FDA Seeks Public Comments on <EM>Salmonella</EM> in Pistachio-Derived Products

Salmonella in Pistachio-Derived Food Products - The FDA Center for Food Safety and Applied Nutrition is seeking public comment on draft " ... guidance for industry entitled Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient ... [which] when finalized, is intended to clarify for manufacturers who produce foods containing a pistachio-derived product as an ingredient that there is a risk that Salmonella species may be present in the incoming pistachio-derived product, and to recommend measures to address that risk ..."

Document Title: The title of the June 29, 2009 Prepublication FDA Notice is "Draft Guidance for Industry on Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient; Availability"

Organization: FDA Center for Food Safety and Applied Nutrition

Summary: The following information is taken from the June 29, 2009 prepublication Notice at
http://www.federalregister.gov/OFRUpload/OFRData/2009-15202_PI.pdf

I. Background

FDA is announcing the availability of a draft guidance for industry entitled Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient. This draft guidance is intended to clarify for manufacturers who produce foods containing a pistachio-derived product as an ingredient that there is a risk that Salmonella species (spp.) may be present in the incoming pistachio-derived product, and to recommend measures to address that risk.

Pistachio-derived products include roasted in-shell pistachios and shelled pistachios (also called kernels) that are roasted or raw.

We are issuing this guidance in light of a recent investigation by FDA and the California Department of Public Health of Salmonella spp. contamination in pistachio-derived products (Ref. 1). 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 (Ref. 1).

FDA is issuing this draft guidance as level 1 guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance represents the agency's current thinking on measures to address the risk for contamination by Salmonella spp. in food containing a pistachio-derived product as an ingredient. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

Go the FDA June 29, 2009 Federal Register Notice for additional information and details.

Comments Due By: The FDA notice states " ... Although you can comment on any guidance at any time ... to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments concerning the draft guidance by [insert date 60 days after date of publication in the Federal Register]"

Web site: The June 26, 2009 FDA CFSAN prepublication notice is posted at
http://www.federalregister.gov/OFRUpload/OFRData/2009-15202_PI.pdf