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Announcing a Pretest of FDA's Food CGMP Survey Instrument

CFSAN Constituent Update - Fruit Basket
CFSAN Constituent Update - CFSAN FDA

November 12, 2008

In an effort to provide additional protection against foodborne illness, the Food and Drug Administration (FDA) has begun the process of bringing the Federal rules that govern the safe manufacturing, processing, packing and holding of food in the U.S. up to date with modern science and technology. These rules, known as the food current good manufacturing practices, or food CGMPs, describe the methods, equipment, physical plants, and controls for producing safe processed food. They were last revised in 1986.

 

FDA intends to conduct a statistical survey of some 2,700 large and small domestic food facilities. These facilities will be asked to respond to the survey instrument and may do so either via the Internet or via mail, as they choose.  In the next few days, FDA will begin pretesting of the survey instrument.  The purpose of the pretest, which will involve sending the instrument via Internet to 50 to 60 facilities, is to ensure that the survey instrument is clear, unambiguous, elicits the information the agency needs and does not impose an undue burden on industry respondents.

The survey will seek information about five key issues relevant to the food CGMP modernization effort:

  • Employee training
  • Sanitation and personal hygiene
  • Allergen controls
  • Process controls, and,
  • Recordkeeping.

 

The results of this survey will assist the FDA in characterizing current food industry practices. While entirely voluntary, industry participation is critical if FDA is to accurately identify safe, cost-effective industry practices for modernized food CGMPs.

 

Responses to the pretest, as well as the actual survey, will be kept strictly confidential. All data will be collected, compiled, and kept by the independent consulting firm, Eastern Research Group, Inc. (ERG). Responses will be used only for statistical purposes. The reports ERG will prepare on this study will summarize findings across the sample and will not associate responses with a specific company or individual. ERG will not provide information that identifies companies to anyone outside the ERG study team at anytime.