TRADE, LABELING, TRACEABILITY AND ISSUES IN BIOSAFETY MANAGEMENT

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2 TRADE, LABELING, TRACEABILITY AND ISSUES IN BIOSAFETY MANAGEMENT - THE SRI LANKAN PERSPECTIVE - Mrs. Gothami Indikadahena Deputy Director of Commerce Department of Commerce

3 Management of Bio-Safety The Governments have been compelled to take very important decisions with respect to safety aspects of GM food, namely, whether the GM products pose zero risks,, which is somewhat unattainable considering the arguments and findings against their safety aspect, whether there is reasonable certainty that some GM products pose no harm,, unless the consumer is convinced either through regulatory systems that demonstrate such certainty or otherwise, whether to take a precautionary approach,, as the evidence on potential danger to health pose by GM products is inconclusive or insufficient or uncertain, Whether the GM products in any form are not acceptable at all.

4 The Rules that have been Introduced to discipline the use of measures Even before Uruguay Round, national food safety, animal and plant health measures affecting trade were subject to General Agreement on Trade & Tariff [GATT] Rules Article I of the GATT- Most Favoured Nation clause required non-discriminatory treatment of imported products from different foreign suppliers; Article III of the GATT - National Treatment clause required that such products be treated no less favourably than domestically produced goods, with respect to any laws or requirements affecting their sale; Article XX:b of the GATT Article XX:b of the GATT - General Exception clause which permitted countries to take measures necessary to protect human, animal or plant health, as long as they do not unjustifiably discriminate between countries nor were a disguised restriction to trade.

5 The Rules that have been Introduced to discipline the use of Measures at Multilateral Level Under World Trade Organisation During Uruguay Round the members felt that measures taken for the protection of human, animal and plant health should not represent disguised trade barriers; be harmonised based on international standards, guidelines,recommendations & of generally accepted scientific principles; special consideration be taken of Developing Countries; transparency be ensured in setting regulations and in solving disputes. The Emergence of WTO Agreements on Sanitary and Phytosanitary Measures & Technical Barriers to Trade

6 What is new in SPS Agreement - It Sets out Κ Clearer and more detailed rights and obligations for food safety and animal and plant measures, which affect trade; Κ The permission to impose only those requirements needed to protect health, which are based on scientific principles; Κ Parameters under which governments can challenge other members food safety or animal & plant health requirements; Κ The requirements for the disclosure of procedures used by the countries in assessing the risks; Κ That governments have to be consistent in their decisions on what is safe food.

7 - Cartagena Protocol on Bio-Safety - When does the Biosafety Protocol enter into force Article 37 states that the Protocol will enter into force 90 days after the date of deposit of the fifteenth instrument of ratification, acceptance, approval or accession by States or regional economic integration organizations that are Parties to the Convention on Biological Diversity. As the fifteenth instrument of ratification was deposited on 13 June 2003, the Protocol entered into force on 11 September SL has signed the protocol, but not yet ratified. Before ratifying, SL is required to put in place a National Bio-Safety Framework.

8 -Cartagena Protocol on Bio-Safety The objective of the Protocol The objective of the Protocol is To contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements. (Article 1) 1

9 What is the "precautionary approach" and How is it reflected in the Protocol The principle 15 of the Rio Declaration on Environment and Development sets out the precautionary approach. It states that "In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage,, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation." Elements of the precautionary approach find reflection in a number of the provisions of the Protocol, such as, the preamble, Article 1, 1 Article 10.6 and 11.8, Annex III on risk assessment.

10 What does the Protocol cover The Protocol applies to the transboundary movement, transit, handling and use of all Living Modified Organisms (LMOs) that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health. (Article 4) 4 However, LMOs that are pharmaceuticals for humans are excluded from the scope of the Protocol if they are covered by other international agreements or arrangements. (Article 5) 5 LMOs are any living organism that possess a novel combination of genetic material obtained through the use of modern bio-technology.

11 What is the relationship between the Protocol and the WTO Agreements The Protocol states in its preamble that it: Recognizes that trade and environment agreements should be mutually supportive; Emphasizes that the Protocol is not interpreted as implying a change in the rights and obligations under any existing agreements; and Understands that the above recital is not intended to subordinate the Protocol to other international agreements.

