Even with its “new” risk-management approach, much of the proposed Preventive Controls rule of the Food Safety Modernization Act (FSMA) is, in its simplest form, a back-to-basics approach to identifying and preventing hazards for food safety.
Sanitation, for example, has always been a basic of a complete food safety program, and this is no different in FSMA. Related words such as sanitation, sanitary, sanitizing, etc. are included 348 times (and “clean” another 185 times) in the proposed rule; and sanitation controls is listed as one of the four key preventive controls to be included in the required written food safety plan (along with process controls, food allergen controls, and a recall plan).
Sanitation controls are critical, the rule explains, because any time a food is exposed to the environment, there is the potential for it to be contaminated. Appropriate sanitation controls in the food facility, however, can minimize the presence and transfer of contaminants to food. Additionally, FDA notes that while the need for sanitation controls related to food workers has long been recognized; “appreciation of the importance of sanitation controls in preventing contamination due to environmental pathogens is more recent.”
The inclusion of sanitation controls as a key factor also is based on findings of a FDA CGMP Modernization Working Group, convened in 2002 to determine if the GMPs were in need of revision.
As one aspect of its review, the group evaluated cGMP-related food recalls, and summarized key factors that contributed to the food safety issues that initiated the recalls. For recalls during 2008–2009, 17 percent were found to have lack of sanitation controls as a contributing factor.
In its report, the group then presented seven opportunities for CGMP modernization, one of which focused on sanitation, recommending: “Requiring food processors to develop and maintain written cleaning and sanitation procedures, at a minimum for all food-contact equipment and food-contact surfaces, that define the scope, cleaning, or sanitation objective; management responsibility; monitoring; corrective action; and recordkeeping associated with the cleaning or sanitation procedure.”
With FSMA’s inclusion of requirements for a written food safety plan in the Preventive Controls rule, the new industry buzz phrase for sanitation and food safety in general is: “If it’s not in writing, it wasn’t done.”
Although the proposed rule goes beyond HACCP, FDA references HACCP repeatedly in the proposed rule. As applies to sanitation, part §117.135(d) of the proposed rule references the eight areas of sanitation of the seafood and juice HACCP.
As explained in the proposed rule, HACCP regulations require monitoring for the eight specified sanitary conditions and practices (referred to as SSOPs) regardless of whether or not these conditions and practices are related to hazards that are reasonably likely to occur. However, the HACCP regulation recommends but does not require written SSOPs for these eight areas.
In contrast, the proposed Preventive Controls rule would require written procedures for identified areas of sanitation and, in addition to monitoring and corrective actions as required in seafood and juice HACCP, would require monitoring procedures and verification activities. The eight areas are:
- Safety of the water that comes into contact with food or food-contact surfaces or that is used in the manufacture of ice.
- Condition and cleanliness of food- contact surfaces, including utensils, gloves, and outer garments.
- Prevention of cross contamination from insanitary objects to food, food packaging material, and other food-contact surfaces, including utensils, gloves, and outer garments, and from raw product to processed product.
- Maintenance of handwashing, hand-sanitizing, and toilet facilities.
- Protection of food, food packaging material, and food-contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants.
- Proper labeling, storage, and use of toxic compounds.
- Control of employee health conditions that could result in microbiological contamination.
- Exclusion of pests.
While it is unlikely to have much impact on the general sanitation provisions of the Preventive Controls rule, it is important to note that FDA is currently revising language in key provisions of the proposed Preventive Controls and Produce Safety rules that affect small and large farmers. FDA plans to reissue these for comment in early summer.
The author is Editor of QA magazine. She can be reached at firstname.lastname@example.org.