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EPA Releases Studies on PV29

The EPA has released 24 studies on pigment violet 29 (PV29) after receiving extensive criticism for withholding health and safety data supporting a risk evaluation under the Toxic Substances Control Act (TSCA) in connection with the substance. In response to its critics, the EPA vowed to more carefully consider the protection of confidential business information (CBI) and to be more forthcoming with information related to chemicals in its evaluations. The agency stated that it is committed to transparency in its evaluation of the nine other chemicals that will be considered.

The controversy began when the EPA released a draft evaluation of pigment violet 29 (PV29) in November 2018. The draft risk evaluation concludes that PV29 does not present an unreasonable risk of injury to human health or the environment under the conditions of use. The evaluation took into consideration 24 studies that were voluntarily submitted by a foreign company which claimed CBI protection over the studies. The studies had been developed pursuant to the EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. According to the EPA, summaries of the studies in conjunction with draft risk evaluations were released to the public in November, but the studies themselves were not released at that time.

Consumer advocacy groups objected to the withholding of the information. The EPA asserted that the studies were subject to protection as CBI under TSCA. Consumer groups, however, asserted that TSCA does not offer CBI protection to health and safety studies like those at issue. Several groups filed a Freedom of Information Act (FOIA) request to obtain access to the CBI. Congressional Democrats also advocated for the public release of the information related to the chemical. Industry representatives, for their part, objected to the potential release of confidential studies, citing the threat that the release would inhibit other companies from voluntarily providing confidential information to assist EPA in conducting its duties under TSCA.

In response to the FOIA request, the EPA required the company that submitted the studies to substantiate its CBI claims. The company waived its CBI claims for 15 studies, and substantiated its CBI claims as to portions of 9 studies. Accordingly, the EPA released the 15 studies in their full form and the 9 studies in a redacted form. The EPA reiterated that the information released in the studies has not altered the “no unreasonable risk” determination that was set forth in the draft risk evaluation.

PV29 is used as a colorant in inks, paints, coatings and plastics.  It was chosen as one of the first ten chemicals for risk evaluation under the TSCA in December 2016.

Grimaldi Law Offices has been advising clients for over 20 years on chemical and product law. For knowledgeable advice and in-depth analysis on your chemical regulatory compliance obligations, contact Grimaldi Law Offices at (415) 463-5186 or email us at [email protected].

 

Ms. Grimaldi maintains a diverse environmental law practice focusing on chemical and product regulation and litigation defense. Her practice areas include Proposition 65, California's Safer Consumer Products Regulations, California's Rigid Plastic Packaging Container Act and the federal Toxic Substances Control Act. Ms. Grimaldi graduated from the University of California Hastings College of the Law magna cum laude and holds a Bachelor of Science Degree in Bacteriology from University of California, Davis. Prior to attending law school, she worked as a research assistant in laboratories at the University of California, San Francisco Cancer Research Institute and at the University of California, San Francisco School of Medicine.