[Federal Register Volume 76, Number 184 (Thursday, September 22, 2011)]
[Notices]
[Page 58813]
From the Federal Register Online via the Government Publishing 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announced the availability of a draft guidance entitled ``Guidance for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