Document ID: FDA-2014-N-0053-0056
Agency: fda
Document Type: Proposed Rule
Title: Requirements for Additional Traceability Records for Certain Foods
Posted Date: 2020-09-23T04:00Z

[Federal Register Volume 85, Number 185 (Wednesday, September 23, 2020)]
[Proposed Rules]
[Pages 59984-60038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20100]

[[Page 59983]]

Vol. 85

Wednesday,

No. 185

September 23, 2020

Part IV

 Department of Health and Human Services

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 Food and Drug Administration

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21 CFR Part 1

Requirements for Additional Traceability Records for Certain Foods; 
Proposed Rule

  Federal Register / Vol. 85 , No. 185 / Wednesday, September 23, 2020 
/ Proposed Rules  

[[Page 59984]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2014-N-0053]
RIN 0910-AI44

Requirements for Additional Traceability Records for Certain 
Foods

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
proposing to establish additional traceability recordkeeping 
requirements for persons that manufacture, process, pack, or hold foods 
the Agency has designated for inclusion on the Food Traceability List. 
The proposed rule would require these entities to establish and 
maintain records containing information on critical tracking events in 
the supply chain for these designated foods, such as growing, shipping, 
receiving, creating, and transforming the foods. The proposed 
requirements are intended to help the Agency rapidly and effectively 
identify recipients of foods to prevent or mitigate foodborne illness 
outbreaks and address credible threats of serious adverse health 
consequences or death resulting from foods being adulterated or 
misbranded. We are issuing this proposed rule in accordance with the 
FDA Food Safety Modernization Act (FSMA).

DATES: Submit either electronic or written comments on the proposed 
rule by January 21, 2021. Submit written comments (including 
recommendations) on the collection of information under the Paperwork 
Reduction Act of 1995 by November 23, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 21, 2021. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked, and identified 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-0053 for ``Requirements for Additional Traceability Records 
for Certain Foods.'' Received comments, those filed in a timely manner 
(see ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    Submit comments on the information collection under the Paperwork 
Reduction Act of 1995 to the Office of Management and Budget (OMB) to 
https://www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under Review--Open for 
Public Comments'' or by using the search function. The title of this 
proposed collection is ``Requirements for Additional Traceability 
Records for Certain Foods.''

FOR FURTHER INFORMATION CONTACT: Regarding the proposed rule: Brian 
Pendleton, Office of Policy, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4614, 
Brian.Pendleton@fda.hhs.gov.
    Regarding the information collection: Domini Bean, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose and Coverage of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits

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II. Table of Abbreviations and Commonly Used Acronyms in This 
Document
III. Background
    A. Introduction
    B. Need for the Regulation
    C. FDA's Current Regulatory Framework
    D. History of the Rulemaking
    E. Improving Traceability for All Foods
IV. Legal Authority
    A. Designation of High-Risk Foods
    B. Additional Recordkeeping Requirements
V. Description of the Proposed Rule
    A. Scope/Applicability (Proposed Sec.  1.1300)
    B. Exemptions (Proposed Sec.  1.1305)
    C. Definitions (Proposed Sec.  1.1310)
    D. Traceability Program Records (Proposed Sec. Sec.  1.1315 to 
1.1320)
    E. Records of Growing, Receiving, Transforming, Creating, and 
Shipping Food (Proposed Sec. Sec.  1.1325 to 1.1350)
    F. Special Requirements for Foods Subjected to a Kill Step 
(Proposed Sec.  1.1355)
    G. Procedures for Modified Requirements and Exemptions (Proposed 
Sec. Sec.  1.1360 to 1.1400)
    H. Waivers (Proposed Sec. Sec.  1.1405-1.1450)
    I. Records Maintenance and Availability (Proposed Sec.  1.1455)
    J. Consequences of Failure To Comply (Proposed Sec.  1.1460)
    K. Updating the Food Traceability List (Proposed Sec.  1.1465)
VI. Proposed Effective and Compliance Dates
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose and Coverage of the Proposed Rule

    In accordance with section 204(d) of FSMA, this proposed rule would 
establish traceability recordkeeping requirements for persons who 
manufacture, process, pack, or hold foods that FDA has designated as 
foods for which additional recordkeeping requirements are appropriate 
and necessary to protect the public health. The requirements are 
intended to help us rapidly and effectively identify recipients of 
these foods to prevent or mitigate a foodborne illness outbreak and to 
address credible threats of serious adverse health consequences or 
death as a result of such foods being adulterated under section 402 of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342) or 
misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)). The 
proposed requirements would reduce the harm to public health caused by 
foodborne illness outbreaks and limit adverse impacts on industry 
sectors affected by these outbreaks by improving the ability to quickly 
and efficiently trace the movement through the supply chain of foods 
identified as causing illness, identify and remove contaminated food 
from the marketplace, and develop mitigation strategies to prevent 
future contamination.
    We are issuing the proposed rule because Congress directed us, in 
section 204(d)(1) of FSMA, to establish recordkeeping requirements for 
these foods that would be additional to the traceability recordkeeping 
requirements in section 414 of the FD&C Act (21 U.S.C. 350c) and FDA 
regulations in 21 CFR part 1, subpart J (subpart J). The existing 
requirements in subpart J are designed to enable FDA to identify the 
immediate previous sources and immediate subsequent recipients of foods 
to address credible threats of serious adverse health consequences or 
death to humans or animals. The proposed rule would adopt additional 
recordkeeping requirements beyond those in subpart J for foods we 
designate as high-risk foods (including foods that contain foods 
designated as high risk) in accordance with factors specified by 
Congress in section 204(d)(2)(A) of FSMA. We will list these designated 
foods on a ``Food Traceability List,'' a draft of which is available 
for comments. We will publish a final version of the Food Traceability 
List on our website when we issue the final rule, and we will update 
the list as appropriate under the procedures set forth in section 
204(d)(2)(B) of FSMA and the proposed rule.

B. Summary of the Major Provisions of the Proposed Rule

    We are proposing recordkeeping requirements for foods on the Food 
Traceability List (``listed foods'') designed to improve the 
traceability information available for these foods during foodborne 
illness outbreaks and to increase the speed and precision of 
traceforward investigations for recall events. The proposed 
requirements are informed by the challenges we have faced in obtaining 
critical tracing information and the advancements in traceability 
approaches that industry has already begun to implement.
    The proposed rule would require persons who manufacture, process, 
pack, or hold foods on the Food Traceability List (including foods that 
contain foods on the list as ingredients) to keep certain records 
describing their traceability operations and the listed foods they 
handle to help FDA investigators understand their traceability 
procedures and records when reviewing them during a foodborne illness 
outbreak or a routine inspection. These traceability program records 
include a description of the reference records (e.g., bills of lading, 
purchase orders) in which they keep required tracing information, a 
list of foods on the Food Traceability List they ship, a description of 
how they assign traceability lot codes, and other information needed to 
understand their traceability programs.
    The core components of the proposed rule are the requirements to 
establish and maintain records containing key data elements (KDEs) 
associated with different critical tracking events (CTEs) in a listed 
food's supply chain, including the growing, receiving, transforming, 
creating, and shipping of listed foods. The recordkeeping requirements 
we propose emphasize the importance of documenting the applicable 
traceability lot codes and linking these codes to other KDEs at 
critical points in the supply chain of a food to aid product tracing 
during an investigation of a foodborne illness outbreak or during a 
recall.
    The proposed rule includes several proposed full and partial 
exemptions from the additional recordkeeping requirements, including 
some specified by Congress and some we are proposing on our own 
initiative. Proposed full exemptions include those for small retail 
food establishments (under one option of a ``co-proposal'' regarding 
such establishments), small farms, farms selling food directly to 
consumers, certain food produced and packaged on a farm, food that 
receives certain types of processing, and transporters of food. Partial 
exemptions would apply to certain commingled raw agricultural 
commodities (not including fruits and vegetables subject to the produce 
safety regulations), fishing vessels, retail food establishments that 
receive a listed food directly from a farm, and farm to school and farm 
to institution programs.
    The proposed rule also includes special requirements for foods on 
the Food Traceability List that are subjected to a kill step.
    In accordance with section 204 of FSMA, we are proposing to 
establish procedures under which persons subject to the proposed rule 
(when finalized) could request modified requirements or an exemption 
from these recordkeeping regulations for a specific food or a type of 
entity on the grounds that application of the requirements to that food 
or type of entity is not necessary to protect public health. In 
addition, the proposed rule includes procedures for requesting a waiver 
of one or more of the requirements for an individual entity or a type 
of entity on the grounds that

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having to meet the requirements would impose an economic hardship.
    The proposed rule also includes procedures for future updating of 
the Food Traceability List in accordance with section 204(d)(2)(B) of 
FSMA.

C. Legal Authority

    Section 204(d)(1) of FSMA directs FDA to publish a notice of 
proposed rulemaking to establish recordkeeping requirements, in 
addition to the requirements under section 414 of the FD&C Act and the 
subpart J regulations, for facilities that manufacture, process, pack, 
or hold foods that FDA designates as foods for which additional 
recordkeeping requirements are needed under section 204(d)(2) of FSMA. 
Section 204(d)(2)(A) of FSMA directs FDA to designate foods for which 
the additional recordkeeping requirements described in section 
204(d)(1) of FSMA are appropriate and necessary to protect the public 
health.

D. Costs and Benefits

    This proposed rule, if finalized, would impose compliance costs on 
affected entities to establish and maintain traceability records for 
foods on the Food Traceability List and costs to read and understand 
the rule. Some entities may also incur initial capital investment and 
training costs. We estimate that the present value of costs of the rule 
over 10 years, if Option 1 of the co-proposal for retail food 
establishments with 10 or fewer full-time equivalent employees (full 
exemption from the rule) were selected, would range from $238 million 
to $17 billion, with a primary estimate of $2.9 billion in 2018 dollars 
at a seven percent discount rate, and from $285 million to $20.1 
billion, with a primary estimate of $3.4 billion at a three percent 
discount rate. At a seven percent discount rate, annualized costs of 
the rule under proposed Option 1 would range from approximately $34 
million to $2.4 billion per year in 2018 dollars, with a primary 
estimate of $411 million per year. At a three percent discount rate, 
annualized costs under proposed Option 1 would range from approximately 
$33 million to $2.4 billion per year, with a primary estimate of $400 
million per year.
    We estimate that the present value of costs of the rule over 10 
years, if Option 2 of the co-proposal for retail food establishments 
with 10 or fewer full-time equivalent employees (exemption from the 
requirement to make available to FDA, in certain circumstances, an 
electronic sortable spreadsheet containing requested traceability 
information) were selected, would range from $301 million to $22.5 
billion, with a primary estimate of $3.8 billion in 2018 dollars at a 
seven percent discount rate, and from $356 million to $26.1 billion, 
with a primary estimate of $4.4 billion at a three percent discount 
rate. At a seven percent discount rate, annualized costs of the rule 
under proposed Option 2 would range from approximately $43 million to 
$3.2 million per year in 2018 dollars, with a primary estimate of $535 
million per year. At a three percent discount rate, annualized costs 
under proposed Option 2 would range from approximately $42 million to 
$3.1 billion per year, with a primary estimate of $513 million per 
year.
    The proposed rule, if finalized, would result in public health 
benefits if it averts foodborne illnesses related to outbreaks linked 
to foods on the Food Traceability List. It would also improve the 
likelihood of conducting more targeted recalls and reduce the cost of 
conducting recalls by avoiding overly broad recalls and market 
withdrawals. Additional benefits may include increased food supply 
system efficiencies, such as improvements in supply chain management 
and inventory control; more expedient initiation and completion of 
recalls; avoidance of costs due to unnecessary preventive actions by 
consumers; and other benefits due to a standardized approach to 
traceability, including an increase in transparency and trust and 
potential deterrence of fraud.
    We estimate public health benefits using several case studies of 
outbreak tracebacks for four pathogens associated with illnesses caused 
by foods on the Food Traceability List. These benefits have a tendency 
toward underestimation of the total public health benefits because 
these four pathogens do not represent the total burden of all illnesses 
associated with listed foods. However, adjustments made for undiagnosed 
and unattributed illnesses may have the opposite tendency of 
overstating both illnesses and benefits associated with listed foods. 
We calculate these monetized benefits from illnesses averted per year 
based on an estimated 84 percent reduction of traceback time resulting 
from the requirements of this rule.
    Under Option 1 of the co-proposal, for an estimated 84 percent 
traceback improvement, the annualized monetized benefits range from $33 
million to $1.4 billion with a primary estimate of $567 million, 
discounted at seven percent over ten years. At a three percent discount 
rate over ten years, the annualized monetized benefits range from $33 
million to $1.4 billion with a primary estimate of $580 million. Under 
Option 2 of the co-proposal, for an estimated 84 percent traceback 
improvement, the annualized monetized benefits range from $36 million 
to $1.5 billion with a primary estimate of $626 million, discounted at 
a seven percent over ten years, and from $37 million to $1.5 billion 
with a primary estimate of $640 million, discounted at three percent 
over ten years. Using examples from three recalls, additional (non-
health) benefits for both Options 1 and 2 of avoiding overly broad 
recalls could range from $1.7 billion to $5.6 billion per year at a 
seven percent discount rate and from $1.7 billion to $5.8 billion using 
a three percent discount rate. We lack complete information on other 
benefits described above and discuss them qualitatively.

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                       Table 1--Costs and Benefits
  [In 2018 dollars annualized over 10 years at 7 percent discount rate]
------------------------------------------------------------------------
                                     Option 1              Option 2
------------------------------------------------------------------------
Total Costs................  $411 million...........  $535 million.
Total Benefits.............  $567 million in public   $626 million in
                              health benefits for an   public health
                              estimated scenario of    benefits for an
                              84 percent traceback     estimated
                              time improvement.        scenario of 84
                              Additional potential     percent traceback
                              benefits that we         time improvement.
                              describe qualitatively   Additional
                              include increased food   potential
                              supply system            benefits that we
                              efficiencies; more       describe
                              expedient initiation     qualitatively
                              and completion of        include increased
                              recalls; avoidance of    food supply
                              costs due to             system
                              unnecessary preventive   efficiencies;
                              actions; and other       more expedient
                              efficiencies from a      initiation and
                              standardized approach    completion of
                              to traceability.         recalls;
                              However, if retail       avoidance of
                              food establishments      costs due to
                              with 10 or fewer full-   unnecessary
                              time equivalent          preventive
                              employees are exempt     actions; and
                              from subpart S           other
                              requirements, the        efficiencies from
                              timeliness, precision,   a standardized
                              and accuracy of          approach to
                              traceability efforts     traceability.
                              can be impacted, and
                              qualitative benefits,
                              such as the ability to
                              narrow the number of
                              lots in a recall and
                              the ability for retail
                              food establishments
                              with 10 or fewer full-
                              time equivalent
                              employees to have the
                              data necessary to
                              quickly identify and
                              remove contaminated
                              products from shelves,
                              will be lessened in
                              comparison to Option 2.
------------------------------------------------------------------------

II. Table of Abbreviations and Commonly Used Acronyms in This Document

------------------------------------------------------------------------
         Abbreviation or acronym                   What it means
------------------------------------------------------------------------
ASN.....................................  Advance shipping notice.
BOL.....................................  Bill of lading.
CDC.....................................  Centers for Disease Control
                                           and Prevention.
CSA.....................................  Community supported
                                           agriculture.
CTE.....................................  Critical tracking event.
FDA.....................................  Food and Drug Administration.
FD&C Act................................  Federal Food, Drug, and
                                           Cosmetic Act.
FSIS....................................  Food Safety and Inspection
                                           Service.
FSMA....................................  FDA Food Safety Modernization
                                           Act.
FOIA....................................  Freedom of Information Act.
GAP.....................................  Good agricultural practices.
GPS.....................................  Global positioning system.
KDE.....................................  Key data element.
LACF....................................  Low-acid canned foods.
OMB.....................................  Office of Management and
                                           Budget.
RAC.....................................  Raw agricultural commodity.
USDA....................................  U.S. Department of
                                           Agriculture.
------------------------------------------------------------------------

III. Background

A. Introduction

    On January 4, 2011, President Obama signed the FDA Food Safety 
Modernization Act (FSMA) (Pub. L. 111-353) into law. As a component of 
FSMA's overhaul of U.S. food safety law to better ensure the safety and 
security of the nation's food supply, section 204(d) of FSMA requires 
that FDA establish recordkeeping requirements for facilities that 
manufacture, process, pack, or hold foods that the Agency designates as 
high-risk to facilitate the rapid and effective traceability of such 
foods. These recordkeeping requirements will be additional to the food 
traceability requirements under section 414 of the FD&C Act (added to 
the FD&C Act in title III, subtitle A, section 306, of the Public 
Health Security and Bioterrorism Preparedness and Response Act of 2002 
(the Bioterrorism Act) (Pub. L. 107-188)) and the implementing 
regulations in subpart J of part 1 of title 21 of the Code of Federal 
Regulations (Sec. Sec.  1.326 to 1.368) (the subpart J regulations). 
Congress directed FDA to adopt the subpart J recordkeeping requirements 
to allow the Agency to identify the immediate previous sources and 
immediate subsequent recipients of foods (commonly referred to as 
``one-up, one-back'' recordkeeping) to address credible threats of 
serious adverse health consequences or death to humans or animals. In 
section 204(d)(1) of FSMA, Congress directed FDA to adopt additional 
recordkeeping requirements to prevent or mitigate foodborne illness 
outbreaks and address credible threats of serious adverse health 
consequences or death to humans or animals resulting from foods being 
adulterated under section 402 of the FD&C Act or misbranded with 
respect to allergen labeling under section 403(w) of the FD&C Act.
    The proposed additional recordkeeping requirements, when finalized, 
will help FDA follow the movement of listed food products and 
ingredients both backward and forward throughout the supply chain. 
Documenting the movement of foods through the supply chain is called 
product tracing or traceability. In the case of a foodborne illness 
outbreak or evidence of contaminated food, product tracing helps 
government agencies identify the points in the food supply chain, 
including the source of the product, where contamination may have 
occurred and, working in partnership with industry, subsequently remove 
the food from the marketplace. It also helps those who sell food to 
notify those in the distribution chain that they may have received the 
product. Efficient traceability enables the government and the food 
industry to take action more quickly, thus preventing illnesses and 
reducing economic harm.
    Traceability includes traceback and traceforward investigations. 
Traceback begins at the end of the supply chain at the point of 
purchase or point of service (e.g., grocery stores and restaurants) and 
follows the food product back through the points of distribution, 
processing, and production to determine the source of the product and 
its ingredients. Traceforward follows the movement of a food in the 
opposite direction, from the source (e.g., a farm or manufacturer) 
forward to the retail shelf, to determine the scope of a potential 
recall and the impact of the contaminated product on the public health.
    Even before the enactment of FSMA, FDA had been considering ways to 
improve food product traceability and increase the speed and accuracy 
of our traceback and traceforward investigations. For example, in 2008 
we held two public meetings to discuss mechanisms to enhance product 
tracing systems for fresh produce and to improve our ability to 
identify the source of contamination associated with fresh produce-
related outbreaks of foodborne illnesses (see 73 FR 55115, September 
24, 2008). In the spring of 2009, we engaged in a pilot project with 
the Institute of Food Technologists (IFT) to conduct a mock traceback 
scenario on tomatoes with representatives of the

[[Page 59988]]

industry, academia, States, and two technology companies (Ref. 1). In 
December 2009, we conducted a public meeting, in collaboration with the 
United States Department of Agriculture's (USDA's) Food Safety and 
Inspection Service (FSIS), regarding product tracing systems for human 
food and animal food (see 74 FR 56843, November 3, 2009).
    After FSMA was enacted, FDA sought public comment, scientific data, 
and information in February 2014 to inform our draft approach to 
identifying high-risk foods (see 79 FR 6596, February 4, 2014). Section 
204(d)(2)(A) of FSMA requires FDA to designate high-risk foods for 
which the proposed additional recordkeeping requirements are 
appropriate and necessary to protect the public health. The high-risk 
food designation must be based on the following factors:
     The 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 (CDC);
     the 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 the food;
     the point in the manufacturing process of the food where 
contamination is most likely to occur;
     the likelihood of contamination and steps taken during the 
manufacturing process to reduce the possibility of contamination;
     the likelihood that consuming a particular food will 
result in a foodborne illness due to contamination of the food; and
     the likely or known severity, including health and 
economic impacts, of a foodborne illness attributed to a particular 
food.
    Section 204(d)(2)(B) of FSMA requires the Agency to publish the 
list of high-risk foods on our website when we issue the final rule 
establishing the additional recordkeeping requirements for high-risk 
foods.

B. Need for the Regulation

    Each day that a foodborne illness outbreak remains unresolved, the 
health of consumers remains at risk. We recognize that to fully realize 
the public health benefits envisioned by FSMA, we need to improve our 
ability to rapidly identify and trace foods that may be causing 
illness. While industry has generally adopted the requirements for one-
up, one-back tracing required under the subpart J regulations, the 
complexity and level of implementation of tracing systems that exceed 
those requirements vary. From our traceback investigations and 
discussions with food industry companies and organizations, we 
recognize that many firms have developed traceability procedures for 
internal use to help ensure the safety of their products and the 
security of their supply chains. A smaller number of firms employ 
tracing systems that are more robust and allow linking of incoming and 
outgoing products throughout the supply chain, primarily through 
reference to applicable lot codes in records documenting the 
production, processing, and distribution of the foods. The proposed 
recordkeeping requirements, which go beyond subpart J, including by 
mandating such linking information, would reduce the harm to public 
health caused by foodborne illness outbreaks and limit adverse impacts 
on industry sectors affected by these outbreaks. The requirements would 
achieve this by improving the ability to (1) quickly and efficiently 
trace the movement of listed foods through the supply chain and (2) 
identify and remove contaminated food from the marketplace during an 
outbreak.
    This proposed rule is intended to establish the framework of 
information needed to be maintained in traceability records to 
accurately and efficiently trace contaminated foods (both domestic and 
imported) across the U.S. food supply chain to protect the health of 
all consumers. The rule would establish a consistent approach for 
product tracing for the different types of products and firms subject 
to this regulation. The rule also specifies the data elements and 
information firms must establish and maintain, along with information 
they must send, in certain circumstances, to the next entity in the 
supply chain. The rule also would help establish a foundation for the 
use of consistent food tracing terminology, a transition from paper-
based recordkeeping to electronic records, and a universal 
understanding of the critical information needed for a standardized and 
efficient system for traceability.
    Tracing a food back in the supply chain from the point of sale or 
service to a common source is important for identifying contaminated 
foods or ingredients and removing those products from the marketplace 
to prevent additional illnesses. Tracing foods forward can help FDA 
understand how the distribution of a food product relates to illnesses 
or illness clusters, especially for outbreaks that are challenging to 
resolve, such as those involving multiple foods and foods with multiple 
ingredients.
    The Agency has sometimes been unable to determine links between 
illnesses and specific product distribution due to inconsistent, 
unstandardized recordkeeping, lack of a deliberate method to connect 
records, and the frequent lack of lot tracing regarding distribution to 
specific retail locations. The retail food establishment is the first 
point in the supply chain where an investigation is initiated to 
collect traceback data to identify the source of a product. The more 
accurate and detailed the data available on the product of interest at 
the retail food establishment, the more refined record collection can 
be throughout the remainder of the supply chain. In 2018, FDA 
investigated a cluster of illnesses caused by Cyclospora cayetanensis 
at small restaurants. We were unable to obtain enough information to 
identify specific farms/growers (from among several suppliers) as the 
source of the products suspected of contamination (e.g., basil, 
cilantro, vegetable trays) due to the restaurants' lack of records 
indicating lot numbers received and lack of linking to information 
throughout the supply chain. In the absence of more specific data at 
the retail food establishment, we had to conduct a broader record 
collection involving numerous suppliers to ensure that we had 
sufficient tracing information to accurately determine what lots likely 
would have been available for consumption or purchase at the 
establishments by the sickened persons. One benefit of the proposed 
requirements is that they would allow us to conduct comparative 
analyses on supply chains of multiple commodities to rule in or out 
specific ingredients in outbreaks in which ill persons have reported 
concerns about mixed-ingredient foods.
    When a foodborne illness outbreak occurs, a firm with an effective 
traceability program can lessen the potential adverse economic impact 
of the event. This is possible when the firm can quickly and precisely 
provide specific traceability information on a suspected product to 
regulatory agencies. This information can enable the confirmation of 
common foods and ingredients associated with illnesses and also help 
determine which foods and ingredients can be potentially eliminated 
from further consideration as possible sources of contamination. As a 
result, regulatory agencies can narrow the scope of necessary recall 
actions, public health alerts, and countrywide import alerts. 
Furthermore, being able to

[[Page 59989]]

identify the source of a contaminated product quickly enables FDA to 
conduct more timely root-cause analysis, which could provide important 
information to help in understanding how contamination may have 
occurred and prevent future outbreaks.
    Lack of traceability has led to delays in product recalls and 
notification to the public, allowing potentially contaminated foods to 
remain on the market longer. In 2017, the manufacturer of a soy nut 
butter product recalled the product after it was found to be the source 
of a multistate outbreak of Shiga toxin-producing Escherichia coli (E. 
coli) that sickened 32 people (81 percent of whom were younger than 18) 
in 12 states (Refs. 2 to 4). Weeks later, another company announced a 
recall of its products because they were made with soy nut butter 
supplied by the original company (Ref. 5). Inadequate traceability 
significantly impeded product actions for potentially contaminated 
product associated with this outbreak investigation.
    Inadequate traceability can affect both traceback and traceforward 
investigations. In 2015, FDA, CDC, and multiple states investigated a 
multistate outbreak of Salmonella associated with imported cucumbers 
that ultimately sickened 907 people (Ref. 6). While the traceback was 
able to identify a single grower of the cucumbers resulting in product 
recalls, the CDC reported additional sporadic cases of Salmonella 6 
months after the recall. Having more robust traceforward information 
could have helped ensure a more complete recall by identifying more 
locations that received the contaminated product and may have helped 
assess whether there were other contaminated products on the market 
subject to the same conditions that led to contamination of cucumbers.
    During an outbreak of Salmonella Typhimurium in 2008, almost 4,000 
peanut butter-containing products were recalled over a period of three 
and a half months. Cases of illness were first seen in patients 
residing in a long-term care facility and other institutional settings. 
Records at these locations identified a common brand of peanut butter, 
which led to a common manufacturer, and a recall of the brand was 
initiated. But illnesses continued to be reported across the United 
States, and further case interviews indicated that the illnesses could 
not be explained by consumption of the recalled brand of peanut butter. 
An extensive traceback and traceforward investigation led to expanded 
recalls over several months, during which many potentially contaminated 
peanut butter products remained available in the marketplace. This 
outbreak illustrates the challenges posed by ingredient-based outbreaks 
and lack of standardized records documenting a product's distribution 
chain. Manual review of a variety of records was necessary to determine 
the subsequent commercial recipients of the peanut butter and the 
inclusion of the peanut butter as an ingredient in other food products. 
This time-consuming review resulted in a delay in the identification of 
the many products ultimately recalled in this outbreak (Ref. 7).
    Poor traceability records also can lead to an inability to 
appropriately narrow the scope of a recall. In 2018, a leafy greens mix 
was linked to an outbreak of Shiga toxin-producing E. coli. FDA 
identified numerous farms that could potentially have produced leafy 
greens linked to the outbreak. Traceback data gathered during the 
investigation led to issuance of a public advisory to not consume 
chopped romaine lettuce from the identified growing region. However, 
lack of traceability records hindered our ability to identify specific 
lots and growers of contaminated product. After the initial advisory 
was issued, we identified an additional cluster of illnesses in people 
who consumed whole-head romaine lettuce from the same region. As a 
result, we expanded the initial public advisory to include all romaine 
lettuce from the identified growing region. Because we were unable to 
identify a point of origin for the food that made people ill, we were 
unable to narrow the scope of the advisory but instead had to expand it 
(Ref. 8).
    Lack of specific lot-level tracing data can impact FDA's ability to 
perform root-cause analyses to determine the point of contamination 
once the source(s) is identified, which can lead to recurring 
outbreaks. For example, in 2013, 2014, and 2015, the CDC and state 
public health officials identified annually recurring outbreaks of 
Cyclospora cayetanensis infections in the United States associated with 
fresh cilantro from the state of Puebla, Mexico. Although not confirmed 
by epidemiological means, FDA reviewed a cluster of cyclosporiasis 
illnesses from 2012 in which the state of Texas had previously 
identified cilantro as one of multiple possible suspect vehicles. FDA 
determined that cilantro from Puebla was supplied to the point of 
service implicated in that outbreak and was one potential source of the 
outbreak. After the outbreak investigation in 2015, FDA implemented an 
import alert for shipments of fresh cilantro from Puebla during April 
through August to align with the seasonality of previous cyclosporiasis 
outbreaks (Ref. 9). There were numerous traceback challenges during all 
three of the investigations due to commingling of product, 
recordkeeping issues, and inconsistencies in documented firm names that 
hindered our ability to identify the suppliers of the contaminated 
cilantro. Poor traceability delayed us from taking product actions to 
ensure contaminated product was removed from the market and conducting 
environmental assessments that could have identified routes of 
contamination to reduce future illnesses.
    Poor traceability can affect not only outbreaks caused by 
infectious pathogens but also illnesses associated with fish 
poisonings. For example, in 2019, FDA investigated a cluster of 50 
illnesses that were attributed to Scombrotoxin fish poisoning. In cases 
of fish toxin poisonings, the illness onset can occur within minutes of 
consuming fish products, making it even more vital to have specific 
tracing data available at the point of sale. Because cases reported a 
variety of frozen tuna products due to inconsistent product 
descriptions, FDA's traceback investigation traced all cuts of tuna 
supplied by two firms rather than narrowing the focus to one specific 
cut of tuna (Ref. 10). The traceback investigation was unable to 
confirm that the most recent shipments to the points of sale contained 
the actual product used to prepare meals reported by the cases, due to 
the extended 2-year shelf life of the frozen product and lack of 
recordkeeping for this product. Additionally, the traceback 
investigation could not identify/implicate lot codes at the point of 
sale because at least two distributors reboxed product into different 
packaging, and there was potential commingling of product at least one 
point of sale. Given the extended shelf life and lack of lot codes 
available at the point of sale, the traceback investigation could not 
determine relevant lot codes for the implicated products. Due to these 
traceability limitations, the Agency was only able to place one of the 
importers of the contaminated tuna products on an import alert, and 
multiple recalls were required to ensure that importers removed all 
contaminated products.
    Inconsistent product descriptions and commingling of product can 
also affect traceability efforts. In June 2017, FDA investigated an 
outbreak of multiple serotypes of Salmonella that caused 220 cases of 
illnesses associated with contaminated papayas (Ref. 11). Tracing the 
contaminated papayas was delayed by inconsistent descriptions of the 
papayas, making it difficult to link the

[[Page 59990]]

product with the records. Ultimately, the traceback investigation was 
not able to implicate the shipments of the contaminated papayas due to 
product commingling, resulting in an inability to differentiate 
suppliers of the papayas.
    As these examples show, while some elements of internal product 
tracing information are kept by many food producers, manufacturers, 
distributors, and retailers, the types of information recorded and 
maintained, the format in which information is kept, the length of time 
information is retained, and the amount of information shared between 
trading partners varies among firms. These challenges are further 
compounded when looking at the traceability of a product moving through 
multiple entities in a supply chain. Standardization of data elements 
is needed to help ensure successful traceability throughout the supply 
chain.
    Recognizing the need for improvement in food traceability, when 
Congress enacted FSMA in 2011 it included provisions, in section 204, 
intended to enhance tracking and tracing of food. As noted, section 
204(d) of FSMA directed FDA to establish additional recordkeeping 
requirements for certain foods. Under section 204(a) of FSMA, Congress 
directed us to establish pilot projects in coordination with the food 
industry to explore and evaluate methods to rapidly and effectively 
identify recipients of food to prevent or mitigate foodborne illness 
outbreaks and address credible threats of serious adverse health 
consequences or death to humans or animals as a result of such food 
being adulterated or misbranded. At FDA's request, the IFT conducted 
two product tracing pilots (involving mock tracebacks and 
traceforwards) of foods that had been implicated in foodborne illness 
outbreaks between 2005 and 2010, assessed the costs and benefits of 
efficient and effective methods for tracking the foods, and evaluated 
the feasibility of such methodologies being adopted by different 
sectors of the food industry. In its 2012 final report to FDA on the 
pilot studies, the IFT found that pilot participants appeared to have 
many tools and procedures needed to capture and communicate key 
traceability information at critical points of product transfer and 
transformation. However, the IFT identified several problems with 
current tracing systems, including inconsistencies in terminology and 
the production of information in formats that cannot be electronically 
manipulated (Ref. 12).

C. FDA's Current Regulatory Framework

    The subpart J traceability recordkeeping requirements stemming from 
the 2002 Bioterrorism Act require firms to know and record the 
immediate previous sources of their food products and ingredients and 
the immediate subsequent recipients of the products they make and/or 
distribute. The regulations, which we adopted in a final rule issued in 
2004 (see 69 FR 71562, December 9, 2004), specify information that 
``non-transporters'' of food (persons who own food or who hold, 
manufacture, process, pack, import, receive, or distribute food for 
purposes other than transportation) must maintain regarding their 
receipt and release of food, with more limited requirements for 
transporters of food. In accordance with section 414(b) of the FD&C 
Act, the subpart J regulations exempt farms and restaurants from the 
requirements. Also exempt are retail food establishments that employ 
ten or fewer full-time equivalent employees.
    Since implementation of the subpart J regulations more than 10 
years ago, FDA has learned that these one-up, one-back recordkeeping 
requirements do not capture all the data elements necessary to 
effectively and rapidly link shipments of food through each point in 
the supply chain. In many outbreak investigations, we typically request 
additional information not explicitly required to be maintained under 
subpart J to help us conduct traceback and traceforward investigations. 
This additional information often is available because many firms 
maintain it for business (other than tracing) purposes. However, 
piecing together information from several types of documents to extract 
useful tracing data at each point in the supply chain is laborious and 
time-consuming, significantly slowing the tracing process and 
potentially putting more consumers at risk.
    Among the most significant gaps in the subpart J recordkeeping 
requirements are the following:
     Lack of coverage of all sectors involved in food 
production, distribution, and sale (e.g., exemptions for farms and 
restaurants).
     Lack of uniform data collection (e.g., regarding the 
source of food ingredients used in each lot of finished product; the 
requirement to record a lot code or other identifier only ``to the 
extent this information exists'' (see Sec. Sec.  1.337(a)(4) and 
1.345(a)(4)); and
     Inability to link incoming with outgoing product within a 
firm and from one point in the supply chain to the next (Ref. 13).
    When FDA faces challenges during a traceback investigation, it is 
often due to one or more of the above-listed gaps in the subpart J 
requirements. The exemptions for point-of-service firms (foodservice 
and retail) affect almost every investigation because consumer data 
often is used to initiate a traceback event. During the investigation 
of an outbreak of E. coli O26 in 2015 at a restaurant, the available 
consumer data could not identify a single ingredient for tracing 
because customers who became ill had consumed a variety of dishes with 
multiple common ingredients. This problem was magnified by the lack of 
information linking the distribution center to the point of sale.
    In the last few years, numerous outbreaks associated with leafy 
greens have resulted in expansive recalls due to, among other reasons, 
a lack of uniform data collection across the supply chain. While our 
traceback activities identified farms that could have supplied affected 
product during the timeframe of interest for those outbreaks, a lack of 
data about the source of individual lots restricted our ability to 
identify which farms actually supplied the contaminated product.
    These limitations in the existing tracing recordkeeping 
requirements have been evident in FDA investigations of foodborne 
illness outbreaks since the adoption of the subpart J requirements. By 
including section 204 in FSMA, Congress recognized the need for 
improvement of food tracking and tracing generally and traceability 
recordkeeping requirements in particular. In not excluding farms and 
restaurants from the scope of the additional requirements for high-risk 
foods, Congress also recognized the importance of ensuring traceability 
to both ends of the supply chain. The requirements of this proposed 
rule, when finalized, will help ensure that the food industry maintains 
the traceability information we have determined is needed to enable us 
to respond quickly and effectively to foodborne illness outbreaks and 
recall events.

