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Step 2 Topic: Data Sources for Further Analysis

2011 August 5

After identifying a group of chemicals for priority review using the factors and data sources in Step 1, EPA in Step 2 plans to use information from additional exposure and hazard data sources to further analyze the chemicals to select specific chemicals for further assessment, including possible risk assessment and risk management action under TSCA.

EPA invites your thoughts on the exposure data sources listed in Table 2 and the hazard data sources listed in Table 3 that the Agency intends to use in this further analysis, including:

  • Should additional data sources beyond those listed in Tables 2 and 3 be included? What sources, and why?
  • Please explain your concerns or comments, if any, relating to the data sources featured in Tables 2 and 3.
  • Please discuss which data sources, if any, should receive greater consideration for analysis than others.

Editor's Note: The opinions expressed here 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.

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15 Responses
  1. Rob permalink
    August 23, 2011

    As mentioned in relation to Step 1, the Canadians Chemicals Management Program collected a significant amount of information from a variety of resources as they prepared their hazard assessments. Similarly programs in the EU, Australia, Japan and elsewhere have also collected and assessed hazard data from a variety of resources. EPA should leverage those relevant at pre-existing efforts in addition to the sources that are mentioned in Table 3. Also noticeably absent from sources mentioned in Table 3 is data that has been generated by manufacturers or users of chemical substances. GLP guideline studies made available to the EPA should be given as much weight as something that has appeared in the open literature.

  2. Derek Swick permalink
    September 8, 2011

    The American Petroleum Institue (API) has concerns with the transparency and other procedural aspects around the EPA prioritization scheme. EPA has not yet explained how it is going to use the data sources (e.g., what models, assumptions, analyses, etc. it will use). How the 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.

    EPA’s Discussion Guide has no mention of the prioritization efforts of other countries such as Canada, Japan, and Australia. In particular, Canada is ahead of the U.S. in the area of chemical prioritization. From 1999 to 2006, it completed a prioritization of approximately 23,000 chemicals on its Domestic Substances List (DSL), and is in the process of further assessing 4300 chemicals through its Chemicals Management Plan (CMP). The U.S. EPA should look to Canada for both data sources and categorization approaches. Some of the particular aspects of work in other countries that we recommend EPA consider adopting include:
    • Petroleum processing streams warrant a tailored categorized approach, such as the sector approach used in Canada.
    • Standard exposure scenarios should be used, rather than using production volume as a surrogate for exposure. Development of these exposure scenarios should be transparent and include stakeholder consultation.
    • Environmental fate modeling can be used when there are data gaps (e.g., where data are lacking on persistence and bioaccumulation).
    • Assessment should be organized with substances grouped into “batches,” with phased schedules that allow for public input at appropriate points in the process.

    EPA should also consider the input information and results of other prioritization efforts (e.g., Canada) to be possible data sources.

    Regarding the specific data sources in Table 2, we are particularly concerned about how EPA might use data from the Toxics Release Inventory (TRI). The TRI comprises data on releases and transfers of chemicals reported annually by facilities subject to the reporting rules. EPA and others have used TRI data in many models and analyses that range in quality. One recent example is EPA’s Risk-Screening Environmental Indicators (RSEI) tool, which EPA developed as a screening model. EPA and others, including members of the public and the media, are using RSEI to evaluate and compare environmental performance among different types of industries and individual industrial facilities. API asked a risk assessment consultant to review and evaluate the RSEI model, and presented those results to EPA. The review concluded that RSEI makes unrealistic and overly conservative assumptions in several key areas, and that the RSEI scoring does not conform to standard health risk assessment practice as recommended elsewhere by EPA, other public agencies, and the scientific community. We mention RSEI here only as an example of what can go wrong when EPA attempts to take TRI data and build models around it as a substitute for conducting proper human health risk assessment. We do not object to TRI as a data source as long as it is used within its limitations and in a scientifically sound manner.

    Once EPA has clarified the process they will use to prioritize chemicals, a more in-depth analysis of the data sources listed in the Tables would help ensure that the data are appropriate for the intended purpose. Of particular interest regarding exposure are the sources listed under data type: General human exposures, including indoor air contaminants. These references are dated, being from the mid-1990’s and earlier. Also, it is unclear why these particular references were chosen since there is a wealth of more recent studies addressing general human exposures.

