Here’s a brief summary of some recent regulatory and policy developments relating to biofuels, bio-based chemicals, and industrial biotechnology.
EPA Biotechnology Regulation under TSCA. After a long period with no updates, EPA recently updated its website listing Microbial Commercial Activity Notices (MCANs) that it has reviewed and cleared. The listing, which appears to cover MCANs submitted up to the end of the 2014 fiscal year (September 30, 2014), shows 19 previously unlisted MCAN filings, bringing the total for FY14 to 21, by far the largest number ever received in a single fiscal year. Included were 6 new MCANs for modified S. cerevisiae for ethanol production, 8 MCANs for production of enzymes from modified Trichoderma reesei strains, two new MCANs from Solazyme for modified microalgae, and a consolidated MCAN from Algenol covering three strains of enhanced algae for ethanol production. Like an earlier MCAN from Joule Unlimited, the Algenol MCANs were approved via a Section 5(e) Consent Order. I hope to analyze these new MCANs further in a future blog post.
Growing Congressional interest in TSCA reform. I’d also note that there has been considerable (and somewhat surprising) momentum in Congress so far this year on TSCA reform – a subject that has been brewing in Congress for the past several years and which now appears to have bipartisan support. Until recently, prospects for passage of TSCA reform were unclear, particularly in view of the current control of Congress by the Republican Party and the 2013 death of a key proponent of TSCA reform, Senator Frank Lautenberg. However, as of this writing, two TSCA reform bills have been introduced in the Senate, one by Senators Udall of New Mexico and Vitter of Louisiana (Senate Bill S.697), which has bipartisan backing, and a competing bill filed by Senators Boxer of California and Markey of Massachusetts (Senate Bill S.725), which addresses liberal concerns by allowing a broader role for the states. In addition, a discussion draft of a House bill for TSCA “modernization” was recently put forward by Representative John Shimkus of Illinois. The reforms proposed in these bills are largely directed at chemical safety and risk assessment, and in my initial analysis nothing proposed so far this year would affect EPA’s biotech rules under TSCA. I hope to report on and analyze TSCA reform efforts in a future blog post.
U.S. Renewable Fuel Standard. As I described in my October 2, 2014 entry and follow-up posts in the blog, last fall EPA announced new guidance for companies wishing to petition for acceptance of new fuel production pathways in the RFS. EPA has now begun granting petitions for new fuel pathways under these new procedures. Most of the approved petitions are for corn starch-to-ethanol pathways under the newly-instituted Efficient Producer program, but recent approvals have also included a new pathway for production of ethanol from algae, submitted by Algenol Biofuels.
There has also been a lot of recent activity regarding EPA’s continuing struggles to issue final volume mandates for 2014 and 2015. I’ve summarized this situation in a post today in my companion blog Biofuel Policy Watch.
AAFCO/FDA Memorandum of Understanding. Of interest to companies developing novel microorganisms for industrial purposes that wish to utilize spent microbial biomass in animal feed, the FDA Center for Veterinary Medicine (CVM) and the Association of American Feed Control Officials (AAFCO) have renewed their Memorandum of Understanding regarding review of new animal feed ingredients. As previously reported in the blog, FDA CVM and AAFCO first entered into such an MOU in 2009 and renewed it in 2012, to specify how they would work together to ensure appropriate scientific review of substances proposed for use in animal feed. The 2012 MOU was slated to expire on September 1, 2015; the new MOU will remain in effect until October 1, 2017. FDA’s brief press release can be found here, and the MOU itself can be found here. At the same time, FDA announced a plan to review the list of ingredients in the AAFCO Official Publication, to determine which of these might be officially given GRAS status, to align the AAFCO ingredient listings with FDA regulatory processes. Industrial biotech companies are increasingly taking advantage of the AAFCO process to gain approvals needed to have spent microbial biomass used in animal feed products such as dried distillers grains.
Other recent developments. In my companion post today on Biofuels Policy Watch, I’ve described recent developments relating to the ongoing efforts to amend the EU Renewable Energy Directive and regarding legislative developments to extend Oregon’s Clean Fuels Program.
D. Glass Associates, Inc.is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.