International Regulation of Microorganisms for Biofuel or Chemical Production: North and South America and Africa
by David Glass (DGlassAssociates.com) … The use of genetically modified microorganisms (GMOs) in manufacturing will likely face a fairly straightforward regulatory process in most countries, because such “contained” uses will generally pose far fewer hypothetical concerns about environmental or public health impacts. In contrast, the use of genetically modified plants as improved biofuel feedstocks will entail the field testing and ultimately the outdoor cultivation of modified plants, and may trigger a more rigorous review of potential environmental impacts. In many cases, national biotechnology laws cover both potential applications, but in today’s post I’ll focus on the regulation of modified microorganisms for the manufacture of biofuels or bio-based chemicals. I won’t explicitly the discuss regulation of transgenic plants in today’s post, although I hope to eventually do so in a subsequent post on the blog.
The following are brief summaries of several countries in North America, South America and Africa having explicit biotechnology laws with reasonably clear applicability to uses of GMO microbes in contained manufacturing ( “contained use” or “confined use”). I’ll cover countries elsewhere in the world in a subsequent post.
Mexico is a signatory to the Cartagena Protocol and has a Bio-Safety Law adopted in 2005. The Bio-Safety Law assigned primary responsibility for biotechnology regulation to three agencies: the Secretariat of Agriculture, Livestock, Rural Development, Fisheries and Food (SAGARPA), the Secretariat of Environment and Natural Resources (SEMARNAT), and the Secretariat of Health (SALUD), and specified each agency’s jurisdiction. The Inter-Ministerial Commission on Biosecurity and Genetically Modified Organisms (CIBIOGEM) coordinates Mexico’s biotechnology oversight activities. The government has issued regulations (known by the Spanish title Reglamento) under the Bio-Safety Law, with the most recent version being issued in March 2008. The Reglamento provides detailed requirements for the use of GMOs outside containment, or for food use, human use, or bioremediation.
The Reglamento ostensibly also provided for a notification scheme for contained uses, but this does not appear to have been fully fleshed out until April 2011, when the government published notice of an agreement between SAGARPA and SEMARNAT regarding a unified approach to notifications for confined uses of GMOs. This notice is available here, apparently only in Spanish. Part of this notice is a lengthy “Annex” containing the proposed unified format for notifications. This notification form requires submission of a good deal of information describing the GMO, how it is proposed to be used, as well as information pertaining to a risk assessment for the proposed use. The amount and type of information required is of a similar scope to what would be required in the U.S. (e.g. in a Microbial Commercial Activity Notice under EPA regulations), but the information would of course need to be submitted in Spanish (EPA’s data requirements are discussed in my previous blog entries from 2010). The form can be a little difficult to understand, in that it specifies that different sections are to be completed for each of several different permit types, and so advance consultation with the relevant regulatory agency would be recommended. READ MORE