    Also please refer to API’s comments under Step 1(a) and Step 1(b) of this online forum.

  3. 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.

  4. 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.

  5. ECHA permalink
    September 14, 2011

    Towards the end of the year the Inventory of C and L for all notified substances will be disseminated on the ECHA website, for further information see:

  6. Kathleen Roberts permalink
    September 14, 2011

    September 14, 2011

    Via Online Submission

    The North American Metals Council (NAMC) is pleased to submit input to Step 2 — Data Sources for Further Analysis 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).

    The Toxics Release Inventory (TRI) Is Not an Appropriate Data Source to Screen for Environmental Releases of Chemicals

    NAMC believes that information generated under the TRI is not an appropriate data source for exposure data to screen priority chemicals. TRI data are strictly a volume-based reporting requirement. The data are not specifically associated with direct human or environmental exposures, nor do they correlate with risk. Indeed, documents posted on EPA’s TRI website include clear statements regarding the limitations of TRI data:

     2009 TRI National Analysis — “Users of TRI information should be aware that TRI release estimates alone are not sufficient to determine human exposure to toxic chemicals or to calculate potential risks to human health and the environment.”

     TRI and Factors to Consider When Using TRI Data — “The presence of a chemical in the environment must be evaluated along with the potential and actual exposures and the route of exposures, the chemical’s fate in the environment, and other key factors before any statements can be made about potential risks associated with the chemical or a release…” and “Toxicity varies among the covered chemicals; data on amounts of the chemicals alone are inadequate to reach conclusions or formulate policy….”

    In addition, because of EPA policies related to TRI reporting for the mining industry, metals and metal substances could be inappropriately identified as candidate chemicals based on perceived high releases. The metal mining industry must report the trace amounts of naturally occurring metal and metal compounds that are present in the rock and dirt that is moved and managed at a mine site as “releases” under the TRI program. In fact, the vast majority of what the metal mining industry reports — from 85 to 99 percent — consists of the management of these naturally occurring substances in rock and dirt. These “releases” are not directly related to exposures to humans or the environment, but are simply movement of rock and dirt on-site that are managed in engineered facilities that are permitted and regulated under exacting state and federal laws. Thus, the TRI release numbers for metals and metal substances from mining facilities do not equate with exposure of the general population or even of the miners themselves.

  7. Paul Dugard permalink
    September 14, 2011

    Tables 2 and 3:
    Many of the data sources listed are superficial, secondary in nature, and developed with little or no critical evaluation. As such, many should be regarded as only starting points for deeper review and evaluation. It is surprising that the IRIS database is not mentioned, although many of the chemicals that have been through an IRIS database health assessment fall into the “well tested and comprehensively regulated” category that should not be the focus of this exercise.
    It is unfortunate that most of the data sources listed for “general human exposures, including indoor air contaminants” were published many years ago. Exposures to chemicals covered in those documents have almost all been reduced substantially and, in many cases, as a result of EPA’s own regulations. It is likely that any chemical reviewed in Step 2 will have to be analyzed individually both for biological properties and exposures.

  8. 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.

  9. Matthew Shudtz permalink
    September 16, 2011

    EPA has done a good job in identifying existing sources of information about hazards and exposures that will allow screening-level risk characterizations to inform the agency’s selection of a manageable number of chemicals for further action.

    I encourage EPA to explore how the data sources listed in Table 2 can be utilized to better understand the environmental justice implications of chemical use. It is important for the agency to consider not only how much of a particular chemical is released into the environment, but also where it is released and what other chemicals are released in the same area. In a recent report, the Center for Progressive Reform identified chemicals that we thought should be assessed by the IRIS program. ( We used TRI data to identify communities with elevated toxic burdens based on a simple analysis of ZIP codes with high numbers of CAA HAPs released in large quantities. I encourage EPA to expand on this concept in “Step 2” and identify for immediate action the chemicals that disproportionately impact particular communities.

