This blog entry describes the possible ways in which uses of algae or cyanobacteria for fuel or chemical production might be regulated in China. 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.
China is a signatory to the Cartagena Protocol, and has implemented a range of biotechnology laws and regulations, with most coming since 2001. Most if not all of these are directed at agricultural biotechnology, in particular to the importation and use of transgenic plants and other agricultural products destined for release into the environment. Although written with a focus on agricultural biotechnology, some of the provisions of the governing law and its regulations potentially cover contained industrial uses, so the following discussion will highlight relevant language potentially applicable both to contained uses and open-environment uses of algae or cyanobacteria in fuel or chemical manufacture.
In particular, initial law and regulations were enacted in 1993 and 1996, respectively, but these provisions were repealed or overruled by new regulations adopted in 2001 and 2002. What is confusing is that the latter documents seem to quite explicitly limit their definitions and applicability to organisms “for use in agricultural production or processing”, and are written with the cycle of agricultural field testing in mind. To an observer outside of China and unfamiliar with its legal system, this begs the question of what law or regulation would cover the use of a modified algae or cyanobacteria, or other microorganism intended for use in an industrial setting, with no application to agriculture. The following discussion will focus on the terms found in the original rules from the 1990s, which perhaps have been superseded by the 2001/2002 rules.
According to Huang and Yang (2011), China’s first biosafety regulation, “Measures for Safety Administration of Genetic Engineering,” was issued by the Ministry of Science and Technology (MOST) in 1993. This regulation consisted of general principles, safety categories, risk evaluation, application and approval, safety control measures, and legal responsibilities. It has been implemented by a series of regulations starting in 1996, mostly all of which pertain to agricultural GMOs, but the following excerpts of the original 1993 law seem to apply to “contained uses”.
This regulation established four “safety classes” of organisms, and provided that applicants should conduct a risk assessment to determine which class its organism falls under. The four classes are as follows, with the expectation that a microorganism for contained industrial production would fall under either class I or II:
- Safety class I: genetic engineering work of this class has no threat to human health and ecological environment.
- Safety class II: genetic engineering work of this class has low‑level risk to human health and ecological environment.
- Safety class III: genetic engineering work of this class has intermediate-level risk to human health and ecological environment.
- Safety class IV: genetic engineering work of this class has high‑level risk to human health and ecological environment.
The 1993 law has general provisions in two of its chapters which relate either to (contained) industrial uses or to open-environment uses of GMOs.
In Chapter Two “Safety Classes and Safety Evaluation”, the following general guidance is provided to institutions:
10. Institutions carrying out genetic engineering pilot experiments or industrial production should conduct safety evaluation on the physical barriers of the equipment and facilities of the culture, fermentation, separation and purification processes according to genetic engineered organisms safety class, to determine the safety class of pilot experiments or industrial production. (emphasis added)
11. Institutions carrying out the release of genetic engineered organisms should conduct evaluation on the safety of genetic engineered organisms, the purpose of the release, ecological environment conditions of the release site, releasing methods, monitoring means and control measures, to determine the safety class of the release. (emphasis added)
Chapter Three “Application and Approval”, requires institutions to “submit applications to relevant administrative departments at various levels according to … [the] product’s utilization scope and safety class”, and then provides this specific guidance for industrial projects or outdoor releases:
16. Genetic engineering industrial production, release of genetic engineered organisms and utilization of genetic engineering products, if in safety class I to III scope, should be approved by relevant administrative departments under the State Council and submitted to the national genetic engineering safety committee for record. (emphasis added)
The 1993 law was implemented by regulations first adopted in 1996, entitled “Safety Administration Implementation Regulation on Agricultural Biological Genetic Engineering”. Although this regulation includes provisions regarding “industrial use”, the applicability of the regulation to contained industrial manufacturing is somewhat unclear because of the way its scope is defined in Section 3 of Chapter One of the regulation, as follows:
3. The “Implementation Regulation” is applicable to agricultural organisms whose genome constitution has been changed by using genetic engineering technologies. The scope of agricultural organism includes plants and animals related to agricultural production, plant-related microorganisms, veterinary microorganisms, aquatic animals and plants.
The applicability of this definition to industrial microorganisms like E. coli or yeast may be ambiguous, but the inclusion of “aquatic animals and plants” may mean that algae or marine cyanobacteria might be covered as well.