D. History of the Rulemaking

    On February 4, 2014, FDA issued a notice in the Federal Register 
(79 FR 6596) announcing the opening of a docket (FDA-2014-N-0053) to 
obtain comments and scientific data and information to help us 
implement section 204(d)(2) of FSMA, which requires us to designate 
high-risk foods (2014 Notice). The 2014 Notice summarized our tentative 
draft approach for the review and evaluation of data to designate high-
risk foods. We

[[Page 59991]]

included as a reference to the notice a draft approach document in 
which we described the process and methodology we were considering 
using to designate high-risk foods. We invited interested parties to 
submit comments, scientific data, and information that would help us 
refine the draft approach to identifying these foods. In addition to 
requesting comment and information related to the draft approach to 
high-risk food designation, we sought information on the following:
     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 food; and
     For representative foods in each food category or 
commodity group, a list of pathogens and chemical contaminants likely 
to be found in the food, the percentage prevalence of contaminants in 
the food, the levels of contaminants in the food, the point in the 
manufacturing process where contaminants are likely to be introduced, 
and 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 (79 FR 6596 at 6597).
1. Risk-Ranking Model and Food Traceability List
    FDA received many comments in response to the 2014 Notice. Taking 
into consideration the comments and other information submitted, we 
developed a draft risk-ranking model and collected data to populate the 
model for chemical and microbiological hazards associated with specific 
foods, with technical assistance from external expert panels. We 
conducted an extensive internal review of the draft model and data with 
Agency subject-matter experts. Two separate peer-review panels of 
independent external experts reviewed the draft model and the data used 
to generate risk scores with the model. Taking into consideration 
comments from these peer reviews (Refs. 14 and 15), we revised the 
model and updated the data.
    As discussed more fully in FDA's ``Methodological Approach to 
Developing a Risk-Ranking Model for Food Tracing FSMA Section 204 (21 
U.S.C. 2223)'' (Ref. 16), which is available in the public docket for 
this rulemaking and on our website, the risk-ranking model uses a 
semiquantitative, multicriteria decision analysis risk-ranking 
approach. The approach is consistent with the factors set forth in 
section 204(d)(2) of FSMA and is operationalized with data relevant to 
those factors, enabling the Agency to rank, on the basis of public 
health risk criteria, commodity-hazard pairs and, ultimately, foods we 
regulate.
    Although section 204(d) of FSMA does not exclude food for animals, 
we have not included animal foods in our risk-ranking model. The 
current risk-ranking model was designed to account only for humans and 
cannot accommodate applicability to other animal species. A principal 
reason for this is that one of the criteria used in the risk model is 
illness data. While human illnesses related to food are tracked by the 
CDC, there is no Federal agency with the authority or capability to 
track foodborne illness outbreaks in animals. Although FDA and state 
animal food regulatory programs have begun efforts to collect data on 
animal food-related illnesses, there are no requirements for reporting 
such illnesses, which has led to significant gaps in the data.
    Although animal foods are not included in FDA's risk-ranking model, 
we may revisit the issue of animal foods when we conduct any future 
reassessments of the model. We welcome comments on whether and how we 
should consider incorporating animal foods or animal food-related 
illness into this or a separate model.
    Using the results of the risk-ranking model, we tentatively 
identified foods for which additional traceability records will be 
required in accordance with section 204 of FSMA (see ``Designation of 
the Food Traceability List Using the Risk-Ranking Model for Food 
Tracing'' (Ref. 17). Based on that analysis, and in accordance with 
section 204(d)(2) of FSMA, following is the tentative list of foods for 
which additional traceability records would be required under the 
proposed rule (the Food Traceability List) (Ref. 18):

                Table 2--Tentative Food Traceability List
------------------------------------------------------------------------
    Food traceability list                    Description
------------------------------------------------------------------------
Cheeses, other than hard       Includes all soft ripened or semi-soft
 cheeses.                       cheeses, and fresh soft cheeses that are
                                made with pasteurized or unpasteurized
                                milk.
Shell eggs...................  Shell egg means the egg of the
                                domesticated chicken.
Nut butter...................  Includes all types of tree nut and peanut
                                butters; does not include soy or seed
                                butters.
Cucumbers....................  Includes all varieties of cucumbers.
Herbs (fresh)................  Includes all types of herbs, such as
                                parsley, cilantro, basil.
Leafy greens, including fresh- Includes all types of leafy greens, such
 cut leafy greens.              as lettuce, (e.g., iceberg, leaf and
                                Romaine lettuces), kale, chicory,
                                watercress, chard, arugula, spinach, pak
                                choi, sorrel, collards, and endive.
Melons.......................  Includes all types of melons, such as
                                cantaloupe, honeydew, and watermelon.
Peppers......................  Includes all varieties of peppers.
Sprouts......................  Includes all varieties of sprouts.
Tomatoes.....................  Includes all varieties of tomatoes.
Tropical tree fruits.........  Includes all types of tropical tree
                                fruit, such as mango, papaya, mamey,
                                guava, lychee, jackfruit, and starfruit.
Fruits and Vegetables (fresh-  Includes all types of fresh-cut fruits
 cut).                          and vegetables.
Finfish, including smoked      Includes all finfish species, such as
 finfish.                       cod, haddock, Alaska pollack, tuna, mahi
                                mahi, mackerel, grouper, barracuda, and
                                salmon; except does not include
                                siluriformes fish, such as catfish.
Crustaceans..................  Includes all crustacean species, such as
                                shrimp, crab, lobster, and crayfish.
Mollusks, bivalves...........  Includes all species of bivalve mollusks,
                                such as oysters, clams, and mussels;
                                does not include scallop adductor
                                muscle.
Ready-to-eat deli salads.....  Includes all types of ready-to-eat deli
                                salads, such as egg salad, potato salad,
                                pasta salad, and seafood salad; does not
                                include meat salads.
------------------------------------------------------------------------

    We note that, as discussed in section V.A, the proposed 
traceability recordkeeping requirements would apply not only to foods 
specifically appearing on the Food Traceability List

[[Page 59992]]

but also to foods that contain foods on the list as ingredients.
    A proposed Food Traceability List, including descriptions of the 
foods on the list (referred to in this document as ``listed foods''), 
is available in the public docket for this rulemaking and on FDA's 
website. In accordance with section 204(d)(2)(B) of FSMA, when we issue 
the final rule, we will publish a finalized Food Traceability List on 
our website. That list might differ from the list we are publishing 
with this proposed rule. We also note that, as discussed in section 
V.K, we anticipate periodically conducting a review to determine 
whether it is appropriate to revise the Food Traceability List in 
accordance with the procedures set forth in the proposed rule.
2. Proposed Recordkeeping Requirements for Foods on the Food 
Traceability List
    To help us develop appropriate traceability recordkeeping 
requirements under section 204(d) of FSMA, we have met with 
stakeholders and reviewed the current state of food traceability 
standards, systems, and technologies. We considered a broad range of 
domestic and international tracing standards and approaches, including 
those of the IFT, the business global standards organization GS1, the 
Produce Traceability Initiative, the International Standards 
Organization, the Global Food Safety Initiative, and others. We 
researched standards and systems for traceability in effect in several 
regions and countries, including the European Union, Canada, Australia, 
Japan, and China. We also discussed traceability approaches and 
concerns with food industry and consumer groups (Ref. 19). In addition, 
we have taken into account our experiences and challenges in conducting 
investigations in response to outbreaks of foodborne illness and recall 
events.
    From our traceback investigations and discussions with food 
industry companies and organizations, we recognize that most firms have 
developed and use some traceability procedures. For those firms that 
have traceability processes, it appears that an increasingly common 
approach to traceability involves the identification of CTEs for which 
KDEs are recorded and maintained. One of the IFT's recommendations in 
its 2012 final report was that FDA require firms to identify and 
maintain records of CTEs and KDEs as determined by the Agency (Ref. 
12). While not all firms at all points in the supply chain employ KDE/
CTE-specific tracing tools and procedures, those that do are 
recognizing the benefits both to their businesses and to public health 
of adopting such an approach to product tracing recordkeeping (Ref. 
20). However, the KDEs/CTEs the food industry uses are not consistently 
implemented across supply chains. Further, many firms have not adopted 
updated traceability approaches and are awaiting further agreement on 
standard KDEs and CTEs to be used throughout the food industry.
    As discussed in more detail in section V.E, the proposed rule 
adopts an approach to recordkeeping for foods on the Food Traceability 
List focused on maintaining and sharing specific KDEs for certain CTEs 
in a food's supply chain, which aligns with consensus standards for 
traceability currently used by industry. The information required to be 
kept would vary depending on the type of supply chain activity, such as 
the growing, receiving, transforming, creating, and shipping of listed 
foods. We believe that the proposed rule will align the tracing 
information for foods on the Food Traceability List with our need to 
quickly and effectively respond to foodborne illness outbreaks and 
other contamination events associated with these foods.

E. Improving Traceability for All Foods

    Ideally, a robust traceability system would provide for 
traceability of all foods, not just foods on the Food Traceability 
List. Regardless of the type of food that is the subject of a foodborne 
illness outbreak investigation, sufficient traceability information is 
needed to identify the source of an outbreak, expedite the removal of 
contaminated food from the marketplace, and prevent additional consumer 
exposures. Although section 204 of FSMA limits recordkeeping 
requirements to foods on the Food Traceability List, the types of 
records required to be maintained under the proposed rule could be used 
by entities in the supply chains of all foods to improve traceability.
    The tracing information required to be kept under the proposed rule 
is consistent with information FDA typically requests during an 
outbreak investigation, regardless of the food commodity. Firms that 
maintain records containing this information can help FDA more quickly 
trace the movement of products through the supply chain, identify the 
source of contamination, and reduce harm to consumers posed by tainted 
food. By facilitating faster and more accurate identification of 
contaminated foods, the availability of such records can help narrow 
the scope of an outbreak investigation and limit the adverse impact of 
an outbreak on affected sectors of the food industry. In addition, 
maintaining records in accordance with the proposed requirements would 
help ensure that a firm is well-prepared if a food the firm produces or 
distributes is added to the Food Traceability List as a result of a 
future reassessment of the list.
    Of particular importance to an effective food traceability system 
under the proposed rule is the use of lot codes in documenting CTEs. 
Tracebacks are most efficient when point-of-service entities can 
provide investigators with as much information as possible about the 
origination of the food. If a point-of-service entity can provide lot 
codes and other relevant information for suspect foods, including the 
originating farm or firm, FDA investigators can more quickly identify 
the potential common source of an outbreak and take regulatory action. 
Tracing the lot information associated with suspect products can narrow 
the scope of an investigation, provide FDA with information to quickly 
go directly to the person that created the lot, and limit further 
illnesses by enabling more rapid removal of contaminated food from the 
marketplace. Lot code information can also allow investigators to more 
quickly determine which products are outside the scope of the 
investigation, reducing the likelihood of unnecessary category-wide 
recalls.
    Although the proposed rule does not require the use of electronic 
records and electronic communications for traceability (except to aid 
FDA's review of records during investigations of foodborne illness 
outbreaks), we encourage all segments of the food industry to 
incorporate electronic recordkeeping and communication procedures into 
their traceability programs. Keeping records of KDEs in electronic, 
rather than paper, form and sharing tracing information electronically 
with others in the supply chain can greatly facilitate the analysis of 
information during investigations into foodborne illness outbreaks and 
speed the completion of traceback and traceforward operations. Sharing 
of standard KDEs electronically allows all entities in the supply chain 
access to reliable information on the traceability of a product.
    Further, while this proposed rule would not require retail 
establishments to maintain KDEs for consumer purchases, we support 
efforts by retailers to identify and provide anonymized consumer 
purchase data for outbreak investigations. Presently, we rely on date 
ranges to identify potentially contaminated products purchased by 
consumers. Access to

[[Page 59993]]

traceability lot codes and product identifiers at the consumer level 
would further enhance our ability to focus on specific products 
purchased and narrow the scope of implicated shipments.
    To realize the full benefits of end-to-end traceability, although 
the proposed rule applies only to foods on the Food Traceability List, 
we encourage all firms involved in food production, distribution, and 
sale to consumers to adopt the recordkeeping practices set forth in the 
proposed rule for all the foods they manufacture, process, pack, and 
hold. Consistent with FDA's ``New Era of Smarter Food Safety'' 
initiative (Ref. 21), we will pursue ways to help all supply chain 
entities adopt practices and technologies that will promote rapid and 
effective tracking and tracing of foods to prevent or mitigate 
foodborne illness outbreaks. The New Era of Smarter Food Safety is 
FDA's FSMA-based, technology-enabled, strategic initiative for 
modernizing food safety. Comments provided during and after the October 
29, 2019, public meeting on the New Era initiative indicated a strong 
desire for FDA to specify required CTEs and KDEs to enable 
interoperability of tracing procedures among all stakeholders. The 
proposed rule defines the minimum CTEs and KDEs necessary for achieving 
the goal of improving food safety and will provide the food industry 
with the framework and language for communicating tracing information 
throughout the supply chain.

IV. Legal Authority

    Under section 204(d) of FSMA, in order to rapidly and effectively 
identify recipients of a food to prevent or mitigate a foodborne 
illness outbreak and to address credible threats of serious adverse 
health consequences or death to humans or animals as a result of such 
food being adulterated under section 402 of the FD&C Act or misbranded 
under section 403(w) of the FD&C Act, FDA is required to issue 
regulations to establish recordkeeping requirements, in addition to the 
requirements under section 414 of the FD&C Act and the subpart J 
regulations (or any successor regulations), for facilities that 
manufacture, process, pack, or hold foods that FDA designates under 
section 204(d)(2) of FSMA as high-risk foods.
    We are proposing these regulations under the following authorities:
     Section 204 of FSMA, the specific provisions of which are 
discussed in the remainder of this section;
     section 701(a) of the FD&C Act (21 U.S.C. 371(a)), which 
provides FDA with the authority to promulgate regulations for the 
efficient enforcement of the FD&C Act; and
     sections 311, 361, and 368 of the Public Health Service 
Act (PHS Act) (42 U.S.C. 243, 264, and 271), which relate to 
communicable disease, including by providing FDA with authority to make 
and enforce such regulations as in FDA's judgment are necessary to 
prevent the introduction, transmission, or spread of communicable 
diseases from foreign countries into the States or possessions, or from 
one State or possession into any other State or possession (see section 
361(a) of the PHS Act).

A. Designation of High-Risk Foods

    Section 204(d)(2) of FSMA directs FDA to designate high-risk foods 
for which the additional recordkeeping requirements promulgated under 
the authority of FSMA section 204(d)(1) are appropriate and necessary 
to protect the public health. Each such designation is to be based on 
the factors enumerated in section 204(d)(2)(A), which are listed in 
section III.A of this document.
    To assist with the fulfillment of this requirement, we developed a 
semi-quantitative risk-ranking model that utilizes multiple data 
sources to score commodity-hazard pairs according to a set of criteria 
that address the factors set out in section 204(d)(2)(A) of FSMA. This 
model is explained in greater detail in Reference 16 of this document. 
Foods were included on the list of foods FDA has tentatively designated 
as high-risk (the ``Food Traceability List'') based on the strength of 
the criteria scores that the model produced (Ref. 16).
    FSMA section 204(d)(2)(B) provides that the list of foods 
designated under section 204(d)(2)(A) (i.e., the Food Traceability 
List) shall be published on FDA's website at the time of publication of 
the final rule that creates the recordkeeping requirements described in 
section 204(d)(1). Proposed Sec.  1.1300 would provide for such 
publication. FSMA section 204(d)(2)(B) further states that FDA may 
update the list to designate new foods or to remove foods that are no 
longer deemed necessary for inclusion, provided that each such update 
to the list is consistent with the requirements of FSMA section 204(d) 
and provided that notice of the update is published in the Federal 
Register. The procedures for updating the list that are set forth in 
proposed Sec.  1.1465 would address this requirement.

B. Additional Recordkeeping Requirements

    Section 204(d)(1)(A)-(M) of FSMA provides both general and specific 
guidelines that FDA must follow in creating the additional 
recordkeeping requirements that are mandated by section 204(d)(1). 
These include the following:
     The requirement that these proposed regulations not 
require the creation and maintenance of duplicate records where the 
information is contained in other company records kept in the normal 
course of business (section 204(d)(1)(E)), which is addressed in 
proposed Sec.  1.1455(e);
     the requirement that persons subject to these regulations 
be allowed to maintain the required records at a central or reasonably 
accessible location provided that such records can be made available to 
FDA not later than 24 hours after we request them (section 
204(d)(1)(H)), which is addressed in proposed Sec.  1.1455(b)(2);
     the requirement to include a process by which FDA may 
issue a waiver of the recordkeeping requirements if we determine that 
such requirements would result in an economic hardship for an 
individual facility or a type of facility (section 204(d)(1)(I)), which 
is addressed in proposed Sec. Sec.  1.1405 through 1.1450; and
     the requirement to include a process by which FDA may 
remove a high-risk food designation developed under section 204(d)(2) 
for a food or type of food (section 204(d)(1)(M)), which is addressed 
in proposed Sec.  1.1465.
    Furthermore, section 204(d)(5) of FSMA provides that FDA may 
require that a facility retain records for not more than 2 years, 
taking into consideration the risk of spoilage, loss of value, or loss 
of palatability of the applicable food when determining the appropriate 
timeframes; this is addressed in proposed Sec.  1.1455(c).
    Section 204(d)(6) of FSMA places a number of limitations on the 
requirements that FDA can impose, including limitations relating to the 
following:
     Farm to school or farm to institution programs (section 
204(d)(6)(A)), which are addressed in proposed Sec.  1.1305(i);
     identity-preserved labels with respect to farm sales of 
food that is produced and packaged on a farm (section 204(d)(6)(B)), 
which are addressed in proposed Sec.  1.1305(c);
     fishing vessels (section 204(d)(6)(C)), which are 
addressed in proposed Sec.  1.1305(j);
     commingled raw agricultural commodities (RACs) (section 
204(d)(6)(D)), which are addressed in proposed Sec.  1.1305(e); and
     the sale of a food directly from the farm that produced it 
to a grocery store

[[Page 59994]]

or consumer (sections 204(d)(6)(G)-(I)), which are addressed in 
proposed Sec.  1.1305(h) and (b), respectively.
    In addition, section 204(d)(6)(E) of FSMA states the conditions 
under which FDA may modify the additional recordkeeping requirements or 
exempt a food or type of facility from those requirements. This process 
is addressed in proposed Sec. Sec.  1.1360 through 1.1400. Section 
204(d)(6)(F) of FSMA sets forth limited requirements for a person or 
food who receives such a modification or exemption, as well as limited 
requirements for any person or food to which a limitation or exemption 
applies under the provisions relating to fishing vessels and commingled 
RACs. These limited requirements are included in the proposed 
provisions that would implement FSMA sections 204(d)(6)(C) through (E).
    In addition to the limitations prescribed by Congress, we have 
identified certain persons or foods that we have tentatively concluded 
should not be covered by the rule. These include the following:
     Certain small originators of food, as described in 
proposed Sec.  1.1305(a);
     foods that receive certain types of processing, as 
described in proposed Sec.  1.1305(d);
     produce that is rarely consumed raw, as described in 
proposed Sec.  1.1305(e);
     transporters of food, as described in proposed Sec.  
1.1305(k);
     nonprofit food establishments, as described in proposed 
Sec.  1.1305(l);
     persons who manufacture, process, pack, or hold food for 
personal consumption, as described in proposed Sec.  1.1305(m); and
     certain persons who hold food on behalf of individual 
consumers, as described in proposed Sec.  1.1305(n).
    In addition, we are proposing (in Sec.  1.1305(h)) to extend 
section 204(d)(6)(G) of FSMA's partial exemption for grocery stores 
(with respect to food they purchase directly from a farm) to all retail 
food establishments.
    To effectuate and efficiently enforce section 204 of FSMA, we are 
proposing several requirements for entities that are covered by the 
proposed rule. In accordance with FSMA section 204(d)(1), proposed 
Sec.  1.1300 provides that, except as specified otherwise, these 
requirements would apply to persons who manufacture, process, pack, or 
hold foods on the Food Traceability List. The proposed requirements are 
as follows:
     Proposed requirements to establish and maintain certain 
traceability program records (proposed Sec.  1.1315); proposed 
requirements related to the establishment of traceability lot codes 
(proposed Sec.  1.1320); proposed requirements for those who grow, 
receive, transform, create, or ship foods on the Food Traceability List 
(proposed Sec. Sec.  1.1325 through 1.1350); proposed special 
requirements related to the application of a kill step (proposed Sec.  
1.1355); and proposed requirements relating to records maintenance and 
availability (proposed Sec.  1.1455). These proposed requirements would 
address Congress's directive to create additional recordkeeping 
requirements for foods of the Food Traceability List.
     proposed requirements for when a traceability lot code 
must be established and when it cannot be established (proposed 
Sec. Sec.  1.1320 and 1.1330(c)), which would help ensure that this key 
data element serves its intended function with respect to traceability, 
as discussed in sections V.D.1 to V.D.2.
     proposed requirements for those who ship a food on the 
Food Traceability List to send records containing certain information 
to the immediate subsequent recipient (other than a transporter) of the 
food (proposed Sec.  1.1350(b)), which would help ensure that the 
recipient of the food has the information they would be required to 
maintain under the proposed rule.
     proposed requirements related to record availability 
(proposed Sec.  1.1455(b)), which would help ensure that FDA has access 
to the required records in the event of an outbreak or other threat to 
the public health, and which would also assist FDA in ensuring 
compliance with these regulations and in identifying any violations.
    The definitions we are proposing in proposed Sec.  1.1310 would 
provide a common terminology, which would help all parties as they 
implement the proposed recordkeeping requirements. The consequences of 
a failure to comply with the recordkeeping requirements established 
under section 204 of FSMA were set forth by Congress in section 
204(j)(1) and (2), which amended sections 301(e) and 801(a) of the FD&C 
Act (21 U.S.C. 331(e) and 381(a)), respectively. These consequences are 
reiterated in proposed Sec.  1.1460.

V. Description of the Proposed Rule

    We are proposing to establish additional traceability recordkeeping 
requirements for persons who manufacture, process, pack, or hold foods 
we have designated as requiring additional traceability records under 
section 204(d) of FSMA. Because we propose to establish these new 
requirements in a new subpart S to part 1 of the FDA regulations, we 
refer to the proposed requirements as ``the subpart S regulations.''

A. Scope/Applicability (Proposed Sec.  1.1300)

    Proposed Sec.  1.1300 answers the question, ``Who is subject to 
this subpart?'' Proposed Sec.  1.1300 would provide that, except as 
specified otherwise in subpart S, the proposed regulations would apply 
to persons who manufacture, process, pack, or hold foods that appear on 
the list of foods for which additional traceability records are 
required in accordance with section 204(d)(2) of FSMA (the ``Food 
Traceability List''). Proposed Sec.  1.1300 also states that we will 
publish the Food Traceability List on our website in accordance with 
section 204(d)(2)(B) of FSMA.
    Although section 204(d)(1) of FSMA refers to ``facilities'' that 
manufacture, process, pack, or hold food, we propose that the rule 
would apply to ``persons'' that manufacture, process, pack, or hold 
food to avoid possible confusion with other uses of the term 
``facilities'' in other FDA food regulations. For example, regulations 
such as those on preventive controls for human food (21 CFR part 117), 
preventive controls for animal food (21 CFR part 507), and foreign 
supplier verification programs (21 CFR part 1, subpart L) define 
``facility'' in part as a domestic or foreign entity that is required 
to register with FDA under section 415 of the FD&C Act (21 U.S.C. 
350d). It is clear that Congress intended that these proposed 
recordkeeping requirements would apply to some persons that are not 
required to register with FDA, such as grocery stores (see section 
204(d)(6)(G) of FSMA), which do not have to register with FDA under 
section 415 of the FD&C Act due to the exemption for retail food 
establishments in Sec.  1.226(c). Consequently, we propose that these 
regulations apply to ``persons'' who manufacture, process, pack, or 
hold food, rather than ``facilities,'' to avoid possible confusion with 
other uses of the term ``facility.'' The term ``person,'' as defined in 
section 201(e) of the FD&C Act (21 U.S.C. 321(e)) and proposed Sec.  
1.1310, includes an individual, partnership, corporation, and 
association.
    In accordance with section 204(d)(1) of FSMA, the proposed 
recordkeeping requirements would apply to persons that ``manufacture, 
process, pack, or hold'' foods on the Food Traceability List. We note 
that this differs from the scope of section 414(b) of the FD&C Act and 
the subpart J requirements, which apply to persons (excluding farms and

[[Page 59995]]

restaurants) who manufacture, process, pack, transport, distribute, 
receive, hold, or import food. Unlike section 414 of the FD&C Act, 
section 204 of FSMA does not explicitly apply to persons who transport, 
distribute, receive, or import food. However, with respect to 
importation, section 204(j)(2) of FSMA (codified in section 801(a)(4) 
of the FD&C Act) authorizes FDA to refuse admission to foods for which 
the recordkeeping requirements under section 204 of FSMA have not been 
complied with. As discussed more fully in section V.C., we believe that 
many, but not all, persons who transport, distribute, receive, or 
import food also ``hold'' food, as we propose to define holding.
    We propose that the additional recordkeeping requirements in 
subpart S would apply not only to persons who manufacture, process, 
pack, or hold foods specified on the Food Traceability List, but also 
to persons who manufacture, process, pack, or hold foods that contain 
foods on that list as ingredients. We identified foods on the Food 
Traceability List based on the factors that Congress provided in 
section 204(d)(2) of FSMA. The potential risk associated with these 
foods are not diminished when the foods are used as ingredients in 
other food products (absent application of a kill step). However, it 
would be unwieldy and impractical for the Food Traceability List to 
specify every food product of this sort, i.e., food products whose risk 
derives from their having a listed food as an ingredient. Nonetheless, 
foods that contain foods on the Food Traceability List as ingredients 
would be considered part of the list, as stated in the definition of 
the list in proposed Sec.  1.1310. If the proposed recordkeeping 
requirements did not apply to foods containing an ingredient that is on 
the Food Traceability List, it would be much more difficult for the 
Agency to quickly identify and remove common lots of such an ingredient 
when investigating a foodborne illness outbreak believed to be linked 
to the ingredient. A multi-ingredient food that contains a food on the 
Food Traceability List as an ingredient (e.g., a pre-made sandwich 
containing leafy greens) may be a signal triggering an outbreak 
investigation that ultimately leads to identification of the 
contaminated ingredient. For these reasons, the proposed recordkeeping 
requirements would apply not only to specifically listed foods but also 
to foods that contain listed foods as ingredients. In proposed Sec.  
1.1310, we propose to define ``Food Traceability List'' to include both 
the foods specifically listed and foods that contain foods on the list 
as ingredients. We use the term in this way for the remainder of this 
preamble.

B. Exemptions (Proposed Sec.  1.1305)

    Proposed Sec.  1.1305 answers the question, ``What foods and 
persons are exempt from this subpart?'' We propose to create exemptions 
from the traceability recordkeeping requirements in proposed subpart S 
for certain types of food and certain types of persons who manufacture, 
process, pack, or hold foods on the Food Traceability List. Some of the 
proposed exemptions are specified in section 204 of FSMA, while others 
reflect our thinking that applying the proposed requirements to certain 
persons or foods is not appropriate at this time for the reasons 
discussed later in this document.
1. Exemption for Certain Types of Small Originators (Proposed Sec.  
1.1305(a))
    On our own initiative, we propose to exempt from the proposed 
traceability recordkeeping requirements certain types of small or very 
small farms and other originators of food (i.e., persons who grow, 
raise, or catch food or who harvest a non-produce commodity). These 
firms include very small produce farms, small producers of shell eggs, 
and other small originators of food. Given the relatively low volume of 
food produced by these entities, and the fact that subsequent parties 
in the supply chain will be required to maintain records regarding the 
food produced by these entities, covering these small originators would 
produce little measurable public health benefit.
a. Farms That Have No More Than $25,000 in Annual Sales of Produce
    Proposed Sec.  1.1305(a)(1) would provide that subpart S would not 
apply to farms or the farm activities of farm mixed-type facilities 
with respect to the produce (as defined in 21 CFR 112.3 (Sec.  112.3) 
in the produce safety regulations) (21 CFR part 112) they grow, when 
the farm is not a covered farm under the produce safety regulations in 
accordance with Sec.  112.4(a). The farms addressed in Sec.  112.4(a) 
have no more than $25,000 in annual sales of produce.
b. Certain Producers of Shell Eggs
    Proposed Sec.  1.1305(a)(2) would provide that subpart S would not 
apply to shell egg producers with fewer than 3,000 laying hens at a 
particular farm, with respect to the shell eggs produced at that farm. 
This designation of small shell egg producers as those with fewer than 
3,000 laying hens is consistent with the regulations on shell egg 
production, storage, and transportation (see 21 CFR 118.1(a) (Sec.  
118.1(a))) and other FDA food safety regulations (e.g., foreign 
supplier verification program regulations (see 21 CFR 
1.512(a)(2)(iii))).
c. Certain Other Originators of Food
    Proposed Sec.  1.1305(a)(3) would provide that subpart S would not 
apply to originators of food with an average annual monetary value of 
food sold during the previous 3-year period of no more than $25,000 (on 
a rolling basis), adjusted for inflation using 2019 as the baseline 
year for calculating the adjustment. This exemption would apply to, for 
example, small aquaculture farms and small farms that grow non-produce 
foods that may be on the Food Traceability List in the future.
2. Exemption for Farms Regarding Food Sold Directly to Consumers 
(Proposed Sec.  1.1305(b))
    Consistent with section 204(d)(6)(H) and (I) of FSMA, we propose to 
exempt farms from the proposed traceability recordkeeping requirements 
with respect to food produced on the farm (including food that is also 
packaged on the farm) when the owner, operator, or agent in charge of 
the farm sells the food directly to a consumer (proposed Sec.  
1.1305(b)). This means that if the owner, operator, or agent in charge 
of a farm sells food that is produced (or both produced and packaged) 
on the farm directly to a consumer, the farm would not be subject to 
the proposed subpart S requirements with respect to that food (e.g., 
recordkeeping requirements applicable to food growers). These direct-
to-consumer sales by farms would include applicable sales at farmers' 
markets, roadside stands, over the internet, and through community-
supported agriculture programs.
3. Inapplicability to Certain Food Produced and Packaged on a Farm 
(Proposed Sec.  1.1305(c))
    In addition to the farm-related exemptions in proposed Sec.  
1.1305(a) and (b), proposed Sec.  1.1305(c) would provide, consistent 
with section 204(d)(6)(B) of FSMA, that the proposed traceability 
recordkeeping requirements would not apply to food produced and 
packaged on a farm, provided that:
     The packaging of the food remains in place until the food 
reaches the consumer, and such packaging maintains the integrity of the 
product and prevents subsequent contamination or alteration of the 
product (proposed Sec.  1.1305(c)(1)); and
     the labeling of the food that reaches the consumer 
includes the name,

[[Page 59996]]

complete address (street address, town, State, country, and zip or 
other postal code for a domestic farm and comparable information for a 
foreign farm), and business phone number of the farm on which the food 
was produced and packaged (proposed Sec.  1.1305(c)(2)).
    In accordance with section 204(d)(6)(B) of FSMA, upon request we 
would waive the requirement for the farm to include a business phone 
number, as appropriate, to accommodate a religious belief of the 
individual in charge of the farm (proposed Sec.  1.1305(c)(2)).
    Examples of foods that might be exempt under proposed Sec.  
1.1305(c), provided the specified packaging and labeling requirements 
were met, include the following:
     Iceberg whole head lettuce that is harvested and packaged 
for the consumer in the field with individual non-vented cellophane 
wrapping that maintains the integrity of the lettuce and prevents 
subsequent contamination or alteration; and
     English cucumbers individually wrapped for the consumer by 
a farm in sealed plastic that maintains the integrity of the cucumbers 
and prevents subsequent contamination or alteration.
    However, produce packed or packaged in containers such as 
clamshells with holes, cardboard boxes, vented crates, plastic bags 
with holes, or netted bags would not be eligible for this exemption 
from the subpart S requirements because such packaging does not 
necessarily maintain the product's integrity and prevent subsequent 
contamination and alteration.
    We note that, consistent with section 204(d)(6)(B) of FSMA, the 
exemption in proposed Sec.  1.1305(c) would only apply if, among other 
things, the labeling of the food that reaches the consumer includes the 
farm's complete address, including the street address, town, State, 
country, and zip or other postal code for a domestic farm and 
comparable information for a foreign farm. However, we recognize that 
not all farms have a street address. In the event that a farm without a 
street address wanted to rely on this proposed exemption for certain 
food produced and packaged on that farm, the farm could substitute its 
geographical coordinates for a traditional street address in the 
labeling of the food that reaches the consumer.
    While the statute requires this exemption, we encourage retail food 
establishments to keep records on foods covered under the exemption as 
a best practice because packaging is often discarded by consumers, 
resulting in loss of information identifying the farm. We recommend 
that retail food establishments maintain records on the receipt of the 
produce including the date of receipt and the name, complete address 
(street address, town, State, country, and zip or other postal code), 
and business phone number of the farm on which the food was produced 
and packaged.
4. Inapplicability to Foods That Receive Certain Types of Processing 
(Proposed Sec.  1.1305(d))
    On our own initiative, we propose to exempt from the proposed 
traceability recordkeeping requirements produce and shell eggs that 
receive certain types of processing. Under proposed Sec.  1.1305(d)(1), 
subpart S would not apply to produce that receives commercial 
processing that adequately reduces the presence of microorganisms of 
public health significance, provided the conditions set forth in Sec.  
112.2(b) in the produce safety regulations are met for the produce. We 
believe that because of the lesser risk to public health posed by this 
produce (as reflected in its being exempt from almost all of the 
requirements of the produce safety regulations), it is not necessary to 
apply the additional recordkeeping requirements to this food. This 
proposed exemption would apply to all persons who manufacture, process, 
pack, or hold such produce, not just the farms that grow it. This means 
that no persons handling produce that receives the commercial 
processing exemption in accordance with Sec.  112.2(b) would be 
required to keep subpart S records for the produce.
    Similarly, subpart S would not apply to shell eggs when all the 
eggs produced at a particular farm receive a treatment (as defined in 
21 CFR 118.3 (Sec.  118.3)) in accordance with Sec.  118.1(a)(2). 
Section 118.3 of the shell egg regulations (21 CFR part 118) defines 
``treatment'' as a technology or process that achieves at least a 5-log 
destruction of Salmonella Enteritidis for shell eggs, or the processing 
of egg products in accordance with the Egg Products Inspection Act. 
Under Sec.  118.1(a)(2), if all shell eggs produced at a particular 
farm receive a treatment, the producer must comply only with the 
refrigeration requirements in Sec.  118.4(e) for production of eggs on 
that farm and with the registration requirements in Sec.  118.11. We 
believe that the lesser risk to public health posed by shell eggs that 
have received this treatment in accordance with Sec.  118.1(a)(2) makes 
it unnecessary to apply the subpart S requirements to these eggs.
5. Exemption for Produce That Is Rarely Consumed Raw (Proposed Sec.  
1.1305(e))
    On our own initiative, we propose to exempt from the proposed 
traceability recordkeeping requirements produce that is listed as 
``rarely consumed raw'' in Sec.  112.2(a)(1) in the produce safety 
regulations. We believe that because of the lesser risk to public 
health posed by this produce (as reflected in its being exempt from the 
produce safety regulations), it is not necessary to apply the 
additional recordkeeping requirements to these foods.
6. Partial Exemption of Commingled Raw Agricultural Commodities 
(Proposed Sec.  1.1305(f))
    Proposed Sec.  1.1305(f)(1) would provide that, except as specified 
in proposed Sec.  1.1305(f)(2), subpart S would not apply to commingled 
RACs, in accordance with section 204(d)(6)(D) of FSMA. Consistent with 
section 204(d)(6)(D) of FSMA, we propose to define ``commingled raw 
agricultural commodity'' for the purposes of this exemption as any 
commodity that is combined or mixed after harvesting but before 
processing, except that the term ``commingled raw agricultural 
commodity'' would not include types of fruits and vegetables that are 
RACs to which the standards for the growing, harvesting, packing, and 
holding of produce for human consumption in part 112 apply (proposed 
Sec.  1.305(e)(1)). As a result, the proposed exemption would not apply 
to produce subject to the produce safety regulations.
    For the purpose of the definition of ``commingled raw agricultural 
commodity,'' a commodity would be regarded as ``combined or mixed . . . 
before processing'' only when the combination or mixing involves food 
from different farms (proposed Sec.  1.1305(f)(1)). We believe this 
clarification is appropriate because most of the traceability 
challenges associated with commingling of food from different farms are 
less present (or entirely absent) when food from different parts of a 
single farm is commingled.
    In keeping with section 204(d)(6)(D)(ii)(III) of FSMA, the term 
``processing'' as used in the definition of commingled RAC would mean 
operations that alter the general state of the commodity, such as 
canning, cooking, freezing, dehydration, milling, grinding, 
pasteurization, or homogenization (proposed Sec.  1.1305(f)(1)).
    An example of a RAC that would be exempt from the proposed 
traceability recordkeeping requirements when they are commingled is 
shell eggs. For the

