[Federal Register Volume 75, Number 75 (Tuesday, April 20, 2010)]
[Notices]
[Pages 20615-20616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9010]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0195]


Risk Profile: Pathogens and Filth in Spices: Request for Comments 
and for Scientific Data and Information

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; request for comments and for scientific data and 
information.

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SUMMARY:  The Food and Drug Administration (FDA) is requesting comments 
and scientific data and information that would assist the agency in its 
plans to conduct a risk profile for pathogens and filth in spices. The 
purpose of the risk profile is to ascertain the current state of 
knowledge about spices contaminated with microbiological pathogens and/
or filth, and the effectiveness of current and potential new 
interventions to reduce or prevent illnesses from contaminated spices.

DATES:  Submit electronic or written comments and scientific data and 
information by June 21, 2010.

ADDRESSES:  Submit electronic comments and scientific data and 
information to http://www.regulations.gov. Submit written comments and 
scientific data and information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Sherri B. Dennis, Center for Food 
Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1914.

SUPPLEMENTARY INFORMATION:

I. Background

    A risk profile is a science-based document that describes the 
current state of knowledge about a specific food safety problem or 
issue and provides an evaluation of the data and information to support 
current interventions or new approaches to reduce or prevent illnesses 
(Ref. 1). FDA has adapted this tool as a new approach to assist the 
agency in its regulatory decisionmaking. Unlike a quantitative risk 
assessment, which provides information about the number of people 
affected by a hazard in food and how this number might be changed if 
various control options were implemented, a risk profile provides 
qualitative answers to questions about the hazard and options for 
controlling it, based on available data. The information in a risk 
profile may affect a range of decisions, such as whether or not to 
commission a quantitative risk assessment or a request for research, or 
whether or not to implement an immediate and/or provisional regulatory 
decision. In some cases, it may reveal that no further action is 
needed.
    The risk profile for pathogens and filth in spices will provide 
information for FDA to use in the development of plans to reduce or 
prevent illness from spices contaminated by microbial pathogens and/or 
filth. Concerns regarding the effectiveness of current control measures 
to reduce or prevent illness from spices have been renewed by recent 
outbreaks of Salmonella associated with spices, including the imported 
ground white and black pepper products linked to an April 2009 outbreak 
of Salmonella Rissen illness, and the black and red pepper products 
recalled in March 2010 in response to an outbreak of Salmonella 
Montevideo illness (Refs. 2 and 3).
    For the purpose of this risk profile, the term ``spice'' means any 
aromatic vegetable substances in the whole, broken, or ground form, 
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. The specific hazards in spices to 
be considered in this risk profile include those microbiological 
pathogens and filth in spices that are identified in the published 
literature, outbreaks, recalls, and submissions to the Reportable Food 
Registry (RFR).\1\ For purposes of this risk profile, FDA considers 
``filth'' to mean ``extraneous materials'' as defined in FDA's Defect 
Levels Handbook (Ref. 4). The Defect Levels Handbook defines 
``extraneous materials'' as ``any foreign matter in a product 
associated with objectionable conditions or practices in production, 
storage, or distribution * * * [including] objectionable matter 
contributed by insects, rodents, and birds; decomposed material; and 
miscellaneous matter such as sand, soil, glass, rust, or other foreign 
substances.''
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    \1\ The RFR is an electronic portal where responsible parties 
are required to file a report when there is a reasonable probability 
that the use of, or exposure to, an article of food will cause 
serious adverse health consequences or death to humans or animals 
(Ref. 5).
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    The overall objectives of the risk profile are to:
     Describe the nature and extent of the public health risk, 
by identifying the most commonly occurring microbial and filth hazards 
in spices;
     Describe and evaluate current mitigation and control 
options;
     Identify potential additional mitigation or control 
options;
     Identify research needs and data gaps.
    The specific questions to be addressed by the risk profile 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, intermediary 
processing (where spices are used as ingredients in multi-component 
products), distribution (including importation), retail sale/use, and 
the consumer's home)?
     What is known about differences in production and 
contamination of imported and domestic spices?
     What is known about the effectiveness, cost, and 
practicality of currently available and potential future interventions 
to prevent human illnesses associated with pathogen and/or filth 
contamination of 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 pathogens and/or filth in spices?

