Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson, Charles M. Auer, Richard E. Engler, Ph.D., and Oscar Hernandez, Ph.D.

The U.S. Environmental Protection Agency’s (EPA) release of its Toxic Substances Control Act (TSCA) Section 5(a)(3)(C) determination for P-16-0510 represents a significant step in EPA’s implementation of the New Chemicals Program under new TSCA.  The substance is a polymer (a copolymer of ethylene glycol and propylene glycol end-capped with acrylamide groups).  It is intended to be used as a deodorizer in a variety of products, including floor cleaners, cat litter, fabric freshener sprays, and other consumer products.

Notably, EPA’s determination document specifies the conditions of use that are intended, known, and reasonably foreseen.  EPA states that there are no known or reasonably foreseen conditions of use other than those intended by the submitter.  This may appear to be a controversial statement.  Based on EPA’s interpretation of “conditions of use,” it would not pass legal muster to speculate that “anybody could manufacture or use it for anything” and, hence, impose use restrictions to prevent purely speculative applications with no basis in fact or reality.  EPA has repeatedly stated that it would base what is reasonably foreseen on information, knowledge, or experience, not on any conceivable condition of use.

EPA identifies the new chemical’s potential health hazard endpoints based on the acrylate/acrylamide category.  The concerns are based on acrylamide itself and some low molecular acrylamide analogs and include mutagenicity, developmental toxicity, reproductive effects, neurotoxicity, and a “marginal potential” for oncogenicity.  This too may sound alarming.  The real question, however, is how toxic is the new chemical and are exposures expected to exceed a “safe” level. 

In this case, EPA specifically considers the low-molecular weight (LMW) components of the polymer (i.e., the “worst case”) in its assessment and identifies two analogs of the LMW components.  Both analogs have similar structural features (they are end-capped with acrylates), so both are expected to share the same mode of action, and have similar molecular weights as the LMW components of the premanufacture notification (PMN) substance.  EPA states that it also considered the toxicity of acrylamide in its assessment.  We note, however, that acrylamide is not a good analog because it is substantially lower molecular weight than the LMW components of the PMN substance.  Based on the identified analogs, EPA set a no observable adverse effect level (NOAEL) of 250 mg/kg/day for systemic toxicity based on a combined repeat dose/reproductive/developmental toxicity screening test (OECD 422).  This study tests for a chemical’s potential to cause toxicity and the primary endpoints of concern relevant to the category (developmental, reproductive, and neurotoxicity).  This NOAEL would put the substance in the low-to-moderate toxicity category.  Note that despite the nominally alarming set of health endpoints identified in EPA’s category assessment, the 422 study shows the analog is not especially toxic to mammals.  By way of contrast, EPA’s most recent Integrated Risk Information System (IRIS) assessment of acrylamide identified a NOAEL of 0.5 mg/kg-day.

EPA also identifies ecotoxicity concerns.  Using its predictive models, EPA predicts toxicity levels for both acute and chronic effects to aquatic species and sets concentrations of concern (CoC) at 425 ppb for acute exposures and 43 ppb for chronic exposures.  These levels put the substance in the “moderate” category for environmental hazard.

EPA then applies exposure modeling to predict exposures to workers, the general population, and consumers.  EPA found that predicted exposures are sufficiently below EPA’s concern level to not present an unreasonable risk to workers, the general population, or consumers.  EPA even found that at the “worst case” of 100 percent PMN substance, exposures would still be sufficiently below EPA’s concern level.  EPA also evaluated surface water concentrations and found that the estimated maximum acute and chronic concentrations did not exceed the CoCs.

Summary

EPA reviewed the PMN, reviewed likely and potential exposures to workers, the general population, consumers, and aquatic species, and did not identify any foreseeable conditions of use that would lead EPA to predict that unreasonable risk was likely. 

This is a marked and welcomed departure from previous TSCA Section 5(a)(3)(C) decisions. In nearly all cases in the past, EPA only made a not likely determination if it identified a low hazard for both health and ecological effects (“low/low” cases).  Absent a low/low finding, EPA seemingly believed that there could be some conditions of use that could contribute exposures that could exceed EPA’s concern levels. Based on our review, EPA did not explain how it differentiated between “any possible/foreseeable” and “reasonably foreseeable” conditions of use.  Instead, if EPA could imagine a set of circumstances that could elicit an exceedance, EPA was of the view that new TSCA precluded it from making a Section 5(a)(3)(C) finding. (While some stakeholders might applaud an approach based on concepts such as the European Union’s Precautionary Principle, this is not how new TSCA, or U.S. environmental legislation more generally, is structured.) 

In the case of P-16-0510, EPA more carefully applied new TSCA as written when it identified a low/moderate health concern and a moderate eco concern, and nevertheless took a reasonable approach grounded on the law to go beyond mere consideration of potential hazard and to interpret the “reasonably foreseen” conditions of use and assess unreasonable risk as new TSCA requires.  We support this more measured approach and believe it better meets the statutory intent and requirements. As we have written previously, in our view, a “not likely” finding is not limited to cases in which toxicity is so low that exceedances are unimaginable.  Rather, EPA must limit its consideration to those conditions of use that are reasonably likely to occur and must evaluate unreasonable risks, not merely hazard, and regulate to protect to the “extent necessary” to protect against such unreasonable risks. 

