THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

21 September 2004

Dear Friends and colleagues,

RE: BIOSAFETY PROTOCOL AND FOOD AID

Attached below please find a paper presented by Lim Li Ching at a meeting in which she discusses the link between the Cartagena Protocol on Biosafety and food aid with particular reference to Africa.

With best wishes,

Lim Li Lin and Chee Yoke Heong

Third World Network

121-S Jalan Utama

10450 Penang

Malaysia

Email: twnet@po.jaring.my

REF: Doc.TWN/Biosafety/2004/I

The Cartagena Protocol on Biosafety and Food Aid

By Lim Li Ching, Third World Network

September 2004

Paper presented at the International Conference on Hunger, Food Aid and GMOs, Maputo, Mozambique, 15-16 July 2004

Introduction

The Cartagena Protocol on Biosafety entered into force on 11 September 2003. It is the first and only international law to specifically regulate genetic engineering and genetically modified organisms (GMOs).

The Biosafety Protocol is legally binding in the international legal system and in the legal systems of countries that have ratified, approved, accepted or acceded to it. As of 5 August 2004, there are 107 Parties to the Protocol. Most of the Parties are developing countries, with the majority from Africa and small island developing states.

The First Meeting of the Parties (MOP1) was held in Kuala Lumpur, Malaysia from 23-27 February 2004.

Significance of the Biosafety Protocol

The Biosafety Protocol recognises for the first time in international law that GMOs are inherently different from other naturally occurring organisms and carry special risks and hazards, and therefore need to be regulated internationally. It addresses the fact that GMOs may have biodiversity, human health and socio-economic impacts, and that these impacts need to be risk assessed.

The Biosafety Protocol puts the Precautionary Principle into operation in decision-making (i.e. in the absence of scientific certainty, a party should err on the side of caution and could restrict or ban the import of GMOs on account of their potential adverse effects) and further establishes it in international law. It also establishes the principle of prior informed consent with regard to the import of GMOs and preserves the right of a country to reject applications for the import of GMOs.

The Protocol establishes the foundations of international law on the regulation of GMOs. While many aspects of biosafety regulation are best addressed by national legislation, aspects relating to transboundary movement are difficult to regulate domestically. An international law is therefore necessary. Importantly, the Protocol mandates Parties to elaborate an international liability and redress regime for damage resulting from GMOs.

Some key elements

The Biosafety Protocol primarily regulates the transboundary movement of GMOs - export and import, and other movements between countries. However its scope extends to the transit, handling, and use of all GMOs. The battle to have a comprehensive scope was crucial, as all GMOs carry similar fundamental risks, whether living or not, and regardless of whether they are used in agriculture, medicine or research, or classified as commodities or pharmaceuticals. Although the general scope of the Protocol applies to all GMOs, its application to genetically engineered (GE) pharmaceuticals for humans (e.g. GE vaccines) is unclear, and its application to GMOs in transit and GMOs for contained use is regrettably limited. 

The advanced informed agreement (AIA) procedure is the ‘backbone’ of the Protocol. It is a procedure for obtaining prior informed consent from the importing Party before a GMO crosses national boundaries. The onus is on the exporting Party to notify and furnish relevant information to the importing Party. The latter will then make a decision based on risk assessment and the Precautionary Principle.

However, due to the difficult negotiations, the Protocol eventually excluded some GMOs from the AIA procedure - GMOs in transit, for contained use, and GMOs for food or feed, or for processing. The AIA procedure only applies to the first transboundary movement of GMOs destined to be released into the environment of importing Parties.

Moreover, for legal, commercial and political reasons, the United States was instrumental in substituting the term ‘prior informed consent’ with ‘advance informed agreement’, and ‘genetically modified organism’ with ‘living modified organism’. The latter was contentious as it arguably excludes non-living modified organisms, potentially excluding all GMOs except those intended for growing in fields, GE animals and GE microorganisms. Malaysia made a written declaration on signing the Convention on Biological Diversity (CBD; the Protocol’s parent convention) that the term ‘LMO’ would be understood as meaning ‘GMO’. Laws in the European Union (EU) and a number of other countries use the term ‘GMO’. As such, countries can formulate national laws where the term used, whether ‘LMO’ or ‘GMO’, is clearly defined so as to be comprehensive.

The Biosafety Protocol is a negotiated framework international law that sets minimum standards for national biosafety implementation. Sovereign countries are free to interpret and implement the Protocol in a more comprehensive way, and with higher standards. Article 2(4) of the Protocol states: “Nothing in this Protocol shall be interpreted as restricting the right of a Party to take action that is more protective of the conservation and sustainable use of biological diversity than called for in this Protocol, provided that such action is consistent with the objective and the provisions of this Protocol and is in accordance with that Party’s other obligations under international law”.

