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AFFI Hails China Trade Victory.

Washington, D.C.--Calling it a victory for companies throughout the food supply chain, AFFI hailed the House of Representatives' vote to grant permanent normal trade relations status to China. By a margin of 237 to 197, the House approved legislation which would end annual congressional review of China's trade status and give American companies access to China's opening markets.

"This truly is a monumental accomplishment for the U.S. Congress and U.S. enterprise. With this vote, the House has leveled the playing field for American businesses, and has opened the door to a market that includes more than one billion people. By improving trade relations with China, the U.S. will be positioned better to compete with other nations in today's global marketplace," said Leslie G. Sarasin, president and chief executive officer of AFFI.

In addition to granting permanent trade relations status to China, the U.S. also is supporting the nation's bid to join the World Trade Organization (WTO). In exchange for this backing, China has offered to lower its high trade barriers which have cost American manufacturers and farmers billions of dollars in lost sales annually.

Sarasin continued, "As China enters the WTO, AFFI member companies stand to gain from substantial tariff reductions on frozen food products. These new market opportunities, combined with the rapid technological advancements occurring in China and other Pacific Rim countries, offer tremendous growth potential for frozen food companies."

Exports of frozen food products have increased steadily in recent years, and in 1998, reached $1.2 billion in sales. According to the most current data available, the largest percentage of U.S. frozen food exports is sold to Japan. With the opening of new international markets, particularly China, U.S. shipments overseas are expected to increase substantially.

Included in the final negotiations of the China trade bill were two key amendments: a measure to establish an oversight commission to monitor human rights in China, and a provision to help protect U.S. industries against surges in imports from China.

The legislation will be sent to the Senate for its consideration.

AFFI Petitions FDA and FTC For Biotechnology Labeling and Advertising "Rules of the Road"

On May 5, 2000, AFFI, in conjunction with other industry groups, submitted citizen petitions both to the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). The petition submitted to FDA calls on the agency to establish "rules of the road" for modern biotechnology and labeling claims. The second petition, delivered to FTC, addresses the appropriate uses of terms such as "GMO-free" and "non-GM" in advertising.

AFFI's submissions to FDA and the FTC follow a recent Clinton administration proposal, which intends to increase the oversight functions of FDA and USDA on products modified through biotechnology. One tenet of the Clinton administration's proposal will create an FDA regulatory mechanism allowing food manufacturers the option of voluntarily labeling foods as free of genealtering ingredients.

"Voluntary labeling could be a valuable tool to increase consumer comprehension and acceptance of products derived through modern biotechnology. However, without specific `rules of the road' these labels may only serve to increase consumer confusion," noted Leslie G. Sarasin, CAE, AFFI's president and chief executive officer.

To avoid confusion in the realms of labeling and advertising, AFFI and other associations are petitioning the agencies to establish guidelines that clearly identify whether a product is free of gene-altering ingredients. The petition defines and suggests appropriate uses of terms such as "GM-free," to refer to products without genetic modification, and "GMO-free," to refer to products without genetically modified organisms.

"Labeling and advertising claims about biotechnology must not be deceptive or misleading. Labeling should clarify product composition, and claims that imply the absence of biotechnology should be backed by research and reliable evidence," said Sarasin.

The petition guidelines suggested by AFFI and others would build on existing FDA rules and increase the agency's focus without expanding or restricting current federal laws. This petition has gained strong support in the food industry. Industry representatives such as: the Grocery Manufactures of America. Food Marketing Institute, the International Dairy Foods Association, and the Snack Food Association joined AFFI in filing these joint petitions to FDA and the FTC.

AFFI Provides Input to FDA on Implementation of its Trans Fatty Acid Labeling Proposal

In written comments submitted to the Food and Drug Administration (FDA), AFFI urged the agency to provide an appropriate implementation period for the many food companies that would be impacted by its proposed changes to trans fatty acid labeling requirements. The agency's proposal would constitute the first major labeling changes to the Nutrition Facts Panel since its introduction in 1993.

Published in the Federal Register on November 17, 1999, the proposed rule would amend the nutrition labeling requirement for conventional foods and dietary supplements by combining the number of grams of trans fatty acids with the grams of saturated fat reported on the label. FDA also would require manufacturers to include a footnote specifying the specific amount of trans fatty acids in the product. The agency estimates that implementation of the proposed rule would cost companies between $401 and $854 million.

AFFI President and Chief Executive Officer Leslie G. Sarasin, CAE, wrote, "AFFI is concerned that FDA's estimate of the costs associated with the proposed rule appears to underestimate the financial burden on the industry. Companies would have to analyze and relabel thousands of products--an expensive and time consuming process." AFFI recommended the agency provide a period of two years following publication of a final rule for companies to comply with the new requirements.

