[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Rules and Regulations]
[Pages 70910-71088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24417]



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Vol. 87

Monday,

No. 223

November 21, 2022

Part II





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

  Federal Register / Vol. 87, No. 223 / Monday, November 21, 2022 / 
Rules and Regulations  

[[Page 70910]]


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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
issuing a final rule establishing additional recordkeeping requirements 
for persons who manufacture, process, pack, or hold foods the Agency 
has designated for inclusion on the Food Traceability List (FTL). The 
final rule adopts provisions requiring these entities to maintain 
records containing information on critical tracking events in the 
supply chain for these designated foods, such as initially packing, 
shipping, receiving, and transforming these foods. The requirements 
established in the final rule will 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 regulation in accordance 
with the FDA Food Safety Modernization Act (FSMA).

DATES: This rule is effective January 20, 2023. For the applicable 
compliance dates, see section VI ``Effective and Compliance Dates'' in 
the SUPPLEMENTARY INFORMATION section of this document.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this final rule, 
into the ``Search'' box and follow the prompts, and/or go to the 
Dockets Management Staff (HFA-305), 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: 
    With regard to the final rule: Katherine Vierk, Office of Analytics 
and Outreach, Center for Food Safety and Applied Nutrition, Food and 
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2122, [email protected].
    With regard to 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, 
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose and Coverage of the Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Need for the Regulation/History of This Rulemaking
    B. Summary of Comments on the Proposed Rule
    C. General Overview of the Final Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Food Traceability List
    C. General Comments on the Proposal
    D. Scope (Sec.  1.1300)
    E. Exemptions (Sec.  1.1305)
    F. Definitions (Sec.  1.1310)
    G. Traceability Plan (Sec.  1.1315)
    H. Assignment of Traceability Lot Codes (Sec.  1.1320)
    I. Critical Tracking Events Framework
    J. Records of Harvesting and Cooling (Sec.  1.1325)
    K. Records of Initial Packing (Sec.  1.1330)
    L. Records of First Land-Based Receiving of Food Obtained From a 
Fishing Vessel (Sec.  1.1335)
    M. Records of Shipping (Sec.  1.1340)
    N. Records of Receiving (Sec.  1.1345)
    O. Records of Transformation (Sec.  1.1350)
    P. Procedures for Modified Requirements and Exemptions 
(Sec. Sec.  1.1360 to 1.1400)
    Q. Waiver Procedures (Sec. Sec.  1.1405 to 1.1450)
    R. Records Maintenance and Availability (Sec.  1.1455)
    S. Consequences of Failure To Comply (Sec.  1.1460)
    T. Updating the FTL (Sec.  1.1465)
    U. Other Issues
VI. 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 Rule

    This final rule, which is part of FDA's implementation of FSMA 
(Pub. L. 111-353), establishes additional traceability recordkeeping 
requirements for persons who manufacture, process, pack, or hold foods 
for which the Agency has determined these additional requirements are 
appropriate and necessary to protect the public health in accordance 
with FSMA. These traceability recordkeeping requirements will help FDA 
rapidly and effectively identify recipients of such foods to prevent or 
mitigate a foodborne illness outbreak and address threats of serious 
adverse health consequences or death as a result of such foods being 
adulterated or misbranded (with respect to allergen labeling) under the 
Federal Food, Drug, and Cosmetic Act (FD&C Act). The requirements will 
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 foods from the marketplace, 
and develop mitigation strategies to prevent future contamination.
    We are issuing this rule because Congress directed us, in FSMA, to 
establish recordkeeping requirements for foods we designate that would 
be additional to the existing traceability recordkeeping requirements 
in the FD&C Act and FDA regulations. The existing regulations 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. This 
final rule adopts additional recordkeeping requirements for foods we 
have designated as high-risk foods in accordance with factors specified 
by Congress in FSMA. We are listing these foods on an FTL, which is 
included as a reference for the final rule. In accordance with FSMA, we 
also are publishing the FTL on our website concurrently with the 
issuance of the final rule. (See section V.B of this document for more 
information on the FTL.)

B. Summary of the Major Provisions of the Final Rule

    The requirements of the final rule are focused on having persons 
who manufacture, process, pack, or hold FTL foods maintain and provide 
to their supply chain partners specific information (key data elements) 
for certain critical tracking events (CTEs) in the handling of the 
food, consistent with the developing industry consensus approach to 
food tracing. The information that firms must keep and send forward 
under the rule varies depending on the type of supply chain activities 
they perform with respect to an FTL food, from harvesting or production 
of the food through

[[Page 70911]]

processing, distribution, and receipt at retail or other point of 
service. Central to the proposed requirements is the assignment, 
recording, and sharing of traceability lot codes for FTL foods, as well 
as linking these lot codes to other information identifying the foods 
as they move through the supply chain.
    The final rule requires persons who manufacture, process, pack, or 
hold an FTL food to establish and maintain a traceability plan that, 
among other things, describes their procedures for maintenance of 
records under the new requirements, identification of FTL foods 
handled, and assignment of traceability lot codes to FTL foods. 
Entities that grow or raise an FTL food (other than eggs) will also 
need to keep (as part of their traceability plan) a farm map showing 
the area in which the food is grown or raised, including geographic 
coordinates for the growing/raising area. Harvesters and coolers of raw 
agricultural commodities (RACs) (not obtained from a fishing vessel) 
that are on the FTL must keep records of their activities and provide 
information on them to the initial packers of these RACs. These initial 
packers, along with the first land-based receivers of FTL foods 
obtained from a fishing vessel, as well as entities that transform an 
FTL food (by manufacturing/processing a food or by changing the food or 
its packaging or labeling), must assign a traceability lot code to the 
food to help ensure accurate identification of the food as it moves 
through the supply chain, as well as maintain other records relating to 
their activities. Shippers and receivers of FTL foods must keep records 
of these actions, and shippers must provide the traceability lot code 
and other information identifying the food to the recipients of the 
food, including information relating to the traceability lot code 
source (i.e., the entity that assigned the traceability lot code to the 
food). To avoid disclosing confidential information about their 
suppliers, instead of directly identifying the traceability lot code 
source of an FTL food, the shipper may instead choose to provide a 
traceability lot code source ``reference,'' such as an FDA Food 
Facility Registration number or a web address (which could be 
configured to require authentication for access), that provides an 
alternative means for FDA to identify and contact the traceability lot 
code source for the food. Taken together, these core subpart S 
requirements establish a structure for maintaining and providing 
traceability information that will enable FDA to more rapidly and 
effectively identify the source of contamination when investigating a 
foodborne illness outbreak than is possible under existing traceability 
recordkeeping requirements.
    The final rule exempts certain small producers (including small 
produce farms, shell egg producers, and other producers of RACs) and, 
at the other end of the supply chain, certain small retail food 
establishments (RFEs) and restaurants. The rule also provides several 
other exemptions, including, but not limited to, those for the 
following: farms when food is sold or donated directly to consumers; 
food produced and packaged on a farm whose packaging maintains product 
integrity and prevents subsequent contamination; foods that receive 
certain types of processing, including produce that receives commercial 
processing that adequately reduces the presence of microorganisms of 
public health significance, shell eggs that receive a certain 
treatment, foods that are subjected to a kill step, and foods changed 
such that they are no longer on the FTL; produce rarely consumed raw; 
certain raw bivalve molluscan shellfish; persons who manufacture, 
process, pack, or hold FTL foods during or after the time when the food 
is within the exclusive jurisdiction of the U.S. Department of 
Agriculture (USDA); commingled RACs (not including fruits and 
vegetables subject to the produce safety regulation); RFEs and 
restaurants purchasing directly from a farm; certain ad hoc purchases 
by RFEs and restaurants from other such entities; farm to school and 
farm to institution programs; fishing vessels; transporters; nonprofit 
food establishments; and food for research or evaluation. (See section 
V.E of this document for more information on exemptions provided in the 
final rule.)
    In addition to the exemptions codified in the final rule, the rule 
establishes procedures under which persons may request modified 
requirements or an exemption from the new traceability recordkeeping 
requirements 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 the public health. The rule also establishes 
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 having 
to meet the requirements would result in an economic hardship due to 
the unique circumstances of that entity or type of entity.
    The rule specifies that persons subject to subpart S may have 
another entity establish and maintain required records on their behalf, 
although the person remains responsible for ensuring the records can be 
provided onsite to FDA within 24 hours of our request for official 
review. In addition, when necessary to help prevent or mitigate a 
foodborne illness outbreak, assist in the implementation of a recall, 
or otherwise address a threat to public health, firms must provide an 
electronic sortable spreadsheet containing information FDA requests on 
CTEs involving particular FTL foods for the date ranges or traceability 
lot codes specified in our request. Certain smaller entities are exempt 
from the requirement to provide this information in an electronic 
sortable spreadsheet, though they must still provide the information in 
other electronic or paper form. To help speed our access to information 
in such exigent circumstances, we may request the information remotely 
(e.g., by phone) instead of onsite at the entity's place of business.
    In response to many comments expressing concern about the ability 
of some entities to come into compliance within 2 years after the 
rule's effective date (as proposed), the final rule extends the 
compliance date for all persons subject to the rule to 3 years after 
the effective date. In this interim period, we intend to provide 
outreach and training, as well as guidance and other materials, to help 
all sectors of the food industry come into compliance with the new 
traceability recordkeeping requirements applicable to them under the 
new regulation.

C. Legal Authority

    FSMA directs FDA to publish a notice of proposed rulemaking to 
establish recordkeeping requirements, in addition to the requirements 
under the FD&C Act and existing regulations, for facilities that 
manufacture, process, pack, or hold foods FDA designates. FSMA also 
directs FDA to designate the foods for which such additional 
recordkeeping requirements are appropriate and necessary to protect the 
public health.

D. Costs and Benefits

    This final rule will impose compliance costs on covered entities by 
increasing the number of records that are required for covered foods. 
Entities that manufacture, process, pack, or hold covered foods will 
incur costs to establish and maintain a traceability plan and 
traceability records and one-time costs of reading and understanding 
the rule. Some firms may also incur initial and recurring capital 
investment and training costs for systems that will enable them to 
keep, maintain, and make available to other supply chain entities (and 
to us upon our request)

[[Page 70912]]

their traceability records. We estimate that the present value of costs 
of the rule over 20 years ranges from about $0.7 billion to $24.6 
billion, with a primary estimate of about $6 billion in 2020 dollars at 
a 7 percent discount rate, and from $0.8 billion to $33.7 billion, with 
a primary estimate of $8.2 billion at a 3 percent discount rate. At a 7 
percent discount rate, annualized costs range from about $63 million to 
$2.3 billion, with a primary estimate of $570 million per year. At a 3 
percent discount rate, annualized costs range from about $53 million to 
$2.3 billion, with a primary estimate of $551 million per year.
    By allowing faster identification of contaminated foods and 
increasing rates of successful tracing completions, the rule will 
result in public health benefits if foodborne illnesses directly 
related to those outbreaks are averted. This might 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 covered 
foods. We estimate public health benefits using several case studies of 
outbreak tracebacks for four pathogens associated with illnesses caused 
by covered foods. We calculate these benefits based on an estimated 83 
percent reduction of traceback time resulting from the requirements of 
this rule. 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 foods on 
the FTL. However, adjustments made for undiagnosed and unattributed 
illnesses may have the opposite tendency of overstating both illnesses 
and benefits associated with listed foods. The present value of health 
benefits over 20 years ranges from about $0.6 billion to $23.7 billion, 
with a primary estimate of $8.3 billion at a 7 percent discount rate, 
and from about $0.9 billion to $34.5 billion, with a primary estimate 
of $12.0 billion at a 3 percent discount rate. The annualized monetized 
health benefits range from $59 million to $2.2 billion, with a primary 
estimate of $780 million at a 7 percent discount rate, and from $61 
million to $2.3 billion, with a primary estimate of $810 million at a 3 
percent discount rate.
    The present value of (non-health) benefits from avoiding overly 
broad recalls and market withdrawals and advisories over 20 years 
ranges from about $2.5 billion to $18.8 billion, with a primary 
estimate of $6.1 billion at a 7 percent discount rate, and from about 
$3.6 billion to $27.3 billion, with a primary estimate of $8.9 billion 
at a 3 percent discount rate. At a 7 percent discount rate over 20 
years, these benefits range from $233 million to $1.8 billion, with a 
primary estimate of $575 million. At a 3 percent discount rate over 20 
years, these benefits range from $242 million to $1.8 billion, with a 
primary estimate of $596 million. Additional benefits of the rule 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; reduction of food waste; 
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.

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

------------------------------------------------------------------------
       Abbreviation or acronym                   What it means
------------------------------------------------------------------------
ASN.................................  Advance shipping notice.
BOL.................................  Bill of lading.
CSA.................................  Community supported agriculture.
CTE.................................  Critical tracking event.
FDA.................................  Food and Drug Administration.
FD&C Act............................  Federal Food, Drug, and Cosmetic
                                       Act.
FOIA................................  Freedom of Information Act.
FSIS................................  Food Safety and Inspection
                                       Service.
FSMA................................  FDA Food Safety Modernization Act.
FTL.................................  Food Traceability List.
FTE.................................  Full-time equivalent employee.
GPS.................................  Global positioning system.
HACCP...............................  Hazard analysis and critical
                                       control point.
KDE.................................  Key data element.
LACF................................  Low-acid canned food.
NSSP................................  National Shellfish Sanitation
                                       Program.
OMB.................................  Office of Management and Budget.
PTI.................................  Produce Traceability Initiative.
RCR.................................  Rarely consumed raw.
RAC.................................  Raw agricultural commodity.
RTE.................................  Ready-to-eat.
RFR.................................  Reportable Foods Registry.
SECG................................  Small entity compliance guide.
SOI.................................  Standards of identity.
SME.................................  Subject matter expert.
USDA................................  U.S. Department of Agriculture.
WGS.................................  Whole genome sequencing.
------------------------------------------------------------------------

III. Background

A. Need for the Regulation/History of This Rulemaking

    On January 4, 2011, President Obama signed FSMA (Pub. L. 111-353) 
into law. As a component of FSMA's overhaul of U.S. food safety law to 
ensure the safety and security of the nation's food supply, section 204 
of FSMA requires FDA to establish recordkeeping requirements for 
facilities that manufacture, process, pack, or hold foods the Agency 
designates as high risk to facilitate the rapid and effective 
traceability of such foods. These recordkeeping requirements are 
additional to the food traceability requirements under section 414 of 
the FD&C Act (21 U.S.C. 350c) (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 regulation in subpart J of part 1 of 
title 21 of the Code of Federal Regulations (CFR) (Sec. Sec.  1.326 to 
1.368) (the subpart J regulation).
    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. 
We issued a final rule promulgating the subpart J regulation in 2004 
(69 FR 71562, December 9, 2004).
    In the case of a foodborne illness outbreak or evidence of 
contaminated food, the ability to follow the movement of foods through 
the supply chain--called product tracing or traceability--helps 
government agencies identify the points in the food supply chain, 
including the source of the product, where contamination may have 
occurred and, working with industry, remove the food from the 
marketplace. Efficient traceability enables the government and the food 
industry to take action more quickly to prevent illnesses and reduce 
economic harm.
    In the years following the adoption of the subpart J regulation, 
FDA has learned that the one-up, one-back recordkeeping requirements in 
those regulations do not capture all the data elements necessary to 
effectively and rapidly link shipments of food through each point in 
the supply chain. Among the significant gaps in the subpart J 
requirements are the following:
     The lack of coverage of all sectors involved in food 
production,

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distribution, and sale (e.g., farms and restaurants are exempt);
     The lack of uniform data collection (e.g., regarding the 
source of food ingredients used in each lot of finished product; no 
requirement to record a lot code or other identifier for all foods); 
and
     An inability to link incoming product with outgoing 
product within a firm and from one point in the supply chain to the 
next (see 85 FR 59984 at 59990, September 23, 2020).
    These shortcomings of the subpart J regulation have hindered FDA 
outbreak investigations in many ways, including by making it more 
difficult to obtain tracing information from point-of-service firms 
that are exempt from the regulations. Even when such information is 
available, the records required under subpart J often are inadequate to 
facilitate swift and accurate traceback through the distribution chain 
to the producer of a contaminated food.
    Recognizing the need for improvement in food traceability, in 
section 204(d)(1) of FSMA, Congress directed the Agency 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 (21 U.S.C. 342) or 
misbranded with respect to allergen labeling under section 403(w) of 
the FD&C Act (21 U.S.C. 343(w)). The additional recordkeeping 
requirements set forth in this final rule, which will be codified in 21 
CFR part 1, subpart S (the subpart S regulation), will help FDA more 
effectively follow the movement of food products and ingredients on the 
FTL (``FTL foods'') both backward and forward throughout the supply 
chain.
    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, including holding 
public meetings and engaging in a pilot tracing project. Following the 
enactment of FSMA, FDA continued its work to improve food product 
traceability and to lay the groundwork for this rulemaking. Section 
204(a) of FSMA directed FDA to establish pilot projects in coordination 
with the food industry to explore and evaluate methods to rapidly and 
effectively identify recipients of food. At FDA's request, and in 
accordance with that provision, the Institute of Food Technologists 
(IFT) conducted two product tracing pilots and issued a 2012 final 
report to FDA regarding those pilot studies (Ref. 1). In 2016, in 
accordance with section 204(a)(3) of FSMA, FDA submitted a Report to 
Congress that discussed the findings of the pilot projects and included 
recommendations for improving the tracking and tracing of food (Ref. 
2).
    In addition, on February 4, 2014, we issued a notice in the Federal 
Register (79 FR 6596) seeking public comment, scientific data, and 
other information to inform our draft approach to identifying high-risk 
foods. Section 204(d)(2)(A) of FSMA requires that the designation of 
high-risk foods 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 such 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.
    On September 23, 2020, FDA published a proposed rule entitled 
``Requirements for Additional Traceability Records for Certain Foods'' 
(85 FR 59984), to establish additional recordkeeping requirements for 
foods on the FTL, a proposed version of which was made available in the 
public docket for the rulemaking as well as on our website (Ref. 3). At 
the same time, we made available our ``Methodological Approach to 
Developing a Risk-Ranking Model for Food Tracing FSMA Section 204 (21 
U.S.C. 2223)'' (RRM-FT Methodological Approach Report) (Ref. 4), which 
described how we generated the results from the risk-ranking model for 
food tracing (``RRM-FT'' or ``the Model'') that we used to help develop 
the FTL. The Model, which was peer reviewed, used a semiquantitative, 
multicriteria decision analysis risk-ranking approach, consistent with 
the factors set forth in section 204(d)(2) of FSMA, and it was 
operationalized with data relevant to those factors to generate results 
for foods we regulate (85 FR 59984 at 59991). We also made available a 
memorandum entitled ``Designation of the Food Traceability List Using 
the Risk-Ranking Model for Food Tracing'' (Ref. 5), explaining how we 
designated the foods on the FTL using the results of the RRM-FT.
    As stated in the preamble to the proposed rule, the proposed 
traceability requirements were focused on having persons who 
manufacture, process, pack, or hold FTL foods maintain and share 
specific key data elements (KDEs) for certain CTEs in a food's supply 
chain, consistent with the developing industry consensus approach to 
food tracing. The information that firms would need to keep and send to 
their supply chain partners would vary depending on the type of supply 
chain activity they were performing with respect to an FTL food, from 
production of the food through processing, distribution, and receipt at 
retail or other point of service. Central to the proposed requirements 
is the assignment, recording, and sharing of traceability lot codes and 
traceability lot code sources (i.e., the entity that assigned the 
traceability lot code) for FTL foods, as well as linking the 
traceability lot codes to other information identifying the foods as 
they move through the supply chain.
    Since the publication of the proposed rule, there is still a need 
for improved traceability. Foodborne illness continues to have serious 
public health impacts. In the United States, there are approximately 
800 foodborne illness outbreaks reported every year from all foods 
according to CDC outbreak surveillance reports, including about 200 
outbreaks caused by foods covered by this rule (Refs. 6, 16). We 
estimate that nearly 770,000 illnesses annually in the United States 
are associated with foods covered by the rule (Ref. 16). Further, many 
Americans, besides those who become ill, are impacted by supply chain 
disruptions and temporary shortages due to overly broad recalls and 
less than fully efficient traceback investigations. A lack of 
consistent recordkeeping continues to hinder FDA's traceback 
investigations (Ref. 7). As described in the proposed rule, we have 
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. A 
lack of effective traceability

[[Page 70914]]

throughout the food supply has led to delays in product recalls and 
notification to the public, allowing potentially contaminated foods to 
remain on the market longer. While this rulemaking does not prevent the 
occurrence of outbreaks, these recordkeeping requirements can help 
identify the source of the contaminated food more quickly, potentially 
reducing the severity of the outbreak.
    While parts of the industry have made progress in implementing 
traceability systems, the success has been confined to a subset of 
firms and product types, primarily in large firms where there is 
vertical integration in the supply chain or across the production of 
relatively homogenous products. Coordination through the supply chain 
across a wide range of firms varying in size, product mix, and 
production systems remains burdensome for many firms, especially those 
not vertically integrated. It is unlikely that without regulation the 
industry will ever achieve the level of systematic uniformity, 
accuracy, and efficiency needed to protect public health. The final 
rule--which applies only to covered foods and maintains the CTE/KDE 
structure of the proposed rule, but with modifications to address 
concerns raised in comments--provides a uniform set of requirements and 
expectations for traceability, reducing the challenges of coordination 
through the supply chain. The rule will greatly improve the efficiency 
and accuracy of FDA's traceback and traceforward operations, which 
should have a direct impact on the public health by allowing us to more 
quickly identify the source of contaminated food and remove it from the 
market.

B. Summary of Comments to the Proposed Rule

    Although many comments express support for the proposed rule and 
its purposes, a number of comments request changes to simplify the 
traceability recordkeeping and record-sending requirements and reduce 
the burden of the rule on entities throughout the supply chain. Several 
comments ask that we reduce and simplify the CTEs for which records 
must be kept and the KDEs that firms must maintain for each event. 
While many comments acknowledge the importance of documenting the 
traceability lot code as an FTL food moves through the supply chain, 
several question how much information on the product and its producer 
is necessary or appropriate to share with downstream supply chain 
members.
    Some comments ask that we broaden the circumstances under which a 
traceability lot code may be assigned. Several comments express concern 
about the feasibility of establishing requirements applicable to the 
``first receiver'' of an FTL food, suggesting that others in the supply 
chain would be better suited to having and maintaining the required 
KDEs. Several comments request that we streamline the KDEs to be 
documented for shipping, receiving, and transformation events, and 
revise the information that shippers would be required to send to the 
recipients of the FTL foods, including the requirements applicable to 
farms.
    Several comments ask that we clarify the scope of proposed 
exemptions from the FTL recordkeeping requirements, with some 
requesting that we broaden those exemptions to cover additional foods 
and/or firms. In particular, many comments maintain that having to 
comply with the rule would impose an undue burden on small farms and 
small RFEs, as well as other small supply chain firms. In addition, 
some comments request that we establish additional exemptions 
(different from those we proposed) for certain foods and supply chain 
entities.
    Many comments object to the proposed requirement to make available 
to FDA, when necessary to help prevent or mitigate a foodborne illness 
outbreak, assist in the implementation of a recall, or otherwise 
address a threat to public health, an electronic sortable spreadsheet 
containing information in required traceability records for specified 
FTL foods and date ranges. In addition, although the proposed rule 
would permit firms to use existing records to meet the proposed 
recordkeeping requirements, several comments assert that the proposed 
rule would require unnecessary creation of duplicative records.
    The comments generally express support for the proposed RRM-FT we 
used to determine the foods on the FTL, although some comments take 
issue with certain aspects of the Model as well as how we used it to 
generate the FTL. In addition, many comments request clarification as 
to whether particular foods or food products are on the FTL, and 
several comments ask that the final FTL not include several foods that 
were on the proposed FTL.

