WTO Dispute Settlement Proceeding Regarding Measures of the European Communities Affecting the Approval and Marketing of Biotech Products

AGENCY:

Office of the United States Trade Representative.

ACTION:

Notice; request for comments.

SUMMARY:

The Office of the United States Trade Representative (USTR) is providing notice that on March 4, 2004, a dispute settlement panel was composed under the Marrakesh Agreement Establishing the World Trade Organization (“WTO Agreement”) concerning measures of the European Communities (EC) affecting the approval and marketing of the products of agricultural biotechnology (“biotech products”). USTR invites written comments from the public concerning the issues raised in this dispute.

DATES:

Although USTR will accept comments received throughout the course of the dispute settlement proceedings, comments should be received on or before April 6, 2004, to be assured of timely consideration by USTR.

ADDRESSES:

Comments should be submitted either (i) electronically, to FR040@ustr.gov, with “EC-Biotech Dispute” in the subject line, or (ii) by fax, to Sandy McKinzy at 202-395-3640 with a confirmation copy sent electronically to the e-mail address above.

FOR FURTHER INFORMATION CONTACT:

William Busis, Associate General Counsel, (202) 395-3150, or Richard White, Director, Sanitary and Phytosanitary Affairs, (202) 395-6127.

SUPPLEMENTARY INFORMATION:

Pursuant to section 127(b) of the Uruguay Round Agreements Act (URAA) (19 U.S.C. 3537(b)), USTR is providing notice that, at the request of the United States, the WTO Dispute Settlement Body (DSB) has composed a panel to examine EC measures affecting the approval and marketing of biotech products. The DSB has also composed panels at the request of Argentina and Canada to examine the EC measures. The three proceedings have been combined and will be heard by a single panel.

Since October 1998, the EC has applied a moratorium on the approval of biotech products. Pursuant to the moratorium, the EC has suspended consideration of applications for, or granting of, approval of biotech products under the EC approval system. In particular, the EC has blocked in the approval process under EC legislation all applications for placing biotech products on the market, and has not considered any application for final approval. The approvals moratorium has restricted imports of agricultural and food products from the United States.

In addition, EC member States maintain a number of national marketing and import bans on biotech products even though those products have already been approved by the EC for import and marketing in the EC. The national marketing and import bans have restricted imports of agricultural and food products from the United States.

The United States panel request explains that the United States considers that these measures of the EC and its member States are inconsistent with the EC's obligations under the Agreement on the Application of Sanitary and Phytosanitary Measures (“SPS Agreement”), the General Agreement on Tariffs and Trade 1994 (“GATT 1994”), the Agreement on Agriculture (“Agriculture Agreement”), and the Agreement on Technical Barriers to Trade (“TBT Agreement”). The specific EC measures are as follows:

(1) The suspension by the EC of consideration of applications for, or granting of, approval of biotech products;

(2) The failure by the EC to consider for approval applications for the biotech products mentioned in Annexes I and II to this notice; and

(3) National marketing and import bans maintained by EC member States, as described in Annex III to this notice.

Public Comment: Requirements for Submissions

Interested persons are invited to submit written comments concerning the issues raised by the United states in this dispute. Persons submitting comments may either send one copy by fax to Sandy McKinzy at 202-395-3640, or transmit a copy electronically to FR0401@ustr.gov, with “EC-Biotech Dispute” in the subject line. For documents sent by fax, USTR requests that the submitter provide a confirmation copy electronically.

USTR encourages the submission of documents in Adobe PDF format, as attachments to an electronic mail. Interested persons who make submissions by electronic mail should not provide separate cover letters; information that might appear in a cover letter should be included in the submission itself. Similarly, to the extent possible, any attachments to the submission should be included in the same file as the submission itself, and not as separate files.

A person requesting that information contained in a comment submitted by that person be treated as confidential business information must certify that such information is business confidential and would not customarily be released to the public by the submitter. Confidential business information must be clearly designated as such and marked “BUSINESS CONFIDENTIAL” at the top and bottom of the cover page and each succeeding page of the submission.

