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CFSAN/Office of Plant and Dairy Foods
October 7, 2005; Revised August 2006
Comments and suggestions regarding this document may be submitted at any time. Submit comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
For questions regarding this document, contact Michael E. Kashtock at the Center for Food Safety and Applied Nutrition (CFSAN) at (Tel) (301) 436-2022, (Fax) (301) 436-2651, or email .
Additional copies are available from:
Office of Plant and Dairy Foods
Division of Plant Product Safety HFS-305
Center for Food Safety and Applied Nutrition
Food and Drug Administration, 5100 Paint Branch Parkway
College Park, MD 20740
http://www.cfsan.fda.gov/guidance.html
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Plant and Dairy Foods
Issued October 7, 2005
Revised August 2006
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
This guidance is intended to provide information and references that can be used for the decontamination of food transport vehicles following hurricanes. The scope of this guidance is limited to decontamination of trucks, rail cars, and cold storage units that have been flooded or otherwise impacted by hurricanes, before being placed back in service to transport or store food.
FDA's guidance documents, including this document, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
All food transport vehicles that have been subjected to flood waters should be decontaminated before being returned to service to transport or store food. If not decontaminated, they should be used for other purposes or decommissioned and/or placed in salvage.
Decontamination should be accomplished in a manner which remediates any insanitary condition due to the presence of harmful microorganisms or chemical residues, or filth that could adulterate food transported in the vehicle. Upon decontamination, the condition of the vehicle should be such that any food in the vehicle will be protected against physical, chemical and microbial contamination, as well as against deterioration of the food and the container, as required by 21 CFR 110.93. Normal decontamination procedures such as chemical sanitization or disinfection should be adequate for this purpose.
The decontamination of transport vehicles such as trucks, rail cars, and cold storage units should be performed by a person qualified to provide such services. The person should be knowledgeable of the applicable requirements of the Occupational Safety and Health Administration (OSHA), the Environmental Protection Agency (EPA), and the Department of Transportation (DOT). Although training and certification requirements may differ according to state regulation, personnel performing such activities should have the necessary credentials for their particular jurisdiction.
The person performing the decontamination should be able to provide assurance that the procedure has been properly performed, including any testing for efficacy, as appropriate.
Several types of disinfectant or sanitizing agents may be used (e.g., chlorine, iodine, phenolic and quaternary ammonium compounds, aldehydes). Since the internal surfaces of the vehicles or units may vary (e.g., steel, aluminum, fiberglass, etc.), a specific agent is not identified in this guidance. The person providing the service should ensure that any use of a disinfectant or sanitizer complies with all of the applicable requirements of the Environmental Protection Agency (EPA). For example, some surfaces may require repeat applications to ensure that the surface is treated for the required contact time. At concentrations known to be effective for proper disinfection, some disinfectants may also react with the inner surfaces of the vehicles and units. Therefore, it is recommended that owners of vehicles and units first consult with the person providing the service.
In addition:
For questions concerning implementation of this guidance for the affected geographic area, contact the FDA District or Regional office for your area.
Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
The Environmental Protection Agency (EPA) Office of Pesticide Programs - "What are Antimicrobial Pesticides?"
Antimicrobial products registered with the EPA as sterilizers (available in PDF)
CDC National Institute for Occupational Safety and Health (NIOSH) - Safety and Health Topic: Emergency Response Resources
The above document supercedes the previous version issued October 7, 2005.