C. General Overview of the Final Rule

    In response to comments we received, we have made several changes 
to the proposed traceability recordkeeping requirements for FTL foods 
that will make the final rule easier for supply chain entities to 
understand and comply with, while still ensuring that the rule 
substantially improves FDA's ability to respond quickly and effectively 
to foodborne illness outbreaks involving foods on the FTL. We believe 
the final rule more closely aligns the FTL recordkeeping requirements 
with developing industry best practices and effectively addresses 
stakeholder concerns about the complexity of the requirements and the 
need to protect the confidentiality of commercial information regarding 
suppliers.
    The final rule includes changes to the requirements for a 
traceability plan (referred to in the proposed rule as ``traceability 
program records''), including more streamlined requirements for what 
must be included in the plan and deletion of the proposed requirement 
to maintain a list of FTL foods shipped. In addition, for those who 
grow or raise an FTL food, the final rule requires the retention of a 
relevant farm map containing geographic coordinates instead of the 
proposed records documenting the growing area coordinates for 
individual traceability lots of the food.
    The final rule also includes changes to certain of the CTEs for 
which persons subject to the rule must maintain KDEs. Instead of 
requiring the ``first receiver'' of an FTL food (which the proposed 
rule had defined as the first person other than a farm who purchases 
and takes physical possession of an FTL food that has been grown, 
raised, caught, or (in the case of a non-produce commodity) harvested) 
to maintain information on the origination, harvesting, cooling, and 
packing of food, the final rule places similar responsibility on the 
initial packer of a RAC (other than a food obtained from a fishing 
vessel) or the first land-based receiver of a food obtained from a 
fishing vessel. The KDEs required for shipping and receiving FTL foods 
have been streamlined and the shipping KDEs no longer apply to 
shipments that occur before a RAC is initially packed. A new CTE has 
been added to explain the requirements specific to harvesting and 
cooling of RACs before they are initially packed, and the CTEs for 
``transformation'' and ``creation'' of an FTL food have been combined 
and clarified under a single transformation CTE.
    The final rule includes changes to protect the privacy of 
individuals employed by supply chain entities and the confidentiality 
of business information concerning suppliers. To address the former, 
the final rule only requires firms to identify a point of contact 
within their traceability plan and the point of contact can be 
identified as a job title (along with a phone number), instead of the 
person's

[[Page 70915]]

name; all of the proposed requirements to provide a point of contact as 
part of the records sent to other supply chain entities have been 
deleted. In response to concerns about having to pass forward 
information on the traceability lot code generator for an FTL food, 
which could reveal information about a firm's suppliers, the final rule 
permits firms to provide a traceability lot code source reference, 
which is an alternative method through which information on the 
traceability lot code source could be made available to FDA, such as 
through a web address that provides the location description for the 
traceability lot code source. If the firm uses a web address as the 
traceability lot code source reference, the associated website may 
employ reasonable security measures, such as only being accessible to a 
government email address, provided the Agency has access to the 
information at no cost and without delay.
    The final rule includes revisions to several of the proposed 
exemptions from the rule (generally broadening or clarifying the 
exemptions). We revised exemptions for certain small producers, and we 
expanded the exemption for farms when food is sold directly to 
consumers, such that it now covers donations as well as sales. We 
expanded the exemptions for foods that are subjected to a kill step and 
commingled RACs to extend these partial exemptions to include certain 
situations where it is known that the food will be subjected to a kill 
step (by an entity other than an RFE, restaurant, or consumer) or be 
commingled in the future, and to include foods that will be changed 
such that they are no longer on the FTL. Regarding the co-proposal for 
the exemption of small RFEs (full exemption vs. exemption from the 
requirement to make available, in certain circumstances, an electronic 
sortable spreadsheet containing requested tracing information), we have 
elected to fully exempt certain small RFEs and restaurants but also 
exempt from the requirement to provide a sortable spreadsheet somewhat 
larger but still relatively small RFEs and restaurants (along with 
certain farms and other entities that are relatively small). In 
addition, in response to comments we have added other partial or full 
exemptions from the regulations, including for the following: raw 
bivalve molluscan shellfish; persons who manufacture, process, pack, or 
hold certain foods subject to regulation by the USDA; certain ad hoc 
purchases by RFEs and restaurants from other such entities; and food 
for research or evaluation.
    We have not made any changes to the risk-ranking model that we 
developed, consistent with the factors set forth in section 
204(d)(2)(A) of FSMA, to determine which foods should be placed on the 
FTL. With respect to the FTL itself, on January 11, 2021, we provided 
additional clarity on the foods on the proposed FTL in response to 
stakeholder input following the release of the proposed rule (Ref. 8). 
With the publication of the final rule, we are providing additional 
description and clarification of FTL foods, including examples of foods 
that are and are not considered part of certain commodity designations 
on the FTL.
    Finally, in response to the many comments expressing concern about 
the ability of farms, manufacturers, distributors, retail food 
establishments, and others to come into compliance with the new 
traceability recordkeeping requirements within 2 years after the 
effective date of the final rule, as we had proposed, we are extending 
the compliance date for all persons subject to the rule to 3 years 
after its effective date (which is 60 days after the date of 
publication of the final rule in the Federal Register).

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 was required to publish a 
proposed rule to establish recordkeeping requirements, in addition to 
the requirements under section 414 of the FD&C Act and the subpart J 
regulation, for facilities that manufacture, process, pack, or hold 
foods that FDA designates under section 204(d)(2) of FSMA as high-risk 
foods. We published the required proposed rule on September 23, 2020, 
and we are completing the rulemaking process with this final rule by 
establishing the subpart S regulation. We are promulgating this 
regulation under the following authorities:
     Section 204 of FSMA, the specific provisions of which are 
discussed throughout this document;
     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).

The legal authority for this rulemaking is discussed further in the 
preamble to the proposed rule (see 85 FR 59984 at 59993 and 59994).

V. Comments on the Proposed Rule and FDA Response

A. Introduction

    We received approximately 1,100 comment submissions on the proposed 
rule to establish traceability recordkeeping requirements for persons 
who handle FTL foods (including comments on the FTL itself and the 
risk-ranking model used to develop it) by the close of the comment 
period, each containing one or more comments on one or more issues. We 
received comments from consumers, consumer groups, trade organizations, 
farmers, industry (e.g., food manufacturers, processors, distributors), 
public health organizations, State and local governments, foreign 
governments and organizations, and others.
    We describe and respond to the comments in Sections V.B through V.U 
of this document, as well as certain comments in Sections VI through 
IX. We have numbered each comment to help distinguish between different 
comments. We have grouped similar comments together under the same 
number, and, in some cases, we have separated different issues 
discussed in the same comment and designated them as distinct comments 
for purposes of our responses. The number assigned to each comment or 
comment topic is purely for organizational purposes and does not 
signify the comment's value or importance or the order in which 
comments were received.

B. Food Traceability List

    Included as a reference to this final rule (and as seen in table 1) 
is the FTL, which sets forth the foods that will be subject to the 
subpart S requirements. In accordance with section 204(d)(2)(B) of FSMA 
and Sec.  1.1300 of the final rule, we are publishing the FTL on our 
website concurrently with the issuance of this final rule. We included 
as a reference to the proposed rule the RRM-FT Methodological Approach 
Report (Ref.

[[Page 70916]]

4), which discusses the risk-ranking model for food tracing we used to 
determine the foods on the FTL. As stated in the proposed rule, the 
RRM-FT uses a semiquantitative, multicriteria decision analysis risk-
ranking approach that is consistent with the factors specified in 
section 204(d)(2) of FSMA for use in designating the foods that will be 
subject to the additional traceability recordkeeping requirements and 
is operationalized with data relevant to those factors.
    Using the results of the RRM-FT, we tentatively identified foods 
for which additional traceability records will be required, as we 
discussed in the Designation of the FTL Memorandum (Ref. 5). Based on 
that analysis, we developed a tentative list of FTL foods (Ref. 3). In 
response to questions and comments we received regarding the tentative 
FTL, in January 2021 we updated the table on our website showing the 
tentative FTL (Ref. 8). The updated table did not reflect a change in 
which foods were on the tentative FTL, but it included text to clarify 
the food products that are included in certain categories of foods on 
the tentative FTL.
    Table 1 shows the current FTL that we are publishing with this 
final rule. The FTL being published with the final rule has not changed 
from the tentative list issued with the proposed rule. However, we have 
provided additional revisions to the descriptions of the commodities on 
the FTL to address some of the comments we received and provide greater 
clarity. The process for changing the FTL, which includes advance 
notice and an opportunity for the public to provide comment, is 
discussed in Section V.T of this document. We intend to update the FTL 
approximately every 5 years, subject to available resources. For the 
initial update to the FTL following publication of the final rule, we 
will take into consideration the compliance date for the final rule 
when deciding when to begin the process.

                     Table 1--Food Traceability List
------------------------------------------------------------------------
      Food traceability list                     Description
------------------------------------------------------------------------
Cheeses, other than hard cheeses,
 specifically:
     Cheese (made from      Includes soft unripened/fresh soft
     pasteurized milk), fresh soft   cheeses. Examples include, but are
     or soft unripened.              not limited to, cottage, chevre,
                                     cream cheese, mascarpone, ricotta,
                                     queso blanco, queso fresco, queso
                                     de crema, and queso de puna. Does
                                     not include cheeses that are
                                     frozen, shelf stable at ambient
                                     temperature, or aseptically
                                     processed and packaged.
     Cheese (made from      Includes soft ripened/semi-soft
     pasteurized milk), soft         cheeses. Examples include, but are
     ripened or semi-soft.           not limited to, brie, camembert,
                                     feta, mozzarella, taleggio, blue,
                                     brick, fontina, monterey jack, and
                                     muenster. Does not include cheeses
                                     that are frozen, shelf stable at
                                     ambient temperature, or aseptically
                                     processed and packaged.
     Cheese (made from      Includes all cheeses made with
     unpasteurized milk), other      unpasteurized milk, other than hard
     than hard cheese \1\.           cheeses. Does not include cheeses
                                     that are frozen, shelf stable at
                                     ambient temperature, or aseptically
                                     processed and packaged.
Shell eggs........................  Shell egg means the egg of the
                                     domesticated chicken.
Nut butters.......................  Includes all types of tree nut and
                                     peanut butters. Examples include,
                                     but are not limited to, almond,
                                     cashew, chestnut, coconut,
                                     hazelnut, peanut, pistachio, and
                                     walnut butters. Does not include
                                     soy or seed butters.
Cucumbers (fresh).................  Includes all varieties of fresh
                                     cucumbers.
Herbs (fresh).....................  Includes all types of fresh herbs.
                                     Examples include, but are not
                                     limited to, parsley, cilantro, and
                                     basil. Herbs listed in 21 CFR
                                     112.2(a)(1), such as dill, are
                                     exempt from the requirements of the
                                     rule under 21 CFR 1.1305(e).
Leafy greens (fresh)..............  Includes all types of fresh leafy
                                     greens. Examples include, but are
                                     not limited to, arugula, baby leaf,
                                     butter lettuce, chard, chicory,
                                     endive, escarole, green leaf,
                                     iceberg lettuce, kale, red leaf,
                                     pak choi, Romaine, sorrel, spinach,
                                     and watercress. Does not include
                                     whole head cabbages such as green
                                     cabbage, red cabbage, or savoy
                                     cabbage. Does not include banana
                                     leaf, grape leaf, and leaves that
                                     are grown on trees. Leafy greens
                                     listed in Sec.   112.2(a)(1), such
                                     as collards, are exempt from the
                                     requirements of the rule under Sec.
                                       1.1305(e).
Leafy greens (fresh-cut)..........  Includes all types of fresh-cut
                                     leafy greens, including single and
                                     mixed greens.
Melons (fresh)....................  Includes all types of fresh melons.
                                     Examples include, but are not
                                     limited to, cantaloupe, honeydew,
                                     muskmelon, and watermelon.
Peppers (fresh)...................  Includes all varieties of fresh
                                     peppers.
Sprouts (fresh)...................  Includes all varieties of fresh
                                     sprouts (irrespective of seed
                                     source), including single and mixed
                                     sprouts. Examples include, but are
                                     not limited to, alfalfa sprouts,
                                     allium sprouts, bean sprouts,
                                     broccoli sprouts, clover sprouts,
                                     radish sprouts, alfalfa & radish
                                     sprouts, and other fresh sprouted
                                     grains, nuts, and seeds.
Tomatoes (fresh)..................  Includes all varieties of fresh
                                     tomatoes.
Tropical tree fruits (fresh)......  Includes all types of fresh tropical
                                     tree fruit. Examples include, but
                                     are not limited to, mango, papaya,
                                     mamey, guava, lychee, jackfruit,
                                     and starfruit. Does not include non-
                                     tree fruits such as bananas,
                                     pineapple, dates, soursop, jujube,
                                     passionfruit, Loquat, pomegranate,
                                     sapodilla, and figs. Does not
                                     include tree nuts such as coconut.
                                     Does not include pit fruits such as
                                     avocado. Does not include citrus,
                                     such as orange, clementine,
                                     tangerine, mandarins, lemon, lime,
                                     citron, grapefruit, kumquat, and
                                     pomelo.
Fruits (fresh-cut)................  Includes all types of fresh-cut
                                     fruits. Fruits listed in Sec.
                                     112.2(a)(1) are exempt from the
                                     requirements of the rule under Sec.
                                       1.1305(e).
Vegetables other than leafy greens  Includes all types of fresh-cut
 (fresh-cut).                        vegetables other than leafy greens.
                                     Vegetables listed in Sec.
                                     112.2(a)(1) are exempt from the
                                     requirements of the rule under Sec.
                                       1.1305(e).
Finfish (fresh and frozen),
 specifically:
     Finfish, histamine-    Includes all histamine-producing
     producing species.              species of finfish. Examples
                                     include, but are not limited to,
                                     tuna, mahi mahi, mackerel,
                                     amberjack, jack, swordfish, and
                                     yellowtail.
     Finfish, species       Includes all finfish species
     potentially contaminated with   potentially contaminated with
     ciguatoxin.                     ciguatoxin. Examples include, but
                                     are not limited to, grouper,
                                     barracuda, and snapper.
     Finfish, species not   Includes all species of finfish not
     associated with histamine or    associated with histamine or
     ciguatoxin.                     ciguatoxin. Examples include, but
                                     are not limited to, cod, haddock,
                                     Alaska pollock, salmon, tilapia,
                                     and trout.\2\ Siluriformes fish,
                                     such as catfish, are not
                                     included.\3\

[[Page 70917]]

 
Smoked finfish (refrigerated and    Includes all types of smoked
 frozen).                            finfish, including cold smoked
                                     finfish and hot smoked finfish.\4\
Crustaceans (fresh and frozen)....  Includes all crustacean species.
                                     Examples include but are not
                                     limited to shrimp, crab, lobster,
                                     and crayfish.
Molluscan shellfish, bivalves       Includes all species of bivalve
 (fresh and frozen) \5\.             mollusks. Examples include, but are
                                     not limited to, oysters, clams, and
                                     mussels. Does not include scallop
                                     adductor muscle. Raw bivalve
                                     molluscan shellfish that are (1)
                                     covered by the requirements of the
                                     National Shellfish Sanitation
                                     Program; (2) subject to the
                                     requirements of 21 CFR part 123,
                                     subpart C, and 21 CFR 1240.60; or
                                     (3) covered by a final equivalence
                                     determination by FDA for raw
                                     bivalve molluscan shellfish are
                                     exempt from the requirements of the
                                     rule under Sec.   1.1305(f).
Ready-to-eat deli salads            Includes all types of refrigerated
 (refrigerated).                     ready-to-eat deli salads. Examples
                                     include, but are not limited to,
                                     egg salad, potato salad, pasta
                                     salad, and seafood salad. Does not
                                     include meat salads.
------------------------------------------------------------------------
\1\ ``Hard cheese'' includes hard cheeses as defined in 21 CFR 133.150,
  colby cheese as defined in 21 CFR 133.118 and caciocavallo siciliano
  as defined in 21 CFR 133.111. Examples of hard cheese include, but are
  not limited to, cheddar, romano, and parmesan.
\2\ For a more comprehensive list, see Chapter 3 of the Fish and Fishery
  Products Hazards and Controls Guidance at https://www.fda.gov/media/80637/download 80637/download.
\3\ Data for catfish were excluded from the Risk-Ranking Model because
  Siluriformes fish (such as catfish) are primarily regulated by the
  U.S. Department of Agriculture.
\4\ ``Smoked finfish'' refers to a finfish product that meets the
  definition of a smoked or smoke-flavored fishery product in 21 CFR
  123.3(s).
\5\ Under 21 CFR 123.3(h), molluscan shellfish means any edible species
  of fresh or frozen oysters, clams, mussels, or scallops, or edible
  portions of such species, except when the product consists entirely of
  the shucked adductor muscle.

    We received several comments on the RRM-FT, the designation of 
foods on the FTL, and whether certain foods should or should not be 
included on the FTL. We respond to these comments in the following 
paragraphs.
1. Risk-Ranking Model for Food Tracing
    (Comment 1) Several comments express general support for the RRM-FT 
methodology and the process FDA used to develop the FTL, as well as for 
our solicitation of stakeholder input. The comments maintain that the 
methodology is grounded in science and the process (including peer 
reviews) was rigorous, resulting in a targeted list of foods on the 
FTL. Conversely, other comments assert that the FTL fails to include 
key FSMA requirements and that the RRM-FT approach is not consistent 
with the goal or the statutory factors in section 204(d)(2)(A) of FSMA. 
These comments assert that the RRM-FT differs significantly from some 
of the FSMA requirements by adding criteria not in the statute and 
inappropriately merging multiple statutory factors into one Model 
criterion.
    (Response 1) We appreciate the support for the RRM-FT and disagree 
with the assertions that it does not align with the statutory factors 
or that it differs from the FSMA requirements. As discussed in the 
Response to External Peer Review--Model Review (Ref. 9), subject matter 
experts (SMEs) reviewed the types of concerns raised in the comments 
when developing the draft RRM-FT, and peer reviewers generally agreed 
that the seven criteria we adopted were appropriately within the bounds 
of the FSMA-mandated factors.
    (Comment 2) One comment claims that the RRM-FT methodology and the 
weighting used were not developed according to best practices for a 
multicriteria model, and the necessary expertise was not available to 
develop the Model appropriately. The comment maintains that the RRM-FT 
uses ``an additive weighted approach'' that is not appropriate when the 
model criteria are not preferentially independent because it would 
likely lead to some double counting of information.
    (Response 2) We disagree with this comment. The results of the RRM-
FT are founded on well-constructed criteria and the best available 
data. FDA addressed the issues raised by the comment during the peer 
review process (Ref. 9). As described in the final version of the RRM-
FT Methodological Approach Report (Ref. 10), we recognize that mutual 
independence of criteria is desirable in a multicriteria-based model 
such as the RRM-FT. Within the constraints of the FSMA-mandated 
factors, we acknowledge that there are some correlations among the 
seven criteria or overlaps of data and information used in scoring, but 
we have taken steps to minimize potential overlaps. Most importantly, 
in cases where criteria are correlated, the RRM-FT defines them to 
represent separate aspects of value (of the data and information) to 
help ensure that the criteria represent independent preferences in 
ranking (see Methodological Approach Report, section 5.5 (Ref. 10)). 
The RRM-FT Methodological Approach Report and the peer review-model 
review report provide further explanation on how the RRM-FT 
operationalizes the seven criteria to minimize potential overlaps. FDA 
relied on the expertise of SMEs both within and outside of the Agency 
to develop the RRM-FT.
    In developing the RRM-FT, we reviewed a number of available risk 
tools, including some developed by FDA and others from the published 
literature, including qualitative, semi-quantitative, and quantitative 
methods. We directly addressed the criteria independence issue by 
consulting with the project advisory group and multiple external expert 
panels and by considering comments and suggestions provided by peer 
reviewers.
    (Comment 3) Many comments suggest that data used in the RRM-FT 
should be timely and reflect current food safety practices adopted by 
the industry. A few comments express support for using a 20-year 
timeframe (with appropriate weighting based on the year) for data for 
outbreaks and recalls and suggest that data older than 20 years not be 
used. Some comments express concern that the 20-year timeframe used in 
the RRM-FT is too long and suggest use of a shorter timeframe, such as 
10 years, to reflect current industry practices. Whether comments 
prefer the use of 10 or 20 years, their concerns about older data are 
that it may not represent the current state of the industry because of 
advancements in science and food safety management, including the 
implementation of the produce safety regulation and the regulation on 
preventive controls for human food promulgated under FSMA. Furthermore, 
the comments assert that because industry usually attempts to address 
food safety problems and adopt enhanced food safety practices and 
mitigations to prevent recurrence of outbreaks, the use of older data 
may misrepresent risk. A few comments express support for the data 
weighting method in the RRM-FT, in which a weight of 0.4, 0.7, or 1 is 
applied

[[Page 70918]]

depending on the age of the data, but they request clarification as to 
whether we will always use the most recent 20 years of data and whether 
we will continue to use the same data weighting method in future 
updates of the Model.
    (Response 3) We concur that data used in the RRM-FT should be 
timely and agree with the comment suggesting that a 20-year timeframe 
for outbreak and recall data is appropriate, while giving lower weight 
to (down-weighting) the older data. The RRM-FT incorporates a rolling 
data window in which the most recent 20-year data is used for scoring 
Criterion 1 (Frequency of Outbreaks and Occurrence of Illnesses), 
Criterion 7 (Cost of Illness), and Criterion 3 (Likelihood of 
Contamination), and within the 20-year timeframe, we down-weight older 
data. We believe a 20-year timeframe with down-weighting for older data 
provides an appropriate time window and scoring method to accurately 
capture the history of outbreaks and contamination associated with a 
commodity.
    Criterion 5 (Manufacturing Process Contamination Probability and 
Industry-Wide Intervention) in the RRM-FT considers the current state 
of industry-wide interventions applied to each commodity-hazard pair. 
We acknowledge that industry may make concerted efforts to address food 
safety problems such as in response to outbreaks, and that food safety 
management practices may improve because of the implementation of 
regulations such as those for produce safety or preventive controls for 
human food, and these efforts are accounted for in the RRM-FT through 
the scoring of Criterion 5. Furthermore, to the extent that industry-
wide preventive controls and interventions reduce food safety risk, the 
reduction in risk would also be reflected in the scoring, such as when 
the number of recent outbreaks (not down-weighted) is declining 
compared to older outbreaks, which would be down-weighted.
    (Comment 4) Many comments state the RRM-FT criteria should be 
weighted differently, with more emphasis given to foods with validated 
preventive controls and less to epidemiological data. Specifically, 
some comments claim that the RRM-FT does not give sufficient weight to 
the three factors specified by Congress in FSMA section 204(d)(2)(A) 
that are related to contamination and production and processing 
activities, i.e., factors (ii) (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 such food), (iii) 
(the point in the manufacturing process of the food where contamination 
is most likely to occur), and (iv) (the likelihood of contamination and 
steps taken during the manufacturing process to reduce the possibility 
of contamination). According to the comments, the RRM-FT gives too much 
weight to the other three FSMA factors, which are related to outbreaks 
or are epidemiological in nature. The comments assert that because the 
RRM-FT has five criteria to represent the three factors that are 
epidemiological in nature, this places too much emphasis on those 
factors in comparison to the two criteria that represent the factors 
related to the nature of food and manufacturing activities. The 
comments maintain that the over-emphasis of epidemiology in the Model 
contradicts Congressional intent and results in certain RACs such as 
leafy greens, herbs, tomatoes, cucumbers, peppers, and melons being 
deemed risky when, in the view of the comments, industry and the 
scientific community have greater food safety concerns about further 
processing of fresh produce such as fresh-cut fruits and vegetables 
(e.g., because of a greater potential for contamination and for 
pathogen growth).
    Conversely, other comments maintain that the Model puts too much 
weight on poor processing conditions rather than on inherent risk. The 
comments recommend that we weight criteria so that when a food goes 
through a validated kill step or other preventive control (including 
hurdle technology), the food is not on the FTL. Similarly, some 
comments ask FDA to weight Criterion 5 most heavily and not give too 
much weight to Criterion 6 (Consumption), maintaining that if there are 
strong industry interventions, the amount consumed is less relevant. 
Finally, some comments claim the sensitivity analysis in the RRM-FT is 
very limited and that we have not provided sufficient information to 
justify equal weighting of the criteria in the Model or the impact of 
such equal weighting on the ranking.
    (Response 4) We do not agree with these comments concerning the 
appropriate weighting of the statutory risk factors, and the comments 
have not provided data to support their recommendations. As indicated 
in the RRM-FT Methodological Approach Report (Ref. 10), the RRM-FT uses 
the FSMA statutory factors to define the seven criteria used in the 
Model, and FDA considered different criteria weighting schemes in the 
approach that was peer reviewed. Peer reviewers generally agreed the 
Model's seven criteria were appropriate, and there was no general 
consensus for use of a different weighting scheme other than equal 
weighting of the criteria (Ref. 9). Therefore, we decided to weight the 
seven criteria equally in the RRM-FT. With regard to the comments 
requesting acknowledgment of the importance of a kill step in risk 
reduction, we agree and, as discussed in Section V.E.5 of this 
document, Sec.  1.1305(d) of the final rule sets forth exemptions and 
partial exemptions for FTL foods that receive or will receive a kill 
step.
    (Comment 5) Several comments suggest that FDA consider relevant 
data representative of the inherent food safety risk, including data 
relevant to intrinsic characteristics of the food (e.g., pH, 
application of a validated kill step) and outbreak data from credible 
sources (both State and Federal Agencies). The comments assert that it 
is not appropriate to use outbreak data and other information from 
isolated events or problems specific to a particular facility or 
consumer misuse of the food, such as data from the Reportable Food 
Registry (RFR), because this information concerns facility-specific 
incidents that do not reflect overall risks to public health. The 
comments also suggest that FDA should have a scientific basis for 
including any food on the FTL.
    (Response 5) The RRM-FT provides the scientific basis for the 
designation of the foods on the FTL. As described in the RRM-FT 
Methodological Approach Report (Ref. 10), the RRM-FT uses data and 
information on the intrinsic characteristics of the food and considers 
information on validated control measures in risk scoring. The RRM-FT 
uses the FDA Coordinated Outbreak Response and Evaluation (CORE) 
outbreak dataset (Ref. 11) that includes the CDC outbreak data for 
outbreaks in which the outbreak investigation demonstrated an 
association with FDA-regulated products. In addition, for outbreaks 
involving Vibrio spp. and marine and plant biotoxins, the Model uses 
data from CDC's National Outbreak Reporting System (NORS). To the 
extent that State agencies and other health departments report their 
foodborne illness outbreaks involving microbial and chemical hazards to 
the NORS, outbreaks relevant to FDA-regulated human foods have been 
considered in the RRM-FT. To apply the factors specified in FSMA 
section 204(d)(2)(A), it is necessary to consider both the 
characteristics of foods and hazards. In the RRM-FT, we classify FDA-
regulated human foods into 47 commodity categories. Within each 
commodity

