[Federal Register Volume 78, Number 43 (Tuesday, March 5, 2013)]
[Notices]
[Pages 14309-14311]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04997]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1153]


Implementation of the FDA Food Safety Modernization Act Provision 
Requiring FDA To Establish Pilot Projects and Submit a Report to 
Congress for the Improvement of Tracking and Tracing of Food; Request 
for Comments and for Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments and information.

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SUMMARY: In September 2011, the Food and Drug Administration (FDA or 
the Agency) asked the Institute of Food Technologists (IFT) to execute 
product tracing pilot projects as described in the FDA Food Safety 
Modernization Act (FSMA). FDA recently released a report from IFT on 
these pilot projects, entitled ``Pilot Projects for Improving Product 
Tracing along the Food Supply System.'' FDA is announcing the opening 
of a docket to provide stakeholders and other interested parties an 
opportunity to submit comments and information that will help the 
Agency as it forms its own recommendations, to be contained in the 
Agency's report to Congress, and as it implements the FSMA provisions 
relating to the tracking and tracing of food.

DATES: Submit electronic or written comments and information by April 
4, 2013.

ADDRESSES: You may submit comments and information, identified by 
Docket No.FDA-2012-N-2012-N-1153, by any of the following methods:

Electronic Submissions

    Submit electronic comments and information in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments and information.

Written Submissions

    Submit written submissions in the following way:
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
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-2012-N-1153 for this notice. All comments 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 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 information received, go to http://www.regulations.gov and 
insert the docket number(s), 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 A. McGarry, Office of Foods, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 
1212, Silver Spring, MD 20903, 301-796-3851.

SUPPLEMENTARY INFORMATION: 

I. Background

A. FSMA Provisions Regarding Enhanced Tracking and Tracing of Food and 
Recordkeeping

    On January 4, 2011, the President signed FSMA (Pub. L. 111-353) 
into law. Section 204 of FSMA, 21 U.S.C. 2223, relates to enhanced 
tracking and tracing of food and recordkeeping. As part of this 
provision, FDA must, among other things, complete the following:
    1. Establish pilot projects in coordination with the food industry 
to explore and evaluate methods for rapid and effective tracking and 
tracing of foods. FDA is required to submit a report to Congress on the 
findings of the pilot projects together with FDA's recommendations for 
improving tracking and tracing of food;
    2. Assess the costs and benefits associated with the adoption and 
use of several product tracing technologies and the feasibility of such 
technologies for different sectors of the food industry (including 
small businesses);
    3. To the extent practicable in assessing the costs, benefits, and

[[Page 14310]]

feasibility of several product tracing technologies, evaluate domestic 
and international product tracing practices; consider international 
efforts and compatibility with global tracing systems, as appropriate; 
and consult with a diverse and broad range of experts and stakeholders;
    4. Establish within FDA, as appropriate, a product tracing system 
to receive information that improves the capacity of the Secretary to 
effectively and rapidly track and trace food;
    5. Publish a notice of proposed rulemaking to establish additional 
recordkeeping requirements for high risk foods;
    6. Designate high-risk foods for which the additional recordkeeping 
requirements are appropriate and necessary to protect the public 
health. The list of high-risk foods is to be published on FDA's 
Internet Web site when the Agency issues the final rule establishing 
additional recordkeeping requirements for high-risk foods; and
    7. Issue a small entity compliance guide within 6 months after the 
final rule is issued.

B. FSMA Provisions Directing FDA To Establish Pilot Projects To Explore 
and Evaluate Methods for Rapid and Effective Tracking and Tracing of 
Foods