12 Comparison Between Protocol and WTO Agreements Bio-Safety Protocol o Sets out rules that countries exporting & importing GM products are required to be abide by; o Special procedures for intentional release of seeds and other products into the environment to be abide by the exporting country Advanced Informed Agreement o Three pronged Special Approval procedures for GM Food material Establishment of an appropriate regulatory framework; Notifying the Biosafety Clearing House about the decision to permit the domestic use of such products; When there is scientific uncertainty, take appropriate decisions with regard to imports. SPS & TBT Agreements o Sets out rules that countries importing products are required to be abide by, when taking certain restricted measures for health reasons; o Measures are not maintained without scientific evidence; o No special procedures based on the nature of product (all are like products), but different measures are permissible depending on the level of risks. o Permits the adoption of SPS measures on a provisional basis as a precautionary step, in cases where there is an immediate risks and where the scientific evidence is insufficient o Selection of method to manage the level of risks more or less trade restrictive [import ban or labelling]

13 The Significant Differences Between Precautionary Principles in SPS Agreement and Bio-Safety Protocol Bio-Safety Protocol(Art.11.8) SPS Agreement (Art.5.7) Lack of scientific certainly due to In cases where relevant scientific insufficient relevant scientific evidence is insufficient, a member information and knowledge may adopt sanitary or phyto regarding the extent of the sanitary measure on the basis of potential adverse effects of a available pertinent information, LMO on the conservation and including that from other sustainable use of biological international organisations as well diversity in the Party of import, as from sanitary and taking also into account risks to phytosanitary measures applied by human health, shall not prevent other Members. that Party from taking a decision, In such circumstances, Members as appropriate, with regard to shall seek to obtain additional the import of that LMO intended information necessary for a more for direct use as food or feed or objective assessment of risks and processing,, in order to avoid or review the sanitary and minimise such potential adverse phytosanitary measure effects. accordingly within a reasonable period of time.

14 The Significant Differences Between SPS Agreement and Bio-Safety Protocol Bio-Safety Protocol Risk assessment to be made by the exporting country; Allows import bans; Import ban can last till importing country decides to have reached evidence about the effects; No limit on the measure to be placed; There is no obligation to seek additional information; SPS Agreement Risk assessment to be made by the importing country; Allows import ban under very special circumstances; Import ban is allowed provisionally, therefore measure is provisional; There are limits on the measure to be placed; There is an obligation to seek additional information and review the measure within a reasonable time;

15 The Situations Where Potential Differences/Inconsistencies between the Provisions WTO Agreements and the Protocol 1. WTO Members could challenge the documentation requirements that will be imposed by the Parties to the Protocol [ documentation accompanying LMOs]; 2. A WTO Member could contest particular import prohibitions or restrictions introduced by another WTO member under the Protocol, affecting trade in either A specific LMO for intentional introduction into environment; A specific LMO commodity. 3. Other WTO Members may challenge national laws of another WTO Member, which has incorporated some or all the procedures and rules that Parties to the Protocol have to follow, when making decisions in importing LMOs; 4. WTO Members could introduce trade restrictions, neither explicitly required nor allowed under the Protocol, but taken with reference to the objectives of the Protocol.

16 Which WTO Agreements should be applied to measure the question SPS Agreement TBT Agreement GATT 1994 Article I of GATT [MFN Principle] Article III of GATT [National Treatment Principle] Article XI of GATT [Prohibitions and Restrictions] Article XX of GATT [General Exceptions]

17 Interpretation of WTO Rules in Light of the Bio-Safety Protocol The provisions of any WTO Agreement must be interpreted in accordance with customary rules of interpretation of public international law. Such rules mandate that WTO Agreements should be interpreted according to the ordinary meaning of the terms in their context and in the light of the object and purpose of the treaty. Referring to the Protocol in interpreting certain legal tests under WTO Agreements is an attempt to interpret both the protocol and WTO Agreements in a harmonious manner. The Protocol is used as an interpretative element, not as a set of legal rules that apply independently of WTO rules.

