designations of other bodies. Many chemicals are listed under specific California legal provisions that require a chemical to be listed if it is formally identified as a carcinogen by an “authoritative” body or if a State or federal agency formally requires it to be identified or labeled as a carcinogen—even if other authorities have concluded differently.

    The Downstream Coalitions believes that EPA should rely on lists from primary sources (e.g. NTP, which from our review are already included in the Agency’s proposal). Further, authoritative sources, government agencies or formalized scientific organizations used as data sources should meet requirements that:

    • Chemicals are characterized pursuant to an open, deliberative and transparent scientific process in which stakeholders are able to participate formally, communicating directly with the authoritative body through written and oral comments.
    • It is widely perceived to be objective, scientifically based, and does not engage in advocacy.
    • Characterization of chemicals is based on a weight-of-evidence approach. To the extent available, it considers multiple reliable studies, conducted by different laboratories, at different times, and involving not only different strains but different species and gives full consideration to mode of action, confounding factors, maternal toxicity, historical controls and any other scientific information that may be relevant to understanding the potential effects of chemicals on health and the environment.
    • Characterization of chemicals is published through governmental regulations, periodic reports, monographs or similar publications.

    Finally, one of the data sources for “chemicals used in consumer products” EPA will rely on, the 2006 IUR, includes a data field that provides both commercial and consumer uses. This could introduce some uncertainty in the outcomes of EPA’s prioritization, since some chemicals might have only commercial and not consumer uses. This again points out the need for EPA to be open to timely submission of additional information on candidate chemicals before finalizing its list of priority chemicals for further assessment. In future rounds of prioritization, EPA should fully utilize the more specific information on uses that will be submitted under the Chemical Data Reporting (CDR) rule.

  14. Fred Corey permalink
    September 21, 2011

    The National Oceanic and Atmospheric Administration (NOAA) has developed a national marine mammal contaminant monitoring program. According to NOAA, marine mammals are considered sentinels of ocean health since they reside at the top of the marine food chain. In addition, marine mammals and fish can be considered as sentinels of human health as well, because in the case of some chemicals such as PBDEs, they were first detected in fish, and have now been detected in human breast milk.

    EPA’s CERCLA program maintains a phytoremediation database that documents the ability of certain plants to bioaccumulate specific chemicals. Although the chemicals are not necessarily toxic to plants (this would limit the usefulness of the plants for phytoremediation), these contaminant uptakes by plants are indicative of potential pathways for chemicals to enter the food chain. In addition, the CERCLA program also maintains the CERCLIS database, which represents uncontrolled chemical releases at locations across the country. This is another potentially rich source of information regarding significant chemical releases and exposures in the United States.

  15. Tyrone Wilson permalink
    September 21, 2011

    This point is related to concerns about how EPA might use data from the Toxic Release Inventory (TRI) for the prioritization process. As many stakeholders are aware, the TRI comprises data on releases and transfers of chemicals reported annually by facilities subjected to the TRI reporting rules.

    The concern is that on past occassions, EPA has combined TRI data with hazard data in models that have resulted in questionable analysis. EPA should be careful about building models around combined TRI and hazard data without doing proper human risk assessments. Commingling these two data sources (TRI and hazard) could lead to the generation of useless data. We do not believe this is the goal of the agency’s prioritization process.
    The bottom-line point here is that TRI data – if it is to serve as one of the data sources under consideration – should be used within its limitations and in a scientifically sound manner.

  16. James Cooper permalink
    September 21, 2011

    Comments on Step 1(b): Data Sources for Prioritization Factors

    NPRA believes that the proposed data sources appear in many cases to follow a list-driven approach. Some of the sources contain outdated or questionable data (e.g., NOES, California Proposition 65, Washington State Children’s Safe Product Act, NHATS, NHEXAS, etc.). EPA should rely more on measured data to refine assessments than whether or not a particular chemical appears on a list. Measured data can be obtained through Section 8 reporting of existing hazard and exposure information (after the initial screening), and possible Section 4 testing for situations where EPA needs specific hazard data in the risk assessment process.

    To avoid penalizing data-rich chemicals and new chemicals for which there is limited, measured hazard data, NPRA suggests that EPA use its predictive models, structure-activity-relationship (SAR) analysis and internal databases for the first tier in the screening process. EPA should make its first tier results publicly available, taking confidential business information into consideration, and place the burden on industry to provide measured data or other relevant scientific arguments to refine the initial assessments.

    Another important component of the overall risk assessment process is the employment of a weight-of-the-evidence approach, which can only be accomplished by weighting data according to scientific certainty, clarity and quality. An appropriate weighting scheme should be developed and made publicly available for comment to assist in refining assessments and priorities in the overall process.

  17. James Cooper permalink
    September 21, 2011

    General Comments on Priority-setting:

    The National Petrochemical and Refiners Association, NPRA, appreciates the opportunity to comment on EPA’s proposed chemical prioritization plan. NPRA commends EPA on its interest in establishing a risk-based priority process. First and foremost, any priority process should be fully transparent and viewed holistically in the context of tiered and targeted risk assessment and risk management. Transparency can be accomplished by developing thorough guidance, complete with full descriptions of each step in the priority-setting process, potential outcomes of each step, criteria used in decision-making and appropriate weighting for decision factors.