The structure of the 1996 regulations parallels the 1993 law, and so its Chapter Two goes into detail regarding the type of safety evaluation applicants are required to conduct in each of the four Safety Classes of organisms. Chapter Three goes into a little more detail about the application and review process, with Section 12 of this chapter stating:
12. Genetic engineering industrial production, environment release of genetic engineered organisms, if in Safety Class I to III scope, should be approved by the Ministry of Agriculture. The work in Safety Class IV should be examined by the Ministry of Agriculture and be submitted to the National Genetic Engineering Safety Committee for approval. (emphasis added)
Finally, Appendix V of the 1996 regulations provides principles for safety assessments of “Genetic Engineered Organism and Its Products Acquired from Aquatic Animal and Plant,” although the regulations do not specify what types of organisms would be considered “aquatic”.
It is hard to know if, under these initial rules, the jurisdiction of the Agriculture Ministry would extend to non-agricultural industrial uses of microorganisms. The Biosafety Clearing-House web page for China indicates that the Ministry of Environmental Protection and the Ministry of Agriculture are the competent national authorities for implementation of the Cartagena Protocol. The entry for the Environment ministry indicates that its jurisdiction includes “bacteria”, but it is not clear what exactly this ministry’s role may be in such oversight, since most of the regulatory documents available on this site and elsewhere pertain to agricultural activities under the purview of the Ministry of Agriculture. In fact, the 2001/2002 rules make it even more explicit that the Agriculture Ministry has primary responsibility over agricultural GMOs.
Although it seems unclear whether GMOs intended for contained manufacturing would be covered under the current regulations, it does seem clear that import of a GMO into China would require government approval. The relevant agency is the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), and applicants proposing to import a GMO into China must apply in advance to this agency and provide information about the organism as required on the application form.
Applicants wishing to use a GMO in manufacturing in China should therefore make early contact with AQSIQ regarding importation requirements, and also to consult with both the Ministries of Agriculture and Environment to understand which agency would have authority over the proposed use, whether a permit application would be needed, and if so what the applicable requirements would be. It is possible that some of the required approvals may take several months, if not 1-2 years in some cases, so early consultation with these agencies, through a Chinese corporate partner or attorney, would be recommended.
Although not explicit, it would be prudent to assume that any proposed open-environment use of a modified algae or cyanobacteria would need to go through the same regulatory procedures as for agricultural microorganisms or plants. These are largely described in the 2002 document “Implementation Regulations on Safety Assessment of Agricultural Genetically Modified Organisms”. These regulations require institutions to conduct appropriate safety assessments for submission to an Office of Biosafety Administration (OBA) within the Agriculture Ministry. The regulations also assume that projects will proceed in the stepwise field testing method that is typical for agricultural product development, and approvals would be needed at each successively-larger field use. The Implementation Regulations include a series of detailed appendices describing the necessary components of risk assessments for the different uses potentially covered under the rules.
This is a very, very brief summary of the 67-page 2002 document. Suffice it to say that it is likely that open-pond uses of modified algae would be subject to the regulatory procedures set up in China for review of agricultural field tests and commercialization.
The following is a brief summary of aquaculture regulations in China 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.
The applicable law in China is the Fisheries Law (1986, as amended in 2000), whose goal is to enhance the production, increase, development and reasonable utilization of the nation’s fishery resources. It requires the adoption of policies to promote the simultaneous development of aquaculture, fishing and processing, with special emphasis on aquaculture. The Law is implemented by the Regulation for the Implementation of the Fisheries Law (1987).
Neither the law nor the regulations define “aquaculture”, so their applicability to algae or marine cyanobacteria is not clear. Chapter III, Articles 10-13, of the regulations cover aquaculture, and require “state and collectively-owned units engaged in aquaculture using state-owned water surfaces and tidal flats [to] apply to the people’s governments at or above the county level for licenses”. The regulations also require the protection of “natural spawning, breeding or feeding grounds of fish, shrimp, crab, shellfish and algae” and prohibit their use as aquaculture grounds.
Due to uncertainty over the applicability of these regulations to uses of algae or cyanobacteria, early consultation with local partners or attorneys, or with the applicable government agency, would be recommended.
According to transportpolicy.net, fuel quality standards in China are issued by the Standardization Administration of China (SAC) under the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ). There are nationwide standards for gasoline and diesel that generally follow European precedent. There appear to be obligations for fuel producers and sellers to conduct testing to ensure that their fuels comply with the standards.
China does not have an ethanol mandate or a national biodiesel mandate, but reportedly there are ten provinces having an E10 mandate for ethanol.
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.