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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...
October 6, 2017
Inside EPA Quotes B&C Memorandum on EPA, FDA Jurisdiction for Mosquito Related Products
On October 6, 2017, Inside EPA quoted a recent memorandum from The Acta Group (Acta®) in the article “EPA wins power to oversee biotech mosquito controls.” EPA and the Food and Drug Administration (FDA) have issued new guidance clarifying that EPA has authority for regulating biotechnology (Bt) products such as genetically modified mosquitoes that are used to control the pests, a step that one industry law firm says will be helpful for navigating a federal...
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...
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 Microbiology Laboratory Branch (MLB) SOP MB-28: Procedure for the Production and Storage of Spores of Clostridium difficile for Use in the Efficacy Evaluation of Antimicrobial Agents; and EPA MLB...
ARGENTINA Argentine Ministry Begins Work On New Hazardous Waste Law: The Argentinian Ministerio de Medio Ambiente y Desarrollo Sostenible (Ministry of Environment and Sustainable Development) has begun discussions with the Consejo Federal de Medio Ambiente (Federal Environmental Council, COFEMA) regarding a draft hazardous waste regulation to replace the existing statute, Reglamentación de la...
September 22, 2017
Inside EPA Quotes B&C TSCAblogTM in Article Regarding Rejected TSCA Section 21 Fluoride Petition
On September 22, 2017, Inside EPA quoted the post “EPA Denies TSCA Section 21 Petition on Fluoride Chemicals in Drinking Water; Provides Response to Petition,” from Bergeson & Campbell, P.C.’s (B&C®) TSCAblogTM in the article “Suit Over Rejected Fluoride Petition Could Test EPA's Stance On TCSA 'Uses'.” Observers tracking EPA's implementation of the new TSCA law said last spring shortly before the suit was filed that it would provide a test case...
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 September 12, 2017. Governor Jerry Brown (D) has...
The Acta Group L.L.C. (Acta) affiliate Bergeson & Campbell, P.C. (B&C®) is seeking an assistant regulatory compliance chemist to join our growing team of regulatory consultants, scientists, and policy experts. This position will be based in our Washington, D.C. office, although telework arrangements may be considered for the right candidate. Applicants must have experience with the Toxic Substances Control Act (TSCA), the Canadian Environmental Protection Act (CEPA), the...
September 18, 2017
Career Opportunity – Regulatory Compliance Chemist or Senior Regulatory Compliance Chemist
The Acta Group L.L.C. (Acta) affilate Bergeson & Campbell, P.C. (B&C®) is seeking a regulatory compliance chemist to join our growing team of scientists, regulatory consultants, and policy experts. This position will be based in our Washington, D.C. office, although telework arrangements may be considered for the right candidate. Applicants must hold a Ph.D. in chemistry, biochemistry, or related science and be must be highly experienced with the Registration, Evaluation,...
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...