The Trump EPA is poised to grant the chemical industry yet another of its wishes under TSCA

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

The chemical industry has long sought to have the Environmental Protection Agency (EPA) rubber-stamp as “safe” as many of its chemicals as possible without imposing any burden on the industry to develop the information needed to actually demonstrate safety.  It has repeatedly pushed for EPA to set aside large numbers of chemicals in commerce and ensure they don’t have to undergo evaluations of their potential or actual risk.

During the debate over reform of the Toxic Substances Control Act (TSCA), various industry associations advocated for an approach that would have required EPA to quickly review all chemicals in commerce using whatever information was available (which is virtually none for the great majority of such chemicals), and set aside as “low-priority” any that EPA could not demonstrate were harmful.[pullquote]It appears EPA is trying to install a new parallel process, outside of TSCA’s statutory boundaries, that EPA will use to set aside thousands of chemicals from any further review indefinitely and with no recourse for the public.[/pullquote]When that didn’t fly (more on this below), industry commenters demanded that, in promulgating its Prioritization Rule, EPA designate long lists of chemicals as low-priority without any review.  One of the few positives of that final rule was that it rejected those calls as well.

But lest you think the issue is settled, think again.  Leave it to the Trump EPA to find an even more devious way of granting the industry’s wish.  

EPA’s ill-conceived proposal to “bin” the entire TSCA Inventory

EPA’s latest move comes in its proposal called “binning the TSCA Inventory.”  It constitutes the second half of a White Paper EPA released in September titled “A Working Approach for Identifying Potential Candidate Chemicals for Prioritization.”  Last night, EDF filed extensive comments on this document.  Among our many other concerns, we voiced strong opposition to EPA’s proposal for binning the entire TSCA Inventory, which numbers in the tens of thousands of chemicals.  Here’s why.

EPA’s White Paper is clear as to EPA’s purpose in binning the Inventory (emphases added):  “[I]ts purpose is not to identify a list of high-priority candidates.  Nor is its purpose to signal that the EPA has concerns with particular chemicals or categories of chemical substances” but rather “to identify a portion of the Active Inventory that can be set aside as not containing candidates for high-priority designation.”  Sound familiar?

The problem with this is that the 2016 amendments to TSCA already established a process for EPA to use to set aside chemicals not warranting further risk evaluation:  the authority and mandate for EPA to designate certain chemicals as “low-priority substances.”  This was a highly controversial aspect of TSCA reform:  Many stakeholders and members of Congress were concerned that it could be abused to shove large numbers of chemicals into that bin based on only limited information and a cursory review by EPA, thereby indefinitely or even permanently putting them off-limits to the process called for under TSCA to actually evaluate their potential risks.

To guard against this, Congress carefully circumscribed the process for low-priority designations EPA was to use.  Among the key safeguards:

• SUFFICIENT INFORMATION: Such designations have to be “based on information sufficient to establish that a chemical does not meet the standard … for designating a chemical substance a high-priority substance.”
• JUDICIAL REVIEW: Such designations can be challenged in court by any person.
• MODEST PACE OF DESIGNATION: TSCA anticipates an approximate balance in the pace at which high- and low-priority substance designations are made by indicating that EPA should make 20 of each type of finding within three and a half years of enactment.
• PUBLIC NOTICE AND COMMENT: TSCA requires that EPA “publish the proposed designations … along with an identification of the information, analysis, and basis used to make the proposed designations, and provide 90 days for public comment on each such proposed designation.”

EPA’s new Inventory binning proposal includes none of these safeguards (though the courts may ultimately conclude that binning decisions are subject to judicial review).  Instead, it appears EPA is trying to install a new parallel process, outside of TSCA’s statutory boundaries, that EPA will use to set aside thousands of chemicals from any further review indefinitely and with no recourse for the public.