[[Page 59997]]

purposes of this rule, we would consider commingled shell eggs to be 
eggs from separate farms under different company management that are 
physically mixed before packing. Packed eggs that are from a single 
farm or from separate farms under the same management would not be 
considered commingled shell eggs. Shell eggs are the only commingled 
RAC (as defined in proposed Sec.  1.1305(f)(1)) on the current proposed 
Food Traceability List. Although the limited exemption for commingled 
RACs in Sec.  1.1305(f) applies to commingled shell eggs, we 
nevertheless encourage shell egg producers to keep records on the 
commingling of eggs as a transformation event to help ensure that we 
are able to determine the source of contaminated eggs in a foodborne 
illness outbreak or recall event.
    Notwithstanding this proposed exemption from the subpart S 
requirements for commingled RACs, and in accordance with section 
204(d)(6)(D) and (F) of FSMA, proposed Sec.  1.1305(f)(2) would specify 
that, with respect to a commingled RAC that receives the exemption in 
proposed Sec.  1.1305(f)(1), if a person manufactures, processes, 
packs, or holds a commingled RAC and is required to register with FDA 
under section 415 of the FD&C Act in accordance with 21 CFR part 1, 
subpart H (subpart H), such person must maintain records identifying 
the immediate previous source of such food and the immediate subsequent 
recipient of such food in accordance with the subpart J traceability 
requirements in Sec. Sec.  1.337 and 1.345 (which apply to the receipt 
and release of foods by nontransporters of food). Thus, although 
certain commingled RACs (as defined in proposed Sec.  1.1305(f)(1)) 
generally would be exempt from the proposed rule, persons who 
manufacture, process, pack, or hold these RACs who are required to 
register with FDA as a food facility would have to comply with the 
existing food traceability recordkeeping requirements in Sec. Sec.  
1.337 and 1.345. While we recognize that many firms are already 
required to comply with Sec. Sec.  1.337 and 1.345 because they are 
subject to the subpart J recordkeeping requirements, this provision 
creates an independent obligation to comply with these provisions with 
respect to foods on the Food Traceability List, including for firms 
that are not subject to subpart J.
    Proposed Sec.  1.1305(f)(2) would further specify that such records 
identifying immediate previous sources and immediate subsequent 
recipients of these commingled RACs would have to be maintained for 2 
years, consistent with the retention requirement for other records 
maintained in accordance with subpart S. We discuss the proposed 
retention requirements for subpart S records in more detail in section 
V.H.3.
7. Exemption or Partial Exemption for Small Retail Food Establishments 
(Proposed Sec.  1.1305(g))
    On our own initiative, we are co-proposing either a full exemption 
or a partial exemption from the proposed subpart S requirements for 
retail food establishments that employ 10 or fewer full-time equivalent 
employees. Such retail food establishments are exempt from the subpart 
J requirements under Sec.  1.327(f), except that they are subject to 
Sec. Sec.  1.361 and 1.363, which relate to record availability. 
Although we are considering adopting a full exemption from the proposed 
subpart S recordkeeping requirements for small retail food 
establishments, we also are considering whether a more limited 
exemption for these firms would be appropriate. Therefore, in proposed 
Sec.  1.1305(g), we are co-proposing two options for full or partial 
exemption for small retail food establishments, as discussed in the 
following paragraphs.
a. Option 1: Full Exemption for Small Retail Food Establishments
    Option 1 of the co-proposal would specify that subpart S does not 
apply to retail food establishments that employ 10 or fewer full-time 
equivalent employees. Option 1 would further state that the number of 
full-time equivalent employees is based on the number of such employees 
at each retail food establishment and not the entire business, which 
may own numerous retail stores. Because these smaller retail food 
establishments might handle a lesser volume of food than larger 
establishments, it is possible that requiring the smaller 
establishments to comply with subpart S would impose costs that would 
outweigh the benefits of such compliance. In addition, because many of 
the foods sold at small retail food establishments are nationally 
distributed and are also sold at larger retail food establishments, we 
may be able to obtain relevant information about the source of a 
foodborne illness outbreak from a larger establishment that sold the 
same food using the same distributor.
    On the other hand, because these smaller firms might also be more 
likely to have less robust traceability records and procedures, fully 
exempting these firms from the proposed recordkeeping requirements 
would make it more difficult for FDA to obtain needed tracing 
information from these firms when investigating a foodborne illness 
outbreak. There would likely be significant delays in obtaining 
pertinent tracing data due to the variability of information maintained 
by these small establishments. The need to rely on the supplier of 
these small establishments for the tracing data that would be required 
under this rule would likely result in at least a 24- to 48-hour delay 
in the traceback. In addition, small retail food establishments can 
make a particularly important contribution to tracebacks by serving to 
narrow the scope of products implicated during an investigation. Key 
data elements, such as lot codes, are not required at the consumer 
level, requiring traceback investigations to implicate all lot codes 
available for purchase on a given purchase date identified by the 
consumer. Retail food establishments, especially larger ones, often 
receive the same product from multiple distributors, which makes it 
difficult to narrow the suppliers of interest in an investigation. On 
the other hand, small establishments often receive product from limited 
sources, which can make them particularly valuable during an outbreak 
in narrowing the suppliers of interest and focusing the traceback 
investigation. The inability to narrow the suppliers of interest and 
focus the information relevant to the potential source of contamination 
not only prolongs a traceback effort but might also result in 
conducting a broader recall than would otherwise be necessary had the 
firms maintained records required under subpart S (Ref. 22).
b. Option 2: Partial Exemption for Small Retail Food Establishments
    Option 2 for proposed Sec.  1.1305(g) would specify that the 
requirement in proposed Sec.  1.1455(b)(3) to make available to FDA 
under specified circumstances an electronic sortable spreadsheet 
containing the information required to be maintained under this subpart 
(for the foods and date ranges specified in FDA's request) does not 
apply to retail food establishments that employ 10 or fewer full-time 
equivalent employees. (The above-stated text regarding determination of 
the number of full-time equivalent employees also would be included.) 
As discussed in section V.I.2, we propose to require that, when 
necessary to help FDA prevent or mitigate a foodborne illness outbreak, 
or to assist in the implementation of a recall, or to otherwise address 
a threat to the public health, persons subject to the subpart S 
requirements must make available, within 24 hours of request by an 
authorized FDA representative, an

[[Page 59998]]

electronic sortable spreadsheet containing the information in the 
records they are required to maintain under subpart S, for the foods 
and date ranges specified in the request. We believe that having access 
to a firm's required traceability information in such electronic form 
would help us more quickly identify the source of potentially 
contaminated food on the Food Traceability List and remove the food 
from the marketplace. Nevertheless, we recognize that smaller firms 
might be less likely to have the resources to readily produce their 
traceability information in such a format. Exempting small retail food 
establishments from this requirement could reduce their burden of 
complying with the subpart S requirements, while still providing us 
with access to relevant and specific tracing information when 
investigating foodborne illness outbreaks involving listed foods 
received by such establishments.
    We request comment on whether we should adopt Option 1 of the co-
proposal for Sec.  1.1305(g), which would fully exempt small retail 
food establishments from subpart S, or Option 2, which would exempt 
these firms from the requirement to provide to FDA, under certain 
circumstances, an electronic sortable spreadsheet containing required 
traceability information. Of course, you may also comment on whether 
any full or partial exemption for small retail food establishments from 
the proposed traceability recordkeeping requirements is appropriate. We 
also request comment on whether having 10 or fewer full-time equivalent 
employees is an appropriate size limit for a ``small'' retail food 
establishment under these proposed options and, if not, what an 
appropriate limit would be.
8. Partial Exemption for Retail Food Establishments (Proposed Sec.  
1.1305(h))
    In addition to the proposed full or partial exemption for small 
retail food establishments in proposed Sec.  1.1305(g), in accordance 
with section 204(d)(6)(G) of FSMA, we propose to adopt a partial 
exemption from the subpart S requirements for all retail food 
establishments when they receive foods on the Food Traceability List 
directly from a farm. Proposed Sec.  1.1305(h)(1) would provide that 
subpart S would not apply to a retail food establishment with respect 
to foods on the Food Traceability List that are produced on a farm 
(including foods produced and packaged on the farm) and sold directly 
to the retail food establishment by the owner, operator, or agent in 
charge of that farm, except as specified in proposed Sec.  
1.1305(h)(2). Under proposed Sec.  1.1305(h)(2), when a retail food 
establishment purchases a food on the Food Traceability List directly 
from the owner, operator, or agent in charge of a farm, the retail food 
establishment would be required to establish and maintain a record 
documenting the name and address of the farm that was the source of the 
food. Consistent with section 204(d)(6)(G) of FSMA, retail food 
establishments would be required to maintain these farm identification 
records for 180 days.
    Although section 204(d)(6)(G) of FSMA specifies that this limited 
tracing requirement to document the farm that was the source of the 
food applies to grocery stores, we propose to broaden the application 
of this partial exemption to include all retail food establishments 
purchasing food directly from farms. We believe it is appropriate to 
apply this partial exemption to all retail food establishments because 
we think there is no meaningful or easy way to distinguish grocery 
stores from other retail food establishments such as convenience stores 
and vending machine locations.
9. Partial Exemption for Farm to School and Farm to Institution 
Programs (Proposed Sec.  1.1305(i))
    Having consulted with the USDA in accordance with section 
204(d)(6)(A) of FSMA, we believe it is appropriate to establish, in 
proposed Sec.  1.1305(i), a partial exemption from the subpart S 
requirements for farm to school and farm to institution programs 
operated under the auspices of the USDA, State agencies, or local 
jurisdictions to avoid placing undue burdens on these programs. Farm to 
school programs include, but are not limited to, programs in which 
farms sell food such as fruits, vegetables, eggs, beans, and meat to: 
(1) Schools under competitive procurement; (2) competitively procured 
food distributors; and (3) Child Nutrition Programs, including the USDA 
DoD Fresh Fruit and Vegetable Program, that provide USDA-purchased 
domestic agricultural products (USDA Foods). Proposed Sec.  
1.1305(i)(1) would provide that, except as specified in Sec.  
1.1305(i)(2), the subpart S requirements would not apply to an 
institution operating a child nutrition program authorized under the 
Richard B. Russell National School Lunch Act or Section 4 of the Child 
Nutrition Act of 1966, or any other entity conducting a farm to school 
or farm to institution program, with respect to a food on the Food 
Traceability List that is produced on a farm (including food produced 
and packaged on the farm) and sold directly to the school or 
institution. Under proposed Sec.  1.1305(i)(2), when a school or 
institution conducting farm to school or farm to institution activities 
purchases a food on the Food Traceability List directly from a farm, 
the school food authority or relevant food procurement entity must 
establish and maintain a record documenting the name and address of the 
farm that was the source of the food. Proposed Sec.  1.1305(i)(2) 
specifies that the school food authority or relevant food procurement 
entity must maintain the records identifying the farm for 180 days, the 
same retention period that we propose for records maintained under the 
partial exemption for retail food establishments in proposed Sec.  
1.1305(g).
10. Partial Exemption for Fishing Vessels (Proposed Sec.  1.1305(j))
    In accordance with section 204(d)(6)(C) of FSMA, we propose to 
adopt a partial exemption from the proposed traceability recordkeeping 
requirements for fishing vessels. Proposed Sec.  1.1305(j)(1) would 
provide that, except as specified in proposed Sec.  1.1305(j)(2), with 
respect to a food produced through the use of a fishing vessel, subpart 
S would not apply to the owner, operator, or agent in charge of the 
fishing vessel. In accordance with section 204(d)(6)(C) of FSMA, 
``fishing vessel'' would be defined (in proposed Sec.  1.1310) as that 
term is defined in section 3(18) of the Magnuson-Stevens Fishery 
Conservation and Management Act (16 U.S.C. 1802(18)), i.e., as any 
vessel, boat, ship, or other craft which is used for, equipped to be 
used for, or of a type which is normally used for: (1) Fishing or (2) 
aiding or assisting one or more vessels at sea in the performance of 
any activity relating to fishing, including, but not limited to, 
preparation, supply, storage, refrigeration, transportation, or 
processing. Under this partial exemption, activities of fishing vessels 
such as harvesting, transporting, heading, eviscerating, and freezing 
fish would generally not be subject to the proposed recordkeeping 
requirements.
    Under this exemption, the owner, operator, or agent in charge of a 
fishing vessel also would not have to keep tracing records on the sale 
and shipment of food produced through the use of the vessel, except as 
provided in proposed Sec.  1.1305(j)(2) (discussed in the following 
paragraph). Section 204(d)(6)(C) of FSMA somewhat ambiguously states 
that the section 204(d) requirements applicable to fishing vessels 
would be limited to certain requirements for vessels that are required 
to register with FDA (set forth in proposed

[[Page 59999]]

Sec.  1.1305(j)(2)) ``until such time as the food is sold by the owner, 
operator, or agent in charge of such fishing vessel.'' Although the 
phrase ``until such time'' could be interpreted as meaning that the 
owner, operator, or agent in charge of the fishing vessel could be 
subject to requirements relating to the sale of the relevant food, we 
believe it is appropriate to exempt the owner, operator, or agent in 
charge of the fishing vessel from all requirements relating to the 
relevant food (except as specified in proposed Sec.  1.1305(j)(2)).
    In accordance with section 204(d)(6)(C) and (F) of FSMA, proposed 
Sec.  1.1305(j)(2) would specify that if the owner, operator, or agent 
in charge of the fishing vessel who receives the exemption in proposed 
Sec.  1.1305(j)(1) is required to register with FDA under section 415 
of the FD&C Act with respect to the manufacturing, processing, packing, 
or holding of the applicable food, in accordance with subpart H, that 
person would be required to maintain records identifying the immediate 
previous source of such food and the immediate subsequent recipient of 
such food in accordance with Sec. Sec.  1.337 and 1.345. This means 
that fishing vessels that must register with FDA because they process 
fish on the vessel would be required to comply with the existing 
subpart J traceability recordkeeping requirements in Sec. Sec.  1.337 
and 1.345, even though many such fishing vessels are currently exempt 
from those requirements under Sec.  1.327(c). Affected fishing vessels 
would be required to maintain such records for 2 years (proposed Sec.  
1.1305(j)(2)), the retention period for subpart S records specified in 
proposed Sec.  1.1460(c) (see section V.H.3).
11. Exemption for Transporters (Proposed Sec.  1.1305(k))
    On our own initiative, we propose to exempt transporters of food 
from the proposed traceability recordkeeping requirements (proposed 
Sec.  1.1305(k)). We propose to define a ``transporter'' as a person 
who has possession, custody, or control of an article of food for the 
sole purpose of transporting the food, whether by road, rail, water, or 
air (proposed Sec.  1.1310). We believe that transporters should be 
exempt from the proposed rule because we find that in most of our 
investigations of potential foodborne illness outbreaks, it is not 
necessary to inspect records maintained by food transporters because we 
generally are able to obtain the tracing information we need from other 
persons in the food's supply chain. If necessary, we could review 
records maintained by transporters of the food in the usual course of 
business or, when applicable, in accordance with the subpart J 
regulations.
12. Exemption for Nonprofit Food Establishments (Proposed Sec.  
1.1305(l))
    Proposed Sec.  1.1305(l) would provide that subpart S would not 
apply to nonprofit food establishments, consistent with their exclusion 
from the subpart J regulations (see Sec.  1.327(l)). We propose to 
define a nonprofit food establishment as in subpart J (Sec.  1.328), 
i.e., as a charitable entity that prepares or serves food directly to 
the consumer or otherwise provides food or meals for consumption by 
humans or animals in the United States (proposed Sec.  1.1310). The 
term would include central food banks, soup kitchens, and nonprofit 
food delivery services. In addition, to be considered a nonprofit food 
establishment, the establishment must meet the terms of section 
501(c)(3) of the U.S. Internal Revenue Code (26 U.S.C. 501(c)(3)).
13. Exemption for Persons Who Manufacture, Process, Pack, or Hold Food 
for Personal Consumption (Proposed Sec.  1.1305(m))
    Proposed Sec.  1.1305(m) would provide that subpart S would not 
apply to persons who manufacture, process, pack, or hold food for 
personal consumption. Such persons are excluded from the subpart J 
requirements under Sec.  1.327(m). As discussed in the preamble to the 
final rule adopting the subpart J requirements (69 FR 71562 at 71579), 
whether a food is for personal consumption depends on many factors, but 
we would consider food prepared in a private home and transported for 
other than business purposes (e.g., to a ``pot luck'' dinner with 
friends) to qualify for this exemption.
14. Exemption for Persons Who Hold Food for Individual Consumers 
(Proposed Sec.  1.1305(n))
    Proposed Sec.  1.1305(n) would provide that subpart S would not 
apply to persons who hold food on behalf of specific individual 
consumers, provided that such persons: (1) Are not parties to the 
transaction involving the food they hold and (2) are not in the 
business of distributing food. This would mirror the exemption for such 
persons from the subpart J requirements (see Sec.  1.327(n)). This 
exemption would cover persons such as a hotel concierge, reception desk 
staff in an apartment building, and staff at an office complex who 
receive and store a food on the Food Traceability List on behalf of the 
consumer but are not parties to the purchase of the food they hold and 
are not in the business of distributing food (see 69 FR 71562 at 71570 
to 71571).

C. Definitions (Proposed Sec.  1.1310)

    Proposed Sec.  1.1310 sets forth the meaning of several terms we 
propose to use in the regulations on additional traceability 
recordkeeping. Some of the definitions are self-explanatory or are 
being used for consistency with the existing traceability recordkeeping 
requirements in subpart J and/or other food safety regulations. In the 
following paragraphs we discuss definitions of terms used in the 
proposed rule.
1. Category
    We propose to define ``category'' as a code or term used to 
classify a food product in accordance with a recognized industry or 
regulatory classification scheme, or a classification scheme a person 
develops for their own use. Examples of industry or regulatory 
classification schemes include the GS1 Global Product Classification 
standard, the United Nations Standard Products and Services Code, the 
Food and Agriculture Organization of the United Nations 3-Alpha Seafood 
Species Code, and the European Union Common Procurement Vocabulary. 
Rather than use a recognized product classification scheme, a firm 
might choose to develop its own classification scheme to meet its 
unique product, customer, or other business needs.
2. Cooling
    We propose to define ``cooling'' as active temperature reduction of 
a food using hydrocooling, icing, forced air cooling, vacuum cooling, 
or a similar process, either before or after packing. We discuss 
proposed recordkeeping requirements related to the cooling of listed 
foods beginning in section V.E.2.
3. Creating
    We propose to define ``creating'' as making or producing a food on 
the Food Traceability List (e.g., through manufacturing or processing) 
using only ingredient(s) that are not on the Food Traceability List. 
The definition further states that creating does not include 
originating or transforming a food. We discuss proposed recordkeeping 
requirements related to the creation of listed foods in sections V.D 
and V.E.4.
4. Critical Tracking Event
    We propose to define ``critical tracking event'' as an event in the 
supply chain of a food involving the growing, receiving (including 
receipt by a first receiver), transforming, creating, or shipping of 
the food. We discuss

[[Page 60000]]

proposed recordkeeping requirements for particular critical tracking 
events in section V.E.
5. Farm
    The proposed rule would define ``farm'' as it is defined in Sec.  
1.328 of the subpart J traceability regulations (and other FDA food 
safety regulations). The definition further states that, for producers 
of shell eggs, ``farm'' means all poultry houses and grounds 
immediately surrounding the poultry houses covered under a single 
biosecurity program (matching the definition of farm under Sec.  118.3 
in the shell egg production regulations).
6. First Receiver
    We propose to define ``first receiver'' as the first person (other 
than a farm) who purchases and takes physical possession of a food on 
the Food Traceability List that has been grown, raised, caught, or (in 
the case of a non-produce commodity) harvested. A first receiver of a 
food might be a manufacturer/processor, distributor, or other non-farm 
entity who receives a food that has been originated. As discussed in 
section V.E.2, we believe it is appropriate to require first receivers 
of listed foods to maintain records containing information about the 
production of the foods (including information on the harvesting, 
cooling, and packing of the foods, if applicable) and, for first 
receivers of seafood, information related to the harvest date range and 
locations for the trip during which the seafood was caught.
    However, an entity that receives a listed food after it has been 
created (e.g., the first purchaser of a nut butter product) would not 
be a first receiver under the proposed rule. It would not be 
appropriate to require the first purchaser of a created food to 
establish and maintain the first receiver KDEs because those KDEs focus 
on on-farm practices and other originating events, while created foods 
have already undergone some form of manufacturing or processing.
7. Fishing Vessel
    We propose to define ``fishing vessel'' as any vessel, boat, ship, 
or other craft which is used for, equipped to be used for, or of a type 
which is normally used for: (a) Fishing; or (b) aiding or assisting one 
or more vessels at sea in the performance of any activity relating to 
fishing, including, but not limited to, preparation, supply, storage, 
refrigeration, transportation, or processing. In accordance with 
section 204(d)(6)(C) of FSMA, this matches the definition of ``fishing 
vessel'' in section 3(18) of the Magnuson-Stevens Fishery Conservation 
and Management Act.
8. Food Traceability List
    We propose to define the ``Food Traceability List'' as the list of 
foods for which additional traceability records are required to be 
maintained, as designated in accordance with section 204(d)(2) of FSMA. 
The definition further states that the term ``Food Traceability List'' 
includes both the foods specifically listed and foods that contain 
specifically listed foods as ingredients.
9. Growing Area Coordinates
    We propose to define ``growing area coordinates'' as the 
geographical coordinates (under the global positioning system (GPS) or 
latitude/longitude) for the entry point of the physical location where 
the food was grown and harvested. We discuss the importance for 
traceability of requiring growers of food to maintain information on 
the growing area coordinates for the food in section V.E.1.
10. Harvesting
    We propose to define ``harvesting'' as it is defined in the subpart 
J regulations and other FDA food safety regulations, with some minor 
differences. Thus, ``harvesting'' applies to farms and farm mixed-type 
facilities and means activities that are traditionally performed on 
farms for the purpose of removing raw agricultural commodities from the 
place they were grown or raised and preparing them for use as food. 
Harvesting is limited to activities performed on raw agricultural 
commodities, or on processed foods created by drying/dehydrating a raw 
agricultural commodity without additional manufacturing/processing, on 
a farm. Harvesting does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the FD&C Act. Examples of harvesting include cutting (or 
otherwise separating) the edible portion of the raw agricultural 
commodity from the crop plant and removing or trimming part of the raw 
agricultural commodity (e.g., foliage, husks, roots, or stems). 
Examples of harvesting also include collecting eggs, taking of fish and 
other seafood in aquaculture operations, milking, field coring, 
filtering, gathering, hulling, shelling, sifting, threshing, trimming 
of outer leaves of, and washing raw agricultural commodities grown on a 
farm. Although egg collection and taking of fish and other seafood in 
aquaculture operations are not included among the examples of 
harvesting in the definition in subpart J, we want to make clear that 
we consider these activities to be harvesting. We propose not to 
include ``cooling'' as an example of harvesting activities under 
subpart S, even though it is included in the subpart J definition, 
because for traceability purposes we wish to distinguish cooling from 
harvesting.
11. Holding
    We propose to define ``holding'' as storage of food, and to also 
include activities performed incidental to storage of a food (e.g., 
activities performed for the safe or effective storage of that food, 
such as fumigating food during storage, and drying/dehydrating raw 
agricultural commodities when the drying/dehydrating does not create a 
distinct commodity (such as drying/dehydrating hay or alfalfa)). 
Holding would also include activities performed as a practical 
necessity for the distribution of that food (such as blending of the 
same raw agricultural commodity and breaking down pallets) but would 
not include activities that transform a raw agricultural commodity into 
a processed food as defined in section 201(gg) of the FD&C Act. The 
proposed definition specifies that holding facilities include 
warehouses, cold storage facilities, storage silos, grain elevators, 
and liquid storage tanks.
    We believe that persons who do not physically possess food are not 
engaged in holding of food within the meaning of the proposed rule. 
This means, for example, that a person who coordinates the import of a 
listed food but never takes physical possession of the food would not 
be subject to the rule, while a person who imports a listed food they 
physically possess would be subject to the rule unless an exemption 
applied. For example, some firms buy food produced in foreign 
countries, arrange for the importation of the food into the United 
States, and sell the food to other U.S. firms without ever taking 
physical possession of the food; such firms would not be subject to the 
rule. Similarly, food brokers who negotiate sales of food from 
producers to wholesalers, retail stores, and others but never 
physically possess the food would not be subject to the rule.
    We are aware that such importers and brokers often maintain tracing 
information on the food, while some firms that would be subject to the 
rule because they hold food (such as distributors) might not currently 
maintain tracing information. For example, a cold storage facility that 
receives imported produce might not keep tracing records on such 
produce because the importer of record, broker,

[[Page 60001]]

or other firm has the relevant information on the produce. As discussed 
in section V.D.1, we propose to allow persons subject to the proposed 
rule to designate an individual or firm who will establish and maintain 
tracing records on behalf of the person, although the person subject to 
the rule would remain responsible for meeting the subpart S 
requirements. This would enable firms who hold imported foods to enter 
into agreements with importers of record, brokers, and others to keep 
required tracing records for the foods on their behalf.
    We also recognize that the headquarters for retail food 
establishments typically provide centralized information technology 
resources for their stores, distribution centers, and, in most cases, 
franchisee locations. For example, even though a firm's headquarters 
location may not hold food, the firm may decide that headquarters will 
maintain the records for each of the firm's retail food establishment 
locations. In addition, retail food establishments may designate third 
parties to maintain their traceability records on their behalf 
(although the establishment would remain responsible for ensuring the 
subpart S requirements are met for the foods the firm holds).
12. Key Data Element
    We proposed to define ``key data element'' as information 
associated with a CTE for which a record must be established and 
maintained in accordance with subpart S. We discuss proposed 
requirements for records containing KDEs associated with CTEs in 
section V.E.
13. Kill Step
    We propose to define ``kill step'' as processing that significantly 
minimizes pathogens in a food. Examples of kill steps include cooking, 
pasteurization, heat treatment, high-pressure processing, and 
irradiation, as long as those processes are conducted in a manner that 
significantly minimizes pathogens in the food. We discuss proposed 
requirements for foods on the Food Traceability List that are subjected 
to a kill step in section V.F.
14. Location Description
    We propose to define ``location description'' as a complete 
physical address and other key contact information, specifically the 
business name, physical location name, primary phone number, physical 
location street address (or geographical coordinates), city, state, and 
zip code for domestic facilities and comparable information for foreign 
facilities, including country; except that for fishing vessels, 
``location description'' would mean the name of the fishing vessel that 
caught the seafood, the country in which the fishing vessel's license 
(if any) was issued, and a point of contact for the fishing vessel.
    Location descriptions are typically stored in business systems used 
for purchasing, manufacturing, and selling goods and services. Table 3 
provides an example of the data attributes in a location description 
for a food processor.

      Table 3--Example of Data Attributes for Location Description
------------------------------------------------------------------------
             KDE                 Data attributes           Example
------------------------------------------------------------------------
Location Description........  Business name.......  Fin-to-Tail
                                                     Processing Co.
                              Physical location     Facility #345.
                               name.
                              primary phone number  222.222.2222.
                              Physical location     456 Blue Water Way.
                               street address.
                              City................  Sarasota.
                              State...............  FL.
                              ZIP code............  98765.
------------------------------------------------------------------------

15. Location Identifier
    We propose to define ``location identifier'' as a unique 
identification code that an entity assigns to the physical location 
name identified in the corresponding location description; except that 
for fishing vessels, ``location identifier'' would mean the vessel 
identification number or license number (both if available) for the 
fishing vessel. Location identifiers are typically stored with location 
descriptions in business systems used for purchasing, manufacturing, 
and selling goods and services.
    Along with location descriptions, firms could keep all the location 
identifiers for their suppliers, customers, and other supply chain 
partners in an electronic master file. Many firms maintain ``master 
data'' containing information on products, companies, and locations, as 
well as other key commercial information. Trading partners often share 
certain master data information with each other to simplify business 
transactions. Persons subject to the proposed rule could meet their 
requirements to keep records on different location descriptions and 
identifiers (e.g., for firms from which they receive foods and firms to 
which they ship food) in electronic master data files. Table 4 
illustrates how a firm might maintain relevant information identifying 
the locations of its supply chain partners using location identifier 
and location description KDEs.

                                                    Table 4--Example of Location Master Data Listing
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Location description
                      ----------------------------------------------------------------------------------------------------------------------------------
 Location identifier                        Physical Location
                          Business Name           Name            Primary Phone          Street               City             State         Zip code
--------------------------------------------------------------------------------------------------------------------------------------------------------
ALPHA-01.............  Alpha Eggs........  Bldg. 3...........        999.999.9999  101 Birch.........  Springfield......  MO............          111111
GG-CA-01.............  Gary Greens.......  Field 21..........        888.888.8888  818 Elm...........  Salinas..........  CA............          222222
GG-AZ-02.............  Gary Greens.......  Cooler #1.........        777.777.7777  789 Maple.........  Yuma.............  AZ............          333333
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 60002]]

16. Lot
    We propose to define ``lot'' as the food produced during a period 
of time at a single physical location and identified by a specific 
code, noting that a lot may also be referred to as a ``batch'' or 
``production run.'' While each firm determines the size or quantity of 
a lot, we recommend that lots consist of product produced under uniform 
conditions, be as small as possible, and generally not exceed 24 hours 
of production. Limiting the size of a lot allows for more precise 
traceability of a product and helps narrow the scope of potentially 
recalled product.
17. Manufacturing/Processing
    We propose to define ``manufacturing/processing'' as it is defined 
in subpart J and other FDA food safety regulations, i.e., making food 
from one or more ingredients, or synthesizing, preparing, treating, 
modifying, or manipulating food, including food crops or ingredients. 
The definition further provides that examples of manufacturing/
processing activities include the following: baking, boiling, bottling, 
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw 
agricultural commodities to create a distinct commodity (such as 
drying/dehydrating grapes to produce raisins), evaporating, 
eviscerating, extracting juice, formulating, freezing, grinding, 
homogenizing, irradiating, labeling, milling, mixing, packaging 
(including modified atmosphere packaging), pasteurizing, peeling, 
rendering, treating to manipulate ripening, trimming, washing, or 
waxing. The definition also states that for farms and farm mixed-type 
facilities, manufacturing/processing does not include activities that 
are part of harvesting, packing, or holding.
18. Mixed-Type Facility
    We propose to define ``mixed-type facility'' as it is defined in 
subpart J, i.e., an establishment that engages in both activities that 
are exempt from registration under section 415 of the FD&C Act and 
activities that require the establishment to be registered. The 
proposed definition further states that an example of a mixed-type 
facility is a farm mixed-type facility, which is an establishment that 
is a farm but also conducts activities outside the farm definition that 
require the establishment to be registered.
19. Nonprofit Food Establishment
    We propose to define ``nonprofit food establishment'' as it is 
defined in subpart J, i.e., a charitable entity that prepares or serves 
food directly to the consumer or otherwise provides food or meals for 
consumption by humans or animals in the United States. The term would 
include central food banks, soup kitchens, and nonprofit food delivery 
services. To be considered a nonprofit food establishment, the 
establishment would be required to meet the terms of section 501(c)(3) 
of the U.S. Internal Revenue Code.
20. Originating
    We propose to define ``originating'' as an event in a food's supply 
chain involving the growing, raising, or catching of a food (typically 
on a farm, a ranch, or at sea), or the harvesting of a non-produce 
commodity. Section V.E.2 discusses a proposed requirement that the 
first receiver of a listed food keep information on the originator of 
the food, such as a farm.
21. Originator
    We propose to define ``originator'' as a person who grows, raises, 
or catches a food, or harvests a non-produce commodity.
22. Packing
    We propose to define ``packing'' as it is defined in subpart J and 
other food safety regulations, i.e., placing food into a container 
other than packaging the food. ``Packing'' also includes re-packing and 
activities performed incidental to packing or re-packing a food (e.g., 
activities performed for the safe or effective packing or re-packing of 
that food (such as sorting, culling, grading, and weighing or conveying 
incidental to packing or re-packing)), but would not include activities 
that transform a raw agricultural commodity (as defined in section 
201(r) of the FD&C Act) into a processed food as defined in section 
201(gg) of the FD&C Act.
23. Person
    We propose to define ``person'' as including an individual, 
partnership, corporation, and association. This matches the definition 
of ``person'' in section 201(e) of the FD&C Act.
24. Physical Location Name
    We propose to define ``physical location name'' as the word(s) used 
to identify the specific physical site of a business entity where a 
particular CTE occurs. Examples could be ``Packing Shed 2,'' ``Store 
#7228,'' or ``Warehouse A.'' The definition further states that a 
physical location name might be the same as an entity's business name 
if the entity has only one physical location. Tables 3 and 4 provide 
additional examples of physical location names.
25. Point of Contact
    We propose to define ``point of contact'' as an individual having 
familiarity with an entity's procedures for traceability, including 
their name, telephone number, and, if available, their email address 
and fax number. As discussed, beginning in section V.E.2, the proposed 
rule would require certain first receivers, receivers, and shippers of 
listed foods to maintain information on points of contact for certain 
entities in a food's supply chain.
26. Produce
    We propose to define ``produce'' to mean produce as defined in 
Sec.  112.3 in the produce safety regulations.
27. Receiving
    We propose to define ``receiving'' as an event in a food's supply 
chain in which a food is received by a customer (other than a consumer) 
at a defined location after being transported (e.g., by truck or ship) 
from another defined location. We discuss the traceability records we 
propose to require for receipt of foods on the Food Traceability List 
in section V.E.3.
28. Reference Record
    We propose to define ``reference record'' as a record used to 
identify an event in the supply chain of a food, such as a shipping, 
receiving, growing, creating, or transformation event. The proposed 
definition states that types of reference records include, but are not 
limited to, bills of lading (BOL), purchase orders, advance shipping 
notices (ASNs), work orders, invoices, batch logs, production logs, and 
receipts. We discuss the use of reference records in product tracing 
beginning in section V.D.1.
29. Reference Record Number
    We propose to define ``reference record number'' as the 
identification number assigned to a reference record, such as a 
purchase order number, bill of lading number, or work order number.
30. Retail Food Establishment
    We propose to define ``retail food establishment'' as it is defined 
in the food facility registration regulations (Sec.  1.227)), i.e., as 
an establishment that sells food products directly to consumers as its 
primary function. The definition further specifies the following:
     The term ``retail food establishment'' includes facilities 
that manufacture, process, pack, or hold food if the establishment's 
primary function is to sell from that establishment food, including 
food that

[[Page 60003]]

it manufactures, processes, packs, or holds, directly to consumers;
     a retail food establishment's primary function is to sell 
food directly to consumers if the annual monetary value of sales of 
food products directly to consumers exceeds the annual monetary value 
of sales of food products to all other buyers;
     the term ``consumers'' in the definition does not include 
businesses; and
     retail food establishments include, but are not limited 
to, grocery stores, convenient stores, and vending machine locations.
    The definition of ``retail food establishment'' also includes 
certain farm-operated businesses selling food directly to consumers as 
their primary function. The definition further specifies that the sale 
of food directly to consumers from an establishment located on a farm 
includes sales by that establishment directly to consumers in the 
following circumstances:
     At a roadside stand (a stand situated on the side of or 
near a road or thoroughfare at which a farmer sells food from his or 
her farm directly to consumers) or farmers' market (a location where 
one or more local farmers assemble to sell food from their farms 
directly to consumers);
     through a community supported agriculture program. 
Community supported agriculture (CSA) program means a program under 
which a farmer or group of farmers grows food for a group of 
shareholders (or subscribers) who pledge to buy a portion of the 
farmer's crop(s) for that season. This includes CSA programs in which a 
group of farmers consolidate their crops at a central location for 
distribution to shareholders or subscribers; and
     at other such direct-to-consumer sales platforms, 
including door-to-door sales; mail, catalog and internet order, 
including online farmers' markets and online grocery delivery; 
religious or other organization bazaars; and State and local fairs.
    The definition further states that the sale of food directly to 
consumers by a farm-operated business includes the sale of food by that 
farm-operated business directly to consumers in the same circumstances 
just specified with respect to sale of food directly to consumers from 
an establishment located on a farm.
    Although not specified in this definition of ``retail food 
establishment,'' we regard restaurants, online food retailers, and meal 
kit delivery companies as other examples of such establishments.
31. Shipping
    We propose to define ``shipping'' as an event in a food's supply 
chain in which a food is arranged for transport (e.g., by truck or 
ship) from a defined location to another defined location at a 
different farm, a first receiver, or a subsequent receiver. This would 
mean that, for example, shipping would not include arranging for 
transport of a food between different locations of a single farm. The 
definition further specifies that shipping does not include the sale or 
shipment of a food directly to a consumer or the donation of surplus 
food.
    As with the subpart J regulations, the proposed traceability 
recordkeeping requirements would not apply to the sale of food to 
consumers by retail food establishments, such as grocery stores, 
convenience stores, and restaurants. We have tentatively concluded that 
to require retail facilities to keep records of each individual 
recipient consumer would be too burdensome and not necessary to address 
credible threats of serious adverse health consequences or death to 
humans or animals. However, we acknowledge that some retail food 
establishments are able to use their consumer loyalty cards to provide 
consumer-level data (see 68 FR 25188 at 25192, May 9, 2003). We discuss 
the traceability records we propose to require for shipment of foods on 
the Food Traceability List in section V.E.5.
32. Traceability Lot
    We propose to define ``traceability lot'' as a lot of food that has 
been originated, transformed, or created.
33. Traceability Lot Code
    We propose to define ``traceability lot code'' to mean a 
descriptor, often alphanumeric, used to identify a traceability lot. As 
with location descriptions and location identifiers, traceability lot 
codes are typically stored in business systems and printed in human 
readable and machine-readable format on food product packaging. We 
discuss the generation and use of traceability lot codes in product 
tracing in section V.D.1.
34. Traceability Lot Code Generator
    We propose to define ``traceability lot code generator'' to mean 
the person who assigns a traceability lot code to a product.
35. Traceability Product Description
    We propose to define ``traceability product description'' to mean a 
description of a food product typically used commercially for 
purchasing, stocking, or selling, and includes the category code or 
term, category name, and trade description. As with traceability lot 
codes, traceability product descriptions are typically stored in 
business systems and printed in human readable format on food product 
packaging.
    The definition of ``traceability product description'' further 
states that for single-ingredient products, the trade description 
includes the brand name, commodity, variety, packaging size, and 
packaging style; for multiple-ingredient food products, the trade 
description includes the brand name, product name, packaging size, and 
packaging style.
    The same term might be used for different components of the 
traceability product description of a food. For example, ``cucumber'' 
may be used as both the category and the commodity.
36. Traceability Product Identifier
    We propose to define ``traceability product identifier'' as a 
unique identification code (such as an alphanumeric code) that an 
entity assigns to designate a specific type of food product. As with 
traceability lot codes and traceability product descriptions, 
traceability product identifiers are typically stored in business 
systems and printed in human and machine-readable format on food 
product packaging. We discuss the use of traceability product 
identifiers in section V.E.3.
    Table 5 illustrates how information in traceability product 
identifiers and descriptions could be maintained.

