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Regulatory Compliance

Regulatory Compliance

Food facility planning, layout, and design cannot be undertaken without considering the variety of government and third-party standards and requirements. Regulatory agencies such as the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) have governing authority over most of the food production operations in the United States.  The requirements for Hazard Analysis and Critical Control Point plans (HACCP), the FDA's requirements for Good Manufacturing Practice (GMP) compliance, as well as the passage of the Food Safety Modernization Act (FSMA) have led to an increase in regulations from government agencies.

In addition to regulatory compliance, many customers of food manufacturers are requiring third-party audits of facilities. The necessity for Safe Quality Food (SQF) or British Resource Consortium (BRC) audits adds another layer of conformance.

In order to produce food products in the current regulatory and audit environment, key factors should be considered when laying out and designing the facility. For instance, how the food preparation, production and packaging flow are integrated into the layout of the facility affects the ability to implement FDA, USDA, HACCP, SQF and BRC requirements. Also, the flow of this process and how it is integrated with employee movement is important for both efficiency and food safety. 

 Food safety plans are typically governed by a facility‚Äôs HACCP plans.  However, effective food safety plans  seek to minimize the number of critical control points required in a HACCP plan.  This may be accomplished by eliminating certain physical, chemical, and microbiological hazards through sound facility design.  Condensation is one  common microbiological hazard that can be eliminated  with sound design practices.  Below is a list of additional hazards addressed with facility design:

Physical hazards: Flaking paint, dirt, and debris can be controlled with proper material selection and utility systems by specifying materials and finishes that will hold up to the rigors of the food-facility sanitation environment.  Also, eliminating or reducing horizontal piping, conduit and ductwork will reduce ledges in the processing area where dirt and debris might collect.  When possible, also avoid placing piping, lighting and structural members above open product areas. 

Chemical hazards: Cleaning chemicals and pesticides can be controlled by segregating them until the time of use.  Chemical storage and dispensing areas can be utilized to maintain segregation from the food-processing operation, and to provide adequate ventilation so chemical odors do not enter the rest of the facility.

Microbiological hazards:  Proper design controls the risk of microbiological contamination. Many HACCP plans indicate temperature limits as critical control points for various steps of the production process.  These product temperature limits must be maintained and documented for raw product storage, thermal processing, product chilling and finished product storage.  Maintaining acceptable product temperature can be achieved through properly designed cold storage production rooms, coolers, and freezers as well as appropriately-sized refrigeration and ventilation systems. 

These design features can also prevent contamination from condensation. Of course, microbiological hazards may be introduced through the air stream within the building as well. Well-balanced ventilation systems  help to pressurize areas with exposed product to prevent contamination from other areas of the facility. Finally, incorporating a linear production flow will help prevent cross contamination from raw to cooked products.  The use of employee sanitation foyers to allow for hand washing, coat/glove/hair net donning and boot washing, also helps restrict possible contaminants in the production areas.