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 ...
Final TSCA reporting and recordkeeping rule for nanoscale materials available
On January 12, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a Section 8(a) of the Toxic Substances Control Act (TSCA) rule establishing reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale. According to a pre-publication version of the final rule, manufacturers and processers, or persons who intend to manufacture or process these chemical substances must report certain information...
EPA Publishes Final 2017 RFS Requirements
On December 12, 2016, the U.S. Environmental Protection Agency (EPA) published a final rule, Renewable Fuel Standard Program: Standards for 2017 and Biomass-Based Diesel Volume for 2018, in the Federal Register. This final rule sets the annual percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel for motor vehicle gasoline and diesel produced or imported in 2017, as reported in the Biobased and Renewable Products Advocacy Group’s (BRAG®) blog post...
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...