The Biosafety Protocol and food aid

‘Food aid’ is not explicitly mentioned in the Biosafety Protocol, but food aid that consists of or contains genetically engineered grain (e.g. whole corn or whole soybeans) has to be regulated under the Protocol, particularly with regard to its import and export. Such food aid containing genetically engineered grain is a GMO intended for direct use as food or feed, or for processing; these are commonly referred to as LMO-FFPs.

The World Food Programme (WFP), in its Operational Guidelines on the Donation of Foods Derived from Modern Biotechnology (2004), confirms that “any commodity distributed by WFP to or transiting through a Party to the Protocol that meets the definition of an LMO (which at present would apply only to unprocessed maize and soybeans) should be considered as “intended for direct use as food or feed, or for processing” under terms of the Protocol.”

Thus, the procedures of the Protocol applying to LMO-FFPs apply to grain food aid. Processed foods, such as maize meal, soy flour, corn-soy blends and vegetable oils, are not regulated under the Biosafety Protocol (although there is an indirect obligation to consider the risks associated with products of GMOs, where the genetic material is detectable). However, national legislation can regulate this category of GE food aid. The WFP states unequivocally that it will abide by the decisions of each national government on its definition of what is a regulated GE food import. The WFP is also clear that its country offices must comply with any national regulations and policies on the transit and importation of food, including any that may relate to GE foods.

How are GMOs destined for food or feed, or for processing, treated under the Protocol?

LMO-FFPs were a contentious issue during the Protocol negotiations. These commodities are the bulk of traded GMOs, and GMO exporting countries initially did not want LMO-FFPs to be included in the Protocol. Once it was agreed that they would be, debate focused on whether they should be subject to the AIA procedure.

Eventually, provisions that would have required the prior informed consent of the importing Party before LMO-FFPs are shipped to that country were dropped, and LMO-FFPs were exempt from the AIA procedure. Instead, for LMO-FFPs, Article 11 of the Protocol only foresees a multilateral information exchange system facilitated by the Biosafety Clearing House (BCH), administered by the CBD Secretariat.

A Party making a decision regarding domestic use (e.g. an approval or placing on the market) of a GMO that may be exported for direct use as food or feed, or for processing, must inform other Parties of the decision, through the BCH. It must provide, at a minimum, some information on that LMO-FFP. Among other things, this includes information on the GMO, the genetic modification, the donor and recipient organisms, and a risk assessment report. This is the extent of the obligation of the potential exporting country. It does not have to provide any notification or information directly to the importing Party, although once the decision is placed on the BCH, any Party can request additional information from the authority making that decision.

Thus, the onus is on a potential importing Party to check the BCH for information on new LMO-FFPs that may enter international trade, and if it wishes, to subject them to domestic regulation. Potential importers have to initiate procedures for risk assessment and decision-making without knowing whether that LMO-FFP will ever be exported, or whether it will be exported to them. The burden of regulation has thus been shifted from exporting countries onto other countries, and from international to domestic regulatory procedures.

However, the Protocol preserves the right of Parties to take a decision on the import of LMO-FFPs according to its domestic regulatory framework. Article 11(4) asserts the right of Parties to subject imports of LMO-FFPs to independent, prior risk assessment and approval. The importing Party’s domestic regulation could, for example, trigger procedures for LMO-FFPs requiring prior notification, risk assessment and explicit written approval.

In the absence of a domestic regulatory framework, a developing country Party or a Party with an economy in transition can still take a decision on an LMO-FFP in accordance with a prior risk assessment and within a specified timeframe, provided that this intention has been previously declared through the BCH. Any failure to communicate a decision within the stipulated timeframe does not imply consent or refusal to import the LMO-FFP.

In any case, the Precautionary Principle applies to decision-making regarding the import of an LMO-FFP; if there is scientific uncertainty on the potential adverse effect of that LMO-FFP, a Party can take an appropriate decision in order to avoid or minimize the potential effects. This could include restrictions (e.g. a request that the grain be milled to prevent planting and potential adverse environmental impacts) or bans. Countries should also place decisions and copies of any national laws, regulations and guidelines applicable to the import of LMO-FFPs on the BCH.

Documentation accompanying LMO-FFPs 

Documentation accompanying GMO shipments are a means of identifying and tracking their transboundary movement. They are a key element for Parties of import to know whether they are receiving a GMO shipment. During the Protocol negotiations, GMO exporting countries did not want clear identification requirements for LMO-FFPs, which they feared could indirectly impose segregation or identity preservation obligations.

