[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Draft Guidance for Industry on Measures to Address the Risk for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availability of a draft guidance for industry entitled ``Guidance for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Ingredient'' (draft guidance). The draft guidance, when finalized, is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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments concerning the draft
guidance by August 28, 2009.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Food Safety, Center for Food Safety and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written comments on the draft guidance to the Division of Dockets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 Submit electronic comments on the draft
guidance to http://www.regulations.gov.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INFORMATION section for electronic access to the draft guidance.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FDA is announcing the availability of a draft guidance for industry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