18 Interpretation of WTO Rules in Light of the Bio-Safety Protocol The Protocol will be relevant not only in case when both disputing parties are Parties to the Protocol, but also when only one of the disputing party is legally bound by the Protocol. The Protocol will be a piece of evidence showing that there are risks related to LMOs and hence measures may be necessary to protect against these risks. The Protocol can be construed as a relevant rule of international law pursuant to Article 31.3 (c ) of the Vienna Convention on the Law of Treaties. When there is a conflict between two agreements, the Protocol prevails over the WTO Agreements under Article 30.4 of the Vienna Convention.

19 Application of Rules at National Level Experience by Sri Lanka Ministry of Health issued the Food (Genetically Modified Foods) Regulation 2001 in terms of Section 32 of the Food Act No. 26 of 1980 through the Government Gazette No. 1178/18 on 6 th April 2001, which banned import, manufacture, storage, distribution and sale of GM Food products more than 21 products in Sri Lanka. The Regulation, which was not temporary in nature, came into force on 01 st May The grounds for imposition of the ban was that the products of GM content is not proven safe for human consumption, safety evaluation procedures are not in place and final findings of the Codex Committee on the safety aspects of GM food is being awaited for further measure.

20 Application of Rules at National Level- Experience by Sri Lanka ( It was pointed out that the ban did not comply with certain provisions in the SPS Agreement: The inadequate notice to the exporters. As per paragraph 5 of Annex nex B of the SPS Agreement, minimum of 90 days notice of new or change of an existing SPS Measure should have been given. This is particularly so, whenever international standards do not exist for the country to base its measure; As the measure has been already in place, Sri Lanka should have notified the measure immediately and follow the required procedures thereafter; r; Sri Lanka should have adopted a least trade restrictive measure rather than opting on an import ban, which is considered in the WTO being a more trade restrictive measure. Sri Lanka has not made effective the ban on all life forms GM products, p which would have more risks than the processed GM food products Sri Lanka has not made effective the ban on domestic production of GM products

21 Experience by Sri Lanka ( Under these circumstances, Sri Lanka had to notify the measure to the SPS Committee as a provisional measure under Article 5.7 of the SPS Agreement. Therefore, as required by the Article 5.7 of the SPS Agreement, Sri Lanka was required to comply with additional requirements, Provide Provide reasonable notice to other WTO Members Conducting more objective assessment on the risks pose by GM food on human and animal health and negative effects on the environment Setting Setting up of a proper system for effective implementation of the ban Monitoring Monitoring of evolving developments in the filed of GM food

22 Experience by Sri Lanka ( Ministry of Health issued the Second Genetically Modified Foods (Provisional) Regulation No. 1 of 2001, through the Government Gazette No. 1190/5 on 26 th June 2001, which provided a reasonable time limit for exporters for compliance, before the ban on import of GM foods came into force. The Regulation was due to come into force on 01 st September ( Still there was resistance from some WTO members that Sri Lanka has not opted for a less trade restrictive measure than a ban. ( They were of the view that Sri Lanka could have achieved the same objective by adopting a less trade restrictive measure like labeling; ; Ministry of Health deferred the entry into force of GM Foods (Provisional) Regulation No. 1 of 2001 on 29 th August 2001 by Government Gazette of 29 th August 2001 until further notice.

23 Experience by Sri Lanka ( Subsequently the Government appointed an Ad- Hoc Scientific Committee to look into the issue and requested it to make recommendations on the future course of action on the issue of GM products. ( The Committee recommended, among other things, an introduction of a Mandatory labeling system to be in force, applicable for all GM content products, by allowing consumers to make the right choice. These recommendations however have not been implemented as yet. ( The most recent scenario is the submission of a Cabinet Memorandum by the Ministry of Commerce to remove the import-licensing requirement imposed on the importation of maize seeds into Sri Lanka. ( As a response to this paper Ministry of Environment has indicated d their objection to this removal on the grounds that most of the maize traded world- wide is genetically modified and removal would pave the way for such products to enter Sri Lanka. The Ministry has argued that as a signatory s to Bio-Safety protocol, there is an obligation to adopt safety measures to control such GM products prior to their release into the local environment. nt.