This blog entry describes the possible ways in which uses of algae or cyanobacteria for fuel or chemical production might be regulated in Australia. 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.
Australia has a Gene Technology Act of 2000, implemented by the Gene Technology Regulations of 2001, which would dictate whether the use of modified microorganisms for biofuel production would require a license. The Act and regulations established the Gene Technology Regulator (GTR) as the central office that administers the Act. The GTR plays the key role in assessing, regulating and licensing GMOs and enforcing license conditions. The Gene Technology Act defines gene technology as any technique for the modification of genes or other genetic material, although there is an exception for “homologous recombination” that appears quite narrow.
The most important features of the Gene Technology Regulations are the clarification of procedures for licensing certain uses of GMOs (activities involving GMOs are referred to by the term “Dealings”). The regulations also provide for the establishment of “exempt dealings”, which are a category of dealings with GMOs that have been assessed over time as posing a very low risk. As listed on the GTR website, exempt dealings primarily include contained research activities involving very well understood organisms, and although many industrially-useful host organisms appear on this list, the list does not include any algae or cyanobacteria. Of the dealings requiring a license, a distinction is made between those involving a deliberate release of a GMO into the environment, and those that do not, with the latter being referred to as a DNIR (“dealing not involving release”). Applicants for either type of license are required to submit certain information to the GTR, which is then used to prepare a risk assessment and risk management plan, which forms the basis for the GTR’s decision.
One interesting feature of the Australian Gene Technology Regulations is that, in order to qualify to have confidential information protected in any submitted application, companies must submit a separate application to the GTR to obtain a “declaration that specified information is confidential commercial information”. This application would be submitted and considered by the GTR in parallel with the license application that contains the confidential information, and the application must also specify exactly what information in the license application is claimed as confidential. The needed form can be obtained from the GTR website, but the website does not appear to specify the timeframes for GTR decisions on claims of confidentiality.
“DNIR” Licenses would be required for certain contained uses of GMOs under Australian law. Although most DNIR licenses granted to date cover laboratory research involving potentially pathogenic organisms, the industrial use of a modified microorganism for fuel or chemical production would potentially require a license. However, many common industrial production organisms such as E. coli, S. cerevisiae and others are included on the “exempt list”, so that their use may not require a DNIR license. However, use of modified algae or cyanobacteria for industrial purposes would not be covered by an exemption and would likely require a DNIR license from the GTR. The GTR website has links to the application forms, and the form for application for a DNIR license can be downloaded here. The application form is quite detailed, although the scientific information it requires is similar to the information that would be submitted to the U.S. EPA in a Microbial Commercial Activity Notice, which were summarized in one of my 2010 posts.
Procedures for review of DNIR license applications are specified on the GTR website. All license applications must first be reviewed and approved by an Institutional Biosafety Committee (IBC). The law and regulations specify requirements for such committees, and it appears that to meet such requirements, applicants would need to use an IBC in Australia. Once submitted the GTR has 90 working days to review the application, and its review may include consultation with outside experts and/or the Gene Technology Technical Advisory Committee. A formal Risk Assessment and Risk Management Plan (RARMP) may be needed, , and public involvement may be sought (although these do not seem to be required for DNIR applications as would be for proposals for deliberate releases). Although there do not seem to be any precedents for DNIR licenses granted for industrial manufacturing, it is likely that the process would be fairly straightforward, provided the applicant consulted with the GTR prior to preparing and submitting its application.
The possible use of modified algae or cyanobacteria in an open-pond or similar type of outdoor reactor would likely require a “DIR” (Dealing Involving Release”) license from the GTR. Procedures for review of DIR license applications are, in many respects, similar to that described above for DNIR licenses, and are specified on the GTR website. One major difference is that the GTR is afforded a greater amount of time to review DIR applications – up to 255 working days (essentially one full calendar year) for most applications or 150-170 working days for limited and controlled release applications.
“Limited and controlled releases” is a category created by Article 50A of the Gene Technology Act, that is meant to cover outdoor activities with GMOs for research purposes, in which the applicant intends to implement controls to restrict the dissemination or persistence of the GMO and its genetic material in the environment and to impose limits on the proposed release of the GMO in the activity (“controls” and “limits” are both defined in the Act). The category primarily covers research field tests of agricultural GMOs, and most of the “Limited and Controlled” licenses that have been issued to date have been for field tests of transgenic plants. It appears likely that this category of license would be available for any proposed use of a modified algae in a pilot plant and possibly also in larger demonstration-scale plants.