    Under section 204(a) of FSMA, in September 2011, FDA established 
pilot projects in coordination with the food industry to explore and 
evaluate methods for rapid and effective tracking and tracing of foods. 
These product tracing pilots were executed through an existing contract 
with the IFT. IFT was required to:
    1. Conduct two food product tracing pilot projects--one in 
coordination with the processed food sector and one in coordination 
with the produce sectors--working in consultation with the U.S. 
Department of Agriculture, State public health agencies, and 
nongovernmental organizations that represent the interests of 
consumers;
    2. Conduct the pilot projects to reflect the diversity of the food 
supply and consider/address confounding factors, such as commingling 
and transshipment;
    3. Include different types of FDA-regulated foods that were the 
subject of significant outbreaks between 2005 and 2010;
    4. Use the selected foods to develop and demonstrate methods for 
rapid and effective tracking and tracing of foods that are practical 
for facilities of varying sizes, including small businesses;
    5. Use the selected foods to demonstrate appropriate technologies 
that enhance the tracking and tracing of foods along the supply chain 
from source to points of service;
    6. Demonstrate the tracking and tracing of: (a) A selected 
processed food and its key ingredients (minimum of two ingredients) and 
(b) a selected fruit and/or vegetable along the supply chain;
    7. Assess the costs and benefits of the methods for rapid and 
effective tracking and tracing of the selected foods and key 
ingredients; and
    8. Determine the feasibility of product tracing technologies for 
different sectors of the food industry, including small businesses.
    FDA released the report containing the findings of the pilot 
projects, entitled ``Pilot Projects for Improving Product Tracing along 
the Food Supply System'' in March 2013. The report is available on 
FDA's Product Tracing Web page at http://www.fda.gov/Food/FoodSafety/FSMA/ucm270851.htm. This extensive report is being reviewed by FDA. 
After careful review of this report and information previously 
gathered, FDA will submit its report to Congress containing FDA 
recommendations for improving product tracing. This docket is being 
opened in order to request comments on the pilot project report's 
findings and recommendations to help inform FDA in preparing its 
recommendations in the Agency's report to Congress.

C. Request for Comments and Information

    In addition to providing the findings of the pilot projects, the 
report contains IFT's recommendations for FDA on improving tracking and 
tracing of food. FDA released this report to make it available for 
stakeholders and to solicit input that may be helpful as FDA forms its 
own recommendations, to be contained in the Agency's report to 
Congress, and as FDA implements other FSMA requirements related to 
product tracing. FDA invites comment on the findings and 
recommendations contained in the IFT report and the submission of 
information relevant to improving product tracing. In addition, FDA 
would like specific comment on the following:
    1. The report contains specific recommendations regarding key data 
elements (KDEs) and critical tracking events (CTEs). How might this 
work for your industry segment? What would you keep the same or change 
in Table 2 in the Executive Brief of the report? Please include an 
explanation of why you would keep the same or change.
    2. The report recommends that all foods be covered, not just high-
risk foods. The rulemaking requirement in section 204(d) of FSMA only 
refers to high-risk foods. Should FDA pursue implementation of some or 
all of the report's recommendations with respect to all foods, not just 
high-risk foods? If so, what routes might the Agency use?
    3. The report recommends that each member of the food supply chain 
should be required to develop, document, and exercise a product tracing 
plan. FDA is aware that industry often conducts and documents recall 
exercises, which are essentially traceforward exercises. Is it feasible 
to add a traceback to existing procedures and exercises? Should FDA 
include this IFT recommendation as one of its recommendations in the 
Agency's report to Congress? Please explain why the FDA should or 
should not include.
    4. What additional information and data sources could be used to 
determine cost and benefits associated with implementing IFT's 
recommendations for KDEs and CTEs?
    5. How might FDA more clearly and consistently articulate the 
information it needs to conduct product tracing investigations? Would 
posting information on FDA's Web site on how FDA typically conducts a 
traceback or traceforward be helpful?
    6. The report recommends that FDA develop standardized electronic 
mechanisms for the reporting and acquiring of CTEs and KDEs during 
product tracing investigations. How would this work for your industry 
segment? How might it be achieved most expeditiously?
    7. Is there anything else FDA should consider in preparing its 
recommendations for improving product tracing in the Agency's report to 
Congress?

II. Comments

    Interested persons may submit either electronic comments 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. 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. References

    The following reference has 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 is 
available electronically at http://www.regulations.gov.


[[Page 14311]]


1. McEntire, Jennifer and Bhatt, Tejas, ``Pilot Projects for 
Improving Product Tracing Along the Food Supply System--Final 
Report,'' Institute of Food Technologists, August 2012.

    Dated: February 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04997 Filed 3-4-13; 8:45 am]
BILLING CODE 4160-01-P