TSCA reform legislation: Consideration of costs and other non-risk factors

Richard Denison, Ph.D.is a Lead Senior Scientist.

Part 1              Part 2              Part 3              Part 4              Part 5

[NOTES:  (1) This post reflects the latest versions of TSCA reform legislation:

(2) All of the earlier posts in this series have been updated to reflect these latest versions.]

This is the fifth in a series of blog posts looking at less talked-about, but critically important, elements of bipartisan legislative proposals to reform the Toxic Substances Control Act (TSCA).  This post deals with how costs and other non-risk considerations factor into safety and regulatory risk management decisions.  

The safety standard

Under current TSCA, EPA’s determination of whether or not a chemical presents an “unreasonable risk” requires the agency to formally balance consideration of costs and other non-risk factors against the potential danger to human health or the environment.

The Lautenberg Act retains the term “unreasonable risk” as its safety standard but, in defining the standard, explicitly precludes EPA from considering costs and other non-risk factors in making safety determinations.  This same exclusion of costs and other non-risk factors is made in each relevant provision throughout TSCA where the term “unreasonable risk” is used, to make clear that EPA’s decisions as to the safety of chemicals are based solely on considerations of risks to human health and the environment.

The TSCA Modernization Act of 2015 [UPDATE 5-28-15:  H.R. 2576] also retains the term “unreasonable risk” as its safety standard, but does not define the safety standard.  The bill clarifies that [UPDATE 5-28-15:  in conducting a risk evaluation, EPA “shall not include information on cost and other factors not directly related to health or the environment;” and that] “[t]he Administrator shall not consider costs or other non-risk factors when deciding whether to initiate a rulemaking under subsection (a).”  The bill does not explicitly state, however, whether the determination of “unreasonable risk” is to be based solely on risks to human health or the environment.

The House bill, like the earlier drafts, includes the requirement that EPA show a chemical “may present an unreasonable risk” in order to initiate a risk evaluation of the chemical.  While the bill has been modified to indicate the finding can be made “because of potential hazard and a potential route of exposure under the intended conditions of use,” the language still requires EPA to make a risk finding in advance of and as a condition for initiating a risk evaluation, a potential Catch-22.

Regulatory requirements

Under current TSCA, EPA is required to conduct a formal analysis of costs and benefits of any proposed restriction of a chemical, and to show that the benefits of the restriction outweigh its costs. It also must demonstrate that any restrictions it chooses to impose are the “least burdensome” among those able to address the identified risks, a showing that in practice has proven excessively onerous. These requirements have proven to be fatal flaws in TSCA, imposing evidentiary and analytic burdens on EPA so severe that it could not meet them even for the deadly human carcinogen asbestos.

The Lautenberg Act strikes the “least burdensome” language and clarifies that a balancing test for costs and benefits is not required.  It goes further to make clear that cost considerations cannot override the requirement that restrictions be sufficient to ensure chemical safety:  Where a chemical does not meet the safety standard, EPA “shall promulgate a rule establishing restrictions necessary to ensure that the chemical substance meets the safety standard.”

In deciding what restrictions to impose on a chemical found not to meet the safety standard, EPA is to consider “to the extent practicable based on reasonably available information, quantifiable and nonquantifiable costs and benefits of the proposed regulatory action and of the 1 or more primary alternative regulatory actions considered by the Administrator.”  EPA is also to review alternatives to the chemical it deems relevant and technically and economically feasible.

In the case of a ban or phase-out, in deciding whether any exemptions should be allowed EPA must also consider “to the extent practicable based on reasonably available information, the quantifiable and nonquantifiable costs and benefits of the 1 or more technically and economically feasible alternatives to the chemical substance most likely to be used in place of the chemical substance under the conditions of use if the rule is promulgated.”

The TSCA Modernization Act of 2015 [UPDATE 5-28-15:  H.R. 2576] also strikes the “least burdensome” language of current TSCA.  Where EPA determines a chemical presents an unreasonable risk, it is to impose requirements “to the extent necessary [UPDATE 5-28-15:  so that the chemical substance no longer presents or will present an unreasonable risk, including an identified unreasonable risk to a potentially exposed subpopulationto protect adequately against such risk.”]  In deciding what restrictions to impose, EPA must consider the “reasonably ascertainable economic consequences of the rule, including the likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health.” This broad language would place substantial evidentiary and analytic burdens on the EPA in order to regulate a chemical.

The House bill also adds to these two mandatory cost-related evidentiary and analytic requirements not in current TSCA:

  • EPA must show that any requirements it imposes on a chemical are “cost-effective, except where the Administrator determines that [UPDATE 5-28-15:  additional or different requirements … are necessaryit is not practicable to protect against the identified risk using cost-effective requirements.”]
  • In deciding whether to impose a ban or effective ban on specific uses of a chemical, and in setting compliance dates, EPA must “determine whether technically and economically feasible alternatives that benefit health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or restriction takes effect.”

While the latter of these two requirements does not expressly preclude EPA from banning a use of a chemical if a safer, viable alternative is not available, it comes close, raising concerns similar to those I raised about a House discussion draft introduced in the last Congress.

Collectively, these requirements that must be met for EPA to regulate a chemical would appear to place burdens on EPA comparable to the requirement under current TSCA (struck in the draft) that EPA demonstrate its regulation imposes the “least burdensome requirements.”

Relationship to other Federal laws

Under current TSCA (Section 9), EPA must consider whether any risks it identifies could be addressed either by another federal agency or by EPA acting under another statute.  Various procedures must be followed where EPA so determines.

The Lautenberg Act retains these requirements of current TSCA.

The TSCA Modernization Act of 2015 [UDPATE 5-28-15:  H.R. 2576] retains these requirements but adds a new cost-related requirement that EPA would have to meet before taking any regulatory action under TSCA instead of another law EPA administers:  “[T]he Administrator shall compare the relative risks, estimated costs, and efficiencies of the action to be taken under this title and an action to be taken under such other law to protect against such risk.”

This new set of analytic and evidentiary requirements is in addition to TSCA’s existing requirement that EPA show that acting under TSCA is “in the public interest” (which currently is determined at the Administrator’s discretion).

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