[Federal Register Volume 79, Number 23 (Tuesday, February 4, 2014)]
[Notices]
[Pages 6596-6598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02255]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0053]
Designation of High-Risk Foods for Tracing; 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'' or ``we'') is
announcing the opening of a docket to obtain comments and scientific
data and information that will help us to implement the section of the
FDA Food Safety Modernization Act (FSMA) that requires FDA to designate
high-risk foods. We are providing an opportunity for interested parties
to submit comments and scientific data and information that will help
us develop our process for implementing this provision.
DATES: Submit electronic or written comments and scientific data and
information by April 7, 2014.
ADDRESSES: You may submit comments and scientific data and information,
identified by Docket No. FDA-2014-N-0053, by any of the following
methods:
Electronic Submissions
Submit electronic comments and scientific data and information in
the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments and scientific data and
information.
Written Submissions
Submit written submissions in the following ways:
Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2014-N-0053 for this notice. All comments and
scientific data and information received may be posted without change
to http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments and
scientific data and information, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments and scientific data and information received, go to http://www.regulations.gov and insert the docket number found in brackets in
the heading of this document into the ``Search'' box and follow the
prompts and/or go 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 Dennis, Center for Food Safety
and Applied Nutrition (HFS-005), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-1914.
SUPPLEMENTARY INFORMATION:
I. Background
A. FDA Food Safety Modernization Act Provision Requiring Designation of
High-Risk Foods
On January 4, 2011, the President signed the FDA Food Safety
Modernization Act (FSMA) (Pub. L. 111-353) into law. Section 204 of
FSMA requires, among other things, the designation of high-risk foods.
Specifically, section 204(d)(2)(A) of FSMA requires FDA to designate
high-risk foods for which additional recordkeeping requirements are
appropriate and necessary to protect the public health, and to do so
not later than 1 year after the date of enactment of FSMA (and
thereafter, if necessary). Section 204(d)(2)(B) requires FDA to publish
the list of high-risk foods on the Internet Web site of FDA at the time
when FDA issues final rules to establish the additional recordkeeping
requirements for high-risk foods.
Section 204(d)(2)(A) of FSMA specifically states that the
designation of high-risk foods must be based on the: (1) Known safety
risks of a particular food, including the history and severity of
foodborne illness outbreaks attributed to such food, taking into
consideration foodborne illness data collected by the Centers for
Disease Control and Prevention; (2) likelihood that a particular food
has a high potential risk for microbiological or chemical contamination
or would support the growth of pathogenic microorganisms due to the
nature of the food or the processes used to produce such food; (3)
point in the manufacturing process of the food where contamination is
most likely to occur; (4) likelihood of contamination and steps taken
during the manufacturing process to reduce the possibility of
contamination; (5) likelihood that consuming a particular food will
result in a foodborne illness due to contamination of the food; and (6)
likely or known severity, including health and economic impacts, of a
foodborne illness attributed to a particular food.
Through this notice, we are establishing a docket to provide an
opportunity for interested parties to provide comments and scientific
data and information that will help us refine our draft approach to
identifying high-risk foods, as required by section 204(d)(2) of FSMA.
Section I.B summarizes our tentative draft approach for the review and
evaluation of data to designate high-risk foods. Attached as a
reference to this notice is a draft approach document in which we
describe the process and methodology we are considering using for
designating high-risk foods. After reviewing comments received in
response to this notice on the draft approach described here, we plan
to further revise the approach as necessary. We also anticipate that
the approach will be reviewed by scientific experts (``peer
reviewed'').
While section 204(d)(2)(A) of FSMA includes a statutory deadline
within 1 year of the enactment of FSMA, FDA is issuing this notice to
solicit comments and scientific data and information that will help us
refine our draft approach to identifying high-risk foods. In section
II.B, there are a number of specific
[[Page 6597]]
topics on which we think various stakeholders and the public at large
could provide valuable comments and scientific data and information to
assist us in implementing section 204 of FSMA. We anticipate that this
input will be critical to our effective implementation of section 204
of FSMA.
B. Draft Approach To Implement Section 204(d)(2) of FSMA--Designation
of High-Risk Foods
Data and information developed to identify the most significant
foodborne contaminants, including data and information regarding the
number, severity, and related costs of illnesses, may be used as data
inputs for the high-risk foods approach, where applicable and
appropriate.