Regardless of whether the DIR application qualifies as a “limited and controlled” application, it would undergo a rigorous review by the GTR, through what the GTR website calls “a comprehensive, science-based, case-by-case analysis process” as described in Sections 48 – 67 of the Gene Technology Act. The Act also establishes a clear process that the GTR must follow in preparing a the RARMP risk assessment document (which is required for DIR applications) and in making a decision about whether or not to issue a license. In addition, the GTR will notify and solicit opinions about the proposal from a broad range of stakeholders, including the public, state, territorial and local governments, other national agencies including the Ministry of the Environment, and the Gene Technology Technical Advisory Committee.
The GTR appears to have little or no experience with license applications for any industrial application resembling an open-pond algae reactor, and so prior consultation with the GTR would be very important. It would also make sense to make use of the “limited and controlled” license process by beginning with an application for a smaller-scale (e.g. pilot-scale) reactor, so that the GTR could assess the potential environmental impact of the technology in a stepwise manner, and so the data and experience from small-scale use can be used in support of larger-scale activities.
The following is a brief summary of aquaculture regulations in Australia 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.
Under the Australian Constitution, responsibility for regulation of aquatic resources is shared by the central Australian Government and the individual state and territory governments. Specifically, each state or territory has primary responsibility for management of land and waters within its their boundaries as well as management of its inland and coastal waters out to the three nautical mile limit. The Australian Government has the responsibility for management of marine waters between the three and two hundred nautical mile limits. However, as summarized in the FAO page for Australia and a 2004 report commissioned by the government, there is no national legislation specific for fisheries or aquaculture, although there may be applicable provisions of general national environmental laws. So the most relevant legislation and regulations will lie with individual state or territorial governments.
As these two references report, all of these regional governments have laws that cover commercial fisheries or aquaculture. However, many of these laws either do not define “aquaculture” or define it more narrowly to apply only to fisheries, and so many of these laws would arguably not apply to industrial uses of algae. However, in South Australia, which is reported to be the state with the largest aquaculture industry, the applicable definition is broad enough to encompass algae. In the South Australia Aquaculture Act (2001, as amended in 2003 and 2005), aquaculture is defined to mean “farming of aquatic organisms for the purposes of trade or business or research, but does not include an activity declared by regulation not to be aquaculture.” Note that “aquatic organism” is defined to mean “an aquatic organism of any species, and includes the reproductive products and body parts of an aquatic organism”. Also, the term “farming of aquatic organisms” means “an organized rearing process involving propagation or regular stocking or feeding of the organisms or protection of the organisms from predators or other similar intervention in the organisms’ natural life cycles”.
In the state of South Australia, aquaculture activities must be licensed by the state government. Licenses are only granted if the area to be used for aquaculture is subject to a lease, which may or may not be controlled by the entity applying for the license.
According to transportpolicy.net, fuel quality in Australia is regulated by the Department of Sustainability, Environment, Water, Population and Communities, under the Fuel Quality Standards Act (2000) and the Fuel Quality Standards Regulations (2001). This agency has set both environmental standards and operability standards for fuels, with the standards for diesel and gasoline conforming with international standards such as those of the ASTM. There is also a biodiesel standard that is derived from international standards. Fuel producers and sellers are required to document that their fuels are in compliance with standards, and although the agency’s website calls this “industry self-regulation”, a company’s documentation of compliance are subject to investigation by regulators.
Australia does not appear to have a national ethanol mandate (i.e. there are no minimum ethanol levels) and ethanol content in gasoline is limited to 10%, but there are applicable laws in certain Australian states. The state of New South Wales has a 4% blending mandate, although at one point it was contemplated that this would be raised to 6%. The state of Queensland was to have adopted a 5% mandate, scheduled to take effect in 2010 or 2011, but this has been put on hold due to interest group opposition. Similarly, although there is no national biodiesel mandate, the state of New South Wales maintains a B2 mandate.
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. 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.