In addition, AFFI emphasized the importance of coordination between FDA and the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) since many AFFI member companies produce products that fall under the regulation of both agencies. AFFI believes a uniform rule by FSIS and FDA would enhance the food label's nutrition education function and simplify the regulatory burden on companies.

"Any trans fatty acid final rule will have a significant impact on the food industry as a whole, and specifically, the economic impact of this rule should be judged based on its cost to the entire food industry and not to FDA regulated products alone. In the interest of one `food system,' which both FDA and USDA have advocated recently, and for purposes of uniformity, AFFI recommends that FDA republish this rule as a joint FDA/FSIS proposal," said Sarasin.

AFFI Urges FDA to Create a "Safe Harbor" for Compliant Companies

AFFI recently submitted written comments to the Food and Drug Administration (FDA) urging the agency to give companies which comply with FDA's good guidance practices a "safe harbor" from further enforcement action. In its letter, AFFI emphasized that companies which comply with existing FDA guidance policies do so in good faith, and a company's compliance with good guidance practices should provide evidence of its intent to adhere to current FDA regulations.

Published in the Federal Register on February 14, 2000, the proposed rule is intended to clarify the agency's procedures for creating, issuing and using good guidance documents. AFFI recognizes and supports the proposed rule's attempt to clarify FDA's good guidance documents. However, the Institute believes there are steps other than codification which should be considered. Although guidance documents are neither legally binding on the agency or the industry, companies which comply with existing FDA guidance policies should not be singled out for enforcement action.

AFFI President and Chief Executive Officer Leslie G. Sarasin, CAE, wrote, "In all fairness, if a company adheres to the agency's own interpretation of its requirements, FDA should be willing to recognize the company's attempt at compliance." Instead of enforcement action, FDA should quickly revise its guidance documents to reflect the agency's most current policy.

Under the Food and Drug Administration Modernization Act of 1997, FDA is required to create guidance documents that uphold current FDA policy. The act further requires FDA to provide an appeals mechanism to address complaints of misuse of guidance documents by the agency. This appeals mechanism is an important means for the public to address its concerns about good guidance practices to FDA. However, without providing compliant companies with a "safe harbor," this appeals mechanism will be an insufficient means to address concerns raised by FDA regulated companies.

"If FDA takes the position that the guidance documents will not provide a safe harbor, then, at the very least, AFFI believes that compliance with an FDA guidance document should provide evidence of a company's intent to comply with agency regulations in any related enforcement proceeding," said Sarasin.

AFFI Opposes FDA's Proposed Changes to Citizen Petition Rules

In written comments submitted to the U.S. Food and Drug Administration (FDA), AFFI voiced its strong opposition to the agency's proposed revisions to its existing citizen petition rules, stating that the changes would suppress valuable feedback on pertinent issues and stifle innovation in the food industry.

Under the proposed revisions, which were published in the Federal Register on November 30, 1999, FDA would give a "brief denial" to all petitions deemed to be without public health significance. Included on its list of such denials would be requests by the food industry to approve or revise standards of identity for food products. Without such request opportunities, frozen food companies would be unable to test-market new products that differ from the accepted standard of identity.

One "real life" example of the type of petition that would be automatically denied is the petition AFFI filed to allow frozen fruits and vegetables to be labeled as "healthy," which FDA approved in 1998. This ruling enabled frozen produce to achieve equal footing from a nutritional perspective with their fresh counterparts.

"AFFI opposes restricting the scope of the citizen petition process and is particularly troubled by the implication in the proposed rule that citizen petitions are appropriate only to address significant public health issues. This approach would threaten industry's ability to experiment with and improve standardized foods," wrote Leslie G. Sarasin, CAE, AFFI's president and chief executive officer.

The Institute recognizes that FDA's resources are limited, and supports measures which enable the agency to use its resources more effectively and efficiently. However, AFFI believes this latest proposal will do little to further that goal. If the rule is enacted, it would not decrease the number of frivolous petitions filed, but only limit the number of issues which FDA takes under serious consideration.

Sarasin continued, "Unless companies can petition the agency, existing regulations and standards of identity will remain in their current form indefinitely, leaving no room for innovation. In effect, the regulations will hold both companies and consumers `hostage."'

In concluding her comments, Sarasin reminded FDA that the existing rules have provided a workable system for ensuring effective public participation in the agency's rulemaking and related processes for more than 20 years. AFFI recommended that instead of proposing changes to a largely successful system, FDA more carefully increase its efficiency through management changes and other internal modifications.
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Publication:Frozen Food Digest
Article Type:Statistical Data Included
Geographic Code:1USA
Date:Jul 1, 2000
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