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Industry Resources

FDA Information:

FSMA proposed regulations have been released and FDA is looking for comments.  If you would like to read the document the link has been provided below.  If your business processes, packages, repackages products in such a way as to expose food to the environment, then that portion of your operation is no longer considered a warehouse and must comply with the full version of the final version of the processing rules.

For warehouse/distribution facilities:

FDA is proposing modified requirements for warehouses solely engaged in the storage of packaged food that is not exposed to the environment in proposed §117.7 (discussed in section X.D of proposed regulations) and proposed §117.206 (discussed in section XII.B of proposed regulations).

Exemptions for warehouses are defined by what FDA means by a packaged food not exposed to the environment or "unexposed packaged food".  FDA considers "not exposed to the environment" and "unexposed" as meaning the food is in a form that prevents any direct human contact with the food (closed container).

FDA will expect that a dry warehouse with unexposed food will have procedures in place addressing general controls, such as sanitation, pest control, storage, segregation, security, and recordkeeping.  FDA will expect a food defense plan and a recall plan to facilitate a supplier recall.

However, distributors who sell refrigerated products are affected by proposed §117.206.  If you sell Potentially Hazardous Foods which are "time/temperature controlled for safety" (TCS), even if they are unexposed product, FDA will require a written food safety plan, which includes

  • a hazard analysis
  • process controls
  • food allergen controls
  • sanitation controls
  • monitoring (of process controls, allergen controls, sanitation controls)
  • records
  • corrective actions
  • verification and validation of process controls
  • a recall plan
  • As well as meeting GMP requirements such as pest management and facility controls that are required of a dry warehouse
  • FDA will expect staff training and review of food safety plans

If you have passed a 3rd party HACCP or GMP audit in the past year then you should be in good shape.  If you have not had a 3rd party audit or do not have a written Food Safety Plan and you sell refrigerated products then you should begin to work on a plan

http://www.fda.gov/Food/FoodSafety/FSMA/ucm334115.htm

Contact Anne Barker-Smith at abarker-smith@legacyfoodservicealliance.com for additional information.