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U.S. Department of Health and Human Services

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Guidance for Industry and FDA: Letter to Industry, State and Local Food Regulators and Inspectors Regarding Web-based ALERT Training

Contains Nonbinding Recommendations

February 22, 2007

Additional copies are available from:
Office of Food Defense, Communication and Emergency Response
Food Defense Oversight Team (HFS-007)
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
(Tel) 301-436-2428 (Updated phone: 240-402-2428)
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
February 21, 2007


Contains Nonbinding Recommendations

Guidance for Industry and FDA(1)
Letter to Industry, State and Local Food Regulators and Inspectors
Regarding Web-based ALERT Training

This guidance document 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 can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, please contact the Office of Food Defense, Communication and Emergency Response, Food Defense Oversight Team at (301) 436-2428.

This letter informs stakeholders that the five Food and Cosmetic Security (Defense) Preventative Measures guidance documents that are posted on CFSAN's guidance document site have been developed into an FDA Food Defense Awareness Initiative called ALERT. This new ALERT initiative is intended to raise awareness of state and local government agencies and the food industry regarding food defense issues. ALERT identifies five key points that industry can use to decrease the risk of intentional contamination at their facility. This information is now available in a web-based training module. To view the ALERT web-based training and obtain more information on ALERT, go to www.cfsan.fda.gov/fooddefense. The guidance documents are available at http://www.cfsan.fda.gov/~dms/defguids.html (updated web address: Food Security Preventative Measures Guidance).


Dear Colleague:

In July 2006, the U.S. Food and Drug Administration (FDA), Department of Health and Human Services, announced its new Food Defense Awareness Initiative ALERT. This new ALERT initiative is intended to raise the awareness of state and local government agencies and the food industry regarding food defense issues. ALERT identifies five key points that industry and businesses can use to decrease the risk of intentional food contamination at their facility.

In an effort to ensure that all stakeholders have access to the ALERT message, FDA has developed an ALERT: Food Defense Awareness web-based training module. The purpose of the ALERT web-based training module is to raise awareness of the issues related to food defense. This course can be used by FDA investigators, other federal, state and local regulatory agencies, and industry operators and managers. This training module will provide stakeholders with the information they need to begin thinking about ways to prevent intentional food contamination within their span of control and facilities.

Training Objectives:

  • Describe the five parts of the ALERT initiative
  • List examples of preventive measures that can be taken to protect business and industry from intentional food contamination
  • Identify several elements that can become part of a continuous improvement plan
  • Increase awareness among personnel in the food industry and encourage them to adopt practices that help protect the food supply

Upon completion of the ALERT training module, you should have gained the information necessary for implementing a food defense plan in your facility.

The Best Defense is to Be Prepared: View the ALERT training module and obtain more information on ALERT or other food defense related issues at www.cfsan.fda.gov/fooddefense.

If you have any questions regarding this correspondence or the content of the ALERT web-based training module, please contact Ms. Marion Allen, Office of Food Defense, Communication and Emergency Response via email at Marion.Allen@fda.hhs.gov or at (301) 436-1584.

Sincerely,

Dr. David Acheson, M.D.
Chief Medical Officer and Director,
Office of Food Defense, Communication and Emergency Response
Center for Food Safety and Applied Nutrition


(1) This guidance has been prepared by the Office of Food Defense, Communication and Emergency Response, Center for Food Safety and Applied Nutrition, at the Food and Drug Administration (FDA).