[[Page 60004]]

                                         Table 5--Example of Data Attributes for Traceability Product Descriptions and Traceability Product Identifiers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Traceability product description data attributes
                           ---------------------------------------------------------------------------------------------------------------------------------------------------------------------
   Traceability product                   Category                                                                       Trade Description
        identifier         ---------------------------------------------------------------------------------------------------------------------------------------------------------------------
                             Category code or
                                   term          Category name        Brand name           Commodity             Variety            Product name      Packaging size        Packaging style
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
614141007349..............  10006162 \1\.....  Cherry Tomatoes--  Brand ABC........  Tomatoes............  Cherry.............  n/a................  25 LB...........  Carton.
                                                Round \1\.
183859303020..............  10006260 \1\.....  Sprouts (Fresh)    Brand ABC........  n/a.................  n/a................  Sprout Mix.........  4 oz............  Clamshell.
                                                \1\.
20614141004366............  BFT \2\..........  Blue Fin Tuna \2\  Brand 123........  Tuna................  Atlantic Bluefin...  n/a................  10 KG...........  Bin.
498265800732..............  Soft Cheese \3\..  Soft Cheese \3\..  Brand XYZ........  N/A.................  N/A................  Queso Fresco.......  12 x 8 Ounce....  Vac Pack.
5 1462872318 2............  Fresh Cut Produce  Fresh Cut Produce  Brand 999........  N/A.................  N/A................  Small Vegetable      6 oz............  Tray.
                             \3\.               \3\.                                                                             Tray w/dip.
7483945748383.............  10000161 \1\.....  Biscuits/Cookies   Brand CDE........  N/A.................  N/A................  Peanut Butter        12 oz...........  Box.
                                                (Shelf Stable)                                                                   Sandwich Cracker.
                                                \1\.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Example of a category that is assigned using the GS1 Global Product Classification Scheme.
\2\ Example of a category that is assigned using the United Nations Food and Agriculture Organization's Aquatic Sciences and Fisheries Information System (ASFIS) List of Species for Fishery
  Statistics Purposes, 3A code.
\3\ Example of a category that is self-assigned by a firm.

37. Transformation
    We propose to define ``transformation'' as an event in a food's 
supply chain that involves changing a food on the Food Traceability 
List, its package, and/or its label (regarding the traceability lot 
code or traceability product identifier), such as by combining 
ingredients or processing a food (e.g., by cutting, cooking, 
commingling, repacking, or repackaging). The definition would further 
specify that transformation does not include initial packing of a 
single-ingredient food or creating a food. We understand that this 
definition of ``transformation'' might differ from the way the term is 
defined in other traceability systems and approaches; however, we 
believe this definition is appropriate for use with traceability 
records for foods on the Food Traceability List, as discussed in 
section V.E.4.
38. Transporter
    We propose to define ``transporter'' as a person who has 
possession, custody, or control of an article of food for the sole 
purpose of transporting the food, whether by road, rail, water, or air. 
This definition of ``transporter'' is the same as in subpart J except 
that it omits language differentiating foreign from domestic 
transporters, which is not necessary under subpart S. As discussed in 
section V.B.9, we propose to exempt transporters from the subpart S 
requirements.
39. Vessel Identification Number
    We propose to define ``vessel identification number'' to mean the 
number assigned to a fishing vessel by the International Maritime 
Organization, or by any entity or organization, for the purpose of 
uniquely identifying the vessel. We request comment on whether the 
proposed definition provides appropriate flexibility regarding the 
manner in which fishing vessels are uniquely identified.

D. Traceability Program Records (Proposed Sec. Sec.  1.1315 Through 
1.1320)

    We propose to require persons who manufacture, process, pack, or 
hold foods on the Food Traceability List to create and maintain certain 
records related to their internal traceability program. As described 
further below, these ``traceability program records'' concern the use 
of reference records, maintaining a list of foods on the Food 
Traceability List that are shipped, the assignment of traceability lot 
codes to listed foods, and information on the classification schemes a 
firm uses for traceability.
    We encourage firms to maintain required traceability information in 
electronic form. Because electronic recordkeeping itself has not yet 
been universally adopted, it is especially important that firms be able 
to provide information on how they conduct their required traceability 
operations to help us more quickly review and understand the 
information we need to conduct an investigation into a foodborne 
illness outbreak involving a listed food.
1. Traceability Program Records (Proposed Sec.  1.1315)
    Proposed Sec.  1.1315 answers the question, ``What traceability 
program records must I have for foods on the Food Traceability List 
that I manufacture, process, pack, or hold?'' Proposed Sec.  1.1315(a) 
would require persons subject to subpart S to establish and maintain 
certain traceability program records. We note that, for these and all 
other records required under subpart S, persons subject to these 
requirements may enter into agreements with individuals or firms to 
create and keep the records required under this rule on their behalf. 
As discussed later in this document, this could include records 
documenting KDEs for CTEs such as growing, receiving, shipping, 
transforming, and creating listed foods. Firms could, for example, 
retain consultants or other outside entities to perform some or all of 
their subpart S responsibilities, or rely on their supply chain 
partners, such as their brokers or suppliers, to establish and maintain 
required records on their behalf. We believe that allowing firms to 
enter into such agreements will allow for flexibility and accommodate 
current business practices while ensuring that persons subject to the 
rule remain responsible for ensuring that these recordkeeping 
requirements are met.
a. Description of Reference Records (Proposed Sec.  1.1315(a)(1))
    Proposed Sec.  1.1315(a)(1) would require persons subject to 
subpart S to establish and maintain a description of the reference 
records in which they

[[Page 60005]]

maintain the information required under subpart S, an explanation of 
where on the records the required information appears, and, if 
applicable, a description of how reference records for different 
tracing events for a food (e.g., receipt, transformation, shipment) are 
linked. We encourage firms to maintain required traceability 
information in a single electronic system; however, we recognize there 
are firms that currently do not have product tracing systems that 
enable them to do this. We therefore propose to require firms to 
describe the particular types of reference records in which they keep 
the required tracing information to help expedite the firm's production 
of records and facilitate our review of those records during a 
foodborne illness outbreak investigation. In some recent foodborne 
illness outbreaks, some firms' inability to quickly identify and make 
available to us pertinent information on such matters as production, 
receipt, and shipment of a possibly contaminated food has significantly 
delayed completion of our investigation, resulting in greater harm to 
consumers. Furthermore, even when a firm produces the relevant records, 
additional delays can occur when it is difficult for us to find the 
relevant information on those records.
    Proposed Sec.  1.1315(a)(1) also would require documentation, if 
applicable, of how the reference records used for different tracing 
events for a food are linked. The ability to link incoming with 
outgoing products within a firm and from one point in the supply chain 
to the next is critical for traceability. Rarely are there identifiers 
that link a product as it moves from firm to firm through the supply 
chain, and often identifiers are lacking within a single firm. One firm 
may assign a lot code to a product shipment, and the firm receiving the 
product may assign a new lot code or other identifying code to the 
product that is not connected by records to the incoming product. 
Additionally, the incoming product may be processed and used as an 
ingredient in many different products without any documentation of the 
link between the ingredient and the finished products, thus compounding 
the challenge of linking incoming products within a firm to outgoing 
products.
    Another challenge associated with linking of traceability records 
is that a food product may not always retain the same description as it 
moves through the supply chain. For example, an FDA traceback of 
iceberg lettuce during a cyclosporiasis outbreak in 2013 revealed that 
the lettuce was referred to as ``iceberg lettuce'' by some firms and as 
``lettuce liner size 24'' by others. In a 2012 outbreak of Salmonella 
Bareilly in tuna, the tuna was identified as ``tuna ground meat AAA'' 
by one supplier and ``frozen yellow fin tuna CO treated'' by the next 
firm in the supply chain. Use of different descriptions for the same 
product can make it very difficult or impossible to determine whether 
two records refer to the same products or shipments.
    Having information on how a firm links its records of incoming and 
outgoing food products, including records of any transformation that 
may occur at the firm, can help verify movement of a received product 
through the firm regardless of any changes made to the product or its 
naming convention. For example, a distributor may use invoices and BOLs 
as reference records for their traceability information. Knowing which 
pieces of information are kept within each type of reference record and 
how those records can be used to show the movement of products within 
the firm would help FDA understand the products a firm received and 
what the firm did with them. For example, if a distributor's BOL 
records contain the necessary information on products received and its 
invoice records contain the information on products shipped, the 
distributor could indicate in its traceability program records that an 
invoice sent to the next point in the supply chain contains the BOL 
number for the distributor's receipt of the product. This information 
would help FDA understand the distributor's recordkeeping system and 
verify movement of incoming and outgoing products at the firm.
b. List of Foods on the Food Traceability List Shipped (Proposed Sec.  
1.1315(a)(2))
    Proposed Sec.  1.1315(a)(2) would require persons subject to 
subpart S to establish and maintain a list of foods on the Food 
Traceability List that they ship, including the traceability product 
identifier and traceability product description for each food. 
Depending on the volume of product that a firm handles, if they did not 
maintain the list required under proposed Sec.  1.1315(a)(2), during an 
outbreak investigation we might not be able to quickly and easily 
determine all of the foods on the Food Traceability List that the firm 
manufactures, processes, packs, or holds, which could delay completion 
of product tracing or recall. In addition, reviewing a firm's list 
would help us more quickly analyze information for traceforward 
purposes during an outbreak, such as when a firm has received and used 
a recalled ingredient in manufacturing other listed foods of which we 
were unaware. For example, in a 2008 outbreak involving peanut butter, 
numerous recalls spanning several months were conducted due to the use 
of the contaminated peanut butter in other products. Even though we 
were able to identify the firm that was the source of the peanut 
butter, having access to a comprehensive list of peanut butter products 
produced and shipped from the source may have avoided multiple expanded 
recalls by the same firm over several weeks. In addition, review of a 
complete list of peanut butter products may have led to efficient and 
quick traceforward activities to determine additional recipients of 
potentially contaminated products, which might have enabled faster 
identification of products produced with potentially contaminated 
peanut butter by other firms, leading to earlier notification to 
consumers to avoid such products. In addition, reviewing a firm's list 
of all foods on the Food Traceability List the firm manufactures, 
processes, packs, or holds also would help us evaluate the firm's 
compliance with the subpart S requirements, and we anticipate it will 
also help firms with their own internal compliance programs.
    Although proposed Sec.  1.1315(a)(2) would only require maintenance 
of a list of foods on the Food Traceability List that a firm ships, 
best practice would be for a firm to maintain a list of all foods it 
ships. Firms following that practice could satisfy the requirements of 
Sec.  1.1315(a)(2) by denoting the foods that are on the Food 
Traceability List (e.g., with an asterisk).
    We realize that a firm's list of foods on the Food Traceability 
List that they ship may not be accurate in real time if the firm is 
temporarily out of a commodity or only handles certain products 
seasonally. The list of foods would indicate which foods on the Food 
Traceability List a firm generally ships, even if there are gaps in 
those shipments.
c. Description of How Traceability Lot Codes Are Established and 
Assigned (Proposed Sec.  1.1315(a)(3))
    Proposed Sec.  1.1315(a)(3) would require persons subject to 
subpart S to establish and maintain a description of how they establish 
and assign traceability lot codes to foods on the Food Traceability 
List that they originate, transform, or create, if applicable. 
Assignment of a lot code allows a food product to be uniquely 
identified and provides information needed to link shipments of a food 
between different entities in the supply chain. We believe that 
tracking

[[Page 60006]]

foods to the lot level provides adequate information for traceability 
operations. (Although some firms conduct product tracing to the case 
level, the proposed rule would not require that, in accordance with 
section 204(d)(1)(L)(iii) of FSMA.) During a tracing or recall event, 
FDA routinely requests lot code information from firms to effectively 
link movement of foods within a firm and shipments throughout the 
supply chain. The availability of lot codes along an entire supply 
chain can facilitate identifying the specific food involved in a 
contamination event and limiting the scope of a recall event. Lot codes 
can contain data such as the production line used, plant location, or 
harvest date. Because of the significance of lot codes in food tracing, 
understanding how a firm creates and assigns traceability lot codes 
would provide us with information about the relevance of a code to a 
particular outbreak investigation and insight on how the code can help 
us appropriately narrow or broaden the investigation.
d. Other Information Needed To Understand Data (Proposed Sec.  
1.1315(a)(4))
    Proposed Sec.  1.1315(a)(4) would require persons subject to 
subpart S to establish and maintain records containing any other 
information needed to understand the data provided within any required 
subpart S records, such as internal or external coding systems, 
glossaries, and abbreviations. We need this information to be able to 
adequately understand the terminology, methods, and systems a firm uses 
in its traceability operations. For example, many firms use 
classification schemes developed by industry (such as the GS1 Global 
Product Classification standard and the Food and Agriculture 
Organization of the United Nations Fisheries and Aquaculture and 
Information Branch List of Species for Fishery Statistics Purposes) or 
regulatory agency schemes (such as the United Nations Standard Products 
and Services Code and the European Union Common Procurement Vocabulary) 
to categorize foods for traceability purposes. Use of standardized 
product classification schemes, lookup tables, and abbreviations can 
streamline a firm's internal records and promote interoperability 
throughout the supply chain, which can speed outbreak investigations. 
When the records kept in accordance with subpart S make use of such 
classification schemes, abbreviations, or similar methods, it is 
important that firms be able to provide us with the information we need 
to understand those records.
e. Retention Requirement for Traceability Program Records (Proposed 
Sec.  1.1315(b))
    Although we are proposing that most subpart S records be retained 
for 2 years from the date of creation (see section V.I.3), proposed 
Sec.  1.1315(b) would require firms to retain the records required 
under proposed Sec.  1.1315(a) for 2 years after their use is 
discontinued (e.g., because the firm changes the records in which the 
required information is maintained, updates the list of foods on the 
Food Traceability List it ships, or changes its procedures for 
establishing and assigning traceability lot codes). We believe that a 
different retention period is appropriate because the records in Sec.  
1.1315(a) involve procedures and processes, rather than documentation 
of the production and handling of particular lots of food products. For 
example, proposed Sec.  1.1315(b) would ensure that even if a firm uses 
the same procedures to establish and assign traceability lot codes for 
many years, a record of these procedures will remain available for FDA 
review for 2 years after the procedures are discontinued.
2. When Traceability Lot Codes Must Be Assigned (Proposed Sec.  1.1320)
    Proposed Sec.  1.1320 answers the question, ``When must I establish 
and assign traceability lot codes to foods on the Food Traceability 
List?'' Proposed Sec.  1.1320(a) would require a person subject to 
subpart S to establish and assign a traceability lot code when they 
originate, transform, or create a food on the Food Traceability List. 
Proposed Sec.  1.1320(b) would specify that, except as otherwise 
specified in the subpart S regulations, a person may not establish a 
new traceability lot code when conducting other activities (e.g., 
shipping, receiving) in the supply chain for a food on the Food 
Traceability List.
    Typically, persons who grow or otherwise originate food assign a 
lot code to the food; the same is true when a food is transformed 
(e.g., processed in some way) or ``created'' by combining several 
different ingredients. As previously discussed, lot codes provide 
important tracing information for a food product. Therefore, we propose 
to require the assignment of a traceability lot code when a firm 
originates, transforms, or creates a food on the Food Traceability 
List. However, some firms assign lot codes to foods they receive even 
though they do not transform the food or use the food to create a new 
food product. We believe that assignment of new lot codes to foods in 
such circumstances can create confusion that can hinder traceback and 
traceforward efforts during investigation of foodborne illness 
outbreaks. Therefore, the proposed rule generally would prohibit 
establishment of a traceability lot code (for the purpose of meeting 
the proposed subpart S requirements) for a listed food except when 
originating, transforming, or creating a listed food. However, under 
proposed Sec.  1.1330(c) (discussed in section V.F.2), if a first 
receiver receives a listed food to which the originator has not 
assigned a traceability lot code, the first receiver would be required 
to establish (and maintain a record of) a traceability lot code for the 
food.

E. Records of Growing, Receiving, Transforming, Creating, and Shipping 
Food (Proposed Sec. Sec.  1.1325 to 1.1350)

    As discussed in section III.D.2, we are proposing to require 
persons who manufacture, process, pack, or hold foods on the Food 
Traceability List to establish and maintain records containing KDEs 
related to CTEs in the production and transfer of such foods. Under the 
proposed rule, the CTEs for which records must be kept are growing a 
listed food, receiving a listed food (including receipt by a first 
receiver of a listed food), transforming a listed food, creating a 
listed food, and shipping a listed food. In addition, the proposed rule 
includes KDE requirements concerning activities such as harvesting, 
cooling, and packing food that are included in the CTE requirements 
just noted. The proposed rule also includes requirements concerning 
KDEs that shippers of foods on the Food Traceability List must provide 
to their customers.
    As discussed in more detail in the following paragraphs, the KDEs 
required to be kept would vary depending on the type of supply chain 
activity. In developing the recordkeeping requirements, we identified 
which KDEs would be necessary to effectively trace a product based on 
the CTEs a firm performs (e.g., receiving, transformation, shipping). 
Not all KDEs are relevant for each CTE; however, firms that perform 
multiple CTEs would be required to maintain all the KDEs that pertain 
to the CTEs they perform. For example, a firm that receives a food on 
the Food Traceability List and then transforms and ships it would be 
required to keep records of KDEs relevant to the receiving, 
transforming, and shipping events.
    The proposed KDE/CTE recordkeeping requirements would require the 
person performing the relevant CTE to establish and maintain records 
containing and linking the

[[Page 60007]]

food's traceability lot code to the KDEs that must be kept. As 
discussed in sections III.B and IV.D.1, lot codes play a critical role 
in linking a food to events in the food's supply chain, allowing firms 
and regulators to identify and verify the movement of a food throughout 
its supply chain to facilitate traceback and traceforward operations. 
For this reason, it is critical that firms maintain records, such as 
purchase orders and BOLs, that indicate a food's traceability lot code 
and link it to other information about the food.
    For the most part, the proposed requirements related to KDEs 
associated with CTEs in a food's supply chain reflect tracing practices 
in use by many, though not all, sectors and individual firms in the 
food industry. We believe that firms' compliance with the proposed 
requirements would substantially improve our ability to understand how 
and where potentially harmful foods have moved in the supply chain and 
facilitate removal of such foods from the market.
1. Records of Growing a Food on the Food Traceability List (Proposed 
Sec.  1.1325)
    Proposed Sec.  1.1325 answers the question, ``What records must I 
keep when I grow a food on the Food Traceability List?'' We propose to 
require persons who grow foods on the Food Traceability List (e.g., 
certain fruits and vegetables) to establish and maintain records on 
certain matters related to the growing of the food because they are the 
persons most likely to have certain information that is critical for 
traceability of the foods. We note that, in addition to these 
requirements for records of the growing of listed foods, farms are also 
subject to the proposed recordkeeping requirements applicable to the 
shipment of listed foods, which are discussed later in this document. 
Furthermore, farms would be subject to the proposed recordkeeping 
requirements for the receipt and transformation of listed foods, when 
applicable, as discussed later in this document.
    For each food on the Food Traceability List grown, proposed Sec.  
1.1325 would require the grower of the food to establish and maintain 
records containing and linking the traceability lot code of the food to 
the following information:
     The growing area coordinates (proposed Sec.  1.1325(a)); 
and
     for growers of sprouts, the following information (if 
applicable):
    [cir] The location identifier and location description of the 
grower of seeds for sprouting, the associated seed lot code assigned by 
the seed grower, and the date of seed harvesting (proposed Sec.  
1.1325(b)(1));
    [cir] the location identifier and location description of the seed 
conditioner or processor, the associated seed lot code assigned by the 
seed conditioner or processor, and the date of conditioning or 
processing (proposed Sec.  1.1325(b)(2));
    [cir] the location identifier and location description of the seed 
packinghouse (including any repackers, if applicable), the associated 
seed lot code assigned by the seed packinghouse, and the date of 
packing (and of repacking, if applicable) (proposed Sec.  
1.1325(b)(3));
    [cir] the location identifier and location description of the seed 
supplier (proposed Sec.  1.1325(b)(4));
    [cir] a description of the seeds, including the seed type or 
taxonomic name, growing specifications, volume, type of packaging, and 
antimicrobial treatment (proposed Sec.  1.1325(b)(5));
    [cir] the seed lot code assigned by the seed supplier, including 
the master lot and sub-lot codes, and any new seed lot code assigned by 
the sprouter (proposed Sec.  1.1325(b)(6));
    [cir] the date of receipt of the seeds by the sprouter (proposed 
Sec.  1.1325(b)(7)); and
    [cir] for each seed lot code received by the sprouter, the sprout 
traceability lot code(s) and the date(s) of production associated with 
that seed lot code (proposed Sec.  1.1325(b)(8)).
a. Growing Area Coordinates (Proposed Sec.  1.1325(a))
    Proposed Sec.  1.1325(a) would require persons who grow a listed 
food to keep a record linking each traceability lot of the food to the 
growing area coordinates for that lot. Many farms are in rural 
locations that lack street addresses; in addition, many farms have 
multiple fields in which the same commodity is grown. FDA often 
requests growing area coordinates for foods under investigation to more 
precisely identify the place where the food was grown and to determine 
proximity to other farms that have been identified in the 
investigation. To meet this requirement to record growing area 
coordinates, farms typically would maintain the GPS coordinates for the 
entrance of the specific field or ranch where the food was grown. This 
information allows us to pinpoint the source of the food more 
specifically than would be possible with the address information for 
the farm. For example, in a 2018 traceback investigation of leafy 
greens, firms provided GPS coordinates for the locations at which the 
greens were grown, enabling us to triangulate the farms and narrow the 
focus of the investigation to a limited number of farms.
b. Information on Seeds for Sprouting (Proposed Sec.  1.1325(b))
    Because sprouts pose unique food safety concerns, as reflected in 
the special provisions for sprouts in the produce safety regulations 
(subpart M of part 112) (see, e.g., 78 FR 3504 at 3594 to 3595 (January 
16, 2013); 80 FR 74354 at 74496 to 74497 (November 27, 2015)), proposed 
Sec.  1.1325(b) would require growers of sprouts to keep records 
linking the traceability lot code for each lot of sprouts to certain 
information about the grower and supply chain of the seeds they use for 
sprouting. (By ``seeds'' we mean everything sprouted to produce sprouts 
for human consumption, including beans.) Seeds have been the underlying 
source of contamination in numerous sprout outbreaks (Refs. 23 and 24). 
Although FDA encourages sprout operations to use seed that was grown 
according to good agricultural practices (GAPs), this does not always 
occur. Most seeds produced in the United States are used as planting 
stock to produce forages for livestock or for field cultivation. Such 
seeds are generally not grown according to GAPs, and may be grown, 
conditioned/processed, harvested, and/or stored under conditions where 
contamination is likely to occur. These seeds are sometimes diverted to 
be used for sprouting, which can create a risk to the public health. 
Contaminated seed represents a particular food safety issue for sprouts 
because the conditions under which sprouts are produced (time, 
temperature, water activity, pH, and available nutrients) are also 
ideal for the growth of pathogens, if present.
    During sprout-related outbreak investigations, FDA frequently has 
been unable to obtain information needed to determine the scope of 
potentially affected sprouts and take action against firms that sold 
adulterated seeds or processed, packed, or re-packed seeds in a way 
that might result in adulterated product. Requiring sprout growers to 
keep records identifying seed growers, processors, packers, repackers, 
and suppliers (proposed Sec.  1.1325(b)(1) through (4)) would provide 
the Agency with information needed to avoid these hurdles as well as 
help us conduct outbreak follow-up activities that would aid in 
preventing future outbreaks. Similarly, requiring sprout growers to 
keep records on seed lot codes assigned by seed harvesters, 
conditioners, processors, and repackers, along with the dates of seed 
harvesting, conditioning, processing, and repacking (proposed Sec.  
1.1325(b)(1) through (3)),

[[Page 60008]]

would help us scope a sprout recall event and identify the seed lot 
used to grow the sprouts involved in a contamination event.
    The description of the seeds the sprout grower used, as required 
under proposed Sec.  1.1325(b)(5), includes the seed type or taxonomic 
name, growing specifications, volume, type of packaging, and 
antimicrobial treatment. Examples of growing specifications could 
include production in accordance with GAP standards and/or FDA's draft 
guidance for industry on ``Reducing Microbial Food Safety Hazards in 
the Production of Seed for Sprouting'' (Ref. 25), certification under 
USDA's Seeds for Sprouting Export Certification Program, information on 
seed purity or germination rate, and whether the seeds are organic or 
conventionally grown. Antimicrobial treatment refers to treatment of 
seeds or beans conducted by a grower, distributor, or supplier of the 
seeds or beans using a scientifically valid method to reduce 
microorganisms of public health significance. If seeds are not grown to 
any growing specifications or antimicrobial treatments are not used, 
that information should be included as part of the description.
    Sprout growers would also be required to keep records of the lot 
codes for the seeds used for sprouting (including the master lot and 
sub-lot codes assigned by the seed supplier and any new seed lot code 
assigned by the sprouter) (proposed Sec.  1.1325(b)(6)), the date of 
receipt of seeds by the sprouter (proposed Sec.  1.1325(b)(7)), and 
sprout traceability lot codes for the sprouts produced from each lot of 
seeds received by the sprouter (and the dates of production) (proposed 
Sec.  1.1325(b)(8)). Having information to identify incoming seed lots, 
any changes to seed lot codes, and outgoing sprout lots would greatly 
improve our ability to trace sprout-related foodborne illness outbreaks 
to their source.
2. Records To Be Kept by First Receivers of Foods on the Food 
Traceability List (Proposed Sec.  1.1330)
    Proposed Sec.  1.1330 answers the question, ``What records must I 
keep when I am the first receiver of a food on the Food Traceability 
List?'' As stated in section V.C.3, a first receiver of a food is the 
first person (other than a farm) who purchases and takes physical 
possession of a listed food. Examples of first receivers could include 
manufacturers, processors, buyers of seafood from fishing vessels, and 
distribution centers. Only listed foods that are originated (i.e., 
grown, harvested (if a non-produce commodity), raised, or caught) would 
have a first receiver. As stated in section V.C.3, when a food on the 
Food Traceability List is created exclusively from ingredients that are 
not on the Food Traceability List, the first person who purchases and 
takes physical possession of the food would not be a first receiver. In 
other words, when a listed food is created, rather than originated, 
there would not be a first receiver.
    We are proposing to establish the term ``first receiver'' of a food 
on the Food Traceability List and to require that first receivers keep 
certain records of their receipt (in addition to the receiving records 
they are required to keep under proposed Sec.  1.1335) because a first 
receiver is the person who is best positioned to maintain comprehensive 
information about the origination and subsequent handling of a food. 
This includes information identifying the persons who originated, 
harvested, cooled, and packed the food. The foods on the Food 
Traceability List include foods in several different commodity types 
with varying growing and production practices and associated business 
relationships. For some foods, firms that conduct on-farm production 
and handling activities may not own the food and may not be well-
positioned to maintain the necessary records. Furthermore, on-farm 
activities can involve movement of a food between different entities 
(e.g., growers, harvesters, coolers) without sale of the food, and the 
relevant business relationships can be complex. Identifying the first 
receiver of a food as the first person who purchases and takes physical 
possession of the food ensures that comprehensive records relating to 
the origination and handling of the food are maintained by a single 
person who both owns and possesses the food.
    Because unique tracing information is relevant for seafood products 
obtained from fishing vessels, we are proposing to adopt separate 
recordkeeping requirements for: (1) First receivers of foods on the 
Food Traceability List other than food produced through the use of a 
fishing vessel (proposed Sec.  1.1330(a)) and (2) first receivers of 
listed seafood products obtained from fishing vessels (proposed Sec.  
1.1330(b)), as discussed in the following paragraphs.
a. First Receivers of Food (Other Than Food Produced Through the Use of 
a Fishing Vessel) (Proposed Sec.  1.1330(a))
    Proposed Sec.  1.1330(a) would require each first receiver of a 
food on the Food Traceability List (except first receivers of food 
produced through the use of a fishing vessel, as addressed in proposed 
Sec.  1.1330(b)) to establish and maintain records, in addition to the 
records of receipt of foods required under proposed Sec.  1.1335 
(discussed in section V.F.3), containing and linking the traceability 
lot code of the food received to the following information:
     The location identifier and location description of the 
originator of the food (proposed Sec.  1.1330(a)(1));
     the business name, point of contact, and phone number of 
the harvester of the food, and the date(s) and time(s) of harvesting 
(proposed Sec.  1.1330(a)(2));
     the location identifier and location description of the 
place where the food was cooled, and the date and time of cooling (if 
applicable) (proposed Sec.  1.1330(a)(3)); and
     the location identifier and location description of the 
place where the food was packed, and the date and time of packing 
(proposed Sec.  1.1330(a)(4)).
    Maintenance of these records by first receivers of a listed food 
will help prevent delays in determining who grew and physically handled 
a product by alleviating the initial need to visit each entity 
performing farm activities. In addition, requiring first receivers to 
keep this information could help identify precisely where originating 
and handling activities occurred. In some cases, a food might undergo 
several handling steps (e.g., cooling, packing) at different locations 
before the first receiver takes physical possession of the food. 
Sometimes all these activities are conducted by the originator of the 
food (e.g., the farm that grew it), but in some cases other firms 
harvest, cool, and/or pack the food with or without taking ownership of 
it. During outbreak investigations, FDA has experienced delays in 
determining who was responsible for handling the contaminated product 
identified in a traceback because the documents available to us did not 
accurately indicate who conducted different activities with the 
product. Given the wide variety of business models used in the farming 
community, we believe it will be most efficient to have the first non-
farm entity that has purchased and taken physical possession of a 
listed food--i.e., the first receiver--maintain the tracing information 
provided by the farm(s) that originated and handled the product.
    With respect to the location description for the cooler of a food, 
when a food has been cooled by a portable cooler, the first receiver of 
the food could satisfy the requirement in proposed Sec.  1.1330(a)(3) 
by keeping a record of the location description for the headquarters of 
the firm that performed

[[Page 60009]]

the cooling. In this case, the physical location name would be the 
words identifying the portable cooler (e.g., ``Cooler No. 17'').
    As noted above, not all of the proposed requirements would apply to 
every first receiver of a listed food. For example, not all foods 
undergo cooling before the first receiver takes possession of the food.
b. First Receivers of Food Produced Through Use of a Fishing Vessels 
(Proposed Sec.  1.1330(b))
    Proposed Sec.  1.1330(b) would require each first receiver of a 
seafood product on the Food Traceability List that was produced through 
use of a fishing vessel to establish and maintain records, in addition 
to the records of receipt of foods required under proposed Sec.  1.1335 
(discussed in section V.F.3), containing and linking the traceability 
lot code of the seafood product received to the harvest date range and 
locations (National Marine Fisheries Service Ocean Geographic Code or 
geographical coordinates) for the trip during which the seafood was 
caught. Compliance with these requirements by first receivers of 
seafood from fishing vessels would facilitate traceback efforts by 
helping us more quickly identify physical locations and date ranges 
that might be linked to a foodborne illness outbreak involving a 
seafood product.
c. Establishment of Traceability Lot Codes (Proposed Sec.  1.1330(c))
    Proposed Sec.  1.1330(c) would require a first receiver of a food 
on the Food Traceability List to which the originator of the food has 
not assigned a traceability lot code to establish a traceability lot 
code for the food and maintain a record of the traceability lot code 
linked to the information specified in proposed Sec.  1.1330(a) or (b) 
(as applicable to the type of food received). Although originators of 
food would be required to establish and assign a traceability lot code 
to the food under proposed Sec.  1.1320(a), not all originators would 
be subject to the rule. For example, certain small farms, small shell 
egg producers, and other small originators of food would be exempt from 
subpart S under proposed Sec.  1.1305(a). Because we believe it is 
critical that a traceability lot code is assigned to a food as early in 
its supply chain as possible, we propose to require first receivers of 
listed foods to establish a traceability lot code for the food when the 
food's originator has not done so. For example, by establishing a 
traceability lot code for seafood produced from a fishing vessel that 
lacked such a lot code, the first receiver of the seafood would 
facilitate traceback and traceforward operations to remove contaminated 
seafood from the market.
3. Records for Receipt of Foods on the Food Traceability List (Proposed 
Sec.  1.1335)
    Proposed Sec.  1.1335 answers the question, ``What records must I 
keep when I receive a food on the Food Traceability List?'' Consistent 
with the existing subpart J regulations and common industry practice, 
we propose to require persons who receive foods on the Food 
Traceability List to keep certain records documenting this critical 
tracking event for the foods. We propose that, for each food on the 
Food Traceability List that is received, the receiver must establish 
and maintain records containing and linking the traceability lot code 
for the food to the following information:
     The location identifier and location description for the 
immediate previous source (other than a transporter) of the food 
(proposed Sec.  1.1335(a));
     the entry number assigned to the food (if the food was 
imported) (proposed Sec.  1.1335(b));
     the location identifier and location description of where 
the food was received, and date and time the food was received 
(proposed Sec.  1.1335(c));
     the quantity and unit of measure of the food (e.g., 6 
cases, 25 returnable plastic containers, 100 tanks, 200 pounds) 
(proposed Sec.  1.1335(d));
     the traceability product identifier and traceability 
product description for the food (proposed Sec.  1.1335(e));
     the location identifier, location description, and point 
of contact for the traceability lot code generator (proposed Sec.  
1.1335(f));
     the reference record type(s) and reference record 
number(s) (e.g., ``Invoice 750A,'' ``BOL 042520 XYX'') for the 
document(s) containing the information specified in proposed Sec.  
1.1335(a) through (f) (proposed Sec.  1.1335(g)); and
     the name of the transporter who transported the food to 
the receiver (proposed Sec.  1.1335(h)).
    Information linking the lot code for a received food with the 
immediate previous source of the food, the entry number (for an 
imported food), the location and date the food was received, and the 
quantity and unit of measure of the food received (proposed Sec.  
1.1335(a) through (d)) is widely regarded in the food industry as 
essential for effective tracing of food. For imported foods, knowing 
the entry number assigned to a food by U.S. Customs and Border 
Protection (who assigns the first three alphanumeric digits of a food's 
entry number) and the food's filer/broker (who assigns the remaining 
parts of the entry number) can help FDA identify the shipper of an 
imported food, such as the foreign farm that grew imported produce. We 
note that if an imported food is subsequently transformed (as discussed 
in section V.E.4 of this document), the resulting food is not regarded 
as being imported, and the receiver of the food produced through 
transformation would not be required to keep a record of the entry 
number for any imported food that is a component of such food.
    Although subpart J only requires receivers of food who manufacture, 
process, or pack food to record the lot code for the food ``to the 
extent this information exists'' (Sec.  1.337(a)(4)), we believe that 
all persons who receive listed foods should keep a record of the food's 
traceability lot code because lot codes provide important tracing 
information that can link received food not just to manufacturers/
processors and packers but also to others in the supply chain who 
receive the food, including distributors and retail food 
establishments. In addition, although it is not required under Sec.  
1.337(a)(3) (the provision in subpart J that requires receivers of 
foods to keep a record of the date of receipt), we believe that the 
time of receipt (proposed Sec.  1.1335(c)) also is needed to more 
precisely identify foods that might be implicated in a foodborne 
illness outbreak, given that many firms receive multiple shipments of 
different food products each day.
    We propose to require receivers of listed foods to maintain the 
traceability product identifier and traceability product description 
for each listed food they receive (proposed Sec.  1.1335(e)) because 
this would provide descriptive information about the food to which the 
traceability lot code was assigned. For example, the originator 
(grower) of a lot of papayas might describe them as Maradol papayas or 
assign to the lot an identification code that the grower uses for 
papayas of this type. The availability of such product information 
would help prevent confusion during traceback investigations in 
situations in which a subsequent firm in the supply chain uses a 
different product identifier for the food. In addition, having 
information on the location of the person who generated the 
traceability lot code (proposed Sec.  1.1335(f)) would provide another 
way of confirming that a traceability lot code applies to a particular 
food, as well as help the Agency identify the previous point in the 
supply chain that transformed, created, or originated the food (and 
generated the lot code for the food).

