Monthly Archives: May 2019

FDA to Hold Public Hearing on Cannabis

The Food and Drug Administration (FDA) announced that it will hold a public hearing to collect information related to the safety, production, and sale of cannabis products. The hearing is scheduled for May 31, 2019. The goal of the hearing conducted by the FDA is to provide information to the regulatory oversight committee about the safety of cannabis in FDA regulated products. The FDA has additionally announced its plan to form a committee to assess the process for lawfully marketing dietary supplements and food products containing cannabidiol (CBD). Safety concerns regarding cannabis have increased as the use of cannabis products…

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OEHHA Revises its Proposed Regulation on Cancer Warnings for Coffee

The California Office of Environmental Health Hazard Assessment (OEHHA) announced that a final ruling on a Proposition 65 exemption for carcinogens generated by the coffee brewing and roasting process would be delayed pending another comment period. The additional comment period, which concluded on April 2, focused on a modification to the wording of proposed Section 25704. According to the proposal, the exemption would apply to only those carcinogens identified on the Proposition 65 list as of March 15, 2019. Therefore, it would not apply to carcinogens that are subsequently added to the Proposition 65 list, thereby excluding from the exemption…

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Understanding EPA’s Prioritization Process

The procedure for assessing the safety of existing chemicals is set forth in the Toxic Substances Control Act (TSCA), which was substantially amended in 2016. Under this process, prioritization is the fist step in evaluating chemicals for safety. TSCA provides that the EPA must identify at least 20 chemicals as high priority and 20 chemicals as low priority by December 22, 2019. The EPA’s guide to prioritization is described in “A Working Approach for Identifying Potential Candidate Chemicals for Prioritization.” This guide provides both the immediate goals of identifying chemicals and the long-term goals of evaluating risks for the broader…

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EPA Announces Priority Designations for Chemicals

On March 20, 2019, the EPA announced the first group of proposed 20 “high priority” and 20 “low priority” chemicals for prioritization for risk assessment under the Toxic Substances Control Act (TSCA) as amended in 2016. EPA is required, under the 2016 TSCA amendments, to designate 20 chemicals in each category by the end of 2019. Under TSCA Section 2605(b)(1)(B), “high priority” refers to a chemical that the EPA determines, “without consideration of costs or other non-risk factors, may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of…

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American Chemistry Council Reviews EPA Role in TSCA Implementation

The American Chemistry Council (ACC) has publicly expressed its confidence in the EPA’s implementation of the Toxic Substances Control Act (TSCA). ACC views the new EPA administrator Andrew Wheeler as a significant victory in its goal of fully implementing the TSCA. At the same time, the EPA faces significant challenges in the near future including deadlines for final risk evaluations on a first set of ten chemicals and the designation of the next 20 chemicals for evaluation.  The ACC has set forth several goals in effectively implementing the TSCA, which include: Enhancing communication between the industry and the EPA with…

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