Joule Unlimited’s successful first MCAN is among several that have recently been listed as favorably reviewed on the EPA website.
As described in several previous entries in this blog from 2010 (beginning here), the U.S. Environmental Protection Agency (EPA) regulations under the Toxic Substances Control Act (TSCA) require the filing of Microbial Commercial Activity Notices (MCANs) before the commercial use of certain genetically modified microorganisms in biofuel or bio-based chemical production. In one of these posts, I briefly listed and summarized several MCANs that had been filed up to the time of that initial post, covering novel microorganisms intended for use in fuel production, as well as those covering microbes engineered to produce novel enzymes. From time to time, I’ve posted descriptions of additional biofuel or biobased chemical related MCANs that had been filed more recently (see posts of January 10, 2013 and August 28, 2013), and in today’s entry I’ll describe a number of new MCANs filed in 2012 and 2013 that have only recently been added to the list on EPA’s website.
To summarize my prior blog entries, the TSCA Biotech Rule covers certain modified microorganisms, specifically those containing deliberate combinations of coding nucleic acids derived from more than one taxonomic genus, but only when those organisms are used for commercial purposes not regulated by other federal agencies. The uses of microorganisms or algae to produce ethanol, butanol, biodiesel, other biofuels, or bio-based chemicals are industrial applications that fall under TSCA jurisdiction. Most R&D uses of such organisms would be exempt from MCAN reporting, and there are also commercial exemptions available for certain host organisms such as E. coli or S. cerevisiae, as described in my previous posts.
In late May 2014, EPA updated its website listings of MCAN submissions to add a fairly large number of submissions that had originally been filed over the past two years. These are as follows.
- Solazyme, Inc., MCAN J12-0003, received 03/23/12, modified microalgae, strain confidential, for chemical production.
- Joule Unlimited Technologies, MCAN J12-0006, received 07/11/12, modified Synechococcus for ethanol production. Regulated with a 5(e) Consent Order, 07/23/13 (see below).
- Company confidential, MCAN J13-0009, received 05/15/13, Modified microorganism for enzyme production.
- Danisco US, Inc. MCAN J13-0010, received 06/21/13, Saccharomyces cerevisiae, strain confidential, for ethanol production.
- Solazyme, Inc., MCAN J13-0030, received 08/16/13, modified microalgae, strain confidential, for chemical production.
- Danisco US, Inc. MCAN J13-0050, received 06/21/13, Trichoderma reesei, strain confidential, to produce alpha-amylase.
- Lessafre Yeast, MCAN J14-0001, received 11/27/13, Saccharomyces cerevisiae modified, for ethanol production.
- Company confidential, MCAN J14-0002, received 11/29/13, Modified microorganism, for chemical production
- DSM Nutritional Products, Inc., MCANs J14-0003 to -0006, received 12/02/13, Saccharomyces cerevisiae modified, for ethanol production.
Note that MCANs are reviewed by EPA, but no formal “approval” is needed. If the Agency does not identify any unusual risks or any reason to extend its review during the 90 day review period, the MCAN is deemed to be cleared (or “dropped from review”) and the applicant can proceed to commercialization. Except for the Joule MCAN, which was handled differently as I’ll describe below, all of the MCANs listed above were favorably reviewed by EPA and thus “dropped from review”.
I won’t comment in detail about these MCANs but will make a few observations. As has been the case in recent years, most of these have been for new yeast strains for ethanol production, other modified microorganisms for production of unspecified chemicals, or production strains for industrial enzymes. However, this batch of MCANs is notable for two reasons. First are the two MCANs from Solazyme, which are the first received and favorably reviewed by EPA under its TSCA regulatory program for the industrial use of modified eukaryotic algae. Although the identify of the microalgae species has been claimed as confidential in these MCANs, presumably one or both are for modified versions of the same algae species, Prototheca moriformis, that has been identified in online documents describing Solazyme’s approval for commercial use in Brazil (see my February 20, 2014 post for more detail). Unlike many industrial uses of microalgae, Solazyme grows its algae strains in traditional fermentations, with the organisms growing heterotrophically, i.e. deriving their energy from chemical nutrients rather than via photosynthesis.
Second is the MCAN from Joule, which is the first for a modified cyanobacterium (i.e. a prokaryotic blue-green algae) under this program (although Algenol’s CEO has stated in public presentations that his company has recently filed its first MCAN for a modified cyanobacteria strain, also for ethanol production). Joule’s MCAN is unique among all previously-filed MCANs in that the organisms would be grown outdoors, in durable, contained transparent photobioreactors arrayed horizontally to gather sunlight, rather than in a traditional stainless-steel ferementer. I coordinated the preparation of Joule’s MCAN during my time as director of regulatory affairs for the company, and also handled all interactions with EPA during its review of the filing.
In its evaluation of Joule’s MCAN, EPA concluded that the use of the MCAN strain at Joule’s Hobbs, New Mexico facility would not pose unreasonable risks. However, because of the innovative nature of Joule’s photobioreactors, EPA was not prepared to simpy drop the MCAN from review, thereby granting the company unlimited rights to use the MCAN strain under any conditions. Instead, EPA and Joule entered into a voluntary consent order, which allows Joule to use the strain commercially at the Hobbs facility, while also providing EPA with further data resulting from such use. Joule has recently announced the favorable outcome of EPA’s review of this MCAN, and I have discussed Joule’s experience as a case study in my December 2013 talk at the BIO Pacific Rim Conference.
EPA’s addition to its website of these 9 submissions is evidence of the increasing pace and frequency of MCAN filings (as shown in the Figure, with the 2014 entry accounting for perhaps half of the federal fiscal year). I’ve commented on this in past blog entries, and it is indicative of the growing interest in biofuels and bio-based chemicals, and in particular the growing acceptance within the industry that the use of genetically modified microorganisms (and algae) are possible, and in fact may be needed, to enable the economical manufacture of fuels and chemicals at large commercial scale.
D. Glass Associates, Inc. is a consulting company specializing in government and regulatory 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 Joule Unlimited Technologies, Inc. or any other organization with which Dr. Glass is affiliated.