In January 2011, President Obama signed the Food Safety Modernization Act. This Act, known as FSMA, directs the FDA to make sweeping changes to how America's food supply is regulated. For the following two years, not much happened. Although inspections and enforcement actions are now more frequent, the most anticipated new regulations remained under wraps.
On January 4, 2013—the second anniversary of FSMA's enactment—the FDA published drafts of two of the most important new regulations: the Produce Standards rule and the Preventive Controls rule. These rules are not in their final form, and won't be enforced for several years—but when they are, they will have a big impact on the industry.
For at least the next month, affected businesses can voice their opinions on the proposed rules by submitting written comments. Our next Commentary will discuss how to take advantage of this important opportunity to shape the proposed regulations. The FDA also obtained reactions to the proposed rules by holding three public meetings at which participants were encouraged to provide informal, face-to-face feedback. A report of the first of these meetings can be found below.
The FDA's Perspective on FSMA and the Two New Rules
The FDA views FSMA as the most important change to food regulation since the Food, Drug, and Cosmetic Act was passed in 1938. These changes will result in compliance costs to industry that the FDA estimates at well over $1 billion each year. Although the FDA is attempting to balance increased safety against the compliance costs, safety is its chief concern.
Accordingly, the FDA intends its new rules to be preventive, risk-based, and science-based. In English, this means, first, that the purpose of the additional regulations is preventing food-borne illnesses, rather than merely reacting to outbreaks.
Second, the nature of a firm's responsibilities for preventing contamination will depend on the risks posed by that firm's operations. This is both good and bad. It is helpful that the FDA recognizes that one-size-fits-all solutions are cumbersome and often inappropriate. But the flexibility of this approach also makes it harder to determine exactly what must be done to comply.
Third, the regulations are supposed to reflect real-world risks, as proven by scientific evidence, and mandate efforts that are scientifically proven to be effective in reducing these risks....
Read on by Jonathan Berman , June K. Ghezzi and Harold K. Gordon at: http://www.lexology.com/library/detail.aspx?g=1a2a3352-6c6e-42a3-8fc9-06924de6034f