The draft approach would use a multicriteria decision analysis
approach, similar to that of Anderson et al., 2011 (Ref. 1), to
identify those foods which should be designated as high-risk. This
approach would use the specific criteria identified in section
204(d)(2)(A) of FSMA and would implement those criteria within a risk
model. For each of the food and hazard pairs identified, we would
determine a total risk score by the weighted sum of the score for each
of the defined criteria. For foods that have multiple risk scores
because they appear in the list associated with more than one hazard,
we would determine the total score for that food using each of the
individual food-hazard pair total risk scores. Inclusion on the high-
risk food list would be based on the total risk score for foods or food
categories. We describe our draft approach, criteria, and scoring
system, and provide examples, in the document entitled ``FDA's Draft
Approach for Designating High-Risk Foods as Required by Section 204 of
FSMA'' (Ref. 2). Although the analysis would encompass food-hazard
pairs, we do not anticipate this to be a food-hazard list but rather a
food list. This draft approach may be further refined pending
stakeholder input in response to this notice.
II. Request for Comments and Scientific Data and Information
We invite comments on the draft approach outlined in section I.B
and the submission of scientific data and information relevant to high-
risk food designation. We anticipate that this general input, along
with the more specific input we solicit below, will significantly
assist the Agency in fulfilling the requirements of section 204 of
FSMA. In particular, we invite comment, scientific data, and
information on the following topics:
Considering available data, uncertainty with the data, and
the intended methods, what alternative approaches should we consider to
identify high-risk foods?
What additional criteria should we consider, within the
bounds of the factors Congress mandated in section 204(d)(2)(A) of
FSMA, to develop the list of high-risk foods? For example, in addition
to the public health related economic impact of foodborne illnesses,
which the draft approach takes into account, should the approach
include nonpublic health economic impact factors, such as costs related
to disruption in the food supply following a foodborne illness
outbreak? If so, how should we determine these costs given the variety
of foods and different market values for various foods?
What changes should we consider making to the scoring
system to ensure the range of possibilities for the foods and hazards
is comprehensive and to enhance the scoring?
What changes should we consider making to the approach to
better evaluate risk associated with animal food?
The draft approach would equally weight the criteria.
Should individual weights be assigned to each criterion? If so, which
criteria should receive more weight and how should those weights be
assigned?
The draft approach would utilize the food categorization
scheme used for the Reportable Food Registry (Ref. 3). What other
practical alternatives to this food categorization scheme should we
consider in light of the practical constraints of evaluating individual
commodities?
Adverse reactions may occur when allergic consumers are
exposed to foods that contain undeclared allergens. Undeclared
allergens may be present in a food through either mislabeling or cross-
contact during processing and handling. Both situations present a risk
to allergic consumers because they lead to incomplete or inaccurate
product labels. How should food allergens, including the major food
allergens defined in the Food Allergen Labeling and Consumer Protection
Act of 2004 (Pub. L. 108-282, Title II) (milk, eggs, fish, Crustacean
shellfish, tree nuts, peanuts, wheat, and soybeans), be considered in
the development of the high-risk food list?
C. Additional Information and Data Requested
We also are interested in the following types of information and
data:
Scientific data and methods that can be used to assess the
public health impact of acute or chronic exposures to pathogens and
chemical contaminants in human food or animal food. In particular,
scientific data and methods related to chronic exposures to chemical
contaminants in food.
For representative foods in each food category or
commodity group to be evaluated:
[cir] A list of the pathogens and chemical contaminants likely to
be found in the food;
[cir] The percentage prevalence of contaminants in the food;
[cir] The levels of contaminants in the food;
[cir] The point in the manufacturing process where the contaminants
are likely to be introduced in the food; and
[cir] The typical steps and control measures taken in the
manufacturing process to reduce the possibility of contamination of the
food with the pathogen or chemical contaminant.
III. Comments
Interested persons may submit either electronic comments and
scientific data and information regarding this document 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 and scientific data and information. Identify comments and
scientific data and information 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, and will
be posted to the docket at 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. (FDA
has 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. Anderson, M., Jaykus, L.-A., Beaulieu, S. et al. ``Pathogen-
produce pair attribution risk ranking tool to prioritize fresh
produce commodity and pathogen combinations for further evaluation
(P\3\ARRT).'' Food Control 22, (2011): 1865-1872. 10.1016/
j.foodcont.2011.04.028.
2. Food and Drug Administration. ``FDA's Draft Approach for
Designating High-Risk Foods as Required by Section 204 of FSMA.''
2013. Available at http://www.fda.gov/
[[Page 6598]]
downloads/Food/GuidanceRegulation/FSMA/UCM380212.pdf.
3. Food and Drug Administration. ``U.S. Food and Drug
Administration, Reportable Food Summary Report, Definitions.''
Available at http://www.fda.gov/downloads/Food/FoodSafety/FoodSafetyPrograms/RFR/UCM211534.pdf. Last Modified April 2012.
Dated: January 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02255 Filed 2-3-14; 8:45 am]
BILLING CODE 4160-01-P