Guidance for Industry; Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient; Availability, 58813 [2011-24317]

Download as PDF Federal Register / Vol. 76, No. 184 / Thursday, September 22, 2011 / Notices More information on PSOs can be obtained through AHRQ’s PSO Web site at https://www.pso.AHRQ.gov/ index.html. [FR Doc. 2011–24100 Filed 9–21–11; 8:45 am] BILLING CODE 4160–90–M 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 Food and Drug Administration, HHS. ACTION: Notice. 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 https://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, jlentini on DSK4TPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:29 Sep 21, 2011 SUPPLEMENTARY INFORMATION: Jkt 223001 BILLING CODE 4160–01–P In the Federal Register of June 29, 2009 (74 FR 31038), FDA announced the availability of a draft guidance entitled ‘‘Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an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 https:// www.fda.gov/FoodGuidances or https:// www.regulations.gov. PO 00000 Frm 00047 Fmt 4703 Dated: September 16, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–24317 Filed 9–21–11; 8:45 am] I. Background Dated: September 8, 2011 Carolyn M. Clancy, Director. AGENCY: 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–2022. 58813 Sfmt 4703 DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS–2011–0096] Homeland Security Advisory Council The Office of Policy, DHS. Notice of open teleconference Federal Advisory Committee meeting. AGENCY: ACTION: The Homeland Security Advisory Council (HSAC) will meet via teleconference for the purpose of reviewing and deliberating on recommendations by the HSAC’s Southwest Border Task Force. DATES: The HSAC conference call will take place from 4 p.m. to 5 p.m. EDT on Monday, October 17, 2011. Please be advised that the meeting is scheduled for one hour and may end early if all business is completed before 5 p.m. ADDRESSES: The HSAC meeting will be held via teleconference. Members of the public interested in participating in this teleconference meeting may do so by following the process outlined below (see ‘‘Public Participation’’). Written comments must be submitted and received by October 14, 2011. Comments must be identified by Docket No. DHS–2011–0096 and may be submitted by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • E-mail: HSAC@dhs.gov. Include docket number in the subject line of the message. • Fax: (202) 282–9207 • Mail: Homeland Security Advisory Council, Department of Homeland Security, Mailstop 0445, 245 Murray Lane, SW., Washington, DC 20528. Instructions: All submissions received must include the words ‘‘Department of Homeland Security’’ and DHS–2011– 0096, the docket number for this action. Comments received will be posted without alteration at https:// www.regulations.gov, including any personal information provided. Docket: For access to the docket to read comments received by the DHS Homeland Security Advisory Council, go to https://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Pat McQuillan at hsac@dhs.gov or 202–447– 3135. SUMMARY: E:\FR\FM\22SEN1.SGM 22SEN1

Agencies

[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.

-----------------------------------------------------------------------

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 https://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 
https://www.fda.gov/FoodGuidances or https://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
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