[[Page 70919]]

category, we identify food commodities and associated known or 
reasonably foreseeable hazards, i.e., commodity-hazard pairs, using 
outbreak data, contamination data, and other information from multiple 
sources (Ref. 10). The RRM-FT uses RFR data as a source for scoring 
Criterion 3 only when sampling data are not available. When RFR data 
are used in the RRM-FT, these data are aggregated, e.g., RFR reports 
from 2009 to 2019 are attributed to a commodity-hazard pair (a specific 
hazard in a specific food such as Shiga toxin-producing Escherichia 
coli O157 (STEC O157) in leafy greens), which minimizes the potential 
issue raised in the comments about overemphasis of facility-specific 
problems.
    (Comment 6) Several comments state that the FTL should exclude 
foods that, according to the comments, are ``not inherently 
dangerous.'' Many comments maintain that fresh produce commodities have 
varying degrees of food safety risk; furthermore, the comments assert 
that fresh produce itself is not inherently risky and that risks are 
introduced by food production conditions and processing activities. 
These comments maintain that the risk of contamination is much greater 
with fresh-cut produce than intact RACs and that covering unprocessed 
produce under the food traceability rule will not improve public 
health. Several comments suggest that we factor production methods 
(e.g., controlled environment vs. field environments for growing 
produce) and growing conditions for RACs into the RRM-FT, or that the 
designation of foods on the list be specific to where the food was 
produced. One comment states that the likelihood of contamination for 
fresh produce varies greatly because growing conditions vary greatly 
across farms and regions. The comment provides contrasting examples of 
fresh produce sourced from protected high tunnels irrigated with well 
water vs. from open fields irrigated with water from a canal near 
concentrated animal feeding operations. According to the comment, the 
risk of a fresh produce commodity (e.g., leafy greens) is related to 
the latter type of growing environment and conditions. Therefore, the 
comment maintains that FDA should not require all leafy greens to meet 
the same traceability requirements because this would not be science-
based or consistent with requirements in FSMA. Another comment asserts 
that, compared to field-grown leafy greens, those produced under 
controlled environments have a significantly lower risk of causing 
foodborne illness because of different risk factors (including minimal 
exposure to animals, potable water irrigation through root systems, 
minimal impacts from weather events, and other control measures). The 
comment suggests that such ``controlled environment-produced leafy 
greens'' should be given different consideration in the RRM-FT than 
other leafy greens.
    (Response 6) We disagree with these comments, and the comments do 
not provide scientific data to support their assertions. As previously 
stated, the RRM-FT scores commodity-hazard pairs according to data and 
information relevant for seven criteria that account for the factors 
specified in FSMA section 204(d)(2)(A). As discussed in the RRM-FT 
Methodological Approach Report (Ref. 10), the RRM-FT criteria are 
related not only to the characteristics of the food but also to the 
production and manufacturing processes at the commodity level. For 
example, we evaluate the impact of fresh-cut processing by first 
identifying a variety of commodities under the Produce--RAC commodity 
category, and a variety of commodities under the Produce--Fresh Cut 
commodity category; for each of the commodities, we then identify known 
or reasonably foreseeable hazards, i.e., commodity-hazard pairs for the 
commodities of Leafy Greens and Leafy Greens (Fresh-cut). Thus, the 
methodology accommodates on-farm production practices by identifying 
and evaluating hazards introduced on-farm (e.g., STEC O157 in Leafy 
Greens), and it accommodates processing activities by identifying and 
evaluating hazards introduced in a processing facility (e.g., Listeria 
monocytogenes (L. monocytogenes) in Leafy Greens (Fresh-cut)). The 
Model then scores each commodity-hazard pair using data and information 
relevant to the seven RRM-FT criteria. For example, the impacts of 
production conditions and processing activities are reflected, on an 
industry-wide basis, in the data used to score Criterion 3 (Likelihood 
of Contamination) and the expert judgment used to score Criterion 5 
(Manufacturing Process Contamination Probability and Industry-Wide 
Intervention). As such, the Model does consider production and 
manufacturing risks, as well as other aspects of risks such as the 
potential for the food to support growth of a pathogen (if present).
    We agree with the comments that not all fresh produce is the same. 
Therefore, the Model identifies approximately two dozen fresh produce 
commodities based on the nature of the food and evaluates each of them 
separately, e.g., Leafy Greens, Melons, Tomatoes, Stem Vegetables (see 
Ref. 10, Table A-2). In the Model, the identification of commodity-
hazard pairs is based on available data and information, e.g., foods 
and hazards associated with outbreaks and illnesses and detection of 
hazards in foods. The Model does not rank fresh produce at a more 
granular level than at the commodity level. Regardless of production 
practices (e.g., field-grown vs. controlled environment), fresh produce 
within the same commodity group typically share similar characteristics 
in the potential for the food to support pathogen growth, and many 
contamination risk factors in controlled environments are similar to 
those found in traditional agriculture (Ref. 12). Moreover, we are not 
aware of data that warrant a separate evaluation based on production 
practices, and data are not available to evaluate commodity-hazard 
pairs at that level of granularity for the various criteria in the 
Model.
    (Comment 7) Several comments maintain that the RRM-FT 
inappropriately grouped foods of different natures. According to the 
comments, FDA's approach to risk ranking is problematic because it 
groups different types of commodities together without consideration of 
the variety in each commodity, and, the comment claims, the risk of the 
commodity (e.g., melons, leafy greens) varies depending on the variety 
(e.g., watermelon vs. cantaloupe, spinach vs. lettuce). Several 
comments state that there are no data to suggest certain fresh herbs 
(e.g., fresh bay leaf, makrut lime leaf, curry leaf, rosemary leaf) 
present any significant risk to human health or to support 
identification of many tropical fruits and leafy greens as high-risk 
foods. One comment asserts that while foods within a category may share 
similar characteristics in production and processing, the RRM-FT's 
analysis of a broad food category cannot adequately consider all the 
criteria because some criteria are specific to varieties, not 
commodities (e.g., food safety technologies and innovations are usually 
developed for particular foods, not commodity groups). The comments 
suggest that we conduct individual analyses for particular foods and 
revise the FTL accordingly.
    (Response 7) The RRM-FT considers the nature of the food through a 
categorization scheme that classifies FDA-regulated foods into 47 
commodity categories. Furthermore, within each commodity category, the 
RRM-FT identifies individual commodities. In total, the RRM-FT 
identifies more than 200 commodities (see Ref. 10, Table A-2).

[[Page 70920]]

    The Model does not rank commodities such as fresh produce at a more 
granular level than at the commodity level. We are not aware of 
scientific evidence that warrants a separate evaluation based on the 
varieties within a fresh produce commodity. Moreover, data on 
individual foods, such as specific varietals, are sparse and 
inconsistent across the variety of foods in the Model and on the FTL. 
For the purposes of the FTL, we determined that the appropriate level 
of granularity is at the level of ``commodity,'' e.g., ``tomatoes 
(fresh)'' rather than ``Roma tomatoes'' or ``cherry tomatoes.'' Food 
items within the same ``commodity'' designation generally have similar 
characteristics, associated hazards, and production and supply chain 
practices and conditions, and peer review for the RRM-FT supported this 
approach (Ref. 13). Further, data used to assess components of the 
Model (e.g., outbreak and illness data, likelihood of contamination, 
degree to which product supports growth, consumption, annual cost of 
illness) are available and adequate at the ``commodity'' level of 
granularity.
    (Comment 8) A few comments assert that the RRM-FT does not 
adequately represent FSMA section 204(d)(2)(A) factors (iii) and (iv) 
(i.e., ``the point in the manufacturing process of the food where 
contamination is most likely to occur'' and ``the likelihood of 
contamination and steps taken during the manufacturing process to 
reduce the possibility of contamination'') and that the Model does not 
appropriately reflect differences in production systems and practices. 
According to the comments, the RRM-FT uses one criterion (Criterion 5: 
Manufacturing Process Contamination Probability and Industry-wide 
Intervention) to represent the two FSMA factors, which minimizes their 
impact on risk ranking, especially if there is a validated kill step 
for pathogens in the manufacturing process. The comments suggest that 
we consider more broadly the point in the overall supply chain where 
contamination is most likely to occur and include data to represent 
differences in potential contamination associated with different 
production, manufacturing, and handling processes and practices. The 
comments request that we revise the RRM-FT and the FTL to address their 
concerns and provide the public with an opportunity to comment on the 
revisions.
    (Response 8) We decline to revise the RRM-FT and to solicit 
additional public comment before issuing the final rule. Regarding FSMA 
section 204(d)(2)(A) factors (iii) and (iv), these are incorporated 
into Criterion 5 of the RRM-FT (Manufacturing Process Contamination 
Probability and Industry-wide Intervention) as well as through the 
identification of commodity-hazard pairs under the broad range of 
commodity categories of FDA-regulated human foods. The commodities and 
the commodity categories (see Table A-1 in the RRM-FT Methodological 
Approach Report (Ref. 10)) represent a broad range of foods at 
different points in the supply chain with differences in production, 
manufacturing, and handling processes and practices. As discussed in 
the Response to External Peer Review--Model Review (Ref. 9), subject 
matter experts reviewed and addressed the types of concerns raised in 
the comments during the development of the draft RRM-FT, and peer 
reviewers generally agreed that the seven criteria we adopted were 
appropriately within the bounds of the FSMA-mandated factors, including 
the representation of FSMA factors (iii) and (iv) in the Model.
    (Comment 9) Many comments assert that fresh produce from smaller-
scale farms with relatively short supply chains (sometimes just a few 
miles) have lower risk than produce grown on larger farms, shipped long 
distance, or transformed without a kill step and shipped long distance. 
The comments maintain that locally grown commodities on the FTL, such 
as tomatoes, leafy greens, peppers, and cucumbers, do not have a 
greater risk than fresh crops not on the FTL. Some comments also assert 
that it is not scientifically sound to group locally grown and non-
locally grown produce into one commodity in the RRM-FT because supply 
chain conditions and complexity vary between the two, so the food 
safety risk varies. The comments express concerns that such broad 
grouping will hurt the local food system, drive up the price of food, 
and limit the availability of fresh produce without reducing the risk 
of foodborne illness. Similarly, several comments claim the scoring of 
Criterion 5 in the RRM-FT is subjective, subject to change over time, 
and might not adequately represent small farms or local and regional 
food systems (LRFS). According to the comments, the scoring of 
Criterion 5, which is based on expert elicitations with several expert 
panels, reflects outcomes rather than root causes. One comment 
maintains that the size and type of production system and the length of 
supply chain are among the root causes of foodborne illness from fresh 
produce, but these factors are not adequately considered in the Model. 
Comments also note that the Criterion 5 score could change when 
industry improves production and manufacturing processes to better 
manage risk, which could affect both large and small operations. The 
comments suggest FDA obtain and use qualitative data that represent the 
scale and diversity of small, local farms and food businesses serving 
LRFS supply chains for scoring Criterion 5 and for use otherwise in the 
Model.
    (Response 9) We do not agree that locally produced foods are 
inherently less risky than non-locally produced foods, and the comments 
do not provide scientific data to support their assertions. The Model 
does not differentiate locally grown fresh produce because how near to 
the point of sale the produce was grown does not change the 
characteristics of the food (e.g., the potential for supporting 
pathogen growth) or the potential for on-farm contamination. The RRM-FT 
considers customary shelf life of fresh produce in scoring the 
potential for growth at a temperature at which the commodity (locally 
grown or not) is intended to be held and stored. While locally grown 
produce might be purchased and consumed within a time period shorter 
than that for non-locally grown produce, data are not available to show 
the potential for pathogen growth is sufficiently different between the 
two to result in a different score in Criterion 4 (Growth Potential, 
with Consideration of Shelf Life). Fresh produce commodities on the 
FTL, including locally grown produce, score higher than fresh produce 
commodities not on the FTL based on data relevant to the seven criteria 
in the RRM-FT. While we do not agree that locally grown FTL food is 
less risky than non-locally grown food, we understand that small 
operations may be particularly burdened by the provisions of the rule. 
We also understand that full traceability records may not be necessary 
when a consumer or RFE purchases food directly from a farm. Therefore, 
the final rule provides exemptions from some or all of the provisions 
of subpart S for certain smaller operations and in certain short supply 
chain situations, as discussed in sections V.E.2 and V.E.3, 
respectively, of this document.
    With regard to the scoring of Criterion 5, FDA scores the seven 
criteria in the Model based on available data, both quantitative and 
qualitative. If quantitative data are not available for a certain 
criterion, the criterion is scored based on qualitative data. The RRM-
FT relies on qualitative information from consultations with SMEs, 
including external expert panels, to score Criterion 5. The scoring of 
Criterion 5 is based on

[[Page 70921]]

the SMEs' assessments of each of the commodity-hazard pairs based on 
the status of industry-wide interventions as of 2019 (Ref. 10). The 
SMEs' assessment is based on the entire industry sector, including 
consideration of farms and operations of all sizes and scale 
collectively. It is not feasible to assess a commodity specific to the 
scale of a farm or LRFS supply chain because data for the seven 
criteria are unavailable at that level of granularity. In the peer 
review process, we specifically inquired about the adequacy of the 
expert elicitation process used to obtain qualitative data and address 
data gaps in the RRM-FT (Ref. 13), and there was general consensus 
among the peer reviewers that the process was adequate for the purpose. 
Changes in industry-wide interventions over time will be assessed as 
the data in the Model are updated in the future (see Response 488 about 
updating the Model).
    (Comment 10) Several comments state that certain ingredients (e.g., 
peanut butter) could be considered low risk but, because of their 
incorporation into many diverse foods, the magnitude of the impact if a 
contamination issue arises becomes greater, especially if no kill step 
is applied.
    (Response 10) We agree that ingredients that are incorporated into 
many different foods have the potential to introduce widespread 
contamination. In the Model, we consider this possibility by including 
multi-ingredient foods, identifying and evaluating multi-ingredient 
commodity-hazard pairs based on data (e.g., from outbreaks, recalls, 
and surveillance studies) and expert knowledge.
    (Comment 11) One comment maintains that the RRM-FT does not provide 
justification for the criteria scores of 1, 3, and 9. According to the 
comment, these values can inappropriately inflate risk scores, and it 
is unusual to have the same value for a high, medium, and low score for 
all criteria when the ranges of values in each of the criteria are 
different. The comment also maintains that a multi-criteria model 
should include the elicitation of the value function, but the RRM-FT 
does not show that such an elicitation was done. The comment asserts 
that the RRM-FT uses arbitrary scoring bins of 0, 1, 3, and 9, leading 
to the top bin score of 9 being 9 times as bad as the bin score of 1, 
and FDA does not justify this difference. Another comment suggests that 
FDA use more evenly distributed scoring bins, claiming the 0-1-3-9 
binning approach could over-inflate the criterion score, especially for 
Criterion 1 (Frequency of Outbreaks and Occurrence of Illnesses), 
Criterion 4 (Growth Potential, with Consideration of Shelf Life), and 
Criterion 5 (Manufacturing Process Contamination Probability and 
Industry-wide Intervention).
    (Response 11) In developing the RRM-FT, we evaluated multiple value 
functions, including using an evenly distributed scale (1-2-3-4) and 
essentially a logarithmic scale (0-1-3-9) for scoring Model criteria. 
The scoring and binning methodology chosen was based on extensive 
consultations with external and internal SMEs as well as peer review. 
Given the intended use of the Model, an essentially logarithmic scale 
was recommended by multiple external panels in the expert elicitation 
process and the peer reviewers in the Model review panel. A 
justification of the chosen methodology is provided in the RRM-FT 
Methodological Approach Report (Ref. 10). The rationale behind using 
the scoring scale of 0-1-3-9 is that risk is not necessarily operating 
on a linear scale. Furthermore, using the 0-1-3-9 scale facilitates a 
greater degree of differentiation between higher- and lower-ranked 
food-hazard pairs, which is useful for informing the designation of the 
FTL. The RRM-FT methodology does not consider a criterion score of 9 to 
be 9 times ``as bad as'' a score of 1. Rather, as is the case with all 
multi-criteria decision analysis models, results from the RRM-FT 
provide a risk ranking of alternatives but do not directly quantify 
risk to the consumer (e.g., the probability of illnesses), which 
requires a different methodology such as a quantitative risk 
assessment. The RRM-FT methodology appropriately gives the same 
criterion score to a range of data points that fall into the same 
scoring bin because, for its intended purpose, the RRM-FT does not 
attempt to quantify risk on a continuous risk basis, as would be done 
in a quantitative risk assessment.
    (Comment 12) One comment claims the RRM-FT uses a method to 
determine the contribution of multiple hazards in which the total risk 
score for a food is determined by summing the risk scores of the food-
hazard pairs associated with the food. According to the comment, this 
method makes a food associated with multiple hazards more likely to be 
designated high-risk because it would have a higher score. Furthermore, 
the comment suggests that FDA consider other factors (such as 
processing controls) so that a food is not more likely to be designated 
high-risk simply because it is associated with multiple hazards.
    (Response 12) The RRM-FT does not use the summing method stated by 
the comment; instead, the Model uses an aggregation method that 
involves exponential transformation, summing, and log transformation 
taking into consideration the risk scores for all food-hazard pairs 
under the food. This aggregation method is not sensitive to the number 
of hazards associated with the commodity, but rather the risk score for 
the commodity is driven by the highest-scored commodity-hazard pair(s). 
With regard to considering processing controls, the RRM-FT considers 
processing controls when scoring Criterion 5, which accounts for steps 
taken to reduce contamination and industry-wide interventions.
    (Comment 13) Several comments claim that Criterion 6 (Consumption) 
in the RRM-FT does not align with FSMA section 204(d)(2)(A)(v), which 
directs FDA to consider the ``likelihood that consuming a particular 
food will result in a foodborne illness due to contamination of the 
food. . . .'' The comments maintain that section 204(d)(2)(A)(v) was 
intended to be more about consumer handling of the food, such as 
whether there is temperature abuse, whether the food is cooked 
properly, and amount consumed. The comments maintain that the 
consumption criterion in the RRM-FT (which focuses on frequency and 
amount of consumption) may skew risk ranking, especially for popular 
foods. One comment acknowledges that higher consumption of a food could 
cause an outbreak with greater public health consequences but argues 
that is not what Congress directed FDA to evaluate.
    (Response 13) We disagree with the comments and believe that 
Criterion 6 in the Model appropriately reflects FSMA factor (v) because 
consumption patterns affect the likelihood that consuming a particular 
food will result in a foodborne illness when the food is contaminated. 
Inclusion of the consumption criterion in the RRM-FT is based on 
extensive consultation with SMEs including external expert panels, and 
it has been subject to peer review (Refs. 9 and 13). Additionally, 
consumption is a standard component of a risk assessment, as described 
in the Food and Agriculture Organization (FAO)/World Health 
Organization (WHO) microbiological risk assessment guidance for food 
(Ref. 14). FDA defines Criterion 6 by using two data indicators, 
consumption rate and amount consumed (Ref. 10). When contaminated, 
products that are consumed frequently, in large amount, or both are 
more likely to cause widespread outbreaks. We think that FSMA factor 
(ii) (``the likelihood that a particular food has a high potential risk 
for microbiological or chemical

[[Page 70922]]

contamination or would support the growth of pathogenic microorganisms 
due to the nature of the food or the processes used to produce such 
food'') is the factor that relates more directly to the consequence 
from the potential for temperature abuse during the customary shelf 
life of the food, and we therefore considered that issue in the scoring 
of Criterion 4 (Growth Potential, with Consideration of Shelf Life) for 
the commodity-hazard pair. The RRM-FT does not consider consumer 
cooking because the commodities in the RRM-FT are defined as foods 
available for purchase by consumers.
    (Comment 14) One comment asserts that the Model does not identify 
or explain a ``cut-off'' risk score above which foods are on the FTL, 
which makes it impossible to evaluate the impacts of the Model.
    (Response 14) The RRM-FT methodology is designed to evaluate what 
the risk score is, not what risk score is used to designate a line 
above which foods are on the FTL. The final version of the Designation 
of the FTL Memorandum (Ref. 15) describes this cut-off score and 
explains how FDA uses results from the Model to determine whether a 
food is on the FTL.
    (Comment 15) One comment asserts that the Model attributes fresh-
cut leafy green outbreaks to both fresh-cut and RAC leafy green 
commodities. According to the comment, this inappropriately inflates 
the risk scores for both categories, particularly in the case of RAC 
products where it is often unknown if the contamination occurred after 
processing, and results in the RRM-FT scoring RAC leafy greens as 
higher risk than fresh-cut leafy greens. The comment asserts that this 
contradicts industry understanding and well-known science that fresh-
cut produce by its very nature presents a higher risk than the same 
produce in RAC form.
    (Response 15) The RRM-FT does not attribute outbreaks associated 
with fresh-cut leafy greens to both fresh-cut and RAC leafy green 
commodities. The Model does not ``double count'' outbreaks; each 
outbreak is attributed to a single commodity-hazard pair, e.g., either 
the RAC or the fresh-cut product, depending on the source of the 
outbreak. FDA scores Criterion 1 (Frequency of Outbreaks and Occurrence 
of Illnesses) in the RRM-FT based on the Agency's determination of the 
source implicated in an outbreak, i.e., whether it was determined to be 
a food vehicle (such as fresh salsa) or a contaminated ingredient used 
in the vehicle (such as contaminated tomatoes used in the fresh salsa) 
(Ref. 10). We attribute the number of illnesses and outbreaks to a 
commodity-hazard pair according to information on the contaminated 
ingredient (i.e., the source of the contamination), not to the food 
vehicle implicated (if it is different from the contaminated 
ingredient), when both the contaminated ingredient and the food vehicle 
were identified in the outbreak investigation. For example, if fresh 
salsa was implicated in a foodborne illness outbreak but tomatoes were 
identified as the contaminated ingredient, the outbreak would be 
attributed to tomatoes and not fresh salsa.
    We disagree with the comment's assertion that the RRM-FT 
methodology contradicts the current scientific understanding of the 
route of pathogen contamination in fresh produce. We considered public 
comments on the 2014 draft methodological approach in the development 
of the RRM-FT (Ref. 4), and we had the methodological approach peer 
reviewed in 2016 (Refs. 9 and 13). Based on the peer-reviewed approach, 
we updated the underlying data, where major data sources for scoring in 
the Model were updated to 2019 or the latest available data (Ref. 10). 
Consequently, our approach to outbreak attribution is based on the best 
available information on the source of contamination, which remains 
consistent with current scientific understanding. For example, the fact 
that the commodity-hazard pair risk score is higher for the pair 
``Leafy greens--STEC O157'' than for the pair ``Leafy greens (fresh-
cut)--STEC O157'' (risk score of 430 vs. 310) (Ref. 10) reflects the 
fact that STEC O157 is more likely to originate in RAC leafy greens 
(but can sometimes remain in fresh-cut leafy greens after processing). 
However, for a hazard associated with leafy greens for which the 
processing environment is a typical route of contamination (such as L. 
monocytogenes), the risk score is higher for ``Leafy greens (fresh-
cut)--L. monocytogenes'' than ``Leafy greens--L. monocytogenes'' (risk 
score of 370 vs. 330). The RRM-FT systematically scores relevant 
commodity-hazard pairs for RAC leafy greens and fresh-cut leafy greens. 
The Model then calculates a risk score for each commodity using an 
appropriate aggregation method (Ref. 10), where the risk score for the 
commodity is driven by the risk score for the highest-scored commodity-
hazard pair(s); this results in a commodity risk score that is higher 
for RAC leafy greens than fresh-cut leafy greens.
    (Comment 16) One comment suggests that we consider the wide 
variations in shelf life and pathogen growth potential among dairy 
products. As an example, the comment compares a pathogen like L. 
monocytogenes in a soft Hispanic-style cheese, which has strong growth 
potential, to any pathogen in ice cream, which has effectively zero 
growth potential. The comment maintains that having two indicators for 
scoring Criterion 4 (i.e., using a scoring matrix of Growth Potential 
and Shelf Life) is problematic and may skew the criterion score for a 
commodity as a whole compared to the scores for individual foods. For 
example, the comment maintains that it does not seem accurate to have 
the same Criterion 4 score for a dairy product with a short shelf life/
strong growth potential as for a dairy product with a moderate shelf 
life/moderate growth potential.
    (Response 16) We agree that it is important to consider the 
variations in pathogen growth potential. Consistent with the comment's 
suggestion, results from the Model show a wide range of Criterion 4 
scores among commodity-hazard pairs for dairy commodities. To determine 
the score for Criterion 4, we use a single indicator based on the 
potential that a food would support the growth of pathogenic 
microorganisms due to the nature of the food, and the extent of growth 
as affected by the customary shelf life of the food and the temperature 
at which the food is intended to be held and stored. This reflects a 
revision that we made to the draft approach, taking into consideration 
comments we had received from the public and from peer reviews of the 
RRM-FT (Refs. 9, 13). The commenter incorrectly stated that Criterion 4 
in the 2020 RRM-FT Methodological Approach Report (Ref. 4) used for the 
proposed rule included two indicators. We changed the Criterion 4 
scoring definition to one indicator in the revised Model (2020) in 
response to comments peer reviewers and stakeholders had made on the 
2014 draft. As a result, the revised Model uses only one indicator to 
score Criterion 4, which is ``Growth potential, with consideration of 
shelf life,'' instead of using ``Growth potential/shelf life,'' which 
was evaluated as two separate indicators in the draft approach. The 
scoring definition for Criterion 4 includes the amount of growth 
(log10 increase) given customary shelf life. As described in 
the RRM-FT Methodological Approach Report (Ref. 10), the revised 
definition allows us to appropriately apply data from growth studies 
and predictive microbiology databases, as well as avoid potentially 
skewing the criterion score if two indicators were used.

