June 30, 2009
The U.S. Food and Drug Administration (FDA) has published a Notice of Availability in the Federal Register of June 29, 2009, asking for comment on its Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product As An Ingredient Draft Guidance. This draft guidance is intended for food manufacturers and processors who use a pistachio-derived product as an ingredient in a food product. Pistachio-derived products include roasted in-shell pistachios and shelled pistachios (also called kernels) that are roasted or raw.
FDA is issuing this guidance in light of a recent investigation by FDA and the California Department of Public Health of Salmonella species (Salmonella spp.) contamination in pistachio-derived products. The producer issued a voluntary recall involving a substantial quantity of its products. Because the recalled pistachio-derived products were used as ingredients in a variety of foods, this recall affected many products and resulted in additional recalls.
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the blood stream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis.
The draft guidance discusses the issues producers of pistachio-derived products should consider in order to adequately reduce the presence of Salmonella spp. It does not provide recommendations for specific pistachio-derived products. Most important, this guidance does not diminish the responsibility of producers of pistachio-derived products to ensure that foods that they produce are not "adulterated" under the Federal Food, Drug, and Cosmetic Act or otherwise in violation of the law. FDA has contacted producers of pistachio-derived products to remind them that our current good manufacturing practice (CGMP) regulations apply to them.
The draft guidance can be accessed on the FDA web site at Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product As An Ingredient; Draft Guidance or http://www.regulations.gov
Interested parties have 60 days from the date of publication to submit comments to FDA. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments on the draft guidance to http://www.regulations.gov. Address written requests for single copies of the draft guidance to the Office of Food Defense, Communication and Emergency Response, Center for Food Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request.