House Energy and Commerce Chairman Henry Waxman is prioritizing improving FDA's food safety enforcement over creating a separate food agency.

The California Democrat says it is critical for food safety legislation to pass "in the next few months."

Food safety reform has climbed Congress' priority list due to hundreds of cases of food-borne illness, nine deaths and a flurry of product recalls related to salmonella-tainted peanut products manufactured by the Peanut Corporation of America (¹ Also see "Peanut Butter Firm’s GMP “Deviation” Offers Lessons For Manufacturers" - Pink Sheet, 2 February, 2009., p. 8).

Waxman said a March 11 Health Subcommittee hearing on the food safety was "the first step on the legislative path."

"A lot of good points have been made about the need to improve our fragmented system and ensure that food safety is given appropriate attention by our regulatory agencies," he said.

However, he added, that "reorganizing federal bureaucracies takes a great deal of time - and this is time we do not have when it comes to food safety."

Waxman said his first priority is to fix problems in the current system. After reforms are passed and implemented, Congress could consider "whether a reorganization is necessary" for food safety enforcement, he said.

Subcommittee Chairman Frank Pallone, D-N.J., noted firms "should be responsible for the products they make" and regulatory agencies must hold firms accountable.

In his opening remarks, Pallone said legislation he and Michigan Democrats John Dingell and Bart Stupak introduced Jan. 28 offers a possible solution (see story, p. 14).

The FDA Globalization Act of 2009, H.R. 759, proposes a comprehensive approach to improving the safety of food, drugs, devices and cosmetics (² Also see "Salmonella Problem Stirs Food Safety Bills, Hearing From Energy & Commerce" - Pink Sheet, 2 February, 2009., p. 6).

However, Waxman's preferred approach indicates the House will likely split up the comprehensive FDAGA into bite-sized chunks. He said FDAGA's food provisions are "an ideal starting point" and the committee will use FDAGA as "a foundation" for its legislation.

Food Safety Across Congress

Energy and Commerce Ranking Member Joe Barton is co-sponsoring the Safe Food Enforcement, Assessment, Standards and Targeting Act, H.R. 1332. The Texas Republican says the bill introduced March 5 "requires the FDA to focus its resources on high-risk facilities first, where we can get the most bang for our regulatory buck."

The bill includes provisions for mandatory recalls, a hazard analysis and risk-based prevention approach, collecting re-inspection fees, enhancing traceability and recordkeeping and focusing on imports.

Legislation introduced recently by Sen. Dick Durbin, D-Ill., the FDA Food Safety Modernization Act, S. 510, has some similarities to FDAGA's food provisions and could be a model for Waxman's bill.

While Durbin, the assistant majority leader and a close ally of the president, is on record for supporting creating a separate food agency, he said that is a long-term goal and S. 510 does not include such a provision (³ Also see "Durbin Food Safety Bill Emphasizes Targeted Fees, Industry Responsibility" - Pink Sheet, 9 March, 2009., p. 6).

Rep. Rosa DeLauro, D-Conn., has introduced the Food Safety Modernization Act, which would move some divisions out of FDA to form a Department of Health and Human Services agency for food safety. The bill, H.R. 875, has 40 cosponsors.

Rep. Anna Eshoo backs DeLauro's bill, saying more funding is necessary. "We are doing [food safety enforcement] on the cheap ... and as long as we do that, we'll be plagued" with contamination problems, the California Democrat said during the hearing.

Rep. Diana DeGette, D-Colo., agreed with Waxman not to rule out later looking into a separate food agency. Meanwhile, immediate legislative action is imperative and should include traceability provisions to form a comprehensive food safety system, she said.

A witness testifying at the hearing, William Hubbard, a former associate commissioner at FDA, said he agreed Congress should first address current problems before looking at a separate agency.

On what a food safety bill should include, Hubbard and the other witnesses testified they supported FDA having mandatory recall authority over foods and employing risk-based approaches for enforcement and inspection activities. They also emphasized food firms must develop safety plans.

The Oversight and Investigations Subcommittee has scheduled a hearing March 19 to discuss further the peanut product contaminations.

Reform Should Protect Small Business

At a same-day hearing, the House Small Business Subcommittee on Regulations and Healthcare discussed the impact from ongoing salmonella-related food recalls.

Subcommittee Chairwoman Kathy Dahlkemper, D-Pa., and other members heard testimony from FDA and the Department of Agriculture officials as well as executives with small businesses.

In her opening statement, Dahlkemper noted the recent food-borne illness outbreaks have made "clear the need to strengthen our nation's food safety net."

She said small businesses with "strong safety records end up being punished through a loss in consumer sales as well as the burden in clearing tainted product out of their inventory."

"Quick responses by all levels of the food industry are critical to save lives and protect consumers during product recalls," she said. "Too often, however, small businesses bear the brunt of financial losses, even when they were not at fault in the first place."

- Katie Stevenson (k.stevenson@elsevier.com)

First Course For Waxman: Fix Food Safety, Hold The Separate Agency Plan

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