[[Page 60010]]

    Information on the reference record (specific type and number) 
associated with receipt of a listed food (proposed Sec.  1.1335(g)) 
would provide important documentation of receipt. As stated in section 
V.C.23, a reference record is a record used to identify an event in a 
food's supply chain; reference records commonly used to document 
receipt of a food include BOLs, invoices, sale receipts, and ASNs. 
Although keeping a reference record for receipt of a food is not 
required under subpart J, many firms do retain reference records, and 
we typically request reference records in our traceback investigations. 
We believe maintaining reference records for receipt of foods provides 
an important ``cross-check'' of relevant traceability lot codes as a 
food moves between supply chain partners.
    Consistent with the subpart J requirements, we propose to require 
persons who receive listed foods to keep a record of the name of the 
transporter who delivered the food (proposed Sec.  1.1335(h)). However, 
we believe it is not necessary for the receiver to retain other 
information on the transporter (e.g., address, telephone number). We 
note that in many cases, the receiver will have this information as a 
result of subpart J requirements (see Sec.  1.337(a)(6)).
    As stated in section V.E.2, in addition to meeting the requirements 
for ``first receivers'' of listed foods stated in proposed Sec.  
1.1330, the first receiver of a listed food would be required to 
establish and maintain records of receipt for the food in accordance 
with proposed Sec.  1.1335.
4. Records of Transformation of Foods on the Food Traceability List 
(Proposed Sec.  1.1340)
    Proposed Sec.  1.1340 answers the question ``What records must I 
keep when I transform a food on the Food Traceability List?'' As 
previously stated, transformation of a food, such as by processing it 
or combining it with other foods to make a new food product, is another 
critical event in product tracing. Foods (and their packaging and 
labeling) can be changed in a variety of ways, such as by cutting, 
cooking, commingling, boiling, mixing, freezing, milling, repacking, 
and repackaging. Documentation of transformation is needed to ensure 
traceability between the food that is changed during transformation and 
the resulting new product.
    Transformation of a food on the Food Traceability List involves 
taking a listed food and changing the food (or its packaging and/or 
labeling) such as by processing it, combining it with other 
ingredients, commingling it, or repackaging it. For example, processing 
whole head lettuce (a listed food) for inclusion in a bagged salad mix 
would involve transformation of the lettuce. We propose to require 
firms that transform listed foods to keep certain records of the 
transformation. However, we propose that this requirement would not 
apply to retail food establishments with respect to the listed foods 
they sell directly to consumers, as discussed in the following 
paragraphs.
    Except as specified in proposed Sec.  1.1340(b), proposed Sec.  
1.1340(a) would require, for each new traceability lot of food produced 
through transformation of foods on the Food Traceability List, that the 
person who transforms the food establish and maintain records 
containing and linking the traceability lot code of the food 
transformed to certain information regarding: (1) The food on the Food 
Traceability List used in transformation and (2) the food produced 
through transformation. For the food(s) on the Food Traceability List 
used in transformation (proposed Sec.  1.1340(a)(1)), the transformer 
of the food must establish and maintain records containing and linking 
the traceability lot code of the food to the following information:
     The traceability lot code(s) for the food (proposed Sec.  
1.1340(a)(1)(i));
     the traceability product identifier and traceability 
product description for the foods to which the traceability lot code 
applies (proposed Sec.  1.1340(a)(1)(ii)); and
     the quantity of each traceability lot of the food(proposed 
Sec.  1.1340(a)(1)(iii)).
    For the food produced through transformation (proposed Sec.  
1.1340(a)(2)), the transformer of the food must establish and maintain 
records containing and linking the traceability lot code of the food to 
the following information:
     The location identifier and location description for where 
the food was transformed (e.g., by a manufacturing/processing step), 
and the date the transformation was completed (proposed Sec.  
1.1340(a)(2)(i));
     the new traceability product identifier and traceability 
product description for the food produced through transformation to 
which the new traceability lot code applies (proposed Sec.  
1.1340(a)(2)(ii)); and
     the quantity and unit of measure of the food produced 
through transformation for each new traceability code (e.g., 6 cases, 
25 returnable plastic containers, 100 tanks, 200 pounds) (proposed 
Sec.  1.1340(a)(2)(iii)).
    In addition to this information on foods used in transformation and 
foods produced through transformation, the transformer of a listed food 
would have to establish and maintain records containing and linking the 
new traceability lot code for the food produced through transformation 
to the reference record type(s) and reference record number(s) (e.g., 
``Production Log 123,'' ``Batch Log 01202021'') for the documents 
containing the information specified in proposed Sec.  1.1340(a)(1) and 
(2) (proposed Sec.  1.1340(a)(3)).
    The traceability lot code, traceability product identifier and 
traceability product description, and the quantity of each traceability 
lot for the food that is to be transformed (proposed Sec.  
1.1340(a)(1)(i) through (iii)) all provide important data linking the 
food produced through transformation to products the transforming firm 
has received from its suppliers. With respect to the food that has 
undergone transformation, the transformer of the food would have to 
keep information on the location and date the transformation was 
completed, the new traceability product identifier and traceability 
product description, and the quantity and unit of measure of the food 
produced through transformation (proposed Sec.  1.1340(a)(2)(i) through 
(iii)). Finally, the transformer of a listed food would keep the 
reference record type (such as a production log) and reference record 
number that links the food produced through transformation with the 
listed food that was received and transformed (proposed Sec.  
1.1340(a)(3)). These proposed recordkeeping requirements for the 
transformation of listed foods would help ensure that vital tracing 
information linking a food produced through transformation to the 
incoming food that was subjected to transformation is available for 
review in a traceback investigation.
    Most firms can provide information about what lots of product were 
available for potential use during the transformation or manufacturing 
process. However, some firms currently lack the ability to connect the 
finished transformed product to its ingredients and the amount of each 
ingredient lot used during the transformation. Depending on the 
quantity of food in an ingredient lot, one lot could be used for 
multiple days of production and commingled with other lots of the same 
ingredient. An inability to precisely identify ingredient lots used in 
transformation could adversely affect a traceback or recall by limiting 
our ability to accurately identify the products within the scope of 
such action. We believe that compliance with the proposed recordkeeping 
requirements for transformation of foods

[[Page 60011]]

will substantially improve traceability for these foods.
    As previously stated, we propose to exempt retail food 
establishments (under certain circumstances) from this proposed 
requirement to keep records of transformation of listed foods. Proposed 
Sec.  1.1340(b) would provide that proposed Sec.  1.1340(a) would not 
apply to retail food establishments with respect to foods they do not 
ship (e.g., foods they sell or send directly to consumers). As 
previously stated, we do not believe it is reasonable to expect 
restaurants, grocery stores, and other retail food establishments to 
keep traceability records of their sales of food to consumers. We 
believe that a similar exemption from recordkeeping requirements should 
apply when retail food establishments transform food they then sell 
directly to consumers (or that they donate or dispose of, if it is not 
sold). We would still be able to trace the movement of listed foods to 
retail food establishments from farms, manufacturers, distributors, and 
others because retail food establishments will be required, under 
proposed Sec.  1.1335, to keep records on listed foods they receive.
    However, this proposed exemption for retail food establishments 
would not apply when an establishment transforms a listed food it then 
ships to a distributor or another retail food establishment instead of 
selling the food directly to consumers. Because a retail food 
establishment that transforms a food and ships it to another business 
(rather than to consumers) would be functioning as a manufacturer, it 
is necessary and appropriate for effective traceability that such a 
retail food establishment be required to keep tracing records of the 
transformation in accordance with proposed Sec.  1.1340(a).
5. Records of Creation of Foods on the Food Traceability List (Proposed 
Sec.  1.1345)
    Proposed Sec.  1.1345 answers the question, ``What records must I 
keep when I create a food on the Food Traceability List?'' Creating a 
food on the Food Traceability List is a critical tracking event. 
Creation of a food on the Food Traceability List involves making or 
producing a listed food (such as through manufacturing or processing) 
using only ingredients that are not on the Food Traceability List. For 
example, manufacturing peanut butter, which is on the Food Traceability 
List, would constitute creating a listed food because none of the 
ingredients of peanut butter are listed foods. Because listed foods are 
not used in the creation (as opposed to transformation) of a listed 
food, and we therefore cannot expect that firms will necessarily have 
relevant records for any of the ingredients in a created food, it is 
appropriate to apply different recordkeeping requirements to 
transformation and creation events.
    We propose to require firms that create listed foods to keep 
tracing records of the creation, with a partial exemption for retail 
food establishments as proposed for transformation of listed foods. 
Therefore, except as specified in proposed Sec.  1.1345(b), proposed 
Sec.  1.1345(a) would require a person who creates a food on the Food 
Traceability List to establish and maintain records containing and 
linking the traceability lot code of the food created to the following 
information:
     The location identifier and location description for where 
the food was created (e.g., by a manufacturing/processing step), and 
the date creation was completed (proposed Sec.  1.1345(a)(1));
     the traceability product identifier and traceability 
product description for the food (proposed Sec.  1.1345(a)(2));
     the quantity and unit of measure of the food (e.g., 6 
cases, 25 returnable plastic containers, 100 tanks, 200 pounds) 
(proposed Sec.  1.1345(a)(3)); and
     the reference record type(s) and reference record 
number(s) (e.g., ``Production Lot 123,'' ``Batch Log 01202021'') for 
the document(s) containing the information specified in proposed Sec.  
1.1345(a)(1) through (3) (proposed Sec.  1.1345(a)(4)).
    Because creation of a food on the Food Traceability List does not 
involve the use of any listed foods as ingredients, the creator of a 
listed food would not be required to maintain tracing records on the 
ingredients used to create the listed food. Instead, the creator of the 
food would only have to keep records providing information on the 
created food, including the location and date of creation, the 
traceability lot code, the traceability product identifier and product 
description, the quantity and unit of measure for each traceability lot 
code, and the reference record type and number for the created food. 
Although such records would not by themselves provide full traceability 
(because the product is made from foods not on the list), they would 
provide the principal information needed to trace the created food 
through the rest of the supply chain.
    For the reasons discussed in section V.F.4, proposed Sec.  
1.1345(b) would provide that the requirement to establish and maintain 
records on the creation of listed foods would not apply to retail food 
establishments with respect to foods they do not ship (e.g., foods they 
sell or send directly to consumers).
6. Records To Be Kept and Sent for Shipment of Foods on the Food 
Traceability List (Proposed Sec.  1.1350)
    Proposed Sec.  1.1350 answers the question, ``What records must I 
keep and send when I ship a food on the Food Traceability List?'' 
Shipment or release of foods from one person in the supply chain to 
another is widely recognized as a critical tracking event. As with 
records of receipt of foods, maintaining tracing records of shipment of 
foods to others in the supply chain is common industry practice and 
required under the subpart J regulations. Therefore, we propose to 
require persons who ship foods on the Food Traceability List to keep 
certain records documenting these shipments. In addition, to help 
ensure that those who receive listed foods obtain the information they 
would be required to keep under the proposed rule, we propose to 
require persons who ship listed foods to provide their customers with 
certain information related to the foods they ship, as this information 
might not always be provided under current commercial practices.
a. Records of Shipment (Proposed Sec.  1.1350(a)).
    Proposed Sec.  1.1350(a) would require persons who ship a food on 
the Food Traceability List to establish and maintain records containing 
and linking the traceability lot code for the food to the following 
information:
     The entry number(s) assigned to the food (if the food is 
imported) (proposed Sec.  1.1350(a)(1));
     the quantity and unit of measure of the food (e.g., 6 
cases, 25 returnable plastic containers, 100 tanks, 200 pounds) 
(proposed Sec.  1.1350(a)(2));
     the traceability product identifier and traceability 
product description for the food (proposed Sec.  1.1350(a)(3));
     the location identifier, location description, and point 
of contact for the traceability lot code generator (proposed Sec.  
1.1350(a)(4));
     the location identifier and location description for the 
immediate subsequent recipient (other than a transporter) of the food 
(proposed Sec.  1.1350(a)(5));
     the location identifier and location description for the 
location from which the food was shipped, and the date and time the 
food was shipped (proposed Sec.  1.1350(a)(6));
     the reference record type(s) and reference record 
number(s) (e.g., ``BOL No. 123,'' ``ASN 10212025'') for the document(s) 
containing the information

[[Page 60012]]

specified in proposed Sec.  1.1350(a)(1) through (6) (proposed Sec.  
1.1350(a)(7)); and
     the name of the transporter who transported the food from 
the shipper (proposed Sec.  1.1350(a)(8)).
    The records we propose to require shippers of listed foods to keep 
are similar to the records that receivers of food would have to keep, 
except that rather than information on an incoming food, its source, 
and the place and date it was received, the shipper would keep 
information on the food it sent out, the recipient of the food, and the 
date of shipment and location from which the food was shipped. As with 
the requirements for receivers of food, if an imported food is 
subsequently transformed, a shipper of the food produced through 
transformation would not be required to keep (or send forward) a record 
of the entry number for any imported food that is a component of such 
food.
    As described in proposed Sec.  1.1320, there are circumstances in 
which the shipper would be required to establish and assign the 
traceability lot code for the shipped food. In all other circumstances, 
the traceability lot code would be the code assigned by a previous 
entity in the food's supply chain, which could be the immediate 
previous source of the food or a person several steps previous in the 
supply chain.
b. Records To Be Sent to Recipients of the Food (Proposed Sec.  
1.1350(b))
    In many cases, persons who would be required under the proposed 
rule to keep certain records containing key information on events such 
as receipt and transformation of food either receive or generate this 
information in the normal course of business, such as in shipping 
records (e.g., bills of lading, purchase orders) and production records 
(e.g., batch logs, work orders, repack logs). However, as previously 
stated, in some circumstances firms such as manufacturers, 
distributors, and retailers may not always have all the information on 
foods they receive that we believe is essential for ensuring 
traceability of the foods throughout the supply chain. For example, 
some reference records will state a firm's post office box number but 
not identify the location where the food was handled. During a recent 
outbreak, FDA was delayed in gathering records from a distributor 
because the records available to us from the retailer of the food 
listed a home address of the distributor rather than the address of the 
physical location of the firm. This lack of critical tracing 
information can result in significant delays in completing a traceback 
investigation.
    For this reason, proposed Sec.  1.1350(b) would require persons who 
ship a food on the Food Traceability List to send records (in 
electronic or other written form) containing the following information 
to the immediate subsequent recipient (other than a transporter) of 
each traceability lot shipped:
     The information in proposed Sec.  1.1350(a)(1) through (6) 
(i.e., traceability lot code, quantity and unit measure of food shipped 
for each traceability lot code, traceability product identifier and 
traceability product description, information on the traceability lot 
code generator, location identifier and location description for the 
immediate subsequent recipient, and location identifier and location 
description for the place of shipment) (proposed Sec.  1.1350(b)(1)); 
and
     if the shipper is a farm, the following information (if 
applicable) for each traceability lot of the food:
    [cir] A statement that the shipper is a farm (proposed Sec.  
1.1350(b)(2)(i));
    [cir] the location identifier and location description of the 
originator of the food (if not the shipper) (proposed Sec.  
1.1350(b)(2)(ii));
    [cir] the business name, point of contact, and phone number of the 
harvester of the food (if not the shipper), and the date(s) and time(s) 
of harvesting (proposed Sec.  1.1350(b)(2)(iii));
    [cir] the location identifier and location description of the place 
where the food was cooled (if not by the shipper), and the date and 
time of cooling (proposed Sec.  1.1350(b)(2)(iv)); and
    [cir] the location identifier and location description of the place 
where the food was packed (if not by the shipper), and the date and 
time of packing (proposed Sec.  1.1350(b)(2)(v)).
    Shippers of listed foods would have to send the information in 
proposed Sec.  1.1350(b) to the recipients of the food in electronic or 
other written form. We would encourage firms to send the information 
electronically, such as in an email to their customer or an ASN, but 
shippers could elect to send the information in other written form, 
such as by mailing paper documents or including the information on the 
documents that accompany the shipment, such as the BOL.
    We believe it is necessary to require shippers of listed foods to 
send their customers the information in proposed Sec.  1.1350(a)(1) 
through (6) (i.e., traceability lot code, quantity of food shipped and 
unit measure of food shipped for each traceability lot code, 
traceability product identifier and product description, information on 
the traceability lot code generator, location identifier and location 
description for the immediate subsequent recipient, and location 
identifier and location description for the place of shipment) because, 
as previously noted, this information is not always provided by firms 
to their customers under current businesses practices. Because we need 
to be able to review this information when we visit such a customer 
during a tracing investigation involving a listed food, we propose to 
require that shippers provide this information to their customers.
    We are proposing the additional information disclosure requirements 
for shippers who are farms because we propose to require that the first 
receiver of a food on the Food Traceability List (i.e., the first 
person other than a farm who purchases and takes physical possession of 
the food) maintain this information, and we understand that not all 
farms routinely provide this information to firms that buy food from 
the farms. Therefore, we believe it is appropriate to require farms to 
provide information on the origination (if not by the farm), 
harvesting, cooling, and packing of the food (if applicable) when they 
ship the food.
    In situations where food is sold from one farm to a second farm 
before being sold to a first receiver, this system would allow for all 
of the necessary information to reach the first receiver, even if some 
of the activities (e.g., origination and harvesting) took place on the 
first farm, while others (e.g., cooling and packing) took place on the 
second farm. In that situation, the first farm would be obligated under 
proposed Sec.  1.1350(b)(1) to send information about their location to 
the second farm, and they would be obligated under proposed Sec.  
1.1350(b)(3)(iii) to send the second farm information about the date 
and time of harvesting. This would allow the second farm to fulfill its 
obligation under proposed Sec.  1.1350(b)(2)(ii) and (iii) to send the 
first receiver information about the originator of the food and the 
date and time of harvesting. Moreover, the statement that the sender is 
a farm would allow the first receiver to recognize its status as a 
first receiver of a listed food, which might not otherwise be clear in 
this situation, where the second farm did not originate the food but 
nonetheless is a farm as defined in proposed Sec.  1.1310.

[[Page 60013]]

F. Special Requirements for Foods Subjected to a Kill Step (Proposed 
Sec.  1.1355)

    We are proposing to adopt special recordkeeping requirements for 
foods on the Food Traceability List that are subjected to a kill step 
to more appropriately address traceability issues associated with these 
foods. Proposed Sec.  1.1355 answers the question, ``What recordkeeping 
requirements apply to foods on the Food Traceability List that are 
subjected to a kill step?'' We recognize that applying a kill step to a 
food can reduce the food's potential to harm public health by 
significantly minimizing the presence of pathogens in the food. 
Adequately applying a kill step to a food on the Food Traceability List 
could potentially reduce the risk posed by the food and reduce the 
likelihood that the food would be involved in an outbreak, thereby 
reducing the need for further tracing of that food. Therefore, proposed 
Sec.  1.1355(a) would provide that if a person applies a kill step to a 
food on the Food Traceability List, the proposed subpart S 
recordkeeping requirements would not apply to that person's subsequent 
shipping of the food, provided that the person maintained a record of 
application of the kill step. We anticipate that many manufacturers/
processors would be able to use records required under existing 
regulations, such as those requiring documentation of monitoring of a 
preventive control (see Sec.  117.190(a)(2)) or documentation of 
thermal processing of low-acid canned foods (LACF) (see 21 CFR 113.100 
(Sec.  113.100)), to meet the requirement to document application of 
the kill step to the food. In addition, proposed Sec.  1.1355(b) would 
specify that if a person receives a food on the Food Traceability List 
that has been subjected to a kill step, the proposed recordkeeping 
requirements would not apply to that person's receipt or subsequent 
transformation and/or shipping of the food.
    As an example of application of these proposed provisions, consider 
the production of canned sardines. A manufacturer of canned sardines 
would be required to maintain records of receipt of the sardines under 
proposed Sec.  1.1335 (assuming sardines are on the Food Traceability 
List at the time, as they are now), and the manufacturer would have to 
maintain records of transformation of the sardines under proposed Sec.  
1.1340(a) because it processes the sardines (including by canning 
them). These records would include the new traceability lot code that 
the manufacturer would be required to assign to the canned sardines 
under proposed Sec.  1.1320(a) (see proposed Sec.  1.1340(a)(6)). 
However, under proposed Sec.  1.1355(a), the manufacturer would not be 
required to maintain tracing records of shipment of the canned sardines 
(as otherwise would be required under proposed Sec.  1.1350) provided 
that the manufacturer maintained a record of its application of the 
kill step to the sardines. The requirement to maintain records 
documenting the kill step could be fulfilled using records that are 
already required under the regulations on LACF (part 113) and hazard 
analysis and critical control point operations for seafood (21 CFR part 
123). Documentation of the kill step would have to be maintained for 2 
years, in accordance with proposed Sec.  1.1460(c). In addition, under 
proposed Sec.  1.1355(b), because the kill step had been applied, the 
manufacturer's customer and subsequent persons in the supply chain 
would not be required to maintain any records required under proposed 
subpart S regarding receipt, transformation, or shipment of the canned 
sardines. However, both the manufacturer and subsequent persons in the 
supply chain would still need to maintain any records that are required 
of them under the subpart J regulations.

G. Procedures for Modified Requirements and Exemptions (Proposed 
Sec. Sec.  1.1360 to 1.1400)

    The proposed rule includes provisions allowing the Agency to modify 
the recordkeeping requirements applicable to certain foods or types of 
entities, or to exempt foods or types of entities from the 
requirements, under certain circumstances. Section 204(d)(6)(E) of FSMA 
states that FDA may, by notice in the Federal Register, modify the 
recordkeeping requirements applicable to a food or type of facility 
under section 204(d), or exempt a food or type of facility from these 
requirements, if we determine that product tracing requirements for 
such food or type of facility are not necessary to protect the public 
health. However, section 204(d)(6)(E) and (F) of FSMA also provide 
that, in situations where such modification or exemption applies, if 
the person who manufactures, processes, packs, or holds the food is 
required to register with FDA under section 415 of the FD&C Act with 
respect to the manufacturing, processing, packing, or holding of the 
food, we shall require the person to maintain records that identify the 
immediate previous source of the food and the immediate subsequent 
recipient of the food.
    The following paragraphs discuss our proposed procedures for 
adopting exemptions from, and modifications to, the proposed 
traceability recordkeeping requirements for particular foods or types 
of entities.
1. Circumstances Under Which FDA Will Modify Requirements or Grant 
Exemptions (Proposed Sec.  1.1360)
    Proposed Sec.  1.1360 answers the question, ``Under what 
circumstances will FDA modify the requirements in this subpart that 
apply to a food or type of entity or exempt a food or type of entity 
from the requirements of this subpart?'' Proposed Sec.  1.1360(a) would 
specify that, except as stated in proposed Sec.  1.1360(b), FDA will 
modify the requirements of subpart S applicable to a food or type of 
entity, or exempt a food or type of entity from subpart S, when we 
determine that application of the requirements that would otherwise 
apply to the food or type of entity is not necessary to protect the 
public health.
    Under proposed Sec.  1.1360(b), if a person to whom modified 
requirements or an exemption applies under Sec.  1.1360(a) (including a 
person who manufactures, processes, packs, or holds a food to which 
modified requirements or an exemption applies under Sec.  1.1360(a)) is 
required to register with FDA under section 415 of the FD&C Act (and in 
accordance with subpart H) with respect to the manufacturing, 
processing, packing, or holding of the applicable food, such person 
must maintain records identifying the immediate previous source of such 
food and the immediate subsequent recipient of such food in accordance 
with Sec. Sec.  1.337 and 1.345. Proposed Sec.  1.1360(b) further 
states that such records would have to be maintained for 2 years, 
consistent with the record retention requirement we are proposing for 
subpart S records (see section V.H.3).
2. Means by Which FDA Will Consider Whether To Adopt Modified 
Requirements or Grant Exemptions (Proposed Sec.  1.1365)
    Proposed Sec.  1.1365 answers the question, ``How will FDA consider 
whether to adopt modified requirements or grant an exemption from the 
requirements of this subpart?'' Proposed Sec.  1.1365 would provide 
that we will consider modifying subpart S requirements applicable to a 
food or type of entity, or exempting a food or type of entity from 
these requirements, on our own initiative or in response to a citizen 
petition submitted under 21 CFR 10.30 (Sec.  10.30) by any interested 
party. FDA's citizen petition regulations in Sec.  10.30 provide 
standardized

[[Page 60014]]

procedures for requesting that FDA take (or refrain from taking) an 
administrative action. A citizen petition may be submitted by any 
person (including a person who is not a citizen of the United States). 
Among other things, the citizen petition regulations provide a format 
for such requests and a procedure under which a docket is created and 
interested persons may submit comments to the docket regarding the 
requested action.
3. Requirements for Citizen Petition Requesting Modified Requirements 
or an Exemption (Proposed Sec.  1.1370)
    Proposed Sec.  1.1370 answers the question, ``What must be included 
in a petition requesting modified requirements or an exemption from the 
requirements?'' Proposed Sec.  1.1370 would require that, in addition 
to meeting the requirements on the content and format of a citizen 
petition in Sec.  10.30, a petition requesting modified requirements or 
an exemption from the subpart S requirements would have to:
     Specify the food or type of entity to which the modified 
requirements or exemption would apply (proposed Sec.  1.1370(a));
     if the petition requests modified requirements, specify 
the proposed modifications to the subpart S requirements (proposed 
Sec.  1.1370(b)); and
     present information demonstrating why application of the 
requirements requested to be modified or from which exemption is 
requested is not necessary to protect the public health (proposed Sec.  
1.1370(c)).
4. Public Availability of Information in a Citizen Petition (Proposed 
Sec.  1.1375)
    Proposed Sec.  1.1375 answers the question, ``What information 
submitted in a petition requesting modified requirements or an 
exemption, or information in comments on such a petition, is publicly 
available?'' Proposed Sec.  1.1375 would specify that FDA will presume 
that information submitted in a petition requesting modified 
requirements or an exemption, as well as information in comments 
submitted on such a petition, does not contain information exempt from 
public disclosure under 21 CFR part 20 (part 20) (FDA's regulations on 
public information) and would be made public as part of the docket 
associated with the petition.
5. Process for Citizen Petitions Requesting Modified Requirements or an 
Exemption (Proposed Sec.  1.1380)
    Proposed Sec.  1.1380 answers the question, ``What process applies 
to a petition requesting modified requirements or an exemption?'' 
Proposed Sec.  1.1380 would establish a process for FDA's handling of 
citizen petitions requesting modified requirements or an exemption from 
subpart S. Proposed Sec.  1.1380(a) would provide that, in general, the 
procedures in Sec.  10.30 would govern our response to such a petition, 
and an interested person could submit comments on such a petition in 
accordance with Sec.  10.30(d). Proposed Sec.  1.1380(b) would specify 
that, under Sec.  10.30(h)(3), we would publish a notification in the 
Federal Register requesting information and views on a submitted 
petition, including information and views from persons who could be 
affected by the modified requirements or exemption if we granted the 
petition.
    Proposed Sec.  1.1380(c) would provide that, under Sec.  
10.30(e)(3), we would respond to a petitioner in writing. If we granted 
the petition either in whole or in part, we would publish a 
notification in the Federal Register setting forth any modified 
requirements or exemptions and the reasons for them (proposed Sec.  
1.1380(c)(1)). If we denied the petition (including a partial denial), 
our written response to the petitioner would explain the reasons for 
the denial (proposed Sec.  1.1380(c)(2)).
    Proposed Sec.  1.1380(d) states that we will make readily 
accessible to the public, and periodically update, a list of petitions 
requesting modified requirements or exemptions, including the status of 
each petition (for example, pending, granted, or denied). We believe 
that maintaining such a list would help ensure that all persons who 
might be affected by or otherwise interested in these petitions have 
access to information about the status of the petitions.
6. Adopting Modified Requirements or Granting an Exemption on FDA's Own 
Initiative (Proposed Sec.  1.1385)
    Proposed Sec.  1.1385 answers the question, ``What process will FDA 
follow when adopting modified requirements or granting an exemption on 
our own initiative?'' Proposed Sec.  1.1385 would establish the 
procedures we would follow if, on our own initiative, we proposed to 
adopt modified requirements or grant an exemption from the traceability 
recordkeeping requirements. Proposed Sec.  1.1385(a) would provide that 
if we, on our own initiative, determine that adopting modified 
requirements or granting an exemption from the requirements for a food 
or type of entity is appropriate, we will publish a notification in the 
Federal Register setting forth the proposed modified requirements or 
exemption and the reasons for the proposal. The notification will 
establish a public docket so that interested persons may submit written 
comments on the proposal. Proposed Sec.  1.1385(b) would provide that, 
after considering any comments timely submitted, we will publish a 
notification in the Federal Register stating whether we are adopting 
modified requirements or granting an exemption, and the reasons for our 
decision.
7. When Modified Requirements and Exemptions Become Effective (Proposed 
Sec.  1.1390)
    Proposed Sec.  1.1390 answers the question, ``When will modified 
requirements that we adopt or an exemption that we grant become 
effective?'' Proposed Sec.  1.1390 would provide that any modified 
requirements that we adopt or exemption that we grant will become 
effective on the date that notice of the modified requirements or 
exemption is published in the Federal Register, unless otherwise stated 
in the notification.
8. Circumstances Under Which FDA Might Revise or Revoke Modified 
Requirements or an Exemption (Proposed Sec.  1.1395)
    Proposed Sec.  1.1395 answers the question, ``Under what 
circumstances may FDA revise or revoke modified requirements or an 
exemption?'' Proposed Sec.  1.1395 would provide that we may revise or 
revoke modified requirements or an exemption if we determine that such 
revision or revocation is necessary to protect the public health. For 
example, we might conclude that revocation of an exemption was 
appropriate following the emergence of a significant safety concern 
(e.g., repeated contamination events) associated with the food or type 
of entity for which the exemption had been granted.
9. Procedures for Revision or Revocation of Modified Requirements or an 
Exemption (Proposed Sec.  1.1400)
    Proposed Sec.  1.1400 answers the question, ``What procedures apply 
if FDA tentatively determines that modified requirements or an 
exemption should be revised or revoked?'' Proposed Sec.  1.1400(a) 
would provide that if we tentatively determine that we should revise or 
revoke modified requirements or an exemption, we will provide the 
following notifications:
     We will notify the person that originally requested the 
modified requirements or exemption (if we

[[Page 60015]]

adopted modified requirements or granted an exemption in response to a 
petition) in writing at the address identified in the petition 
(proposed Sec.  1.1400(a)(1)); and
     we will publish in the Federal Register a notification of 
our tentative determination that the modified requirements or exemption 
should be revised or revoked and the reasons for our tentative 
decision. The notification will establish a public docket so that 
interested persons may submit written comments on our tentative 
determination (proposed Sec.  1.1400(a)(2)).
    Under proposed Sec.  1.1400(b), after considering any comments 
timely submitted, we will publish in the Federal Register a 
notification of our decision whether to revise or revoke the modified 
requirements or exemption and the reasons for the decision. Proposed 
Sec.  1.1400(b) further states that if we do revise or revoke the 
modified requirements or exemption, the effective date of the decision 
will be 1 year after the date of publication of the notification, 
unless otherwise stated in the notification.

H. Waivers (Proposed Sec. Sec.  1.1405 to 1.1450)

    In accordance with section 204(d)(1)(I) of FSMA, we propose to 
establish a process for the issuance of a waiver of the additional 
traceability recordkeeping requirements in subpart S if we determine 
that application of the requirements would result in an economic 
hardship for an individual entity or a type of entity. Under the 
proposed procedures, a person could request a waiver for an individual 
entity by submitting a written request to FDA, or a person could 
request a waiver for a type of entity by submitting a citizen petition 
to FDA. In addition, we could elect to issue a waiver for an individual 
entity or a type of entity on our own initiative.
1. Circumstances Under Which FDA Will Waive Requirements (Proposed 
Sec.  1.1405)
    Proposed Sec.  1.1405 answers the question, ``Under what 
circumstances will FDA waive one or more of the requirements of this 
subpart for an individual entity or a type of entity?'' Proposed Sec.  
1.1405 would provide that we will waive one or more of the subpart S 
requirements when we determine that all of the following conditions are 
met:
     Application of the requirements would result in an 
economic hardship for an individual entity or a type of entity, due to 
the unique circumstances of the individual entity or type of entity 
(proposed Sec.  1.1405(a));
     the waiver will not significantly impair our ability to 
rapidly and effectively identify recipients of a food to prevent or 
mitigate a foodborne illness outbreak or to address credible threats of 
serious adverse health consequences or death to humans or animals as a 
result of such food being adulterated under section 402 of the FD&C Act 
or misbranded under section 403(w) of the FD&C Act (proposed Sec.  
1.1405(b)); and
     the waiver will not otherwise be contrary to the public 
interest (proposed Sec.  1.1405(c)).
    Proposed Sec.  1.1405(a) incorporates the concept of ``economic 
hardship'' that Congress set forth in section 204(d)(1)(I) of FSMA, 
while clarifying that such hardship must stem from the unique 
circumstances of the individual entity or type of entity. Examples of 
``unique circumstances'' might include, but are not limited to, issues 
related to unique business operations or geographical factors. We note 
that merely having relatively low revenue or relatively few employees 
would not ordinarily constitute an economic hardship sufficient to 
qualify for a waiver from the subpart S requirements. As previously 
discussed, the proposed rule includes exemptions from the subpart S 
requirements for certain small produce farms, small shell egg 
producers, and other small originators of food (see section V.B.1), and 
it would either fully exempt retail food establishments having ten or 
fewer full-time equivalent employees from the rule (under Option 1 of 
the co-proposal) or exempt such establishments from the proposed 
requirement to provide traceability information to FDA in an electronic 
spreadsheet upon request during situations such as outbreak 
investigations (under Option 2 of the co-proposal) (see section V.B.7). 
The waiver process in proposed Sec.  1.1405 is not meant to substitute 
for the decisions discussed in sections V.B.1 and V.B.7 regarding these 
proposed exemptions.
    Under proposed Sec.  1.1405(b) we would grant a waiver only if 
doing so would not significantly impair our ability to rapidly and 
effectively identify recipients of a food to prevent or mitigate a 
foodborne illness outbreak or to address credible threats of serious 
adverse health consequences or death to humans or animals as a result 
of such food being adulterated under section 402 of the FD&C Act or 
misbranded under section 403(w) of the FD&C Act. In section 204(d)(1) 
of FSMA, Congress specified rapidly and effectively identifying 
recipients of a food in such circumstances as the purpose for 
developing these proposed regulations. Therefore, we propose to adopt, 
as a condition for granting a waiver, a determination that the waiver 
would not undermine this central purpose of subpart S. For example, we 
likely would not grant a waiver to a certain type of entity that 
processes, distributes, or sells a food on the Food Traceability List 
if granting the waiver could significantly impair our ability to 
conduct traceback operations in response to a foodborne illness 
outbreak involving that food.
    Proposed Sec.  1.1405(c) states, as a final condition for a waiver, 
that the waiver will not otherwise be contrary to the public interest. 
For example, we might conclude that a waiver for an individual entity 
would not be appropriate because it might provide an unfair economic 
advantage over similarly situated firms in a particular sector of the 
food industry.
    We request comment on the proposed criteria for granting a waiver 
of the proposed recordkeeping requirements and, in particular, what 
should constitute an economic hardship warranting such a waiver.
2. Mechanisms by Which FDA Will Waive Requirements (Proposed Sec.  
1.1410)
    Proposed Sec.  1.1410 answers the question, ``How will FDA consider 
whether to waive a requirement of this subpart?'' Proposed Sec.  1.1410 
would provide that we will consider whether to waive a requirement of 
subpart S on our own initiative or in response to the following:
     A written request for a waiver for an individual entity 
(proposed Sec.  1.1410(a)); or
     a citizen petition requesting a waiver for a type of 
entity submitted under Sec.  10.30 by any person subject to the 
requirements of subpart S (proposed Sec.  1.1410(b)).
    For a waiver request regarding an individual entity, we think that 
a written request to the Agency is sufficient, and the citizen petition 
process is unnecessary. But for requests that concern a type of entity, 
we believe that the fact that the waiver could apply to multiple 
parties, including persons unaware that the waiver request had been 
submitted, makes it appropriate to require that the request be 
submitted in a citizen petition.
3. Requesting a Waiver for an Individual Entity (Proposed Sec.  1.1415)
    Proposed Sec.  1.1415 answers the question, ``How may I request a 
waiver for an individual entity?'' Proposed Sec.  1.1415 would provide 
that a person

[[Page 60016]]

may request a waiver of one or more requirements of subpart S for an 
individual entity by submitting a written request to FDA that includes 
the following:
     The name, address, and point of contact of the individual 
entity to which the waiver would apply (proposed Sec.  1.1415(a));
     the requirements of subpart S to which the waiver would 
apply (proposed Sec.  1.1415(b));
     information demonstrating why application of the 
requirements requested to be waived would result in an economic 
hardship for the entity, including information about the unique 
circumstances faced by the entity that result in unusual economic 
hardship from the application of these requirements (proposed Sec.  
1.1415(c));
     information demonstrating why the waiver will not 
significantly impair FDA's ability to rapidly and effectively identify 
recipients of a food to prevent or mitigate a foodborne illness 
outbreak or to address credible threats of serious adverse health 
consequences or death to humans or animals as a result of such food 
being adulterated under section 402 of the FD&C Act or misbranded under 
section 403(w) of the FD&C Act (proposed Sec.  1.1415(d)); and
     information demonstrating why the waiver would not 
otherwise be contrary to the public interest (proposed Sec.  
1.1415(e)).
    We anticipate that after we publish the final rule on additional 
traceability requirements, we will establish an electronic mailbox to 
receive requests for waivers for individual entities. We also expect 
that we will publish on our website information about how to submit 
materials to this electronic mailbox, as well as specifying a physical 
FDA address to which waiver requests could be mailed.
4. Process for Request for Waiver for Individual Entity (Proposed Sec.  
1.1420)
    Proposed Sec.  1.1420 answers the question, ``What process applies 
to a request for a waiver for an individual entity?'' Proposed Sec.  
1.1420(a) would provide that, after considering the information 
submitted in a request for a waiver for an individual entity, we will 
respond in writing to the person that submitted the waiver request 
stating whether we are granting the waiver (in whole or in part) and 
the reasons for the decision. Proposed Sec.  1.1420(b) would specify 
that any waiver for an individual entity that we grant will become 
effective on the date we issue our response to the waiver request, 
unless otherwise stated in the response.
5. Citizen Petition for Waiver for Type of Entity (Proposed Sec.  
1.1425)
    Proposed Sec.  1.1425 answers the question, ``What must be included 
in a petition requesting a waiver for a type of entity?'' Proposed 
Sec.  1.1425 would provide that, in addition to meeting the 
requirements on the content and format of a citizen petition in Sec.  
10.30, a petition requesting a waiver for a type of entity must:
     Specify the type of entity to which the waiver would apply 
and the requirements of subpart S to which the waiver would apply 
(proposed Sec.  1.1425(a));
     present information demonstrating why application of the 
requirements requested to be waived would result in an economic 
hardship for the type of entity, including information about the unique 
circumstances faced by the type of entity that result in unusual 
economic hardship from the application of these requirements (proposed 
Sec.  1.1425(b));
     present information demonstrating why the waiver will not 
significantly impair FDA's ability to rapidly and effectively identify 
recipients of a food to prevent or mitigate a foodborne illness 
outbreak or to address credible threats of serious adverse health 
consequences or death to humans or animals as a result of such food 
being adulterated under section 402 of the FD&C Act or misbranded under 
section 403(w) of the FD&C Act (proposed Sec.  1.1425(c)); and
     present information demonstrating why the waiver would not 
otherwise be contrary to the public interest (proposed Sec.  
1.1425(d)).
6. Public Availability of Information in Citizen Petition Requesting a 
Waiver (Proposed Sec.  1.1430)
    Proposed Sec.  1.1430 answers the question, ``What information 
submitted in a petition requesting a waiver for a type of entity, or 
information in comments on such a petition, is publicly available?'' 
Proposed Sec.  1.1430 would specify that we will presume that 
information submitted in a petition requesting a waiver for a type of 
entity, as well as information in comments submitted on such a 
petition, does not contain information exempt from public disclosure 
under part 20 and would be made public as part of the docket associated 
with the petition.
7. Process for Citizen Petition Requesting a Waiver (Proposed Sec.  
1.1435)
    Proposed Sec.  1.1435 answers the question, ``What process applies 
to a petition requesting a waiver for a type of entity?'' Proposed 
Sec.  1.1435(a) would specify that, in general, the procedures in Sec.  
10.30 govern FDA's response to a petition requesting a waiver, and that 
an interested person may submit comments on a petition requesting a 
waiver in accordance with Sec.  10.30(d). Proposed Sec.  1.1435(b) 
would provide that, under Sec.  10.30(h)(3), we will publish a 
notification in the Federal Register requesting information and views 
on a submitted petition requesting a waiver for a type of entity, 
including information and views from persons who could be affected by 
the waiver if we granted the petition.
    Under proposed Sec.  1.1435(c), we would respond to a petitioner in 
writing under Sec.  10.30(e)(3), as follows:
     If we grant a petition either in whole or in part, we will 
publish a notification in the Federal Register setting forth any 
requirements we have waived and the reasons for the waiver (proposed 
Sec.  1.1435(c)(1)); and
     if we deny the petition (including a partial denial), our 
written response to the petitioner will explain the reasons for the 
denial (proposed Sec.  1.1435(c)(2)).
    Proposed Sec.  1.1435(d) would provide that we will make readily 
accessible to the public, and periodically update, a list of petitions 
requesting waivers for types of entities, including the status of each 
petition (for example, pending, granted, or denied). As with citizen 
petitions requesting modified requirements or an exemption from subpart 
S, we believe that maintaining a list of these waiver petitions would 
help ensure that all persons who might be affected by or are otherwise 
interested in these petitions can obtain information about them.
8. Process for Granting Waivers on FDA's Own Initiative (Proposed Sec.  
1.1440)
    Proposed Sec.  1.1440 answers the question, ``What process will FDA 
follow when waiving a requirement of this subpart on our own 
initiative?'' Proposed Sec.  1.1440(a) would provide that if FDA, on 
its own initiative, determines that a waiver of one or more 
requirements for an individual entity or type of entity is appropriate, 
we will publish a notification in the Federal Register setting forth 
the proposed waiver and the reasons for such waiver. The notification 
will establish a public docket so that interested persons may submit 
written comments on the proposal. Proposed Sec.  1.1440(b) would 
provide that after considering any comments timely submitted, we will 
publish a notification in the Federal Register stating whether we are 
granting the waiver (in whole or in part) and the

[[Page 60017]]

reasons for our decision. Under proposed Sec.  1.1440(c), any waiver 
for a type of entity that we grant will become effective on the date 
that notice of the waiver is published in the Federal Register, unless 
otherwise stated in the notification.
9. Circumstances Under Which FDA May Modify or Revoke a Waiver 
(Proposed Sec.  1.1445)
    Proposed Sec.  1.1445 answers the question, ``Under what 
circumstances may FDA modify or revoke a waiver?'' Proposed Sec.  
1.1445 would provide that we may modify or revoke a waiver if we 
determine that:
     Compliance with the waived requirements would no longer 
impose a unique economic hardship on the individual entity or type of 
entity to which the waiver applies (proposed Sec.  1.1445(a));
     the waiver could significantly impair our ability to 
rapidly and effectively identify recipients of a food to prevent or 
mitigate a foodborne illness outbreak or to address credible threats of 
serious adverse health consequences or death to humans or animals as a 
result of such food being adulterated under section 402 of the FD&C Act 
or misbranded under section 403(w) of the FD&C Act (proposed Sec.  
1.1445(b)); or
     the waiver is otherwise contrary to the public interest 
(proposed Sec.  1.1445(c)).
    One way in which we might become aware that the circumstances under 
which we had granted a waiver to a firm had changed might be through a 
routine inspection of the firm or an inspection in the course of an 
investigation into a foodborne illness outbreak. In addition, we would 
encourage firms to which we had granted a waiver to notify us if their 
economic/financial circumstances had changed such that compliance with 
subpart S would no longer result in an economic hardship for them.
10. Procedures for Modification or Revocation of a Waiver (Proposed 
Sec.  1.1450)
    Proposed Sec.  1.1450 answers the question, ``What procedures apply 
if FDA tentatively determines that a waiver should be modified or 
revoked?'' As with respect to requests for waivers, we propose to 
establish different procedures for modifications and revocations of 
waivers for (1) individual entities and (2) types of entities. Proposed 
Sec.  1.1450(a)(1) would provide that if we tentatively determine that 
we should modify or revoke a waiver for an individual entity, we will 
notify the person that had received the waiver in writing of our 
tentative determination that the waiver should be modified or revoked. 
The notice will provide the waiver recipient 60 days in which to submit 
information stating why the waiver should not be modified or revoked. 
Proposed Sec.  1.1450(a)(2) would provide that upon consideration of 
any information submitted by the waiver recipient, we will respond in 
writing stating our decision whether to modify or revoke the waiver and 
the reasons for the decision. The provision further states that if we 
modify or revoke the waiver, the effective date of the decision will be 
1 year after the date of our response to the waiver recipient, unless 
otherwise stated in the response.
    Proposed Sec.  1.1450(b)(1)(i) would provide that if we tentatively 
determine that we should modify or revoke a waiver for a type of 
entity, we will notify the person that originally requested the waiver 
(if we granted the waiver in response to a petition) in writing at the 
address identified in the petition. Proposed Sec.  1.1450(b)(1)(ii) 
would specify that we will also publish a notification in the Federal 
Register of our tentative determination that the waiver should be 
modified or revoked and the reasons for our tentative decision. The 
proposed provision further states that the notification will establish 
a public docket so that interested persons may submit written comments 
on our tentative determination.
    Proposed Sec.  1.1450(b)(2) would provide that, after considering 
any comments timely submitted, we will publish a notification in the 
Federal Register of our decision whether to modify or revoke the waiver 
and the reasons for the decision. Proposed Sec.  1.1450(b)(2) further 
states that if we modify or revoke the waiver, the effective date of 
the decision will be 1 year after the date of publication of the 
notification, unless otherwise stated in that notification.

