In 1976, Congress passed the Toxic Substances Control Act (“TSCA”). TSCA gives EPA the authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures. In 2016, Congress passed the Lautenberg Chemical Safety Act (the “Lautenberg Act”) to strengthen provisions and requirements in TSCA and created a track for reviewing chemicals. First, EPA must prioritize chemicals as ‘high’ or ‘low’ priority substances based on a new “unreasonable risk” standard then perform thorough risk evaluations to determine the nature of any “unreasonable risk” and create an action plan to address it. The Lautenberg Act also imposes deadlines for EPA to complete risk evaluations for all ‘high’ priority chemicals, and mandates that EPA have ten ongoing risk evaluations within 180 days of implementation and twenty within 3 ½ years of implementation. On June 24, 2020, the Environmental Law Institute held a three-part webinar to discuss the EPA’s process of implementing TSCA given the Lautenberg Act. The following are some takeaways from that event regarding the current science and regulatory issues surrounding TSCA from the panelists (comprised of representatives of EPA and private experts).
EPA is currently completing risk evaluations on numerous chemicals under its TSCA authority, including, but not limited to, the ten high priority chemicals it initially selected for review. The EPA completed its final risk evaluation of methylene chloride, one of first ten high priority chemicals, in June 2020. The EPA is in various stages of completing its evaluation of the remaining nine high priority chemical with the goal of publishing a final risk evaluation for all nine by the end of 2020.
Notably, EPA has also taken two actions under TSCA to ban PFAS (Per and Poly-fluoroalkyl chemicals a/k/a “forever chemicals”). PFAS have been used in numerous consumer products from non-stick coatings on pans to clothing. However, there are thousands of PFAS compounds. EPA has set a deadline of 2023 to review more than 150 PFAS under the National Defense Authorization Act. Two days prior to this webinar, EPA issued a new rule preventing any company that manufactures, processes, or imports any product containing PFAS from selling those products in the United States without EPA’s review and approval. This webinar focused heavily of EPA’s methods of review and outcomes.
Data collection on exposures was a frequent topic of discussion during the second panel (a Q&A session) that focused on the technical science of assessments and risk evaluations of chemicals under TSCA. There appeared to be a consensus among the panelists that obtaining the most exposure data possible is optimal when performing risk evaluations. However, specific comments were made regarding the consequences from limited exposure data and how EPA can use the authority granted to it in TSCA to request additional exposure data from companies. It was also acknowledged that there are limitations to EPA’s authority to request certain information from companies under TSCA (i.e., data regarding legacy use exposures). There were also a few panelists who expressed their concerns that the limited exposure data that EPA has currently collected is insufficient. In this regard, it was suggested that an emphasis must be made toward more collaborative approaches. Specific suggestions included EPA engaging companies in ways to promote the sharing of information and EPA utilizing private labs to assist in risk evaluations. Other topics of discussion included, but were not limited to, the scientific community’s positive move away from animal tests, and the reliability of new methodology to replace animal tests. The science panel discussion was generally steered away from specifically criticizing EPA, however, the panelists collectively left an impression on the audience that more should be done by EPA going forward. This turned out to be a good segue into the third and final panel focusing on regulatory and policy issues.
The final panel sent a general message to the audience: the EPA has made great progress on prioritizing chemicals, however, it has not sufficiently implemented TSCA’s provisions or conducted adequate risk assessment once it completed the initial prioritization phase. Four years in, they have not seen a significant reduction in risk. Also seeing an “understatement of risk” in some instances. The panelists also encouraged a more holistic approach in assessing risk and determining susceptible sub populations, including children, the elderly, and pregnant women. The panelists specifically discussed in regard to PFAS, the issue of multiple data gaps and the difficulties to further regulate these compounds (added on to the difficulty that there are thousands of varieties that have different toxicity levels).
What does this mean for litigants and their lawyers?
The general tenner of the scientists toward EPA’s implementation of TSCA should give litigators just a little concern (I cannot stress the qualifier enough). Cases arising from toxic exposures turn on two simple concepts: (1) the chemical at issue is generally capable of causing a specific disease in a human after a certain level of exposure, and (2) the plaintiff was similarly exposed to a sufficient level of that chemical and developed the same disease. If EPA risk evaluations are looked at by the scientific community as unreliable then there will be consequences for toxic tort litigation. For instance, plaintiff attorneys may have a more difficult time proving that a particular chemical is generally able to cause a particular disease, and defense attorneys may have difficulties arguing that their client had no duty to warn and/or an exposure to their client’s product is not capable of causing a the plaintiff’s alleged disease. We can look to the Glyphosate Litigation as a recent high-profile toxic tort litigation where EPA’s finding/position was a focal point.
In this regard, EPA’s current risk evaluations of Methylene-Chloride and Asbestos may be susceptible to the general concerns expressed over limited data regarding legacy use exposures for chemicals that have been long-known to cause disease. In addition, the general concerns regarding EPA not using its authority under TSCA to request additional data may implicate its studies of PFAS as a new group of chemicals that EPA has just begun to regulate. This is particularly important given the new PFAS regulation promulgated by EPA that prevents the sale of any new product that contains a PFAS chemical in the United States without EPA’s review and approval. While it is significant regulation that will protect the public, it would be naive to think that any impacted companies will not seek legal advice on the scope and authority of this new regulation. Notwithstanding, there are positive takeaways from this webinar: it is apparent that the scientific community is aware of the shortcomings of the current implementation of TSCA, the scientific community is preparing to peer-review EPA’s findings in attempt to strengthen the reliability and validity of any final determinations by EPA, and the scientific community uses events like this webinar to encourage EPA to re-evaluate certain aspects of its current approach in real-time.
CMBG3 Law LLC has represented clients in toxic torts matters for many years. We provide the most current legal advice to our clients by staying on top of developments in science, medicine, and regulations regarding a wide variety of substances and products used by consumers every day. If you have any questions or would like more information about the issues referenced in this article, please contact Clifford V. Pascarella, II, Esq. (email him).
 In 2018, EPA published an initiative for eliminating the use of animal studies for studying disease response. There was brief discussion regarding the pros and cons given the humane/ethical advantages of transitioning from animal tests to in vitro tests; and a brief discussion of the availability of specific types of vitro tests that could replace specific animal tests that are highly reliable predictors of specific disease responses in humans.
Clifford V. Pascarella, II, Esq.