Senate passes food safety bill ... but
December 7, 2010
by Jay Sjerven
WASHINGTON — The U.S. Senate voted 73 to 25 to approve the F.D.A. Food Safety Modernization Act, S. 510, which, if enacted, would give the nation’s food safety system its first major overhaul in 70 years. But elation over the bill’s passage among consumer activists and food industry associations quickly turned to frustration when it was discovered a portion of the bill calling for new fees violated congressional procedures outlined in the Constitution. Some of the fees were considered revenue raisers, i.e. taxes, and all tax measures must originate in the House of Representatives.
The Senate’s error put the House leadership on the spot as the House may have to consider passing the Senate bill despite reservations that otherwise may have prompted a conference between the chambers to resolve differences, and even if the House passes the Senate bill and sends it back to the Senate, the bill may be caught in the logjam building because the Republican leadership said it would block all legislative action until the fate of the Bush-era tax cuts was determined and a continuing resolution is passed to keep the government functioning until appropriation bills are passed.
That food safety reform had the support of the Obama administration and won the approval of 73% of the nation’s senators and nearly two-thirds of the members of the House and still may not become law before Congress adjourns at the end of the year chagrined reform proponents.
The F.D.A. Food Safety Modernization Act long enjoyed strong bipartisan support in the Senate. Its passage was delayed until the lame-duck session primarily because of obstacles raised by Senator Tom Coburn of Oklahoma that required the bill to run a gauntlet of procedural votes before advancing to the final tally.
“Today’s vote will finally give the Food and Drug Administration the tools it needs to help ensure that the food on dinner tables and store shelves is safe,” Senator Richard Durbin of Illinois, who introduced the bill more than two years ago, said after the Senate finally voted on Nov. 30. “This bill will have a dramatic impact on the way the F.D.A. operates, providing it with more resources for inspection, mandatory recall authority, and the technology to trace an outbreak back to its source. I am proud of the work we have done, but our vigilance must continue.”
Senator Mike Enzi of Wyoming, ranking minority member on the Health, Education, Labor and Pensions (HELP) committee, said, “The F.D.A. Food Safety Modernization Act will help protect the food served on dinner tables across the entire country. It addresses issues including food-borne illness outbreaks and product recalls. This bill helps make sure our imported food is safe.
“What the bill the Senate passed today would not do is change how meat is regulated or sold. The bill would not regulate backyard gardens, produce grown for sale at farmers markets, locally sold foods, organizational picnics or bake sales, or food grown by individuals and their families. The bill would not add recordkeeping requirements for farms or allow the F.D.A. to inspect farms.”
The House of Representatives passed its version of food safety reform legislation, the Food Safety Enhancement Act, on July 30, 2009. The House leadership now must decide whether to pass the Senate version of the bill, which House Democratic leaders indicated they might consider because of other pressing business and time constraints of the lame-duck session, or request a conference with the Senate to resolve differences and produce a joint bill that may be passed and sent to the president.
It was noted the House Democrats indicated they might consider supporting passage of the Senate bill before the latter took its final form with the inclusion of the controversial Tester amendment, which exempts from the bill’s requirements small producers whose annual sales are less than $500,000 and who market their products within a 275-mile radius of their farms or facilities.
Representative Henry Waxman of California, chairman of the House Committee on Energy and Commerce, told Food Business News after the Senate vote, “I am glad that the Senate sent over the food safety bill, and we are evaluating our options moving forward.”
Reviewing the details
Both Senate and House bills would require food facilities, foreign (those exporting products to the United States) and domestic, to develop and implement plans for preventive controls to minimize the risk of food contamination, increase the frequency of F.D.A. inspections of food facilities based on risk assessment and provide the F.D.A. with mandatory recall authority. Each bill would require registration of food facilities with the F.D.A. empowered to suspend a facility’s registration if there was reasonable probability food from the facility may cause serious adverse health consequences or death. Each bill would give the F.D.A. greater access to company records in the course of inspection or investigation. Each bill would enhance tracking and tracing of high-risk foods.
But there were differences between the two bills on how these ends would be accomplished, some minor but others not. Among the more contentious differences was the House bill’s levying of an annual facility registration fee to help defray the costs of increased inspections. The Senate instead requires biennial as opposed to annual registration and would levy no registration fees.
Another key difference is how the bills approach traceability. The House bill includes a section directing the F.D.A. to establish a tracing system requiring manufacturers and handlers of food to maintain “a full pedigree” of the origin and previous history of the food; link that history with the subsequent distribution of the food; establish and maintain a system for tracing food that is interoperable with the systems established and maintained by other such persons, and use a unique identifier for each facility.
S. 510 instead requires the F.D.A. to launch at least two pilot studies, one involving the processed food industry and the other the fresh produce industry, each with the aim of developing and demonstrating methods for rapid and effective tracking and tracing of foods in a manner that is practicable for facilities of varying sizes, including small businesses, and developing and demonstrating appropriate technologies to be used. The goal was to establish within the F.D.A. a product-tracing system to receive information that improves the capacity of the Secretary of Health and Human Services “to effectively and rapidly track and trace food that is in the United States or offered for import into the United States.”
With regard to private recordkeeping obligations in connection with product tracking and tracing, the Senate bill specifically stated an individual entity’s records would not be required to include “a full pedigree, or a record of the complete previous distribution history of the food from the point of origin of such food,” nor would they need to include a record of recipients of a food beyond the immediate subsequent recipient of such food.
The challenges ahead
Members of the House have had the opportunity to view the evolution of the Senate bill during the 16 months since they passed the Food Safety Enhancement Act, and they may have pretty firm ideas on what compromises with the Senate they’re willing to make in order to forward a bill to the president before the 111th Congress adjourns. But the Tester amendment may be difficult for the House to accept given the House bill overall seeks more stringent requirements on private entities than does the Senate bill.
The Tester amendment resulted in the withdrawal of the support of the Produce Marketing Association and the United Fresh Produce Association from the Senate bill. Bryan Silbermann, president and chief executive officer of the P.M.A., said, “We stand firm that the entire produce industry must be committed to providing safe fruits and vegetables, no exceptions, because pathogens don’t discriminate based on company size, commodity or distance to market.”
Robert Guenther, senior vice-president, public policy, at United Fresh, urged the House leadership to request a conference to reconcile differences between the House and Senate bills.
“The House bill makes no arbitrary exemptions from basic food safety standards,” he said. “This principle is at risk of being discarded for temporary convenience to pass a bill, but it is a fundamental mistake that will come back to haunt consumers, the food industry and even those producers who think they are escaping from food safety requirements.”
At the same time, other members of the coalition supporting the Senate process and bill called on the House to accept the Senate bill with no changes.
“This is a sound and balanced approach to food safety in the United States,” said Robb MacKie, president and chief executive officer of the American Bakers Association. “It gives the F.D.A. needed tools to ensure consumers have confidence in our food by building on the industry’s good manufacturing processes.”
The National Grain and Feed Association also called upon the House of Representatives to pass the Senate bill without changes.
“While we continue to have issues with both bills, the Senate’s version is much preferable to the House-passed legislation, and we would have very serious concerns if the House were to deviate from the Senate-passed measure if it proceeds to consider the bill during the congressional lame-duck session,” said Kendell W. Keith, president of the N.G.F.A.
“This landmark legislation provides F.D.A. with the resources and authorities the agency needs to help strengthen our nation’s food safety system by making prevention the focus of our food safety strategies,” said Pamela Bailey, president and c.e.o. of the Grocery Manufacturers Association. “We urge the House of Representatives to follow suit so the president can sign this important legislation as soon as possible.”