This blog entry describes the possible ways in which uses of algae or cyanobacteria for fuel or chemical production might be regulated in Japan. 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.
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,” to place Japanese law in conformance with the Protocol. (Note: this law and other documents referenced here can be downloaded in English from the Japan Biosafety Clearing House website). Law 97 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 as follows:
5. In this Law, “Type 1 Use” shall mean use not subject to taking the measures provided for in the following paragraph.
6. In this Law, “Type 2 Use” shall mean use undertaken with the intention of preventing the dispersal of living modified organisms into the air, water or soil outside facilities, equipment or other structures (hereinafter “Facilities”) in accordance with measures specifying this fact or other measures stipulated in the ordinance of the competent ministries.
Therefore, any proposed use of modified algae or cyanobacteria in contained manufacturing would likely be considered as a Type 2 Use, while open-pond use would be considered as a Type 1 Use. The regulatory requirements for approvals for these two categories of use have been set forth in a series of other regulatory documents, as described below.
The provisions governing Type 2 (Contained) Uses are covered in Chapter 2, Section 2 (Articles 12-15) of Law No. 97. These articles contain general provisions specifying that appropriate containment procedures must be put in place, and specifying procedures to be implemented in the event of an accidental release of an organism.
To implement Law 97, the government adopted “Regulations related to the Enforcement of the Law concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms”. Article 40(3) of these Regulations specify which “competent ministers” have responsibility for Type 2 Uses, either for R&D or commercial purposes. Jurisdiction for R&D is more clear: under subparagraph (i) of this Article, either the Minister of Education, Science and Technology or the Minister of the Environment would have jurisdiction over Type 2 R&D Uses. Subparagraph (ii) of this Article covers activities other than R&D, and specifies that the competent minister depends on who “has jurisdiction over the undertakings performed by persons who make of the Type 2 Use, along with the Minister of the Environment”. Presumably this means that the Minister with jurisdiction would be the Minister ordinarily responsible for the type of commercial activity to which biotechnology is to be applied, with additional responsibility assigned to the Minister of the Environment. As discussed below, it is possible that uses of modified marine microorganisms (algae or cyanobacteria) would fall under the jurisdiction of the Minister of Agriculture, Forestry and Fisheries (MAFF).
Japanese regulatory law is structured via a series of hierarchical regulations, such that the procedures applicable to commercial Type 2 Uses are further governed by another document, “The Ministerial Ordinance Providing Containment Measures to Be Taken in the Industrial Use of Type 2 Use of Living Modified Organisms” (there is also an equivalent document for Type 2 R&D Uses). The “Ministerial Ordinance” goes into more specific detail about appropriate containment provisions for microorganisms, plants and animals. For microorganisms, the procedures required for the lowest risk category generally correspond to Good Industrial Large Scale Practice (GILSP). The Ministerial Ordinance also includes the application form needed to be submitted to the competent minister. This is “Form 1”, which asks for information about the LMO and its properties and the measures to be adopted to ensure containment. These data provisions appear to be equivalent to those in place in other countries around the world.
MAFF issued a regulation in 2000 entitled “Guidelines for Application of Recombinant DNA Organisms in Agriculture, Forestry, Fisheries, The Food Industry and Other Related Industries”. Under this regulation, microalgae are considered to be microorganisms, and the provisions for “production processes using rDNA microorganisms” (i.e. contained uses) are similar to those described above, in that the applicant is responsible for assigning a risk category to the organism and adopting appropriate procedures for the organism’s use. Since these regulations preceded adoption of Law No. 97 in 2003, it is not clear to what extent they are still applicable.
It is not clear whether there have been any Type 2 Use applications in Japan for commercial activities outside of the pharmaceutical field. While the applicable procedures and data requirements appear straightforward, given the intricacies of the Japanese legal and regulatory system, it would naturally be advisable for foreign companies to work with a Japanese partner and/or attorney, and to hold early discussions with the applicable regulatory agencies in advance of any submission.
The provisions governing Type 1 (Non-Contained) Uses are covered in Chapter 2, Section 1 (Articles 4-11) of Law No. 97. These articles contain general provisions pertaining to the procedures to follow to apply for approval for a Type 1 Use and the types of information that needs to be included in any such application. In addition, Article 4(2) of the Law requires that all applicants for Type 1 Uses must “assess the [potential] adverse effect on biological diversity caused by the Type 1 Use,” by completing and submitting to the applicable government ministry a “Biological Diversity Risk Assessment Report”. The Law also provides for the possible consultation with appropriate outside experts. Otherwise, the provisions of the Law relating to the requirements for approvals of Type 1 Uses are quite general, and as is the case with the Type 2 regulations, the more specific provisions are spelled out in the additional documents in the regulatory hierarchy.
