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      Helping EPA ensure its chemical review ‘pipeline’ under Lautenberg Act delivers as Congress intended

      The Lautenberg Chemical Safety Act (LCSA) is described as having three “framework rules” – Inventory Reset, Prioritization, and Risk Evaluation.  All three are designed to work together to set the stage for, and then deliver, efficient and streamlined risk evaluations of chemicals under the federal program.  EPA has described this ongoing process of prioritization and risk evaluation as a “pipeline.”

      A system that works as Congress intended

      LCSA creates a long-term framework for evaluation of chemicals.  Part of the promise of LCSA is a system that assures that all chemicals in commerce will be reviewed for safety.  LCSA gives EPA many tools to achieve this.

      • First, there’s the structure of the statute itself. Risk evaluation actually begins with a “reset” of the TSCA Inventory which is the full catalog of chemistries in U.S. commerce. The LCSA requires that the TSCA Inventory be sorted, so that chemicals that are currently active in commerce are separated from those not currently manufactured, imported or processed.  This enables EPA to focus resources for its multi-year, time-and-resource intensive risk evaluations on chemicals that are actually in current use.
      • Next, the Prioritization step allows EPA to refine its focus a second time, designating low priority chemicals and high priority chemicals that warrant moving on to a risk evaluation.
      • Then, the Risk Evaluation step allows EPA to hone its focus yet again, as EPA must decide on the scope of the risk evaluation—that is, exactly what will be included in the evaluation.

      Criteria for designating high or low priority

      The Inventory Reset process helps ensure that prioritization can focus on those chemicals that are in active use.  The prioritization process then uses a risk-based screening process — in which EPA integrates hazard, use, and exposure information — to designate chemicals or categories of chemicals as either high or low priority for risk evaluations.  Mandatory timelines kick in for chemicals designated high priority, and they move to risk evaluation on a defined schedule.

      All scientific decisions under LCSA decisions in both prioritization and risk evaluation must be based upon the science standards of LCSA Section 26, including best available science and weight of the scientific evidence. The basis for prioritization designations must be transparent, and EPA’s decisions must be communicated objectively and in neutral terms.

      As we illustrated in our comments to EPA, ACC envisions a prioritization process that follows six steps:

      1.) Pool and Batch: EPA must “pool” active chemicals in commerce as candidates for designation as high or low priority for risk evaluation based on transparent criteria/methods/approaches/tools and processes. EPA should then “batch” these candidates for information gathering.

      2.) Information Gathering: Because Congress intended prioritization decisions to be based on reasonably available information, EPA should take a sequenced approach to information gathering on chemicals that it “batches” for prioritization.  EPA should first gather reasonably available information it has or has access to; if needed EPA should then use voluntary call-ins to industry and other stakeholders to gather additional, reasonably available information; if needed, EPA should then use its Section 8(a) and 8(d) rules to gather more reasonably available information.  Under the LCSA, only if EPA determines that new information is needed for prioritization can EPA use Section 4(a) rules/order/consent agreements to develop new information for prioritization If

      3.) Sufficient Information to Designate: Once EPA has the information it needs to designate the priority of a substance, it can move that substance to the “Initiation of prioritization” step.

      • If EPA concludes it has sufficient information to designate a substance as a high priority chemical, it should conduct a “pre-screening” review to identify potential data/information needs for scoping the risk evaluation (a bridging step between prioritization and scoping).
      • If information on the chemical is deemed sufficient for scoping, the chemical can then be put into the queue for “initiation” of the prioritization process at the appropriate time.
      • If information is determined not sufficient for scoping, EPA should begin to collect/develop the information needed.

      4.) Initiate the Priority Designation: EPA must announce a candidate for prioritization and request “relevant information” about that chemical from manufacturers and processors.

      5.) Propose Priority Designation: EPA must propose a designation of a chemical as a high or low priority, including the basis for its proposal.

      6.) Finalize the Designation: EPA must finalize its designation of the chemical as either a high or low priority within the statutory deadlines (no less than 9 months and no more than 12 months after EPA has “initiated” the prioritization process).

      High priority chemicals move to the risk evaluation stage.

      Risk Evaluation: Realizing the vision Congress described

      If EPA is to get its job done, risk evaluations must be scoped, conducted, and completed to meet both statutory deadlines and quality requirements.  Congress gave EPA the tools to meet its statutory deadlines by using tiered approaches, flexibly scoping risk evaluations, and encouraging prioritization and focus.  Congress gave EPA flexibility to consider aggregate exposures in those risk evaluations where appropriate, but did not mandate it.  While Congress defined susceptible subpopulations, Congress also gave EPA flexibility to determine whether and which subpopulations are appropriately considered for each risk evaluation.  And Congress gave EPA flexibility to determine which conditions of use are relevant and appropriate to each risk evaluation.  Now, it’s up to EPA to use these tools wisely and well.

      EPA should apply a tiered approach throughout the risk evaluation process. The tiered approach includes an initial screening-level evaluation; if necessary, a more detailed evaluation to quantify potential risks would then be conducted.

      EPA must flexibly scope risk evaluations to focus on the most relevant, greatest potential for risk, considering one or more conditions of use in an efficient and practical manner. This means the Agency rightfully focuses on conditions of use that are relevant and meaningful to a fit-for-purpose risk evaluation, and well-tailored to the problems and decisions at hand.

      We cannot overstate the importance of tiering and flexible scoping – these tools are essential to delivering the throughput on risk evaluations contemplated by Congress.

      So, the entire “pipeline”  “flows” – the process should look like this.

      Chemical Review Pipeline

      Finally, just like in the earlier prioritization process, EPA must incorporate Section 26 science standards including using the best available science and a full weight of the scientific evidence approach throughout the risk evaluation process.

      These requirements are fundamental to the proper function of LSCA risk evaluations so they must be described fully and defined in the regulation so they are applied consistently.  Only then will stakeholders have adequate notice to participate and contribute fully in the development of the risk evaluations. This means that EPA must articulate in the risk evaluation itself, with specificity, the scientific approaches and methods it will use in the risk evaluation, rather than simply pointing to Agency guidance, which is often outdated, inconsistently interpreted, and inconsistently applied.

      Working together to get it right

      ACC and our members are excited about rolling up our sleeves and working with EPA to improve its proposed rules for the Inventory reset, prioritization and risk evaluation. If we get these framework rules right, the amendments to TSCA will do what they were intended to do: enhance protections for human health and environment, while enabling our industry to continue to innovate, create jobs, and grow the economy.

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