FSMA’s GMPs: Blocking Risks of Cross-Contamination

The FDA has announced, or perhaps admitted, that the current Good Manufacturing Practices (cGMPs) as outlined in 21 CFR 110 do not adequately address the safety issues associated with the manufacturing, processing, packing, or holding food products. Indeed, “high-profile outbreaks of foodborne illness…strik(ing) one in six Americans each year have caused a widespread recognition that we need a new, modern food safety system that prevents food safety problems in the first place.” The FDA, through the proposed Food Safety Modernization Act (FSMA), is attempting to decrease risk by imposing regulations on how facilities manage their food safety systems. They have data to suggest that governmental oversight is helpful. For example, between 1976 and 1997, the average size of a Listeria monocytogenes outbreak was 53.8 cases. After PulseNet, between 1996 and 2004, the average outbreak involved 21.5 cases and with the CDC Listeria initiative in conjunction with PulseNet (2004 to 2008), the average outbreak was reduced to 7.2 cases. These data suggest that increased surveillance decreased food safety cases in the U.S. from 1976 to 2008. Why then are there still multistate outbreaks that include numerous deaths, as in 2011 when the largest Listeria outbreak occurred due to contaminated cantaloupes that sickened 1,476 and killed 33? The fundamental question is this: Will GMPs included in FSMA be enough to control the risk of cross-contamination for hazards in food manufacturing?

FSMA Proposed Revisions

The FSMA changes would require facilities to have a written Food Safety Plan to include the following elements: a risk-based hazard analysis, preventive controls for hazards determined to be reasonably likely to occur, monitoring, corrective actions, verification, and associated records and documentation.

Concomitant to a risk-based hazard analysis, proposed FSMA regulations also state that there must be formalized and documented supporting preventative control programs that reduce or eliminate identified hazards. Hazard plans are only the start of a food safety process because they merely outline the hazards and controls to minimize or reduce their risk. Once the hazards have been identified, it is incumbent upon the plant to devise preventative control programs to address activities of the manufacturing process that can reduce or eliminate them. These programs, outlined in FSMA include Manufacturing Process, Allergens, Sanitation, and Recall. It is also stated that the facility must develop “other” programs “as needed.”

Proposed cGMPs

While FDA is not specifically requiring cGMPs as a Preventive Control Program (at this time), subparts of the current 21 CFR 110 may be redesignated and included in 21 CFR 117. Primary proposed provisions include programs that address: allergens, personal hygiene, plants and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, warehousing and distribution, and employee training.

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