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,...
October 2, 2017
Methods and Guidance for Testing the Efficacy of Antimicrobials against Spores of Clostridium difficile
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...
September 21, 2017
California Bill Would Require Disclosure of Cleaning Product Ingredients
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...
September 14, 2017
Cefic Provides Circular Economy Comments On EC’s Stakeholder Consultation, and Other Recent REACH Developments
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...
September 13, 2017
EC Officially Adopts EDC Identification Criteria For BPR, and Other Recent BPR Developments
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...
August 3, 2017
EPA Seeks Comment on Nominations to “Augmented” Science Advisory Committee on Chemicals
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,...
Click here to open full PDF report. Click here to open full PDF report....
July 27, 2017
Bergeson & Campbell, P.C.’s Comments on New Category Documents under the New Chemicals Program
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...
July 18, 2017
Court Tosses RCRA Verified Recycler Exclusion but Retains Balance of Definition of Solid Waste Rule
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...
The Acta Group (Acta®) has been closely tracking the development of Brazil’s Industrial Chemicals Regulation (Regulação de Substâncias Químicas Industriais, or Regulação), which still only exists in draft form. As discussed in our Global Regulatory Update for June 2017, “on May 22, 2017, it was announced that, due to changes inside the Brazilian Ministry of Environment (Ministério do Meio Ambiente, or MMA), the extraordinary meetings of the National Commission of...
The U.S. Environmental Protection Agency (EPA) released on June 22, 2017, the pre-publication Federal Register notices of the final framework actions under the Toxic Substances Control Act (TSCA), as revised by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (new TSCA). The final rules include the prioritization process rule, which establishes EPA’s process and criteria for identifying High-Priority chemicals for risk evaluation and Low-Priority chemicals for which...
June 20, 2017
Minamata Convention on Mercury Achieves Ratification: International Use and Mining of Mercury Targeted for Scale Down
The Minamata Convention on Mercury (Convention), a global treaty aimed at scaling down mercury use and production developed by the United Nations Environment Program (UNEP), recently surpassed the 50-country threshold required for it to become legally binding for all of its parties. This occurred on May 18, 2017, when the European Union (EU) and seven of its member states (Bulgaria, Denmark, Hungary, Malta, the Netherlands, Romania, and Sweden) ratified the Convention. The...
On May 23, 2017, the White House unveiled the full version of President Trump’s proposed budget for fiscal year (FY) 2018 entitled “A New Foundation for American Greatness.” As signaled in the President’s “skinny budget” released earlier this year, the proposed budget would fund the U.S. Environmental Protection Agency (EPA) at $5.7 billion — a more than 30 percent decrease from the current funding of nearly eight billion. EPA’s congressionally enacted budget has...
With the recent release of the 2016 Chemical Data Reporting (CDR) dataset and the initial interim list of active substances released with the February 2017 copy of the Toxic Substances Control Act (TSCA) Inventory (Inventory), the magnitude of effort that will be needed for the Section 8(b)(4) Inventory Reset is becoming clear. Stakeholders should waste no time in preparing to meet their obligations. Non-confidential Portion of the Inventory Bergeson & Campbell, P.C. (B&C®)...