Not only is there no statutory basis for EPA’s proposal, there is no need for it and undertaking it would seriously detract from EPA’s many other (and, in some cases, unmet) obligations to properly implement the 2016 TSCA amendments.

An unwarranted diversion of scarce EPA resources for TSCA implementation

Our detailed comments further discuss each of the following additional points:

• Nothing in TSCA mandates or authorizes binning of the TSCA Inventory.
• Nothing in TSCA requires binning of the TSCA Inventory. There is no reason or need for EPA to look at tens of thousands of chemicals when, even well into the future, EPA will need to have identified at most a few hundred chemicals under TSCA’s prioritization and risk evaluation processes.
• EPA should not divert its already stretched-thin and limited TSCA resources to undertake an exercise not mandated under TSCA, especially when it is not meeting all of its obligations under the new law.
• EPA has seriously underestimated the resources needed to fulfill its mandatory duties under TSCA, including those it is not adequately fulfilling.
• There is no indication EPA has budgeted the resources needed to carry out the proposed binning.
• EPA’s claim that other countries (e.g., Canada) are undertaking similar exercises is misleading.
• EPA’s proposal is contrary to TSCA’s process and criteria for setting aside chemicals and subverts Congress’ intent to ensure EPA uses a rigorous process to do so.

EPA’s binning process will favor industry data over the published scientific literature

As detailed in our comments, the binning exercise will not only be resource-intensive, it will also be incomplete and biased.  In order to “bin” the tens of thousands of chemicals on the Inventory, EPA would utilize an automated approach that only considers certain, limited types of studies and information.  As a result, EPA’s proposed approach would include industry studies conducted for regulatory purposes, while excluding the large majority of information published in the scientific literature, including key epidemiological and ecological studies.  Thus, EPA will make binning decisions on chemicals while ignoring reasonably available information about their risks.

This approach is particularly problematic because of how it would handle false positives (i.e., chemicals erroneously flagged as high-concern when they are actually low-concern) vs. false negatives (i.e., chemicals erroneously flagged as low-concern when they are high-concern), both of which would inevitably be generated.  Any false positives would be identified and remedied promptly as the agency moved them to the next stage of evaluation and considered such substances for prioritization and risk evaluation.  In contrast, the false negatives would be set aside indefinitely, effectively deemed “safe,” and likely never be revisited.

Will EPA give the chemical industry a direct role in selecting chemicals for prioritization?

Another highly disturbing aspect of EPA’s White Paper we discuss in our comments is EPA’s suggestion that it may give the industry a direct role in the designation of the priority to be assigned to chemicals.  Citing comments it received on its earlier proposals for identifying candidates for prioritization, EPA states (emphases added):

Stakeholders suggested that, after information from designating the required 20 low- priority chemicals is publicly available, they may wish to volunteer to sponsor the development of information that could be used by EPA to identify candidates that may be designated as low-priority chemicals, beyond the required 20.  The experience that EPA and stakeholders gain in designating the first 20 low-priority chemicals could set the stage for an enhanced stakeholder role in designation of additional substances.  Similarly, the experiences EPA and stakeholders gain in designating the first 20 high-priority chemicals could also set the stage for an enhanced stakeholder role.

EPA’s reference to “stakeholders” is misleading, as the only stakeholders making such comments were from the chemical industry.

While it should be obvious, the chemical industry has a clear conflict of interest in decisions about which chemicals are identified as candidates for low- or high-priority substances.  EPA’s suggestion that it may provide the industry an “enhanced role” in the designation of such substances is nothing less than appalling.

Instead of abdicating its responsibilities and authorities by resorting to “enhanced stakeholder roles” for industry in selecting the priority to be assigned to a chemical, and relying on voluntary industry sponsorship programs (that have failed in the past) to fill information gaps, EPA should do the job Congress intended it to do and actually utilize the enhanced mandatory information authorities provided in the 2016 amendments to TSCA – authorities it has yet to even hint at using, two and a half years after the passage of those reforms.