Memoranda

On December 21, 2018, the U.S. Environmental Protection Agency (EPA) denied a petition filed under Section 21 of the Toxic Substances Control Act (TSCA) requesting that EPA initiate rulemaking to amend the TSCA Chemical Data Reporting (CDR) rule to increase reporting of asbestos. EPA denied the September 27, 2018, petition on the grounds that the petitioners, the Asbestos Disease Awareness Organization, American Public Health Association, Center for Environmental Health, Environmental...

On December 12, 2018, the House passed the Conference Report for H.R. 2 (the Agriculture Improvement Act of 2018, also known as the Farm Bill) to provide for the reform and continuation of agricultural and other programs of the United States Department of Agriculture (USDA) through fiscal year 2023. The Senate passed the Conference Report on December 11, 2018. Sec. 10101. Specialty crops market news allocation. Sec. 10102. Local agriculture market program. Sec. 10103. Organic...

On December 11, 2018, the U.S. Environmental Protection Agency’s (EPA) Acting Administrator Andrew Wheeler announced EPA’s and the U.S. Army Corps of Engineers’ (Corps) release of their highly anticipated proposed replacement definition of “Waters of the U.S.” (WOTUS) that defines the scope of waters and wetlands that fall under federal Clean Water Act (CWA) jurisdiction. The 2018 WOTUS rule proposal is currently available in pre-publication format on EPA’s...

On November 16, 2018, California’s Office of Environmental Health Hazard Assessment (OEHHA) proposed amendments to Proposition 65 (Prop 65) regulations setting forth the circumstances when a “retail seller” is required to provide a consumer product exposure warning.  Retail sellers are defined under the regulations as: [A] person or business that sells or otherwise provides consumer products directly to consumers by any means, including via the internet. For purposes of this...

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 15, 2018, announcing the availability of and seeking public comment on the first draft chemical risk evaluation under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg).  The draft risk evaluation for Colour Index (C.I.) Pigment Violet 29 is intended to determine whether C.I. Pigment Violet 29...

In the Trump Administration’s Unified Agenda of Regulatory and Deregulatory Actions (Regulatory Agenda) issued on October 17, 2018, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) published a Proposed Rule Stage item titled “Update to the Hazard Communication Standard,” RIN 1218-AC93, and scheduled the Notice of Proposed Rulemaking (NPRM) to be issued by March 2019. The full description of the item is: OSHA and other U.S. agencies have been...

Effective October 26, 2018, California’s Office of Environmental Health Hazard Assessment (OEHHA) added nickel (soluble compounds) to the list of chemicals known to the state to cause reproductive toxicity for purposes of Proposition 65 (Prop 65).  Importantly, “soluble” is not defined in the listing.  On October 11, 2018, OEHHA’s Developmental and Reproductive Toxicant Identification Committee (DARTIC), in its official capacity as the “state’s qualified experts”...

The U.S. Environmental Protection Agency (EPA) issued on October 16, 2018, a proposed rule that would establish significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN).  83 Fed. Reg. 52179.  The proposed rule is significant.  Unlike other recent SNURs (i.e., those acted on since entry into force of amended TSCA), the 13 chemical substances are not also subject...

As part of Amazon’s commitment to responsible sourcing, Amazon has posted its chemicals policy, which includes its first Restricted Substance List (RSL). Amazon states that it defines chemicals of concern as those chemicals that: (1) meet the criteria for classification as a carcinogen, mutagen, reproductive, or other systemic toxicant; or (2) are persistent, bioaccumulative, and toxic. Amazon “strategically prioritize[s] which chemicals of concern to focus on based on product...

On September 28, 2018, the U.S. Environmental Protection Agency (EPA) released the general approaches that the Office of Pollution Prevention and Toxics (OPPT) may use to identify potential candidate chemicals for prioritization under the Toxic Substances Control Act (TSCA). EPA notes that it will seek public comment on the approach document and on which chemicals should be identified as potential candidates for the initial 20 high-priority and 20 low-priority chemicals that must be...

On September 27, 2018, the U.S. Environmental Protection Agency (EPA) issued a final fees rule under the Toxic Substances Control Act (TSCA). The final rule largely tracks the proposed rule. In its press release, EPA states that the fees collected from chemical manufacturers “will go toward developing risk evaluations for existing chemicals; collecting and reviewing toxicity and exposure data and other information; reviewing Confidential Business Information (CBI); and making...

On August 21, 2018, Susan Bodine, Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Enforcement and Compliance Assurance (OECA), issued a memorandum to EPA Regional Administrators ordering a shift in OECA’s activities from enforcement to compliance.  This column reports on this important shift in Agency focus. Background For over two decades, EPA has strategically focused its enforcement and compliance resources on priorities it deems the...

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 for the...

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: The proposed rule, issued on April 30, 2018, originally had a comment...

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 and Pollution...

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 enactment of...