In last week’s Special Report on Scale-up in Industrial Biotechnology, the Digest noted that a consistent lesson shared by leading biotech heavyweights at the BIO World Congress scale-up session is to “avoid an afterthought approach to regulatory compliance.” As luck and good scheduling would have it, after lunch on the same day, savvy conference-goers got up-close-and-personal with two senior U.S. Environmental Protection Agency (EPA) regulators and a seasoned company executive...
May 28, 2014
Inside EPA features B&C commentary in “Legal Limit May Drive Novel Voluntary Plan In EPA’s TSCA Fracking Rule.”
“In a May 20 analysis of the ANPR, the law firm Bergeson & Campbell also flags the ‘processors’ issue, saying the notice raises a host questions relating to ‘significant and difficult legal, procedural and policy issues. Noting that the ANPR includes service companies in its discussion of the companies that may be subject to Section 8 reporting, which ordinarily would not apply to ‘users,’ the analysis says, that though such service providers may ‘process’ the chemical while...
May 22, 2014
Lynn L. Bergeson, “Spotlight Shines on Plant Safety,” Chemical Processing, May 22, 2014.
Chemical plant safety is once again in the limelight due to some high profile and very public catastrophes. On January 3, 2014, a federal working group created by the Obama administration’s Executive Order (EO) 13650 issued a set of preliminary options intended to improve chemical plant safety and security. This is a priority topic commanding considerable attention and readers should be aware of and engaged in these developments. This column explains why.
May 21, 2014
House Subcommittee Holds Hearing on Nanotechnology: From Laboratories to Commercial Products
The House Science, Space, and Technology Subcommittee on Research and Technology held a hearing on May 20, 2014, on "Nanotechnology: From Laboratories to Commercial Products." The purpose of the hearing was to examine the current state of nanotechnology research and development (R&D), as well as future opportunities and challenges. In addition, the hearing discussed policy issues surrounding nanotechnology applications and activities, federal funding levels for nanotechnology R&D, and...
Kathleen M. Roberts was quoted in an article in Bloomberg BNA Daily Environment Report titled “EPA, Industry Far Apart on Agency Stance on Listing Mandate for Chemical Fractions.” “Kathleen Roberts, a vice presidentwith Bergeson & Campbell Consortia Management (BCCM), said the biobased and petroleum-based chemical manufacturers she works with through the Alliance for Chemical Nomenclature she manages would like to avoid a fight. Companies are genuinely confused when it comes to...
The U.S. Environmental Protection Agency (EPA) published in the May 19, 2014, Federal Register an advance notice of proposed rulemaking (ANPR) to seek comment on the information that should be reported or disclosed for hydraulic fracturing chemical substances and mixtures and the mechanism for obtaining this information. According to EPA, this mechanism could be regulatory (under Sections 8(a) and/or 8(d) of the Toxic Substances Control Act (TSCA)), voluntary, or a combination of both....
May 20, 2014
Lynn L. Bergeson, “Chemical Safety and Drinking Water Protection Act,” Pollution Engineering, May 20, 2014.
The tragic spill of a chemical into the Elk River in West Virginia that occurred on Jan. 9, 2014, has spurred the development of new legislation. On Jan. 27, 2014, Senators Joe Manchin (D-W.V.), Barbara Boxer (D-Calif.), Chair of the Environment and Public Works Committee, and Jay Rockefeller (D-W.V.) introduced the Chemical Safety and Drinking Water Protection Act of 2014. The regrettable spill and the mismanagement of the spill’s consequences by federal and state regulators reads like a case...
May 19, 2014
J. Brian Xu, M.D., Ph.D., D.A.B.T., Joins Bergeson & Campbell, P.C. and The Acta Group as Toxicologist
Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta) are pleased to announce the addition of Brian Xu, Ph.D., to our firms. Dr. Xu, a board-certified toxicologist and medical doctor, will assist clients in developing and managing international projects involving U.S. Food and Drug Administration (FDA) and U.S. Environmental Protection Agency (EPA) regulated consumer products, pharmaceuticals, cosmetics, industrial and specialty chemicals, agrochemicals, and antimicrobials. Dr. Xu...
The European Chemicals Agency (ECHA) Biocidal Products Committee (BPC) adopted an opinion on April 10, 2014, concerning HeiQ AGS-20 (AGS-20). See http://echa.europa.eu/documents/10162/21680461/bpc_opinion_heiq_ags-20_en.pdf.