[[Page 70923]]

    (Comment 17) One comment expresses concern about treating ``Dairy'' 
as one group in the RRM-FT and asserts that foods selected in the RRM-
FT are not representative of the wide diversity of the dairy industry. 
The comment states that the dairy industry makes a wide variety of 
products, including ice cream, yogurt and cultured dairy products, 
butter, hard cheeses, soft cheeses, sour cream, cottage cheese, dips, 
canned sweetened condensed and evaporated milks, pasteurized flavored 
and unflavored fluid milks, dried milk, whey powders, raw milk, and raw 
milk products. The comment asserts that each of these products has 
unique intrinsic characteristics and that the manufacturing process of 
each product may involve a unique combination of processing steps. The 
comment further maintains that it is not appropriate to combine 
pasteurized and unpasteurized dairy products into a single category 
because some dairy products are virtually risk-free, while raw milk and 
raw milk products are inherently risky. For support, the comment cites 
CDC data indicating that over 70 percent of outbreaks associated with 
dairy products are attributed to raw milk and raw milk cheeses. 
Therefore, the comment suggests that we revise the dairy food 
classification considering intrinsic properties (e.g., pH and 
aw) and potential for pathogen growth in the product, choose 
representative dairy foods that reflect the diversity of the industry, 
and ensure that risks from raw milk and raw milk products do not affect 
the risk scores of other dairy products. The comment specifically 
recommends that we separate dairy products into three categories--
cheese, ice cream, and milk--and further divide the cheese category 
into four subcategories: soft ripened cheese, semi-soft cheese, hard 
cheese, and other cheese. The comment also suggests that we amend the 
food facility registration classification scheme by adding a new 
category for yogurt and other fermented milks and cultured dairy 
products because of their unique intrinsic properties. Finally, the 
comment urges us to put raw milk and raw milk products in a stand-alone 
category named ``Raw Milk for Consumption and Raw Milk Products.''
    (Response 17) We do not believe it is necessary to make the 
revisions suggested by the comment. We agree that each of the dairy 
commodities has its unique food characteristics and manufacturing 
processes. In fact, the RRM-FT considers such unique characteristics 
and processes, as well as most of the dairy products suggested by the 
comment, in scoring each of the dairy commodities and associated 
commodity-hazard pairs.
    The RRM-FT does not treat ``Dairy'' as one group but instead 
includes six separate commodity categories for dairy products (see Ref. 
10, Table A-1), several of which contain multiple specific commodities 
(see Ref. 10, Table A-2). The Model identifies as separate commodities 
different types of cheeses (fresh cheese, soft-ripened cheese, and hard 
cheese) made from pasteurized milk. Furthermore, cheeses made from raw 
milk are classified into their own commodities separate from cheeses 
made from pasteurized milk. Ultimately the RRM-FT identifies and 
evaluates 21 individual dairy commodities (see Ref. 10, Table A-2).
    The concerns expressed in the comment do not reflect the handling 
of the dairy commodity categories in the Model (Ref. 10). The RRM-FT 
uses data relevant to seven criteria for each commodity and associated 
commodity-hazard pairs to generate risk scores, taking into 
consideration the intrinsic characteristics of the food (such as the 
low pH of yogurt) in scoring Criterion 4 (Growth Potential, with 
Consideration of Shelf Life), among other data. The RRM-FT does 
consider ``Dairy--Fermented dairy products other than cheese'' as a 
stand-alone commodity category that includes two separate commodities 
(Yogurt and Cultured Products (excluding yogurt)) and associated 
commodity-hazard pairs. Amending the food facility registration scheme 
to add a new category for yogurt as the comment suggests is beyond the 
scope of this rulemaking. Additionally, while the RRM-FT does not 
include a raw milk commodity because FDA prohibits the sale of raw milk 
in interstate commerce, the RRM-FT evaluates raw milk in two separate 
commodities, one for hard cheeses made from unpasteurized milk and one 
for cheeses other than hard made from unpasteurized milk.
    (Comment 18) One comment asserts that FDA did not include or 
consider costs of complying with the FTL traceability rule in Criterion 
7 (Cost of Illness) of the RRM-FT and recommends that we include these 
costs.
    (Response 18) The RRM-FT includes public health risk criteria as 
specified by FSMA section 204(d)(2)(A). Criterion 7 of the RRM-FT is 
defined as the cost of illness for the commodity-hazard pair; 
therefore, it is not appropriate to include in this criterion non-
public health economic impacts such as the cost of complying with the 
rule. FDA considers the costs and benefits associated with the rule in 
the Final Regulatory Impact Analysis (FRIA) (Ref. 16).
    (Comment 19) One comment requests clarification on how FDA will 
address changes in consumer habits. Specifically, for a food that is 
not on the FTL because FDA has determined that the food is rarely 
consumed raw, the comment requests clarification on whether covered 
entities are responsible for knowing that consumer habits have changed 
such that the product is no longer rarely consumed raw or if the FTL 
remains the same until FDA changes it. The comment also asks if we will 
indicate that we are planning to update the FTL due to changes in 
consumer habits.
    (Response 19) The FTL will remain the same until we change it. The 
process for changing the FTL, which includes advance notice and an 
opportunity for the public to provide comment, is discussed in Section 
V.S of this document.
    It is possible for a food to be part of a commodity that is on the 
FTL but to nonetheless be exempt under Sec.  1.1305(e) of the final 
rule because it is listed as rarely consumed raw in Sec.  112.2(a)(1) 
(21 CFR 112.2(a)(1)). For example, collards fall within the commodity 
``Leafy Greens,'' but they are exempt from the subpart S requirements 
because they are listed as rarely consumed raw in Sec.  112.2(a)(1). 
Because any changes to the rarely consumed raw list in Sec.  
112.2(a)(1) would have to be made through notice and comment 
rulemaking, firms would receive notice that the rarely consumed raw 
list might change and would have an opportunity to provide comments on 
the potential change.
    (Comment 20) Some comments ask FDA to clarify the growing and 
production processes that were evaluated and used to place foods on the 
FTL. The comments also request that we clarify, if processes and 
practices change, how that type of information will be used to support 
inclusion or removal of foods from the FTL.
    (Response 20) The growing and production processes that we 
evaluated and used to place foods on the FTL are described in the RRM-
FT Methodological Approach Report (Ref. 10), specifically in section 3 
of the report (``Identification of Food-Hazard Pairs''), where we 
describe the food classification scheme, and in the description of 
Criterion 5 (Manufacturing Process Contamination Probability and 
Industry-wide Intervention), which evaluates the possibility of hazard 
introduction

[[Page 70924]]

during manufacturing and the ability to control contamination with 
interventions through growing and production practices and processes 
throughout the supply chain. We will consider changes in industry 
processes and practices when we update the Model (see Response 488).
    (Comment 21) Several comments ask that we make an interactive model 
tool available for stakeholders to test hypothetical changes to the 
scores for each criterion in the RRM-FT. Additionally, the comments ask 
that we make the data inputs and risk scores for all foods evaluated 
(not just those on the FTL) available to the public to increase 
transparency and help stakeholders with future business decisions. 
Comments also request that we provide the commodity category level 
analyses as well as the analyses for individual commodities in the 
commodity category. One comment that requests revisions to the RRM-FT 
further suggests that we conduct a pilot test with an interactive 
version of the revised RRM-FT to demonstrate to stakeholders how the 
scores are determined for the criteria and how that results in food 
being placed on the FTL. This comment suggests that stakeholders be 
given an opportunity to comment on the revised Model and the 
demonstration, which the comment maintains would give credibility to 
the Model and promote public acceptance.
    (Response 21) We have already made public a substantial amount of 
information that allows stakeholders to analyze and interact with 
information relating to the RRM-FT, including testing hypothetical 
changes to the Model scores. For example, we provided a web-based tool 
(Ref. 17), the RRM-FT Methodological Approach Report (Ref. 10), and a 
full list of references for the data and information used in the Model 
(see link to references in Ref. 17). These materials provide the 
details of the methods on which the analyses are based (including 
examples) with all the information stakeholders need to reproduce such 
analyses. The tool also provides the total score for each of the 
commodities on the FTL as well as the criteria scores for the 
commodity-hazard pairs that make up each commodity on the FTL. In 
response to comments, we are considering making public the scores for 
all the foods evaluated in the Model, including those food/hazard pairs 
not included on the FTL. The Designation of the FTL Memorandum (Ref. 
15) describes key aspects of how FDA uses the RRM-FT to designate the 
FTL.
    With regard to the suggested pilot of the Model and additional 
opportunities for stakeholder comment, we have provided stakeholders 
with opportunities to comment throughout the development of the FTL. As 
previously stated, we published our draft approach for developing a 
risk-ranking model for public comment in 2014. We then refined the 
approach, taking into consideration the public comments received. Two 
separate external peer-review panels reviewed a draft model and the 
data used to generate risk scores with the Model, respectively. 
Concurrently with issuance of the proposed rule, we made available a 
revised model and updated the data, taking into consideration comments 
from the peer reviews. Additionally, we provided opportunities for 
stakeholders to obtain clarity on how the scores are determined for the 
criteria and which foods would be placed on the FTL during three public 
meetings. When we develop a new FTL in the future, we intend to publish 
a proposed updated FTL in the Federal Register for public input, review 
comments from the public, and publish a final updated FTL in the 
Federal Register. We believe this will provide stakeholders sufficient 
opportunity to provide input on any potential changes to the FTL.
    (Comment 22) Several comments suggest that FDA use the RRM-FT to 
evaluate the risk of any new food, such as a multi-ingredient food that 
contains an ingredient on the FTL (FTL ingredient). The comments 
maintain that the dose-response curve should be considered in each 
instance and the risk of a multi-ingredient food that contains an FTL 
food may change depending on the ability of the relevant microbial 
pathogen(s) to survive and grow in the new food. The comments 
acknowledge practical challenges in a potentially enormous number of 
new foods that contain FTL ingredients that would each need to be 
evaluated. The comments suggest that, if FDA does not have the 
resources to evaluate all the new foods, it should apply a threshold to 
the amount of an FTL food that needs to be in a multi-ingredient food 
for the new food to be on the FTL, or help industry use the RRM-FT 
methodology to self-assess the risk of a new food to determine whether 
subpart S would apply.
    (Response 22) We decline to use the RRM-FT to make individual 
evaluations of each multi-ingredient food that contains an FTL food. 
This would not be practical, nor is it necessary. Elsewhere in the 
final rule, we are providing additional clarity on which foods 
containing FTL foods as ingredients are on the FTL (see Response 27). 
For example, for a food that is specified on the FTL as being fresh or 
fresh-cut, if the nature of the FTL food has not changed in the new 
multi-ingredient food containing the FTL food as an ingredient (e.g., 
bagged salad mix containing lettuce, smoothie containing fresh 
cantaloupe, sandwich containing fresh-cut tomato), the risk of the FTL 
food used as an ingredient in the new food is not expected to decrease. 
In fact, in some cases, the ability of bacterial pathogens to grow 
could be greater in the fresh FTL food when it is cut or sliced and 
included in the new multi-ingredient food.
    With respect to the dose-response curve, we acknowledge there might 
be different levels of risk of illness when a different amount of an 
FTL food is consumed. However, there is no generalizable evidence with 
regard to risk of illness from a specific amount of the FTL foods that 
would enable us to set a threshold amount for FTL foods used as 
ingredients in other foods, as suggested by the comments.
    (Comment 23) One comment maintains that in developing the RRM-FT, 
FDA should have ensured that risk managers agreed the Model criteria 
were relevant to the decision for designating the FTL. The comment 
maintains that FDA did not report work done in this area.
    (Response 23) We disagree with the comment. FSMA section 
204(d)(2)(A) establishes six factors for assessing risk of foods and 
designating the FTL that are represented by the criteria in the RRM-FT. 
The RRM-FT Methodological Approach Report (Ref. 10) describes the 
iterative process for developing the RRM-FT. This process included 
extensive and iterative consultations with an FDA Project Advisory 
Group, consisting of members from FDA's Center for Food Safety and 
Applied Nutrition, Office of Foods and Veterinary Medicine, Office of 
Food Policy and Response, Office of Policy, Legislation and 
International Affairs, Center for Veterinary Medicine, and Office of 
Regulatory Affairs, as well as the CDC (Ref. 10). The Project Advisory 
Group provided both technical and policy perspectives in the 
development of the Model. Furthermore, as discussed above in Response 
2, during the development of the Model we consulted multiple external 
expert panels and considered comments and suggestions provided by peer 
reviewers.
    (Comment 24) Several comments oppose using customer reviews as data 
for scoring in the RRM-FT. The comments voice concern with FDA's 
expressed interest in using artificial intelligence to mine non-
traditional data

[[Page 70925]]

sources, specifically customer online reviews, as part of our efforts 
to gather additional data to support risk modeling and inspection 
prioritization. These comments do not believe customer online reviews 
will meaningfully contribute to data gathering.
    (Response 24) The RRM-FT does not use customer reviews in scoring 
because the Model only includes data relevant to seven criteria based 
on the factors specified in section 204(d)(2)(A) of FSMA (Ref. 10), 
including the number of reported outbreaks and illnesses for commodity-
hazard pairs. However, under FDA's New Era of Smarter Food Safety 
initiative, we will continue to explore ways to utilize non-traditional 
data sources and the use of artificial intelligence to protect the U.S. 
food supply. Additional information on this effort can be found in 
FDA's Blueprint for New Era of Smarter Food Safety (Ref. 18).
    (Comment 25) Several comments assert that FDA does not appear to 
have considered comments they submitted on FDA's draft methodological 
approach in 2014. Specifically, the comments maintain that some issues 
they had submitted in 2014 remain not adequately addressed in the RRM-
FT (2020 version), including the following claims: (1) the RRM-FT is 
not aligned with FSMA section 204(d)(2)(A) because it combines factors 
(iii) and (iv) into one criterion (Criterion 5--Manufacturing Process 
Contamination Probability and Industry-wide Intervention) and the 
Model's consumption criterion does not align with FSMA; (2) foods 
selected are not representative of the diversity of the dairy industry; 
(3) having two indicators for Criterion 4 (i.e., using a scoring matrix 
of Growth Potential and Shelf Life) is problematic; (4) use of summing 
as an aggregation method (i.e., summing risk scores for commodity-
hazard pairs to calculate a risk score for the commodity) is not 
appropriate; and (5) the RRM-FT does not provide a cut-off score for 
foods on the FTL.
    (Response 25) We considered each of these issues that were 
submitted in comments on the draft methodological approach in 2014 in 
the iterative process we used to develop and refine the RRM-FT. As 
previously stated, the iterative approach involved consulting with the 
RRM-FT Project Advisory Group and multiple external expert panels, and 
considering comments and suggestions provided by peer reviewers. As 
previously discussed, we have responded to these issues in this final 
rule (see Response 26 for discussion of the RRM-FT alignment with 
statutory factors in FSMA section 204(d)(2)(A); Response 17 for 
discussion of foods selected in the Dairy group; Response 16 for 
discussion of the indicators for Criterion 4; Response 12 for 
discussion of the aggregation method used for risk scores in the RRM-
FT; and Response 14 for discussion of the cut-off score for foods on 
the FTL).
2. Designation of Foods on the FTL
a. General
    (Comment 26) Some comments are supportive of the designation of the 
foods on the FTL. Conversely, other comments raise concerns with how we 
determine which foods are on the FTL and suggest our approach was not 
what Congress intended.
    (Response 26) We appreciate the comments that are supportive of the 
FTL. In section 204(d)(1) of FSMA, Congress directed us to establish 
recordkeeping requirements for certain designated foods that would be 
additional to the traceability recordkeeping requirements in section 
414 of the FD&C Act and the subpart J regulations. In section 204(d)(2) 
of FSMA, Congress directed us to consider specific factors in 
determining for which foods additional traceability recordkeeping 
requirements are needed. To determine which foods should be included on 
the FTL, we developed the RRM-FT based on the factors Congress 
identified in section 204(d)(2)(A) of FSMA. The Model considers FDA-
regulated human foods, identifies commodities available for purchase at 
retail, and for each commodity identifies associated known or 
reasonably foreseeable hazards. The Model scores commodity-hazard pairs 
according to data and information relevant to the seven criteria 
described in the RRM-FT Methodological Approach Report (Ref. 10), which 
are based on the factors Congress identified in section 204(d)(2)(A) of 
FSMA. A commodity was included on the FTL if its risk score, aggregated 
across all associated hazards, was 330 or higher in the Model or if the 
evidence of outbreaks and illnesses and cost of illness scores for one 
or more associated commodity hazard pairs was ``strong'' (Ref. 15). 
This approach is science-based and reflects the intent of Congress in 
identifying the foods for which additional traceability records are 
necessary.
b. FTL Foods as Ingredients
    (Comment 27) Some comments support our proposal to include on the 
FTL both foods specifically listed as well as foods that contain a 
listed food as an ingredient. However, many comments oppose this 
approach. Some comments claim that FDA exceeded its statutory authority 
by expanding the FTL beyond ``particular'' foods (as specified in 
section 204(d)(2)(A)(i), (ii), (v), and (vi) of FSMA). Some comments 
assert that the proposed approach would impose a burden on industry to 
identify every food that contains an FTL food as an ingredient without 
a corresponding public health benefit. Other comments maintain that 
this approach would lead to confusion and a lack of clarity for the 
food industry and increase the burden, particularly on retailers and 
distributors. One comment asserts that this approach would reduce 
consumption of produce because multi-ingredient foods would be 
formulated to avoid including foods on the FTL, such as certain produce 
items. Some comments provide examples of products for which we should 
not require additional recordkeeping for traceability, such as frozen 
pizza with cheese, granola bars with dried fruit, herbed bread, and 
quiches that use different types of peppers. Many comments ask that we 
exempt foods containing FTL foods as ingredients unless they are 
otherwise a listed food, such as a deli salad containing tomatoes, or 
to specifically list on the FTL certain multi-ingredient foods that 
should be covered under the final rule, such as bagged salads. Some 
comments recommend that the final rule apply only to foods on the FTL 
and foods containing listed foods as ingredients that will be consumed 
without a kill step.
    (Response 27) We are clarifying our approach to the FTL in response 
to the comments. For several of the commodities on the FTL, we have 
clarified which version of the commodity is on the FTL and therefore 
covered by the final rule. For example, if a commodity is specified as 
``fresh'' on the FTL, then only the fresh version of the commodity is 
covered by the final rule. If such a commodity is used in its fresh 
form as part of a multi-ingredient food, then the multi-ingredient food 
would be covered under the final rule. For example, fresh lettuce used 
in a bagged salad mix, fresh cantaloupe in a commercially prepared 
smoothie, or a sandwich containing a fresh tomato would be covered, but 
a frozen pizza with a spinach topping or trail mix with dried papaya 
would not be covered. We believe this approach is appropriate because 
the risk of the fresh FTL food would not be diminished just because it 
is used as an ingredient in a multi-ingredient food, if no kill step is 
applied or the FTL food is not otherwise changed, for example by drying 
or

