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Introduction to the Cartagena Protocol on Biosafety

Entered into force: 11 September 2003

As of 2 July 2004, 101 countries are Parties Most of the Parties are developing countries, with the majority from Africa and small island states CPB: 1st and only international law on genetic engineering/genetically modified organisms 1st Meeting of the Parties was held in Kuala Lumpur from 23-27 February 2004

Significance of the Protocol

Recognises for the 1st 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 Recognises that GMOs may have biodiversity, human health and socio-economic impacts; and that these impacts must be risk assessed Recognises the crucial importance of centres of origin and diversity

Significance of the Protocol

Operationalises the Precautionary Principle in decision-making; further establishes the Precautionary Principle in international law Principle of prior informed consent Establishes the right to say ‘no’ Provides a measure of protection for countries implementing biosafety from WTO threats Deals with international transboundary movement and international liability Opens political space internationally & nationally

Cartagena Protocol on Biosafety

• Deals mainly with the transboundary movement of GMOs through the AIA (advance informed agreement/ prior informed consent) procedure Decisions made based on risk assessment and the Precautionary Principle Scope of the CPB covers all GMOs Exclusion of some GMOs from the AIA procedure (transit, contained use, LMO-FFPs) GM pharmaceuticals for humans

National Implementation

The Cartagena Protocol is a negotiated framework international law that sets minimum standards for national biosafety implementation Sovereign countries are free to interpret, and implement the Cartagena Protocol in a more comprehensive way, and with higher standards Article 2.4: “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…”

The CPB and Food Aid

‘Food aid’ is not explicitly mentioned in the CPB, but, must be considered as GM grain is LMO-FFP (e.g. whole corn and whole soybeans) WFP recognises any GM commodity (as defined by CPB) distributed by WFP to or transiting through a Party, should be considered LMO-FFPs So procedures of the CPB applying to LMO-FFPs apply to grain food aid [Processed food e.g. corn-soy blend, not considered under CPB, but national legislation can regulate this]

LMO-FFPs under the CPB

Exempt from AIA procedure. A Party making a decision regarding domestic use must inform Parties of decision, through the Biosafety Clearing House (BCH). Must provide, at a minimum, some information (includes info on the genetic modification, donor & recipient organism, risk assessment report) Any Party can request additional information from the authority making that decision Precautionary Principle applies to decisionmaking

LMO-FFPs under the CPB

CPB preserves the right of Parties to take a decision on the import of LMO-FFPs according to its domestic regulatory framework In the absence of a domestic framework, a developing country Party can still take a decision on an LMO-FFP in accordance with a risk assessment, as long as the intention’s made known Failure to communicate a decision within the stipulated timeframe does not imply consent or refusal to import the LMO-FFP

Documentation accompanying LMO-FFPs

Clearly identifies that they “may contain” LMOs and are not intended for intentional introduction into the environment Contact point for further information MOP must take decision on detailed requirements, no later than 2 years after entry into force (i.e. by Sept. 2005)

MOP1 Decision on Documentation

Reaffirms the criteria set out in the Protocol Parties and other Govts urged to further include common, scientific & commercial names, the transformation event code or unique identifier Encourages Parties and other Governments to require exporters to declare that the documentation accompanying LMO-FFPs are identified as such with no ambiguity (not “may contain”) An expert group was set up to elaborate detailed requirements and report to the next MOP in 2005. The above measures are thus interim, but countries are requested or urged to take them now

USDA Guidance on Art.18.2(a) for Food Aid Program Partners

The US is not a Party; it maintains that it cannot require that US exporters comply with the CPB. “It is the responsibility of exporters to meet the Parties’ requirements under the Protocol when exporting to Parties.” Recognises that exporters should comply with recipient country regulations, if they exist If recipient country has no domestic regulations on LMO-FFPs documentation, and is a Party, USDA recommends:
(1) “may contain” declaration on commercial invoice;
(2) last exporter and first importer as contact points;
(3) for all whole grain shipments of commodities of GM varieties approved and grown in the US (i.e. whole corn & soy);
(4) adventitious presence should not trigger “may contain”