    I also encourage EPA to build on OSHA’s ongoing efforts to address chemicals in the workplace. Last year, OSHA hosted a “PELs Forum” in an effort to identify the chemicals for which new occupational exposure reduction strategies are needed. The responses are available here: EPA should consider these public responses and the expert advice of OSHA staff who have been working on the PELs update project. And while it is good that EPA plans to analyze data available from OSHA monitoring studies, it is worth noting that most OSHA monitoring data focus on the relatively small number of chemicals for which OSHA has an enforceable standard. Companies with good industrial hygiene programs may sample other chemicals and EPA should consider using its authority under TSCA section 11(c) to obtain summaries of those data.

  10. 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.

    Data Sources for Further Analysis Must Be Reliable and Reproducible
    EPA’s second step is to use information from additional exposure and hazard data sources to further analyze the candidate chemicals to select specific chemicals for further assessment. We recommend the Agency supplement Table 2 and 3 sources with robust and reliable information for specific chemicals that industry and other stakeholders have provided EPA. IRIS, NTP, HPV and other hazard information sources used in Step 1 should be included in Step 2 consideration.

    The Downstream Coalition recommends that Step 2 clearly identify science-based and transparent criteria by which EPA would compare hazard data and indicators of exposure to determine which chemicals “pass through” to become priorities for review and further risk assessment and potential risk management actions. The Discussion Guide is not transparent on this. Studies used to assess hazards and exposures should be reliable and reproducible. They should be designed and conducted according to internationally recognized scientific principles. Evaluations should be based on total weight of evidence.

    To that end, we recommend that EPA consider the US and OECD HPV information as well as information submitted in REACH. Member companies represented in the Downstream Coalition have expended extensive resources into compiling and submitting high quality data. Besides REACH, EPA has created the Chemical Data Access Tool, which provides HPV and other data. In addition, OECD’s eChemPortal provides additional information from 22 member country databases. It is important to consider the science-based, reliable, available data in this process. EPA would be doing itself a disservice not to consider these important data sources to inform prioritization.

    Some of the Step 2 data sources are dated and perhaps not the most authoritative for understanding of hazard or indications of exposure in 2011’s US population. The 2011 CDR should provide the strongest basis for indicating current use and exposure information.

    Specific concerns on Step 1 and 2 sources:

    EPA Region 5 PBT Identification Project (Syracuse Research Corp.). Chemicals identified as potential candidate via modeled information should be confirmed via testing information before becoming priority chemicals for review.

    Chemicals proposed to UNECE LRTAP POPs and Stockholm Convention on POPs. Proposed POPs should be confirmed via testing information before becoming priority chemicals for review.

    California Proposition 65 (Safe Drinking Water and Toxic Enforcement Act of 1986). Proposition 65 Labor Code listings do not require deliberative scientific process and should not be included in EPA’s consideration.

    Washington State Children’s Safe Product Act. This is a derivative list, and EPA should defer use of this until reporting is completed, as described above.

    Voluntary Children’s Chemical Evaluation Program. VCCEP chemicals that have undergone assessment and review that did not find concerns should not be included unless new information indicates potential risk.

    NIH Household Products Database and Hazardous Substances Data Bank. Not reliable sources—often contains old information and not regularly updated

    PAIR information. Caution on use of old submissions from 1980’s and 1990’s.

    General Human Exposures. Recommend not using. Published paper sources are quite old and may not be representative of current exposures.

    NOES Monitoring. Recommend not using. Very old data, and may not be representative of current exposures.

    Hazard Information. Sources are good, however, not all data is rated for quality and reliability similar to HPV and REACH data.

  11. Fred Corey permalink
    September 21, 2011

    EPA has funded many Tribal studies of contaminants in Tribal natural resources. These studies represent an additional source of information regarding chemical fate and transport in the natural environment. As previously indicated, Tribal exposures to contaminants have resulted in some Tribal communities having the distinction of being the most highly chemically-exposed people on earth.

  12. Christina Franz permalink
    September 21, 2011

    I. The Environmental Protection Agency (EPA) has Authority to Prioritize Chemicals:

    Contrary to Mr. Denison’s assertion in his blog entry, EPA clearly has the legal authority under current TSCA to prioritize chemicals in commerce. That authority extends to smaller subsets of chemicals for review as well as the entire Inventory. This is an inherent power implicit in TSCA so long as its priorities do not conflict with Congressional deadlines. EPA is essentially free to set its priorities in addressing existing chemical substances.

