
[Federal Register: June 29, 2009 (Volume 74, Number 123)]
[Notices]               
[Page 31038]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jn09-65]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0271]

 
Draft Guidance for Industry on Measures to Address the Risk for 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

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availability of a draft guidance for industry entitled ``Guidance for 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Ingredient'' (draft guidance). The draft guidance, when finalized, is 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.

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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments concerning the draft 
guidance by August 28, 2009.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Food Safety, Center for Food Safety and 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written comments on the draft guidance to the Division of Dockets 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 Submit electronic comments on the draft 
guidance to http://www.regulations.gov.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INFORMATION section for electronic access to the draft guidance.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.
[FR Doc. E9-15202 Filed 6-26-09; 8:45 am]

BILLING CODE 4160-01-S
