International Information Programs Biotechnology

17 April 2000

Text: USDA's Woteki Says U.S. Achieved Its Codex Objectives

Discussions to continue on precaution in risk analysis

Paris -- Discussions will continue in the Codex Alimentarius Committee on General Principles into next year on the role of precaution in analyzing the potential food safety risks from biotechnology, U.S. Under Secretary of Agriculture Catherine Woteki says.

The Codex committee met in Paris April 10-14 to consider international food safety guidelines and how to analyze the safety of foods derived from agricultural biotechnology. The committee will discuss the role of precaution in a multi-stage process through next year before reaching final guidelines, Woteki said in an April 14 U.S. Department of Agriculture (USDA) announcement.

The United States has not endorsed the "precautionary principle," said Woteki, who is under secretary for food safety at USDA. Rather, she said, the Codex committee has agreed to continue the discussions "in what we believe is the appropriate forum -- the international food safety standard setting body of Codex Alimentarius."

The precautionary principle as proposed by a number of advocates, including the European Union (EU), generally would require banning products -- such as genetically engineered Bt corn [maize] -- even if there is no definitive scientific proof of harm.

The European Union (EU) has proposed use of the "precautionary principle" in a number of different forums, but the United States has not accepted or endorsed the principle, Woteki said.

"There are countries that use what they call the 'precautionary principle' domestically, and it is in the interest of the United States to ensure that it is only used in clearly defined, limited instances," Woteki said. The United States has maintained that food safety risk analysis must be based on accepted scientific criteria.

Following is the text of the USDA announcement:

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Food Safety and Inspection Service
U.S. Department of Agriculture
Washington, D.C.

April 14, 2000

U.S. Reports from Codex Meeting

Paris -- U.S. Department of Agriculture Under Secretary for Food Safety and head of the U.S. Codex delegation Catherine Woteki announced today that the United States achieved its objectives regarding discussion of the use of precaution in food safety decisions when the Codex Alimentarius Committee on General Principles (CCGP) earlier in the day adopted its final report at a meeting in Paris. In that report, the CCGP acknowledged that precaution is an essential part of risk analysis and agreed to follow a three-step process that will permit further discussions within Codex.

"The U.S. has not endorsed the 'precautionary principle' in any way," said Woteki, "but I am pleased that we were able to have a thoughtful and substantive discussion in the Committee and that these discussions will continue to take place in what we believe is the appropriate forum -- the international food safety standard setting body of Codex Alimentarius."

Woteki also said, "There are countries that use what they call the 'precautionary principle' domestically, and it is in the interest of the United States to ensure that it is only used in clearly defined, limited instances."

Regarding the use of precaution, Woteki said there were many areas of agreement among the 165 countries represented on Codex. Woteki stressed that the United States has had precaution built into its food laws since the beginning of the 1900's.

During the deliberations of the CCGP, the United States and many other delegates objected to the original text presented to the CCGP. The CCGP considered two alternative proposals, one that was constructed using separate texts developed by the European Commission and other delegations, including the U.S. That text was amended further by the Codex Secretariat and presented to the CCGP as the "Chairman's Proposal." This text was viewed as conducive to a full discussion of many important issues before the CCGP. The other amended text was prepared by Malaysia. The U.S. also intervened to support the Malaysian text. Although there was full discussion of both proposals, the United States objected to moving to the next step of adoption of language.

Instead, the CCGP endorsed a process that calls for Codex to discuss the use of precaution in risk analysis. The three-step process includes the establishment of a drafting group that will work throughout the next year via electronic mail to develop new proposals on the definition and criteria for application of precaution when scientific evidence is insufficient to objectively and fully assess risk from a hazard in food.

There may also be one or more educational workshops on precaution for all Codex members that will be held prior to the next meeting of the CCGP.

Finally, the entire risk analysis paper that contained the precaution issue will be recirculated for comment by all Codex members and be considered by a working group that will meet immediately before next year's CCGP meeting. The document will be officially placed on the agenda of the 2001 CCGP meeting.

Both amended proposals are attached below.

Malaysian Proposal

No. 38;

In line with Article 5.7 of the SPS Agreement, to replace this paragraph with the following:

["Where relevant scientific evidence is insufficient, precaution can be exercised as an interim measure to protect the health of consumers. However, additional information for a more objective risk assessment should be sought and the measures taken reviewed accordingly within a reasonable time frame."]

Chairman's Proposal

No. 38;

[When relevant scientific evidence is insufficient to objectively and robustly assess risk from a hazard in food (1), and where there is reasonable evidence to suggest that adverse effects on human health may occur, the nature and extent of which are difficult to evaluate, precautionary measures may be taken by risk managers in the interim to apply precaution to protect the health of consumers, without awaiting additional scientific data and a full risk assessment, in accordance with the following criteria: (2)

(1) It is recognized that hazard identification is a crucial step in this process.

(2) Some members refer to this concept as the "precautionary principle".]

The document into which the paragraphs will be placed for discussion purposes is still at Step 3 of the Codex process and did not move to Step 5.

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