[[Page 70926]]

freezing, such that it is no longer on the FTL. Further, the multi-
ingredient food may be a key signal in an outbreak investigation that 
ultimately leads to identification of the contaminated ingredient. For 
example, we may receive a signal of fresh salsa in an outbreak 
investigation, and after further investigation be able to attribute the 
outbreak to the fresh tomatoes in the salsa. This example demonstrates 
not only why it is important to have the multi-ingredient food covered 
by the rule (because it is causing illness and serves as a key signal), 
but also why a commodity such as fresh salsa might not independently 
appear on the list if it is associated with outbreaks that are not 
attributed to it in our outbreak database because they are found to 
have been caused by an ingredient such as fresh tomatoes (see Response 
15). Therefore, we believe it is appropriately protective of public 
health for the subpart S requirements to apply to multi-ingredient 
foods with FTL foods as ingredients, provided the FTL food remains in 
the same form (e.g., ``fresh'') that is specified on the FTL. We do not 
think Congress's use of the word ``particular'' in section 
204(d)(2)(A)(i), (ii), (v), and (vi) of FSMA precludes this approach.
    For foods on the FTL that are not designated as ``fresh,'' if those 
FTL foods are used as ingredients in a multi-ingredient food and no 
kill step is applied or the FTL food is not otherwise changed such that 
it is no longer on the FTL, then the multi-ingredient food would be 
covered by the final rule. For example, peanut butter in a sandwich 
cracker for which no kill step is applied (to either the peanut butter 
or the peanut butter sandwich cracker) will be covered by the rule. As 
discussed in Response 75, the commodities on the FTL related to finfish 
and seafood include both the fresh and frozen forms of those products. 
As such, freezing finfish or seafood would not be considered a change 
such that the food is no longer on the FTL, so frozen finfish or 
seafood would not be exempt from the subpart S requirements.
    (Comment 28) One comment asserts that additional recordkeeping 
requirements are unnecessary for foods containing FTL foods as 
ingredients because processors already keep records under the 
preventive controls for human food regulation and the FSVP regulation, 
which require documentation of application of a kill step and 
verification of suppliers. In addition, the comment maintains that food 
companies still have to keep records for the immediate previous source 
and immediate subsequent recipient of the food under subpart J.
    (Response 28) While many food companies are required to keep 
records under subpart J documenting the immediate previous source and 
immediate subsequent recipient of their food, FSMA directed FDA to 
develop a regulation requiring additional traceability records for 
certain foods beyond what FDA already requires under subpart J. We 
recognize that food processors also must keep records under other 
regulations, but many of those records are for purposes other than 
traceability. For records required under subpart S, Sec.  1.1455(f) 
specifies that firms may use records kept for other purposes and do not 
have to duplicate records (see Section V.R.3 of this document). For 
example, 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 21 
CFR 117.190(a)(2)) or documentation of thermal processing of low-acid 
canned foods (LACF) (see 21 CFR 113.100), to meet the requirement in 
Sec.  1.1305(d)(3)(ii) to document application of the kill step to a 
food.
    (Comment 29) One comment requests that we exclude foods from the 
final rule for which the Harmonized Commodity Description and Coding 
System does not provide sufficient classification of the food because 
it would be too confusing, particularly for trading partners, to 
clearly identify the food on the FTL if there is not a corresponding 
code in that system. Another comment suggests that we use the 
Harmonized Commodity Description and Coding System to provide 
additional clarity on the foods on the FTL.
    (Response 29) We decline the comment's suggestion to exempt from 
the final rule foods that are insufficiently classified under the 
Harmonized Commodity Description and Coding System. We believe the FTL 
issued with the final rule (Ref. 19) provides sufficient information 
for firms to know whether a particular food is on the FTL. While 
Harmonized Commodity Description and Coding System codes are typically 
used for tariff and not food safety purposes, we recognize that in some 
cases providing additional information on FTL foods using 
classification systems used by importers could be useful. We will 
explore ways to provide additional guidance for importers as needed 
regarding identification of foods on the FTL.
c. Changing the Form of an FTL Food
    (Comment 30) Many comments request clarification on the version of 
the food that is covered by the proposed rule and whether a fresh 
version of an FTL food would be considered an ingredient in a dried or 
frozen version of the food and be covered, or if the dried or frozen 
version of the food would not be considered an FTL food. The comments 
note that the Model contains separate commodity designations for some 
frozen foods such as frozen fruits and frozen vegetables. If the dried 
or frozen version is covered by the rule, the comments ask for 
clarification on which KDEs would apply to the food. The comments 
maintain that including on the FTL these foods that have changed their 
form would result in coverage of numerous foods that do not present the 
same public health risk as listed foods and would increase the rule's 
economic and resource burden on covered entities.
    (Response 30) We have clarified the FTL in response to the 
comments. For foods that are designated as ``fresh'' on the FTL, if the 
form of the food is no longer fresh and has been changed (i.e., through 
freezing, drying, or another change in the form of the food), then the 
food would no longer be an FTL food. For example, frozen spinach, 
frozen cut mangoes, dried peppers, or dried herbs would not be covered 
by the rule if only the fresh form is listed on the FTL. The person 
changing the FTL food such that it is no longer on the FTL would need 
to maintain receiving records of the FTL food but would not be required 
to maintain subpart S records for its subsequent handling of the food 
(e.g., transformation and shipping), and subsequent recipients of the 
food would not have to maintain records under the rule.
    However, as discussed in Response 75, the commodities on the FTL 
related to finfish and seafood include both the fresh and frozen forms 
of those products. As such, freezing finfish or seafood would not be 
considered a change such that the food is no longer on the FTL, and 
frozen finfish and seafood are therefore covered by the final rule.
    We believe our approach to this issue is appropriate because of how 
foods are categorized within the Model. For example, the Model includes 
several commodity designations that could include peppers (e.g., 
peppers (fresh), frozen vegetables, dried vegetables), but it is the 
fresh peppers that had a risk score high enough to be included on the 
FTL. Frozen vegetables and dried vegetables did not have a risk score 
that

[[Page 70927]]

placed them on the FTL (see Response 26 for a description of the method 
by which foods on the FTL were determined).
d. Clarify Foods on the FTL
    (Comment 31) Several comments express appreciation for the 
additional clarification FDA provided on the FTL on January 11, 2021, 
and request that we include those clarifications in the final rule. 
Many comments ask that we provide additional clarity and specificity in 
describing the foods on the FTL, maintaining that this would reduce 
confusion for the food industry and regulators.
    (Response 31) As the comments note, we provided additional clarity 
regarding the foods on the FTL on January 11, 2021, in response to 
stakeholder input following the publication of the proposed rule. The 
FTL we are issuing with the publication of the final rule maintains 
those clarifications and provides additional clarifications and 
descriptions for the commodities on the FTL (Ref. 19). For some 
commodities, we have added examples of foods that are and are not 
considered part of that commodity designation on the FTL.
    (Comment 32) Multiple comments request that we provide exhaustive 
lists of the foods for each commodity on the FTL and for commodities 
not on the FTL.
    (Response 32) Considering the variety and range of food products 
for each commodity, it would be very challenging to provide an 
exhaustive list of foods for each commodity. As stated in Response 31, 
we have provided additional clarifications and descriptions for the 
commodities on the FTL, and for some commodities we have added examples 
of foods that are and are not considered part of that commodity 
designation on the FTL. We believe these clarifications and examples 
will help stakeholders better understand the foods under each commodity 
on the FTL.
    (Comment 33) One comment asks where they can find the commodity 
risk scores mentioned in the proposed rule.
    (Response 33) The risk scores for the commodities on the FTL are 
available in the RRM-FT Methodological Approach Report (Ref. 10).
    (Comment 34) A few comments support the use of the term ``Food 
Traceability List'' to identify the list of foods that are covered by 
the rule. The comments note that the term is preferable to use of the 
term ``high-risk list,'' which could result in consumers avoiding 
certain foods such as fruits and vegetables due to public perception of 
the term ``high-risk.'' One comment argues that FDA must use the term 
``high-risk list'' in the food traceability regulation to be consistent 
with the language and intent of FSMA.
    (Response 34) While we acknowledge that section 204(d) of FSMA uses 
the phrase ``high-risk foods,'' we believe the term ``Food Traceability 
List'' is appropriate for the purposes of this rule. We agree with the 
concerns raised about potential negative consumer perceptions of a 
``high-risk list'' and resulting efforts to avoid foods on the list. 
Furthermore, the FTL is based on specific concerns related to 
traceability and is not meant to encompass all possible risk factors 
associated with foods. To determine which foods should be included on 
the FTL, we developed the RRM-FT based on the factors that Congress 
identified in section 204(d)(2)(A) of FSMA. Those factors are specific 
to what Congress required under FSMA and may not reflect other 
approaches to assessing risk. Furthermore, in identifying foods for 
inclusion on the FTL, we focused on hazards for which improved 
traceability records would help protect the public health. For example, 
as discussed below (see Response 86), we concluded that enhanced 
traceability recordkeeping requirements would not greatly improve our 
ability to identify and respond to undeclared allergens in food. 
Therefore, although undeclared allergens pose a significant risk, we 
did not incorporate this risk into our decision of which foods to 
designate for the FTL. Consequently, to avoid unnecessary consumer 
concerns and confusion with other risk determinations, we conclude that 
it is appropriate to use the term ``Food Traceability List'' rather 
than ``High-Risk Foods List.''
e. Foods vs. Commodities
    (Comment 35) Several comments claim that FSMA required FDA to 
designate ``particular foods'' for the FTL rather than commodities. The 
comments maintain that some foods within certain commodities, if scored 
separately, would not have sufficient risk scores to be listed on the 
FTL. One comment argues that grouping foods into commodities does not 
accurately capture the risk of individual foods. Some comments assert 
that the boundaries of the commodities on the FTL are not clearly 
defined, which could result in confusion and ambiguity for some parts 
of the industry. These comments maintain that submitting questions 
through the FDA Technical Assistance Network (TAN) to inquire about 
coverage of specific foods is complicated and not timely.
    (Response 35) We interpret the term ``particular food'' in section 
204(d)(2)(A)(i), (ii), (v), and (vi) of FSMA in a way that is 
reasonable and consistent with section 204(d), and that accurately 
reflects the specificity of data available to us in developing the FTL. 
As discussed in Response 7, data on individual foods, such as specific 
varietals, is sparse and inconsistent across the variety of foods in 
the Model and on the FTL. For the purposes of the FTL, we determined 
that the appropriate level of granularity is at the level of 
``commodity,'' e.g., ``tomatoes (fresh)'' rather than ``Roma tomatoes'' 
or ``cherry tomatoes.'' Food items within the same ``commodity'' 
designation generally have similar characteristics, associated hazards, 
and production and supply chain practices and conditions. Further, data 
used to assess components of the Model (e.g., outbreak and illness 
data, likelihood of contamination, degree to which product supports 
growth, consumption, annual cost of illness) are available and adequate 
at the ``commodity'' level of granularity. See also Response 68 for a 
discussion on the scope of the seafood commodity categories.
    As stated in Response 31, we have provided additional 
clarifications and descriptions for the commodities on the FTL, and for 
some commodities we have added examples of foods that are or are not 
considered part of that commodity designation on the FTL. We believe 
these clarifications and examples will help stakeholders better 
understand the foods under each commodity on the FTL. As part of our 
outreach to stakeholders regarding the final rule (see Section V.U.4 of 
this document), we will continue to use the TAN to provide timely 
responses to questions about the FTL and the subpart S requirements, 
recognizing that some answers may take longer depending on the nature 
of the question.
    (Comment 36) One comment argues that listing commodities would make 
it more difficult to remove foods from the FTL because new food safety 
technologies are typically applied to individual foods rather than 
commodities as a group.
    (Response 36) As discussed in Section V.T.1 of this document, we 
plan to periodically conduct a review to determine whether it is 
appropriate to revise the FTL in accordance with the procedures set 
forth in Sec.  1.1465 of the final rule. While there are several 
factors that we must consider in determining which foods are on the 
FTL, changes in industry practice, such as the use of new food safety 
technologies, may result in a sufficient change in the risk score of a 
commodity such that it would no longer be on the FTL.

[[Page 70928]]

    We encourage the development and adoption of new food safety 
technologies to improve the safety of specific foods. If a company 
develops a new food safety technology which they believe provides an 
additional level of food safety for the food they produce, that company 
might consider submitting a citizen petition requesting modified 
requirements or an exemption from subpart S for certain products based 
on use of that technology, using the procedure set forth in Sec.  
1.1370 (see Section V.P of this document). We note that if new 
technologies provide a ``kill step'' to FTL foods, the food might be 
exempt from subpart S under Sec.  1.1305(d) of the final rule.
f. Add Foods to the FTL
    (Comment 37) Several comments suggest additions to the FTL. A few 
comments suggest the FTL should be expanded to include all foods or all 
foods that have caused foodborne illness. A few comments suggest 
expanding the FTL to include all produce and all seafood. One comment 
suggests expanding the FTL to include additional foods associated with 
outbreaks, such as dried and frozen fruits, tahini, pistachios, 
hazelnuts, and flour.
    (Response 37) We decline to make these changes to the FTL. Congress 
explicitly directed us to establish additional recordkeeping 
requirements for traceability for foods that meet certain risk-based 
criteria. To determine which foods should be included on the FTL, we 
developed the RRM-FT based on the factors that Congress identified in 
section 204(d)(2)(A) of FSMA. The Model scores commodity-hazard pairs 
according to data and information relevant to seven criteria described 
in the RRM-FT Methodological Approach Report (Ref. 10). A commodity was 
included on the FTL if its risk score, aggregated across all associated 
hazards, was 330 or higher in the Model or if the evidence of outbreaks 
and illnesses and cost of illness scores for one or more associated 
commodity hazard pairs was ``strong'' (Ref. 15). If the foods suggested 
by the comments are not on the FTL, it is because their risk scores 
were not high enough to warrant inclusion on the FTL. As noted 
elsewhere, we intend to revise the FTL on a regular basis based on 
updates of the data in the Model. If the risk scores for foods 
(including those specified in the comments) change, those foods could 
be added to the FTL in a subsequent update to the list.
    We recognize that there are foods that have been linked to past 
outbreaks but that are not on the FTL. Future outbreaks might also 
occur among foods not on the FTL. No food is completely risk-free, and 
we encourage all supply chain members to have systems and procedures in 
place to enable them to rapidly and effectively engage in traceback and 
traceforward activities for all of their foods, including those not on 
the FTL. However, Congress made clear that the additional recordkeeping 
requirements established by this rulemaking should only apply to foods 
that FDA designated for inclusion on the FTL, and that these 
requirements should have no effect on foods that are not so designated 
(see section 204(d)(7) of FSMA).
g. The FTL and the High-Risk Designation
    (Comment 38) One comment requests that we not use the FTL for 
purposes other than the traceability recordkeeping requirements, such 
as establishing inspection frequencies or setting performance 
standards. The comment asserts that ``high-risk'' is defined 
differently depending on its context or use.
    (Response 38) We agree that ``high-risk'' is defined differently 
depending on its context or use. Congress directed us to consider 
specific factors in determining which foods should have additional 
recordkeeping requirements for traceability. Those factors were 
specific to section 204(d) of FSMA. Section 201 of FSMA, which is 
codified as section 421 of the FD&C Act (21 U.S.C. 350j), directs FDA 
to consider a different set of factors to identify high-risk facilities 
for the purpose of determining the frequency of domestic inspections. 
Performance standards can be used in a wide range of settings, and any 
risk determination used for a performance standard would have to be 
appropriate to that context.
h. Description of Foods on the FTL
    (Comment 39) One comment requests that we provide the scientific 
name of plants and animals on the FTL. Another comment requests that we 
use the naming conventions of the Codex Alimentarius or the Code of 
Federal Regulations in identifying foods on the FTL.
    (Response 39) We decline these requests. The foods identified on 
the FTL were based, in part, on data from FDA's RFR and facility 
registration systems, which have existing naming conventions within FDA 
systems. Further, FDA typically uses the common name of plants and 
animals in its documents to help ensure that all stakeholders have an 
understanding of the foods to which regulations or guidance apply. 
Regarding requests to use other naming conventions, such as those in 
the Codex Alimentarius or the Code of Federal Regulations, those naming 
conventions were not developed for traceability, nor do they 
necessarily conform to FDA's typical naming conventions.
i. Produce
    (Comment 40) Several comments ask for clarifications on the types 
of melons that would be covered in the ``melon'' category and how 
melons were deemed to be high-risk foods. The comments also request 
that whole fresh watermelon be excluded from the FTL.
    (Response 40) In the melon category, the FTL includes all types of 
fresh melons. Examples include, but are not limited to, cantaloupe, 
honeydew, muskmelon, winter melon, bitter melon, and watermelon. As 
previously stated, a commodity was included on the FTL if its risk 
score, aggregated across all associated hazards, was 330 or higher in 
the Model, or if the evidence of outbreaks and illnesses and cost of 
illness scores for one or more associated commodity hazard pairs was 
``strong.'' Based on the seven criteria used in the Model and the data 
we have for melons, this commodity has a risk score that warrants its 
inclusion on the FTL. Response 26 provides a description of the method 
by which foods, including melons, on the FTL were determined, while 
Response 6 discusses why the list uses commodity groupings (such as 
melons) rather than individual foods (such as watermelons).
    (Comment 41) Several comments ask for clarification on how tropical 
fruits were determined to be in the tropical tree fruit category and 
whether certain fruits like bananas, avocado, and citrus are in that 
category.
    (Response 41) The RRM-FT Methodological Approach Report (Ref. 10) 
describes the classification of food commodities, including tropical 
tree fruits. The tropical tree fruit designation allows for a grouping 
of similar tree fruits, not other tropical fruit, that are typical to 
locations that are hot and humid and whose longer day lengths allow for 
fruit maturity. Examples of tropical tree fruits include (but are not 
limited to) mango, papaya, mamey, guava, lychee, jackfruit, and 
starfruit. Tropical tree fruits do not include non-tree fruits (such as 
bananas, pineapple, dates, soursop, jujube, passionfruit, loquat, 
pomegranate, sapodilla, and figs); tree nuts (such as coconut); pit 
fruit (such as avocado); or citrus (such as orange, clementine, 
tangerine, mandarins, lemon, lime, citron, grapefruit, kumquat, and 
pomelo). However, derivatives or components of

[[Page 70929]]

some of the fruits that are not considered tropical tree fruits may be 
on the FTL in other commodity categories, such as coconut butter in the 
nut butter category, as discussed in this document.
    (Comment 42) Several comments ask whether the ``Tropical Tree 
Fruits (fresh)'' category is limited to high-risk tree fruits and 
includes other tropical tree fruit products that have undergone 
processing but not a validated kill step, such as guava paste.
    (Response 42) The ``Tropical Tree Fruits (fresh)'' commodity is one 
of two dozen commodities we identify in the commodity category 
``Produce--RAC (raw agricultural commodity)'' based on the 
consideration of the characteristics of the foods and production and 
supply chain practices and conditions. The RRM-FT evaluates several 
commodities for fresh fruits, including Tropical Tree Fruits (e.g., 
papaya), Tropical Fruits NEC. (e.g., banana), Citrus (e.g., orange), 
Pome Fruits (e.g., apple), and Pit Fruits (e.g., avocado), and finds 
that only the Tropical Tree Fruits commodity has a high enough risk 
score to meet the threshold for inclusion on the FTL. Therefore, the 
FTL includes fresh tropical tree fruits but does not include other 
fresh tropical fruits. Fresh guava is covered under the ``Tropical Tree 
Fruits (fresh)'' commodity. If fresh guava is used as an ingredient in 
guava paste, the guava paste would also be included on the FLT. 
However, if the guava paste is subjected to a kill step, the exemption 
language in Sec.  1.1305(d) would apply.
    (Comment 43) Several comments request that we clarify the scope and 
definition of leafy greens that are on the FTL. Some comments also 
suggest that the FTL align with the Leafy Greens Marketing Association 
(LGMA) definition of leafy greens.
    (Response 43) We have provided additional clarification to the 
description of the commodity ``Leafy Greens (fresh)'' on the FTL, 
specifying that it includes all types of fresh leafy greens (Ref. 19). 
Examples include, but are not limited to, arugula, baby leaf, butter 
lettuce, chard, chicory, endive, escarole, green leaf, iceberg lettuce, 
kale, red leaf, pak choi, Romaine, sorrel, spinach, and watercress. The 
``Leafy Greens (fresh)'' category does not include whole head cabbages 
such as green cabbage, red cabbage, and savoy cabbage, nor does it 
include banana leaf, grape leaf, and leaves that grow on trees. Also 
note that fresh leafy greens listed as rarely consumed raw in Sec.  
112.2(a)(1), such as collards, are exempt from the requirements of 
subpart S under Sec.  1.1305(e) of the final rule.
    We believe the description of ``Leafy Greens (fresh)'' that is on 
the FTL is generally aligned with the LGMA list of leafy greens. 
However, we acknowledge that there are some differences. The LGMA list 
includes whole head cabbages, which are not on the FTL, and spring mix, 
which is not part of the ``Leafy Greens (fresh)'' category on the FTL 
(but which is nonetheless on the FTL as part of the commodity ``Leafy 
Greens (fresh-cut)''). The FTL description of ``Leafy Greens (fresh)'' 
includes some leafy greens that are not on the LGMA list, such as 
chicory, watercress, pak choi, and sorrel.
    (Comment 44) A few comments request that collards be removed from 
the proposed FTL as they are listed in the produce safety regulation 
(in Sec.  112.2(a)(1)) as rarely consumed raw.
    (Response 44) Collards are exempt from the subpart S requirements 
under Sec.  1.1305(e) of the final rule because they are currently 
listed as rarely consumed raw in Sec.  112.2(a)(1). Otherwise, collards 
would be subject to subpart S because they are part of the leafy greens 
commodity category. To avoid confusion, we have removed collards from 
the list of examples of leafy greens on the FTL.
    (Comment 45) One comment requests that we individually list, with 
the applicable plant part(s), every fruit, vegetable, and culinary herb 
that is subject to the rule, or expand the language in each category to 
fully describe the intended subjects, including information such as the 
species name(s), the plant part(s), the botanical characteristics 
(e.g., whether the plant grows on the ground vs. a tree or a climbing 
vine) and other information as appropriate to provide clear and 
accurate descriptions.
    (Response 45) We do not agree that this level of detail is 
necessary. Furthermore, adding botanical names could inadvertently 
include or exclude commodities not intended to be on or off the FTL. 
However, the revised FTL (Ref. 19) points out differences when 
necessary, such as between beet root and beet greens, as well as dill 
leaves and dill seed. The revised FTL also includes additional examples 
of foods on the FTL.
    (Comment 46) Some comments ask that we confirm that ``frozen'' and 
``fresh-frozen'' vegetables are not included on the FTL.
    (Response 46) Vegetables that are sold as ``frozen'' or ``fresh-
frozen'' are not included on the FTL because this product category was 
analyzed separately from vegetables that are sold in other forms (e.g., 
fresh, dried), and frozen/fresh-frozen vegetables did not meet the 
scoring criteria for inclusion on the FTL.
    (Comment 47) One comment agrees with FDA that whole apples, pears, 
cherries, and fresh berries should not be on the FTL.
    (Response 47) Whole apples, pears, cherries, and fresh berries did 
not have risk scores high enough to be included on the FTL and 
therefore are not covered by the final rule.
    (Comment 48) Several comments request that we limit the FTL to 
sprouts, fresh produce, and/or high-risk herbs like cilantro with risk 
scores above the cutoff threshold of 330, and then phase in other foods 
as part of subsequent FTL updates. The comments maintain that this 
would allow FDA to ``test'' its traceability approach in the final 
rule, especially since some sectors of the produce industry have 
experience with traceability via participation in private traceability 
initiatives.
    (Response 48) We decline to adopt the phased-in approach suggested 
by the comments. Congress directed FDA to identify foods for which 
additional recordkeeping requirements for traceability are necessary to 
protect the public health. Limiting the foods on the FTL to a subset of 
the commodities that had risk scores that merited inclusion on the list 
would not be based in science and would reduce the public health 
protections anticipated for the food traceability regulation.
    (Comment 49) A comment suggests that we clarify whether fresh-cut 
produce that is ``rarely consumed raw'' under the produce safety 
regulation falls under the subpart S requirements for fresh-cut 
produce. One comment suggests that we provide more clarity about which 
fresh-cut produce is included on the FTL, and additional clarity on the 
methodology used to reach these conclusions.
    (Response 49) Produce that is ``rarely consumed raw'' according to 
the produce safety regulation (Sec.  112.2(a)(1)) is exempt from the 
subpart S regulations under Sec.  1.1305(e) for the entirety of the 
supply chain, regardless of whether it is fresh-cut. For example, 
although all fresh-cut fruits and vegetables are on the FTL, a fresh-
cut ``rarely consumed raw'' vegetable such as fresh diced butternut 
squash would be exempt under Sec.  1.1305(e) because the fact that the 
butternut squash is fresh-cut does not change its status as ``rarely 
consumed raw.''
    (Comment 50) Some comments suggest that we reevaluate coverage of 
mung bean sprouts under the FTL. These comments maintain that mung bean 
sprouts should be considered rarely consumed raw and assert that few 
food safety issues have been linked to mung bean sprouts and mung 
beans.

