I presented a poster on May 14-15 at the 2014 BIO World Congress on Industrial Biotechnology, summarizing the regulation of industrial biotechnology in several countries and regions around the world. You can find the poster here on my SlideShare site. The poster presents very brief summaries of relevant regulations in several important countries and global regions that might affect the use of genetically modified microorganisms, algae or plants for the production of biofuels or bio-based chemicals. Regulatory regimes are described for three industrial approaches: contained use of microorganisms in fuel or chemical manufacture; open-pond use of algae or photosynthetic bacteria to produce fuels or chemicals; and the field testing and commercial cultivation of transgenic plants as feedstocks.
This is the third of a series of blog posts providing further detail on some of the regulations discussed in the Poster. The first post covered North America. The second post covered Brazil, the European Union and South Africa. Today’s post covers several Asian countries and Australia.
Japan is a signatory to the Cartagena Protocol, and it has adopted Law 97 of 2003, entitled “Law Concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms.” This law placed Japanese law in conformance with the Protocol, and forms the basis for Japan’s biotechnology regulatory regime. Among the defined terms of Law 97 are definitions of two categories of use of Living Modified Organisms (LMOs). “Type 1” Uses correspond to what is typically called “deliberate releases”, while “Type 2” Uses are “contained uses”, which are both defined in Article 2 of the Law.
Contained manufacturing: Under the biotechnology laws, contained uses of modified organisms are regulated as “Type 2” uses: the Ministry having jurisdiction may vary, and could be either the Agriculture Ministry or the Environment Ministry. For more details on this regulatory regime, please see my prior post of September 27, 2013.
Open Ponds and Transgenic Plants would be regulated more stringently as “Type 1” uses. According to the most recent USDA GAIN report, four ministries are involved in regulation of the commercialization of genetically modified plant products: the Ministry of Agriculture, Forestry and Fishes (MAFF), the Ministry of Health, Labor and Welfare (MHLW), the Ministry of Environment (MOE), and the Ministry of Education, Culture, Sports, Science and Technology (MEXT). However, transgenic energy crops would not be used for food purposes and would not require the same level of scrutiny given GMO crop plants in Japan, and presumably MAFF would have the lead in conducting risk assessments of proposed field tests and ultimately commercial use of transgenic energy crops. According to the GAIN Report, over 120 “events” in 8 crops have been approved for environmental release. Presumably these are all food crops (but none have been approved for commercial cultivation), although there has apparently been an approval for commercial growth of a modified rose plant.
Discussion of the regulation of contained uses can be found in a post of March 26, 2013. Further discussion, including an overview of the regulation of open-pond uses, can be found in the post of September 27, 2013.
Contained manufacturing and open ponds: Under China’s Biosafety laws and regulations, open-pond use of modified microorganisms would likely require approval from the Agriculture Ministry. Jurisdiction over contained uses is less certain, although approval would be needed to import LMOs into China for any purpose. Please see the post of September 30, 2013 for a discussion of how contained and open-pond uses of microorganisms would be regulated in China.
Novel Plant Feedstocks: Approval for field tests and commercial uses needed from the Agriculture Ministry (MOA). Much of the biosafety legal framework China has put in place in recent years has been directed at oversight over transgenic plants. This framework is discussed in the most recent USDA GAIN Report. According to the Report:
The biotechnology regulatory environment for agriculture is outlined in State Council regulations “Food and Agricultural Import Regulations and Standard” and “Agricultural Genetically Modified Organisms Safety Administration Regulations 2001” and implemented by MOA under Ministerial Decrees 8, 9 and 10. Other decrees (Measures on the Safety Evaluation Administration of Agricultural Genetically Modified Organisms, Measures on the Safety Evaluation Administration of Agricultural GMO Imports, and Measures on Agricultural GMO Labeling Administration govern domestic approval, import approval, and labeling, respectively. The State Forestry Administration has also released its Review and Administration Measures on Conducting Activities Related to Genetically Engineered Forestry Wood Products.
English translations of some of these regulations and decrees can be obtained from the MOA website, or in some cases are included in earlier USDA GAIN reports. However, much of these regulations are geared towards the food uses of transgenic plants, and so would likely be applicable to biofuel feedstocks only as they apply to field testing and commercial cultivation. In any event, there have been a considerable number of transgenic plant varieties approved for field testing in China, as well as some approvals for commercial cultivation of GMO crop plants.
