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


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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.

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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 http://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 http://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 http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the draft risk 
profile at either (http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM367337.pdf) or http://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 http://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 http://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 http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM367338.pdf.
3. U.S. Food and Drug Administration (2013). Reportable Food 
Registry Annual Report. Accessible at http://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