I. Records Maintenance and Availability (Proposed Sec.  1.1455)

    Proposed Sec.  1.1455 answers the question, ``How must records 
required by this subpart be maintained?'' We propose to adopt several 
requirements concerning the maintenance of records required by subpart 
S and FDA access to these records.
1. General Requirements (Proposed Sec.  1.1455(a))
    Proposed Sec.  1.1455(a)(1) would require that records be kept as 
original paper or electronic records or true copies (such as 
photocopies, pictures, scanned copies, or other accurate reproductions 
of the original records). Proposed Sec.  1.1455(a)(2) would require 
that all records be legible and stored to prevent deterioration or 
loss.
    As discussed in section IV.D, we understand that many firms in the 
food industry, including farms, manufacturers, distributors, and retail 
food establishments, have begun maintaining and sharing product 
information in electronic records, which can have substantial benefits 
for tracing foods throughout the supply chain. The use of paper 
records, on the other hand, can delay traceback activities as FDA 
investigators must request the records, wait for the firm to gather 
them, and then sort through the records by hand. In addition, 
individual paper records may not contain all the necessary information, 
and investigators may need to request additional information to 
determine how the records can be linked together for tracing purposes. 
When paper records are handwritten, there can be additional delays if 
the handwriting is not legible. In contrast, when firms provide data 
electronically in a sortable format, investigators can trace food 
through the supply chain more quickly. As previously stated, we 
strongly encourage all entities in the food industry to adopt the use 
of electronic data systems for their traceability operations, including 
for maintenance of KDEs, reference records, and traceability program 
records. However, we are aware that not all firms have systems in place 
that would allow for the maintenance of these records in electronic 
form, and it might be burdensome for some firms if we required that all 
subpart S records be kept electronically. Therefore, proposed Sec.  
1.1455(a)(1) would not require the maintenance of records in electronic 
form, although we strongly encourage electronic recordkeeping.
2. Record Availability (Proposed Sec.  1.1455(b))
    Proposed Sec.  1.1455(b) sets forth proposed requirements on making 
records available to FDA. Proposed Sec.  1.1455(b)(1) would require 
that all records required to be kept under the proposed regulations be 
made available to an authorized FDA representative as soon as possible 
but not later than 24 hours after the request. Proposed Sec.  
1.1455(b)(2) would specify that offsite storage of records is permitted 
if such records can be retrieved and provided onsite within 24 hours of 
request for official review; electronic records would be considered to 
be onsite if they are accessible from an onsite location.
    Proposed Sec.  1.1455(b)(3) would require that, when necessary to 
help FDA

[[Page 60018]]

prevent or mitigate a foodborne illness outbreak, or to assist in the 
implementation of a recall, or to otherwise address a threat to the 
public health, including but not limited to situations where FDA has a 
reasonable belief that an article of food (and any other article of 
food that FDA reasonably believes is likely to be affected in a similar 
manner) presents a threat of serious adverse health consequences or 
death to humans or animals as a result of the food being adulterated 
under section 402 of the FD&C Act or misbranded under section 403(w) of 
the FD&C Act, persons subject to the subpart S requirements must make 
available, within 24 hours of request by an authorized FDA 
representative, an electronic sortable spreadsheet containing the 
information in the records they are required to maintain under subpart 
S, for the foods and date ranges specified in the request. Proposed 
Sec.  1.1455(b)(3) further states that we will withdraw a request for 
such a spreadsheet when necessary to accommodate a religious belief of 
a person asked to provide a spreadsheet. (As previously discussed in 
section V.B.7, under Option 2 of our co-proposal regarding proposed 
Sec.  1.1305(g), we would exempt retail food establishments with 10 or 
fewer full-time equivalent employees from this requirement.)
    We believe that this proposed requirement to provide an electronic 
sortable spreadsheet containing traceability information on foods that 
are the focus of an FDA investigation into a foodborne illness outbreak 
or other threat to public health would be one of the most effective 
ways to improve the speed and efficiency of our traceback efforts. The 
electronic spreadsheet would contain, in a searchable format, all of 
the information the person is required to maintain under the proposed 
regulations, such as applicable records of shipment, receipt, and 
transformation, for the foods (and relevant date ranges) that are the 
subject of FDA's records request.
    As noted, we would only request the specified spreadsheet when we 
conclude that obtaining the information in this format is necessary to 
help us prevent or mitigate a foodborne illness outbreak, assist in 
implementation of a recall, or address a credible threat of serious 
adverse health consequences or death due to an adulterated or 
misbranded food. Reviewing an electronic sortable spreadsheet would 
allow us to more quickly aggregate tracing information to link points 
in the supply chain of a potentially contaminated food, leading to 
faster removal of the food from the market. Although we realize that 
not all persons subject to the proposed rule currently maintain such a 
spreadsheet or other electronic records, we believe it is not unduly 
burdensome to require firms to have the capacity to create such a 
spreadsheet--limited to the specific scope of the foods and dates at 
issue--in the event of an outbreak or other threat to the public 
health. Furthermore, requiring firms to make their tracing information 
available to us in such a concise yet comprehensive and accessible form 
is needed to facilitate Agency review of tracing information and 
consequently help minimize the potential harm to public health 
resulting from foodborne illness outbreaks.
    We request comment on the appropriateness and feasibility of the 
proposed requirement that information be made available to FDA in this 
form when needed to prevent or mitigate a foodborne illness outbreak, 
assist in implementation of a recall, or address credible threats of 
serious adverse health consequences or death due to an adulterated or 
misbranded food, and, if not appropriate and/or feasible, what 
alternate approaches might be appropriate to address the need for 
expedited access to critical traceability information in such 
circumstances.
    Proposed Sec.  1.1455(b)(4) would specify that, upon FDA request, 
persons subject to the proposed recordkeeping requirements must provide 
within a reasonable time an English translation of records maintained 
in a language other than English. A reasonable time for translation 
might vary, for example, from a few days to several days, depending on 
the volume of records requested to be translated and the extent to 
which persons with the necessary language fluency are available to 
perform the translation.
3. Record Retention (Proposed Sec.  1.1455(c))
    Proposed Sec.  1.1455(c) would specify that persons subject to 
these recordkeeping requirements must maintain the records containing 
information required under subpart S for 2 years from the date they 
created the records, except as specified elsewhere in subpart S. We 
note that this proposed record retention period differs from the 
retention periods in subpart J (Sec.  1.360), which applies different 
record retention requirements depending on the length of time before a 
food experiences a significant risk of spoilage, loss of value, or loss 
of palatability. For example, under Sec.  1.360(b) through (d), 
nontransporters of food must retain records according to the following 
schedule:
     Foods having a significant risk of spoilage, loss of 
value, or loss of palatability within 60 days after the date of receipt 
or release: Retain records for 6 months;
     foods for which a significant risk of spoilage, loss of 
value, or loss of palatability occurs 60 days to 6 months after the 
date of receipt or release: Retain records for 1 year; and
     foods for which a significant risk of spoilage, loss of 
value, or loss of palatability does not occur sooner than 6 months 
after the date of receipt or release: Retain records for 2 years.
    These criteria are similar to the definitions of perishable, 
semiperishable, and long shelf-life food used in regulations of the 
National Institute of Standards and Technology (NIST). We adopted this 
record retention schedule for subpart J records because we concluded 
that the food industry was familiar with the classification of foods 
into these three categories due to existing regulations and practices, 
and we believed that use of this classification would mitigate the 
concern, raised by some commenters, regarding inadequate infrastructure 
for long-term storage of records for shorter shelf-life foods (69 FR 
71562 at 71602 to 71603).
    However, we believe that this tiered record retention approach 
would not be appropriate for the proposed additional traceability 
recordkeeping requirements in subpart S. Instead, we believe that, 
except for certain limited exceptions previously discussed in this 
document, records for all foods on the Food Traceability List should be 
retained for 2 years. Even though a highly perishable food might pose a 
risk to consumers for only a few weeks, illnesses caused by a 
contaminated food can be linked retrospectively to past illnesses 
through whole genome sequencing and other evidence months or even years 
after the food was sold. Exposure and consumption information collected 
from illness cases can be compared to such information from past cases 
of illness with the same whole genome sequencing pattern. Having access 
to traceability records for the food for up to 2 years after the 
records were created could greatly aid our investigation into an 
illness outbreak involving the food. In addition, if we could review 
food production records up to 2 years old, it could help us determine 
whether a current foodborne illness outbreak was part of a long-
standing contamination problem with a food or firm. For these reasons, 
we propose to require that traceability records for all foods on the

[[Page 60019]]

Food Traceability List be maintained for 2 years after the records were 
created.
4. Electronic Records (Proposed Sec.  1.1455(d))
    Proposed Sec.  1.1455(d) would provide that records that are 
established or maintained to satisfy the requirements of subpart S and 
that meet the definition of electronic records in 21 CFR 11.3(b)(6) 
(Sec.  11.3(b)(6)) are exempt from the requirements of 21 CFR part 11 
(part 11), which contains FDA regulations on electronic records and 
electronic signatures. Proposed Sec.  1.1455(d) would further specify 
that records that satisfy the requirements of subpart S, but that also 
are required under other applicable statutory provisions or 
regulations, remain subject to part 11, if not otherwise exempt (e.g., 
under other regulations).
5. Use of Existing Records (Proposed Sec.  1.1455(e))
    Proposed Sec.  1.1455(e) would provide that persons subject to 
these recordkeeping requirements would not have to duplicate existing 
records (e.g., records kept in the ordinary course of business or that 
are maintained to comply with other Federal, State, Tribal, 
territorial, or local regulations) if the records contain all of the 
information required under the proposed rule. For example, firms would 
be able to rely on tracing records they keep in accordance with subpart 
J to meet some of the requirements that would apply to them under 
proposed subpart S. Proposed Sec.  1.1455(e) further states that 
persons may supplement any such existing records as necessary to 
include all of the information required by subpart S. Proposed Sec.  
1.1455(e) is consistent with section 204(d)(1)(E) of FSMA, which in 
part directs that the proposed traceability recordkeeping requirements 
not require the creation and maintenance of duplicate records where the 
required information is contained in other company records kept in the 
normal course of business.
    Proposed Sec.  1.1455(e) would also provide that persons subject to 
the recordkeeping requirements would not have to keep all of the 
required information in one set of records. However, the provision 
would specify that if a person keeps the required information in more 
than one set of records, the person must indicate the different records 
in which the information is maintained in accordance with proposed 
Sec.  1.1315(a), which would require persons subject to subpart S to 
maintain a document describing the reference records in which required 
information is kept.

J. Consequences of Failure To Comply (Proposed Sec.  1.1460)

    Proposed Sec.  1.1460 answers the question, ``What consequences 
could result from failing to comply with the requirements of this 
subpart?'' Section 204(j)(1) of FSMA amends section 301(e) of the FD&C 
Act to make it a prohibited act to violate any recordkeeping 
requirement under section 204 (except when the violation is committed 
by a farm). Therefore, proposed Sec.  1.1460(a) would specify that the 
violation of any recordkeeping requirement under section 204 of FSMA, 
including the violation of any requirement of subpart S, is prohibited 
under section 301(e) of the FD&C Act, except when such violation is 
committed by a farm.
    Section 204(j)(2) of FSMA amended section 801(a) of the FD&C Act by 
adding paragraph (a)(4), which states that FDA shall refuse admission 
to an article of food if it appears from examination of samples of the 
food or otherwise that the recordkeeping requirements under section 204 
of FSMA (other than the requirements under section 204(f), which 
concern FDA requests for information from farms under certain 
circumstances, and which are not addressed in this rulemaking) have not 
been complied with regarding such article. Therefore, proposed Sec.  
1.1460(b) would specify that an article of food is subject to refusal 
of admission under section 801(a)(4) of the FD&C Act if it appears that 
the recordkeeping requirements under section 204 of FSMA (other than 
the requirements under section 204(f)), including the requirements of 
subpart S, have not been complied with regarding such article.

K. Updating the Food Traceability List (Proposed Sec.  1.1465)

    Proposed Sec.  1.1465 answers the question, ``How will FDA update 
the Food Traceability List?'' Section 204(d)(2)(B) of FSMA states that 
we may update the Food Traceability List to designate new high-risk 
foods and remove foods no longer deemed to be high-risk foods, provided 
that the update of the list is consistent with section 204(d)(2) and we 
publish notice of the update in the Federal Register. We will monitor 
the factors set forth in section 204(d)(2) (e.g., known safety risks of 
foods (including history and severity of attributed foodborne illness 
outbreaks), points in manufacturing processes where contamination is 
likely to occur, likelihood of contamination) and consider new 
scientific data or other scientific information that is relevant to 
these factors. We anticipate periodically performing a review of such 
information to conclude whether it is appropriate to revise the Food 
Traceability List. In addition, we also will consider whether new data 
or other information warrants a reassessment of the methodology used to 
develop the list.
    Upon review of relevant information, we might conclude that it 
would be appropriate to revise the Food Traceability List by deleting a 
food from the list, adding a food to the list, or both. Proposed Sec.  
1.1465(a) would provide that when we tentatively conclude, in 
accordance with section 204(d)(2) of FSMA, that it is appropriate to 
revise the Food Traceability List, we will publish a notice in the 
Federal Register stating the proposed changes to the list and the 
reasons for these changes, and requesting information and views on the 
proposed changes.
    Proposed Sec.  1.1465(b) would provide that after considering any 
information and views submitted on the proposed changes to the list, we 
will publish a notice in the Federal Register stating whether we are 
making any changes to the list and the reasons for the decision. 
Proposed Sec.  1.1465(b) further states that if we revise the list, we 
will also publish the revised list on our website.
    Proposed Sec.  1.1465(c) would specify that when we update the Food 
Traceability List in accordance with Sec.  1.1465, any deletions from 
the list will become effective immediately, but any additions to the 
list will become effective 1 year after the date of publication of the 
Federal Register notice announcing the revised list, unless otherwise 
stated in the notice. We believe it would be appropriate to allow time 
for persons who manufacture, process, pack, or hold a food that we add 
to the Food Traceability List to come into compliance with the 
additional traceability recordkeeping requirements for the food under 
subpart S.

VI. Proposed Effective and Compliance Dates

    We propose that any final rule on additional traceability 
recordkeeping requirements for persons who manufacture, process, pack, 
or hold foods on the Food Traceability List would become effective 60 
days after the date on which the rule is published in the Federal 
Register. However, as discussed below, we are proposing to provide 
additional time before persons subject to the regulations would be 
required to comply with them.
    Section 204(i) of FSMA directs that the traceability recordkeeping

[[Page 60020]]

requirements adopted under section 204(d) will apply to small 
businesses (as defined under section 103 of FSMA) 1 year after the 
effective date of the final regulations, and to very small businesses 
(as defined under section 103 of FSMA) 2 years after the effective date 
of the final regulations. As defined under section 103 of FSMA, a 
``small business'' is a business (including any subsidiaries and 
affiliates) employing fewer than 500 full-time equivalent employees 
(see 21 CFR 117.3); a ``very small business'' is a business (including 
any subsidiaries and affiliates), averaging less than $1,000,000, 
adjusted for inflation, per year, during the 3-year period preceding 
the applicable calendar year in sales of human food plus the market 
value of human food manufactured, processed, packed, or held without 
sale (e.g., held for a fee). Although Congress established these later 
compliance dates for smaller entities, we believe that we could more 
effectively and efficiently implement the new traceability 
recordkeeping regulations by having all persons subject to them come 
into compliance by the same date. In particular, because proposed Sec.  
1.1350(b) would require that certain records be sent to the immediate 
subsequent recipient of the food--a provision which would help the 
recipient comply with the proposed requirements by providing them with 
some of the information necessary to comply--we are concerned that 
staggered compliance dates would hinder the rule's effectiveness. 
Therefore, we propose that the compliance date for all persons subject 
to these recordkeeping requirements would be 2 years after the 
effective date of the final regulations. We request comment on our 
proposed approach to compliance dates.

VII. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, Executive Order 13771, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 
13563 direct us to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). Executive Order 13771 
requires that the costs associated with significant new regulations 
``shall, to the extent permitted by law, be offset by the elimination 
of existing costs associated with at least two prior regulations.'' 
This proposed rule is an economically significant regulatory action as 
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because some small firms may incur annualized costs that 
exceed one percent of their annual revenue, we find that the proposed 
rule will have a significant economic impact on a substantial number of 
small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $156 million, using the most current (2019) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
result in an expenditure in any year that meets or exceeds this amount.
    This proposed rule, if finalized, would allow FDA and industry to 
more rapidly and effectively trace food products that cause illnesses 
back through the food supply system to the source and forward to 
determine recipients of the contaminated product. This rule would only 
apply to foods we have designated for inclusion on the Food 
Traceability List. By allowing faster identification of contaminated 
foods and increasing rates of successful tracing completions, the 
proposed rule may result in public health benefits if foodborne 
illnesses directly related to those outbreaks are averted. This may 
also lead to more efficient use of FDA and industry resources needed 
for outbreak investigations by potentially resulting in more precise 
recalls and avoidance of overly broad market withdrawals and advisories 
for listed foods.
    Benefits from this rule could be generated if the following two 
conditions hold: (1) A foodborne outbreak occurs and (2) the 
traceability records required by this proposed rule help FDA to quickly 
and accurately locate a commercially distributed violative product and 
ensure it is removed from the market. The primary public health 
benefits of this rule are the value from the reduction of the foodborne 
illnesses or deaths because records required by the proposed rule are 
likely to reduce the time that a violative or contaminated food product 
is distributed in the market.
    Other non-health related benefits of this rule, if realized, would 
be from avoiding costs associated with conducting overly broad recalls 
and market withdrawals that affect products that otherwise would not 
need to be withdrawn or recalled. Although recalls of rightly 
implicated foods come with necessary costs, overly broad recalls that 
involve loosely related or unrelated products can make overall recalls 
unnecessarily costly. The costs of a broad recall or market withdrawal 
include lost revenues from unimplicated products, plus expenses 
associated with notifying retailers and consumers, collection, 
shipping, disposal, inventory, and legal costs.\1\ There are no 
benefits from removing unimplicated products from the market. It is 
possible, but not certain, that both of these categories of benefits 
separately or jointly could be experienced to the extent quantified in 
this regulatory impact analysis. On the other hand, it is also 
possible, but not certain, that a given instance of baseline 
contamination would lead to a very broad recall (that could be narrowed 
by the proposed rule) or to illnesses (that could be avoided due to the 
proposed rule), but not both.
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    \1\ For example, in an undifferentiated product recall, a single 
firm's investment in traceability may be ineffective when 
competitors and partners have not instituted a traceability system. 
This is problematic because, for example, in the event of an 
undifferentiated leafy greens outbreak, issuing a broad recall could 
be unavoidable, at least until the implicated product is identified 
and removed from the market. In situations where the recalled 
products are insured, targeted recalls will help prevent unnecessary 
recall of insured products, which may have long-term consequence to 
retailers from increases in their insurance rates due to imprecise 
recalls.
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    Additional benefits may include increased food supply system 
efficiencies, such as improvements in supply chain management and 
inventory control; more expedient initiation and completion of recalls; 
avoidance of costs due to unnecessary preventive actions by consumers; 
and other food supply system efficiencies due to a standardized 
approach to traceability, including an increase in transparency and 
trust and potential deterrence of fraud.
    This proposed rule, if finalized, would impose compliance costs on 
covered entities by increasing the number of records that are required 
for food products on the Food Traceability List. Entities that 
manufacture, process, pack, or hold listed foods would incur costs to 
establish and maintain

[[Page 60021]]

traceability records. Some firms may also incur initial capital 
investment and training costs in systems that would enable them to 
establish, maintain, sort, and make available upon our request their 
traceability records. Moreover, firms would incur one-time costs of 
reading and understanding the rule. The information flows brought about 
by the proposed rule may prompt new protective actions--for example, in 
farming, manufacturing or cooking processes--that themselves would have 
costs. These potential costs have not been quantified but their 
occurrence is likely to be correlated with the realization of health 
and longevity benefits of this rule.
    Tables 6a and 6b summarize the costs and the benefits of the 
proposed rule. Table 6a shows our estimates of the rule's cost if 
proposed Option 1 of the co-proposal regarding retail food 
establishments with 10 or fewer full-time equivalent employees (full 
exemption from the proposed rule) were selected. At a seven percent 
discount rate, ten-year annualized costs would range from approximately 
$34 million to $2.4 billion per year in 2018 dollars, with a primary 
estimate of $411 million per year. At a three percent discount rate, 
annualized costs would range from approximately $33 million to $2.4 
billion per year, with a primary estimate of $400 million per year.
    Table 6b shows our estimates of the rule's cost under proposed 
Option 2 of the co-proposal, which would exempt retail food 
establishments with 10 or fewer full-time equivalent employees from the 
requirement to provide FDA, under certain circumstances, with an 
electronic sortable spreadsheet containing requested tracing 
information. At a seven percent discount rate, annualized costs under 
Option 2 would range from approximately $43 million to $3.2 billion per 
year in 2018 dollars, with a primary estimate of $535 million per year. 
At a three percent discount rate, annualized costs would range from 
approximately $42 million to $3.1 billion per year, with a primary 
estimate of $513 million per year.
    We estimate public health benefits using several case studies of 
outbreaks tracebacks for four pathogens associated with illnesses 
caused by foods on the Food Traceability List. These benefits have a 
tendency toward underestimation of the total public health benefits 
because these four pathogens do not represent the total burden of all 
illnesses associated with listed foods.\2\ However, adjustments made 
for undiagnosed and unattributed illnesses may have the opposite 
tendency of overstating both illnesses and benefits associated with 
listed foods. We calculate these monetized benefits from illnesses 
averted per year based on an estimated 84 percent reduction of 
traceback time resulting from the requirements of this rule. Under 
Option 1 of the co-proposal, for an estimated 84 percent traceback 
improvement, the annualized monetized benefits range from $33 million 
to $1.4 billion with a primary estimate of $567 million, discounted at 
seven percent over ten years.\3\ At a three percent discount rate over 
ten years, the annualized monetized benefits range from $33 million to 
$1.4 billion with a primary estimate of $580 million.
---------------------------------------------------------------------------

    \2\ We cannot scale up to 100 percent because our estimates of 
the percentage of illnesses potentially avoided with improved 
traceability depend on data specific to each pathogen. We describe 
our methods in detail in section II.E.2 (``Public Health Benefits 
from Averted Illnesses'') of the full Preliminary Regulatory Impact 
Analysis (PRIA) for the proposed rule (Ref. 26). In short, these 
four pathogens may account for roughly 95 percent of the total 
dollar value of the illnesses for which traceability might be an 
effective preventive measure.
    \3\ See the PRIA for the proposed rule (Ref. 26) for an 
explanation of the estimated range of benefits of the proposed rule.
---------------------------------------------------------------------------

    Under Option 2 of the co-proposal, for an estimated 84 percent 
traceback improvement, the annualized monetized benefits range from $36 
million to $1.5 billion with a primary estimate of $626 million, 
discounted at seven percent over ten years, and from $37 million to 
$1.6 billion with a primary estimate of $640 million, discounted at 
three percent over ten years. Using examples from three recalls, we 
also estimate that additional (non-health) benefits of avoiding overly 
broad recalls could range from $1.7 billion to $5.6 billion per year at 
a seven percent discount rate and from $1.7 billion to $5.8 billion 
using a three percent discount rate. As noted earlier, it is possible 
that both of these categories of benefits could be experienced to the 
extent quantified in the regulatory impact analysis, either separately 
or jointly. Therefore, tables 6a and 6b avoid a definitive statement 
that they should be summed.
    Costs are lower in Option 1, relative to Option 2, because fewer 
retail food establishments would need to comply with the proposed rule. 
However, if retail food establishments with 10 or fewer full-time 
equivalent employees are exempt from the Subpart S requirements, the 
timeliness, precision, and accuracy of traceability efforts can be 
impacted and non-quantified benefits, such as enhancement of our 
ability to narrow the number of lots in a recall and the ability of 
retail food establishments with 10 or fewer full-time equivalent 
employees to have the data necessary to quickly identify and remove 
contaminated products from shelves, will be lessened in comparison to 
Option 2. Requiring recordkeeping by retail food establishments of all 
sizes allows for more consistent, organized, and specific information 
that covers the entire supply chain.

[[Page 60022]]

                                    Table 6a--Summary of Benefits, Costs and Distributional Effects of Proposed Rule
                                                           [Option 1, in millions of dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Units
                                                                           ------------------------------------
               Category                   Primary       Low        High                               Period                      Notes
                                         estimate    estimate    estimate      Year      Discount     covered
                                                                              dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/           $567         $33      $1,355        2018           7          10  Monetized benefits from an estimated 84%
     year.                                     580          33       1,385        2018           3          10   improvement in traceback time for four
                                                                                                                 pathogens. Additional benefits of
                                                                                                                 avoiding overly broad recalls could
                                                                                                                 range from $1.7 billion to $5.6 billion
                                                                                                                 (7%, 10 years) and $1.7 billion to $5.8
                                                                                                                 billion (3%, 10 years).
                                       -----------------------------------------------------------------------------------------------------------------
    Annualized Quantified.............  ..........  ..........  ..........  ..........  ..........  ..........
                                       -----------------------------------------------------------------------------------------------------------------
    Qualitative.......................       Additional potential benefits include      ..........  ..........
                                          increased food supply system efficiencies;
                                          more expedient initiation and completion of
                                        recalls; avoidance of costs due to unnecessary
                                          preventive actions; and other efficiencies
                                         from a standardized approach to traceability.
                                        However, if retail food establishments with 10
                                          or fewer full-time equivalent employees are
                                            exempt from Subpart S requirements, the
                                            timeliness, precision, and accuracy of
                                           traceability efforts can be impacted, and
                                         qualitative benefits, such as the ability to
                                         narrow the number of lots in a recall and the
                                        ability for retail food establishments with 10
                                          or fewer full-time equivalent employees to
                                          have the data necessary to quickly identify
                                        and remove contaminated products from shelves,
                                          will be lessened in comparison to Option 2.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/           $411         $34      $2,425        2018           7          10  A portion of foreign costs could be
     year.                                     400          33       2,352        2018           3          10   passed on to domestic consumers. We
                                                                                                                 estimate that up to $259 million in
                                                                                                                 annualized costs (7%, 10 years) to
                                                                                                                 foreign facilities could be passed on
                                                                                                                 to domestic consumers.
                                       -----------------------------------------------------------------------------------------------------------------
    Annualized Quantified.............  ..........  ..........  ..........  ..........  ..........  ..........
    Qualitative.......................  ..........  ..........  ..........  ..........  ..........  ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized        ..........  ..........  ..........  ..........  ..........  ..........
     $millions/year.
                                       -----------------------------------------------------------------------------------------------------------------
    From/To...........................  From:
                                        To:
                                       -----------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized          ..........  ..........  ..........  ..........  ..........  ..........
     $millions/year.
                                       -----------------------------------------------------------------------------------------------------------------
    From/To...........................  From:
                                        To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: No significant effect............................................................................................
    Small Business: Potential impact on some small entities that are currently not keeping traceability records described by the proposed rule..........
    Wages: N/A..........................................................................................................................................
    Growth: N/A.........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                    Table 6b--Summary of Benefits, Costs and Distributional Effects of Proposed Rule
                                                           [Option 2, in millions of dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Units
                                                                           ------------------------------------
               Category                   Primary       Low        High                               Period                      Notes
                                         estimate    estimate    estimate      Year      Discount     covered
                                                                              dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:

[[Page 60023]]

 
    Annualized Monetized $millions/           $626         $36      $1,497        2018           7          10  Monetized benefits from an estimated 84%
     year.                                     640          37       1,531        2018           3          10   reduction in traceback time for four
                                                                                                                 pathogens. Additional benefits of
                                                                                                                 avoiding overly broad recalls could
                                                                                                                 range from $1.7 billion to $5.6 billion
                                                                                                                 (7%, 10 years) and $1.7 billion to $5.8
                                                                                                                 billion (3%, 10 years).
                                       -----------------------------------------------------------------------------------------------------------------
    Annualized Quantified.............  ..........  ..........  ..........  ..........  ..........  ..........
                                       -----------------------------------------------------------------------------------------------------------------
    Qualitative.......................     Additional unquantified benefits include     ..........  ..........
                                          increased food supply system efficiencies;
                                          more expedient initiation and completion of
                                        recalls; avoidance of costs due to unnecessary
                                          preventive actions; and other efficiencies
                                         from a standardized approach to traceability.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/            535          43       3,210        2018           7          10  A portion of foreign costs could be
     year.                                     513          42       3,063        2018           3          10   passed on to domestic consumers. We
                                                                                                                 estimate that up to $259 million in
                                                                                                                 annualized costs (7%, 10 years) to
                                                                                                                 foreign facilities could be passed on
                                                                                                                 to domestic consumers.
    Annualized Quantified.............  ..........  ..........  ..........  ..........  ..........  ..........
    Qualitative.......................  ..........  ..........  ..........  ..........  ..........  ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized        ..........  ..........  ..........  ..........  ..........  ..........
     $millions/year.
                                       -----------------------------------------------------------------------------------------------------------------
    From/To...........................  From:
                                        To:
                                       -----------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized          ..........  ..........  ..........  ..........  ..........  ..........
     $millions/year.
                                       -----------------------------------------------------------------------------------------------------------------
    From/To...........................  From:
                                        To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: No significant effect............................................................................................
    Small Business: Potential impact on small entities that are currently not keeping traceability records described by the proposed rule...............
    Wages: N/A..........................................................................................................................................
    Growth: N/A.........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In accordance with Executive Order 13771, in tables 7a and 7b we 
estimate present and annualized values of costs and cost savings of the 
proposed rule over an infinite time horizon. This proposed rule is 
expected to be a regulatory action under Executive Order 13771.

                                       Table 7a--E.O. 13771 Summary Table
                       [Option 1, in millions 2016 dollars, over an infinite time horizon]
----------------------------------------------------------------------------------------------------------------
                                                                      Primary     Lower estimate  Upper estimate
                              Item                                 estimate (7%)       (7%)            (7%)
----------------------------------------------------------------------------------------------------------------
Present Value of Costs..........................................          $5,105            $438         $29,659
Present Value of Cost Savings...................................  ..............  ..............  ..............
Present Value of Net Costs......................................           5,105             438          29,659
Annualized Costs................................................             357              31           2,076
Annualized Cost Savings.........................................  ..............  ..............  ..............
Annualized Net Costs............................................             357              31           2,076
----------------------------------------------------------------------------------------------------------------

[[Page 60024]]

                                       Table 7b--E.O. 13771 Summary Table
                       [Option 2, in millions 2016 dollars, over an infinite time horizon]
----------------------------------------------------------------------------------------------------------------
                                                                      Primary     Lower estimate  Upper estimate
                              Item                                 estimate (7%)       (7%)            (7%)
----------------------------------------------------------------------------------------------------------------
Present Value of Costs..........................................          $6,288            $532         $36,867
Present Value of Cost Savings...................................  ..............  ..............  ..............
Present Value of Net Costs......................................           6,288             532          36,867
Annualized Costs................................................             440              37           2,581
Annualized Cost Savings.........................................  ..............  ..............  ..............
Annualized Net Costs............................................             440              37           2,581
----------------------------------------------------------------------------------------------------------------

    We have also considered an alternative way of describing costs and 
benefits. Given uncertainties in the data underlying our costs and 
benefits estimates, tables 8a and 8b explore the possibility that 
baseline costs of recalls are more fully internalized by market actors.
    Column (a) of tables 8a and 8b explores the possibility that market 
actors do not already account for the costs of foodborne illnesses 
associated with listed foods (e.g., public health benefits of products 
with better traceability are not captured in product price) and/or the 
costs of overly broad recalls (e.g., firms do not invest enough in 
traceability because they do not expect other firms to also invest). 
Primary estimates (and relatively large portions of the uncertainty 
ranges) indicate that benefits of the rule would be greater than the 
rule's cost. Column (b) of tables 8a and 8b considers scenarios where 
market actors already fully account for the costs of overly broad 
recalls. Then recall-associated benefits would not be greater than the 
cost of the rule. This means firms have already invested in 
traceability to the point where further investment would cost more than 
the benefit they would expect to receive. Then the total benefits of 
the rule, including health benefits, may or may not be greater than the 
rule's cost.

