Draft Risk Profile on Pathogens and Filth in Spices; Availability, 66010-66011 [2013-26119]

Download as PDF 66010 Federal Register / Vol. 78, No. 213 / Monday, November 4, 2013 / Notices INVEGA (paliperidone) extendedrelease tablet, 12 mg, was discontinued for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that INVEGA (paliperidone) extended-release tablet, 12 mg, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that INVEGA (paliperidone) extended-release tablet, 12 mg, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of INVEGA (paliperidone) extended-release tablet, 12 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events to determine whether INVEGA (paliperidone) extended-release tablet, 12 mg, was withdrawn for reasons of safety or effectiveness. We have reviewed the available information and determined that the product was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list INVEGA (paliperidone) extended-release tablet, 12 mg, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to INVEGA (paliperidone) extendedrelease tablet, 12 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: October 29, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–26283 Filed 11–1–13; 8:45 am] TKELLEY on DSK3SPTVN1PROD with NOTICES BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1204] Draft Risk Profile on Pathogens and Filth in Spices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing the availability of a draft risk profile entitled ‘‘FDA Draft Risk Profile: Pathogens and Filth in Spices’’ (draft risk profile). Our main objectives were to: Describe the nature and extent of the public health risk posed by consumption of spices in the United States by identifying the most commonly occurring microbial hazards and filth in spice; describe and evaluate current mitigation and control options designed to reduce the public health risk posed by consumption of contaminated spices in the United States; identify potential additional mitigation or control options designed to reduce the public health risk posed by the consumption of contaminated spices in the United States; and identify data gaps and research needs. The draft risk profile is intended to provide information for FDA risk managers to use in regulatory decision making related to the safety of spices in the U.S. food supply. The information may also be useful to stakeholders and interested parties such as spice producers and importers, spice and food manufacturers, retail food establishments, and consumers. DATES: Submit either electronic or written comments on the draft risk profile by January 3, 2014. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written comments on the draft risk profile to Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jane Van Doren, Center for Food Safety and Applied Nutrition (HFS–005), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240– 402–2927. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background In response to recent outbreaks in the United States of human illness associated with consumption of certain VerDate Mar<15>2010 17:07 Nov 01, 2013 Jkt 232001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 spices, as well as other reports in the literature and within FDA suggesting that current pathogen control measures in spices may not adequately protect public health, we developed a draft risk profile on pathogens and filth in spices (Ref. 1). We initiated the draft risk profile in response to a large outbreak of Salmonella Rissen infections in 2008 to 2009 associated with the consumption of ground white pepper in the United States (id.). Subsequently, in 2009 to 2010, the United States had a larger outbreak of Salmonella Montevideo infections associated with consumption of products containing black and red pepper (id.). The objectives of the draft risk profile are to: (1) Describe the nature and extent of the public health risk posed by consumption of spices in the United States by identifying the most commonly occurring microbial hazards and filth in spice; (2) describe and evaluate current mitigation and control options designed to reduce the public health risk posed by consumption of contaminated spices in the United States; (3) identify potential additional mitigation and control options; and (4) identify data gaps and research needs. Specific risk management questions that are addressed include: • What is known about the frequency and levels of pathogen and/or filth contamination of spices throughout the food supply chain (e.g., on the farm, at primary processing/manufacturing, at intermediary processing (where spices are used as ingredients in multicomponent products), at distribution (including importation), at retail sale/ use, and at the consumer’s home)? • What is known about the differences in production and contamination of imported and domestic spices? • What is known about the effectiveness and practicality of currently available and potential future mitigations and control options to prevent human illnesses associated with contaminated spices (e.g., practices and/ or technologies to reduce or prevent contamination, surveillance, inspection, import strategies, or guidance)? • What are the highest priority research needs related to prevention or reduction of contamination of spices with pathogens or filth? The draft risk profile has undergone an independent external peer review, and our response to the peer review is available electronically on the FDA Web site (Ref. 2). For the purpose of the draft risk profile, we consider ‘‘spice’’ to mean any dried aromatic vegetable substances in the whole, broken, or ground form, E:\FR\FM\04NON1.SGM 04NON1 Federal Register / Vol. 78, No. 213 / Monday, November 4, 2013 / Notices except for those substances which have been traditionally regarded as foods, whose significant function in food is seasoning rather than nutritional, and from which no portion of any volatile oil or other flavoring principle has been removed. We also consider dehydrated onion and garlic and other dehydrated vegetables used as seasoning to be spices. The specific microbial hazards and filth in spices that we consider in the draft risk profile include those pathogen and filth adulterants detected in spices, implicated in outbreaks, reported as the reason for recalls, and reported in submissions to the Reportable Food Registry (RFR) (Ref. 3). The draft risk profile focuses on Salmonella, among the pathogens detected in spices, because it is the only spice-associated pathogen linked with human illness, food recalls, and RFR reports in the United States. We invite comments that can help improve: (1) The data and information used; (2) the analytical analyses employed; and (3) the clarity and the transparency of the draft risk profile. II. Comments Interested persons may submit either electronic comments regarding the draft risk profile to https:// www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of 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, and will be posted to the docket at https:// www.regulations.gov. TKELLEY on DSK3SPTVN1PROD with NOTICES III. Electronic Access Persons with access to the Internet may obtain the draft risk profile at either (https://www.fda.gov/downloads/Food/ FoodScienceResearch/ RiskSafetyAssessment/UCM367337.pdf) or https://www.regulations.gov. IV. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m. Monday through Friday, and are available electronically at https:// www.regulations.gov. (We have verified the Web site addresses in this reference section, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) VerDate Mar<15>2010 17:07 Nov 01, 2013 Jkt 232001 1. U.S. Food and Drug Administration (2013). ‘‘FDA Draft Risk Profile: Pathogens and Filth in Spices.’’ Accessible at https:// www.fda.gov/downloads/Food/ FoodScienceResearch/ RiskSafetyAssessment/UCM367337.pdf. 2. U.S. Food and Drug Administration (2013). ‘‘FDA Draft Risk Profile: Pathogens and Filth in Spices: Peer Review Report: External Peer Review Comments and FDA Responses.’’ Accessible at https:// www.fda.gov/downloads/Food/ FoodScienceResearch/ RiskSafetyAssessment/UCM367338.pdf. 3. U.S. Food and Drug Administration (2013). Reportable Food Registry Annual Report. Accessible at https://www.fda.gov/Food/ ComplianceEnforcement/RFR/ default.htm. Dated: October 28, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–26119 Filed 10–30–13; 4:15 pm] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Allergenic Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Allergenic Products Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on December 11, 2013, from 9 a.m. to approximately 3:30 p.m. and on December 12, 2013, from 8:30 a.m. to approximately 2:45 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993–0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. For those unable to attend in person, the meeting will also be Webcast. The PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 66011 link for the Webcast is available at: https://collaboration.fda.gov/apac. Contact Person: Donald W. Jehn or Joanne Lipkind, Center for Biologics Evaluation and Research (HFM–71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–0314, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On December 11, 2013, the committee will meet in open session to discuss and make recommendations on the safety and efficacy of Oralair; a sweet vernal, orchard, perennial rye, Timothy, and Kentucky bluegrass mixed pollens allergen extract tablet for sublingual use, manufactured by Stallergenes. On December 12, 2013, the committee will meet in open session to discuss and make recommendations on the safety and efficacy of Grastek, a Timothy grass pollen allergen extract tablet for sublingual use, manufactured by Merck. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before December 4, 2013. Oral presentations from the public will be scheduled between approximately 12 p.m. and 12:30 p.m. on December 11, 2013, and between approximately 11:10 a.m. and 11:40 a.m. on December 12, 2013. Those individuals interested in making formal oral presentations should E:\FR\FM\04NON1.SGM 04NON1