    As a regulatory agency with substantial responsibilities under TSCA and limited resources, EPA must necessarily set administrative priorities. The question is whether it will have a reasoned, systematic set of priorities, or whether instead it will continue to engage in a series of ad hoc activities. The need for an explicit, rational process for setting priorities under TSCA is apparent from the text of TSCA itself and from critiques by other governmental oversight bodies, to name just a few.

    A. TSCA Supports Risk-Based Prioritization
    Several provisions of TSCA strongly support the need for EPA to have a risk-based prioritization process in place:

    • Section 2(a)(2) addresses a Congressional finding that “among the many chemical substances and mixtures which are constantly being developed and produced, there are some whose manufacture, processing, distribution in commerce, use, or disposal may present an unreasonable risk of injury to health or the environment.” This implies that EPA should focus its attention on those chemicals which may pose such a risk.

    • Section 2(c) presents the intent of Congress that “the Administrator shall carry out this act in a reasonable and prudent manner.” This suggests that EPA should have a reasoned approach toward identifying those chemicals that may pose an unreasonable risk.

    • Section 4(e) calls for recommendations to EPA on the chemical substances to which it “should give priority consideration” regarding testing requirements. Section 4(e) even provides some criteria for prioritization: “In establishing such list, the [Interagency Testing Committee] shall give priority attention to those chemical substances and mixtures which are known to cause or contribute to or which are suspected of causing or contributing to cancer, gene mutations, or birth defects.”

    • Section 8(a) provides EPA with authority to require submission of information on a large number of chemical substances, mainly relating to issues relevant to use and exposure. Thus, it is a mechanism to help EPA identify a set of chemicals on which it should focus its attention. EPA recognized this recently in proposing amendments to the Inventory Update Rule (IUR) under section 8(a), saying “One of the primary purposes of the IUR data collection is to group together similar data for priority setting exercises and activities.”

    • Section 8(d) also authorizes EPA to require submission of information on chemicals, this time focused on health and environmental effects studies, which should inform a prioritization process.

    • Section 8(e) serves to alert EPA to new substantial risk information which may influence its priorities.

    • EPA’s recent stakeholder discussion on prioritization suggests that the Agency believes it has the inherent authority to prioritize chemicals for further assessment and possible regulatory action.

    B. The Government Accountability Office (GAO) Calls for Prioritization Under TSCA:

    The Government Accountability Office (GAO) has called repeatedly for EPA to set priorities under TSCA. These criticisms are mostly in the context of potential legislative improvements to TSCA, including a mandatory prioritization requirement, but they also address EPA’s efforts at prioritization under the current statute. For example, in 1994, the GAO reported to Congress in its Toxic Substances Control Act: Preliminary Observations on Legislative Changes to Make TSCA More Effective:
    [TSCA’s] authorities have not been used effectively when EPA has considered how to address toxic chemical concerns… EPA would need flexibility to focus the agency’s and the industry’s resources on those chemicals that, based on their toxicity, production volumes, and potential exposures, present the highest risk to human health and the environment …
    [E]stablishing priorities would help EPA to focus its efforts on the most serious chemical risks…

    II. Establish Clear and Scientific Prioritization Procedures:

    EPA should incorporate a number of procedures into its prioritization process. They include the following:

    • Set time limits.

    EPA should establish administrative deadlines for making prioritization decisions on individual chemical substances. It should be able to exceed those deadlines in exceptional cases. Without a target time period, EPA may end up deferring decisions indefinitely.

    • Define endpoints.

    EPA should aim to declare certain chemical substances as a high priority for future regulatory action. It is also very important that EPA should then concentrate its administrative resources on chemicals of high priority. Prioritization decisions should not be a substitute for risk assessment or decisions on the need for regulatory action.

    • Make an initial list.

    Based on past judgments, EPA may be able to assemble an initial list of high priority chemical substances relatively fast. Making prioritization decisions on other chemical substances may take longer. EPA should not defer announcing its initial prioritization decisions until after it has considered other chemical substances as well.

    • Communicate accurately about the purpose of the list.

    EPA should be very clear communicating that the list is for purposes of identifying high priority chemicals for further review and assessment and not necessarily for risk management. The determination as to whether any chemical on the list will be subject to risk management measures is a separate decision made following a risk or safety assessment.

    • Identify Factors for Decision-making.