Contained manufacturing: Malaysia ratified the Cartagena Protocol on Biosafety in September 2003 and adopted a Biosafety Law in 2007, along with regulations under this Law in 2010. The law created the National Biosafety Board (NBB) within the Ministry of Natural Resources and Environment, which must be notified before using or importing LMOs in contained manufacturing. The NBB is an inter-ministerial body which reviews biotechnology applications, with scientific expertise provided by the Genetic Modification Advisory Board (GMAC ). From the country’s Biosafety Clearinghouse website, it appears that there have not been any prior approvals for contained commercial use of genetically modified microorganisms.
Open Ponds and Transgenic Plants: The NBB’s Genetic Modification Advisory Committee must approve releases of LMO plants and microorganisms into the environment. Although there are several varieties of GM crop plants which have been approved for commercial use in Malaysia (modified corn and soybean, imported from outside the country), none of these can be grown in the country. The NBB has apparently approved only one confined field test of a genetically modified plant, a transgenic papaya which was approved in 2013. More information on the status of transgenic plant regulation in Malaysia can be found in the most recent USDA GAIN Report on this country.
Contained manufacturing: Indonesia has ratified the Cartagena Protocol, and adopted Law Number 21 of 2004, followed by Government Regulation Number 21 of 2005, to implement its responsibilities under the Protocol. These regulations appear to require an environmental risk assessment for the importation into the country of any GMO, even for contained use. The gist of the regulations is that any GMO either created in the country or imported into Indonesia must undergo a risk assessment to ascertain environmental safety, food safety, or animal feed safety. The Ministry of Environment appears to be the main contact for GMOs, and is listed with the Cartagena Protocol as the “Competent National Authority”.
In addition, Law 21 required the formation of a Biosafety Commission of Genetically Engineered Products (Indonesian acronym KKH), which is assigned to assist relevant agencies in giving recommendations about biosafety, in conducting control over importation and use of genetically engineered products, as well as in the scientific evaluation of applications and reports. Please see my post of March 26, 2013 for a discussion of the regulation of contained uses of microorganisms under the biotechnology law.
Open Ponds and Transgenic Plants: Outdoor uses of modified plants or microorganisms would require approval by the Ministry of Agriculture, following review by the KKH. The process for review of proposed field testing and commercialization of transgenic plants in Indonesia is described in the most recent USDA GAIN Report. According to this report, a number of modified crop plant varieties have been approved for confined field testing, but none so far have been approved for commercial use. The Ministry of Agriculture has issued Regulation No. 61/2011 on the procedures of testing, evaluating, releasing, and withdrawing of GE plant varieties, and the GAIN Report says that this has sped up the approval process, by including aspects of the environmental safety approval processes and the field trials for GE crops.
Australia has one of the more developed biotechnology regulatory frameworks in the world, through the Gene Technology Act of 2000, which has been implemented by the Gene Technology Regulations of 2011. Under the Gene Technology Actand its regulations, both contained and non-contained uses of LMOs would require a license from the government, through the Office of the Gene Technology Regulator (OGTR). The Australian law uses the terminology “dealings” to refer to any proposed use of a genetically modified organism. The application forms and other information required for compliance with the Law can be found on the website of the OGTR.
Contained uses of microorganisms would be considered as “dealings not involving release” (DNIR). Although such uses require government review and approval, in general such proposals would face a shorter, easier approval process than would a proposal for outdoor uses of GMOs. As of this writing, Australia has granted over 500 DNIR licenses, and although the great majority of these have been granted to academic institutions for research projects, there are a number granted to for-profit companies for various commercial purposes. However, none of these appear to be related to biofuel or biobased chemical production. The list of DNIR licenses can be accessed from the OGTR website.
Open-pond uses and transgenic plants would be regulated by OGTR as “dealings involving release” (DIR). These proposed uses would be subject to greater scrutiny and a more involved risk assessment than DNIR applications, but the Australian government has approved a significant number of these applications. The list of granted DIR licenses can be found here. It appears that all the approved licenses have been for transgenic crop plants or for genetically modified vaccines, and none appear to cover either modified energy crops or modified algae or microorganisms.
A discussion about the regulation of contained uses of microorganisms in Australia can be found in a post of March 26, 2013, with additional discussion of how contained and open-pond uses of microorganisms would be regulated in Australia in a post of October 2, 2013.
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.