This blog entry describes the possible ways in which uses of algae or cyanobacteria for fuel or chemical production might be regulated in Canada. This entry is one of several posts that provide additional information in support of a poster I’m presenting at the 2013 Algae Biomass Summit on the regulations in various countries around the world that may be applicable to the use of naturally-occurring or genetically modified algae or cyanobacteria in fuel production. These include three general categories of regulation: biotechnology or biosafety regulations, aquaculture regulations, and renewable fuel standards or volume mandates. You can access the poster on my SlideShare site, and please refer back to my September 16 introductory post for links to posts on the regulatory situation in other countries. Although this discussion centers on algae and cyanobacteria, much of the discussion (other than the section on aquaculture) would be applicable to the use of other genetically modified microorganisms for production of fuel or chemicals.
Canada’s biotechnology regulatory approach resembles that of the U.S., in that existing laws and regulations are used to regulate biotechnology in a product-specific way. Therefore, many products of biotechnology would be regulated in Canada under existing federal laws. In November 1997, Environment Canada (EC) issued biotechnology regulations under the Canadian Environmental Protection Act (CEPA), that are similar in scope and approach to the U.S. EPA’s TSCA biotechnology regulations, and which are meant to cover biotechnology products or microorganisms that are new to commerce in Canada and which are not regulated by other federal agencies. Among products that could fall under this law’s scope would be microbial strains used for biofuel or bio-based chemical production, or for manufacture of enzymes for use in biofuel production. My 2010 post described these regulations in detail, but the following is a brief summary.
EC considers microorganisms as being potentially subject to these “New Substance Notification” (NSN) regulations if they meet the definition of “new substance”. The regulations define “microorganism” (in part) to be “a microscopic organism … classified in the Bacteria, the Archaea, the Protista, which includes protozoa and algae, or the Fungi, which includes yeasts …”. This means that both algae and cyanobacteria (classified as Bacteria) would be covered by the regulations. The law further defines a “new substance” as one intended for introduction into commerce that is not on the Domestic Substance List (DSL) as having been used in commerce in Canada between January 1, 1984 and December 31, 1986. The DSL for microorganisms includes about 70 naturally-occurring species, identified by ATCC accession numbers. Thus, if a microorganism on this list was used in commerce from 1984-86 in a way such that “its entry into the environment was unrestricted”, it is exempt from reporting; but all other microorganisms, regardless of make-up, are subject to reporting. In this way, the Canadian CEPA regulations are broader than those of the U.S. EPA, in subjecting a larger class of microorganisms to regulation, and it is important to note that the regulations are broad enough to include naturally occurring or classically mutated strains, if such strains had never previously been used in commerce.
Under the NSN regulations, any person who manufactures or imports substances subject to notification must provide a notification package to EC, which contains certain information specified in the regulations. EC uses this information to conduct a risk assessment prior to entry into commerce. The required information is generally similar to the information the U.S. EPA requests in MCAN submissions under its TSCA regulations (EPA’s requirements are discussed in my previous blog entries from 2010). Information on the Canadian biotechnology rule is available at the biotechnology home page, and the New Substance regulations themselves can be found here. A Guidelines document that is similar to EPA’s “Points to Consider document” can be accessed here. CEPA published a fact sheet specific for biofuels, which is accessible here.
The New Substance regulations are applicable both to contained uses and environmental uses of new microorganisms. The notification form which is to be used for submissions asks applicants to identify the “notification group” for the proposed use of the microorganism, and specifies the types of data that are needed for each notification group. The notification group “Introduction in a contained facility or for export only” would apply to contained uses of new microorganisms, and for these proposed uses, only the “Schedule 2” data (as summarized in the checklist in Part B of the form) would need to be submitted.
Based on the information currently on the EC website, most of the notifications reviewed and approved to date have been for contained manufacturing uses. These have been described in my 2010 blog post on the Canadian regulations, which includes links to the various decision documents. There do not appear to have been any published decision documents or risk assessments in the time since my earlier blog post. EC’s review focuses on the potential for the proposed use of the microorganism to pose any risks to the environment or to human health.
Proposed use of new strains of algae or cyanobacteria in open ponds would likely trigger a higher level of review by Environment Canada under the NSN regulations. There are several “notification groups” listed on the notification form that would apply to proposed uses of new microorganisms in the open environment. One such group would cover introductions of organisms “anywhere in Canada”, while others would cover only introductions into specified ecozones (one category for ecozones where the microorganism is naturally indigenous, another for ecozones where it is not). There are also notification groups for research field tests or for introductions “in accordance with confinement procedures”. Generally speaking, any notification for a proposed outdoor use of a microorganism would require the submission of the greatest amount of data with the notification, although this would be somewhat relaxed for research uses, or uses under “confinement”. As is the case with contained uses, EC’s review would focus on potential environmental or health risk associated with the proposed use.
