Four Milestones Since the Birth of a Significantly Revised TSCA
Following the one year anniversary of significant amendments to the Toxic Substance Control Act (TSCA), there has been a flurry of activity related to the Act—from new rules issued by the Environmental Protection Agency (EPA) to lawsuits filed across the country. Here are some of the major highlights:
Proposed Expansion of the Science Advisory Committee on Chemicals (SACC)
The SACC was created to provide scientific advice to the EPA on its regulation of chemicals under TSCA. The SACC includes experts in toxicology, environmental risk assessment, exposure assessment, and sciences related to TSCA regulation and currently consists of 18 members. The EPA is proposing to increase the size to 24 members, according to a notice published to the Federal Register on August 3.
The purpose of the call is likely to add more industry voices to the largely academic committee. Members of the SACC are nominated through a public call published in the Federal Register and then appointed by the EPA Administrator. Members serve staggered terms of two to three years.
Defined New Framework Rules
In late June, the EPA issued three new, final framework rules explaining how it will prioritize and evaluate the risks presented by chemicals. The three rules include a prioritization rule, a risk evaluation rule, and a final inventory notification rule, which were respectively published in the Federal Register on July 20 and August 11.
- The prioritization rule lays out how the EPA plans to prioritize chemicals, including determining whether a chemical shall be considered a high priority or low priority. High priority chemicals will require additional study whereas low priority will not require immediate, additional study. The process involved in prioritization includes: initiating the prioritization process, providing opportunities for public comment, screening the chemical against certain criteria, and determining priority. The rule will become effective September 18, 2017. The EPA identified the first ten chemicals in 2016 and is in the process of reviewing them.
- The risk evaluation rule describes how the EPA will determine whether a chemical presents “unreasonable risk of injury to health or the environment.” The risk evaluation step occurs after prioritization. The steps of the process include: scope, hazard assessment, exposure assessment, risk characterization, and a risk determination. The rule will become effective September 18, 2017.
- The final inventory notification rule requires electronic reporting by industry businesses of any chemical that was manufactured in the United States in the last ten years. This rule allows the EPA to determine which chemicals are still active in commerce, focusing the burden of conducting risk evaluations only on those chemicals still being used. The EPA will use the reporting to update the TSCA Inventory—which was reviewed and updated based on internal information alone in June 2017. The rule became effective on August 11, 2017, and manufacturers have until February 2018 to report to the EPA. There is also a provision to allow notification by chemical processors within 420 days of the effective date of the rule.
EPA Issued External Party Guidance for Risk Evaluations
In June, the EPA issued a guidance document for persons, called “external parties” in the document, who are interested in submitting a draft chemical risk evaluation for the EPA to consider. The guidance aims to help external parties submit risk evaluations that are of the same quality as those done by the EPA, so that the TSCA program can be improved through the use of external party risk evaluations. The private party risk evaluation process is new and parties are just beginning to understand and contemplate how this process may short-circuit the EPA’s rather lengthy process of reviewing new chemicals. As we have noted before, the Lautenberg Act changes the standard from a proof of “safety” to a proof of “unreasonable risk.”
The guidance document begins by describing the statutory requirements of risk evaluations as set forth under the TSCA. Next, it describes the scientific standards for evaluations, including a discussion on best available science, the weight of evidence, and data quality. Third, the guidance explains the evaluation process from the scope to exposure and hazard assessments to the risk characterization. The guidance concludes with a discussion of risk determination following a risk evaluation.
Multiple Lawsuits Challenge Framework Rules
In addition to the regulatory activity surrounding the TSCA, several lawsuits have been filed in multiple districts challenging the EPA’s framework rules.
- On August 10, 2017, Safer Chemicals, Healthy Families, et al. filed suit challenging the framework rules in the Ninth Circuit.
- On August 11, 2017, the Alliance of Nurses for Healthy Environments, et al., which includes the Natural Resources Defense Council, challenged the rules in the Fourth Circuit.
- On August 11, 2017, the Environmental Defense Fund filed suit regarding the rules in the Second Circuit.
- On August 15, 2017, Earthjustice filed two suits in the Northern District of California challenging the rules.
While most of the petitions for review do not explicitly list the reasons for seeking review, the Safer Chemicals, Healthy Families challenge does explain its reasoning. It states that it is challenging the framework rules, among other things, as arbitrary and capricious, an abuse of discretion, and in excess of statutory authority.
These changes to the framework rules are designed to give manufacturers clearer guidance on how chemicals will be evaluated and regulated. However, with challenges pending, it remains to be seen how the regulations will ultimately impact the chemical manufacturing industry as well as how chemicals are introduced into commerce.