
[Federal Register Volume 79, Number 23 (Tuesday, February 4, 2014)]
[Notices]
[Pages 6596-6598]
From the Federal Register Online via the Government Printing 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