Article 18(2)(a), which specifies the documentation requirements for LMO-FFPs, temporarily avoids this issue by stipulating that documentation accompanying LMO-FFPs must clearly identify that the shipment “may contain” LMOs and are not intended for intentional introduction into the environment. It must also provide a contact point for further information. The MOP must take a decision on the detailed requirements for this purpose, no later than 2 years after the Protocol’s entry into force (i.e. by Sept. 2005).

MOP1 in Kuala Lumpur made several decisions, one of which was on Article 18 (handling, transport, packaging and identification of GMOs). Specifically, in relation to Article 18(2)(a), the decision reaffirms the minimum criteria for documentation accompanying LMO-FFPs set out in the Protocol, as mentioned above.

In addition, further details and guidance were provided in order to take the interpretation of Article 18(2)(a) forward. Among these, it did not preclude the use of more detailed “stand-alone” documents in future, although commercial invoices or other existing documents were identified, in the first instance, as documentation that should accompany LMO-FFPs. Moreover, Parties and other Governments should require that the documentation include the common, scientific and commercial names, as well as the transformation event code or unique identifier of the LMO-FFP in question. The decision also encourages Parties and other Governments to require exporters to declare unambiguously that their intentional shipments of LMO-FFPs contain LMOs (not “may contain”), their identity and any unique identification. This clarifies Article 18(2)(a) further, and provides more specificity as to the nature and shape of the documentation that should accompany LMO-FFPs.

An expert group was set up to elaborate detailed requirements and will report to the next MOP in 2005. The additional measures set out in the MOP1 decision are thus interim, but countries are requested or urged to take these steps now.

USDA guidance on Article 18(2)(a) for food aid programme partners

The Parties to the Biosafety Protocol are bound by international and national law to follow the procedures prescribed for LMO-FFPs, including as food aid. However, the largest producer and exporter of GMOs, and the largest provider of food aid, the United States, is not a Party to the Protocol. As such, it maintains that it cannot require US exporters to comply with the Protocol, but instead, “It is the responsibility of exporters to meet the Parties’ requirements under the Protocol when exporting to Parties.”

The United States Department of Agriculture (USDA) issued in December 2003 a “Guidance for Meeting Documentation Requirements for Shipments of LMOs for Food, Feed, or for Processing Under the Cartagena Protocol on Biosafety” for its food aid programme partners. It clearly recognises that exporters should comply with recipient country regulations.

If a recipient country has no domestic regulations on the documentation requirements for LMO-FFPs, and is a Party to the Protocol, the USDA recommends the following:

(1)  Shipments of LMOs destined for or transiting Parties’ territories should be     accompanied  by a “may contain” declaration on a commercial invoice;

(2)  The last exporter and first importer after transboundary movements should be named as contact points for further information;

(3)  All whole grain shipments of commodities for which genetically engineered varieties are approved and grown in the US should be accompanied by “may contain” documentation (i.e. only whole corn & whole soybean at this time);

(4)  Adventitious presence (which the USDA defines as “accidental commingling of LMO in a non-LMO shipment; e.g., genetically engineered corn in a sorghum shipment”) should not be a trigger for the “may contain” documentation.

An update provided in April 2004 on the USDA Foreign Agricultural Service (FAS) website (www.fas.usda.gov) stated that the documentation requirements for food aid, as elaborated in the 2003 guidance, remained unchanged following MOP1. However, it acknowledged that the MOP1 decision urges Parties to require detailed information and allows the use of a separate document rather than a commercial invoice.

The USDA guidance can however be seen as an attempt to pre-empt further interpretation of Article 18(2)(a) and to undermine the Protocol, as it sets lower standards than what Parties have already expressed and clearly intend for the future. The USDA provides guidance that the declaration “may contain” should simply be placed on all food aid shipments of whole corn and whole soybean only, as part of the commercial invoice. Yet, MOP1 has gone further in its clarification of these issues, as elaborated above. In addition, adventitious presence has not even been seriously discussed in the Protocol negotiations, yet the USDA sees it fit to state that it should not trigger “may contain” documentation.

EU regulation on transboundary movement of GMOs

In contrast, Regulation (EC) No 1946/2004 on transboundary movement of genetically modified organisms, sets fairly strict standards for EU exporters of GMOs. All exports of GMOs from the EU, including for food aid, must comply with this regulation. The regulation implements the EU’s obligations under the Biosafety Protocol.

With regard to GMOs for direct use as food, or feed, or for processing, the Commission or member state concerned should notify the BCH of a final decision regarding domestic use, including placing on the market, of such GMOs that may be subject to transboundary movement. This is in compliance with Article 11 of the Protocol. Only GMOs that have been authorised within the European Community can be exported.

The EU respects the importing countries’ regulatory biosafety framework, regardless if they are Parties to the Protocol or not. It also requires its exporters to respect any decision on imports of GMOs for food or feed, or for processing, taken in accordance with domestic laws. It recognises the right of any country to choose its own level of health and environmental protection and to rely on its own scientific assessment of GMOs.