 Table 8a--Summary of Benefits and Costs of Proposed Rule (Option 1), As
   a Function of Assumptions Regarding Baseline Cost Internalization *
------------------------------------------------------------------------
                                 Neither adverse      Recall-associated
                               health effects nor      costs, but not
                                recall-associated      adverse health
                                   costs fully         effects, fully
                                 internalized in       internalized in
                               market transactions   market transactions
                                for listed foods      for listed foods
                              (a).................  (b)
------------------------------------------------------------------------
PRIA Section IV.B...........  Health Benefits:      Health Benefits:
                               $567M (range: $33M    $567M (range: $33M
                               to $1.4B).            to $1.4B)
                              and/or..............
PRIA Section II.E.3.........  Recall-Associated     Recall-Associated
                               Benefits: $1.7B to    Benefits: $1.7B to
                               $5.6B.                $5.6B.
                                                    Direct Compliance
                                                     Costs >$1.7B to
                                                     $5.6B.
                                                    Protective Action
                                                     Costs (potential):
                                                     Not quantified.
                                                    or
                                                    Recall-Associated
                                                     Benefits < Costs.
PRIA Sections IV.C and IV.D.  Direct Compliance     Direct Compliance
                               Costs (if foreign     Costs (if foreign
                               passed through to     passed through to
                               U.S. supply chain &   U.S. supply chain &
                               consumers): $670M     consumers): $670M
                               (range: $52M to       (range: $52M to
                               $4B).                 $4B).
                              Direct Compliance     Direct Compliance
                               Costs (if foreign     Costs (if foreign
                               not passed through    not passed through
                               to U.S. supply        to U.S. supply
                               chain & consumers):   chain & consumers):
                               $411M (range: $34M    $411M (range: $34M
                               to $2.4B).            to $2.4B).
                              Protective Action     Protective Action
                               Costs (potential):    Costs (potential):
                               not quantified.       not quantified.
------------------------------------------------------------------------
* Primary estimates presented in this table are calculated with a 7
  percent discount rate; primary estimates discounted at 3 percent
  differ only slightly. All estimates are expressed in 2018 dollars and
  annualized over 10 years. Abbreviations: M = million, B = billion.

 Table 8b--Summary of Benefits and Costs of Proposed Rule (Option 2), As
   a Function of Assumptions Regarding Baseline Cost Internalization *
------------------------------------------------------------------------
                                 Neither adverse      Recall-associated
                               health effects nor      costs, but not
                                recall-associated      adverse health
                                   costs fully         effects, fully
                                 internalized in       internalized in
                               market transactions   market transactions
                                for listed foods      for listed foods
                              (a).................  (b)
------------------------------------------------------------------------
PRIA Section II.E.2.........  Health Benefits:      Health Benefits:
                               $626M (range: $36M    $626M (range: $36M
                               to $1.5B).            to $1.5B).
                              and/or..............  Recall-Associated
                                                     Benefits: $1.7B to
                                                     $5.6B.
PRIA Section II.E.3.........  Recall-Associated     Direct Compliance
                               Benefits: $1.7B to    Costs >$1.7B to
                               $5.6B.                $5.6B
                                                    Protective Action
                                                     Costs (potential):
                                                     Not quantified.
                                                    or
                                                    Recall-Associated
                                                     Benefits < Costs.
RIA Sections II.F and II.H..  Direct Compliance     Direct Compliance
                               Costs (if foreign     Costs (if foreign
                               passed through to     passed through to
                               U.S. supply chain &   U.S. supply chain &
                               consumers): $794M     consumers): $794M
                               (range: $61M to       (range: $61M to
                               $4.8B).               $4.8B).
                              Direct Compliance     Direct Compliance
                               Costs (if foreign     Costs (if foreign
                               not passed through    not passed through
                               to U.S. supply        to U.S. supply
                               chain & consumers):   chain & consumers):
                               $535M (range: $43M    $535M (range: $43M
                               to $3.2B).            to $3.2B).

[[Page 60025]]

 
                              Protective Action     Protective Action
                               Costs (potential):    Costs (potential):
                               Not quantified.       Not quantified.
------------------------------------------------------------------------
* Primary estimates presented in this table are calculated with a 7
  percent discount rate; primary estimates discounted at 3 percent
  differ only slightly. All estimates are expressed in 2018 dollars and
  annualized over 10 years. Abbreviations: M = million, B = billion.

    The full PRIA (Ref. 26) is available in the docket for this 
proposed rule and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm).

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment not an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). A 
description of these provisions is given in the Description section 
with an estimate of the reporting, recordkeeping, and disclosure burden 
associated with the proposed rule. Included in the estimate is the time 
for reviewing instructions, searching existing data sources, gathering 
and maintaining the data needed, and completing and reviewing each 
collection of information.
    FDA invites comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Traceability Records for Certain Foods--OMB Control No. 
0910-0560--Revision.
    Description: If the proposed rule is finalized, provisions in 21 
CFR part 1, subpart S, would implement section 204(d)(1) of FSMA, which 
requires FDA to establish traceability recordkeeping requirements, in 
addition to the requirements under section 414 of the FD&C Act and 21 
CFR part 1, subpart J (the subpart J requirements) (currently approved 
under OMB control number 0910-0560), for facilities that manufacture, 
process, pack, or hold foods that the Agency has designated as high-
risk foods (i.e., placed on the ``Food Traceability List'') in 
accordance with section 204(d)(2) of FSMA. The proposed subpart S 
recordkeeping, reporting, and disclosure requirements are intended to 
strengthen public health protections by improving FDA's ability to 
trace the movement of foods throughout the supply chain to identify the 
source of contaminated foods and aid in the removal of contaminated 
products from the market. Access to and utilization of such records 
would better enable FDA to respond to and contain threats to the public 
health introduced through foods on the Food Traceability List (``listed 
foods''). Existing regulations in subpart J set forth traceability 
recordkeeping requirements for firms that manufacture, process, pack, 
transport, distribute, receive, hold, or import food. We are proposing 
to establish additional recordkeeping requirements for foods on the 
Food Traceability List.
    Description of Respondents: Except as specified otherwise, the 
requirements in the proposed rule apply to persons who manufacture, 
process, pack, or hold foods that appear on the list of foods for which 
additional traceability records are required in accordance with section 
204(d)(2) of FSMA (the Food Traceability List).
    We estimate the burden of the information collection as follows:

                                Table 9--Estimated One-Time Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average burden
       Proposed activity           Number of      records per    Total annual    per record  (in    Total hours
                                  respondents     respondent        records          hours)
----------------------------------------------------------------------------------------------------------------
Reading and understanding the          422,145               1         422,145  3.3.............       1,393,079
 new recordkeeping
 requirements.
Sec.   1.1315; traceability            130,063           1,000     130,063,000  0.03 (2 minutes)       3,901,890
 program records (one-time set-
 up).
Training personnel............          96,644               3         289,932  2...............         579,864
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................       5,874,833
----------------------------------------------------------------------------------------------------------------

    As reflected in table 9, we assume all potential respondents to the 
information collection will incur burden for reading and understanding 
the proposed regulations. Based on our experience with similar 
information collection, we assume that reading and understanding the 
new requirements will require an average of 3.3 hours for each of the 
422,145 respondents, for an estimated burden of 1,393,079 hours. In 
addition, some firms will incur a one-time burden of establishing 
traceability program records under proposed Sec.  1.1315. We estimate 
that 130,063 firms will need 0.03 hours to establish each of an average 
of 1,000 records, for an estimated one-time burden of 3,901,890

[[Page 60026]]

hours. Additionally, upon reviewing the regulations and implementing 
procedures to satisfy the information collection, we expect that some 
firms will incur burden associated with training employees in 
procedures for properly documenting key data elements identified in the 
proposed regulations. We estimate that 96,644 firms will need to 
conduct an average of 2 hours of training with respect to an average of 
3 records, for a total of 579,864 hours. Cumulatively, this results in 
a total of 5,874,833 one-time burden hours for respondents.

                                   Table 10--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
   Proposed reporting activity      respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Sec.   1.1370; Requests for                    5               1               5              10              50
 modified requirements and
 exemptions.....................
Sec.  Sec.   1.1415 through                   15               1              15              10             150
 1.1425; Requests for waivers...
Sec.   1.1465(a); Comments on                  1               1               1               1               1
 proposed revisions to the Food
 Traceability List..............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............              22  ..............             202
----------------------------------------------------------------------------------------------------------------

    Proposed Sec. Sec.  1.1300 and 1.1305 set forth the scope and 
applicability of the regulations, as well as identify certain foods and 
persons that would be exempt from the additional recordkeeping 
requirements. Proposed Sec. Sec.  1.1360 through 1.1400 discuss how 
respondents to the information collection may request modified 
requirements and exemptions from the subpart S requirements for certain 
foods or types of entities. If the proposed rule is finalized, the 
regulations would explain the procedures and identify the content and 
format elements that should be included in such requests submitted to 
FDA, as well as the procedures FDA will follow when proposing modified 
requirements or exemptions on its own initiative. Specifically, the 
proposed regulations provide that respondents requesting modified 
requirements and exemptions must petition the Agency under our 
regulations in Sec.  10.30. In accordance with the proposed 
regulations, FDA will publish a notification in the Federal Register 
requesting information and views on a submitted petition. Based on our 
experience with similar information collection, we assume few requests 
for modified requirements or exemptions will be submitted to the Agency 
and therefore provide a base estimate of five submissions annually, as 
reflected in table 10, row 1. Assuming each submission requires an 
average of 10 hours to prepare, this results in a total of 50 hours. We 
invite comment on the estimated burden associated with requests for 
modified requirements or exemptions from the proposed requirements.
    Proposed Sec. Sec.  1.1410 through 1.1455 pertain to waivers from 
the subpart S requirements for individual entities and types of 
entities. If the rule is finalized, these regulations would specify 
that the procedures for submitting waiver requests for types of 
entities are governed by Sec.  10.30 and would identify requisite 
content and format elements for such requests. The regulations would 
further specify that requests for waivers for individual entities are 
to be made via written requests (not governed by Sec.  10.30). Based on 
our experience with similar information collection, we believe that 
slightly more waiver requests (compared to requests for modified 
requirements or an exemption) will be submitted and we therefore 
provide a base estimate of 15 submissions annually, as reflected in 
table 10, row 2. Assuming each submission requires an average of 10 
hours to prepare, this results in a total of 150 hours. We invite 
comment on the estimated burden associated with requests for waivers 
from the proposed requirements.
    Finally, proposed Sec.  1.1465 provides for FDA publication of 
proposed updates to the Food Traceability List in the Federal Register, 
which would include the opportunity for public comment on proposed 
changes. Because we believe that, on an annualized basis, the burden 
associated with submitting comments on a proposed change to the Food 
Traceability List would be negligible, we provide a minimal estimate of 
one response requiring 1 burden hour annually, as reflected in table 
10, row 3. We invite comment on the estimated burden associated with 
requesting views on a proposed updated Food Traceability List.

                                 Table 11--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                                                 Average burden
                                   Number of       Number of     Total annual          per
 Proposed 21 CFR recordkeeping   recordkeepers    records per       records       recordkeeping     Total hours
                                                 recordkeeper                      (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.   1.1305; partial                       1               1               1  1...............               1
 exemption under: (e)(2)--
 commingled RACs; (h)(2)--
 retail food establishments;
 (i)(2)--farms; (j)(2)--
 fishing vessels.
Sec.   1.1315; traceability            130,063           1,000     130,063,000  0.004 (15                520,252
 program general records                                                         seconds).
 (recurring).
Sec.   1.1325; grower (non-              9,408           1,000       9,408,000  0.03 (2 minutes)         282,240
 sprout growers).
Sec.   1.1325; grower (sprout               51           1,000          51,000  0.07 (4 minutes)           3,570
 growers).
Sec.   1.1330; first receiver.          12,700           1,000      12,700,000  0.03 (2 minutes)         381,000
Sec.   1.1335; receiver.......         265,610           1,000     265,610,000  0.004 (15              1,062,440
                                                                                 seconds).
Sec.   1.1340; transformer....           5,244           1,000       5,244,000  0.03 (2 minutes)         157,320
Sec.   1.1345; creator........             222           1,000         222,000  0.03 (2 minutes)           6,660

[[Page 60027]]

 
Sec.   1.1350; shipper                  12,657          48,333     611,750,781  0.008 (30              4,894,006
 (wholesalers/warehouses/                                                        seconds).
 distribution centers;
 includes disclosure
 requirement).
Sec.   1.1350; shipper (other           16,936           1,000      16,936,000  0.06 (3.5              1,016,160
 shippers; includes disclosure                                                   minutes).
 requirement).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................       8,323,649
----------------------------------------------------------------------------------------------------------------

    Proposed Sec.  1.1305 provides for certain exemptions and partial 
exemptions from the proposed subpart S requirements. For the proposed 
partial exemptions for farm to school programs and for retail food 
establishments with respect to food produced on a farm and sold 
directly to the retail food establishment, we conclude that any burden 
under the proposed rule would be negligible because most retail food 
establishments and farms already keep the records they would be 
required to keep under the partial exemptions (i.e., the name and 
address of the farm that was the source of the food) as part of their 
standard business practices. For these reasons, we therefore provide a 
minimum estimate of one respondent requiring 1 hour to establish one 
record, resulting in an estimated burden of 1 hour. We invite comment 
on the estimated burden associated with these partial exemptions in 
proposed Sec.  1.1305.
    The requirements in Sec. Sec.  1.1315 through 1.1350 would identify 
respondents who are subject to the respective recordkeeping provisions, 
including with respect to general traceability program records and 
records documenting the critical tracking events of growing, receiving 
(including by first receivers), transforming, creating, and shipping 
foods on the Food Traceability List. The requirements specify when 
certain records should be established and the key data elements that 
must be documented.
    In table 11, we provide recordkeeping burden estimates associated 
with these recordkeeping requirements. The number of respondents, 
number of records, and time per recordkeeping activity is consistent 
with figures included in our PRIA for the proposed rule (Ref. 26). 
Although we note that shippers of listed foods must also disclose 
required records in accordance with proposed Sec.  1.1350(b), we have 
included this burden as part of our recordkeeping estimate for this 
provision. This is because we believe that this disclosure burden would 
be minimal since, with the exception of certain information that farms 
must disclose (addressed in table 12 below), respondents must establish 
and maintain such information under the proposed rule. We invite 
comment on the estimated burden associated with both recordkeeping and 
disclosure provisions in Sec. Sec.  1.1315 and 1.1325 through 1.1350 of 
the proposed rule.
    Proposed Sec.  1.1355 would exempt listed foods to which a kill 
step has been applied from all subsequent requirements of the proposed 
rule, provided that a record of application of the kill step is 
maintained. Because firms that apply a kill step to a food are required 
to document this activity under other FDA regulations (e.g., 21 CFR 
113.100, 21 CFR 117.190(a)(2)), the proposed requirement to maintain a 
record of application of a kill step to listed foods would not create 
an additional recordkeeping burden for such firms under the proposed 
rule.
    Proposed Sec.  1.1455 discusses the maintenance and accessibility 
of records. Under proposed Sec.  1.1455(b)(3), when necessary to help 
FDA prevent or mitigate a foodborne illness outbreak, assist in the 
implementation of a recall, or otherwise address a threat to the public 
health, respondents may be asked to make available within 24 hours of 
request by an authorized FDA representative an electronic sortable 
spreadsheet containing the information they are required to maintain 
under subpart S, for the foods and date ranges specified in the 
request. We anticipate that most firms will never be the subject of 
such a request, because the proposed provision only applies to 
situations where there is a threat to the public health. Furthermore, 
we believe that such spreadsheets can be created using software that is 
readily available and that is commonly used for other general business 
purposes. In situations where the firm does not maintain records 
electronically, the information for the specific foods and date ranges 
could be input manually into such software. We therefore estimate any 
additional burden posed by proposed Sec.  1.1455(b)(3) would be 
negligible. We invite comment on this estimated burden.

                                  Table 12--Estimated Annual Disclosure Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                    Number of       Number of      Total annual     burden per
  Proposed disclosure activity     respondents   disclosures per    disclosures     disclosure      Total hours
                                                    respondent                      (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.   1.1350(b)(2); farms.....           9,459            1,000       9,459,000           0.004          37,836
                                --------------------------------------------------------------------------------
    Total......................  ..............  ...............  ..............  ..............  ..............
----------------------------------------------------------------------------------------------------------------

    In addition to the disclosures that entities other than farms must 
make under proposed Sec.  1.1350(b), farms would incur additional 
burden attributable to requirements to disclose information (if 
applicable) about the origination, harvesting, cooling, and packing of 
the food the farm shipped. In table 12 we estimate that 9,459 farms 
will need to make 1,000 such disclosures, resulting in a total 
disclosure burden of 37,836 hours. We

[[Page 60028]]

invite comment on this estimated disclosure burden for farms under 
proposed Sec.  1.1350(b)(2).
    To ensure that comments on information collection are received, OMB 
recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain (see ADDRESSES). All comments should 
be identified with the title of the information collection.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3407(d)), we have submitted the information collection provisions of 
this proposed rule to OMB for review. These information collection 
requirements will not be effective until FDA publishes a final rule, 
OMB approves the information collection requirements, and the rule goes 
into effect. We will announce OMB approval of the information 
collection requirements in the Federal Register.

X. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
the proposed rule does not contain policies that have substantial 
direct effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
we conclude that the rule does not contain policies that have 
federalism implications as defined in the Executive order and, 
consequently, a federalism summary impact statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13175. We have tentatively 
determined that the rule does not contain policies that would have a 
substantial direct effect on one or more Indian Tribes, on the 
relationship between the Federal Government and Indian Tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian Tribes. We invite comments from tribal officials 
on any potential impact on Indian Tribes from this proposed action.

XII. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they are also available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. FDA has verified the website addresses as of 
the date this document publishes in the Federal Register, but websites 
are subject to change over time.

1. * Institute of Food Technologists, ``Task Order No. 7 Final 
Report (revised): Tracing systems: an exercise exploring data needs 
and design,'' 2009.
2. * The SoyNut Butter Co., ``The Soynut Butter Co Recalls I.M. 
Healthy Original Creamy Soynut Butter Because of Possible Health 
Risk,'' March 3, 2017 (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/soynut-butter-co-recalls-im-healthy-original-creamy-soynut-butter-because-possible-health-risk).
3. * CDC, ``Multistate Outbreak of Shiga Toxin-Producing Escherichia 
coli O157:H7 Infections Linked to I.M. Healthy Brand SoyNut Butter 
(Final Update),'' May 4, 2017 (https://www.cdc.gov/ecoli/2017/o157h7-03-17/index.html).
4. * FDA, ``FDA Investigated Multistate Outbreak of E. coli O157:H7 
Infections Linked to SoyNut Butter,'' May 4, 2017 (https://www.fda.gov/food/outbreaks-foodborne-illness/fda-investigated-multistate-outbreak-e-coli-o157h7-infections-linked-soynut-butter).
5. * Pro Sports Club, ``Pro Sports Club Recalls Yogurt Peanut Crunch 
Bar Because of Possible Health Risk,'' March 24, 2017 (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pro-sports-club-recalls-yogurt-peanut-crunch-bar-because-possible-health-risk).
6. Laughlin, M., L. Bottichio, J. Weiss, et al., ``Multistate 
Outbreak of Salmonella Poona Infections Associated with Imported 
Cucumbers, 2015-2016,'' Epidemiology and Infection, 147:1017, 2019.
7. Cavallaro, E., K. Date, C. Medus, et al., ``Salmonella 
Typhimurium Infections Associated with Peanut Products,'' New 
England Journal of Medicine, 365:601-610, 2011.
8. Bottichio, L., A. Keaton, D. Thomas, et al., ``Shiga Toxin-
Producing E. coli Infections Associated With Romaine Lettuce--United 
States, 2018,'' Clinical Infectious Diseases, ciz1182, 2019.
9. Abanyie, F., R.R. Harvey, J.R. Harris, et al., ``2013 multistate 
outbreaks of Cyclospora cayetanensis infections associated with 
fresh produce: Focus on the Texas investigations,'' Epidemiology and 
Infection, 143:3451-3458, 2015.
10. * FDA, ``Outbreak Investigation of Scombrotoxin Fish Poisoning: 
Yellowfin/Ahi Tuna (November 2019),'' January 24, 2020 (https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-scombrotoxin-fish-poisoning-yellowfinahi-tuna-november-2019).
11. Hassan, R., B. Whitney, D.L. Williams, et al., ``Multistate 
Outbreaks of Salmonella Infections Linked to Imported Maradol 
Papayas--United States, December 2016-September 2017,'' Epidemiology 
and Infection, 147:E265, 2019.
12. * Institute of Food Technologists, ``Pilot Projects for 
Improving Product Tracing Along the Food Supply System--Final 
Report,'' August 2012 (https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=3&ved=2ahUKEwiIouiZ6tvnAhU7kHIEHWMoDS0QFjACegQIAxAB&url=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F124149%2Fdownload&usg=AOvVaw0eWDUpKtLegiKqn_c9NdU1).
13. * FDA, ``Report to Congress on Enhancing Tracking and Tracing of 
Food and Recordkeeping. Submitted Pursuant to Section 204 of the FDA 
Food Safety Modernization Act, Public Law 111-353,'' November 16, 
2016 (https://www.fda.gov/media/102784/download).
14. * FDA, ``FDA's Response to External Peer Review--Model Review on 
FDA's `Draft Report for Peer Review: Risk-Ranking Model for Product 
Tracing as Required by Section 204 of FSMA' (September 2015),'' 
August 2020.
15. * FDA, ``FDA's Response to External Peer Review--Data Review on 
FDA's `Draft Report for Peer Review: Risk-Ranking Model for Product 
Tracing as Required by Section 204 of FSMA' (September 2015),'' 
August 2020.
16. * FDA Memorandum, ``Methodological Approach to Developing a 
Risk-Ranking Model for Food Tracing FSMA Section 204 (21 U.S. Code 
Sec.  2223),'' August 2020 (https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-reports-studies).
17. * FDA Memorandum, ``Designation of the Food Traceability List 
Using the Risk-Ranking Model for Food Tracing (2019 Version),'' 
September 2, 2020.
18. * FDA Memorandum, ``Food Traceability List for Requirements for 
Additional Traceability Records for Certain Foods Proposed Rule 
2020,'' August 12, 2020.
19. * FDA Memorandum, ``Summary of Meetings With Stakeholders on 
Development of Additional Recordkeeping Requirements for Certain 
Foods Under Section 204(d) of the FDA Food Safety Modernization 
Act,'' July 20, 2020.
20. Sterling, B., M. Gooch, B. Dent, et al., ``Assessing the Value 
and Role of Seafood Traceability from an Entire Value-Chain 
Perspective,'' Comprehensive Reviews in Food Science and Food 
Safety, 14:205-268, 2015.
21. * FDA, ``A New Era of Smarter Food Safety; Public Meeting; 
Request for Comments,'' Docket No. 2019-N-4187, September 18, 2019 
(https://www.federalregister.gov/documents/

[[Page 60029]]

2019/09/18/2019-20229/a-new-era-of-smarter-food-safety-public-
meeting-request-for-comments).
22. * FDA Memorandum, ``Inclusion of Retail Establishments of All 
Sizes Under FSMA Section 204,'' August 13, 2020.
23. National Advisory Committee on Microbiological Criteria for 
Foods, ``Microbiological Safety Evaluations and Recommendations on 
Sprouted Seeds,'' International Journal of Food Microbiology 52(3): 
123-153 (1999).
24. * FDA Memorandum, ``2012-2020 Sprout-Related Outbreak Data,'' 
July 20, 2020.
25. * FDA, ``Reducing Microbial Food Safety Hazards in the 
Production of Seed for Sprouting: Guidance for Industry'' (Draft 
Guidance), June 2019 (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-reducing-microbial-food-safety-hazards-production-seed-sprouting).
26. * FDA, ``Preliminary Regulatory Impact Analysis; Initial 
Regulatory Flexibility Analysis; Unfunded Mandates Reform Act 
Analysis,'' Docket No. FDA-2014-N-0053, September 2020.

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 1 be amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for part 1 is revised to read as follows:

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 
350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 
374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 
241, 243, 262, 264, 271.

0
2. Add subpart S, consisting of Sec. Sec.  1.1300 through 1.1465, to 
read as follows:
Subpart S--Additional Traceability Records for Certain Foods
Sec.

General Provisions

1.1300 Who is subject to this subpart?
1.1305 What foods and persons are exempt from this subpart?
1.1310 What definitions apply to this subpart?

Traceability Program Records

1.1315 What traceability program records must I have for foods on 
the Food Traceability List that I manufacture, process, pack, or 
hold?
1.1320 When must I establish and assign traceability lot codes to 
foods on the Food Traceability List?

Records of Growing, Receiving, Transforming, Creating, and Shipping 
Food

1.1325 What records must I keep when I grow a food on the Food 
Traceability List?
1.1330 What records must I keep when I am the first receiver of a 
food on the Food Traceability List?
1.1335 What records must I keep when I receive a food on the Food 
Traceability List?
1.1340 What records must I keep when I transform a food on the Food 
Traceability List?
1.1345 What records must I keep when I create a food on the Food 
Traceability List?
1.1350 What records must I keep and send when I ship a food on the 
Food Traceability List?

Special Requirements for Certain Persons and Foods

1.1355 What recordkeeping requirements apply to foods on the Food 
Traceability List that are subjected to a kill step?

Procedures for Modified Requirements and Exemptions

1.1360 Under what circumstances will FDA modify the requirements in 
this subpart that apply to a food or type of entity or exempt a food 
or type of entity from the requirements of this subpart?
1.1365 When will FDA consider whether to adopt modified requirements 
or grant an exemption from the requirements of this subpart?
1.1370 What must be included in a petition requesting modified 
requirements or an exemption from the requirements?
1.1375 What information submitted in a petition requesting modified 
requirements or an exemption, or information in comments on such a 
petition, is publicly available?
1.1380 What process applies to a petition requesting modified 
requirements or an exemption?
1.1385 What process will FDA follow when adopting modified 
requirements or granting an exemption on our own initiative?
1.1390 When will modified requirements that we adopt or an exemption 
that we grant become effective?
1.1395 Under what circumstances may FDA revise or revoke modified 
requirements or an exemption?
1.1400 What procedures apply if FDA tentatively determines that 
modified requirements or an exemption should be revised or revoked?

Waivers

1.1405 Under what circumstances will FDA waive one or more of the 
requirements of this subpart for an individual entity or a type of 
entity?
1.1410 When will FDA consider whether to waive a requirement of this 
subpart?
1.1415 How may I request a waiver for an individual entity?
1.1420 What process applies to a request for a waiver for an 
individual entity?
1.1425 What must be included in a petition requesting a waiver for a 
type of entity?
1.1430 What information submitted in a petition requesting a waiver 
for a type of entity, or information in comments on such a petition, 
is publicly available?
1.1435 What process applies to a petition requesting a waiver for a 
type of entity?
1.1440 What process will FDA follow when waiving a requirement of 
this subpart on our own initiative?
1.1445 Under what circumstances may FDA modify or revoke a waiver?
1.1450 What procedures apply if FDA tentatively determines that a 
waiver should be modified or revoked?

Records Maintenance and Availability

1.1455 How must records required by this subpart be maintained?

Consequences of Failure To Comply

1.1460 What consequences could result from failing to comply with 
the requirements of this subpart?

Updating the Food Traceability List

1.1465 How will FDA update the Food Traceability List?

Subpart S--Additional Traceability Records for Certain Foods

General Provisions

Sec.  1.1300   Who is subject to this subpart?

    Except as specified otherwise in this subpart, the requirements in 
this subpart apply to persons who manufacture, process, pack, or hold 
foods that appear on the list of foods for which additional 
traceability records are required in accordance with section 204(d)(2) 
of the FDA Food Safety Modernization Act (Food Traceability List). FDA 
will publish the Food Traceability List on its website in accordance 
with section 204(d)(2)(B) of the FDA Food Safety Modernization Act.

Sec.  1.1305   What foods and persons are exempt from this subpart?

    (a) Exemptions for small originators--(1) Certain produce farms. 
This subpart does not apply to farms or the farm activities of farm 
mixed-type facilities with respect to the produce (as defined in Sec.  
112.3 of this chapter) they grow, when the farm is not a covered farm 
under part 112 of this chapter in accordance with Sec.  112.4(a) of 
this chapter.
    (2) Certain shell egg producers. This subpart does not apply to 
shell egg producers with fewer than 3,000 laying hens at a particular 
farm, with respect to the shell eggs they produce at that farm.
    (3) Certain other originators of food. This subpart does not apply 
to

[[Page 60030]]

originators of food with an average annual monetary value of food sold 
during the previous 3-year period of no more than $25,000 (on a rolling 
basis), adjusted for inflation using 2019 as the baseline year for 
calculating the adjustment.
    (b) Exemption for farms when food is sold directly to consumers. 
This subpart does not apply to a farm with respect to food produced on 
the farm (including food that is also packaged on the farm) that is 
sold directly to a consumer by the owner, operator, or agent in charge 
of the farm.
    (c) Inapplicability to certain food produced and packaged on a 
farm. This subpart does not apply to food produced and packaged on a 
farm, provided that:
    (1) The packaging of the food remains in place until the food 
reaches the consumer, and such packaging maintains the integrity of the 
product and prevents subsequent contamination or alteration of the 
product; and
    (2) The labeling of the food that reaches the consumer includes the 
name, complete address (street address, town, State, country, and zip 
or other postal code for a domestic farm and comparable information for 
a foreign farm), and business phone number of the farm on which the 
food was produced and packaged. Upon request, FDA will waive the 
requirement to include a business phone number, as appropriate, to 
accommodate a religious belief of the individual in charge of the farm.
    (d) Inapplicability to foods that receive certain types of 
processing. This subpart does not apply to the following foods that 
receive certain processing:
    (1) Produce that receives commercial processing that adequately 
reduces the presence of microorganisms of public health significance, 
provided the conditions set forth in Sec.  112.2(b) of this chapter are 
met for the produce; and
    (2) Shell eggs when all eggs produced at the particular farm 
receive a treatment (as defined in Sec.  118.3 of this chapter) in 
accordance with Sec.  118.1(a)(2) of this chapter.
    (e) Exemption for produce that is rarely consumed raw. This subpart 
does not apply to produce that is listed as rarely consumed raw in 
Sec.  112.2(a)(1) of this chapter.
    (f) Partial exemption of commingled raw agricultural commodities. 
(1) Except as specified in paragraph (f)(2) of this section, this 
subpart does not apply to commingled raw agricultural commodities. For 
the purpose of this subpart, a ``commingled raw agricultural 
commodity'' means any commodity that is combined or mixed after 
harvesting but before processing, except that the term ``commingled raw 
agricultural commodity'' does not include types of fruits and 
vegetables that are raw agricultural commodities to which the standards 
for the growing, harvesting, packing, and holding of produce for human 
consumption in part 112 of this chapter apply. For purposes of this 
paragraph (f)(1), a commodity is ``combined or mixed'' only when the 
combination or mixing involves food from different farms. Also, for 
purposes of this paragraph (f)(1), the term ``processing'' means 
operations that alter the general state of the commodity, such as 
canning, cooking, freezing, dehydration, milling, grinding, 
pasteurization, or homogenization.
    (2) With respect to a commingled raw agricultural commodity that 
receives the exemption set forth in paragraph (f)(1) of this section, 
if a person who manufactures, processes, packs, or holds such 
commingled raw agricultural commodity is required to register with FDA 
under section 415 of the Federal Food, Drug, and Cosmetic Act with 
respect to the manufacturing, processing, packing, or holding of the 
applicable raw agricultural commodity, in accordance with the 
requirements of subpart H of this part, such person must maintain 
records identifying the immediate previous source of such raw 
agricultural commodity and the immediate subsequent recipient of such 
food in accordance with Sec. Sec.  1.337 and 1.345. Such records must 
be maintained for 2 years.
Option 1 for Paragraph (g)
    (g) Exemption for small retail food establishments. This subpart 
does not apply to retail food establishments that employ 10 or fewer 
full-time equivalent employees. The number of full-time equivalent 
employees is based on the number of such employees at each retail food 
establishment and not the entire business, which may own numerous 
retail stores.
Option 2 for Paragraph (g)
    (g) Partial exemption for small retail food establishments. The 
requirement in Sec.  1.1455(b)(3) to make available to FDA under 
specified circumstances an electronic sortable spreadsheet containing 
the information required to be maintained under this subpart (for the 
foods and date ranges specified in FDA's request) does not apply to 
retail food establishments that employ 10 or fewer full-time equivalent 
employees. The number of full-time equivalent employees is based on the 
number of such employees at each retail food establishment and not the 
entire business, which may own numerous retail stores.
    (h) Partial exemption for retail food establishments. (1) Except as 
specified in paragraph (h)(2) of this section, the recordkeeping 
requirements of this subpart do not apply to a retail food 
establishment with respect to a food that is produced on a farm 
(including food produced and packaged on the farm) and sold directly to 
the retail food establishment by the owner, operator, or agent in 
charge of that farm.
    (2) When a retail food establishment purchases a food on the Food 
Traceability List directly from a farm in accordance with paragraph 
(h)(1) of this section, the retail food establishment must establish 
and maintain a record documenting the name and address of the farm that 
was the source of the food. The retail food establishment must maintain 
such records for 180 days.
    (i) Partial exemption for farm to school and farm to institution 
programs. (1) Except as specified in paragraph (i)(2) of this section, 
this subpart does not apply to an institution operating a child 
nutrition program authorized under the Richard B. Russell National 
School Lunch Act or Section 4 of the Child Nutrition Act of 1966, or 
any other entity conducting a farm to school or farm to institution 
program, with respect to a food that is produced on a farm (including 
food produced and packaged on the farm) and sold directly to the school 
or institution.
    (2) When a school or institution conducting farm to school or farm 
to institution activities purchases a food directly from a farm in 
accordance with paragraph (i)(1) of this section, the school food 
authority or relevant food procurement entity must establish and 
maintain a record documenting the name and address of the farm that was 
the source of the food. The school food authority or relevant food 
procurement entity must maintain such records for 180 days.
    (j) Partial exemption for food produced through the use of fishing 
vessels. (1) Except as specified in paragraph (j)(2) of this section, 
with respect to a food that is produced through the use of a fishing 
vessel, this subpart does not apply to the owner, operator, or agent in 
charge of the fishing vessel.
    (2) With respect to the owner, operator, or agent in charge of the 
fishing vessel who receives the partial exemption set forth in 
paragraph (j)(1) of this section, if such person is required to 
register with FDA under section 415 of the Federal Food, Drug, and 
Cosmetic Act with respect to the manufacturing, processing, packing, or 
holding of the

[[Page 60031]]

applicable food, in accordance with the requirements of subpart H of 
this part, such person must maintain records identifying the immediate 
previous source of such food and the immediate subsequent recipient of 
such food in accordance with Sec. Sec.  1.337 and 1.345. Such records 
must be maintained for 2 years.
    (k) Exemption for transporters. This subpart does not apply to 
transporters of food.
    (l) Exemption for nonprofit food establishments. This subpart does 
not apply to nonprofit food establishments.
    (m) Exemption for persons who manufacture, process, pack, or hold 
food for personal consumption. This subpart does not apply to persons 
who manufacture, process, pack, or hold food for personal consumption.
    (n) Exemption for certain persons who hold food on behalf of 
individual consumers. This subpart does not apply to persons who hold 
food on behalf of specific individual consumers, provided that these 
persons:
    (1) Are not parties to the transaction involving the food they 
hold; and
    (2) Are not in the business of distributing food.

Sec.  1.1310   What definitions apply to this subpart?

