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...

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 intended...

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 EPA’s...

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...

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 their consumer...

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...

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...

On April 30, 2018, the U.S. Environmental Protection Agency (EPA) proposed the “Strengthening Transparency in Regulatory Science” (Science Rule) that EPA states is intended to “strengthen the transparency of EPA regulatory science.” 83 Fed. Reg. 18768. EPA states in the preamble that “[t]he proposed regulation provides that when EPA develops regulations, including regulations for which the public is likely to bear the cost of compliance, with regard to those scientific...

We are pleased to report that on April 20, 2018, the American Chemical Society (ACS) Green Chemistry Institute (GCI) announced the opening of the 2018 Green Chemistry Challenge Awards.  Readers will recall that funding for this essential program was zeroed out in the last several budget proposals advanced by the Trump Administration.  The U.S. Environmental Protection Agency (EPA) enacted budget apparently includes the resources to continue to support the Green Chemistry Challenge...

On April 10, 2018, Bergeson & Campbell, P.C. (B&C®) held a complimentary webinar, “FIFRA Hot Topics.”  Co-hosted with Bloomberg BNA, the webinar featured Richard P. Keigwin, Jr., Director, Office of Pesticide Programs (OPP), Office of Chemical Safety and Pollution Prevention (OCSPP), U.S. Environmental Protection Agency (EPA); Daniella Taveau, former International Trade Negotiator for EPA and now Regulatory and Global Trade Strategist, King & Spalding;...

On April 4, 2018, the U.S. Environmental Protection Agency (EPA) announced that the compliance date for emission standards, recordkeeping, and labeling (the manufactured-by date or import-by date) under the Formaldehyde Standards in Composite Wood Products Act (Formaldehyde Act) codified as Title VI of the Toxic Substances Control Act (TSCA) has been set for June 1, 2018, instead of December 12, 2018, per order of the U.S. District Court for the Northern District of...

The European Chemicals Agency’s (ECHA) Directors’ Contact Group (DCG) recently posted guidance for companies that are required to register under the European Union’s (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation by May 31, 2018.  This guidance focuses on specific important issues for companies managing compliance under the 2018 REACH deadline, and should be read in conjunction with DCG’s “Summary Paper on [Four]...

There are less than five months before 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 product, occupational, and environmental exposures.  While some companies have already revised warning requirements prior to this deadline, and an exception permits...

The South Korean Ministry of Environment (MOE) announced on March 14, 2018, that amendments to the Act for the Registration and Evaluation of Chemicals (K-REACH) will be promulgated on March 20, 2018, and be enforced beginning January 1, 2019. As reported in our January 4, 2018, “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018,” MOE proposed changes at the end of 2016 that would drastically alter the current legislation and...

On February 8, 2018, the U.S. Environmental Protection Agency (EPA) announced that EPA Administrator Scott Pruitt signed a proposed rule regarding user fees for the administration of the Toxic Substances Control Act (TSCA). As amended by the Frank Lautenberg Chemical Safety for the 21st Century Act, TSCA provides EPA the authority to levy fees on certain chemical manufacturers, including importers and processors, to “provide a sustainable source of funding to defray resources that are...

On December 27, 2017, the Ministry of Environmental Protection (MEP), Ministry of Industry and Information Technology (MIIT), and National Health and Family Planning Commission (NHFPC) jointly issued the List of Priority Chemicals for Management (first batch) to control strictly chemicals that are hazardous, persistent, and harmful to the environment and human health. The List is based on the mandate issued by the Action Plan for Prevention and Control of Water...

Click here for a PDF brochure of the memorandum Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) are pleased to offer you our Forecast 2018. The document distills key trends in U.S. and global chemical law and regulation, and provides a sneak preview of what our legal, scientific, and regulatory professionals believe we are likely to see in the New Year. Our unique business platform and global team of highly...

On December 6 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a notice alerting stakeholders that amendments were approved related to its August 28, 2016, adopted revisions to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations. These amendments, first proposed on July 21, 2017, are intended to clarify and correct certain sections of Article 6 that OEHHA believed “would be beneficial to the regulated community in...

As previously reported in our blog item on October 26, 2017, the U.S. Environmental Protection Agency (EPA) proposed triennial electronic reporting requirements pertinent to the supply, use, and trade of mercury in the United States. 82 Fed. Reg. 49564. This memorandum provides more information and an in-depth look into EPA’s proposed rule. The 2016 amendments to the Toxic Substances Control Act (TSCA) require EPA to establish periodic mercury reporting requirements for any...

On October 27, 2017, the U.S. Consumer Product Safety Commission (CPSC) issued a final rule prohibiting children’s toys and child care articles that contain specified phthalates.  The rule caps off almost a decade of effort since Congress passed the Consumer Product Safety Improvement Act (CPSIA) in 2008, which requires regulatory action on certain phthalates.  Under the final rule, children’s toys and child care articles that contain concentrations of more than 0.1...

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On October 15, 2017, California Governor Jerry Brown (D) signed the Cleaning Product Right to Know Act of 2017 (S.B. 258). The new law requires manufacturers of cleaning products to disclose certain chemical ingredients on the product label and on the manufacturer’s website. The online disclosure requirements apply to a designated product sold in California on or after January 1, 2020. The product label disclosure requirements would apply to a designated product sold in...

In August 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) released a Questions and Answers for Businesses (Q&A) document related to its August 28, 2016, adopted revisions to its Proposition 65 (Prop 65) Article 6 regulations covering “clear and reasonable warnings” requirements. Information related to OEHHA’s past actions modifying Prop 65 warning regulations, including the August 28, 2016, adoption and the November 27, 2015, and March 25, 2016,...

On October 1, 2017, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment’s (OEHHA) regulations amending the content required in Proposition 65 (Prop 65) Notices of Violation involving occupational exposure became effective.  The regulations (found at Title 27 of the California Code of Regulations, Section 25903(b)(2)(E)), first proposed on May 19, 2017, are intended to clarify that the “Special Compliance Procedure Proof of...

KKDIK, Turkey REACH, was published on June 23, 2017, after long delays, and will enter into force on December 23, 2017. Turkey’s Ministry of Environment and Urbanization (MoEU) will make available 13 guidance documents by the end of the year to assist industry with compliance. Guidance documents to be issued by the end of the year will address the following issues, among others: (1) dossier and substance evaluation; (2) dossier preparation and harmonized...