SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance entitled “Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut-Derived Product as an Ingredient.” This guidance is intended to clarify for manufacturers who produce foods containing a peanut-derived product as an ingredient that there is a risk that Salmonella species (spp.) may be present in the incoming peanut-derived product, and to recommend measures to address that risk. Peanut-derived products include peanuts, peanut butter, peanut paste, peanut meal, and peanut granules.

In the recent past, products made from peanuts have been associated with two large, multi-state Salmonella outbreaks. The first of these, an outbreak of Salmonella Tennessee in 2007 linked to peanut butter, resulted in more than 600 illnesses in 47 states (Ref. 1). More recently, peanut butter and peanut paste have been confirmed as the source of a large multi-state outbreak caused by Salmonella Typhimurium (Ref. 2). Peanut-derived products that have been recalled have been used as ingredients in other products such as cookies, crackers, cereal, candy, and ice cream. This had led to additional recalls.

FDA is issuing this guidance as a level 1 guidance consistent with FDA's good guidance practices regulation § 10.115 (21 CFR 10.115). Consistent with FDA's good guidance practices regulation, the agency will accept comment, but is implementing the guidance document immediately in accordance with § 10.115(g)(2) because the agency has determined that prior public participation is not feasible or appropriate in light of the need to respond expeditiously to the current circumstances. The guidance represents the agency's current thinking on measures to address the risk for contamination by Salmonella spp. in foods containing a peanut-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 guidance at http://www.cfsan.fda.gov/​guidance.html.

IV. References

The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. FDA, FDA Warns Consumers Not to Eat Certain Jars of Peter Pan Peanut Butter and Great Value Peanut Butter; Product May be Contaminated With Salmonella, FDA News, P07-21, available at http://www.fda.gov/​bbs/​topics/​NEWS/​2007/​NEW01563.html, February 14, 2007.

2. FDA, Recall of Products Containing Peanut Butter; Salmonella Typhimurium, available at http://www.fda.gov/​oc/​opacom/​hottopics/​salmonellatyph.html, updated February 4, 2009.