A few of the published risk assessments on the EC website appear to have dealt with proposed environmental uses of new microorganisms. Specifically, there are three approved notifications involving either agricultural microorganisms or microorganisms intended for use in bioremediation. It appears that this may be an area where EC has more limited experience than is the case for proposals for contained uses.
The following is a brief summary of aquaculture regulations in Canada and how they may apply to industrial uses of algae or cyanobacteria. This is necessarily a very brief overview, meant to convey general guidance as to what applicants might expect in the country. More detailed information is available at the websites linked below, particularly including the very useful Fact Sheets maintained for individual countries by the U.N. Food and Agriculture Organization (FAO), which can all be accessed at http://www.fao.org/fishery/nalo/search/en.
Aquaculture in Canada may be regulated under federal or provincial law. However, according to the FAO summary page for Canadian aquaculture regulations, the actual responsibilities for aquaculture have been delegated by the federal government to provincial governments. According to the FAO site, the provinces are responsible for “aquaculture planning, site leasing, licenses and approvals for aquaculture sites, aquaculture training and education, the collection of statistics, the promotion of fish and aquaculture products, and the management of the industry’s day-to-day operations” among other functions.
The applicable federal law is the Fisheries Act of 1985. Although this Act does not define “aquaculture”, its definition of “marine plant” includes “all benthic and detached algae, marine flowering plants, brown algae, red algae, green algae and phytoplankton”, and so would appear that permits are required under Sections 44 through 46 of the Act for the cultivation or harvesting of algae, but possibly not cyanobacteria. Turning to some of the provinces, the Fisheries Act of 1996 of British Columbia defines aquaculture as “the “growing and cultivation of aquatic plants… or fish, for commercial purposes, in any water environment or in human made containers of water,” and moreover this law has a definition for “aquatic plant” identical to the federal definition of “marine plant”. This implies that algae would be covered under the provision for licenses, which reads “A person must not process fish or aquatic plants, or operate a plant in British Columbia or its coastal waters, unless the person holds a license issued for that purpose under this Part.” The FAO site also describes the Newfoundland Aquaculture Act (1990), which defines aquaculture as “the farming of fish, mollusks, crustaceans, aquatic plants and other aquatic organisms with an intervention in the rearing process to enhance production by regular stocking, feeding, and protection from predation” (emphasis added). Although algae is not mentioned by name, it could be considered to be covered by “other aquatic organisms”.
As the regulations and their applicability to algae or cyanobacteria may vary from province to province, it would be advisable to consult with the applicable provincial government before establishing an industrial algae operation in Canada.
In Canada, there are federal and provincial regulations mandating that fuels contain specified percentages of renewable fuels. The governing federal standards are contained in the Renewable Fuel Regulation, which establishes that, on average, the nation’s gasoline pool must include at least 5% renewable fuels (i.e., ethanol), and the “distillate pool” of diesel fuel and heating oil must include at least 2% renewable fuels. In both cases, there are provinces with the same or higher percentage mandate: Ontario requires 5% renewable content in the gasoline pool, while Saskatchewan and Manitoba require 7.5% and 8.5% renewable content, respectively. For the distillate pool, British Columbia has a 4% requirement while Alberta, Saskatchewan and Manitoba mirror the federal 2% requirement (the federal law includes an exemption for the Eastern provinces).
The federal Renewable Fuel Regulation resembles the U.S. RFS in many ways, by placing its obligations primarily on the parties directly selling fuels to end-users and also in its creation of “compliance units” which operate somewhat analogously to the Renewable Identification Numbers (RINs) under the U.S. RFS. The Canadian system, however, poses much simpler compliance obligations for biofuel producers. “Renewable fuels” are defined in the regulations as ethanol, biodiesel, or fuels produced from “renewable feedstocks”, which in turn is defined to include a broad range of feedstocks including algae, so there is no need to conduct a life cycle analysis to show any required threshold level of reduction of greenhouse gas emissions as is the case in the U.S. In Canada, producers of renewable fuels are required to register with the government and to file annual reports, each of which requires only minimal amounts of information regarding the types and amounts of fuel that is being produced. Thus, the burden on companies using modified algae or cyanobacteria to produce fuels should be less onerous in Canada than in the U.S., although for companies using cyanobacteria, it may be worth clarifying whether Environment Canada considers “algae” to include cyanobacteria, as is the case with the U.S. RFS as administered by the Environmental Protection Agency.
Although the Canadian federal regulations do not require any assessment of greenhouse gas emission reductions, it is worth noting that one province, British Columbia, maintains a low-carbon fuel standard that is analogous to the California LCFS. I have briefly described this province’s Renewable and Low Carbon Fuel Requirements Regulation (RLCFRR), which took effect in January 2010, in a blog post earlier this year. This law requires a 10% reduction in carbon intensity by 2020.
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. Dr. Glass also serves as director of regulatory affairs for Joule Unlimited Technologies, Inc. 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. Please visit our other blog, Biofuel Policy Watch.