    NPRA agrees with several other stakeholders that EPA has been slow and, in some cases, reluctant to use certain regulatory authorities granted under TSCA. EPA is moving in the right direction by establishing a priority-setting process and needs to use a tiered, targeted and risk-based approach to ensure that resources are utilized in an effective and efficient manner. Both hazard and exposure should be considered during each tier in the process. The ultimate goal of priority-setting is to allow EPA to focus its resources; therefore, casting a wide net and considering an abundance of different factors too early in the process will only make achieving the agency’s objectives more challenging. Considering all the factors proposed under this blog would result in an initial cut that includes most chemicals subject to IUR reporting, which would put EPA right back at the starting point. NPRA recommends that EPA keep it simple in the first and second tiers, consider the factors that the agency has proposed to develop a “quick-start” list of chemicals for immediate review and movement through the tiers, and move forward in a deliberate and transparent manner. Other factors could be added in subsequent tiers to help refine screening-level assessments and look at a fuller array of potential hazards and exposure pathways.

    The first tier in the process should address all chemicals in commerce that are produced or imported at quantities greater than 25,000 pounds per year – i.e., chemicals reported to the agency under the Inventory Update Reporting (IUR) rule. EPA should develop a software-based sieve to enable it to quickly screen the IUR chemicals. All chemicals in the first tier should be judged using the same tools and criteria to avoid penalizing data-rich chemicals. EPA should use its predictive models, structure-activity-relationship (SAR) analysis and internal databases for the first tier. While some have questioned the accuracy of models and SAR, the intent is not to use an academic risk assessment approach to screen chemicals; rather, the intent is to use conservative assumptions that are protective of health and the environment initially, and refine the assessment using measured data in subsequent tiers. This approach is consistent with current risk assessment processes used by EPA. Each subsequent tier in the process should allow for stakeholders to submit information that could help refine the assessment of the chemical. Additional factors could also be added in subsequent tiers to ensure that chemicals with uncontrolled risks are not set aside as low priorities.

    NPRA supports the concept of a sieve as proposed by the American Chemistry Council and suggests that EPA convene a multi-stakeholder task group to assist in refining the sieve and developing an outline for appropriate guidance. The stakeholder meeting held on September 7 revealed interest in the ACC sieve from a variety of stakeholders. EPA should take advantage of that interest.

    Another important component of the overall risk assessment process is the employment of a weight-of-the-evidence approach, which can only be accomplished by weighting data according to scientific certainty, clarity and quality. An appropriate weighting scheme should be developed and made publicly available for comment to assist in refining assessments and priorities in the overall process.

  18. Barbara Warren, RN, MS & Lin Kaatz Chary, PhD, MPH permalink
    September 21, 2011

    Step 1 b) Data Sources for Prioritization

    We would like to applaud the EPA for proposing to prioritize some chemicals for action. Risk management is extremely important to public health and EPA’s chemical action plans represent important progress, despite the delays in broad TSCA reform. Thank you.
    In general we are very concerned about PBT substances and the need to identify all of the chemicals in production and use that are persistent, bioaccumulative and toxic. While the new Chemicals program is certainly useful at identifying PBTs that may be submitting premanufacture notices, we need to ensure that all of the chemicals in commerce have been adequately screened for these properties.
    We think the data sources identified in Table 1 are too limited and primarily focused on a few well known PBTs, many of which have been banned. We question why the TSCA New Chemicals Program August 2010 Chemical Categories Report is not included for PBTs, using its criteria. In addition, the PBT profiler should be utilized.
    We note that it is important to differentiate between environmental and human toxicity. However, often it is the evidence of toxicity in fish, animals, microbes, etc., which signals the potential for toxicity in other living species. The absence of testing for human toxicity does not mean that a chemical is non-toxic. So we urge inclusion of environmental toxicity, as well as human toxicity. Some states have done considerable work in the area of environmental toxicity, such as Washington State. In relation to PBTs and contamination of environmental media we support the use of data from state agencies and other federal agencies such as USGS and Fish and Wildlife.
    EPA engaged in a process to screen chemicals for endocrine disruptors. Those chemical lists should be used. A lot of work has been done under the EU REACH program. Fifty- three substances of very high concern have been identified and an additional twenty have been proposed for this list. Chem Sec has also developed a list of over 400 chemicals, using REACH criteria, as high priority for CMR, carcinogenic, mutagenic and reproductive properties, as well as endocrine disruptors. This list is known as the SIN list and a brochure describing its development is available at http://www.chemsec.org/images/stories/2011/chemsec/SIN_List_leaflet_110421.pdf
    The Canadian program is also one the EPA might consider.
    We disagree with some industry arguments that NGO work or lists should not be used. Industry prefers that its own work be used, but industry is always burdened with a financial conflict of interest. Public interest NGOs have done credible and reliable scientific work EPA should evaluate other work and lists based on the quality of the work and the methodology, but not make a blanket decision to exclude all NGO work.
    A number of states have been engaged in evaluating and selecting high priority chemicals for attention and we think EPA should make use of this work. The state of Washington and the state of Maine have focused on chemicals of concern to children. California’s Prop 65 was one of the first lists to include reproductive harm. EPA has also been involved in a screening program for endocrine disruptors and these lists should be utilized now to prioritize endocrine disruptors. TEDEx(The Endocrine Disruptor Exchange List, and the NIEHS and SIN lists of endocrine disruptor lists should also be utilized.
    The University of Massachusetts at Lowell has been working with states on developing the science and protocols around safer alternatives assessments. Assessing safer alternatives may be a future step after priorities are established.
    We have recommended that production volume, imports and uses be considered in Step 1 A. We also believe that prevalence of chemicals and their metabolites and degradation products in environmental media are important to understanding human exposure and toxicity.

    Step 2. Select Priority Chemicals for Assessment.

    The process for Step 2 is currently too vague for us to reasonably provide comment. Without a clearer description of Step 2, we cannot see whether the data sources in Table 2 & 3 would further support a particular chemical’s assessment.

    However, in general we support EPA’s effort and it use of a reasonable scientific methodology to achieve public health protection. Therefore we support some flexibility for EPA in its approach to chemical prioritization.

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