In 2007, the Food

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In 2007, the Food and Drug Administration FDA launched self-assessment tools to minimize the risk of intentional contamination of food and cosmetics as part of their comprehensive Food Protection Plan initiative. These tools are companion pieces designed to make previously issued industry guidance documents more user-friendly and practical. Directed at both intentional and unintentional contamination of foods, the tools are aimed at members of the food and cosmetic

industry and are to be used to identify opportunities to better guard against intentional contamination of products, according to FDA Center for Food Safety and Applied Nutrition Acting Center Director David Acheson. In 2003, FDA issued a set of Food and Cosmetic Security Preventive Measures Guidance documents aimed at operators of food and cosmetic establishments, as well as businesses that produce, process, store, repack, re-label, distribute, sell or transport foods, food ingredients, and cosmetics to help them minimize the risk of malicious, criminal, or terrorist actions involving products under their control. Based on industry feedback, the FDA repackaged the information found in the guidance documents and created a corresponding self-assessment tool for each document. By using the tools, industry members can get a quick and detailed assessment of the measures they currently have in place to protect against intentional

contamination of their products, as well as easily determine where meaningful improvements to their current practices can be made. The self-assessment tool asks the participant to mark the presence of a variety of food protection measures with a Y Yes, N No, N/A Not Applicable, or Dont Know for each item. Examples of measures addressed by the self-assessment tools include the possibility of product tampering; identification of security procedures and responsibilities; and evaluation of response strategies in the event of product tampering or other intentional contamination. As with any product that ends up in the hands or stomachs of consumers, it is always better to take a proactive approach toward possible contamination, rather than have to initiate a recall when it may be too late. There are several consulting companies that offer compliance services that meet FDA standards, as well as expertise in validation, production,

quality, and R&D. They can offer manufacturers a proactive approach to getting it right the first time–before a product even hits the shelf–thus negating the need for a reactive response down the road. For more about the Food and Cosmetic Security Preventive Measures Guidance documents and self assessment tools, go here: http://www.cfsan.fda.gov/~dms/defguids.html. For more about the Food Protection Plan, go here: http://www.fda.gov/oc/initiatives/advance/food/plan.html.

Norm Howe, Senior Partner at Validation and Compliance Institute, consultants for the pharmaceutical and medical device industries. He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA. He has held many management positions in FDA regulated industries, most at BASF. http://www.vcillc.com Read More Articles From Norm Howe: http://thephantomwriters.com/recent/author/norm-howe.html