[[Page 70930]]

The comments also ask us to reevaluate mung bean sprout consumption 
data using more recent datasets.
    (Response 50) Fresh mung bean sprouts, as well as other types of 
fresh sprouts, are covered by the produce safety regulation and are not 
considered to be ``rarely consumed raw'' under Sec.  112.2(a)(1). 
Section 112.2(a)(1) codifies an exhaustive list of all produce that is 
considered ``rarely consumed raw,'' and revising that list is outside 
the scope of this rulemaking. The commodity risk scores for fresh 
sprouts, including mung bean sprouts, qualified this commodity for 
inclusion on the FTL, as it has associated commodity-hazard pairs with 
criteria scores in the moderate to strong range (Ref. 15, Table 1 and 
Appendix I). We further note that, according to the FDA CORE Outbreak 
Dataset (Ref. 11), between 1999-2019 there were eight documented 
outbreaks related to consumption of mung bean sprouts, resulting in 319 
illnesses and at least 2 deaths.
j. Herbs and Spices
    (Comment 51) One comment asks that we clarify that it is the fresh 
version of herbs that are on the FTL and not the dried form (i.e., 
spices). The comment further maintains that tomatoes and peppers that 
are dried or will be dried for spices or seasonings should not be 
included on the FTL. The comment also asks for clarification on whether 
capsicum annum pepper, if grown to become a spice, would be covered by 
the rule. Another comment asserts that herbs that are destined to be 
dried should not be covered by the rule because those herbs are grown, 
processed, and consumed differently than fresh herbs. Another comment 
recommends that spices, seasonings, and flavorings not be included on 
the FTL. Another comment states that it understands that dried herbs 
and spices are not covered by the rule because they are a separate 
commodity in the Model and are not on the FTL.
    (Response 51) In the additional information on the FTL that we 
provided on January 11, 2021, we noted that the form of herbs on the 
FTL is the fresh form. Spices, seasonings, and flavorings are not 
included on the FTL and therefore are not covered by the final rule. In 
Response 30, we provide additional clarity regarding foods on the FTL 
that are designated as ``fresh.'' Section 1.1305(d)(4) and (d)(5) of 
the final rule (see Section V.E.5 of this document) provide further 
clarification that if a food is changed such that it is no longer on 
the FTL, then the food would not be covered. Therefore, dried herbs, 
dried tomatoes, and dried peppers would not be covered by the final 
rule because the FTL only includes the fresh versions of those foods.
    In addition, under Sec.  1.1305(d)(6), if an FTL food is destined 
to be changed (e.g., through freezing, drying, or another change in 
form of the food) such that it is no longer on the FTL, then that food 
would not be covered from the point at which it is known that the FTL 
food is destined to be changed, provided that the entities have a 
written agreement as described in Response 196.
    Regarding the capsicum annum pepper, if the peppers are destined to 
be dried for spices and the pepper shipper has a written agreement with 
the receiver that the peppers will be dried, then, as noted above, the 
shipper and receiver of the pepper would not be required to keep 
subpart S records for the food. However, if the pepper shipper does not 
have a written agreement, the shipper would need to maintain the 
relevant subpart S records.
    (Comment 52) Comments request that we provide more clarity 
regarding the specific part of the herb plant that is covered under the 
FTL.
    (Response 52) For fresh herbs, any part of the herb that is fresh 
and sold for human consumption would be covered under the FTL.
    (Comment 53) One comment asks that we limit the FTL to fresh 
culinary herbs rather than all herbs.
    (Response 53) As discussed in Response 51, we have clarified that 
the form of herbs on the FTL is the fresh form. We believe that further 
clarification and distinction as ``culinary'' herbs is not necessary. 
The ``Herbs (fresh)'' commodity is one of two dozen commodities we 
identify in the commodity category ``Produce--RAC'' based on the 
consideration of the characteristics of the foods and production and 
supply chain practices and conditions. The Model scores the commodity-
hazard pairs at the commodity level (e.g., all fresh herbs) regardless 
of the purpose of use because we are not aware of scientific evidence 
that fresh produce within the same commodity does not share a 
similarity in the characteristics of the food and in how they are 
produced. Furthermore, we are not sure how the phrase ``culinary 
herbs'' would be defined. In the Model, the ``Herbs (fresh)'' commodity 
has criteria scores high enough to meet the threshold for inclusion on 
the FTL.
k. Deli Salads
    (Comment 54) Several comments assert that ``deli salad'' is a vague 
term that has different meanings in some sectors of the food industry, 
and other comments request that we clarify how we interpret the deli 
salad category for the RRM-FT. Some comments ask that we specify 
whether an ``antipasti'' salad would be considered a deli salad.
    (Response 54) The ready-to-eat (RTE) deli salads commodity in the 
RRM-FT includes prepared refrigerated and RTE deli salads (e.g., potato 
salad, egg salad, pasta salad, seafood salad). While the term ``deli 
salad'' appears to be a broad term, it is intended to capture multiple 
types of RTE deli salads, including the aforementioned examples as well 
as a prepared antipasti salad. However, a prepared, RTE antipasti salad 
could include meat as an ingredient, which may place it under the 
jurisdiction of USDA and therefore make it exempt from the requirements 
of subpart S under Sec.  1.1305(g).
    (Comment 55) Several comments request exemption of deli salads from 
the subpart S requirements. Some comments assert that RTE deli salads 
like pasta and potato salad that are processed and prepared using 
hurdle technology or other controls to minimize pathogen growth should 
not be included on the FTL. Similarly, other comments assert that these 
types of RTE salads that are processed and prepared using controls such 
as pH and preservatives (e.g., antimicrobials and Listeria inhibitors) 
do not pose the same risk as RTE salads that do not use the hurdle 
approach.
    (Response 55) While we acknowledge that the use of preservatives 
and antimicrobials in deli salads helps to minimize bacterial growth, 
the data provided in the comments do not change how we score deli 
salads in the RRM-FT. The hurdle approach, as opposed to a kill step, 
can vary widely in terms of procedure and is not consistently applied 
throughout industry.
    Therefore, based on the available data, we conclude it is not 
appropriate to grant a blanket exemption for deli salads processed 
using hurdle technology or related procedures.
l. Nut Butters
    (Comment 56) Some comments ask us to include all butters (nut, soy, 
and seed) on the FTL that are considered allergenic. Other comments 
question why soy and seed butters in general were not included on the 
FTL. These comments assert that soy and seed butters have similar 
manufacturing processes and supply chain standards, and thus pose the 
same risk as nut butters. Additionally, some comments assert that 
consumption patterns might be shifting from peanut butter to seed 
butter due to allergies.

[[Page 70931]]

    (Response 56) We decline to include all butters considered 
allergenic or all soy and seed butters on the FTL. As previously 
stated, we developed a risk-ranking model for food tracing based on the 
factors in section 204(d)(2)(A) of FSMA. A commodity was included on 
the FTL if its risk score, aggregated across all associated hazards, 
was 330 or higher in the Model, or if the evidence of outbreaks and 
illnesses and cost of illness scores for one or more associated 
commodity hazard pairs was ``strong.'' Using the RRM-FT, we evaluated 
nut butters (e.g., made from tree nuts and peanuts) and soy and seed 
butters (e.g., made from edible seeds) as separate commodities and 
found that only the nut butters had a risk score high enough to meet 
the threshold for inclusion on the FTL. Therefore, only nut butters are 
covered by the rule. As previously stated, we will periodically review 
data and information relevant to the RRM-FT criteria for commodity-
hazard pairs, including the consideration of consumption patterns and 
food safety improvements across commodities.
    The inclusion of nut butters on the FTL does not relate to the fact 
that nut butters can be allergenic. See Response 86 for a discussion of 
how we assessed the risks that are related to allergens.
    (Comment 57) Several comments request clarification on whether nut 
butters made with raw nuts pose the same level of risk as nuts that are 
roasted, even when applying a process control during the roasting 
process that results in a 4- to 5-log reduction of the pertinent 
pathogen.
    (Response 57) We acknowledge that adequate process controls 
resulting in a 4- to 5-log reduction in the pertinent pathogen should 
minimize the risk associated with nuts. However, it is the nut butter, 
not the nuts, that is on the FTL and covered by the final rule. The nut 
butters commodity, regardless of whether the ingredient nuts were raw 
or roasted, ranked high in the RRM-FT, which is why nut butters are 
included on the FTL. While applying a validated roasting process 
control for peanuts may mitigate the associated hazard, we continue to 
see multiple outbreaks associated with recontamination of peanuts and 
peanut butter after the roasting step. We also know from previous FDA 
investigations that there are sources of environmental pathogens (e.g., 
Salmonella spp., L. monocytogenes) in facilities, and routes of 
contamination for these pathogens into the nut butters have been 
associated with employee practices, insanitary conditions, and 
inadequate sanitation practices. Using roasted nuts that have undergone 
a properly designed and implemented process control should mitigate the 
hazard associated with this ingredient; however, it does not reduce the 
risk of the potentially significant hazards posed by the exposed nut 
butters in the post-processing environment.
    (Comment 58) Several comments ask whether nut meals and powders, 
nut flours, nut flavoring extracts, and similar commodities are on the 
FTL. Some comments request that we clarify whether peanut butter chips 
fall under the nut butter category on the FTL. Some comments assert 
that peanut butter chips should not be considered nut butters but 
should be a separate commodity that is exempt from the rule.
    (Response 58) ``Nut meals and powders,'' ``Flours (wheat, rice or 
soy),'' and ``Flavorings'' are all separate commodity designations from 
the ``nut butters'' designation. These commodities were assessed 
separately in the RRM-FT and did not have risk scores that would 
include them on the FTL.
    Peanut butter chips are not in the ``nut butters'' commodity. 
However, if peanut butter chips are produced using peanut butter as an 
ingredient, they are covered by the rule because they contain an 
ingredient on the FTL (peanut butter). However, if a kill step is 
applied to the peanut butter chips, the exemption in Sec.  1.1305(d) 
would apply.
    (Comment 59) Some comments request that we clarify whether 
``coconut butter'' and ``Chinese chestnut butter'' are covered by the 
rule under the nut butter category. The comments maintain that 
``coconut'' qualifies as a ``tree nut'' for purposes of the Food 
Allergen Labeling and Consumer Protection Act of 2004, but that in many 
countries it is not considered a ``tree nut'' because it does not meet 
common definitions of ``nut,'' nor does it grow on ``trees.'' The 
comments suggest that if we intend ``nut butter'' to include coconut 
butter, we should say so explicitly in the FTL and have data 
appropriate to deem coconut nut butter a ``high-risk food.''
    (Response 59) As discussed in Response 39, we use data from FDA's 
RFR and facility registration systems to help determine commodity 
designations for the FTL. Based on those classification systems, we 
consider coconut to be a nut; therefore, coconut butter is included on 
the FTL as a nut butter. This is consistent with 21 CFR 170.3, which 
also classifies coconut as a nut. We consider Chinese chestnut to be a 
tree nut and, therefore, Chinese chestnut butter also is an FTL food 
subject to the subpart S requirements. We have added both coconut 
butter and chestnut butter to the FTL as examples of ``nut butters'' to 
clarify that they are included in this category. See the RRM-FT results 
tool (Ref. 17) for information about risks associated with nut butters.
    (Comment 60) One comment expresses support for the fact that 
almonds/tree nuts are not on the FTL. The comment further asserts that 
domestically sold almonds are required to apply a kill step, which the 
comment argues is relevant when considering risk of a created product 
that is on the FTL, such as nut butter.
    (Response 60) Nuts are not on the FTL; however, nut butters are on 
the FTL and subject to the rule, regardless of how the raw ingredients 
are processed. For example, almond butter is on the FTL and is covered 
by the rule regardless of whether the almonds received a kill step 
before being processed into almond butter. The RRM-FT considers 
potential hazards that may be introduced from exposure to the 
processing environment after a lethality treatment (Refs. 20 and 21), 
e.g., contamination of Salmonella spp. in a nut butter after roasting 
(which is a kill step for the nut, but not a kill step for the nut 
butter). Based on available data for the seven criteria in the RRM-FT, 
the risk score for the commodity ``nut butters'' meets the criteria for 
inclusion on the FTL.
    (Comment 61) Several comments outline initiatives the peanut butter 
industry has undertaken to significantly reduce the risk of outbreaks 
and illness from peanut butter and peanut butter products. Some 
comments maintain that nut butter scored low on contamination under the 
RRM-FT, but peanut butter scored high for frequency of consumption, 
number of outbreaks, and severity of illness. Other comments assert 
that nut butter was included on the FTL primarily due to the high-
profile recalls that occurred before the adoption of the preventive 
controls for human food regulation. The comments argue that because of 
the efforts by industry and the fact that major peanut butter outbreaks 
occurred several years in the past, peanut butter should not be 
included on the FTL.
    (Response 61) We appreciate the industry interventions to reduce 
the risk of outbreaks and illnesses caused by peanut butter and peanut 
butter products. However, we disagree that these efforts justify 
removal of peanut butter from the FTL at this time. As previously 
stated, a commodity was included on the FTL if its risk score, 
aggregated across all associated hazards, was 330 or higher in the 
Model, or if the evidence of outbreaks and illnesses and cost of 
illness scores for one or more

[[Page 70932]]

associated commodity hazard pairs was ``strong.'' Based on the seven 
criteria used in the Model and the data we have for peanut and tree nut 
butters, these products have risk scores that warrant their inclusion 
on the FTL. We further disagree with the comments asserting that the 
high-profile nut butter recalls that occurred before the adoption of 
the preventive controls for human food regulation were the primary 
reason nut butters made the FTL. As with all commodities, the RRM-FT 
scores for nut butters are specific to data and information on these 
foods relevant to the seven criteria used in the Model. The most recent 
information concerning industry intervention efforts considered in the 
RRM-FT was from 2019. Further, the RRM-FT down-weights older data. As 
stated in Response 488, we will periodically review data and 
information relevant to the RRM-FT seven criteria for commodity-hazard 
pairs, including the consideration of food safety improvements across 
commodities, to determine whether revisions to the FTL may be 
appropriate.
m. Cheese
    (Comment 62) One comment asks for an explanation of why the RRM-FT 
ranks some cheese commodities from pasteurized milk higher than some 
cheese commodities from unpasteurized milk.
    (Response 62) The RRM-FT scores commodity-hazard pairs according to 
data and information relevant to seven criteria described in the 
Methods report (Ref. 10). The semi-quantitative RRM-FT model does not 
directly quantify the probability of illnesses (e.g., the risk of 
illnesses per year or per serving for a consumer) but rather provides a 
ranking of commodities based on risk scores. The model results ranked 
the ``Cheese (made from pasteurized milk), soft ripened or semi-soft'' 
commodity and the ``Cheese (made from pasteurized milk), fresh soft or 
soft unripened'' commodity higher than the ``Cheese (made from 
unpasteurized milk), other than hard cheese'' commodity.
    A 2015 FDA/Health Canada quantitative risk assessment (Ref. 22) of 
soft-ripened cheese showed that on a per serving basis, the risk to 
consumers was higher for raw (unpasteurized) milk soft-ripened cheese 
than for pasteurized milk soft-ripened cheese. The RRM-FT results do 
not conflict with the quantitative risk assessment results. However, 
the RRM-FT is more aligned with a risk estimate on a population basis. 
For example, it includes a criterion that captures the percentage of 
the population that consumes the food in addition to the amount 
consumed per serving. When contaminated foods are consumed by a large 
percentage of the population, they are more likely to cause outbreaks 
or multiple illnesses compared to contaminated foods consumed by only a 
limited percentage of the population, given similar prevalence and 
levels of contamination and serving size. While all seven criteria 
contribute to the overall risk score of each of these commodities, the 
consumption criterion (Criterion 6) is the key to understanding the 
relative ranking of cheese made from unpasteurized milk to cheese made 
from pasteurized milk. In the RRM-FT, data indicated that cheeses made 
with unpasteurized milk are consumed by a much smaller percentage of 
the population than counterpart cheeses made with pasteurized milk, 
while the amount consumed per serving was approximately the same. If 
the percentage of the population consuming unpasteurized milk cheese 
was more comparable to that of the other cheeses, the risk score for 
the ``Cheese (made from unpasteurized milk), other than hard cheese'' 
commodity would have been at least as high as the risk score for the 
highest scoring pasteurized milk cheese commodity on the FTL. The RRM-
FT results tool (Ref. 17) provides more information on the risk scores 
for relevant commodity-hazard pairs.
    (Comment 63) One comment suggests that the cheeses on the FTL 
should be limited to Hispanic soft cheese made from raw milk, queso 
fresco, Latin-style soft cheeses, and soft cheeses. Another comment 
suggests that cheeses on the FTL be limited to soft uncured cheeses 
with no kill step, asserting that those are the only cheeses that have 
triggered a specific FDA warning and related consumer food safety 
education.
    (Response 63) We decline to limit the cheeses on the FTL to 
Hispanic soft cheese made from raw milk, queso fresco, Latin-style soft 
cheeses, and soft cheeses, in particular soft uncured cheeses. Cheeses 
other than these had commodity risk scores under the RRM-FT that 
warranted their inclusion on the FTL. The commodity risk score for 
cheese (made from pasteurized milk) soft ripened or semi-soft was 490; 
the commodity risk score for cheese (made from pasteurized milk) fresh 
soft or soft unripened was 430; and the commodity risk score for cheese 
(made from unpasteurized milk) other than hard cheese was 410. Because 
each of these cheese commodities had a commodity risk score above 330, 
they are all included on the FTL.
    (Comment 64) Several comments request that various cheeses be 
removed from the FTL, including cream cheese, processed mozzarella 
cheese, cheese made from pasteurized milk, processed cheese, process 
cheese products, and LACF cheese. One comment notes that cottage cheese 
is typically produced in Grade ``A'' milk plants regulated under the 
Pasteurized Milk Ordinance (PMO) and argues that the production process 
in those plants results in a product that does not support the survival 
and/or growth of bacteria. Another comment asks whether pasteurization 
of the milk that is used to make cheese is considered a kill step.
    (Response 64) Cottage cheese is covered by the final rule because 
it is included on the FTL in the commodity ``Cheese (made from 
pasteurized milk), fresh soft or soft unripened.'' However, we 
recognize that much of the cottage cheese produced in the United States 
is regulated under the PMO, a Federal program that includes specific 
requirements for processing and frequent testing and inspection by 
regulatory authorities. Therefore, we are considering initiating a 
process under Sec.  1.1360 to determine whether to exempt cottage 
cheese regulated under the PMO from the subpart S requirements.
    As discussed in Section V.E.5 of this document, if a person applies 
a kill step, such as pasteurization, to a cheese on the FTL, the person 
is eligible for a partial exemption from subpart S under Sec.  
1.1305(d)(3). Therefore, pasteurized process and pasteurized prepared 
cheese and cheese products (e.g., pasteurized process cheese, 
pasteurized process cheese food, pasteurized cheese spread, pasteurized 
blended cheese, pasteurized prepared cheese product), as well as 
processed mozzarella cheese, would be eligible for the partial 
exemption in Sec.  1.1305(d)(3). LACF cheeses are a separate category 
in the RRM-FT and are not on the FTL.
    Regarding cheese made with pasteurized milk, as discussed in 
Response 62, the commodity risk scores for both ``Cheese (made from 
pasteurized milk), soft ripened or semi-soft'' and ``Cheese (made from 
pasteurized milk), fresh soft or soft unripened'' were both high enough 
to merit inclusion on the FTL. Similar to the previous discussion in 
Response 60 regarding peanut butter made from roasted peanuts, these 
two categories of cheeses made from pasteurized milk are on the list 
regardless of the fact that one of their ingredients was previously 
subjected to a kill step.
    (Comment 65) Many comments request clarity and definitions for the 
cheese categories, as well as information on which specific cheeses 
within the categories are on the FTL. The

[[Page 70933]]

comments ask that the categories be based on a science- and risk-based 
assessment. Some comments question whether the cheese categories are 
based on relevant standards of identity (SOI) or moisture level in the 
cheeses, further noting that there is no SOI that defines the term 
``soft cheese'' or academic consensus on the definition of ``soft 
cheese.'' The comments maintain that the category ``Cheeses, other than 
hard cheeses'' could include many low-risk and semi-soft cheeses (e.g., 
Asiago and Manchego), and they ask whether the category also includes 
non-hard cheeses packed in wax (e.g., fontina in wax). In addition, 
some comments express concern that FDA inspectors may apply terms like 
``soft cheese'' inconsistently and over-inclusively due to a lack of 
clarity and definitions for the cheese categories.
    (Response 65) The commodity ``Cheese'' is broken down into three 
categories on the FTL:
     Cheese (made from pasteurized milk), fresh soft or soft 
unripened. Examples include, but are not limited to, cottage, chevre, 
cream cheese, mascarpone, ricotta, queso blanco, queso fresco, queso de 
crema, and queso de puna;
     Cheese (made from pasteurized milk), soft ripened or semi-
soft. Examples include, but are not limited to, brie, camembert, feta, 
mozzarella, taleggio, blue, brick, fontina, Monterey jack, and 
muenster; and
     Cheese (made from unpasteurized milk), other than hard 
cheese, which includes all cheeses made with unpasteurized milk, other 
than hard cheeses.
    These three categories encompass all cheeses except hard cheeses. 
Although we cannot provide an exhaustive list of cheeses on the FTL, we 
have revised the FTL to provide additional clarification of the cheese 
categories, better align with the RRM-FT, and provide examples of 
cheeses in each category. The FTL now states the commodity is 
``Cheeses, other than hard cheeses'' and specifies that ``hard 
cheeses'' include hard cheeses as defined in Sec.  133.150 (21 CFR 
133.150), Colby cheese as defined in 21 CFR 133.118, and caciocavallo 
siciliano cheese as defined in 21 CFR 133.111. Examples of hard cheese 
include, but are not limited to, cheddar, Romano, and parmesan. Even 
though there is not a clear definition of ``fresh soft'' or ``soft 
unripened'' cheese (note that ``soft ripened'' cheese is defined in 21 
CFR 133.182), the fact that the only category of cheese that is not on 
the FTL is hard cheese should eliminate concerns of inconsistency in 
applying the final rule. Packaging and wrapping do not affect whether 
or not a cheese is on the FTL.
    We have further clarified that the cheese commodities that are on 
the FTL do not include cheeses that are frozen, shelf stable at ambient 
temperature, or aseptically processed and packaged. This is a result of 
how foods are categorized within the Model (see Response 26 for a 
description of the method by which foods on the FTL were determined). 
Therefore, if a cheese that is on the FTL in its unfrozen form becomes 
frozen--for example, as part of a frozen pizza--that would be 
considered a change such that the food is no longer on the FTL and 
therefore no longer covered by the final rule (see Response 27). 
Cheeses that are shelf stable at ambient temperature or aseptically 
processed and packaged are also not on the FTL and are therefore not 
covered by the final rule.
    (Comment 66) One comment asks how firms can ensure that the 
preceding entity in the supply chain has properly classified the cheese 
so that it does not create an undue burden or put the receiving firm's 
own compliance at risk.
    (Response 66) We expect persons who manufacture, process, pack, or 
hold any FTL food covered by the final rule to be in compliance with 
the regulations. Persons subject to the rule are responsible for 
knowing whether they must keep subpart S records, independent of any 
assessment or classifications made by persons preceding them in the 
supply chain. We expect firms to work with their suppliers to be 
familiar with the products they are providing, and we note that other 
regulations, such as those on preventive controls for human food and 
foreign supplier verification programs (FSVP), require covered entities 
to work with their suppliers to help ensure compliance with those 
regulations.
n. Seafood
    (Comment 67) Comments specific to seafood assert that the scope of 
the FTL exceeds the definition of ``high-risk'' stated in section 204 
of FSMA. The comments ask that we modify the RRM-FT risk criteria by 
limiting it to outbreak and recall data, and be more specific in 
identifying high-risk commodities (e.g., scombrotoxin-forming species, 
RTE seafood) rather than using broad categories (e.g., finfish).
    (Response 67) As discussed in Response 4, section 204(d)(2)(A) of 
FSMA sets forth the factors that FDA is required to consider in 
designating foods for inclusion on the FTL. Because the factors are 
established in the statute, we cannot limit the risk criteria in the 
RRM-FT to outbreak and recall data.
    As discussed in Response 35, we determined that the appropriate 
level of granularity for designating foods on the list is at the level 
of ``commodity'' (e.g., ``Finfish (histamine-producing species'')). In 
the FTL published with the final rule, we have provided additional 
clarifications and descriptions for the commodities on the FTL, for 
example by separately identifying the finfish commodities and providing 
additional examples for each commodity designation.
    (Comment 68) Some comments suggest that the RRM-FT fails to 
recognize the variability of hazards associated with individual seafood 
species and products in identifying foods for inclusion on the list, 
and instead focuses on overly broad commodity groups with limited 
commonalities. Some comments object to the assumption that ``items 
within the same `commodity' designation generally have similar 
characteristics, associated hazards, and production and supply-chain 
practices and conditions.''
    (Response 68) We disagree with the comments. The RRM-FT considers 
the nature of the food through a categorization scheme that classifies 
FDA-regulated foods into 47 commodity categories. The 47 commodity 
categories represent categories of foods available to consumers from 
various supply chains and different production, manufacturing, and 
handling processes and practices. Furthermore, within each commodity 
category, the RRM-FT identifies more than 200 individual commodities, 
again taking into consideration the nature of foods as well as the 
characteristics of their production and manufacturing processes. For 
example, the commodity category ``Seafood-Finfish'' includes four 
commodities that are on the FTL because they have a risk score that 
meets the threshold for inclusion on the FTL: ``Finfish--finfish--
histamine-producing species,'' ``Finfish--finfish--species not 
associated with histamine or ciguatoxin,'' ``Smoked finfish,'' and 
``Finfish--finfish--species potentially contaminated with ciguatoxin.'' 
The identification of individual commodities allows for consideration 
of the differences in the nature of the food, the range of hazards, and 
the production and manufacturing processes. Therefore, we have 
considered variability of hazards through the identification of 
species-specific hazards and hazards associated with processing. The 
identification of commodity-hazard pairs is based on available data and 
information, e.g., foods and hazards

