Regulation of Industrial Use of Algae or Cyanobacteria in Brazil

Introduction

This blog entry describes the possible ways in which uses of algae or cyanobacteria for fuel or chemical production might be regulated in Brazil. 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.

Biotechnology Regulation

            Overview

Brazil has ratified the Cartagena Protocol and has been active in oversight over agricultural and industrial biotechnology. Brazil has a national biosafety law (Law No. 11,105 of March 24, 2005, available here in either English or Portuguese). The law creates a national regulatory framework administered by the Biosafety National Technical Committee (Comissão Técnica Nacional de Biossegurança, known by its Portuguese acronym CTNBio), and the National Biosafety Council (CNBS), with the involvement of the Ministries of Health, Environment and Agriculture, the Special Secretariat of Agriculture and Fishery, and other agencies. CTNBio is a 27-member committee comprised of technical representatives from across the Brazilian government. The CTNBio website, in Portuguese but with some links to English pages, can be found here.

Regulations implementing Law No. 11,105 were put in place by Decree No. 5591 of November 22, 2005. The Law and its regulations require that companies wishing to conduct commercial activities using GMOs or to test or use GM plants in the environment must seek the approval of CTNBio. Specifically, the Law requires approval for any activities involving the “cultivation, production, handling, transport, transfer, commercialization, import, export, storage, consumption, release and disposal of GMOs and their derivatives for commercial purposes.” Thus, unlike some national regulatory frameworks that are largely restricted to covering outdoor use of GMO plants, it is clear that the Law covers not only contained manufacturing but also the importation of GMO strains into Brazil.

Under the Brazilian framework, all applications for use or importation of GMOs and for the registration of facilities for use with GMOs would be submitted to CTNBio. Decisions would be made by CTNBio, although the Law allows CTNBio to request that the CNBS render a separate decision on commercial requests “with regard to the desirability, suitability in social and economic terms, and the national interest”. The Law also provides for public comment on proposed approvals. Once CTNBio gives a positive decision on an application, the needed authorizations are issued by the applicable government agencies: the Ministry of Agriculture, Farming and Food Supply for activities involving animals, in agriculture, farming, and agroindustry; the Ministry of Health for activities relating to human and pharmacological use, and in household cleaning products and related areas; the Ministry of the Environment for activities with GMOs which are to be released into natural ecosystems, or for GMOs that are judged to potentially be a cause of significant degradation of the environment; and the Special Secretariat for Aquaculture and Fisheries for proposed activities in fishing and aquaculture.

It appears that CTNBio’s review period for all applications under the Law is 120 days, but that the committee can extend the review period by up to 180 days. It is likely that all documents would need to be submitted to CTNBio in Portuguese, although this is not explicitly stated in the regulations. Confidential information would be protected, but it appears that CTNBio must first provide public notice of its intent to protect company confidential information. In addition, institutions using or conducting research on GMOs in Brazil are required to establish internal biosafety committees to oversee this work.

            Contained Use

Proposed uses of modified algae or cyanobacteria in contained manufacturing would likely require multiple approvals under the regulations. Not only would the proposed use need to be approved, but any laboratory or manufacturing facilities within Brazil would need to be reviewed and approved by CTNBio, and if the production strains were imported into the country that would likely require its own approval.

There are precedents in Brazil for prior approvals for industrial biotechnology activities. These are two applications that were filed by Amyris for the use of genetically modified strains of S. cerevisiae (yeast) for the production of farnesene for fuel and chemical use. These applications each appear to have been approved by CTNBio within a review period of several months, following submission by the company of a fairly detailed dossier describing the organisms, their construction and proposed use, and a risk assessment of the proposed commercial application. Interestingly, it was determined that, following CTNBio approval, the permit would be issued and administered by the Ministry of Health – there is an explanation in the summary document accompanying this decision, indicating that the decision had to do with the “green” nature of the product. It is not known if this would create a precedent for applications from other industrial biotechnology companies to be treated in the same way.

