Getting the framework right for the new TSCA: EDF comments filed on key EPA proposed rules

Richard Denison, Ph.D., is a Lead Senior Scientist.  Lindsay McCormick is a Project Manager.  Jennifer McPartland, Ph.D., is a Senior Scientist.

Environmental Defense Fund (EDF) filed extensive comments yesterday on the Environmental Protection Agency’s (EPA) proposals for the two most central “framework” rules mandated by last year’s Lautenberg Act amendments to the Toxic Substances Control Act (TSCA).

Our comments address these proposed rules:

Both sets of comments address many different provisions of the proposed rules.  EDF indicated our strong support for many aspects of the proposals, but urged changes to a number of provisions that we cannot support as proposed.  In addition, we identified provisions we believe need to be added to EPA’s rules to be consistent with or meet the requirements of the Lautenberg Act.

EDF emphasized how vital it is for EPA to meet its June 22, 2017, statutory deadline for promulgating these rules.  Because they establish processes that will require several years to begin to yield decisions on specific chemicals, delays in promulgating them in final form so that the processes can commence in the timeframe Congress intended will only serve to undermine public confidence in the new law, counter business interests to restore confidence in the chemicals marketplace, and hamper EPA’s ability to carry out its new mandates.  This is especially the case, given EPA’s appropriate recognition in both proposed rules that it will need to initiate measures as soon as possible to ensure that sufficient information will be available to inform prioritization and risk evaluation decisions.

As discussed in more detail in the comments, EDF strongly supports EPA’s decision not to codify specific scientific policies, procedures and guidance in these rules.  To do so would not be consistent with the law and would more generally represent bad policy.  EDF also agreed with EPA’s proposal not to define in its rules complex, science policy-laden terms such as “weight of the scientific evidence,” “best available science,” and “unreasonable risk.”  These concepts are best elaborated on in guidance and policy statements and best understood in the context of specific decisions on chemical substances.

Some other highlights from each set of EDF’s comments follow.  


EPA appropriately proposes a rule that:

  • is procedural in nature and avoids specifying science policy issues that are better addressed in guidance and policy statements;
  • provides the right level of detail on the prioritization process and does not propose an exact scoring or ranking process;
  • includes a “pre-prioritization” stage to gather needed data and meet the statutory requirements of the Lautenberg Act, which EDF urges the agency to keep simple and informal;
  • makes clear that chemical substances, not specific uses or subsets of uses, are to be prioritized; and
  • sets a higher bar for low-priority than for high-priority designations

EDF raised concerns about several other aspects:

  • EPA’s proposal to “cut off” comments on proposed low-priority designations after the public comment period, which requires several conditions to be acceptable;
  • EPA’s proposal to consider substitutes in the pre-prioritization process;
  • insufficient incorporation of measures to ensure public access to information EPA uses to make prioritization decisions, including Lautenberg Act requirements governing industry confidential business information (CBI) claims;
  • the need to make full studies on which EPA bases prioritization decisions publicly accessible; and
  • the need to incorporate the definition of “potentially exposed or susceptible subpopulations” from the statute, with the refinements EPA has made to it in its proposed risk evaluation rule.

Risk Evaluation

EPA appropriately proposes a rule that:

  • is procedural in nature and avoids specifying science policy issues or defining related terms that are better addressed in guidance and policy statements;
  • establishes a risk evaluation process that is compatible with reasonably available information and applicable deadlines;
  • provides EPA with means by which to collect and require the development of information early and often in the “pipeline” of prioritization and risk evaluation;
  • makes clear that chemical substances, not specific uses or subsets of uses, are to be subject to risk evaluations and risk determinations; and
  • balances the need to consider all conditions of use of a chemical with the ability to:
    • apply different levels of analysis to different conditions of use; and
    • expedite particular conditions of use that clearly present unreasonable risk in order to expedite needed risk management;
  • requires that a manufacturer requesting a risk evaluation must demonstrate there is sufficient information available for EPA to complete the risk evaluation for all conditions of use; and
  • makes clear that risk determinations are policy decisions not subject to peer review.

However, EDF also raised concerns with or called for changes in several aspects of EPA’s proposal, including the need to:

  • more clearly assert and utilize its authorities under amended TSCA to collect and require development of information needed to inform risk evaluations;
  • establish a firm opportunity for public comment on risk evaluation scopes, and to provide more time for public comment on draft risk evaluations;
  • add several conditions to its proposals that any issues not raised during public comment periods on risk evaluation scopes and draft risk evaluations could not be the basis for later objection or challenge, and close a loophole that would allow industry to get around this limitation;
  • broaden the applicability of the provisions that implement Lautenberg Act requirements governing industry confidential business information (CBI) claims;
  • clarify that EPA’s authority to revisit a risk determination only applies after final agency action based on the determination;
  • delineate requirements for EPA consideration of third-party risk evaluations;
  • clarify opportunities for public comment on industry requests for risk evaluations and EPA decisions on those requests;
  • require that full studies on which EPA or third parties rely in risk evaluations be publicly accessible;
  • in applying or updating guidance used to conduct risk evaluations (which should not be codified in this rule):
    • generally employ an aggregate approach to exposure assessment;
    • further integrate systematic review;
    • move away from EPA’s traditional margin-of-exposure approach for noncancer endpoints, as recommended by the National Academy of Sciences; and
    • avoid assigning greater weight to guideline studies over the peer-reviewed literature.


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