On March 13, 2015, the National Academies issued Industrialization Of Biology: A Roadmap To Accelerate The Advanced Manufacturing Of Chemicals, a 143-page report prepared in response to a request from the U.S. Department of Energy (DOE) and the National Science Foundation (NSF) to 'develop a roadmap of necessary advances in basic science and engineering capabilities, including knowledge, tools and skills' to accelerate the advanced manufacturing of chemicals using biological systems. Thirteen committee members with expertise in synthetic biology, metabolic engineering, molecular biology, microbiology, systems biology, synthetic chemistry, chemical engineering, bioinformatics, systems integration, metrology, chemical manufacturing, and law and bioethics worked together with researchers to create a technical roadmap for the future of the biochemicals industry. The report, with chapters including 'Industrial Biotechnology: Past and Present,' 'Vision of the Future: What New Chemicals Could Be Made?,' and 'How Do We Get There?,' examines the regulatory and societal factors limiting the adoption of bioprocessing in the chemical industry today and makes recommendations for EPA, the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and other agencies responsible for governance of existing and emerging biobased chemicals. A prepublication version of the report is available now, with a final publication date to be announced.
- Bergeson & Campbell, P.C.
- Industrialization of biology report released by the national ...
Results of EPA OIG’s Review of EPA’s Antimicrobial Testing Program
On September 19, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report, EPA Needs a Risk-Based Strategy to Assure Continued Effectiveness of Hospital-Level Disinfectants, the result of OIG’s review of EPA’s Antimicrobial Testing Program (ATP) to “determine whether the program ensures the efficacy of EPA-registered hospital sterilants, disinfectants, and tuberculocides (“hospital-level disinfectants”); and to evaluate options...
U.S. EPA approves first enzymatic method for SDWA reporting of nitrate
The US Environmental Protection Agency periodically updates methods laboratories can use for protecting the quality of the nation`s drinking water. The Safe Drinking Water Act office of the EPA published its list of Alternate Test Protocols (ATP) in the Federal Register in July 2016. The list includes NECi Superior Enzymes` enzyme-based nitrate test method. NECi/SE, a small biotechnology firm in Michigan`s Upper Peninsula, applies biotechnology to develop safer methods for measuring the pollutants in our environmen...
Chemical Reporting and 2016 requirements
The EPA views the laws as a major victory for chemical safety, public health and the environment. The EPA altered the CBI certification statement for 2016 CDR submission, to be consistent with the new laws requirements. In addition the EPA is updating the guidance, instructions, and informational documents to be consistent with the new language. Manufactures and importers are required to give the EPA information on the chemicals they manufacture domestically or import into the United States. The EPA uses the data...
What Does The Loss Of “Green Chemistry” Provision From Amended TSCA Mean For Biochemicals?
On July 15, 2016, Environmental Leader published "What Does the Loss of `Green Chemistry` Provision from Amended TSCA Mean for Biochemicals?," featuring comments by Lynn L. Bergeson, Managing Partner of Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell, P.C. (B&C®). Ms. Bergeson expanded on a previous blog post titled "Inside EPA Reports On Loss Of Green Chemistry Provision From TSCA Reform," stating: "While regrettable, the absence of the green chemistry...
2016 Chemical data reporting: What do you need to know.
TheToxic Substances Control Actof 1976 (15 U.S.C. §2601 et seq.) authorizes the U.S. Environmental Protection Agency (EPA) to promulgate and enforce rules on chemical substances in commerce. Section 8 (a) of the law requires the EPA to collect basic exposure-related information on the types, quantities and uses of chemical substances produced domestically and imported into the United States. Called theChemical Data Reporting Rule(CDR) [40 CFR Part 711], this information is collected every four years from...