            Environmental Use

The provisions of Brazilian law and regulation have been written broadly enough so as to specify the needed procedures for any industrial use of GMOs, whether contained or in the open environment. There is quite a bit of precedent in Brazil for review and approval of environmental use of transgenic plants in agriculture, with applications reviewed by CTNBio as described above. All the “commercial approvals” for outdoor use of GMOs on the CTNBio website are all for transgenic crop plants and none appear to involve modified microorganisms.

A proposal to use genetically modified algae or cyanobacteria in an open-pond reactor would presumably follow a similar regulatory path, although it would seem likely that the Ministry of the Environment would be the entity issuing the permit for an open-pond use, after review and approval by CTNBio. However, it is interesting that the Law explicitly provides for a different governing agency (the Special Secretariat for Aquaculture and Fisheries) for applications involving aquaculture, and it is not clear if this agency would have priority for an application involving modified marine algae. This may depend on whether algae would fall under applicable definitions of “aquaculture” – a question which seems somewhat unclear, as is discussed in the next section.

Aquaculture Regulation

The following is a brief summary of aquaculture regulations in Brazil 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 Special Secretariat for Aquaculture and Fisheries (Secretaria Especial de Aqüicultura e Pesca – SEAP) is the main authority for the management and development of fisheries and aquaculture in Brazil, although there may also be applicable state laws. However, according to Brazil’s FAO summary page, the legislative authority for this oversight is “fragmented” and so it is not always easy to identify the governing definitions. In particular, the federal Fisheries Code apparently does not specifically define aquaculture. But the FAO summary page says that applicable definitions are often found in secondary legislation. For example, Decree No.4,895 of 2003 describes aquaculture as the cultivation or breeding of organisms, whose life cycle develops, in natural conditions, totally or partially in an aquatic environment. Similarly, SEAP Normative Instruction No.3 of 2004 regards aquaculture as the cultivation, breeding or holding in captivity, with commercial purposes, of organisms whose life cycle develops, in natural conditions, totally or partially in an aquatic environment. Based on these definitions, it is possible that commercial cultivation of algae or cyanobacteria in open waterways would fall under national legislation, and would require authorization of some kind from SEAP. Commercial algae projects might also require environmental impact assessments under Brazil’s Environmental Policy Act.

Fuels Regulation

Brazil has the longest-standing national program to promote the use of ethanol in motor vehicle fuel. This national program, which dates back to 1975, not only mandated ethanol use in automotive fuel, but also provided for the infrastructure needed to support such use, including incentives for producing ethanol-powered cars and support for upgrading of gasoline stations to accommodate ethanol use. Until recently, Brazilian law mandated that gasoline have a minimum ethanol content of 25%, but this was reduced to 18-20% in 2010 in response to economic pressures. As of May 2013, the minimum blend percentage of 25% was reinstated.

Brazil also has a mandate for 5% blends of biodiesel (“B5” blends), with the goal of reaching B20 by 2020. This was originated as a mandate for 2% blends that was adopted in 2005, and the current B5 mandate was established in 2009. Current and historical aspects of Brazil’s National Biodiesel Program are summarized in a report available here, and also at the very informative transportpolicy.net Brazil Biofuels page.

Specifications for transportation fuels in Brazil are established by the National Agency of Petroleum, Natural Gas and Biofuels (ANP—Agência Nacional do Petróleo, Gás Natural e Biocombustíveis). A summary of the development of the country’s standards for diesel fuel can be found here, and information about biodiesel standards and promotional efforts can be found here. There is also useful information on the transportpolicy.net Brazil Diesel and Gasoline page.  As of 2011, ANP was given responsibility for regulating ethanol supplies in fuel, and this agency has set specifications for fuel ethanol.

According to transportpolicy.net, there are no environmental sustainability criteria required to be met by Brazil’s biofuel mandates, nor is there any required consideration of greenhouse gas emission reduction levels or indirect land use change.  Perhaps the most significant requirement on fuel producers is that certain testing must be done to ensure that ANP’s fuel specifications are  met for any fuel sold in Brazil.

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.

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