    EPA should identify factors it will consider in making prioritization decisions. Such factors may include, for example, information on exposure (particularly among sensitive populations), use, and hazard, including hazards such as carcinogenicity, systemic toxicity, reproductive toxicity, and developmental toxicity, and whether the chemical substance is persistent, bioaccumulative, and toxic.

    • Identify information sources.

    In making prioritization decisions on individual chemical substances, EPA should consider information available in its files on those chemical substances; information available from other governments (e.g., under REACH) on those chemical substances; and extrapolations from information on structurally-related chemical substances, e.g., using qualitative or quantitative structure-activity relationship models, grouping, or read-across. Since prioritization is not a risk assessment or risk management action, EPA should not require the generation of additional information under section 4 as a precondition to making a prioritization decision. However, EPA may want to consider, as appropriate, calling in existing information in the hands of manufacturers or processors under section 8(a) or section 8(d).

    • Announce decisions to designate or not to designate chemical substances as high priority.

    Having made a prioritization decision on individual chemical substances, EPA should announce both those determined to be of high priority and those determined not to be of high priority. Subsequently, EPA should focus its regulatory activity on the high priority chemical substances. It should generally not pursue regulatory activity regarding those found not to be high priority in the absence of additional information, except as available resources allow.

    • Consider public input.

    EPA should consider requests from the public either to designate a chemical substance as high priority or to remove that designation for a chemical previously designated as high priority. EPA should announce a process by which members of the public may make such requests. EPA should respond to those requests within a designated time period and provide the reasons for responding as it did.

    • Keep the list of high priority chemical substances evergreen.

    As EPA decides that additional chemical substances should be designated as high priority, it should add them to the list of high priority substances. As EPA takes regulatory action on a high priority chemical substance, or decides that a chemical substance previously designated as high priority should no longer be so designated, it should remove that chemical substance from the list. EPA should announce its reasons for removing any chemical substance from the list.

    • Make the prioritization process transparent.

    EPA should identify on its website the steps in the prioritization process and the expected timing for each step. It should maintain on its website a current list of high priority chemical substances. It should announce, preferably in the Federal Register, a notice of chemical substances newly designated as high priority.

    • Identify the basis for prioritization decisions.

    EPA should identify on its website and periodically update a summary of publicly available information on each high priority chemical substance, including information on environmental fate and transport; biological fate and transport; acute, subchronic, and chronic human health effects; ecotoxicity; the presence of the chemical substance in human bodily fluids or tissues and in the environment; the categories of uses of the chemical substance; and associated known and potential releases and exposures (using aggregate data); and any other relevant characteristics.

    • Identify information needs for high priority chemical substances.

    EPA should publish in the Federal Register notice summarizing information about individual high priority chemical substances which is currently unavailable to EPA and request comment on whether submission of such information is necessary for purposes of regulatory action and provide an opportunity for companies to submit that information in a useable format and timely manner.

    III. Prioritization Decision-Making Tools:

    ACC recommends that EPA establish guidelines for making its prioritization decisions. Those guidelines should provide a means for distinguishing chemical substances presenting different hazards and different potential for exposure. The guidelines should include categories of increasing environmental hazard, categories of increasing health hazard, and categories of increasing exposure potential. It should present those categories in a matrix which assigns different combinations of environmental hazard, health hazard, and exposure potential to different levels of priority, with those having both high hazard and high exposure potential having the highest priority. ACC’s prioritization concepts provide a basis for a process and guidance for an EPA guidance effort. ACC strongly recommends that EPA provide an opportunity for public notice and comment on the guidance and prioritization process.

    IV. The Value of Prioritization:

    In addition to identifying high priority chemicals for further review and assessment, there is significant value to be gained from EPA identifying medium and low priority chemicals as well. The public would find that information important and useful. Regulators would find that information helpful for avoiding decisions that might trigger “regrettable substitutions” in the marketplace. ACC’s prioritization tool would enable EPA to identify chemicals that need further evaluation and assessment, but also chemicals that the agency could set aside unless or until further information would suggest it warrants placement in a higher priority. ACC’s tool can identify which chemicals fall at the intersection of the highest hazard and the highest exposure, as well as which chemicals hazard and exposure profiles intersect at the medium and low ranges.

