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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2009-D-0060]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# SUMMARY:

                        The Food and Drug Administration (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 may be present in the incoming peanut-derived product, and to recommend measures to address that risk.                    

# DATES:

Submit written or electronic comments on agency guidances at any time.

# ADDRESSES:

                        Submit written comments on the guidance to the Division of                               ( print page 10599)                            Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments on the guidance to                         *http://www.regulations.gov*. Submit written requests for single copies of the 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 request. See the                         **SUPPLEMENTARY INFORMATION**                         section for electronic access to the 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 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.                

Dated: March 9, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

[FR Doc. E9-5367 Filed 3-9-09; 4:15 pm]

BILLING CODE 4160-01-S