Focus On Environmental Control And Monitoring Programs

The Food Safety Modernization Act (FSMA), signed into law by to identify their potential hazards and confirm adequate preventive controls of those hazards. 


The origins of the FSMA can be traced to the growing public concern over the number, size and scope of food product recalls due to contamination issues.   However, it was the 2009 recall of peanut butter manufactured by the Peanut Corporation of America (PCA) that provided the impetus for legPresident Obama on Jan. 4, 2011, provides the FDA with new enforcement authority and a legislative mandate to require comprehensive, science-based preventive controls across the food supply.  The Act represents the most sweeping reform in food safety oversight in over 70 years.  It shifts the regulatory focus to prevention of food safety issues rather than relying primarily on reacting to problems after they occur. The burden is on food processors islative action.  At least 714 people in 47 states were sickened and nine deaths were attributed to Salmonella contaminated PCA products.

The PCA recall sparked a congressional investigation and a national discussion on the safety of the American food supply to which Deibel Labs contributed when Charles Deibel, President, provided expert testimony at a Congressional hearing. 

Products recalled since 2010 include peanut butter, eggs, spices, cookies, meat, bread, soy, potatoes, cheese and sprouts; all recalled because contaminants such as Listeria, Salmonella, and Staphylococcus were either detected or had the potential to be present.

Common to many of the food processers involved in recalls, HACCP plans were in place but missed preventive measures that would have avoided contamination hazards. The lack of definitive critical control points (CCPs) that could eliminate or control identified hazards prevents the effective use of HACCP at all steps of the supply chain1.  Under FSMA, food safety controls can occur at any step of supply chain and hazard controls will include former “Prerequisite Programs” in addition to critical control points identified by a traditional HACCP plan (Table 1).

Beyond HACCP

The FDA requires a hazard analysis for all food safety plans. The analysis applies to all “significant hazards”, defined as “known or reasonably foreseeable hazards” that could occur by natural processes or could be unintentionally introduced.

The FDA expanded the list of potential risks to be evaluated to include biological, chemical, physical, allergenic and radiological hazards. These include parasites, drug residues, and unapproved additives.

Under the law, the manufacturer is responsible for developing a food safety plan with emphasis on preventive controls validated to address the identified hazard.  Not all significant hazards will be controlled by CCPs. 

Preventive controls, as defined by the FSMA, are “risk-based, reasonably appropriate procedures, practices and processes” that would either limit or prevent significant hazard. 

FSMA requires these controls to be part of every Hazard Analysis and Risk-Based Preventive Control (HARPC) plan. Unless exempted by law, every food facility, both in the United States and abroad, requires a HARPC plan that utilizes the following preventive controls specified in the Act:

  • Sanitation procedures for food contact surfaces and utensils and food-contact surfaces of equipment
  • Hygiene training for supervisors, managers and   employees
  • Environmental monitoring to determine the effectiveness of pathogen controls in protecting food from exposure to potential contaminants
  • A program for food allergen control
  • A recall plan
  • Verification of supplier activities that relate to food safety
  • Current Good Manufacturing Practices (cGMP)

Additional controls should also be considered as preventive measures; such as training specific to each employee’s duties and responsibilities.

Additional controls include:

  • Facilities design
  • Personnel practices
  • Equipment design
  • Chemical control program
  • Integrated pest management program

Environmental Control and Monitoring Programs  

Proposed FSMA rules require a facility’s hazard evaluation to include an evaluation of environmental pathogens whenever a ready-to-eat (RTE) food is exposed to the environment prior to packaging and the packaged food will not receive a treatment to control the pathogen. In all other circumstances, the proposed rule leaves it up to the facility to decide whether environmental monitoring is appropriate to the facility, the food, and the nature of the preventive control.

An “environmental pathogen” is defined in the proposed rule to mean “a pathogen capable of surviving and persisting within the manufacturing, processing, packing, or holding environment such that food may be contaminated and may result in foodborne illness if that food is consumed without treatment to significantly minimize the environmental pathogen.” Examples of environmental pathogens include Listeria monocytogenes and Salmonella spp. The spores of pathogenic spore-formers are not included because they are normally present in many foods and present a minimal risk of causing foodborne illness unless the foods are subjected to conditions that allow them to grow and produce toxin.

A non-pathogenic indicator organism may be used as a surrogate for a pathogen only if there is scientific evidence to support a direct relationship between the detection of the surrogate and the presence of a specific pathogen.  To date, the only proven predictive surrogate is Listeria innocua or Listeria spp. which is taken as a direct indicator of the presence of L. monocytogenes.

Monitoring for environmental pathogens and indicator organisms is an important verification activity for a number of control programs including Pest and Sanitation control programs.  

Where contamination of a RTE food with an environmental pathogen is determined to be a significant hazard, a facility must develop an environmental monitoring program for an environmental pathogen to verify the implementation and effectiveness of preventive controls.  

The facility would be required to have written procedures for environmental monitoring that must:

  • Be scientifically valid.
  • Identify the test microorganism(s).
  • Identify the locations from which samples will be collected and the number of sites to be sampled during routine environmental monitoring (Note: the number and location of sampling sites must be adequate to determine whether preventive controls are effective).
  • Identify the timing and frequency for collecting and testing samples (Note: the timing and frequency must be adequate to determine whether preventive controls are effective).
  • Identify the test(s) to be conducted, including the analytical method(s).
  • Identify the laboratory conducting the testing.
  • Include corrective action procedures in the event testing detects an environmental pathogen or indicator organism in the facility environment. 

It is important to note that the FDA will not specify the corrective actions the facility must take.  It is incumbent upon the facility to assure that corrective action procedures identify the cause of the problem and correct it, reduce the likelihood of a recurrence, evaluate all affected food for safety, and prevent affected food from entering commerce, if necessary. 

The facility would also be required to maintain records of environmental monitoring, and the facility’s verification activities would be required to include review of those records by a qualified individual.

In fact, the FSMA gives the FDA more sweeping powers in accessing all company records.  The Agency can now order a company to produce its food safety plan and documents related to it including records of environmental testing.  The FDA has indicated that an Environmental Control Program deemed inadequate could result in regulatory action. Class I recalls of product have occurred based on the finding of an environmental pathogen.

Table 1. Comparison of HACCP and HARPC Plans

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