If a developing country or country in transition (whether a Party or non-Party) with no domestic regulatory framework has declared its intention via the BCH to take a decision according to a prior risk assessment, and within a stipulated timeframe, EU exporters should not proceed with the first export unless these procedures have been followed. Failure by the importing country to acknowledge receipt of a notification or to communicate its decision in accordance with the risk assessment does not imply its consent or refusal to import.

The EU recognises that similar rules to those that apply to the traceability, labelling and identification of GMO imports to the EU, should apply to its exports. Its exporters should ensure that documentation accompanying GMOs intended for direct use as food or feed, or for processing, states:

(1)  that it contains or consists of GMOs;

(2)  the unique identification code(s) if they exist;

(3)  that the GMOs are intended for direct use as food or feed, or for processing, and indicates clearly that they are not intended for deliberate release into the environment;

(4)  details of the contact point for further information.

The requirement for unique identifiers does not apply to products consisting of or containing mixtures of GMOs to be used only and directly as food or feed, or for processing. These products are instead subject to the traceability requirements of EU legislation.

This EU regulation not only implements the Protocol, but it also removes the ambiguity on identification of LMO-FFPs in accompanying documentation. In addition, the European Community policy on GMOs in food aid is to respect the decisions made by recipient Governments, and to try to source food assistance according to recipient countries’ conditions. As such, it strives to expressly inform recipient countries on the GMO content of any food aid and respects domestic regulatory frameworks consistent with the Protocol.

African Model Law on Safety in Biotechnology

Given that national biosafety laws can build upon the minimum standards set by the Protocol and that food aid exporters have to comply with them, what might such laws have to say about food aid? The African Model Law on Safety in Biotechnology is one such framework model for domestic regulation, specifically for African countries.

It does not distinguish between LMO-FFPs and GMOs for intentional introduction to the environment. This means that the advanced informed agreement or explicit written approval of the competent authority is required before any import, transit, contained use, release, or placing on the market of GMOs is carried out. This is important, as the artificial distinction between GMOs for release into the environment and those destined as food or feed, or for processing has been problematic, given that there is no distinction between grain and seed. For example, in Mexico, there was a ban on planting GE maize, as the country is a centre of origin and diversity of maize; however, GE maize was imported as an LMO-FFP and planted, resulting in the contamination of traditional varieties of maize with transgenes.

The African Model Law further explicitly includes food aid under its definition of ‘deliberate release’/’release’ and ‘placing on the market’. This means that food aid containing GMOs is specifically identified, and subject to the regulatory requirements of the Model Law.

It also regulates products of a GMO, which are not regulated under the Biosafety Protocol. Thus, the African Model Law covers not just grain, but also processed foods that are GMOs or that contain GMOs, and food aid in all these forms. All GMOs and products derived from them must also be clearly identified and labelled as such.

Conclusion

In summary, food aid containing genetically engineered grain has to be regulated at the international level according to the procedures laid down in the Biosafety Protocol for GMOs intended for direct use as food or feed, or for processing (LMO-FFPs). These procedures rely on the BCH information exchange system and place certain obligations on the potential exporting country. In addition, the minimum criteria for documentation accompanying LMO-FFPs has been set down by Article 18(2)(a) of the Protocol. These have been further elaborated by the recent MOP1 decision and require more detailed information.

Exporting countries can further craft legislation that places obligations on its own exporters. For example, the EU in its Regulation on transboundary movement on GMOs removes the ambiguity related to the “may contain” declaration, by requiring its exporters to clearly identify that a shipment of GMOs intended for direct use as food or feed, or for processing (including food aid) contains or consists of GMOs. This is also reflected in the progress made by MOP1 in clarifying that if a shipment is know to intentionally contain LMO-FFPs, it should be identified as such with no ambiguity.

Non-Party exporters, although not bound by the Protocol, should ensure their actions do not contradict the Protocol’s objectives nor result in a lower level of protection. They should also provide relevant information to the BCH.

As food aid recipients or importing parties, national legislation is very important in establishing the parameters and detailed requirements of how GE commodities, including food aid, should be treated. These domestic biosafety laws can go beyond the minimum standards set by the Protocol; they could explicitly mention ‘food aid’, and include processed foods, subjecting them to AIA procedures, as exemplified in the African Model Law. Exporting countries and the WFP must comply with the domestic regulations of a food aid recipient.

In all cases, decisions made about the import of an LMO-FFP, including as food aid, should be based on a prior risk assessment and the Precautionary Principle. In the absence of national legislation, a risk assessment can still be required prior to the first import of an LMO-FFP, as provided for under the Biosafety Protocol.