Next Steps on New EPA Toxics Rule Implementation Reinforce the Need to Engage

by Clark Hill PLC
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The passage of the Lautenberg Chemical Safety Act ("2016 TSCA Amendments") was a rare bipartisan success story. However, the August 9-10th Environmental Protection Agency ("EPA") stakeholder public comment meetings on the risk evaluation and prioritization rules that will implement the new law were a sobering counterpoint. They provided a stark reminder that there are still dueling, and in some cases dramatically different, interpretations of the statute and the appropriate policies that should be adopted to put in place under the  Toxic Substances Control Act ("TSCA") moving forward.        

An overview of these initial oral comments reveals the fault lines that are likely to shape this rulemaking. The practical reality is that a substantial number of critical issues were not resolved in the amendments (and could not have been resolved in the legislation). This rulemaking and the associated guidance development process will determine many of EPA's future actions. Product manufacturers - not just chemical manufacturers - need to pay close attention at this stage since, as emphasized by EPA and most speakers, critical risk determinations will largely be a function of the use of products containing these chemicals. 

EPA's summary of its current TSCA risk assessment and prioritization processes suggests that the agency believes that it is already meeting the statutory criteria (although it may not have explained what it has done as clearly as it could). EPA acknowledged that it often does not have data on uses and resulting exposures and lacks even generally accepted methods to measure many exposures, a clear warning flag for products subject to regulation. EPA particularly sought input on how to gather use-specific exposure information, potential exposure (i.e., exposure from misuses of a product), aggregate exposure from all uses,[1] and "sentinel exposures" (a term nowhere defined in the statute, but which appears to correspond to the idea of a warning signal). As EPA's presentation concedes, the term "sentinel exposure" is not a well established TSCA risk evaluation concept; this novelty will likely lead to controversy (see below).

Generally, industry representatives highlighted the following concerns:

  • EPA will benefit and a better scientific process will result if EPA engages early and is transparent. Some stakeholders cited specific shortcomings in the existing TSCA engagement process, including errors and data that were not considered.
  • EPA need not re-invent the wheel on data gathering (given similar programs outside the U.S. and other non-EPA domestic sources).
  • Decisions must be based on the best science that is available, the weight of the evidence, and other requirements in the statute. EPA should be guided by the recommendations articulated in a series of recent National Academy of Sciences ("NAS") reports. Although many comments from other stakeholders urged the use of the best or "modern" science, there is no consensus among stakeholders on what the statutory requirements on the use of science mean, which NAS recommendations should be followed by EPA or how to translate these recommendations into practical regulatory policy (see below).
  • Some industry commenters urged consideration of sentinel exposures, suggesting EPA should consider the most significant remaining exposures after imposing controls, in order to reduce total risk.  
  • EPA should allow a step-by-step approach to avoid the need to gather expensive data. Initially, an unrealistically high exposure assumption is used to calculate a preliminary risk value which is compared to the "unreasonable risk" exposure level. If the unreasonable risk exposure level is not exceeded, no further action is warranted. If it is exceeded, more data must be gathered to refine the risk evaluation. 
  • EPA should develop clear risk communication methods to explain the differences between (1) low risk, low priority chemicals, (2) high priority chemicals (and within the high priority chemicals, the difference between the first twenty high priority chemicals to be evaluated and the other high priority chemicals which may not be evaluated for many years), and (3) an unreasonable risk exposure level.

Not surprisingly, many environmental, community, and some state stakeholders had different recommendations:

  • EPA should not become bogged down by including detailed risk evaluation prioritization methods in regulations (rather than in the more flexible guidance). 
  • EPA should adopt more precautionary assumptions and policies to "ease," "simplify," and/or speed up the risk evaluation and prioritization process. For example, EPA should:
    • Adopt a broad (inclusive) definition of how to estimate probable exposures. EPA should use aggregate exposures (including background levels of chemicals unrelated to the product uses), but not industry's definition of sentinel exposure approach (i.e., considering in the evaluation (and controlling if necessary) the most significant exposures which will also reduce the nonsentinel exposures). One state speaker argued that relatively minor and rare events like spills should be regarded as sentinel exposures. The wide differences in views in the statutory intent of considering sentinel exposures (and exposure in general) make commenting on this issue particularly important.
    • Consider lower income communities and native American communities as susceptible populations requiring extra protection. 
    • Classify as high priority all chemicals to which pregnant women or children might be exposed. 
    • Eliminate the consideration of mechanism of action (one of the traditional factors considered in determining causation) entirely.
    • Unify the method of calculating cancer and noncancer risk (i.e., eliminate the use of reference doses and margins of exposure).
    • Adopt more "modern" risk evaluation methods (often citing NAS recommendations, albeit different NAS recommendations from those cited by industry).
  • EPA should not assume that the absence of data is proof of no adverse effect.  
  • EPA should use an asymmetric higher burden of proof and level of evidence to classify a substance as a low risk, low priority chemical, but require less burden and evidence to designate a substance as high priority.

If any of these positions are of concern to your company, you may want to provide comments to EPA. Your comments should explain how these regulations affect your business and advocate for methodologies and procedures that fulfill the statutory mandate without unduly burdening your business. 

More detailed comments from the speakers and other members of the public should be filed on or before August 24, 2016 (The risk evaluation Docket and prioritizing of chemicals Docket). The deadline for promulgating the two final rules is June 21, 2017. However, the deadline for proposing a risk evaluation rule is mid-December 2016 so there are additional opportunities to comment on the risk evaluation and prioritization process.  

As a practical matter, EPA is likely to consider comments even if they are filed after August 24th, given the statutorily constrained time period for promulgating a final rule and the many requests to provide more opportunities to comment and work cooperatively with EPA. These rules are of central importance to the implementation of the statute. Typically, significant effort is needed to educate EPA about the practical consequences of its regulatory proposals. Companies (or their trade associations) should file comments as soon as possible and supplement them as needed.

[1] EPA has considered multiple types of exposures in prior TSCA risk assessments focused on particular uses rather than all feasible uses. EPA stated that TSCA currently considers dust, biomonitoring data, and other environmental concentrations that reflect chemical release into the environment from many sources, which is an approximation of "aggregate exposure."

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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