Memoranda

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...

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...

On October 4, 2017, the U.S. Food and Drug Administration (FDA) announced the availability of final guidance that helps to clarify FDA and U.S. Environmental Protection Agency (EPA) jurisdiction over the regulation of mosquito-related products intended to function as pesticides, including those produced through the use of biotechnology.  The notice was published in the Federal Register on October 5, 2017.  82 Fed. Reg. 46500.  Guidance for Industry #236,...

On September 29, 2017, the U.S. Environmental Protection Agency (EPA) announced the availability of two final test method Standard Operating Procedures (SOP) for evaluating the efficacy of antimicrobials against spores of Clostridium difficile (C. diff).  EPA also released regulatory guidance for test criteria and pesticide claims for these products, specifically “Methods and Guidance for Testing the Efficacy of Antimicrobial Products Against Spores of Clostridium...

On September 13, 2017, the California Senate passed the final version of the Cleaning Product Right to Know Act of 2017 (S.B. 258), which would require manufacturers of cleaning products to disclose certain chemical ingredients on the product label and on the manufacturer’s website. The Senate passed the bill by a vote of 27 to 13. The California Assembly passed the bill by a vote of 55 to 15, with nine votes not recorded, on...

As reported in our Global Regulatory Update for August 2017, on June 23, 2017, Turkey’s Ministry of Environment and Urbanization (MoEU) published its REACH-like KKDIK Regulation. As reported in The Acta Group’s memorandum entitled “Turkey Catching Up with the [EU’s REACH] Regulation,” the name “KKDIK” is derived from the first letters of “Registration,” “Evaluation,” “Authorization,” and “Restriction” in Turkish. Similar to EU REACH, KKDIK requires companies to...

Cefic Provides Circular Economy Comments On EC’s Stakeholder Consultation: In July, the European Chemical Industry Council (Cefic) provided comments in response to the European Commission’s (EC) “Stakeholder Consultation Paper” on chemicals, products, and waste legislation. In its “feedback to the targeted consultation,” Cefic responded to each of the key issues identified in the EC’s consultation paper. Regarding the first issue of “insufficient information about...

EC Officially Adopts EDC Identification Criteria For BPR: On September 4, 2017, the European Commission (EC) issued a press release entitled “Endocrine disruptors: adoption of scientific criteria for biocides.” The EC’s press release stated that following endorsement by Member States, on July 4, 2017, of the scientific criteria for identification of endocrine disrupting chemicals (EDC) in pesticides, the EC adopted on September 4, 2017, the scientific criteria for identification of...

The Ministry of Environmental Protection of China (MEP) released on August 31, 2017, the Amendment on Data Requirements to the “Guidance for New Chemical Substance Notification and Registration.”  The revisions are expected to become effective on October 15, 2017.  As explained below, the new requirements reduce the data requirements for registration of low tonnage bands, particularly for the Level 1 regular registration but, as the amendment is in abbreviated table...

As Toxic Substances Control Act (TSCA) aficionados know well, September 19, 2017, is a banner date.  By then, information that was submitted and claimed as Confidential Business Information (CBI) between June 22, 2016, and March 21, 2017, must be substantiated.  If you have not already done so, the September 19th deadline looms large. Background On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued an interpretation of TSCA Section 14 concerning...

TSCA New Chemicals Coalition will give the chemical community greater opportunity to engage with EPA on constructive, helpful, and informed improvements to the new chemicals review process. JOIN NOW BACKGROUND Section 5 of the Toxic Substances Control Act (TSCA) addresses new chemical notifications and, as such, is chemical innovation’s regulatory gatekeeper.  The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) amended Section 5.  The U.S. Environmental...

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on August 3, 2017, providing the names and affiliations of additional candidates currently under consideration for appointment to the Science Advisory Committee on Chemicals (SACC). The notice states that the purpose of the SACC is to provide independent advice and expert consultation at the request of the EPA Administrator with respect to the scientific and technical aspects of risk assessments,...

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Bergeson & Campbell, P.C. (B&C®) appreciates the efforts being made by the U.S. Environmental Protection Agency (EPA) to upgrade and update several of the category documents in the New Chemicals Program, encourage EPA’s continued activity in this area, and encourage EPA to engage in a broader effort to solicit public comments.  We recognize the critical role that the new chemicals categories have played in the implementation of the New Chemicals Program.  Over time, however, we...

On July 7, 2017, the U.S. Court of Appeals for the D.C. Circuit found “unreasonable,” and thus threw out, the “verified recycler” exclusion promulgated by the U.S. Environmental Protection Agency (EPA) in its 2015 revisions to the definition of solid waste under the Resource Conservation and Recovery Act (RCRA).  The court reinstated the “transfer-based” exclusion promulgated by EPA under the Bush Administration.  In the case, American Petroleum Institute v....

On May 30, 2017, the Resource Conservation and Recovery Act (RCRA) Hazardous Waste Generator Improvements Rule became effective. 81 Fed. Reg. 85732 (Nov. 28, 2016). The rule will not become effective in RCRA-authorized states, however, until the states adopt the provisions and the U.S. Environmental Protection Agency (EPA) approves those state programs that adopt the rule. Please see our Monthly Update for December 2016 for additional detail on the rule. The potential scope of the...