All Knowledge & Insights By Date

Products that embody tried, true, and especially cutting-edge technologies are generally embraced by retailers as sure-fire pathways to marketing success. What’s not to like about best sellers and newer, faster, cleaner, or otherwise improved products? Sometimes overlooked is what is hidden behind the technology curtain -- what is the secret sauce that makes the product faster, cleaner, or better? In marketing products with new modes of action and spiffy new attributes, retailers are part of a...

On October 6, 2017, Inside EPA quoted a recent Bergeson & Campbell, P.C. (B&C®) memorandum 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 #236,...

On October 3, 2017, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes (MWCNT) and other classes of carbon nanotubes (CNT), which was the subject of premanufacture notice (PMN) P-11-482.

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 SOP MB-31:...

On June 22, 2017, the U.S. Environmental Protection Agency (EPA) issued the final inventory notification rule under the amended Toxic Substances Control Act (TSCA). The rule establishes an electronic notification of chemical substances listed on the TSCA Inventory that were manufactured/imported for nonexempt commercial purposes during the 10-year time period ending on June 21, 2016, with provision to also allow processor notification. These notifications will be used to distinguish...

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...

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 until October...

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...

On September 11, 2017, Michael S. Wenk, M.S., Senior Regulatory Consultant with The Acta Group (Acta®), presented “Chemical Substance Management in Central and South America: Insights into Sustainability, Regulatory and Management Opportunities” at the 17th AOCS Latin American Congress and Exhibition on Fats, Oils, and Lipids in Cancun, Mexico.  In general, Central and South America have no formal chemical inventories in place, no formal pre-notification schemes, and no...