Agencies

[Federal Register Volume 78, Number 213 (Monday, November 4, 2013)]
[Notices]
[Pages 66010-66011]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26119]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1204]


Draft Risk Profile on Pathogens and Filth in Spices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft risk profile entitled ``FDA Draft Risk Profile: 
Pathogens and Filth in Spices'' (draft risk profile). Our main 
objectives were to: Describe the nature and extent of the public health 
risk posed by consumption of spices in the United States by identifying 
the most commonly occurring microbial hazards and filth in spice; 
describe and evaluate current mitigation and control options designed 
to reduce the public health risk posed by consumption of contaminated 
spices in the United States; identify potential additional mitigation 
or control options designed to reduce the public health risk posed by 
the consumption of contaminated spices in the United States; and 
identify data gaps and research needs. The draft risk profile is 
intended to provide information for FDA risk managers to use in 
regulatory decision making related to the safety of spices in the U.S. 
food supply. The information may also be useful to stakeholders and 
interested parties such as spice producers and importers, spice and 
food manufacturers, retail food establishments, and consumers.

DATES: Submit either electronic or written comments on the draft risk 
profile by January 3, 2014.

ADDRESSES: Submit electronic comments to https://www.regulations.gov. 
Submit written comments on the draft risk profile to Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jane Van Doren, Center for Food Safety 
and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2927.

SUPPLEMENTARY INFORMATION: 

I. Background

    In response to recent outbreaks in the United States of human 
illness associated with consumption of certain spices, as well as other 
reports in the literature and within FDA suggesting that current 
pathogen control measures in spices may not adequately protect public 
health, we developed a draft risk profile on pathogens and filth in 
spices (Ref. 1). We initiated the draft risk profile in response to a 
large outbreak of Salmonella Rissen infections in 2008 to 2009 
associated with the consumption of ground white pepper in the United 
States (id.). Subsequently, in 2009 to 2010, the United States had a 
larger outbreak of Salmonella Montevideo infections associated with 
consumption of products containing black and red pepper (id.). The 
objectives of the draft risk profile are to: (1) Describe the nature 
and extent of the public health risk posed by consumption of spices in 
the United States by identifying the most commonly occurring microbial 
hazards and filth in spice; (2) describe and evaluate current 
mitigation and control options designed to reduce the public health 
risk posed by consumption of contaminated spices in the United States; 
(3) identify potential additional mitigation and control options; and 
(4) identify data gaps and research needs.
    Specific risk management questions that are addressed include:
     What is known about the frequency and levels of pathogen 
and/or filth contamination of spices throughout the food supply chain 
(e.g., on the farm, at primary processing/manufacturing, at 
intermediary processing (where spices are used as ingredients in multi-
component products), at distribution (including importation), at retail 
sale/use, and at the consumer's home)?
     What is known about the differences in production and 
contamination of imported and domestic spices?
     What is known about the effectiveness and practicality of 
currently available and potential future mitigations and control 
options to prevent human illnesses associated with contaminated spices 
(e.g., practices and/or technologies to reduce or prevent 
contamination, surveillance, inspection, import strategies, or 
guidance)?
     What are the highest priority research needs related to 
prevention or reduction of contamination of spices with pathogens or 
filth?
    The draft risk profile has undergone an independent external peer 
review, and our response to the peer review is available electronically 
on the FDA Web site (Ref. 2).
    For the purpose of the draft risk profile, we consider ``spice'' to 
mean any dried aromatic vegetable substances in the whole, broken, or 
ground form,

[[Page 66011]]

except for those substances which have been traditionally regarded as 
foods, whose significant function in food is seasoning rather than 
nutritional, and from which no portion of any volatile oil or other 
flavoring principle has been removed. We also consider dehydrated onion 
and garlic and other dehydrated vegetables used as seasoning to be 
spices.
    The specific microbial hazards and filth in spices that we consider 
in the draft risk profile include those pathogen and filth adulterants 
detected in spices, implicated in outbreaks, reported as the reason for 
recalls, and reported in submissions to the Reportable Food Registry 
(RFR) (Ref. 3). The draft risk profile focuses on Salmonella, among the 
pathogens detected in spices, because it is the only spice-associated 
pathogen linked with human illness, food recalls, and RFR reports in 
the United States.
    We invite comments that can help improve: (1) The data and 
information used; (2) the analytical analyses employed; and (3) the 
clarity and the transparency of the draft risk profile.

II. Comments

    Interested persons may submit either electronic comments regarding 
the draft risk profile to https://www.regulations.gov or written 
comments to the Division of Dockets Management (see ADDRESSES). It is 
only necessary to send one set of 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, and will be posted to 
the docket at https://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the draft risk 
profile at either (https://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM367337.pdf) or https://www.regulations.gov.

IV. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m. Monday through Friday, and 
are available electronically at https://www.regulations.gov. (We have 
verified the Web site addresses in this reference section, but we are 
not responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register.)

1. U.S. Food and Drug Administration (2013). ``FDA Draft Risk 
Profile: Pathogens and Filth in Spices.'' Accessible at https://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM367337.pdf.
2. U.S. Food and Drug Administration (2013). ``FDA Draft Risk 
Profile: Pathogens and Filth in Spices: Peer Review Report: External 
Peer Review Comments and FDA Responses.'' Accessible at https://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM367338.pdf.
3. U.S. Food and Drug Administration (2013). Reportable Food 
Registry Annual Report. Accessible at https://www.fda.gov/Food/ComplianceEnforcement/RFR/default.htm.

    Dated: October 28, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26119 Filed 10-30-13; 4:15 pm]
BILLING CODE 4160-01-P
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