Memoranda

On July 27, 2018, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) issued a report entitled EPA’s Chemical Data Reporting Rule Largely Implemented as Intended, but Opportunities for Improvement Exist.  OIG conducted an audit to determine how EPA is ensuring that companies are compliant with the Chemical Data Reporting (CDR) Rule requirements under the Toxic Substances Control Act (TSCA) and whether EPA is using CDR data to prioritize chemicals...

On August 1, 2018, the U.S. Environmental Protection Agency (EPA) issued a direct final rule promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 145 chemical substances that were the subject of premanufacture notices (PMN).  83 Fed. Reg. 37702.  EPA notes that the chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e).  The direct final rule requires persons who intend to manufacture...

On July 20, 2018, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report on its audit of EPA’s implementation of the OIG recommendations for the Presidential Green Chemistry Challenge Awards (PGCCA) Program.  The PGCCA Program is sponsored by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) to promote the environmental and economic benefits of developing and using green chemistry by recognizing industry...

The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) signaled on June 29, 2018, its intent to prepare a “programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms.”  The EIS will have a significant impact on how APHIS chooses to amend its regulation of GE...

On July 17, 2018, the U.S. Environmental Protection Agency (EPA) convened a public hearing on the proposed rule "Strengthening Transparency in Regulatory Science." Stakeholder testimony was scheduled for the three sessions: 8:00 a.m. to 12:00 p.m., 12:00 p.m. to 4:00 p.m., and 4:00 p.m. to 8:00 p.m. Bergeson & Campbell, P.C. (B&C®) attended the morning session. A few takeaways from the meeting include: Congressman Paul Tonko (D-NY) and Congresswoman Suzanne Bonamici (D-OR) provided...

Available On-Demand - TSCA At 2: An Update On Implementation And Hot Topics: A recording of “TSCA at 2: An Update on Implementation and Hot Topics,” the third webinar in the 2018 Chemical Policy Summit Series, is now available. This webinar featured news and updates on Toxic Substances Control Act (TSCA) implementation from Nancy B. Beck, Ph.D., D.A.B.T.®, Deputy Assistant Administrator, U.S. Environmental Protection Agency (EPA) Office of Chemical Safety...

On June 19, 2018, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a press release announcing the availability of a final report entitled Biodefense in the Age of Synthetic Biology. According to the National Academies, the final report concludes that “[s]ynthetic biology expands the possibilities for creating new weapons -- including making existing bacteria and viruses more harmful -- while decreasing the time required to...

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) released its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program.  Development of the Strategic Plan was required under Section 4(h)(2)(A) of the Frank R. Lautenberg Chemical Safety for the 21st Century Act with a deadline of not later than two years after enactment.  Release of the final Strategic Plan occurred on the second anniversary of...

Bergeson & Campbell P.C. (B&C®) will present a webinar regarding confidential business information (CBI) as related to chemical regulation on September 18, 2018. Register for “TSCA Confidential Business Information and Generic Naming: Analyzing the New Rules” online.  This webinar is part of the 2018 Chemical Policy Summit Series presented by B&C and Bloomberg Next. On June 21, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance...

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) published a prepublication version of the final rule regarding reporting requirements for applicable persons to provide information to assist in the preparation of an “inventory of mercury supply, use, and trade in the United States,” where “mercury” is defined as “elemental mercury” and “a mercury compound” (mercury). Section 8(b)(10)(B) of the Toxic Substances Control Act (TSCA), as amended by the Frank...

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) announced that it has met its statutory responsibilities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to release guidance and policy on confidential business information (CBI), a strategy to reduce animal testing, and a final mercury reporting rule. As noted in our June 29, 2016, memorandum, “TSCA Reform: EPA Publishes First Year Implementation Plan,” the Lautenberg Act...

The U.S. Environmental Protection Agency (EPA) issued on June 20, 2018, guidance intended “to improve transparency with the public and with companies seeking Agency review of their new chemical substances under the Toxic Substances Control Act (TSCA).” EPA states that the guidance, entitled Points to Consider When Preparing TSCA New Chemical Notifications (Points to Consider Guidance), “promotes early engagement and communication, and enhances overall understanding of...

The U.S. Environmental Protection Agency (EPA) announced on June 7, 2018, that Charlotte Bertrand, Acting Principal Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention, signed a final rule that will add a category of 13 specific nonylphenol ethoxylates (NPE) to the Emergency Planning and Community Right-to-Know Act (EPCRA) Toxics Release Inventory (TRI). EPA states that this addition “ensures the most up-to-date information is easily accessible to the...

In somewhat of a surprise announcement, the New York State Department of Environmental Conservation (NYSDEC) on June 6, 2018, released its final policy and form for manufacturer disclosures under the Household Cleansing Product Information Disclosure Program. The Disclosure Program is similar to the recently enacted California Cleaning Product Right to Know Act of 2017 which requires the disclosure of cleaning product ingredients by way of website or product label. The Household...

On June 1, 2018, the U.S. Environmental Protection Agency (EPA) announced that it took “three important steps” intended to ensure chemical safety under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), which amended the Toxic Substances Control Act (TSCA).  EPA released the following for public comment:  (1) the first ten problem formulation documents, (2) EPA’s systemic review approach document, and (3) a significant new use rule (SNUR)...

Responding to July 2017 and March 2018 orders issued by the U.S. Court of Appeals for the District of Columbia Circuit, the U.S. Environmental Protection Agency (EPA) on May 30, 2018, issued a final rule revising the Definition of Solid Waste (DSW) under the Resource Conservation and Recovery Act (RCRA). 83 Fed. Reg. 24664. In a somewhat unusual move, EPA relied upon Section 553 of the Administrative Procedure Act (APA) to make the rule immediately effective and dispensed with notice and public...

There are approximately three months until the effective date of the California Office of Environmental Health Hazard Assessment (OEHHA) revisions to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations. By August 30, 2018, companies must comply with the revised regulations for consumer products, occupational, and environmental exposures. Companies that have not already revised warnings to comply with the new requirements must now review...

On May 10, 2018, the U.S. Environmental Protection Agency (EPA) announced several upcoming actions on methylene chloride. Under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA is required to perform risk evaluations on the uses of ten specific chemicals, including methylene chloride. According to EPA, it is nearing completion of problem formulations for these first ten chemicals. EPA’s announcement states that it will send a final methylene chloride rule to the...

On May 7, 2018, the U.S. Environmental Protection Agency (EPA) announced that it is withdrawing certain proposed rules for which EPA no longer intends to issue a final rule.  83 Fed. Reg. 20004. EPA notes that its withdrawal of these proposed rules does not preclude it from initiating the same or a similar rulemaking at a future date. Withdrawing the proposed rules officially terminates the ongoing rulemaking activities, allowing EPA to close out the individual entries for these...

The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT or the Office) has decided to delay its pending reorganization to take and consider staff comments on the revised reorganization. The new plan proposes a six division structure that has separate new and existing chemical risk management divisions complemented by separate new and existing chemical risk assessment divisions. OPPT’s other functions are proposed to be distributed into a...