    V. EPA’S Process for Receiving and Managing Information Received on Chemicals:

    As EPA engages in both near- and long-term prioritization efforts, EPA should clearly establish the “rules of the road” that will bound these efforts. For instance, how will EPA solicit comment from the public on candidate chemicals for further review and assessment? How will EPA control the flow of information that stakeholders might submit on specific chemicals so that EPA can deal with the information in manageable batches? In what format should the public provide information about chemicals to EPA so that EPA can deal with it in a manner that is manageable? What schedule will EPA operate under in a prioritization process? The greater the clarity at the beginning of this process, the better it will be for EPA and the public. ACC urges EPA to address these sorts of “process” issues in an FR notice about EPA’s prioritization plans as well as in stakeholder dialogues on prioritization.

  13. 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.

  14. Christina Franz permalink
    September 21, 2011

    Several of the proposed prioritization data sources for both Step 1 and Step 2 of EPA’s prioritization process are out of date, of poor or questionable quality, or not relevant to U.S. use patterns. ACC would like to flag the following data sources for EPA’s attention, re-examination, and re-consideration as appropriate. At the end of this blog entry, ACC also suggests the addition of some data sources for EPA’s inclusion in its prioritization process.

    Step 1 Data Sources:

    Danish Consumer Product Studies: These show European use patterns, not US.

    National Human Adipose Tissue Survey (NHATs): This survey was conducted in the 1970s and reflects exposures from that period, so is of highly questionable value. ACC also identified many technical concerns with this survey in its comments on databases EPA considered to identify chemicals for the VCCEP.

    Preliminary Assessment Information Reporting (PAIR): While much of this data is reliable, EPA should use caution with respect to use of old submissions from the 1980s or 1990s.

    Children’s Total Exposure to Persistent Pesticides and other Persistent Organic Pollutants (CTEPP) Study: This study is about 20 years old now.
    NIH Household Product Database: this database should be examined to determine whether it’s been updated to eliminate old data and add new data.

    NIH Hazardous Substances Data Bank: This data source requires re-examination to ensure it’s been updated to eliminate old data and add new data.

    1) What does “proposed” mean in the context of chemicals proposed to UNECE LRTAP POPs and Stockholm Convention on POPs. Proposed by whom and under what criteria? Both agreements mandate a process for considering substances nominated as POPs; both consider a substance a POP only when it is added to the relevant treaty annex.
    2) Didn’t the California Proposition 65 include labor code listings (for carcinogenicity and repro/devo) that did not require deliberative scientific processes to judge against criteria?
    3) Didn’t the Washington State Children’s Product Act rely on secondary sources for selection, most of which are already included elsewhere on EPA’s data source lists, rendering this source merely duplicative?
    4) Presence vs. Risk: How will EPA account for the fact that many of the use and exposure data sources merely reflect “presence”, not risk? E.g., Toxic Release Inventory.

    Step 2 Data Sources:
    National Occupational Exposure Survey (NOES) OSHA monitoring studies: These are old, ca. 1984. These should be dropped in favor of the IUR, which is more complete.

    National Contaminant Occurrence Database (NCOD): This database is not as high quality as the USGS databases.

    Additional Data Sources that EPA Should Consider Including in Priority Setting:

    EPA’s Chemical Data Access Tool and its underlying datasets from TSCA submissions and the HPV program.

    REACH submissions (covers nearly 4,000 chemicals)

    eChemPortal (with REACH, OECD, US HPV, etc.): Contains over 625,000 records on chemical toxicity information.

  15. James Cooper permalink
    September 21, 2011

    Step 2: Data Sources for Further Analysis

    NPRA outlined the importance of weighting data and using a weight-of-the-evidence approach to screening, risk assessment and subsequent decision-making in the comments offered under Step 1(b). NPRA does not oppose using a wide variety of data sources, as long as all sources are treated with the same level of scientific scrutiny. Laboratory studies that do not follow Good Laboratory Practices should be given less weight than those that do; additionally, studies that are not able to be repeated using the same procedures should be given very little weight. Biomonitoring studies should be evaluated according to sampling size and representation, statistical relevance and other established criteria for analytical chemistry practices. Since epidemiology studies can only provide associative guidance to establish theories, they should not be given the same weight as laboratory studies designed to measure cause and effect. NPRA advocates the use of well-established scientific principles throughout the prioritization and risk assessment processes.

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