Publication

Intro to Draft Risk Evaluation

The United States Environmental Protection Agency (“EPA”) is currently conducting a chemical risk evaluation of asbestos under the Toxic Substances Control Act (“TSCA”). Before a final risk evaluation can be published, the EPA must issue a draft evaluation, conduct an ad hoc peer review, and allow a 60 day notice and comment period open the public. Earlier this year, the EPA publicly released its Draft Risk Evaluation for Asbestos (the “Draft”). The 310-page Draft identified various Conditions of Use (“COU”) for potential asbestos exposures believed likely experienced by people in the U.S.

This article will focus on the Draft’s COU section related to asbestos exposure from the installation and removal of vehicle brakes and clutches. The Draft looked at exposures to occupational mechanics, bystanders[1], and do-it-yourself mechanics. The only asbestos fiber type the EPA evaluated was commercial chrysotile, and the only potential causative diseases the EPA evaluated were mesothelioma and lung cancer. The EPA chose to evaluate acceptable cancer risks to individuals based on an Inhalation Unit Risk[2] of 0.16 per fiber/cc.

The Draft found that acceptable cancer risks were exceeded for brake and clutch installation and removal for occupational mechanics at both high-end and central tendency exposure levels and for occupational non-users at all high-end levels. For brake repair and replacement performed indoors with compressed air, the Draft found that acceptable risk levels were exceeded for do-it-yourself mechanics and bystanders of do-it-yourself mechanics at high-end and central tendency levels. For brake work performed outdoors, the Draft found that acceptable risks levels were exceeded for do-it-yourself mechanics at high-end tendency levels when mechanic work was performed 30 minutes per day with 62 years of cumulative exposure starting at age 16.[3]

Public Comments and Hearing

 In June, 2020, the EPA held a public comment session on the Draft. The session elicited thousands of pages of comments and criticisms from notable figures in the world of asbestos medicine and science.[4] Various commenters brought many of the same concerns up repeatedly. The key concerns addressed include:

• The Draft solely determined risks based on chrysotile-only exposures, even though there is very little scientific and medical literature that evaluates chrysotile-only exposures. Further, it excluded an entire body of literature on asbestos exposures because the studies are based on mixed dust exposures.
• The Draft applied an exponential model instead of a linear model to evaluate risk.
• The Draft failed to evaluate other types of asbestos that are known to cause disease, such as amphiboles and crocidolite.
• The Draft failed to evaluate talc exposures currently being experienced by consumers.
• The Draft failed to evaluate certain “legacy exposures”[5] because those products are no longer in use, even though those products still provide a potential avenue for current day exposures.
• The Draft failed to evaluate the risk of other asbestos-related diseases such as asbestosis and ovarian cancer.
• The Draft excluded a large body of evidence that shows no increased risk of asbestos related diseases for automotive mechanics, including widely cited meta-analysis and cohort studies.
• The Draft used the North Carolina and South Carolina textile mill cohort studies as the baseline for chrysotile-only asbestos exposures, even though it has been proven that those cohorts were exposed to other types of asbestos, including crocidolite.
• The Draft attempted to determine the risk faced by automotive workers with studies of textile workers and miners, instead of the directly relevant studies of automotive workers themselves.
• The Draft did not differentiate between long-fiber exposures experienced by textile workers in North Carolina and South Carolina cohort studies and the short-fiber exposures shown to be experienced by those working with automotive products.
• The Draft did not call for a complete ban of asbestos in the United States.
• The ad hoc peer review panel contained several experts that consistently testify on behalf of Plaintiffs in asbestos litigation,[6] but contained no experts that routinely testify on behalf of defendants.

Dr. Kanarek

On June 24, 2020, Dr. Kanarek, a member of the ad hoc peer review committee, was deposed in an asbestos litigation case.[7] Dr. Kanarek recalled comments made by Dr. Elizabeth Sheppard, a biostatistician on the review panel, regarding her concern that the EPA was evaluating the risk of brake mechanics based on studies of textile workers and miners while excluding the studies done of actual brake mechanics. Dr. Kanarek agreed that risk assessments can reach widely varied outcomes based on the assumptions made and the pieces of information included and excluded. He also agreed risk assessment works on the assumption that every exposure to chrysotile asbestos is causative of disease, no matter how short in duration or small in intensity. Dr. Kanarek stated it was possible that the EPA could potentially never release a final risk assessment if the reviewers cannot reach a mutually agreed upon conclusion. Contrary to the Draft, Dr. Kanarek admitted that if he were trying to create a study to look at chrysotile-only exposures, it would be improper to use a group of workers that were exposed to mixed asbestos fiber types as the basis for the study. Lastly, Dr. Kanarek conceded that if the peer review panel was comprised of experts that only testified on behalf of Plaintiffs in asbestos litigation, then the decision-making of the panel would not be considered fair and balanced.

Potential Impact

While the final risk assessment evaluation has not been completed, the conclusions found in the current Draft lead to concern that these findings will cause confusion, or even improper influence, on jurors in future asbestos trials. A finding by the EPA that working with and around asbestos-containing brakes and clutches leads to an unacceptable risk of mesothelioma and lung cancer would be used in the opening statements of every asbestos Plaintiffs’ attorney in the country. Although the assessment is based on many assumptions that are not realistic, excludes large swaths of relevant scientific and medical studies, and makes conclusions regarding cancer causation that are entirely out of line with all current legal standards, it would be too complicated and too burdensome to dispute in necessary detail in front of a jury. It would simply be another factoid that will be used to persuade jurors that there is no safe level of chrysotile asbestos exposure and that all exposures cause disease. Surely, many hours of drafting and many tons of ink will be spilt in attempts to keep the findings of the EPA out of the courtroom through pre-trial motions to exclude and motions in limine. This is a future that will soon become all too real if there are not considerable changes made between the current Draft and the EPA’s final risk evaluation.