[Federal Register Volume 74, Number 46 (Wednesday, March 11, 2009)]
[Notices]
[Pages 10598-10599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-5367]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Guidance for Industry: Measures to Address the Risk for 
Contamination by Salmonella Species in Food Containing a Peanut-Derived 
Product as an Ingredient; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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

[[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 Sec.  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 Sec.  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