[[Page 70934]]

associated with outbreaks and illnesses and detection of hazards in 
foods. We use information from RFR reports, published literature, 
scientific studies, technical reports from governmental and other 
organizations, FDA surveillance and testing data, a review of world-
wide published risk assessments, and expert knowledge. As discussed in 
Response 35, in reviewing the data and developing the FTL, we 
determined that the appropriate level of granularity is at the level of 
``commodity.'' The peer reviewers for the Model (Ref. 13) made a 
variety of suggestions on the food classification, particularly 
modifications at the commodity level, so that it would be appropriate 
and supportable by available data. The peer reviewers supported 
grouping foods with similar ecology and manufacturing conditions (even 
if not yet involved in documented outbreaks). Further, data used to 
assess components of the Model (e.g., outbreak and illness data, 
likelihood of contamination, degree to which product supports growth, 
consumption, and annual cost of illness) are available and adequate at 
the ``commodity'' level of granularity.
    (Comment 69) Many comments address the seafood species and products 
included on the FTL and compare these seafood products to FDA's seafood 
safety guidance, ``Fish and Fishery Products Hazards and Controls'' 
(Ref. 23), which is used by regulators and industry in identifying 
likely food safety hazards associated with fish and fishery products. 
The comments assert that the FTL is inconsistent with FDA's existing 
guidance and ask that the final rule provide a rationale for this 
purported inconsistency.
    (Response 69) The purpose of the Fish and Fishery Products Hazards 
and Controls guidance is to help firms identify hazards reasonably 
likely to occur and develop a seafood hazard analysis critical control 
point (HACCP) plan to control these hazards. The guidance is a science-
based tool firms use to help develop preventive controls for the 
seafood they handle. The purpose of the FTL, however, is to improve 
traceability in the event of a foodborne illness outbreak involving 
foods on the list. As discussed in Response 5, the FTL is a list of 
food commodities informed by a risk-ranking model that ranks food-
hazard pairs based on seven criteria.
    (Comment 70) Some comments assert that very few seafood species and 
products were associated with food safety hazards that originate from 
the growing environment. The comments suggest that FDA exclude products 
that have only been associated with recalls related to hazards 
introduced during processing from the burden of tracing back to the 
harvest waters.
    (Response 70) We disagree with these comments. Seafood food safety 
hazards can be introduced throughout the supply chain. Natural marine 
toxins and pathogens are examples of the hazards that are in the 
growing environment and can contaminate seafood. In the RRM-FT, we 
identify and evaluate both species-related (from the growing 
environment) and process-related hazards that are known or reasonably 
foreseeable for more than a dozen seafood commodities (Ref. 17), which 
is consistent with the intent of this regulation to enhance FDA's 
ability to trace foods on the FTL throughout the supply chains of those 
foods.
    (Comment 71) Several comments contend that very few illnesses can 
be attributed to the consumption of shrimp in general and that domestic 
wild-caught shrimp have a drastically lower rate of consumption in the 
United States when compared to aquacultured shrimp. The comments 
further maintain that the open ocean environment in which domestic 
wild-caught shrimp are harvested is unlikely to present any safety 
hazards, and they recommend removing domestic wild-caught shrimp from 
the FTL. Conversely, the comments assert that aquacultured shrimp, 
whose growing conditions have been associated with introduction of food 
safety hazards, is more likely to present a potential health hazard. 
The comments do not request that we exclude foreign wild-caught shrimp 
from the FTL.
    (Response 71) The RRM-FT did not differentiate between wild-caught 
and aquacultured shrimp. We acknowledge that hazards introduced from 
the growing waters for wild-caught shrimp and aquacultured shrimp may 
differ. However, there are commonalities in hazards being introduced 
after harvest, such as the addition of sodium metabisulfites to prevent 
melanosis and pathogen hazards introduced during handling and 
processing after capture, as well as commonalities in the potential for 
shrimp (regardless of wild-caught or aquaculture) to support pathogen 
growth. The RRM-FT considers the totality of the food chain in the 
interest of public safety. As previously discussed, we balanced a 
number of factors in determining the granularity of commodity 
definitions, including the characteristics of the food and availability 
of data used to evaluate the seven criteria for commodity-hazard pairs. 
Shrimp (both wild-caught and aquaculture) is evaluated in the commodity 
``Crustaceans'' (see Response 35 for further discussion of why we 
evaluate risks at the ``commodity'' level).
    (Comment 72) Several comments assert that the requirements of the 
proposed rule are duplicative and not beneficial in the case of canned 
tuna. The comments maintain that: existing harvest certification 
requirements provide traceability to the vessel; LACF product coding 
requirements and National Oceanic and Atmospheric Administration (NOAA) 
product traceability requirements provide traceability throughout the 
food chain; FDA's safety requirements and recommendations in other 
regulations and guidance documents address food safety hazards; and 
canned tuna has a history of being safe based on global recall data.
    (Response 72) Because the commodity ``Canned Seafood'' in the RRM-
FT, which includes canned tuna, did not score high enough to be on the 
FTL, canned tuna is not on the FTL and therefore is not covered by the 
final rule.
    (Comment 73) Some comments request that the allowance for a ``kill 
step'' exemption not exclude smoked fish from the FTL given the history 
of contamination in the finished product due to cross-contamination 
after smoking.
    (Response 73) We agree that smoked finfish should be included on 
the FTL. The ``smoked finfish'' commodity in the RRM-FT includes both 
hot and cold smoked finfish. Based on available data for the seven 
criteria in the RRM-FT, the risk score for ``smoked finfish'' is high 
enough to merit inclusion on the FTL. Therefore, both hot and cold 
smoked finfish are included on the FTL. We note that the hot smoking 
step typically is not applied to the finished product, so it does not 
address potential environmental contamination introduced after smoking 
when the finfish is sliced and otherwise handled before packaging. The 
RRM-FT demonstrated that food safety hazards can be introduced from 
exposure to the processing environment after the lethality treatment 
(e.g., contamination of L. monocytogenes in smoked finfish after 
smoking).
    (Comment 74) Many comments object to the inclusion on the FTL of 
the category ``Finfish, species not associated with histamine or 
ciguatoxin.'' The comments argue that those species have no associated 
species-related safety hazards or have only species-related hazards 
that are controlled because the

[[Page 70935]]

products are normally consumed cooked.
    (Response 74) Finfish species not associated with histamine or 
ciguatoxin are on the FTL in part because they are highly consumed and 
may be contaminated with microbial hazards that can cause severe 
illnesses (e.g., L. monocytogenes, Vibrio parahaemolyticus, Salmonella 
spp.). While there are relatively few documented outbreaks for this 
finfish commodity, it is often difficult to identify the source 
associated with L. monocytogenes outbreaks due to factors such as long 
incubation time and sporadic illnesses, which complicates outbreak 
investigations. Further, data for this commodity in the RRM-FT indicate 
the likelihood of contamination is above 1 percent (i.e., Criterion 3 
score of 9), and consumption and severity of illness both score high. 
Given these high scores, the risk score for the finfish commodity is 
above the line for inclusion on the FTL.
    (Comment 75) Some comments assert that frozen seafood products 
present less of a risk than refrigerated products because maintaining 
seafood in frozen form inhibits pathogen growth and potentially 
eliminates parasites. The comments request that we consider the safety 
effects of freezing as part of risk profiles when identifying high-risk 
products.
    (Response 75) We agree that freezing can inhibit the growth of pre-
existing pathogens and additional development of scombrotoxin and 
potentially can eliminate parasites. However, freezing does not remove 
the presence of pathogens in the way that a kill step does; it does not 
eliminate scombrotoxin that may have formed before freezing and it does 
not eliminate the presence of ciguatoxin. In addition, thawing of the 
product within the commercial seafood chain re-introduces the potential 
for pathogen growth and scombrotoxin formation. It is not uncommon for 
seafood products to be thawed and then refrozen as they move through 
the supply chain, and because the description of a commodity within the 
RRM-FT refers to the state in which the product appears at retail, such 
seafood is classified as ``frozen'' despite having previously been 
thawed. This is one reason why, for many seafood commodities, we have 
classified fresh and frozen products together within the Model, rather 
than separating them into different commodities. Because the Model 
identified many such seafood commodities as scoring high enough to be 
included on the FTL, the enhanced traceability recordkeeping 
requirements of subpart S apply to these types of seafood regardless of 
whether they are sold fresh or frozen. The updated version of the FTL 
we are publishing with this final rule specifies when the frozen form 
of a product is included on the list.
    (Comment 76) Several comments support expanding the FTL to include 
all seafood products, most notably Siluriformes such as catfish, which 
are regulated by USDA, and scallop adductor muscles, which the RRM-FT 
identifies as ``low risk.''
    (Response 76) All fish of the order Siluriformes, including 
catfish, are considered ``amenable species'' under the Federal Meat 
Inspection Act (see 21 U.S.C. 601(w)(2)) and are subject to exclusive 
USDA jurisdiction at certain points in the food production chain. FDA 
does not have the authority to impose recordkeeping requirements on 
facilities that are under exclusive USDA jurisdiction. Consequently, as 
discussed in Section V.E.8 of this document, the final rule (in Sec.  
1.1305(g)) provides an exemption for such food during the time it is 
within the exclusive jurisdiction of the USDA under the Federal Meat 
Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection 
Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 
U.S.C. 1031 et seq.). In addition, we are choosing not to cover food 
after it is within the exclusive jurisdiction of USDA because the most 
successful traceability efforts will have an unbroken chain of records. 
Similarly, we chose not to include Siluriformes such as catfish in the 
risk-ranking model that we used to identify foods for inclusion on the 
FTL. Because Siluriformes are subject to exclusive USDA jurisdiction at 
certain points in the food production chain, we are unable to ensure an 
unbroken chain of traceability records. Therefore, we are not expanding 
the FTL to include Siluriformes such as catfish as requested.
    We also decline to expand the FTL to include scallop adductor 
muscle. As discussed in Section V.E.7 of this document, the final rule 
(in Sec.  1.1305(f)) exempts from the subpart S requirements raw 
bivalve molluscan shellfish, including scallops, that are: covered by 
the requirements of the National Shellfish Sanitation Program (NSSP); 
subject to the requirements of part 123, subpart C (21 CFR part 123, 
subpart C), and Sec.  1240.60 (21 CFR 1240.60); or covered by a final 
equivalence determination by FDA for raw bivalve molluscan shellfish. 
The final product form of the adductor muscle only is not covered by 
the NSSP requirements or subject to the requirements of part 123, 
subpart C, and Sec.  1240.60 (Ref. 23). We have adopted this same 
approach and rationale in the final rule.
    (Comment 77) Several comments recommend expanding the FTL to 
include all seafood products as a means of preventing economic fraud, 
including species substitution, by ensuring product traceability 
throughout the supply chain. One comment suggests that feed for 
aquaculture be covered under the rule to help ensure that products that 
may have been created through forced labor or illegal fishing do not 
enter the U.S. market.
    (Response 77) FSMA section 204(d) defines the scope of this rule 
and limits its coverage to only those foods that FDA designates for 
inclusion on the FTL, based on the factors Congress provided in section 
204(d)(2)(A). The purpose of the rule is to enhance traceability to be 
able to rapidly and effectively identify recipients of a food on the 
FTL to prevent or mitigate a foodborne illness outbreak and to address 
credible threats of serious adverse health consequences or death. We 
cannot expand the scope of the rule to address other concerns, such as 
forced labor or illegal fishing. However, under FDA's New Era of 
Smarter Food Safety initiative, we will continue to explore ways to 
encourage all entities in the supply chain to adopt tracing 
technologies and harmonize tracing activities to support end-to-end 
traceability throughout the food safety system. Additional information 
on this initiative can be found in FDA's Blueprint for New Era of 
Smarter Food Safety (Ref. 18).
o. Dietary Supplements
    (Comment 78) One comment supports the fact that dietary supplements 
are not on the FTL and therefore not covered by the rule, as the 
comment maintains that dietary supplements are rarely implicated in 
foodborne illness outbreaks. One comment suggests that because dried 
spices and dried vegetables are not covered by the rule, dietary 
supplements that include dried herbs and vegetables also should not be 
covered by the rule. The comment further suggests that dietary 
supplements that include fish or krill oil also should not be covered. 
One comment asserts that herbs used in dietary supplements should not 
be covered by the rule because dietary supplements are not covered. 
Another comment maintains that including fresh herbs used in dietary 
supplements under the commodity ``Herbs (fresh)'' is not supported by 
evidence because, according to the comment, FDA uses RFR data to 
identify hazards for fresh

[[Page 70936]]

herbs, but dietary supplements are not included in RFR reporting.
    (Response 78) The RRM-FT includes data regarding dietary 
supplements, and dietary supplements are a separate commodity in the 
Model. The commodity ``Dietary supplements'' did not score high enough 
to merit inclusion on the FTL. Many ingredients that are often found in 
dietary supplements, such as dried herbs, dried vegetables, fish oil, 
and krill oil, are also not on the FTL. Dietary supplements containing 
these ingredients are therefore not covered by the rule. However, if a 
dietary supplement uses fresh herbs, such as in some refrigerated 
dietary supplements, those supplements would be covered by the rule 
because, as discussed in Response 27, the rule covers multi-ingredient 
products that contain specifically listed FTL foods as ingredients, as 
long as the form of the ingredient is the same as the form that appears 
on the FTL (e.g., ``fresh'').
p. Animal Food
    In the preamble to the proposed rule, we stated that although 
section 204(d) of FSMA does not exclude food for animals, we did not 
include animal foods in the RRM-FT. We stated that the RRM-FT was 
designed to account only for humans and cannot accommodate 
applicability to other animal species. However, we stated that we might 
revisit the issue of animal foods when we conduct any future 
reassessments of the Model (see 85 FR 59984 at 59991).
    (Comment 79) Some comments agree that animal food should not be 
covered under the same risk-ranking model as human food. These comments 
generally agree that a primary reason the RRM-FT should not be used for 
animal food is because animal illness data associated with animal food 
is not tracked, not generally available, or not tracked accurately. 
Some comments maintain that because animal food should not be covered 
by the same risk-ranking model as human food, the RRM-FT cannot be used 
to place animal food on the FTL.
    On the other hand, some comments assert that animal food should be 
included on the FTL. These comments state that animal food was not 
excluded from section 204(d) of FSMA, and they maintain that because 
illness in both humans and animals has been attributed to animal food, 
animal food should not be excluded from the subpart S requirements. One 
comment maintains that tracing of animal feed could help ensure that 
pathogens and bacteria are not introduced at the feed stage of the 
supply chain.
    (Response 79) We agree with the comments asserting that animal food 
should not be covered under the same risk-ranking model as human food. 
Information on some of the key criteria used to develop the Model, 
including factors specified by Congress in section 204(d)(2)(A) of 
FSMA, does not exist for animal food. As discussed in the preamble to 
the proposed rule, we do not at this time have reliable data sources or 
ways to generate data related to animal illness caused by consumption 
of animal food. In addition, the RRM-FT does not consider the variation 
in species that would be needed, as risk of hazards may be species-
dependent and vary within a species, and can be dependent on the 
animal's life stage or class of production (e.g., a dry dairy cattle 
vs. a lactating dairy cow). For these reasons, the current RRM-FT is 
not appropriate for animal food, and there are no animal foods on the 
FTL. However, we may consider development of an animal food risk-
ranking model in the future.
    (Comment 80) Some comments ask that we confirm that animal food 
made with food or the by-products of foods on the FTL is not subject to 
the regulation.
    (Response 80) We agree that animal food that is made with food (or 
by-products from production of food) on the FTL would not be subject to 
the subpart S requirements.
    (Comment 81) Some comments ask us to use a formal notice and 
comment process if we intend to update or develop a risk-ranking model 
specific to animal food that would be used to place animal food on the 
FTL.
    (Response 81) We intend to seek public input on an animal food 
risk-ranking model if, in the future, we opt to develop such a model. 
We have a variety of ways (e.g., public meeting, formal notice and 
comment) we can seek public input if we were to undertake work on an 
animal food risk-ranking model. Although we cannot commit to a specific 
mechanism for obtaining public input, we are committed to seeking 
public input on any potential risk-ranking model for animal food.
q. Foods Regulated by the USDA
    (Comment 82) Some comments ask for clarity on whether a multi-
ingredient food that is regulated by USDA's Food Safety and Inspection 
Service (FSIS) but contains an FTL food as an ingredient would be 
covered by the rule. The comment cites an as example a chicken salad 
containing diced celery.
    (Response 82) As discussed in Response 76, we have provided clarity 
on this topic by adding Sec.  1.1305(g) to the final rule. Section 
1.1305(g) states that the subpart S requirements do not apply to 
persons who manufacture, process, pack, or hold food on the FTL during 
or after the time when the food is within the exclusive jurisdiction of 
the USDA under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), 
the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg 
Products Inspection Act (21 U.S.C. 1031 et seq.).
    Thus, when an FDA-regulated facility ships an FTL food to an 
exclusively FSIS-regulated facility, the shipper must maintain and send 
shipping KDEs to the FSIS facility in accordance with the final rule. 
These records can be used by the FSIS facility if traceback of the food 
products is necessary. KDEs are not required to be maintained by the 
FSIS facility or any subsequent receivers of food from the FSIS 
facility.
    While FDA maintains regulatory jurisdiction at retail for all 
foods, including any food that contains an FTL food as an ingredient, 
we are choosing not to exercise our authority in these specific 
circumstances for the purposes of the final rule. The most successful 
traceability efforts will have an unbroken chain of records. FDA does 
not have the authority to impose recordkeeping requirements on 
facilities that are under exclusive USDA jurisdiction. When an FTL food 
is used as an ingredient in a food regulated by FSIS and tracing 
records are not kept by the FSIS-regulated facility, the chain of 
traceability records is broken, and it would be difficult for the RFE 
that receives the food to maintain the required records. Therefore, we 
are exempting from the subpart S requirements all persons who 
manufacture, process, pack, or hold food on the FTL both during and 
after the time when the food is within the exclusive jurisdiction of 
the USDA.
    In the case of the specific example cited by the comment, chicken 
salad would be regulated by FSIS and would not be subject to the FTL 
traceability regulation, even if the chicken salad contains foods like 
fresh-cut celery or fresh-cut onions that are on the FTL. However, the 
supplier of the FTL food, such as fresh-cut celery or fresh-cut onions, 
must maintain and send shipping KDEs to the chicken salad manufacturer. 
If that chicken salad was subsequently used as an ingredient in another 
product, such as a closed-faced sandwich, that is regulated by FDA, we 
would still not consider that chicken salad sandwich to be covered by 
the rule because the food was previously held in a facility that was 
within the exclusive jurisdiction of the USDA.
    (Comment 83) One comment asks that we coordinate with the USDA and 
consider covering animal proteins under

[[Page 70937]]

the FTL traceability regulation in the future.
    (Response 83) Some animal proteins, including beef, lamb, chicken, 
turkey, and pork, are under the exclusive jurisdiction of the USDA at 
certain points in the food production chain. Similar to our decision 
regarding Siluriformes such as catfish (see Response 76), we chose not 
to include these animal proteins in the Model because we would be 
unable to ensure an unbroken chain of traceability records. Congress 
directed FDA to coordinate with the USDA on section 204(d)(6)(A) of 
FSMA related to farm to school and farm to institution programs, which 
we have done, and we will continue to coordinate with the USDA as we 
implement the final rule.
r. Root-Cause Analyses
    (Comment 84) One comment suggests that conducting more root-cause 
analyses of foodborne illness outbreaks could provide additional 
information useful for inclusion in the Model and may provide 
additional clarity for certain commodity designations.
    (Response 84) We agree that root-cause analyses of outbreaks are an 
important tool to help better understand how foods become contaminated 
with certain pathogens. The RRM-FT used data available at the time we 
developed the Model and produced the FTL. Results of some root-cause 
analyses were available and considered when identifying food/hazard 
pairs in the Model. For example, we reviewed some outbreaks for which 
we were able to identify post-kill step contamination in processing 
facilities as a root cause of the outbreak, and data concerning these 
outbreaks were included in the Model. As we update the data for the 
Model in the future, any additional available information from root-
cause analyses will be included.
s. Other Factors
    (Comment 85) Several comments urge us to consider additional 
factors in developing the FTL, such as the fact that traceability 
records are already required under subpart J; that food manufacturers 
keep records under the regulation on preventive controls for human 
food, some of which they argue may be traceability-related; and that 
food manufacturers have greater insight into their supply chains as a 
result of other FSMA regulations, including the preventive controls and 
FSVP regulations.
    (Response 85) Congress required FDA to designate foods for which 
additional traceability recordkeeping requirements are appropriate and 
necessary to protect the public health, based on specific factors 
outlined in section 204(d)(2)(A) of FSMA. While many food companies are 
required to keep records under subpart J documenting the immediate 
previous source and immediate subsequent recipient of their food, FSMA 
directed FDA to develop a regulation requiring additional traceability 
records for foods designated as high-risk. We recognize that food 
processors must keep records under other regulations, but many of those 
records are for purposes other than facilitating traceability. To meet 
requirements under the FTL traceability rule, the final rule allows 
firms to use records kept for other purposes and does not require firms 
to duplicate existing records (see Sec.  1.1455(f)).
t. Hazards
    (Comment 86) One comment agrees with FDA's decision, as described 
in the Designation of the FTL Memorandum (Ref. 5), to consider 
biological hazards and acute hazards, and not chemical hazards related 
to chronic exposure or food allergens, in developing the FTL. Another 
comment cites reports about heavy metals in baby food and recommends 
that we consider whether traceability records would be useful for 
addressing chronic exposures to chemical hazards such as lead.
    (Response 86) We appreciate the comments that agree with the focus 
on biological and acute hazards for the FTL traceability regulation. 
Our traceability activities generally focus on foods contaminated with 
biological or acute chemical toxins that present an immediate public 
health risk. In contrast, enhanced recordkeeping for traceability would 
not be similarly useful for addressing adverse health effects of 
chronic exposure to chemical hazards such as lead or other toxic 
elements. For food allergens, we have found that consumers with food 
allergies usually can identify the food or ingredient that most likely 
caused the allergic reaction, including the brand and packaging of the 
food in most cases. We can then rapidly identify the source of the 
allergen-containing food and take appropriate regulatory action. 
Therefore, additional recordkeeping for traceability would not greatly 
enhance our ability to identify and respond to undeclared allergens in 
food. Therefore, we have determined that for the purposes of developing 
the FTL, we will only consider results from the Model for microbial 
hazards and acute chemical toxins.
u. Food Code
    (Comment 87) One comment notes that the foods on the FTL are 
different from foods identified as potentially hazardous in the Food 
Code. The comment maintains that this could be potentially confusing 
for restaurants and restaurant employees. Therefore, the comment 
suggests that the Food Code be updated to reflect the foods on the FTL 
and that guidance for control of the hazards be provided.
    (Response 87) The Food Code is a separate program and modifications 
to it are beyond the scope of this rulemaking. Changes to the Food Code 
are made through the Conference for Food Protection, which has a 
separate process for revisions and updates.