EU Regulation on Transboundary Movement of GMOs

Recognises that similar rules that apply to traceability, labelling and identification of GMO imports to the EU, should apply to its exports Exporters should ensure documentation accompanying LMO-FFPs should state: (a) that it contains or consists of GMOs; (b) the unique identification code(s); (c) that the GMOs are intended for direct use as FFP, and indicate clearly that not intended for deliberate release into the environment; (d) contact point information [(b) does not apply to mixtures of GMOs to be used only and directly for FFP as EU traceabilility requirements will apply to these]

African Model Law on Safety in Biotechnology

AML doesn’t distinguish between LMO-FFPs and GMOs for intentional introduction to the environment – so all GMOs need AIA or explicit written approval of competent authority (Mex eg) AML explicitly includes food aid under its definition of ‘deliberate release’/ ‘release’ and ‘placing on the market’ AML includes products of a GMO, so it covers not just grain, but also processed foods All GMOs and products thereof must be clearly identified and labelled as such

Summary: Can CPB regulate GM Food Aid?

Yes, as LMO-FFPs – CPB procedures apply –BCH National legislation important – exporting countries and WFP must comply. Can explicitly mention ‘food aid’ in domestic laws, and include processed foods In the absence of national legislation, a risk assessment can still be required prior to 1st import Documentation – clearly identifies as “may contain” Non-Party exporters should ensure their actions do not contradict CPB objectives Exporting countries can have legislation that places obligations on its exporters (e.g. EU, MOP1 decision on Art.18.2(a) on removing ambiguity)

WTO Agreements

3 relevant agreements: - Agreement on the Application of Sanitary & Phytosanitary Measures (SPS) - Agreement on Technical Barriers to Trade (TBT) - General Agreement on Tariffs & Trade 1994 All recognise a Member’s right to take measures it considers appropriate to protect human or animal health or the environment.

What the Agreements Allow

Allow some measures to be taken that are supportive of biosafety, as long as certain criteria are met These measures may be in the form of an import ban on a GMO, risk assessment and risk management requirements i.e. use restrictions, and identification and labelling

SPS Agreement

Regulates sanitary & phytosanitary measures that will affect trade, provided with respect to protecting plant, animal and human health Basic rules on food safety & animal & plant health standards to protect from pests, diseases, etc. Allows countries to set own standards, as long as based on science, and applied only to the extent necessary to protect human, animal, plant health; and doesn’t arbitrarily or unjustifiably discriminate between countries Members can set higher standards than international norms, if scientifically justified & not arbritary

TBT Agreement

Regulates measures affecting trade which are technical and industrial standards (including packaging, marking and labelling requirements) and that do not fall under the SPS Agreement Allows national regulations to fulfill a legitimate objective – national security, prevention of deceptive practices, protection of human health or safety, animal or plant life & health, environment Encourages international standards, but doesn’t require countries to change their level of protection

Which agreement applies?

GATT 1994 is more general and overarching,TBT less so, SPS most specific Which agreement applies would depend on the objective of that measure, e.g. if label GMOs to protect health, it falls under SPS, if it is to inform consumers, falls under TBT If not under the TBT, still have to comply with GATT 1994, which allows members to act in order to protect human, animal or plant life or health, provided non-discriminatory or used as disguised protectionism

Criteria that need to be met

Justified by policy purpose Meet non-discrimination provisions (can’t unjustifiably or arbitrarily discriminate between countries) Must not be more trade restrictive than necessary Products should also not be accorded less favourable treatment than ‘like’ products

Precautionary Principle

SPS allows PP to some extent – it is not necessary to prove causal links between a GMO and specific damage to ban a GMO But must have scientific evidence And rational basis in policy, and non-discriminatory Must continually review this decision