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 the current 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" of 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 standards of identity for food products. Without such

FDA standards, frozen food companies would be unable to test-market new products that differ from the accepted standard of identity.

"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.

AFFI Urges Congress to Strike President Clinton's Food Taxes from Fiscal Year 2001 Budget

In letters to members of the House of Representatives and Senate, AFFI urged Congress to oppose the $534 million in new food industry user fee taxes included in the Clinton Administration Fiscal Year 2001 budget proposal for the U.S. Department of Agriculture (USDA).

Through the user fees, the food industry would fund all in-plant meat and poultry inspections conducted by USDA personnel. Members of Congress and consumer groups have argued that industry funding of the salaries and benefits of in-plant USDA personnel would compromise the public's confidence in the integrity of the food inspection process.

Even USDA's own National Advisory Committee on Meat and Poultry Inspection recommended unanimously that the authority to impose user fees not be sought, either through legislative initiatives, or in the presentation of the President's budget request. The Committee also reaffirmed its view that the funding of basic meat and poultry inspection remains an appropriate federal government responsibility.

"These food industry taxes have been rejected by Congress each time they have been proposed by the executive branch, yet they remain a threat which must be taken seriously. AFFI will actively oppose these taxes on Capitol Hill and expose them for what they are: bad policy which would hit businesses hard and jeopardize the credibility of the nation's food inspection system," said Dina M. Land, CAE, AFFI's vice president of legislative affairs.

In addition to the user fee taxes proposed to fund USDA, the President also is requesting $5.3 million additional taxes to fund food export certifications, which are issued by the Food and Drug Administration. The Administration expects the industry to cover the increased costs associated with a growing number of European Union requirements for certificates attesting to the fact that animal derived foods are free from hormones or genetically-altered organisms.

The user fees included in the USDA and FDA budget proposals are not authorized in current law, and separate legislation would be required to permit the collection of the user fees.

AFFI Blasts OSHA's Proposed Ergonomic Rules

Citing a lack of compelling scientific evidence to support them, AFFI expressed its strong opposition to the new ergonomics regulations published for public comment by the Occupational Safety and Health Administration (OSHA) on November 23, 1999, in the Federal Register. In written comments submitted recently to the agency, AFFI criticized the additional regulations which would result in an across the board regulatory framework with widespread implications for nearly every business. In addition, the regulations would be implemented prior to the completion of a study currently being conducted by the National Academy of Sciences, which would examine the relationship between work exposure and ergonomic injuries.

"AFFI members are dedicated to working with and motivating their employees, and therefore, agree that a workplace free of hazards is the ultimate goal to which companies must aspire. AFFI members believe strongly, however, that uniform rectification of workplace safety issues through a `one size fits all' solution, such that proposed by OSHA, will stifle innovation, inhibit proactive employee/employer interaction in the workplace, and foster adversarial relationships between management and the work force," wrote Leslie G. Sarasin, CAE, president and chief executive officer of AFFI.

Under the proposed rule, all manufacturing and manual handling operations, including frozen food companies, would be required to establish an ergonomics program for those jobs which have demonstrated work-related musculoskeletal disorders (MSDs). In addition, companies whose employees suffer injuries would be required to establish reporting systems, and offer medical care and time off to the injured.

OSHA estimates it will cost, on average, $150 to correct a particular problem with a work station. According to the agency, the total cost of implementing and enforcing the new program would total $4.2 billion annually. In light of the fact that many manufacturing facilities may have to be reconfigured entirely to meet the new ergonomic standards, AFFI warned OSHA that its cost projections may be grossly underestimated.

Sarasin wrote, "AFFI believes OSHA has oversimplified the costs of its proposal, minimized the potential exposure of industries and made a number of assumptions, which may not be accurate in determining the true cost of the proposal.... Based on responses from AFFI's member companies, AFFI gauges that the true cost of the ergonomics proposal is at least four times the estimate."

Moratorium on Mergers

Senators Tom Daschle (D-S.D.) and Patrick Leahy (D-Vt.) have drafted legislation which would limit mergers and acquisitions within the agricultural industry, and would grant the U.S. Department of Agriculture (USDA) greater authority over such business transactions.

Under the draft legislation, all agri-businesses would be required to file a pre-merger notification with USDA if the "acquiring" firm has annual net sales or total assets exceeding $100 million, and the firm which it intends to acquire has annual net sales or total assets exceeding $10 million.

In addition, the bill would require all companies in agribusiness with annual sales more than $100 million to file a report annually with USDA disclosing all strategic alliances, ownership in other agribusiness or related firms, joint ventures, subsidiaries and all representatives and agents who lobby Congress on their behalf.

To implement these provisions, the bill calls for the establishment of a new Office of Special Counsel for Agriculture in the Office of the U.S. Attorney General.

The measure is similar to legislation introduced last year by Sen. Paul Wellstone (D-Minn.). That amendment was struck down in the Senate, and was deemed by a large majority of senators to be anticompetitive and counterproductive to the goal of improving opportunities in the agriculture industry.

Biotechnology Labeling

In a letter to every member of the Senate, AFFI and 34 other trade associations urged senators to reject a recently introduced measure that would require mandatory labeling for foods produced through biotechnology.

AFFI was among several major food, farm, retailer and manufacturer groups that urged lawmakers to reject the legislation introduced by Senator Barbara Boxer (D-Calif.). The legislation would result in consumer confusion, not consumer education, according to the letter.

The trade groups noted that the products of biotechnology are safe and have cleared regulatory hurdles at the Food and Drug Administration (FDA), Environmental Protection Agency and the Department of Agriculture. "These products would not be allowed on the market if they had not met the highest U.S. safety standards, the letters said.

Earlier this year, AFFI appealed to FDA to refrain from mandating additional labeling requirements, which threaten to jeopardize the public's perception of the safety of biotechnologically derived foods. The Institute believes that if such foods are substantially equivalent to their conventional counterpart, there is no need for a specific label statement.

A pivotal issue which could impact the future use of biotechnology in the frozen food industry, and in the food industry in general, is whether U.S. consumers will continue to accept food biotechnology as a positive development that requires no special regulatory framework.

Imported Food Safety

Sen. Susan Collins (R-Maine) is planning to introduce legislation to establish new enforcement authorities for the Food and Drug Administration (FDA) in regulating imported food, as well as authorize funding for food safety research.

The legislative proposal is nearly identical to the bill she introduced last year, S. 1123, with the exception of minor changes designed to ensure referral of the new measure to the Senate Health, Education, Labor and Pension (HELP) Committee rather than the Committee on Agriculture, Nutrition and Forestry. Senator Collins is a member of the HELP Committee. The revised bill differs from S. 1123 in that the term "perishable product" has been substituted for the word "food" throughout.

Following the introduction of S. 1123, the bill was referred to the Committee on Agriculture, and no further action was taken.