[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