II. Request for Comments and for Scientific Data and Information

    FDA is requesting comments on the risk profile approach outlined 
previously in this document and the submission of scientific data and 
information relevant to the risk profile. The agency is particularly 
interested in the following types of information:
    1. Data, including unpublished data, on the incidence of 
contamination in spices according to:
    a. Date tested,
    b. Country exporting the spice and/or country of origin if 
different,
    c. Type of spice,
    d. Pathogen(s) and/or filth type (e.g., insect, rodent, 
extraneous),
    e. Quantitative (enumeration) or qualitative (presence/absence) 
results, and
    f. Other product sample information (e.g., pre- or post-treatment, 
treatment type, stage of production/processing).

[[Page 20616]]

    2. Factors that influence the survival, growth, and levels of 
pathogens in spices including:
    a. On-farm practices,
    b. Manufacturing, processing, or marketing practices,
    c. Shipping, storage, and distribution practices,
    d. Storage conditions encountered throughout the farm-to-table 
continuum, and
    e. Pathways for transfer of pathogens to spices, including data on 
frequencies or amounts of transfer (e.g., cross-contamination 
potential).
    3. Consumption patterns (including serving size and frequency) in 
the United States.
    4. Intended use (e.g., ready-to-eat, ingredient in a prepared 
food).
    5. Manufacturing practices, including the use of spices as 
ingredients in prepared foods.
    6. Data, including unpublished data, on the identity and 
effectiveness of control measures or interventions to reduce levels and 
frequency of pathogens and/or filth in spices during growing, 
harvesting, processing, manufacturing, packaging, storage, and 
transportation prior to retail sale including:
    a. Description of treatment or other control measure,
    b. Country exporting spice using this treatment/control measure,
    c. Name of the specific spice and its form (e.g., whole, cracked, 
ground),
    d. Effect of the treatment/control measure on pathogen and/or filth 
levels, and
    e. Types of validation protocols used to verify the effectiveness 
of treatment/control measures.
    7. Data relating to supplier specifications including required 
treatments, performance standards, microbial testing, and audit 
programs.
    8. Any other data related to the occurrence and control of 
pathogens and/or filth in spices that are applicable to the risk 
profile.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments and scientific data and 
information regarding this document. Submit a single copy of electronic 
comments and scientific data and information to http://www.regulations.gov or two copies of any mailed comments and scientific 
data and information, except that individuals may submit one paper 
copy. Submissions are to be identified with the docket number found in 
brackets in the heading of this document. Received comments and 
scientific data and information may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. References

    We have placed the following references on display in the Division 
of Dockets Management (see ADDRESSES). You may see them between 9 a.m. 
and 4 p.m., Monday through Friday. FDA has verified the Web site 
addresses, but FDA is not responsible for any subsequent changes to the 
Web sites after this document publishes in the Federal Register.
    1. Codex Alimentarius Commission, 19th Procedural Manual, http://www.codexalimentarius.net/web/procedural_manual.jsp, accessed 
April 13, 2010.
    2. Food and Drug Administration, ``FDA Alerts the Public to 
Uncle Chen and Lian How Brand Dry Spice Product Recall,'' April 2, 
2009, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm149555.htm, accessed April 13, 2010.
    3. Food and Drug Administration, ``FDA Update on the 
Investigation into the Salmonella Montevideo Outbreak,'' March 17, 
2010, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm204917.htm, accessed April 13, 2010.
    4. Food and Drug Administration, Defect Levels Handbook, http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Sanitation/ucm056174.htm, accessed April 13, 2010.
    5. Food and Drug Administration, ``Reportable Food Registry for 
Industry,'' http://www.fda.gov/food/foodsafety/FoodSafetyPrograms/RFR/default.htm, accessed April 13, 2010.

    Dated: April 14, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-9010 Filed 4-19-10; 8:45 am]
BILLING CODE 4160-01-S