Food emergencies of all types, including intentional food contamination, have four distinct phases: prevention and preparedness, detection, response, and recovery. Although arguably one of the most important elements of a food emergency, incident recovery is usually absent in planning and funding compared to preparedness, detection, and response. Without a reliable recovery policy, food processors will likely have poor recovery outcomes following any disaster.
Poorly managed recoveries can lead to the closing of businesses, lawsuits, bankruptcy, loss of economic productivity, and unemployment. Perhaps most importantly, any missteps in the recovery phase also may lead to loss of consumer confidence in a commodity or the food supply in general. Additionally, the public could lose faith in the ability of food regulatory officials to ensure that products in the marketplace are safe.
Spinach & Tomatoes – Two Cautionary Examples
In September 2006, for example, E. coli O157:H7 caused a spinach recall that prompted a serious decline in sales for all bagged spinach products regardless of recall status. USA Today reported in November 2007 – one year after the recall – that the spinach industry experienced a 350 million dollar loss and a 20 percent reduction in sales from pre-recall levels.
Likewise, the tomato (and later pepper) recalls in the summer of 2008 – finally traced to Salmonella enterica serotype Saintpaul adulterated peppers from Mexico – cost Florida tomato growers an estimated $500 million, according to the Herald Tribune in July 2008. There was an additional loss of $200 million to the produce industry in general as consumer demand dropped for fresh produce. Many people directed the blame toward the poor response and recovery actions of U.S. Food and Drug Administration.
With unintentional foodborne illness outbreaks able to cause such widespread economic and social effects, the impact an intentional contamination incident would have on the safety, security, and public confidence of the food supply could be devastating. Therefore, it is in the best interest of food processors and the industry in general to develop recovery plans before an incident occurs. This will facilitate an efficient and speedy return to production and help alleviate the public’s confusion and possible mistrust of both the processor and the product. A recovery plan is also a requirement of the Food Safety Modernization Act (Section 1, Title 1, Sec. 103. Hazard analysis and risk-based preventive controls).
Features of a Recovery Plan
Characterization of the Incident – It is important to determine if the contamination incident is accidental or intentional. If industry authorities suspect an intentional act, then law enforcement needs to be involved. At that point, law enforcement agents must approve any pre-planned recovery actions before processors may implement those actions. This ensures the preservation of any evidence for future prosecution. Discussions with local and state law officials would be helpful in developing a comprehensive and effective recovery plan.
Clearance Goals – The goals and expectations of the recovery plan, in the case of a bacterial pathogen, is to validate the elimination of the contaminant, but sterility of the facility is not achievable. To determine clearance goals, there are several key considerations, including but not limited to: (a) the allowable level of bacteria within a “sanitized” facility; (b) the requirement for analysis of total bacteria load in the facility versus the demonstration and verification of sound cleaning and sanitizing procedures; (c) the requirement for waste storage and disposal; and (d) the specific requirements of local, state, and federal officials that must be met before the recovery process is complete and normal production continues. When such goals are being set, producers must keep in mind the recovery plan needs to ensure that they reduce the residual risks to a minimum to satisfy regulatory officials as well as customers and the public.
Site Containment and Preparation – After discovering a contamination incident, it is vital to identify and isolate the contaminated building(s) or area(s) within the building as soon as possible. For small facilities, this may mean shutting down the entire production process area, whereas for large facilities this could mean isolating only the contaminated area and restricting traffic between this area and unaffected locations within the plant. It is likely that production would continue in unaffected areas as long as there is no possibility of cross-contamination from the affected area.
To avoid cross-contamination, temporary structures made of lumber or metal covered with plastic sheeting, tarps, or other materials may be necessary around the contaminated area to eliminate airflow between affected and unaffected areas. The possibility of contamination also may necessitate erecting a roof and sealing all seams on the floor and walls to contain dust and organic matter within the area during the cleaning and sanitizing processes.
Authorities may need to establish a specific entry to and exit from the contaminated area – with proper decontamination controls such as hand-wash stations, footbaths, and appropriate-level personal protective equipment – before permitting anyone to enter or exit the contaminated area. A personnel monitor at each entrance/exit point would ensure that all workers, including outside contractors, are following the specific rules of restricted access to the area. In addition to a training program for establishing sanitary guidelines for all persons expected to monitor or enter the contaminated area, all workers must receive training for any changes in safety procedures required during the recovery process.
Sanitization and Decontamination – The sanitizing and decontaminating process begins after isolating the contaminated site. When using tools and equipment during the remediation process, workers must sanitize them before entering the containment area and, ideally, leave them in the area as dedicated tools for the remainder of the recovery process. If this is not possible, there must be an established protocol that employees and outside contractors must follow for sanitizing tools and equipment before entry and exit. When sanitation requires equipment removal, there should be a specified area located away from the usual cleaning area for equipment parts.
Sanitizing during the recovery process may be more intense than normal production cleaning and sanitizing, so plans should address this possibility. For example, cracked flooring or walls may need repair; equipment that workers cannot reliably decontaminate may need replacement; and floor drains may need reconstruction. To choose the types of cleaners and sanitizers, producers should evaluate some of the newer sanitizers such as gaseous chlorine dioxide, ozone, and vaporous hydrogen peroxide. These gaseous compounds may be the only sanitizer type that will adequately decontaminate processing equipment in enclosed areas.
Decontamination Verification – Verification could well be the most important step in the entire recovery process. Not only do regulatory officials need to give their approval before reinstating normal production, the producer must convince customers and the public that the processor has: (a) solved the problem; (b) taken steps to improve and protect the production process; and (c) ensured that the product is safe.
The most common verification is environmental sampling. Workers use sterile sponges or swabs to collect samples, which they send to a laboratory for contaminant analysis. Although many producers have an environmental sampling program as part of the normal sanitation process, the producer should collect many more samples in order to verify the recovery protocol. For example, adenosine triphosphate (ATP) bioluminescence could be helpful to evaluate the cleaning process but is not sufficient for sanitizing verification.
There are certain swab products on the market, similar to ATP bioluminescence types, that will enumerate total bacteria, coliforms, and E. coli, as well as be helpful in verifying sanitization and decontamination, but verification requires the producer to show the area is contaminant free by all reasonable standards. Even with such swab tests, the producer still may have to hold and test the first several production runs to complete the decontamination verification.
Communication – Producers should designate one specific group or individual to handle all communications, be it safety issues with employees, regulatory officials, law enforcement, or the media. It is important to have a single spokesperson to ensure complete, non-contradictory, and consistent information and updates when addressing the media, the customers, and the public. Public opinion will quickly erode if communications are confusing or uncertain.
Regardless of any requirements of the Food Safety Modernization Act, having a recovery plan to manage product contamination is good common sense. Such actions will limit the time required to restore the facility and will show regulatory officials, customers, and the public that the company is proactive in fixing the problem and has a genuine concern for public safety.
Wm. Mark Cosby
Wm. Mark Cosby has a MS and a Ph.D., both in microbiology. He has been employed by the Food and Drug Protection division of the North Carolina Department of Agriculture and Consumer Services since 2001. He started as the Chief Microbiologist for the division and currently serves as Agriculture Programs Specialist. He is also a Subject Matter Expert for the division’s Rapid Response Team. In 2011 he was awarded a grant from the FDA Innovative Food Defense Program which resulted in the handbook, “Guidelines on the Remediation and Restoration of Food Processing Facilities after an Intentional Contamination Event,” from which the present material is based. To download copies of the guidebook go to http://www.ncagr.gov/fooddrug/ and click on “Restoring Food Processors after a Recall.”