International Regulation of Microorganisms for Biofuel or Chemical Production: the Cartagena Protocol

In two blog entries in 2010, I described the possible regulatory regimes that might affect the use of genetically modified microorganisms or plants in the production of biofuels or bio-based chemicals, focusing on Canada and Europe.  In a forthcoming series of posts, I’ll be updating information on the regulation of genetically modified microorganisms and extending it to a broader group of countries. In preparation for doing so, today’s post will briefly describe an international standard on which many national biotechnology laws are based, particularly in the developing world. That is the Cartagena Protocol on Biosafety, which is an annex to UNEP’s Convention on Biological Diversity.

As explained in my 2010 posts, biotechnology regulations might apply to either of two strategies for the use of advanced biotechnology in biofuel or chemical production, that is, the development either of genetically modified microorganisms or modified plants. In either case, some government review or permitting will likely be needed, and in many countries such oversight would be governed by the provisions of a single law that is based on the Cartagena Biosafety Protocol. The following is an overview of those aspects of the Protocol that are relevant to the potential use of genetically modified microorganisms in contained manufacturing, e.g. of either fuels or chemicals.

Overview

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international agreement which was enacted to ensure the safe handling, transport and use of genetically modified organisms (which the Protocol calls “living modified organisms”, or LMOs) resulting from modern biotechnology that may have adverse effects on biological diversity, and possible risks to human health.  The Protocol was adopted on January 29, 2000 as a supplementary agreement to the Convention on Biological Diversity and took effect on September 11, 2003. Considerable detail on the history of the Protocol and its development can be found on the Biosafety Clearing-House website, which is a site established under the Protocol to be a repository of information from various countries regarding compliance.

The Protocol is intended to ensure that national authorities are notified of proposed deliberate releases or transboundary movement of LMOs in their countries, and to ensure that information about uses of LMOs is provided to the public and to other countries and interested parties. Another important goal of the Protocol is to ensure that rules are in place for the transboundary export of LMOs, particularly those to be used for food or feed. Specifically, the Protocol requires there to be “Advance Informed Agreements” (AIA) when LMOs are shipped across national boundaries, to ensure that the recipient nation is notified of the proposed shipment, and to allow the recipient nation to conduct needed risk assessments. The Protocol specifies that each party to the Convention designate one or more government agencies as the “competent national authority” having responsibility for oversight over activities that are subject to the Protocol.

Signatories to the Convention need to adopt national laws, or amend existing laws, to establish procedures that conform to the provisions of the Protocol. Although such national laws based on the Protocol sometimes feature unified provisions for government review of any biotechnology proposal, in most cases the driving force for the creation of such legislation or regulation has been the desire for adequate oversight over agricultural and food uses of modified crop species, particularly the so-called “deliberate release” of modified crop plants. Therefore, in countries having national biotechnology laws that were enacted to implement the provisions of the Protocol, the best-defined provisions are those that apply to LMOs intended for agricultural and/or food use. Although these are clearly the most widely applicable portions of the Protocol, I won’t describe these provisions any further here, because the focus of today’s post is the impact of the Protocol on contained use of LMOs in commercial manufacturing.

Applicability to Contained Uses of Modified Microorganisms

In the Protocol and often in national laws, the provisions that might apply to “contained” or “confined” uses of microorganisms, for example in a commercial manufacturing process, are not well defined. In fact, although the Protocol contains detailed provisions governing the Advanced Informed Agreements required for transboundary shipments of LMOs, there is an exemption from the AIA procedures for shipments of GMOs intended solely for contained use. Specifically, Article 6(2) of the Protocol reads as follows (emphasis added; note that the term “Party” refers to a country that is a party to the Convention on Biological Diversity):

Notwithstanding Article 4 and without prejudice to any right of a Party to subject all living modified organisms to risk assessment prior to decisions on import and to set standards for contained use within its jurisdiction, the provisions of this Protocol with respect to the advance informed agreement procedure shall not apply to the transboundary movement of living modified organisms destined for contained use undertaken in accordance with the standards of the Party of import.

“Contained Use” is defined in Article 3 as follows:

(b) “Contained use” means any operation, undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment

It’s important to note that Article 6(2) requires that the contained use must be “undertaken in accordance with the standards of the Party of import.” Therefore, what Article 6(2) says is that transboundary shipments solely for contained uses do not necessarily require AIAs under the Protocol, although individual countries are free to set their own standards for contained use and to require and carry out whatever risk assessments or other regulatory requirements they feel are appropriate. This might include not only a review of the proposed importation of the LMO, but also review and possible permitting of the proposed contained use itself. So, for example, in the European Union, where each member state has regulations governing “contained uses” in accordance with the EU contained biotechnology directive, the use of an LMO sent to an EU member state via a transboundary shipment would have to comply with EU or national law, even if the Protocol does not require there to be an AIA.

The Protocol does, however, set some labeling standards for transboundary shipments of GMOs. Article 18(2)(b) reads as follows:

2. Each Party shall take measures to require that documentation accompanying:

…  (b) Living modified organisms that are destined for contained use clearly identifies them as living modified organisms; and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the living modified organisms are consigned

Note that the definition of “contained use” in the Protocol does not distinguish between research uses and commercial uses. This ambiguity carries forward to a number of national laws that I’ve reviewed, sometimes making it unclear whether any there might be any permit requirements for commercial “contained uses” over and above the notification and labeling requirements under the Protocol.

Implications for Use of GMO Microorganisms in Biofuel or Biobased Chemical Production

The Protocol can be viewed as establishing minimum requirements for applicants proposing to use LMOs in contained commercial manufacturing, with the understanding that national laws may impose additional requirements in certain countries. Applicants should therefore consider taking steps such as documenting that the intended use in the country of importation is indeed “contained” in accordance with the definition in Article 3 of the Protocol; documenting in writing that the intended recipients understand that an LMO is to be shipped, and abiding by the labeling requirements for all shipments of the LMO into the country. It would also be advisable to identify the relevant agency(ies) that are the “competent national authority” for the activity to be undertaken, and to consult with that agency in advance. It is possible that national law or regulations or common practice in any given country might be to require a risk assessment even for proposed contained uses of LMOs, and if so, such a risk assessment might need to be carried out in conformance with the Protocol, e.g. as specified in its Annex III. Several of the national laws that I’ll describe in the forthcoming posts will indeed require a risk assessment and sometimes a permit application as part of the review of proposed uses of LMOs in contained manufacturing.

This has been a brief, and highly selective discussion of the Cartagena Protocol and its requirements, and there are many aspects that I’ve omitted here as not necessarily relevant to contained uses of microorganisms. There are a myriad of sources for additional information about the Protocol available online, including some of the sites referenced above (see also a 2003 guide published by IUCN – The World Conservation Union, available here).

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. 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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