FDA Law Shifts Gov. from “Reactive to Proactive”

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On Jan. 4, 2011, President Obama signed into law the Food Safety Modernization Act, which gives more power to the FDA and upgrades safety regulations. The law affects all whole and processed foods except for those under regulation by the U.S. Department of Agriculture. This new law is a big step forward for food safety; Fairfield University’s own Professor Debra M. Strauss of Business Law explained the rules of the Food Safety Modernization Act and the impact it will have on Americans’ food.

How big of an impact does the FDA have on what we eat and medicine we take?

The FDA has the responsibility for overseeing 80 percent of the nation’s food supply and exclusive control over prescription and over-the-counter drugs.  Note, however, that the U.S. Department of Agriculture handles meat and poultry, so these products are not covered by the new law.  Overall, the FDA has a potentially tremendous impact on these areas of our daily life.

What exactly does The Food Safety Modernization Act do? How does it empower the FDA?

This legislation will strengthen food law by enlarging powers of the FDA to inspect plants and order recalls, powers and abilities it did not previously have.  The new law was prompted by recent incidents involving contamination, particularly in eggs, peanuts and produce.

According to the newest figures from the Centers for Disease Control, “Each year roughly 1 out of 6 Americans (or 48 million people) gets sick, 128,000 are hospitalized, and 3,000 die from food borne diseases.” The FDA has in the past had to rely on food companies to voluntarily remove their products from stores.  By granting the agency resources and authority to stop outbreaks before they begin, this shifts the government’s policy from reactive to proactive.

In addition to inspection and recall powers for the FDA, the new law will require food producers to develop food safety plans, including identifying potential risks of contamination or other hazards, and identifying the mechanisms through which those risks would be controlled.  The legislation requires that the FDA create new produce safety regulations for producers of the highest risk fruits and vegetables; and increase inspections of domestic and foreign food facilities, directing the most resources to those operations with the highest risk profiles.  The riskiest domestic facilities would be inspected every three years (in contrast to the rare inspections conducted currently).  In addition, the law will require grocery stores to proactively alert consumers about recalls.

In addition, this legislation grants the FDA more control over food imports, including increased inspection of foreign plants and the ability to set standards for how fruits and vegetables are grown abroad.  The new law will allow the FDA to require importers to certify the safety of their foods before entering the U.S. food supply and to deny entry to foods that do not comply with U.S. food safety requirements or requests for inspections of overseas facilities.

The new law does, however, include exemptions from FDA registration requirements for farms that market more than 50 percent of their product directly from the farm or from farm stands or farmer’s markets, as well as less costly alternatives to HACCP (Hazard Analysis and Critical Control Plans).  Small farms will not need to comply with the traceability and recordkeeping requirements if they sell directly to consumers or grocery stores, but they will have to take other, more “scale-appropriate” measures and will be given priority in a competitive grant program for food safety training.

How will the food tracing system work?

The new law establishes a food tracing system to locate the source of food contamination.  Through this system, consumers can be rapidly identified and deaths and illnesses minimized in the event of a contamination outbreak.  The law will require farms and processors to keep records, as well as permit the FDA access, in order to help the government trace recalled foods.

What do you think the outcome of this new law will be?

This is the first time in 70 years that food law has been changed significantly.  With bipartisan support from both houses of Congress and the President, this new legislation represents a mandate that food safety is at this moment becoming a priority.

As a first significant step in the right direction towards improving food safety, the time is ripe for a reassessment of other areas of food laws—particularly genetically modified foods and the use of milk and meat from cloned animals and their progeny—which are allowed under current U.S. law with no labeling, pre-approvals, or post-market monitoring.  In addition to causing agricultural trade problems, these areas warrant special regulation because they raise concerns for consumers on the safety of the national and global food supply.

Hopefully, there will not be a problem due to funding, as implementing these enlarged powers for the FDA will cost $1.4 billion over the next five years.  The financial component of this legislation is essential to enable the FDA to enforce the new requirements, carry out inspections, and so forth.  In spite of the political rhetoric, there has been and should continue to be a broad coalition of support because this initiative actually benefits businesses, which have lost enormous amounts of money in recent years from food scares.

The fact that this law has received such widespread support from industry trade groups of food producers and grocery stores and the U.S. Chamber of Commerce, as well as food safety and consumer groups, indicates that the food industry realizes a preventative approach of heightened food safety is ultimately in its best interest.

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