South Carolina BAR Journal
SC Lawyer, Sepetember 2011, #3.
A A New Era in Food Safety Regulation
South Carolina LawyerSepetember 2011 A New Era in Food Safety RegulationBy Victor S. Mroczka According to the Center for Disease Control and Prevention, about 48 million people (one in six Americans) get sick, 128,000 are hospitalized and 3,000 die each year from food-related diseases. http://www.cdc.gov/Features/dsFoodborneEstimates/. Many of these may have been avoided had preventive steps been in place to ensure the safety of the U.S. food supply and control the hazards that cause such adverse effects.
With this in mind, on January 4, 2011, President Obama signed into law the Food Safety Modernization Act (FSMA), which gave the U.S. Food and Drug Administration (FDA) broad authority to act to ensure the safety of the U.S. food supply. FDA Food Safety Modernization Act, Pub. L. No. 111-353, 124 Stat. 3885 (codified as amended in scattered sections of 21 U.S.C.). Specifically, the FSMA gives the FDA five tasks:
1. Institution of prevention-based controls across the U.S. food supply; 2. Requiring the inspection of food producers, both foreign and domestic; 3. Ensuring that imported foods meet U.S. standards and are safe for U.S. consumers; 4. Mandatory recall authority so that the FDA will no longer have to rely on industry for recalls; and 5. Strengthening existing collaborations among all food safety agencies, both foreign and domestic.Id. In other words, Congress has given the FDA a legislative mandate to put in place controls so that it can tackle a food safety issue before they impact U.S. consumers of food products, not just after.
One area of particular interest involves the importation of food into the United States. Today, the U.S. food supply is made of food products from more than 150 countries. http://www.fda.gov/Food/FoodSafety/FSMA/ucm247559.htm. The FDA is the agency primarily charged with ensuring that imported food meets U.S. standards and is safe for U.S. consumers.
On May 5, 2011, the FDA issued its first two rules under the FSMA that have a direct impact on imported food products. Many companies located in and around customs ports such as Charleston and Savannah are involved in the importation of food products and they (or those representing them) should become familiar with these new responsibilities required by the FDA.
Rule #1: First, do no harm
While the "do no harm" phrase is generally thought of as applying to the medical profession, it can equally be applied to the regulation of food as well. The first rule issued by the FDA deals with its ability to prevent potentially unsafe food from entering U.S. commerce, and by extension U.S. households. Prior to this, the FDA's main authority allowed it only to detain food products when there was credible evidence presented that the subject food was contaminated or mislabeled in such a way that it would cause serious harm or death to people or animals. A recent example of this occurred in 2007 and 2008 with the melamine contamination scares involving pet...