Biobased and Renewable Products News: Regulation & Policy

November 9, 2018
Call For Candidate Chemicals For Equivalency Determinations
Is your company engaged in Class 2 chemistries that are similar to existing Class 2 chemicals but are derived from an innovative bio-source? We are looking for pioneering companies working on new biobased Class 2 chemicals to assist in advancing an important project with the U.S. Environmental Protection Agency (EPA).   ISSUE:  While EPA sustainability goals would seemingly include adoption of improved biobased technologies, EPA’s policies under the Toxic Substances Control Act (TSCA) mean that many novel, sustainable technologies are considered “new chemicals” ... read more >
May 24, 2019
HHS Announces Availability Of Draft Guidance On Therapeutic Protein Biosimilars
On May 22, 2019, the U.S. Food and Drug Administration’s (FDA) Department of Health and Human Services (HHS) announced via the Federal Register the availability of a draft guidance for industry titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” The draft guidance is a revision of the 2015 guidance titled “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product.” It provides recommendations on the design and evaluation of ... read more >
May 24, 2019
CEC Awards Funding For Clean Energy Projects
On May 15, 2019, the California Energy Commission (CEC) approved approximately $11 million for clean energy demonstration projects that include biofuels, renewable gas, and microgrids. Funded by CEC’s Alternative and Renewable Fuels and Vehicle Technology Program, in support of clean transportation innovation, $2 million from the total funds have been approved for technology and investment solutions in hopes of demonstrating cost-effective and more sustainable processes for creating biomethane for waste hauling trucks. Funding was also awarded in support of renewable gas production ... read more >
April 12, 2019
Minnesota Department Of Agriculture Offers Grant Opportunity
The Minnesota Department of Agriculture is offering an opportunity for funding to advance a bioenergy or biochemical production technology toward commercial scale through the construction and operation of a pilot plant. To be eligible for the AGRI Bioenergy/Biochemical Pilot Project Grant, applicants must be a Minnesota-based company, learning institution, local government unit, Native American Tribal community, or individual (including for-profit businesses and colleges/universities). Eligible grant projects will be for the development of innovative bioenergy or biochemical production ... read more >
March 29, 2019
FDA’s Premarket Voluntary Plant Biotechnology Consultation Program Provides Opportunity For Developers
In a recent statement prepared by U.S. Food and Drug Administration’s (FDA) Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition, and by Dennis Keefe, Ph.D, Director of FDA’s Office of Food Additive Safety, FDA highlights its commitment to assisting plant biotechnology developers to foster innovation and ensure that consumers can confidently trust FDA’s high safety standards.  Plant biotechnology consists of methods used to introduce new traits or characteristics to a plant (e.g., plants resistant to insect pests, plants with reduced ... read more >
March 15, 2019
FDA Commissioner Releases Statement On Biotechnology Innovations
On March 8, 2019, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., released a statement on the continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered (GE) salmon.  In his statement, Dr. Gottlieb emphasized FDA’s mission to evaluate the safety of intentional genomic alterations (IGA) in animals that will ultimately be sold for consumption in the U.S.  According to FDA’s recent framework for the efficient development of safe biotechnology products, Plant and Animal ... read more >
February 15, 2019
State Of Minnesota Announces Grant Opportunity
Minnesota’s Department of Agriculture has announced the AGRI Biofuel Blending Infrastructure Grant to provide funding for biofuel blending infrastructure equipment. In hopes of promoting economic growth and environmentally friendly practices in Minnesota’s biofuels industries, the Grant aims to develop new or enhanced markets that improve blending outcomes, including but not limited to increasing sales and greater access to fuels. The Grant is open to Minnesota-based organizations that are biofuel producers, blending and supplying fuel businesses, and petroleum fuel ... read more >
October 5, 2018
California Air Resources Board Approves Changes To Low Carbon Fuel Standard
On September 27, 2018, the California Air Resources Board (CARB) announced its approval of amendments to the Low Carbon Fuel Standard (LCFS). The LCFS has been in place since 2011, in an effort to reduce greenhouse gas (GHG) emissions. Under the original program, the standard required a ten percent reduction in the carbon intensity of transportation fuels in California by 2020. In 2017 only, the LCFS has successfully led to the replacement of billions of gallons of petroleum and natural gas with renewable and sustainable transportation fuels. Despite its success, however, the approved ... read more >
August 3, 2018
Senators Collins, Coons Introduce Bipartisan Bill To Promote Innovation In Sustainable Chemistry
On July 30, 2018, Senators Susan Collins (R-ME) and Chris Coons (D-DE) reintroduced their sustainable chemistry bill, the Sustainable Chemistry Research and Development Act of 2018 (S. 3296).  This bill encourages the development of new and innovative chemicals, products and processes with an improved “environmental footprint” through efficient use of resources, reducing or eliminating exposure to hazardous substances, or otherwise minimizing harm to human health and the environment.  The legislation is intended to support new innovations in chemistry that benefit the ... read more >
June 29, 2018
FDA Withdraws Draft Guidance On Evaluation Of Analytical Similarity Between A Proposed Biosimilar Product And A Reference Product
On June 21, 2018, the U.S. Food and Drug Administration (FDA) announced it was withdrawing the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017.  The announcement states that the draft guidance, if issued in final as written, “was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the reference product.”  Further, comments submitted to the docket “addressed a range of issues that could impact ... read more >
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