Document ID: FDA-2009-D-0271-0061
Agency: fda
Document Type: Notice
Title: Guidance for Industry; Availability: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing Pistachio, etc.
Posted Date: 2011-09-22T04:00Z

[Federal Register Volume 76, Number 184 (Thursday, September 22, 2011)]
[Notices]
[Page 58813]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24317]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Guidance for Industry; 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 guidance entitled ``Guidance for Industry: Measures 
to Address the Risk for Contamination by Salmonella Species in Food 
Containing a Pistachio-Derived Product as an Ingredient.'' The guidance 
clarifies 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 
recommends measures to address that risk.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Plant and Dairy 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.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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, 240-402-2022.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 29, 2009 (74 FR 31038), FDA 
announced the availability of a draft guidance entitled ``Guidance for 
Industry: Measures to Address the Risk for Contamination by Salmonella 
Species in Food Containing a Pistachio-Derived Product as an 
Ingredient'' and gave interested parties an opportunity to submit 
comments by August 28, 2009. The Agency reviewed and evaluated these 
comments and has modified the guidance where appropriate.
    The guidance clarifies 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 recommends measures to address that risk. 
Pistachio-derived products include roasted in-shell pistachios and 
shelled pistachios (also called kernels) that are roasted or raw. FDA 
is issuing this guidance as level 1 guidance consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The 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) either electronic or written comments regarding the 
guidance. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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.fda.gov/FoodGuidances or http://www.regulations.gov.

    Dated: September 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24317 Filed 9-21-11; 8:45 am]
BILLING CODE 4160-01-P