Great uncertainty seen around food safety legislation outcome

by Jay Sjerven
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WASHINGTON — With wide differences between House and Senate versions of food safety legislation, the final shape the pending law will take remains uncertain, said John W. Bode, an attorney with Olsson Frank Weeda Terman Bode Matz P.C., Washington.

Mr. Bode spoke Oct. 21 about food safety legislation at the NAMA annual meeting at the Sofitel Lafayette Square hotel in Washington.

With regard to food safety, the political environment in Washington has changed substantially, Mr. Bode said.

"It was not just the November election," he said. "Food industry chief executive officers have been paraded before Congress in a very hostile environment. They were sworn in as if they were under criminal investigation. Many of the questions they were asked were inappropriate and hostile. The atmosphere reflected high-visibility outbreaks for foodborne disease and a decline in consumer confidence in the Food and Drug Administration."

While current legislation targets the Food, Drug and Cosmetic Act, Mr. Bode said similar changes are expected from the Agriculture committees for the meat and poultry sectors.

Most of Mr. Bode’s presentation was devoted to parsing out differences between legislation passed in the House in July with legislation under consideration in the Senate.

The House bill, the Food Safety Enhancement Act of 2009, H.R. 2749, passed in July by a 283 to 142 vote.

"Almost all the opposition was Republican," Mr. Bode said. "The truth is that the bill has considerable Republican support. The opposition relates to some broader factors."

A Senate bill, which will be considered seriously when the health care debate is completed, is less hostile than the House version, Mr. Bode said.

"The Senate bill has strong bipartisan support, sponsored by senators Durbin, Burr and Gregg," Mr. Bode said. "It should be taken shortly after health care reform."

The House and Senate bills hardly mirror one another, Mr. Bode said. To the contrary, they could be viewed as "the two poles" of the food safety debate, he said.

He warned of likely pressure to make the Senate bill more like the House bill, particularly from Senator Tom Harkin of Iowa, chairman of the Senate Committee on Health, Education, Labor and Pensions.

"You need to pay careful attention to the House bill," he said.

Among provisions in both houses representing significant changes is a requirement for periodic re-registration of food facilities with prohibitions against unregistered facilities from conducting interstate commerce. Stronger preventive control plans will be required in both bills.

"There will be a more substantial Food and Drug Administration presence in examining operations, examining plants of food companies, including performance standards," Mr.

Bode said.

Prospective new fees include registration, export certification, re-inspection and recall costs.

A likely outcome of the legislation described by Mr. Bode as a "major change" is the creation of requirements that the F.D.A. accredit third-party inspectors.

"If they find the certifying agent wanting, they will have the right to yank the certification," Mr. Bode said. "It is unclear what will happen to entities that have been certified by that certifier."

More inspections are likely with the legislation, Mr. Bode said, with visits every four or five years. "This was a matter of congressional education," he said. "There had been discussion of inspections every six months, but then someone did the math."

Mr. Bode noted the House bill has provisions for a tracing system for food going back to the farm, rules that originally included all food. He asked, "How would that work for grain that would yield information meaningful for food safety?" He congratulated NAMA for helping gain an exemption for grains.

A reportable food registry rule change "has people in the food service industry pretty animated," Mr. Bode said. While such a registry already exists, the updated versions extend the requirement to report incidents from the head of a plant to anyone who works with food, he said.

"Failing to report will be a criminal offense," he said. "The Senate version does not have this provision. The House bill would require submission to F.D.A. any analytical test results. The Senate bill has no such provisions."

Record keeping represents another difference between the two bills with the House requiring storing of records for three years.

Penalties in the House bill total up to $250,000 against a corporation for a violation of the act with $1 million per proceeding. Acknowledging that "this is the kind of issue that only lawyers get worked up about," Mr. Bode expressed concern that the penalties will become a lever for the F.D.A. to impose its will, even beyond the law, using consent orders.

Criminal penalties and country-of-origin labeling currently are part of the House legislation but not the Senate, Mr. Bode said.

Mr. Bode described Margaret Hamburg, the F.D.A. commissioner, as "very methodical and purposeful, very committed to enforcement."

"This change means that warning letters from the F.D.A. are a sign of imminent action," he said. "It is no longer a signal that ‘We need to sit down and talk.’ You should expect a more aggressive regulatory approach using the authority that the F.D.A. has."

The food industry has not been uniform in its response to the legislative proposals, Mr. Bode said. Various reasons may be behind this response, including a desire not to be seen as opposing food safety.

"There is a lot of hardball being played," he said.

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