Draft Guidance for Industry on Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient;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

Summary:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient” (draft guidance). The draft guidance, when finalized, is intended to clarify for manufacturers who produce foods containing a pistachio-derived product as an ingredient that there is a risk that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.

Table of Contents

Dates:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments concerning the draft guidance by August 28, 2009.

Addresses:

Submit written requests for single copies of the draft guidance to the Office of Food Safety, Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD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 requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments on the draft guidance to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.

For further information contact:

Michael E. Kashtock, Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2022.

Supplementary information:

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FDA is announcing the availability of a draft guidance for industry entitled “Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived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 This draft guidance is intended to clarify for manufacturers who produce foods containing a pistachio-derived product as an ingredient that there is a risk that Salmonella species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.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the document at http://www.regulations.gov or at http://www.fda.gov/FoodGuidances.

IV. Reference

The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. FDA, 2009, Pistachio Product Recalls:Salmonella, updated April 16, 2009.

Dated: June 18, 2009. Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

References

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