Information or advice contained in a comment submitted, other than business confidential information, may be determined by USTR to be confidential in accordance with section 135(g)(2) of the Trade Act of 1974 (19 U.S.C. 2155(g)(2)). If the submitting person believes that information or advice may qualify as such, the submitting person—

(1) Must clearly so designate the information or advice;

(2) Must clearly mark the material as “SUBMITTED IN CONFIDENCE” at the top and bottom of each page of the cover page and each succeeding page; and

(3) Is encouraged to provide a non-confidential summary of the information or advice.

Pursuant to section 127(e) of the URAA (19 U.S.C. 3537(e)), USTR will maintain a file on this dispute settlement proceeding, accessible to the public, in the USTR Reading Room, which is located at 1724 F Street, NW., Washington, D.C. 20508. The public file will include non-confidential comments received by USTR from the public with respect to the dispute; if a dispute settlement panel is convened, the U.S. submissions to that panel, the submissions, or non-confidential summaries of submissions, to the panel received from other participants in the dispute, as well as the report of the panel; and, if applicable, the report of the Appellate Body. An appointment to review the public file may be made by calling the USTR Reading Room at (202) 395-6186. The USTR Reading Room is open to the public from 9:30 a.m. to 12 noon and 1 p.m. to 4 p.m., Monday through Friday.

Annex I—Applications Under EC Directives 2001/18 and 90/220—Deliberate Release

Bayer oilseed rape (MS1/RF1)

Bayer hybrid oilseed rape (MS1/RF2)

Bejo Zaden red-hearted chicory (RM3-3, RM3-4 and RM3-6)

Bayer oilseed rape (Falcon GS40/90)

Bayer hybrid oilseed rape (MS8/RF3)

Trifolium/Monsanto/Danisco Roundup Ready fodder beet (A5/15)

Monsanto Bt cotton (531)

Monsanto Roundup Ready cotton (RRC1445)

Amylogene starch potato

Bayer winter oilseed rape (Liberator pHoe6/Ac)

Syngenta glufosinate tolerant and Bt resistant (Bt-11) corn

Monsanto Roundup Ready corn (GA 21)

Monsanto Roundup Ready oilseed rape (GT73)

Syngenta Bt hybrid corn (Bt-11)

Monsanto Roundup Ready oilseed rape (GT73)

Bayer Liberty Link soybeans (A2704-12 and A5547-127)

Monsanto/Syngenta Roundup Ready sugar beet

Bayer Liberty Link oilseed rape (T45 & Topas 19/2) (stack)

Stoneville BXN cotton (10215, 10222, 10224) (formerly held by Aventis and Calgene)

Monsanto MaisGard Roundup Ready (MON 810 & GA21) corn (Stack)

Bayer Liberty Link sugar beet (T120-7)

Pioneer/Dow AgroSciences Bt corn Cry1F (1507)

Pioneer/Dow AgroSciences Bt corn Cry1F (1507)

Monsanto Roundup Ready corn (NK603)

Pioneer Bt corn (MON 809)

Zeneca extended shelf life tomato (TGT7-F)

Monsanto Roundup Ready corn (GA 21)

Pioneer Liberty Link and Bt (T25 & MON 810) corn (stack)

Pioneer/Dupont high-oleic soybean (260-05)

Annex II—Applications Under EC Regulation 258/97—Novel Foods

Bejo-Zaden Transgenic Radicchio rosso

Bejo-Zaden Transgenic Green hearted chicory

Monsanto Roundup Ready corn (GA21)

Syngenta Bt-11 sweet corn

Pioneer/Dupont high-oleic soybean (260-05)

Bayer LibertyLink soybeans

Monsanto MaisGard Roundup Ready corn (GA 21& MON 810) (stack)

Monsanto/Syngenta Roundup Ready sugar beet (77)

Pioneer/Dow AgroSciences Bt corn Cry1F (1507)

Monsanto Roundup Ready corn (NK603)

Pioneer Liberty Link and Bt (T25 x MON 810) corn (stack)

Annex III—EC Member State Marketing and Import Bans

Austria Corn: Bt-176, MON 810, T25

France Repeseed: C/UK/95/M5/1; and C/UK/94/M1/1

Germany Corn: Bt-176

Greece Rapeseed: Topas 19/2

Italy Corn: Bt-11, MON 809, MON 810, T25

Luxembourg Corn: Bt-176