Co-authored by Brian Gross

Foodborne IllnessThe recently enacted Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011, provides the U.S. Food and Drug Administration (FDA) with increased power.  The FSMA, which represents the culmination of more than a decade long effort to reform this country’s food safety oversight system, aims at limiting future occasions of foodborne illness by changing the FDA’s focus from reacting and responding when outbreaks occur to outright prevention.  While the FSMA certainly gives the FDA additional authority to regulate the production of food throughout the farm to table chain, the question remains whether it will have the necessary resources to do so.

The FDA is an agency of the United States Department of Health and Human Services which is responsible for overseeing an incredibly broad range of goods, including food, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, veterinary products, and cosmetics, amongst other things.   The FDA’s food-related responsibilities include regulation and oversight of roughly 80% of our country’s food supply, namely, all food products with the exception of meat and poultry.   The FSMA has given the FDA numerous new tools to perform its duties, a few of which will be discussed herein, including, mandatory recall, increased oversight and regulation of American facilities and those of foreign suppliers, and the implementation of a few small measures aimed at creating a more informed consumer.

Under the old system, the FDA did not have the authority to mandate recall of a food product; all recalls were voluntary.  In other words, companies could not be forced to recall knowingly unsafe products from the market.  Generally, the FDA’s lack of authority in this respect was alleviated by the various forms of soft power it could use to motivate companies to “voluntarily” recall their product, including, the threat of increased regulation, criminal prosecution, potential civil liability, and negative press.   Nevertheless, there were frequent instances of undue delay in which contaminated products remained in the marketplace longer than necessary, causing more consumers to become sick.  Under the new system, companies will still be given the opportunity to voluntarily initiate a recall.  If they fail to do so, however, and the FDA reasonably believes the subject-product to be contaminated, it has the authority to mandate a recall, ensuring that the scope of the potential outbreak remains as small as possible.

The FSMA provides for increased regulations with respect to American companies which process foods.   In order to operate, all American food facilities are required to register with the FDA every two years.  Further, these facilities must develop and implement a comprehensive prevention control plan which identifies the hazards specific to their product and/or facility and illustrates their plan for monitoring and preventing those hazards, as well as remediation in instances when contamination occurs.  If companies fail to comply with the new regulations or are associated with an outbreak of foodborne illness, the FDA has authority to suspend their registration, effectively ceasing operation of the facility pending resolution of the problem.  Companies whose facilities are de-registered can lift the stay on their operations by submitting a corrective action plan to the FDA or successfully contesting the grounds for suspension.  The FDA’s newfound authority is significant because it gives the enactment of increased regulations some teeth, as the FDA now has the power to control or prevent outbreaks by shutting down facilities which neglect to comply with its requirements.

Approximately fifteen percent of the United States food supply is imported, which necessitates increased FDA oversight of foreign goods being brought into the U.S.  The FSMA provides the much needed oversight through several measures, including; (1) mandated foreign facilities inspections; (2) placing the onus on importers to verify the adequacy of the exporter’s control plans; (3) increased cooperation with foreign governments; and (4) requiring certifications as a prerequisite for admission into the country.   The FSMA requires that the FDA inspect no fewer than 600 foreign facilities in 2012.  Further, the act requires that the number of foreign inspections conducted by the FDA double each year from 2012 through 2016, when the FDA must conduct no fewer than 19,200 foreign inspections.   Additionally, the FSMA delegates to American importers the charge of ensuring the sufficiency of foreign suppliers’ control plans, by requiring importers to put a foreign supplier verification program in place.  The foreign supplier verification program requires importers to avow that the foreign suppliers’ facilities comply with all FDA requirements.  The FSMA also mandates that the FDA reach agreements with foreign governments providing for data sharing and multilateral acceptance of each others’ inspections and testing.  Such agreements permit the FDA to lighten its own load by sharing the responsibility for verifying the safety of imported goods with the country from which it originates.  Finally, the FSMA requires that high-risk food and/or food originating from high-risk areas be certified before being permitted into the U.S.  Certifications can be provided either by the foreign government of the originating country or a third-party auditor accredited by the FDA.   This provision also requires that importers notify the FDA of incoming shipments, including providing the anticipated date of arrival and port of entry.

The FSMA also includes regulations which will assist in educating the consumer of potential risks and recalls.   Under the FSMA, the FDA must develop a “consumer friendly” website which allows for easy searches of recalled goods.   The website will provide information pertaining to the recalled product, the status of the recall, the contamination and the resulting illness.  Further, food producers must provide local grocers with notices of a recall, which grocers are required to post in a highly visible area.   These posting will enable food shoppers to access up-to-date information regarding potential sources of foodborne illness at the time when that information is most useful.  These measures will provide consumers with much needed access to information, educating them with respect to foodborne illness and helping to stop the spread of contaminated goods.

The FSMA is undoubtedly progressive in that it heightens the standards imposed upon the producers and importers of food products in the U.S. and provides the FDA with additional power to enforce these regulations.  The increased scope of FDA responsibility and oversight, however, means that the FDA will also need significant increases in funding and manpower to enact and carry-out the FSMA’s vision.  After all, the only way the FSMA can actually reform this country’s food safety oversight system is if the FDA is given the opportunity to put into place the recently legislated programs and ensure compliance with the new regulations.  Without a significant increase in the FDA budget, there is little chance that it will ever have an opportunity to fully realize the potential provided for under the FSMA.   Consider the requirement that the FDA conduct inspections of 600 foreign facilities in 2012 and 19,200 foreign facilities in 2016.  Caroline Smith DeWaal, the director of the food safety program for the Center for Science in the Public Interest, estimates that the cost of performing a foreign facility inspection is $25,000.   Accordingly, the cost of performing 19,200 such inspections in 2016 will be approximately $480 MM, approximately 20% of the FDA’s 2011 $2.45B budget.   That percentage is staggering when you consider that foreign inspections are a small part the FDA’s regulation of food, and food is one of many goods which the FDA is responsible for regulating.   Accordingly, while we applaud Congress’ efforts in enacting legislation which will aid in preventing future outbreaks of foodborne illness, it will be years before we can truly evaluate the extent to which the vision of this country’s food safety system reflected in the FSMA becomes a reality.   Based on the current funding afforded the FDA and our governments many budgetary problems, its hard not to be skeptical.