[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