    The definitions of terms in section 201 of the Federal Food, Drug, 
and Cosmetic Act apply to such terms when used in this subpart. In 
addition, the following definitions apply to words and phrases as they 
are used in this subpart:
    Category means a code or term used to classify a food product in 
accordance with a recognized industry or regulatory classification 
scheme, or a classification scheme a person develops for their own use.
    Cooling means active temperature reduction of a food using 
hydrocooling, icing, forced air cooling, vacuum cooling, or a similar 
process, either before or after packing.
    Creating means making or producing a food on the Food Traceability 
List (e.g., through manufacturing or processing) using only 
ingredient(s) that are not on the Food Traceability List. Creating does 
not include originating or transforming a food.
    Critical tracking event means an event in the supply chain of a 
food involving the growing, receiving (including receipt by a first 
receiver), transforming, creating, or shipping of the food.
    Farm means farm as defined in Sec.  1.328. For producers of shell 
eggs, ``farm'' means all poultry houses and grounds immediately 
surrounding the poultry houses covered under a single biosecurity 
program, as set forth in Sec.  118.3 of this chapter.
    First receiver means the first person (other than a farm) who 
purchases and takes physical possession of a food on the Food 
Traceability List that has been grown, raised, caught, or (in the case 
of a non-produce commodity) harvested.
    Fishing vessel means any vessel, boat, ship, or other craft which 
is used for, equipped to be used for, or of a type which is normally 
used for fishing or aiding or assisting one or more vessels at sea in 
the performance of any activity relating to fishing, including, but not 
limited to, preparation, supply, storage, refrigeration, 
transportation, or processing.
    Food Traceability List means the list of foods for which additional 
traceability records are required to be maintained, as designated in 
accordance with section 204(d)(2) of the FDA Food Safety Modernization 
Act. The term ``Food Traceability List'' includes both the foods 
specifically listed and foods that contain specifically listed foods as 
ingredients.
    Growing area coordinates means the geographical coordinates (under 
the global positioning system or latitude/longitude) for the entry 
point of the physical location where the food was grown and harvested.
    Harvesting applies to farms and farm mixed-type facilities and 
means activities that are traditionally performed on farms for the 
purpose of removing raw agricultural commodities from the place they 
were grown or raised and preparing them for use as food. Harvesting is 
limited to activities performed on raw agricultural commodities, or on 
processed foods created by drying/dehydrating a raw agricultural 
commodity without additional manufacturing/processing, on a farm. 
Harvesting does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of 
harvesting include cutting (or otherwise separating) the edible portion 
of the raw agricultural commodity from the crop plant and removing or 
trimming part of the raw agricultural commodity (e.g., foliage, husks, 
roots, or stems). Examples of harvesting also include collecting eggs, 
taking of fish and other seafood in aquaculture operations, milking, 
field coring, filtering, gathering, hulling, shelling, sifting, 
threshing, trimming of outer leaves of, and washing raw agricultural 
commodities grown on a farm.
    Holding means storage of food and also includes activities 
performed incidental to storage of a food (e.g., activities performed 
for the safe or effective storage of that food, such as fumigating food 
during storage, and drying/dehydrating raw agricultural commodities 
when the drying/dehydrating does not create a distinct commodity (such 
as drying/dehydrating hay or alfalfa)). Holding also includes 
activities performed as a practical necessity for the distribution of 
that food (such as blending of the same raw agricultural commodity and 
breaking down pallets) but does not include activities that transform a 
raw agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities 
include warehouses, cold storage facilities, storage silos, grain 
elevators, and liquid storage tanks.
    Key data element means information associated with a critical 
tracking event for which a record must be established and maintained in 
accordance with this subpart.
    Kill step means processing that significantly minimizes pathogens 
in a food.
    Location description means a complete physical address and other 
key contact information, specifically the business name, physical 
location name, primary phone number, physical location street address 
(or geographical coordinates), city, state, and zip code for domestic 
facilities and comparable information for foreign facilities, including 
country; except that for fishing vessels, location description means 
the name of the fishing vessel that caught the seafood, the country in 
which the fishing vessel's license (if any) was issued, and a point of 
contact for the fishing vessel.
    Location identifier means a unique identification code that an 
entity assigns to the physical location name identified in the 
corresponding location description; except that for fishing vessels, 
location identifier means the vessel identification number or license 
number (both if available) for the fishing vessel.
    Lot means the food produced during a period of time at a single 
physical location and identified by a specific code. A lot may also be 
referred to as a batch or production run.
    Manufacturing/processing means making food from one or more 
ingredients, or synthesizing, preparing, treating, modifying, or 
manipulating food, including food crops or ingredients. Examples of 
manufacturing/processing activities include baking, boiling, bottling, 
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw

[[Page 60032]]

agricultural commodities to create a distinct commodity (such as 
drying/dehydrating grapes to produce raisins), evaporating, 
eviscerating, extracting juice, formulating, freezing, grinding, 
homogenizing, irradiating, labeling, milling, mixing, packaging 
(including modified atmosphere packaging), pasteurizing, peeling, 
rendering, treating to manipulate ripening, trimming, washing, or 
waxing. For farms and farm mixed-type facilities, manufacturing/
processing does not include activities that are part of harvesting, 
packing, or holding.
    Mixed-type facility means an establishment that engages in both 
activities that are exempt from registration under section 415 of the 
Federal Food, Drug, and Cosmetic Act and activities that require the 
establishment to be registered. An example of such a facility is a 
``farm mixed-type facility,'' which is an establishment that is a farm, 
but also conducts activities outside the farm definition that require 
the establishment to be registered.
    Nonprofit food establishment means a charitable entity that 
prepares or serves food directly to the consumer or otherwise provides 
food or meals for consumption by humans or animals in the United 
States. The term includes central food banks, soup kitchens, and 
nonprofit food delivery services. To be considered a nonprofit food 
establishment, the establishment must meet the terms of section 
501(c)(3) of the U.S. Internal Revenue Code (26 U.S.C. 501(c)(3)).
    Originating means an event in a food's supply chain involving the 
growing, raising, or catching of a food (typically on a farm, a ranch, 
or at sea), or the harvesting of a non-produce commodity.
    Originator means a person who grows, raises, or catches a food, or 
harvests a non-produce commodity.
    Packing means placing food into a container other than packaging 
the food and also includes re-packing and activities performed 
incidental to packing or re-packing a food (e.g., activities performed 
for the safe or effective packing or re-packing of that food (such as 
sorting, culling, grading, and weighing or conveying incidental to 
packing or re-packing)), but does not include activities that transform 
a raw agricultural commodity, as defined in section 201(r) of the 
Federal Food, Drug, and Cosmetic Act, into a processed food as defined 
in section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
    Person includes an individual, partnership, corporation, and 
association.
    Physical location name means the word(s) used to identify the 
specific physical site of a business entity where a particular critical 
tracking event occurs. A physical location name might be the same as an 
entity's business name if the entity has only one physical location.
    Point of contact means an individual having familiarity with an 
entity's procedures for traceability, including their name, telephone 
number, and, if available, their email address and fax number.
    Produce means produce as defined in Sec.  112.3 of this chapter.
    Receiving means an event in a food's supply chain in which a food 
is received by a customer (other than a consumer) at a defined location 
after being transported (e.g., by truck or ship) from another defined 
location.
    Reference record means a record used to identify an event in the 
supply chain of a food, such as a shipping, receiving, growing, 
creating, or transformation event. Types of reference records include, 
but are not limited to, bills of lading, purchase orders, advance 
shipping notices, work orders, invoices, batch logs, production logs, 
and receipts.
    Reference record number means the identification number assigned to 
a reference record, such as a purchase order number, bill of lading 
number, or work order number.
    Retail food establishment means an establishment that sells food 
products directly to consumers as its primary function. The term 
``retail food establishment'' includes facilities that manufacture, 
process, pack, or hold food if the establishment's primary function is 
to sell from that establishment food, including food that it 
manufactures, processes, packs, or holds, directly to consumers. A 
retail food establishment's primary function is to sell food directly 
to consumers if the annual monetary value of sales of food products 
directly to consumers exceeds the annual monetary value of sales of 
food products to all other buyers. The term ``consumers'' does not 
include businesses. A ``retail food establishment'' includes grocery 
stores, convenience stores, and vending machine locations. A ``retail 
food establishment'' also includes certain farm-operated businesses 
selling food directly to consumers as their primary function.
    (1) Sale of food directly to consumers from an establishment 
located on a farm includes sales by that establishment directly to 
consumers:
    (i) At a roadside stand (a stand situated on the side of or near a 
road or thoroughfare at which a farmer sells food from his or her farm 
directly to consumers) or farmers' market (a location where one or more 
local farmers assemble to sell food from their farms directly to 
consumers);
    (ii) Through a community supported agriculture program. Community 
supported agriculture (CSA) program means a program under which a 
farmer or group of farmers grows food for a group of shareholders (or 
subscribers) who pledge to buy a portion of the farmer's crop(s) for 
that season. This includes CSA programs in which a group of farmers 
consolidate their crops at a central location for distribution to 
shareholders or subscribers; and
    (iii) At other such direct-to-consumer sales platforms, including 
door-to-door sales; mail, catalog and internet order, including online 
farmers' markets and online grocery delivery; religious or other 
organization bazaars; and State and local fairs.
    (2) Sale of food directly to consumers by a farm-oriented business 
includes the sale of food by that farm-operated business directly to 
consumers:
    (i) At a roadside stand (a stand situated on the side of or near a 
road or thoroughfare at which a farmer sells food from his or her farm 
directly to consumers) or farmers' market (a location where one or more 
local farmers assemble to sell food from their farms directly to 
consumers);
    (ii) Through a community supported agriculture program. Community 
supported agriculture (CSA) program means a program under which a 
farmer or group of farmers grows food for a group of shareholders (or 
subscribers) who pledge to buy a portion of the farmer's crop(s) for 
that season. This includes CSA programs in which a group of farmers 
consolidate their crops at a central location for distribution to 
shareholders or subscribers; and
    (iii) At other such direct-to-consumer sales platforms, including 
door-to-door sales; mail, catalog and internet order, including online 
farmers' markets and online grocery delivery; religious or other 
organization bazaars; and State and local fairs.
    (3) For the purposes of this definition, ``farm-operated business'' 
means a business that is managed by one or more farms and conducts 
manufacturing/processing not on the farm(s).
    Shipping means an event in a food's supply chain in which a food is 
arranged for transport (e.g., by truck or ship) from a defined location 
to another defined location at a different farm, a first receiver, or a 
subsequent receiver. Shipping does not include the sale or shipment of 
a food directly to a

[[Page 60033]]

consumer or the donation of surplus food.
    Traceability lot means a lot of food that has been originated, 
transformed, or created.
    Traceability lot code means a descriptor, often alphanumeric, used 
to identify a traceability lot.
    Traceability lot code generator means the person who assigns a 
traceability lot code to a product.
    Traceability product description means a description of a food 
product typically used commercially for purchasing, stocking, or 
selling, and includes the category code or term, category name, and 
trade description. For single-ingredient products, the trade 
description includes the brand name, commodity, variety, packaging 
size, and packaging style. For multiple-ingredient food products, the 
trade description includes the brand name, product name, packaging 
size, and packaging style.
    Traceability product identifier means a unique identification code 
(such as an alphanumeric code) that an entity assigns to designate a 
specific type of food product.
    Transformation means an event in a food's supply chain that 
involves changing a food on the Food Traceability List, its package, 
and/or its label (regarding the traceability lot code or traceability 
product identifier), such as by combining ingredients or processing a 
food (e.g., by cutting, cooking, commingling, repacking, or 
repackaging). Transformation does not include the initial packing of a 
single-ingredient food or creating a food.
    Transporter means a person who has possession, custody, or control 
of an article of food for the sole purpose of transporting the food, 
whether by road, rail, water, or air.
    Vessel identification number means the number assigned to a fishing 
vessel by the International Maritime Organization, or by any entity or 
organization, for the purpose of uniquely identifying the vessel.
    You means a person subject to this subpart under Sec.  1.1300.

Traceability Program Records

Sec.  1.1315   What traceability program records must I have for foods 
on the Food Traceability List that I manufacture, process, pack, or 
hold?

    (a) If you are subject to the requirements in this subpart, you 
must establish and maintain records containing the following 
information:
    (1) A description of the reference records in which you maintain 
the information required under this subpart, an explanation of where on 
the records the required information appears, and, if applicable, a 
description of how reference records for different tracing events for a 
food (e.g., receipt, transformation, shipment) are linked;
    (2) A list of foods on the Food Traceability List that you ship, 
including the traceability product identifier and traceability product 
description for each food;
    (3) A description of how you establish and assign traceability lot 
codes to foods on the Food Traceability List you originate, transform, 
or create, if applicable; and
    (4) Any other information needed to understand the data provided 
within any records required by this subpart, such as internal or 
external coding systems, glossaries, and abbreviations.
    (b) You must retain the records required under paragraph (a) of 
this section for 2 years after their use is discontinued (e.g., because 
you change the records in which you maintain required information, you 
update the list of foods on the Food Traceability List that you ship, 
or you change your procedures for establishing and assigning 
traceability lot codes).

Sec.  1.1320   When must I establish and assign traceability lot codes 
to foods on the Food Traceability List?

    (a) You must establish and assign a traceability lot code when you 
originate, transform, or create a food on the Food Traceability List.
    (b) Except as specified otherwise in this subpart, you may not 
establish a new traceability lot code when you conduct other activities 
(e.g., shipping, receiving) in the supply chain for a food on the Food 
Traceability List.

Records of Growing, Receiving, Transforming, Creating, and Shipping 
Food

Sec.  1.1325   What records must I keep when I grow a food on the Food 
Traceability List?

    For each food on the Food Traceability List that you grow, you must 
establish and maintain records containing and linking the traceability 
lot code of the food to the following information:
    (a) The growing area coordinates; and
    (b) For growers of sprouts, the following information (if 
applicable):
    (1) The location identifier and location description of the grower 
of seeds for sprouting, the associated seed lot code assigned by the 
seed grower, and the date of seed harvesting;
    (2) The location identifier and location description of the seed 
conditioner or processor, the associated seed lot code assigned by the 
seed conditioner or processor, and the date of conditioning or 
processing;
    (3) The location identifier and location description of the seed 
packinghouse (including any repackers, if applicable), the associated 
seed lot code assigned by the seed packinghouse, and the date of 
packing (and of repacking, if applicable);
    (4) The location identifier and location description of the seed 
supplier;
    (5) A description of the seeds, including the seed type or 
taxonomic name, growing specifications, volume, type of packaging, and 
antimicrobial treatment;
    (6) The seed lot code assigned by the seed supplier, including the 
master lot and sub-lot codes, and any new seed lot code assigned by the 
sprouter;
    (7) The date of receipt of the seeds by the sprouter; and
    (8) For each lot code for seeds received by the sprouter, the 
sprout traceability lot code(s) and the date(s) of production 
associated with that seed lot code.

Sec.  1.1330   What records must I keep when I am the first receiver of 
a food on the Food Traceability List?

    (a) Except as specified in paragraph (b) of this section, in 
addition to the records of receipt of foods required under Sec.  
1.1335, the first receiver of a food on the Food Traceability List must 
establish and maintain records containing and linking the traceability 
lot code of the food received to the following information:
    (1) The location identifier and location description of the 
originator of the food;
    (2) The business name, point of contact, and phone number of the 
harvester of the food, and the date(s) and time(s) of harvesting;
    (3) The location identifier and location description of the place 
where the food was cooled, and the date and time of cooling (if 
applicable); and
    (4) The location identifier and location description of the place 
where the food was packed, and the date and time of packing.
    (b) If you are the first receiver of a seafood product on the Food 
Traceability List that was obtained from a fishing vessel, in addition 
to the records of receipt of foods required under Sec.  1.1335, you 
must establish and maintain records containing and linking the 
traceability lot code of the seafood product received to the harvest 
date range and locations (National Marine Fisheries Service Ocean 
Geographic Code or geographical coordinates) for the trip during which 
the seafood was caught.
    (c) If you are the first receiver of a food on the Food 
Traceability List to

[[Page 60034]]

which the originator of the food has not assigned a traceability lot 
code, you must establish a traceability lot code for the food and 
maintain a record of the traceability lot code linked to the 
information specified in paragraph (a) or (b) of this section (as 
applicable to the type of food received).

Sec.  1.1335   What records must I keep when I receive a food on the 
Food Traceability List?

    For each food on the Food Traceability List you receive, you must 
establish and maintain records containing and linking the traceability 
lot code of the food to the following information:
    (a) The location identifier and location description for the 
immediate previous source (other than a transporter) of the food;
    (b) The entry number(s) assigned to the food (if the food is 
imported);
    (c) The location identifier and location description of where the 
food was received, and date and time you received the food;
    (d) The quantity and unit of measure of the food (e.g., 6 cases, 25 
returnable plastic containers, 100 tanks, 200 pounds);
    (e) The traceability product identifier and traceability product 
description for the food;
    (f) The location identifier, location description, and point of 
contact for the traceability lot code generator;
    (g) The reference record type(s) and reference record number(s) 
(e.g., ``Invoice 750A,'' ``BOL 042520 XYZ'') for the document(s) 
containing the information specified in paragraphs (a) through (f) of 
this section; and
    (h) The name of the transporter who transported the food to you.

Sec.  1.1340   What records must I keep when I transform a food on the 
Food Traceability List?

    (a) Except as specified in paragraph (b) of this section, for each 
new traceability lot of food produced through transformation you must 
establish and maintain records containing and linking the new 
traceability lot code of the food produced through transformation to 
the following information:
    (1) For the food(s) on the Food Traceability List used in 
transformation, the following information:
    (i) The traceability lot code(s) for the food;
    (ii) The traceability product identifier and traceability product 
description for the food to which the traceability lot code applies; 
and
    (iii) The quantity of each traceability lot of the food.
    (2) For the food produced through transformation, the following 
information:
    (i) The location identifier and location description for where you 
transformed the food (e.g., by a manufacturing/processing step), and 
the date transformation was completed;
    (ii) The new traceability product identifier and traceability 
product description for the food to which the new traceability lot code 
applies; and
    (iii) The quantity and unit of measure of the food for each new 
traceability lot code (e.g., 6 cases, 25 returnable plastic containers, 
100 tanks, 200 pounds).
    (3) The reference record type(s) and reference record number(s) 
(e.g., ``Production Log 123,'' ``Batch Log 01202021'') for the 
document(s) containing the information specified in paragraphs (a)(1) 
and (2) of this section.
    (b) Paragraph (a) of this section does not apply to retail food 
establishments with respect to foods they do not ship (e.g., foods they 
sell or send directly to consumers).

Sec.  1.1345   What records must I keep when I create a food on the 
Food Traceability List?

    (a) Except as specified in paragraph (b) of this section, for each 
food on the Food Traceability List you create, you must establish and 
maintain records containing and linking the traceability lot code of 
the food created to the following information:
    (1) The location identifier and location description for where you 
created the food (e.g., by a manufacturing/processing step), and the 
date creation was completed;
    (2) The traceability product identifier and traceability product 
description for the food;
    (3) The quantity and unit of measure of the food (e.g., 6 cases, 25 
returnable plastic containers, 100 tanks, 200 pounds); and
    (4) The reference record type(s) and reference record number(s) 
(e.g., ``Production Log 123,'' ``Batch Log 01202021'') for the 
document(s) containing the information specified in paragraphs (a)(1) 
through (3) of this section.
    (b) Paragraph (a) of this section does not apply to retail food 
establishments with respect to foods they do not ship (e.g., foods they 
sell or send directly to consumers).

Sec.  1.1350   What records must I keep and send when I ship a food on 
the Food Traceability List?

    (a) For each food on the Food Traceability List you ship, you must 
establish and maintain records containing and linking the traceability 
lot code of the food to the following information:
    (1) The entry number(s) assigned to the food (if the food is 
imported);
    (2) The quantity and unit of measure of the food (e.g., 6 cases, 25 
returnable plastic containers, 100 tanks, 200 pounds);
    (3) The traceability product identifier and traceability product 
description for the food;
    (4) The location identifier, location description, and point of 
contact for the traceability lot code generator;
    (5) The location identifier and location description for the 
immediate subsequent recipient (other than a transporter) of the food;
    (6) The location identifier and location description for the 
location from which you shipped the food, and date and time you shipped 
the food;
    (7) The reference record type(s) and reference record number(s) 
(e.g., ``BOL No. 123,'' ``ASN 10212025'') for the document(s) 
containing the information specified in paragraphs (a)(1) through 
(a)(6) of this section; and
    (8) The name of the transporter who transported the food from you.
    (b) You must send records (in electronic or other written form) 
containing the following information to the immediate subsequent 
recipient (other than a transporter) of each traceability lot that you 
ship:
    (1) The information in paragraphs (a)(1) through (6) of this 
section; and
    (2) If you are a farm, the following information (if applicable) 
for each traceability lot of the food:
    (i) A statement that you are a farm;
    (ii) The location identifier and location description of the 
originator of the food (if not you);
    (iii) The business name, point of contact, and phone number of the 
harvester of the food (if not you), and the date(s) and time(s) of 
harvesting;
    (iv) The location identifier and location description of the place 
where the food was cooled (if not by you), and the date and time of 
cooling; and
    (v) The location identifier and location description of the place 
where the food was packed (if not by you), and the date and time of 
packing.

Special Requirements for Certain Persons and Foods

Sec.  1.1355   What recordkeeping requirements apply to foods on the 
Food Traceability List that are subjected to a kill step?

    (a) If you apply a kill step to a food on the Food Traceability 
List, the requirements of this subpart do not apply to your subsequent 
shipping of the food, provided that you maintain a

[[Page 60035]]

record of your application of the kill step.
    (b) If you receive a food on the Food Traceability List that has 
been subjected to a kill step, the requirements of this subpart do not 
apply to your receipt or subsequent transformation and/or shipping of 
the food.

Procedures for Modified Requirements and Exemptions

Sec.  1.1360   Under what circumstances will FDA modify the 
requirements in this subpart that apply to a food or type of entity or 
exempt a food or type of entity from the requirements of this subpart?

    (a) General. Except as specified in paragraph (b) of this section, 
FDA will modify the requirements of this subpart applicable to a food 
or type of entity, or exempt a food or type of entity from the 
requirements of this subpart, when we determine that application of the 
requirements that would otherwise apply to the food or type of entity 
is not necessary to protect the public health.
    (b) Registered facilities. If a person to whom modified 
requirements or an exemption applies under paragraph (a) of this 
section (including a person who manufactures, processes, packs, or 
holds a food to which modified requirements or an exemption applies 
under paragraph (a) of this section) is required to register with FDA 
under section 415 of the Federal Food, Drug, and Cosmetic Act (and in 
accordance with the requirements of subpart H of this part) with 
respect to the manufacturing, processing, packing, or holding of the 
applicable food, such person must maintain records identifying the 
immediate previous source of such food and the immediate subsequent 
recipient of such food in accordance with Sec. Sec.  1.337 and 1.345. 
Such records must be maintained for 2 years.

Sec.  1.1365   When will FDA consider whether to adopt modified 
requirements or grant an exemption from the requirements of this 
subpart?

    FDA will consider modifying the requirements of this subpart 
applicable to a food or type of entity, or exempting a food or type of 
entity from the requirements of this subpart, on our own initiative or 
in response to a citizen petition submitted under Sec.  10.30 of this 
chapter by any interested party.

Sec.  1.1370   What must be included in a petition requesting modified 
requirements or an exemption from the requirements?

    In addition to meeting the requirements on the content and format 
of a citizen petition in Sec.  10.30 of this chapter, a petition 
requesting modified requirements or an exemption from the requirements 
of this subpart must:
    (a) Specify the food or type of entity to which the modified 
requirements or exemption would apply;
    (b) If the petition requests modified requirements, specify the 
proposed modifications to the requirements of this subpart; and
    (c) Present information demonstrating why application of the 
requirements requested to be modified or from which exemption is 
requested is not necessary to protect the public health.

Sec.  1.1375   What information submitted in a petition requesting 
modified requirements or an exemption, or information in comments on 
such a petition, is publicly available?

    FDA will presume that information submitted in a petition 
requesting modified requirements or an exemption, as well as 
information in comments submitted on such a petition, does not contain 
information exempt from public disclosure under part 20 of this chapter 
and will be made public as part of the docket associated with the 
petition.

Sec.  1.1380   What process applies to a petition requesting modified 
requirements or an exemption?

    (a) In general, the procedures set forth in Sec.  10.30 of this 
chapter govern FDA's response to a petition requesting modified 
requirements or an exemption. An interested person may submit comments 
on such a petition in accordance with Sec.  10.30(d) of this chapter.
    (b) Under Sec.  10.30(h)(3) of this chapter, FDA will publish a 
notification in the Federal Register requesting information and views 
on a submitted petition, including information and views from persons 
who could be affected by the modified requirements or exemption if we 
granted the petition.
    (c) Under Sec.  10.30(e)(3) of this chapter, we will respond to the 
petitioner in writing, as follows:
    (1) If we grant the petition either in whole or in part, we will 
publish a notification in the Federal Register setting forth any 
modified requirements or exemptions and the reasons for them.
    (2) If we deny the petition (including a partial denial), our 
written response to the petitioner will explain the reasons for the 
denial.
    (d) We will make readily accessible to the public, and periodically 
update, a list of petitions requesting modified requirements or 
exemptions, including the status of each petition (for example, 
pending, granted, or denied).

Sec.  1.1385   What process will FDA follow when adopting modified 
requirements or granting an exemption on our own initiative?

    (a) If FDA, on our own initiative, determines that adopting 
modified requirements or granting an exemption from the requirements 
for a food or type of entity is appropriate, we will publish a 
notification in the Federal Register setting forth the proposed 
modified requirements or exemption and the reasons for the proposal. 
The notification will establish a public docket so that interested 
persons may submit written comments on the proposal.
    (b) After considering any comments timely submitted, we will 
publish a notification in the Federal Register stating whether we are 
adopting modified requirements or granting an exemption, and the 
reasons for our decision.

Sec.  1.1390   When will modified requirements that we adopt or an 
exemption that we grant become effective?

    Any modified requirements that FDA adopts or exemption that we 
grant will become effective on the date that notice of the modified 
requirements or exemption is published in the Federal Register, unless 
otherwise stated in the notification.

Sec.  1.1395   Under what circumstances may FDA revise or revoke 
modified requirements or an exemption?

    FDA may revise or revoke modified requirements or an exemption if 
we determine that such revision or revocation is necessary to protect 
the public health.

Sec.  1.1400   What procedures apply if FDA tentatively determines that 
modified requirements or an exemption should be revised or revoked?

    (a) If FDA tentatively determines that we should revise or revoke 
modified requirements or an exemption, we will provide the following 
notifications:
    (1) We will notify the person that originally requested the 
modified requirements or exemption (if we adopted modified requirements 
or granted an exemption in response to a petition) in writing at the 
address identified in the petition; and
    (2) We will publish notification in the Federal Register of our 
tentative determination that the modified requirements or exemption 
should be revised or revoked and the reasons for our tentative 
decision. The notification will establish a public docket so that 
interested persons may submit written comments on our tentative 
determination.

[[Page 60036]]

    (b) After considering any comments timely submitted, we will 
publish notification in the Federal Register of our decision whether to 
revise or revoke the modified requirements or exemption and the reasons 
for the decision. If we do revise or revoke the modified requirements 
or exemption, the effective date of the decision will be 1 year after 
the date of publication of the notification, unless otherwise stated in 
the notification.

Waivers

Sec.  1.1405   Under what circumstances will FDA waive one or more of 
the requirements of this subpart for an individual entity or a type of 
entity?

    FDA will waive one or more of the requirements of this subpart when 
we determine that:
    (a) Application of the requirements would result in an economic 
hardship for an individual entity or a type of entity, due to the 
unique circumstances of the individual entity or type of entity;
    (b) The waiver will not significantly impair our ability to rapidly 
and effectively identify recipients of a food to prevent or mitigate a 
foodborne illness outbreak or to address credible threats of serious 
adverse health consequences or death to humans or animals as a result 
of such food being adulterated under section 402 of the Federal Food, 
Drug, and Cosmetic Act or misbranded under section 403(w) of the 
Federal Food, Drug, and Cosmetic Act; and
    (c) The waiver will not otherwise be contrary to the public 
interest.

Sec.  1.1410   When will FDA consider whether to waive a requirement of 
this subpart?

    FDA will consider whether to waive a requirement of this subpart on 
our own initiative or in response to the following:
    (a) A written request for a waiver for an individual entity; or
    (b) A citizen petition requesting a waiver for a type of entity 
submitted under Sec.  10.30 of this chapter by any person subject to 
the requirements of this subpart.

Sec.  1.1415   How may I request a waiver for an individual entity?

    You may request a waiver of one or more requirements of this 
subpart for an individual entity by submitting a written request to the 
Food and Drug Administration. The request for a waiver must include the 
following:
    (a) The name, address, and point of contact of the individual 
entity to which the waiver would apply;
    (b) The requirements of this subpart to which the waiver would 
apply;
    (c) Information demonstrating why application of the requirements 
requested to be waived would result in an economic hardship for the 
entity, including information about the unique circumstances faced by 
the entity that result in unusual economic hardship from the 
application of these requirements;
    (d) Information demonstrating why the waiver will not significantly 
impair FDA's ability to rapidly and effectively identify recipients of 
a food to prevent or mitigate a foodborne illness outbreak or to 
address credible threats of serious adverse health consequences or 
death to humans or animals as a result of such food being adulterated 
under section 402 of the Federal Food, Drug, and Cosmetic Act or 
misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic 
Act; and
    (e) Information demonstrating why the waiver would not otherwise be 
contrary to the public interest.

Sec.  1.1420   What process applies to a request for a waiver for an 
individual entity?

    (a) After considering the information submitted in a request for a 
waiver for an individual entity, we will respond in writing to the 
person that submitted the waiver request stating whether we are 
granting the waiver (in whole or in part) and the reasons for the 
decision.
    (b) Any waiver for an individual entity that FDA grants will become 
effective on the date we issue our response to the waiver request, 
unless otherwise stated in the response.

Sec.  1.1425   What must be included in a petition requesting a waiver 
for a type of entity?

    In addition to meeting the requirements on the content and format 
of a citizen petition in Sec.  10.30 of this chapter, a petition 
requesting a waiver for a type of entity must:
    (a) Specify the type of entity to which the waiver would apply and 
the requirements of this subpart to which the waiver would apply;
    (b) Present information demonstrating why application of the 
requirements requested to be waived would result in an economic 
hardship for the type of entity, including information about the unique 
circumstances faced by the type of entity that result in unusual 
economic hardship from the application of these requirements;
    (c) Present information demonstrating why the waiver will not 
significantly impair FDA's ability to rapidly and effectively identify 
recipients of a food to prevent or mitigate a foodborne illness 
outbreak or to address credible threats of serious adverse health 
consequences or death to humans or animals as a result of such food 
being adulterated under section 402 of the Federal Food, Drug, and 
Cosmetic Act or misbranded under section 403(w) of the Federal Food, 
Drug, and Cosmetic Act; and
    (d) Present information demonstrating why the waiver would not 
otherwise be contrary to the public interest.

Sec.  1.1430   What information submitted in a petition requesting a 
waiver for a type of entity, or information in comments on such a 
petition, is publicly available?

    FDA will presume that information submitted in a petition 
requesting a waiver for a type of entity, as well as information in 
comments submitted on such a petition, does not contain information 
exempt from public disclosure under part 20 of this chapter and will be 
made public as part of the docket associated with the petition.

Sec.  1.1435   What process applies to a petition requesting a waiver 
for a type of entity?

    (a) In general, the procedures set forth in Sec.  10.30 of this 
chapter govern FDA's response to a petition requesting a waiver. An 
interested person may submit comments on such a petition in accordance 
with Sec.  10.30(d) of this chapter.
    (b) Under Sec.  10.30(h)(3) of this chapter, FDA will publish a 
notification in the Federal Register requesting information and views 
on a submitted petition requesting a waiver for a type of entity, 
including information and views from persons who could be affected by 
the waiver if we granted the petition.
    (c) Under Sec.  10.30(e)(3) of this chapter, we will respond to the 
petitioner in writing, as follows:
    (1) If we grant the petition either in whole or in part, we will 
publish a notification in the Federal Register setting forth any 
requirements we have waived and the reasons for the waiver.
    (2) If we deny the petition (including a partial denial), our 
written response to the petitioner will explain the reasons for the 
denial.
    (d) We will make readily accessible to the public, and periodically 
update, a list of petitions requesting waivers for types of entities, 
including the status of each petition (for example, pending, granted, 
or denied).

Sec.  1.1440   What process will FDA follow when waiving a requirement 
of this subpart on our own initiative?

    (a) If FDA, on our own initiative, determines that a waiver of one 
or more requirements for an individual entity or type of entity is 
appropriate, we will publish a notification in the Federal Register 
setting forth the proposed

[[Page 60037]]

waiver and the reasons for such waiver. The notification will establish 
a public docket so that interested persons may submit written comments 
on the proposal.
    (b) After considering any comments timely submitted, we will 
publish a document in the Federal Register stating whether we are 
granting the waiver (in whole or in part) and the reasons for our 
decision.
    (c) Any waiver for a type of entity that FDA grants will become 
effective on the date that notice of the waiver is published in the 
Federal Register, unless otherwise stated in the notification.

Sec.  1.1445   Under what circumstances may FDA modify or revoke a 
waiver?

    FDA may modify or revoke a waiver if we determine that:
    (a) Compliance with the waived requirements would no longer impose 
a unique economic hardship on the individual entity or type of entity 
to which the waiver applies;
    (b) The waiver could significantly impair our ability to rapidly 
and effectively identify recipients of a food to prevent or mitigate a 
foodborne illness outbreak or to address credible threats of serious 
adverse health consequences or death to humans or animals as a result 
of such food being adulterated under section 402 of the Federal Food, 
Drug, and Cosmetic Act or misbranded under section 403(w) of the 
Federal Food, Drug, and Cosmetic Act; or
    (c) The waiver is otherwise contrary to the public interest.

Sec.  1.1450   What procedures apply if FDA tentatively determines that 
a waiver should be modified or revoked?

    (a) Waiver for an individual entity. (1) If FDA tentatively 
determines that we should modify or revoke a waiver for an individual 
entity, we will notify the person that had received the waiver in 
writing of our tentative determination that the waiver should be 
modified or revoked. The notice will provide the waiver recipient 60 
days in which to submit information stating why the waiver should not 
be modified or revoked.
    (2) Upon consideration of any information submitted by the waiver 
recipient, we will respond in writing stating our decision whether to 
modify or revoke the waiver and the reasons for the decision. If we 
modify or revoke the waiver, the effective date of the decision will be 
1 year after the date of our response to the waiver recipient, unless 
otherwise stated in the response.
    (b) Waiver for a type of entity. (1) If FDA tentatively determines 
that we should modify or revoke a waiver for a type of entity, we will 
provide the following notifications:
    (i) We will notify the person that originally requested the waiver 
(if we granted the waiver in response to a petition) in writing at the 
address identified in the petition.
    (ii) We will publish notification in the Federal Register of our 
tentative determination that the waiver should be modified or revoked 
and the reasons for our tentative decision. The notification will 
establish a public docket so that interested persons may submit written 
comments on our tentative determination.
    (2) After considering any comments timely submitted, we will 
publish notification in the Federal Register of our decision whether to 
modify or revoke the waiver and the reasons for the decision. If we do 
modify or revoke the waiver, the effective date of the decision will be 
1 year after the date of publication of the notification, unless 
otherwise stated in the notification.

Records Maintenance and Availability

Sec.  1.1455   How must records required by this subpart be maintained?

    (a) General requirements for records. (1) You must keep records as 
original paper or electronic records or true copies (such as 
photocopies, pictures, scanned copies, or other accurate reproductions 
of the original records).
    (2) All records must be legible and stored to prevent deterioration 
or loss.
    (b) Record availability. (1) You must make all records required 
under this subpart available to an authorized FDA representative as 
soon as possible but not later than 24 hours after the request.
    (2) Offsite storage of records is permitted if such records can be 
retrieved and provided onsite within 24 hours of request for official 
review. Electronic records are considered to be onsite if they are 
accessible from an onsite location.
    (3) When necessary to help FDA prevent or mitigate a foodborne 
illness outbreak, or to assist in the implementation of a recall, or to 
otherwise address a threat to the public health, including but not 
limited to situations where FDA has a reasonable belief that an article 
of food (and any other article of food that FDA reasonably believes is 
likely to be affected in a similar manner) presents a threat of serious 
adverse health consequences or death to humans or animals as a result 
of the food being adulterated under section 402 of the Federal Food, 
Drug, and Cosmetic Act or misbranded under section 403(w) of the 
Federal Food, Drug, and Cosmetic Act, you must make available, within 
24 hours of request by an authorized FDA representative, an electronic 
sortable spreadsheet containing the information in the records you are 
required to maintain under this subpart, for the foods and date ranges 
specified in the request. FDA will withdraw a request for such a 
spreadsheet when necessary to accommodate a religious belief of a 
person asked to provide such a spreadsheet.
    (4) Upon FDA request, you must provide within a reasonable time an 
English translation of records maintained in a language other than 
English.
    (c) Record retention. Except as specified otherwise in this 
subpart, you must maintain records containing the information required 
by this subpart for 2 years from the date you created the records.
    (d) Electronic records. Records that are established or maintained 
to satisfy the requirements of this subpart and that meet the 
definition of electronic records in Sec.  11.3(b)(6) of this chapter 
are exempt from the requirements of part 11 of this chapter. Records 
that satisfy the requirements of this subpart, but that also are 
required under other applicable statutory provisions or regulations, 
remain subject to part 11, if not otherwise exempt.
    (e) Use of existing records. You do not need to duplicate existing 
records you have (e.g., records that you keep in the ordinary course of 
business or that you maintain to comply with other Federal, State, 
Tribal, territorial, or local regulations) if they contain the 
information required by this subpart. You may supplement any such 
existing records as necessary to include all of the information 
required by this subpart. In addition, you do not have to keep all of 
the information required by this subpart in one set of records. 
However, you must indicate the different records in which you keep this 
information in accordance with Sec.  1.1315(a).

Consequences of Failure To Comply

Sec.  1.1460   What consequences could result from failing to comply 
with the requirements of this subpart?

    (a) Prohibited act. The violation of any recordkeeping requirement 
under section 204 of the FDA Food Safety Modernization Act, including 
the violation of any requirement of this subpart, is prohibited under 
section 301(e) of the Federal Food, Drug, and Cosmetic Act, except when 
such violation is committed by a farm.
    (b) Refusal of admission. An article of food is subject to refusal 
of admission

[[Page 60038]]

under section 801(a)(4) of the Federal Food, Drug, and Cosmetic Act if 
it appears that the recordkeeping requirements under section 204 of the 
FDA Food Safety Modernization Act (other than the requirements under 
subsection (f) of that section), including the requirements of this 
subpart, have not been complied with regarding such article.

Updating the Food Traceability List

Sec.  1.1465   How will FDA update the Food Traceability List?

    (a) When FDA tentatively concludes, in accordance with section 
204(d)(2) of the FDA Food Safety Modernization Act, that it is 
appropriate to revise the Food Traceability List, we will publish a 
notice in the Federal Register stating the proposed changes to the list 
and the reasons for these changes and requesting information and views 
on the proposed changes.
    (b) After considering any information and views submitted on the 
proposed changes to the Food Traceability List, FDA will publish a 
notice in the Federal Register stating whether we are making any 
changes to the list and the reasons for the decision. If FDA revises 
the list, we will also publish the revised list on our website.
    (c) When FDA updates the Food Traceability List in accordance with 
this section, any deletions from the list will become effective 
immediately. Any additions to the list will become effective 1 year 
after the date of publication of the Federal Register notice announcing 
the revised list, unless otherwise stated in the notice.

    Dated: September 8, 2020.
Stephen M. Hahn,
Commissioner of Food and Drugs.
[FR Doc. 2020-20100 Filed 9-21-20; 11:15 am]
BILLING CODE 4164-01-P