We applaud EPA’s more measured approach that likely indicates a maturation of its understanding of what is needed to meet a not likely determination. We urge EPA to articulate its thinking on what is and is not “reasonably foreseeable” and what PMN submitters can do to help EPA understand not only what is intended, but what might be reasonably foreseen to occur.


 

By Lynn L. Bergeson, Charles M. Auer, and Margaret R. Graham

On December 21, 2017, the U.S. District Court for the Northern District of California ruled that the U.S. Environmental Protection Agency (EPA) had wrongly dismissed a Toxic Substances Control Act (TSCA) Section 21 petition submitted by Food & Water Watch, Inc. and other citizens seeking the regulation of fluoridation of drinking water supplies under TSCA Section 6(a) on grounds that the ingestion of fluoride poses an unreasonable risk to humans.  Food & Water Watch, Inc. v. EPA, Case No. 17-cv-02162-EMC (N.D. Cal.) (Food & Water Watch).  In 2017, EPA denied the Section 21 petition on the grounds that it failed to address conditions of use other than the fluoridation of drinking water.  82 Fed. Reg. 11878 (Feb. 27, 2017). 

In a fairly scathing rebuke of EPA’s legal positions, the court denied EPA’s motion to dismiss the petitioner’s judicial challenge of EPA’s administrative denial of the Section 21 petition and, in so doing, essentially rejected EPA’s interpretation that a citizen petition must evaluate all conditions of use of a chemical substance in a TSCA Section 6(b) risk evaluation.  While we are hesitant to note that “we told you so” in our March 7, 2017, blog item, the analysis noted there was spot on.

At issue in Food & Water Watch is EPA’s legal position that TSCA Section 6 requires that EPA consider all conditions of use in proceedings under that provision.  The court rejected this view noting that the “argument has no basis in the statutory text,” and there “is no good reason to believe that the term’s [conditions of use] appearance … [in Section 21] … obligates all citizen petitioners to address all conditions of use.”  The court also noted that EPA’s interpretation creates “a disparity between citizen petitions and manufacturer requests” for a Section 6(b) risk evaluation.  Under the rules, a manufacturer’s request may be limited only to those particular conditions of use of interest to the manufacturer, citing 40 C.F.R. Section 702.37(b)(4).  The court also noted EPA’s change of view on this issue between the proposed and final risk evaluation rule.  EPA initially proposed that risk evaluations must consider all conditions of use, but concluded in the final rule that EPA may focus its review on fewer than all conditions of use.

The court’s analysis is clear and well written, and goes into some detail on EPA’s legal reasoning and the problems it identified with it.

Commentary

This ruling raises interesting issues when viewed in the broader context of pending judicial challenges to EPA’s TSCA framework rules.  In those challenges, citizen advocates challenge EPA’s view, as articulated in the final framework rules, that the Agency retains discretion to assess those conditions of use it believes are most relevant for a particular chemical evaluation.  In other words, they challenge EPA’s view that fewer than all conditions of use must be considered in a risk evaluation, the very position the court in Food & Water Watch rejected for purposes of Section 21 petitions challenging EPA’s interpretation of a citizen’s legal burden under TSCA Section 6(a).  Given that the judicial challenge to the risk evaluation final rule is being heard in the U.S. Court of Appeals for the Ninth Circuit, this district court decision is particularly relevant.


 

Bergeson & Campbell, P.C. (B&C®) Managing Partner Lynn L. Bergeson and Senior Policy and Regulatory Advisor Charles M. Auer have recently published two articles on important issues as related to the amended Toxic Substances Control Act (TSCA): 

The concept of “conditions of use” plays an important role in TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  Conditions of use is a centralizing concept under which the U.S. Environmental Protection Agency (EPA) determines how a chemical is made, processed, used, and disposed.  The term is defined in TSCA Section 3 and also appears one or more times in the following Sections:  5, 6, 9, 14, 18, 21, and 26.  The term is not used in Sections 4 and 8.  B&C’s BNA article explores the use and application of conditions of use under Sections 5 and 6 and provides insights into the implications of what may be its unusual use in Section 5 in comparison to Section 6.

Among its other requirements and authorities, Section 5 of new TSCA generally requires that a company timely submit to EPA a notice of its intent to manufacture or process a new chemical or significant new use (NC/SNU).  EPA is then required to conduct a review of the Section 5(a)(1) notice and make a determination on the NC/SNU and take required additional actions.  Questions have been raised as to whether the review period is fixed and requires that EPA determinations and actions be completed within that period, or if the statute can be read to permit a more flexible review period along the lines of how it was interpreted and applied in old TSCA with the use of voluntary suspensions.  Charles M. Auer and Lynn L. Bergeson’s September ABA article analyzes that question.

Other B&C articles on amended TSCA and other regulatory issues of interest are available on our website.