In the case of Type 1 Uses, most of the relevant information is included in the “Regulations related to the Enforcement of the Law concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms” that was discussed above. In fact, this Regulation (in Articles 7 and 8) includes the specific information that is needed to apply for permission for a Type 1 Use application, and includes as an appendix the form needed to make such an application (Form No. 1). These Regulations also specify which “competent ministers” have responsibility for Type 1 Uses. According to Article 40(1), jurisdiction for R&D would fall either to the Minister of Education, Science and Technology or the Minister of the Environment, and for activities other than R&D, the competent minister would be the one “who had jurisdiction over the production or circulation of the living modified organisms”, along with the Minister of the Environment”. These requirements are stated similarly to those for Type 2 Uses discussed above. As mentioned, uses of modified marine microorganisms (algae or cyanobacteria) would likely fall under the jurisdiction of MAFF.
Although the “Regulations related to the Enforcement” includes the application form needed to apply for Type 1 approvals, one additional document includes further information relevant to such applications. This document is “The Guidance of Implementation of Assessment of Adverse Effect on Biological Diversity of Type 1 Use of Living Modified Organisms,” and in Sections 2 and 3 and Tables 1 and 2 of this guidance document, there are detailed lists of the information and data needed to create the “Biological Diversity Risk Assessment Report” that is required under the Law.
Under the MAFF regulation from 2000 discussed above, algae would be considered as microorganisms, and the regulation specifies that “application of rDNA microorganisms in an open system” must proceed in a stepwise manner, with applicants first conducting a safety evaluation in a laboratory, followed by testing in an artificial microcosm before seeking approval for outdoor use. Again, it is not clear to what extent this regulation is still applicable in view of the legislative and regulatory actions which were adopted after its promulgation.
It is likely that most or all the precedents for review and approval of Type 1 Uses of GMOs in Japan have been for field tests of transgenic plants. So it is hard to predict how the regulatory process would proceed for a proposed use of a GMO algae in an open-pond or similar reactor. As always, early consultation with the appropriate regulatory agency and/or Japanese partner(s) or attorneys would be advised.
The following is a brief summary of aquaculture regulations in Japan 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.
According to the FAO page devoted to Japan, the primary law that regulates fishery activities is the Fisheries Law (1949, as revised in 1962), which is administered by the Ministry of Agriculture, Forestry and Fisheries (MAFF). However, in practice many responsibilities have been delegated to the prefecture governments. Within MAFF, the Fisheries Agency (FA) would be the primary agency with responsibility for aquaculture. According to the FAO site, there is no legal definition of aquaculture. However, the Fisheries Law defines fishery as “an industry which carries on gathering, taking or culturing of aquatic animals and plants”. It is not clear if this definition would include aquatic microorganisms like algae or marine cyanobacteria.
Marine waters in Japan are divided into a number of sea areas for administrative purposes, and for the most part each sea area corresponds to the maritime zone of one of the coastal prefectures. Presumably, activities within such zones would be governed by the prefecture rather than the central government. As explained in more detail on the FAO page, the Fisheries Law created three principal categories of fishery rights, and of these, the category known as “demarcated fishery rights” are said to be applicable to pond aquaculture activities that occupy a defined and fixed site. To the extent the Fisheries Law applies to algae, it would seem that most potential uses of algae in aquaculture might fall under this category. These rights are granted by the prefecture governments, through the involvement of Fisheries Cooperative Associations (FCAs) which have been created to have responsibility for particular geographical areas and whose membership are local fishermen.
The applicability of these provisions to algae or cyanobacteria are not clear. Consultation with MAFF or with partner institutions in Japan would seem to be advisable before planning activities with modified algae or cyanobacteria in that country.
The regulatory body in Japan with authority over fuels is the Ministry of Economy, Trade and Industry (METI), and the governing law is the Law on the Quality Control of Gasoline and Other Fuels (the “Fuel Quality Control Law”: Japanese language version available here). According to the Japan transportpolicy.net site for diesel and gasoline, Within METI, the Agency for Natural Resources and Energy is in charge of enforcing the quality of gasoline, diesel and kerosene sold on the market through the authority of the Fuel Quality Control Law, and this law also established mandatory specifications for ten gasoline properties and three diesel properties. Although METI conducts its own fuel sampling and testing, refiners and importers are reportedly required to conduct their own tests of fuel quality.
Japan does not appear to have any ethanol mandate, but there are laws relating to biodiesel. There are two quality standards for biodiesel fuels in Japan: a mandatory standard specified in the Law on the Quality Control of Gasoline and Other Fuels, which allows up to 5% biodiesel, and a voluntary Japanese Industrial Standard (JIS). The Ministry of the Environment apparently has a regulatory role over the biodiesel standards.
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.