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World Trade Organization: Comments on WTO Dispute Settlement Proceedings Regarding Biotech Products

March 10, 2016

RE: Notice, Request for Comment WTO Dispute Settlement Proceedings Regarding Measures of the European Communities Affecting the Approval and Marketing of Biotech Products (Federal Register Vol. 73, No. 16 January 24, 2008)

Dear Sir/Madam:

The following is submitted on behalf of the Biotechnology Industry Organization (BIO) in response to the Federal Register notice of January 24, 2008, requesting comments on the WTO Dispute Settlement Proceedings Regarding Measures of the European Communities Affecting the Approval and Marketing of Biotech Products.

BIO represents more than 1,180 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology technologies.

The European Union (EU) is not yet in compliance with the World Trade Organization’s (WTO) panel report on “European Communities – Measures Affecting the Approval and Marketing of Biotech Products,” (DS-291). Under Annex C(1)(a) of the Agreement on the Application of Sanitary and Phytosanitary Measures, the European Communities is to undertake biotech approvals without undue delay. With over 40 biotechnology products awaiting approval in the EU, science-based, timely decisions on agricultural biotechnology product applications need to be made to be in compliance with the WTO panel report.

If and at such time the United States moves forward to withdraw concessions from the EU as a result of its continued non-compliance with its obligations, BIO requests that the U.S. government consider the following.

1) Any products identified for withdrawal of concessions should have significant negative economic impact on EU economic and political interests. In other disputes, the United States has chosen to withdraw concessions on some “luxury” products, for which higher tariffs can have little impact on the level of imports.

2) All tariff lines for goods need to be considered for withdrawal of concessions, not just agricultural tariff lines, to provide maximum flexibility in identifying those products which will have the most leverage on EU interests.

3) In considering which member states to target for withdrawal of concessions, consideration should be given to products from countries and regions of countries that can influence the operation of the regulatory process at all levels – the European Food Safety Authority, Regulatory Committee, the Council of Ministers and the Commission. Consideration should be given to targeting products from the home regions of EU elected officials and Commissioners.

4) We recognize that the U.S. government considers the impact of a withdrawal of concessions on U.S. import interests. We suggest that careful analysis should be done if there are concerns about affecting U.S. import interests in light of the likelihood that in today’s global economy, any essential products needed by American consumers are likely to be sourced from areas other than the European Union.

Thank you for considering these comments as the U.S. Trade Representative continues efforts to normalize trade in agricultural biotechnology products with the European Union.


Sharon Bomer Lauritsen
Executive Vice President
Food and Agriculture

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