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With the pending implementation dates of several core elements of the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), many manufacturers are challenged in addressing efficiently and smartly supply chain complexities. This webinar, presented by Karin F. Baron, MSPH, Senior Regulatory Consultant, Bergeson & Campbell, P.C. (B&C®), Lynn L. Bergeson, Managing Partner, B&C, and Scott J. Burya, Ph.D., Regulatory Chemist, B&C, showed...

The Nanotechnology Industries Association (NIA) announced on October 5, 2018, that the NanoReg2 project, of which NIA is a partner, has published a comprehensive review of European Union (EU) legislation addressing chemical substances and the potential for grouping and read across in nanomaterials.  The article, “Insights into possibilities for grouping and read-across for nanomaterials in EU chemicals legislation,” considers both the overarching regulation of chemical substances under the...

The Environment Council of the Council of the European Union (EU) met on October 9, 2018.  According to the outcome of the Council meeting, the items debated under any other business included the “Berlin Declaration” on nanomaterials, submitted by the German delegation and supported by the French and Luxembourg delegations.  The Berlin Declaration summarizes the conclusions and recommendations of the 12th International Nano-Authorities Dialogue of Germany, Liechtenstein,...

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...

By Lynn L. Bergeson On October 9, 2018, the U.S. Department of Energy (DOE) announced a memorandum of understanding (MOU) with the U.S. Army on a collaborative project designed to develop hydrogen and fuel cell technologies for civilian and military use. The MOU was signed by the U.S. Department of Army’s Tank & Automotive Research Development and Engineering Command (TARDEC) and the DOE’s Fuel Cell Technologies Office (FCTO). It aims to facilitate the research and development of...

On October 8, 2018, Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), moderated “Sustainable Investment in Agriculture: Improving Agricultural Land Investment Contracts and the Contracting Process” at the legal profession’s largest international event, the International Bar Association (IBA) Annual Conference held this year in Rome, Italy. Ms. Bergeson is Vice Chairman of IBA’s Agricultural Law Committee. Panelists Katherine Cook, Matrix...

On October 5, 2018, the U.S. Environmental Protection Agency (EPA) issued the general approaches that the Office of Pollution Prevention and Toxics (OPPT) may use to identify potential candidate chemicals for prioritization under TSCA.  83 Fed. Reg. 50366.  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 identified...

On September 28, 2018, the U.S. Environmental Protection Agency (EPA) announced it was accepting public nominations of scientific experts to be considered for ad hoc participation on the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) through membership on the Food Quality Protection Act (FQPA) Science Review Board (SRB).  83 Fed. Reg. 49091.  EPA states that “all nominees will be considered for ad...

On September 25, 2018, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report Measures and Management Controls Needed to Improve EPA’s Pesticide Emergency Exemption Process that details the results from the its audit done to determine whether EPA has a comprehensive pesticide emergency exemption approval process that maintains environmental and human health safeguards.  Section 18 of the Federal Insecticide, Fungicide, and...

Register now for our Wednesday webinar -- “Keeping up with FSMA -- Rules, Obligations, and Key Compliance Dates,” October 17, 2018, 1:00 p.m. - 2:00 p.m. (EDT). With the pending implementation dates of several core elements of the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), many manufacturers are challenged in addressing efficiently and smartly supply chain complexities. This webinar will help you prepare for the forthcoming deadlines and explain how...

On September 24, 2018, in the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit), respondents U.S. Environmental Protection Agency (EPA) and Acting EPA Administrator Andrew Wheeler (collectively EPA) petitioned for an en banc and panel rehearing concerning the Ninth Circuit’s August 9, 2018, decision that granted judicial review of EPA’s initial order denying an administrative petition by the Pesticide Action Network North America (PANNA) and the Natural Resources Defense...

On September 28, 2018, the U.S. Environmental Protection Agency (EPA) announced it was releasing the approach it will use to identify chemicals that could be included in the next group of risk evaluations under the Toxic Substances Control Act (TSCA) titled “A Working Approach for Identifying Potential Candidate Chemicals for Prioritization” (Working Approach).  EPA states that the information set forth in this document is “intended to describe the general approaches EPA may...

Biofuels Digest, “Enerkem Produces a New Clean, Renewable Alternative Solution to Diesel Fuel for the Transportation Sector” 

By Lynn L. Bergeson On September 25, 2018, the U.S. House of Representatives passed without objection the Pandemic and All-Hazards Preparedness And Advancing Innovation Act of 2018. Introduced on July 16, 2018, by Congresswoman Susan W. Brooks (R-IN), this Act reauthorizes certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act, and amends the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. Amongst these reauthorized programs are the federal...

By Lynn L. Bergeson The U.S. Environmental Protection Agency (EPA) has included a new data portal on its website to promote greater transparency on small refineries exemptions to the Renewable Fuel Standard (RFS). Criticized in the past for its lack of transparency, EPA’s new RFS data portal also provides previously undisclosed information on Renewable Identification Number (RIN) transactions, renewable fuel volume production, average RIN prices, and RIN transaction volumes. The data...

The Nanotechnology Industries Association (NIA) published an open newsletter on September 19, 2018, that includes an invitation to NIA’s October 11, 2018, open webinar on regulatory priorities.  The open webinar will cover the latest news on the nanomaterials definition, amendments to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Annexes, the Organization for Economic Cooperation and Development (OECD) Malta project, and the latest news on nanowaste...

On September 27, 2018, the U.S. Environmental Protection Agency (EPA) issued the user fees final rule for the administration of the Toxic Substances Control Act (TSCA), the fourth and remaining framework rule to be issued in final under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). This final rule, that amends 40 C.F.R. Parts 700, 720, 723, 725, 790, and 791, “describes the final TSCA fees and fee categories for fiscal...