If the product in violation is not voluntarily recalled by a firm, FDA will issue a recall order and must provide a hearing within two days of the order. Refusal to comply can lead to injunction, criminal charges, and civil fines.
Another authority under the new law is something called “Administrative Detention.” Here FDA has the authority to detain products it believes are in violation of FDA rules, and this requires only a “reason to believe” that the food or feed is adulterated or misbranded. Products may be detained up to 20 days, with a 10-day extension possible.
FSMA also provides what is called “Whistle-Blower Protection.” Under this provision, employees have the right to report violations of FSMA or FDCA, to their employer or authorities with no retribution, discrimination or loss of their job. If the employee feels they have been subject to retribution, they may report concerns to the U.S. Department of Labor, who will assign Occupational Safety and Health Administration (OSHA) to investigate. If found liable, a firm may owe for back pay, benefits, damages, legal fees, litigation costs and witness fees.
Another area the new law covers is “Enhanced Record Access.” This comes along with the “reasonable belief” clause cited above — where FDA may believe that a food or feed will cause serious adverse health effects. An example of serious adverse health impact would be horse feed contaminated with elevated levels of monensin antibiotic. In these cases, the firm must provide access to records for the product in question as well as access to records for any other article of food or feed that may also have been affected. This access pertains to processing, packing, distribution, receipt, holding or importation records.
FSMA also requires manufacturers to register with FDA and re-registration is required every two years. This registration commences October, 2012. New regulations also provide for suspension of facility registration by FDA if there is reasonable probability of causing serious adverse health consequences or death to humans or animals.
Pending FSMA regulations
Preventive standards and food safety plans
Animal food facilities will be required to analyze food or feed hazards in their manufacturing systems, identify and implement preventive controls to these hazards, monitor the controls and maintain monitoring records, and conduct verification activities. FDA will be using a Hazard Analysis Critical Control Points (HACCP) approach in developing this new regulation, and firms must document their controls through a “Food Safety Plan.” (See “How to Improve Grain Quality Through Hazard Prevention” on page 16 for more information on developing Food Safety Plans.)
Some example controls for animal feed include correct labeling of pet and animal feed to take into account different nutritional requirements, control of feed nutrient content, control of Salmonella in pet food (could cause illness in humans by cross-contact during pet feeding), and finally control of aflatoxin contamination in dairy feed — which could cause carcinogenic residue in milk consumed by humans.
Prevention standards mandates: Protection against intentional adulteration (food defense)
These regulations deal with the prevention of malicious attacks on our food system, and will require vulnerability assessments of production facilities. These assessments will then be used to develop mitigation strategies to prevent food terrorism incidents.
Prevention standards mandates: Sanitary transportation of food
This section addresses implementation of the Sanitary Food Transportation Act of 2005, which requires persons engaged in food transportation to use sanitary transportation practices to ensure that food is not transported under conditions that may render it adulterated. Originally due out seven years ago, this regulation will have a significant impact on rail and truck transporters of feed.