C. General Comments on the Proposal

    Many comments make general remarks supporting or opposing the 
proposed rule without focusing on a particular proposed provision. In 
addition, many comments address issues with the proposed rule that do 
not involve a specific proposed provision or that concern multiple 
provisions. In the following paragraphs, we discuss and respond to such 
general comments.
1. General Support for and Opposition to the Proposed Rule
    (Comment 88) Many comments express general support for the proposed 
rule. Some comments state that existing traceability recordkeeping 
requirements are inadequate, current traceability capability in the 
industry is lacking, and there is a need to modernize and standardize 
traceability processes. Some comments suggest that the rule will: save 
lives and reduce illnesses by enabling faster identification of 
contaminated food and recipients of the food; help FDA conduct 
investigations and enable the Agency to skip steps in the supply chain; 
facilitate faster, more targeted recalls at lower cost and reduce broad 
market withdrawals; reduce the number and frequency of public health 
warnings and recall announcements; help consumers feel safer about the 
food they eat by increasing the transparency between consumers and 
producers; help prevent needless food waste when possibly unsafe 
products must be discarded; yield improvements in inventory control and 
firms' ability to keep accurate shipping and receiving records; prevent 
underconsumption of FTL foods due to safety concerns; and reduce 
liability damage costs to manufacturers. Several comments maintain that 
the benefits of the rule,

[[Page 70938]]

including a reduced risk of adverse economic consequences for entities 
in the supply chain, outweigh the costs of meeting the additional 
recordkeeping requirements.
    On the other hand, many comments express opposition to the proposed 
rule. One comment maintains that the rule would cause hardships for 
producers and force more importation of food produced in less sanitary 
systems. Several comments maintain that compliance with the rule would 
be infeasible or too costly for many supply chain entities, including 
many farms, producers, and RFEs, and that the costs of the rule would 
outweigh its public health benefits. Some comments contend that the 
rule would increase costs to consumers and limit consumers' ability to 
obtain fresh, local food. Some comments assert that existing 
traceability requirements are adequate and additional regulation of 
farms and firms would be unnecessary and burdensome. Some comments 
maintain that many common industry supply chain operations would not 
fit within the proposed rule's framework for CTEs. Some comments 
contend that the rule would create a barrier to firms looking to enter 
the industry or the U.S. market, as well as to firms that are reluctant 
to adopt technology. Some comments assert that while other FSMA rules 
have essentially codified existing food safety best practices, the 
proposed rule would create an entirely new and at times duplicative 
recordkeeping system. Several comments claim that the rule assigns 
demanding responsibilities to industry with little or no additional 
safety benefits beyond existing controls.
    (Response 88) As directed by Congress in section 204(d)(1) of FSMA, 
we are establishing additional traceability recordkeeping requirements 
for foods we have designated as high-risk in accordance with the 
criteria Congress specified in section 204(d)(2)(A) of FSMA. Consistent 
with Congress' directive, we believe that the requirements of the final 
rule will help the Agency better protect the public health by enabling 
us to more rapidly and effectively identify recipients of a food to 
prevent or mitigate foodborne illness outbreaks and address credible 
threats of serious adverse health consequences or death. We believe 
that the final rule addresses many of the limitations of the existing 
traceability recordkeeping requirements in subpart J as discussed in 
Response 105, and will help us respond more quickly and effectively to 
foodborne illness outbreaks and recall events involving FTL foods, 
which will benefit both public health and the food industry. As 
discussed later in this document, the final rule includes several 
changes to, and additional exemptions from, the proposed requirements 
that we believe will reduce the burden of the rule on entities 
throughout the supply chain while still producing the benefits of 
faster and more efficient traceability. We note that the rule will 
apply to imported FTL foods as well as domestically produced FTL foods, 
and that the rule would not require duplication of records. Specific 
comments relating to the costs and benefits of the rule are discussed 
in Section VII of this document.
    (Comment 89) Some comments maintain that the rule would increase 
the costs of production and cause the price of food to increase for 
consumers and throughout the supply chain.
    (Response 89) The FRIA (Ref. 16) attempts to comprehensively 
represent the total costs of compliance with the rule to industry and 
society as a whole. Section II.F of the FRIA estimates compliance costs 
to various covered domestic entities depending on their size and role 
in the supply chain, and section II.H discusses costs to foreign 
entities. However, we do not determine the exact incidence of those 
costs, which might be passed on to other entities in the supply chain. 
We acknowledge consumer concerns about food prices, but we do not think 
that the rule will cause food and ingredient prices to rise 
substantially, although depending on entities' market power some costs 
of the rule might be passed all the way to consumers and retail buyers. 
We believe that the exemptions and partial exemptions in the final rule 
(see Section V.E of this document), along with the streamlining and 
simplification of certain requirements (see Response 104), should help 
to limit the potential impact of the rule on prices for ingredients and 
final goods if some of the costs of the rule are passed on to consumers 
and retail buyers.
    (Comment 90) Some comments assert that the rule would decrease food 
availability because the difficulty of complying would force some small 
producers to close. Some comments maintain that small operations have 
proven key to local food security when larger operations have been 
forced to temporarily shut down during emergencies, such as the COVID-
19 pandemic. Some comments assert that if small farms shut down there 
will be reduced access to healthy food.
    (Response 90) We do not agree that the rule will substantially 
reduce food availability, reduce access to healthy food, or force 
businesses to close. The comments did not provide any evidence that 
shutdowns would occur or that food access would be restricted because 
of the rule. As previously discussed, we have made changes in the final 
rule to reduce the chances that any business, especially smaller firms 
and farms, will feel so burdened by the requirements that it must shut 
down.
    (Comment 91) One comment asserts that the unintended consequences 
of the rule could include increasing food waste from the elimination of 
grocery returns.
    (Response 91) We disagree with the comment that the rule will 
increase food waste by discouraging or eliminating grocery returns. The 
rule does not create any recordkeeping requirements relating to the 
sale of food to consumers or to the return of such food by consumers.
2. Treatment of Different Sizes and Types of Entities
    (Comment 92) Several comments assert that the rule favors and is 
intended for larger entities in food supply chains. Some comments 
contend that FDA failed to seek input on the proposed recordkeeping 
requirements from smaller firms and farms. Some comments assert that by 
unnecessarily burdening small businesses, the rule would further 
encourage the consolidation of the food system, which the comments 
maintain has led to more outbreaks. Some comments assert that many 
smaller firms and farms lack the money, technology, and infrastructure 
to meet the proposed requirements, and that the rule will have a more 
severe impact on smaller firms that will need to develop a traceability 
system from scratch. Some comments maintain that the cost of complying 
with the rule will force many smaller firms out of business without any 
corresponding benefit to the public health. Some comments assert that 
many smaller retailers will stop doing business with local food vendors 
because many of those small suppliers will be unable to meet the new 
requirements. Some comments assert that the exemptions in the proposed 
rule are overly narrow in scope or inappropriately targeted, so changes 
are needed to ensure the rule can be feasibly implemented by smaller 
entities.
    (Response 92) We do not agree that the final rule favors or is 
intended for larger firms. As discussed later in this document, the 
final rule includes several full and partial exemptions that apply to 
smaller entities such as small farms, RFEs, and other entities, 
including additional exemptions not included in the proposed rule. In 
addition, we believe that all entities subject to the rule will be able 
to meet

[[Page 70939]]

the requirements that apply to them. As discussed later in this 
document, we have reduced the amount of information on CTEs that 
entities are required to keep and to provide to their customers. And 
although we encourage the use of electronic records and communications 
for traceability, the final rule does not require electronic 
recordkeeping or any technologies for records maintenance or supply 
chain communications. Nevertheless, we understand that coming into 
compliance with the final rule might pose more challenges for entities 
with fewer resources and less experience in traceability, and we intend 
to provide outreach and guidance to help smaller entities understand 
and comply with the applicable requirements of the final rule. In 
addition, in accordance with section 204(h) of FSMA, not later than 180 
days after promulgation of this final rule we will issue a small entity 
compliance guide (SECG) that explains the requirements of subpart S in 
plain language, with the goal of assisting small entities, including 
farms and small businesses, in complying with these new requirements.
    (Comment 93) Some comments assert that the proposed rule places an 
undue burden on small farms, including those just above the proposed 
exemption threshold; that small farms could not comply or would have 
significant difficulty complying with the rule; and that the rule could 
cause some small farms to go out of business and cause consolidation in 
the industry. Some comments state that FDA should support small farms, 
not burden them. Some comments provide the following reasons why the 
rule would potentially hurt small farms: (1) the industry is already 
overregulated, and the COVID-19 pandemic and the current state of the 
economy mean any new burden will be difficult for small farms to bear; 
(2) the proposed requirements are too numerous and too stringent; (3) 
small farms would have to hire additional staff to keep the records, or 
the rule would depress worker ``profits'' by forcing them to perform 
additional unpaid recordkeeping work; (4) small farms do not have 
electronic capabilities, especially in underserved (in electronic 
infrastructure) geographic regions and in some religious communities; 
(5) the requirements of the rule would be a barrier to entry and growth 
for small-scale farms, and the rule would make it difficult for them to 
compete with larger farms; and (6) many of the crops on the FTL are 
mainstays of small farms. Some comments simply maintain that the rule 
is overburdensome, while others ask that we exempt small farms or 
small-scale farms from the rule, or simply not issue any final rule.
    (Response 93) We appreciate that this rule for the first time will 
establish traceability recordkeeping requirements applicable to farms, 
and that complying with the subpart S requirements may place a burden 
on many smaller farms, particularly in the economic environment 
accompanying the COVID-19 pandemic. We agree it is important to try to 
reduce the burden of the rule on businesses that may have fewer 
resources to apply to compliance, while minimizing the additional 
health risk caused by consumer exposure to products that would 
otherwise be covered by the regulation. Therefore, as discussed in 
Section V.E.2 of this document, the final rule includes exemptions and 
partial exemptions for smaller farms. Furthermore, as discussed in 
Section V.I, the final rule streamlines the KDE requirements, including 
by eliminating the proposed requirements for growers. Because of these 
exemptions, revised KDEs, and the flexibility provided in the final 
rule, we conclude that the rule will not establish significant barriers 
to entry for farms or be the cause of significant consolidation in the 
industry. Further, as discussed in Section V.U.4 of this document, we 
will provide education, training, and technical assistance to farmers, 
and we will be issuing materials, including an SECG, specifically aimed 
at assisting smaller farms in complying with the requirements of this 
rule.
    Regarding the comments about electronic capabilities, we note that 
the only portion of the final rule that requires such capabilities is 
the electronic sortable spreadsheet requirement in Sec.  
1.1455(c)(3)(ii). Under Sec.  1.1455(c)(3)(iii)(A), farms with annual 
sales of no more than $250,000 are exempt from this requirement. 
Furthermore, under Sec.  1.1455(c)(3)(iv), FDA will withdraw a request 
for an electronic sortable spreadsheet to accommodate a religious 
belief of a person asked to provide such a spreadsheet.
    (Comment 94) One comment states that, in addition to exempting 
small and medium producers and retailers, larger retailers should only 
be required to obtain tracking information from very large producers so 
as not to overburden small producers that would otherwise be exempt.
    (Response 94) We do not agree that large retailers should only have 
to keep records of FTL foods obtained from very large producers, as 
this could significantly reduce the traceability information available 
to FDA in some circumstances. However, we recognize that when firms 
obtain food from suppliers that are not subject to subpart S, they 
might not receive certain information their supplier would be required 
to provide if they were subject to the rule. Therefore, as discussed in 
Section V.N.2 of this document, the final rule clarifies the 
traceability information to be kept when a person receives an FTL food 
from a person to whom subpart S does not apply.
    (Comment 95) Some comments assert that Congress recognized in the 
2002 Bioterrorism Act that foods can be traced without imposing 
requirements on the first or last links in the supply chain, i.e., the 
farmer/rancher and the entity that sells or serves the food to the 
consumer, and that Congress reaffirmed this approach to traceability in 
FSMA. These comments also maintain that, in FSMA, Congress also 
recognized the importance of protecting small and local food businesses 
from expensive regulations not needed for small operations, and that 
FDA incorporated this principle in adopting other regulations under 
FSMA, such as the provisions for ``very small businesses'' in the 
preventive controls regulation. The comments maintain that FDA is 
contradicting these principles and imposing costly, burdensome 
requirements on farms, RFEs, and very small businesses.
    (Response 95) We do not agree with the comments' characterizations. 
Unlike the Bioterrorism Act traceability provisions (section 414(b) of 
the FD&C Act), section 204(d)(1) of FSMA does not exclude entities at 
the beginning (e.g., farms) or end (e.g., restaurants) of the supply 
chain from the scope of the law. Rather, in referring to entities such 
as farms and grocery stores, Congress recognized the importance of 
ensuring traceability to both ends of the supply chain. With respect to 
smaller businesses, the different components of FSMA were designed to 
serve different food safety purposes, and they do not specify a uniform 
approach to the application of implementing regulations to smaller 
firms and farms. In any event, as discussed later in this document, the 
final rule fully exempts from subpart S certain small food producers 
and small RFEs and restaurants, and provides partial exemptions for 
certain other smaller entities, as well as exemptions relating to short 
supply chains.
    (Comment 96) Some comments maintain that the proposed requirements 
should only be applied to large firms because foodborne illness 
outbreaks are only a concern with large firms. One comment asserts that 
the rule

[[Page 70940]]

could lead to an increase in foodborne illnesses since small firms 
cause fewer illnesses and have the highest level of traceability, and 
they will likely cease production due to the cost of compliance. Some 
comments state that foodborne illness outbreaks are always traced back 
to large farming operations, such as ``mega-farm'' facilities, 
concentrated animal-feeding operations (CAFOs), monocrop operations, 
and those that sell through aggregators and large distributors. One 
comment suggests that small firms have every incentive to ensure their 
foods are safe because their customers know the source of the products 
and will make it known if their products cause illness. One comment 
maintains that outbreaks only become a factor with central processing 
facilities, where items from across the country are processed and 
packaged, and that there is no reason to impose the recordkeeping 
requirements on items with a short supply chain from producer to 
consumer. One comment asserts that, although the rule is intended to 
fix a problem caused by firms being too large to maintain healthy 
standards, it will ruin the small producers who are not the source of 
the problem.
    (Response 96) We do not agree with the comments that foodborne 
illness outbreaks are only associated with larger food producers and 
facilities, and the comments do not provide data to support this 
assertion. Firm size does not change the characteristics of the food 
(e.g., the potential for supporting pathogen growth). Nevertheless, as 
stated in section V.E.2 of this document, the final rule includes 
several exemptions and partial exemptions for smaller entities, 
including those involved in shorter supply chains, and we do not 
believe that the rule imposes an unnecessary or unreasonable burden on 
those entities that are subject to these recordkeeping requirements.
    (Comment 97) Some comments suggest that most foodborne illnesses 
result from contamination in the middle of the supply chain and ask 
that the rule account for the lower risk associated with farms and 
restaurants.
    (Response 97) As discussed in the preamble to the proposed rule (85 
FR 59984 at 59990), point-of-service firms (foodservice and retail) 
affect almost every traceback investigation FDA conducts because 
information concerning consumer purchases from point-of-service firms 
often is used to initiate a traceback. Coverage of RFEs and restaurants 
is therefore a vital part of the subpart S 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 these requirements, Congress also 
recognized the importance of ensuring traceability to both ends of the 
supply chain. While we realize that contamination in the middle of the 
supply chain can result in foodborne illness outbreaks, in recent 
years, numerous outbreaks that CORE has worked on related to FTL foods 
have been linked to growers and other entities at the start of the 
supply chain (Ref. 7). The requirements of this rule 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.
    While we continue to believe that traceability is important at the 
beginning and end of the supply chain, we recognize that various full 
or partial exemptions are appropriate to provide certain farms as well 
as RFEs and restaurants with flexibility and/or relief in meeting the 
subpart S requirements, while ensuring that appropriate measures are in 
place to allow for efficient traceability activities when needed. These 
full and partial exemptions are discussed in Section V.E of this 
document.
    (Comment 98) One comment asserts that because many growers take on 
a significant recordkeeping burden to comply with food safety 
requirements at the request of their customers, FDA should ensure that 
the subpart S requirements can easily integrate with a farm's existing 
food safety protocols and complement rather than duplicate food safety 
efforts already occurring in the marketplace.
    (Response 98) We agree with the comment. We believe that the 
requirements in the final rule applicable to farms coordinate well with 
food safety measures many farms have adopted in recent years in 
response to the demands of their customers. In addition, as discussed 
in Response 104, we believe the KDEs-for-CTEs recordkeeping approach 
the final rule establishes is generally consistent with traceability 
plans and systems in place in many supply chains. Moreover, as 
discussed in Section V.E.2 of this document, smaller farms that might 
be especially burdened by additional traceability requirements for FTL 
foods are exempt from the final rule.
    (Comment 99) One comment maintains that the rule would penalize a 
farm for being diversified and having total sales that prevent 
exemption. The comment maintains that while the inclusion of an 
exemption by reference to the produce safety regulation is laudable, 
the rule would nevertheless have a disproportionate impact on 
diversified farms.
    (Response 99) We do not agree that the rule has a disproportionate 
or improper impact on diversified farms. In accordance with section 
204(d)(1) of FSMA, the rule applies to persons who manufacture, 
process, pack, or hold foods on the FTL. Although the fact that a farm 
grows several different RACs might increase the chances that the farm 
grows a RAC that is on the FTL, being subject to the rule with respect 
to that FTL food would not constitute a penalty but rather the 
appropriate application of the recordkeeping requirements Congress 
concluded were necessary to protect against the risks posed by such 
foods. Furthermore, if growing several crops enables a farm to achieve 
a level of sales making it ineligible for exemption as a small 
producer, the size of its earnings would make it less likely that 
compliance with subpart S would pose an undue burden on the farm.
3. Application of the Rule to All Foods
    (Comment 100) Some comments suggest that the proposed traceability 
recordkeeping requirements be applied to all foods, not just foods on 
the FTL. One comment acknowledges that FSMA limited the additional 
recordkeeping requirements to foods on the FTL but maintains that this 
approach is flawed and suggests that it be reconsidered. One comment 
asserts that FDA could have relied on other provisions of the FD&C Act 
to more broadly apply the proposed traceability requirements, and they 
encourage all food producers and processers to voluntarily follow the 
final rule. One comment commends FDA for recommending adoption of end-
to-end digital traceability systems for all foods but recognizes that 
the Agency is statutorily restricted from requiring traceability for 
foods beyond those on the FTL.
    On the other hand, several comments raise concerns that firms may 
have to keep traceability records for all foods, not just FTL foods, 
based on supply chain pressures. One comment asserts that to ensure 
compliance, some firms likely will request all information required 
under the rule for receivers from all their suppliers, regardless of 
whether the food or the supplier is exempt from the rule, which will 
effectively force all manufacturers to comply with the rule's 
requirements for shipping records. Some comments maintain that the rule 
will indirectly affect non-FTL foods because many

[[Page 70941]]

firms will not have the capacity to operate two sets of recordkeeping 
systems for their products. One comment asserts that the rule is not 
feasible for the entire food sector and that it is unlikely that food 
companies could voluntarily adopt this approach for many ingredients 
not on the FTL. One comment asserts that the rule should not be applied 
to all foods, adding that any future decision to extend additional 
traceability recordkeeping requirements to non-high-risk foods would 
depend on a decision by Congress to impose additional regulatory costs 
throughout the food chain, including on segments that, according to the 
comment, present no or limited risks.
    (Response 100) The subpart S requirements set forth in the final 
rule apply only to persons who manufacture, process, pack, or hold 
foods on the FTL; the rule does not apply to non-FTL foods. Section 
204(d)(7) of FSMA states that the recordkeeping requirements FDA 
establishes under section 204(d)(1) shall have no effect on foods that 
the Agency has not designated as high-risk foods under section 
204(d)(2), and that foods not so designated are subject solely to the 
one-up, one-back recordkeeping requirements under section 414 of the 
FD&C Act and subpart J of the regulations. In accordance with section 
204(d)(7) of FSMA, subpart S does not impose any requirements with 
respect to non-FTL foods.
    However, as stated in the preamble to the proposed rule, we believe 
that applying to all foods the approach to recordkeeping required under 
subpart S for FTL foods would benefit both industry and American 
consumers by facilitating faster traceback and identification of 
contaminated food, thereby limiting the adverse impact of an outbreak 
on consumers and affected sectors of the food industry. Although we 
acknowledge that conducting more robust recordkeeping for all foods 
might not be feasible for all firms, especially those with fewer 
resources to devote to traceability measures, we hope all entities in 
the supply chain recognize the importance of subpart S's emphasis on 
the documenting and sharing of lot code information as a product moves 
through its supply chain.
4. Application of the Rule to Imported Foods
    (Comment 101) Some comments urge FDA to uphold a ``level playing 
field'' by requiring both domestic and foreign firms to comply with the 
traceability recordkeeping requirements for FTL foods. One comment 
contends that once a product is manufactured and shipped, imported 
product traceability details are no longer maintained; if the product 
does not bear the imported product's traceability information, a 
traceback to the point of origin and any root-cause analysis is 
limited. The comment asserts that this lack of information could 
subject domestic produce and produce growing areas to a product or 
market recall even though all traceability rules are followed. One 
comment states that, considering the potential expense incurred, it is 
critical that both domestic and imported foods adhere to the same 
traceability requirements.
    (Response 101) The requirements of the final rule apply to all 
persons who manufacture, process, pack, or hold foods on the FTL 
(unless an exemption applies), regardless of whether the person is in 
the United States or a foreign country. It is possible that, with 
respect to some imported FTL foods, the rule requires documentation of 
the production of the food that not all importers or other entities 
currently maintain, but they will be required to do so under subpart S. 
For example, regardless of whether an FTL food is domestic or foreign 
in origin, the rule requires that shippers of FTL foods provide 
information on the traceability lot code source of the food and that 
receivers of FTL foods record the traceability lot code source 
information. In short, the final rule applies equally to domestic and 
foreign persons who manufacture, process, pack, or hold FTL foods.
    (Comment 102) Two comments ask that we explain how the proposed 
traceability requirements and the FSVP regulation differ.
    (Response 102) The subpart S traceability recordkeeping 
requirements are designed to help FDA more quickly identify the source 
of a foodborne illness outbreak and remove contaminated food from the 
marketplace. These requirements apply to persons who manufacture, 
process, pack, or hold foods on the FTL. The FSVP regulation (subpart L 
of 21 CFR part 1), on the other hand, is designed to help ensure that 
persons who import food into the United States verify that the foreign 
supplier uses processes and procedures that provide the same level of 
public health protection as the FDA requirements on standards for 
produce safety and preventive controls for human and animal food, as 
applicable, and to ensure that the food is not adulterated under 
section 402 of the FD&C Act or misbranded with respect to labeling for 
the presence of major food allergens under section 403(w) of the FD&C 
Act. In short, while this final rule focuses on improving traceability 
for both domestic and foreign foods on the FTL, the FSVP regulation is 
intended to help ensure that importers take certain steps to verify, 
before importing food, that the imported food meets applicable FDA food 
safety requirements.
    (Comment 103) Several comments express concern about foreign 
compliance with the rule, particularly because some foreign suppliers 
of FTL foods might not know that their products will be exported to the 
United States. The comments state that this would be especially 
problematic because the proposed rule would require firms to pass 
traceability lot codes forward through the supply chain while 
prohibiting assignment or changing of codes except at initial packing 
and transformation. The comments assert that the rule would be 
burdensome because the requirements might be applied to products that 
might not ultimately be exported to the United States. The comments 
further maintain that complying with the rule would be practically and 
technically difficult for many operations because they would need to 
update their traceability systems to comply.
    (Response 103) FDA is aware that many firms, both domestic and 
foreign, will have to update their traceability systems to comply with 
the rule. However, we think the subpart S requirements are justified in 
light of the benefits associated with more efficient and effective 
tracing during foodborne illness outbreaks. Regarding the concern that 
some foreign suppliers may have to provide traceability information for 
products that, in the end, are not exported to the United States, U.S. 
importers will need to work with their upstream suppliers in foreign 
countries to ensure there is an understanding of the potential for 
foods on the FTL list to be exported to the United States and the 
traceability information required for these products. The final rule 
provides flexibility in how this information is provided, which should 
make maintenance and sharing of the information easier as firms can 
decide the method that is best suited to their operations. We expect 
that much of the information required to be provided to customers under 
the rule is already being shared between trading partners, and firms 
would not be required to duplicate those records to comply with the 
rule.
5. Reduction and Simplification of Requirements
    (Comment 104) Many comments request that FDA simplify the proposed 
recordkeeping requirements by reducing the number of CTEs for which 
firms

[[Page 70942]]

must keep records and streamlining the number of KDEs they must record 
for each CTE. Several comments claim that the proposed rule is 
needlessly complex, overly prescriptive, and goes beyond what is 
necessary for traceback purposes. Several comments maintain that the 
required KDEs should be limited to information that is absolutely 
necessary. Some comments assert that the rule would impose redundant 
requirements or requirements of minimal value. Several comments assert 
that the proposed CTE/KDE structure is too complex to understand how 
the rule would apply to each food a firm handles. One comment maintains 
that the burden this complexity will place on industry will detract 
from the effectiveness of recordkeeping programs and prevent the rule 
from achieving its intended public health benefit. Some comments 
suggest that a simpler system would make the rule more readily 
understandable and accurately implemented by industry at a lower cost. 
Some comments assert that FDA could fulfill its statutory mandate and 
achieve similar public health benefits through simpler and less costly 
alternatives that leverage already successful traceability 
recordkeeping systems, like those of foodservice distributors.
    (Response 104) We agree with the comments that the requirements of 
the rule should be as simple and few as possible while still enabling 
the rule to achieve its purpose of improving the traceability of FTL 
foods. In response to comments, we have made several revisions to the 
CTEs for which records must be maintained, and we have streamlined and 
simplified the KDEs required to be kept and provided to the recipient 
of shipped food. As discussed later in this document, for each of the 
CTEs we have tried to streamline the KDEs so that they include only the 
information we need to conduct timely and efficient investigations into 
foodborne illness outbreaks, as well as information that firms must 
provide to their customers to ensure consistency and enable them to 
meet their requirements under subpart S. We believe the changes we have 
made to the CTE/KDE requirements will make it easier for those persons 
who are subject to the rule to understand and comply with the 
applicable requirements, thereby making the rule more effective yet 
less burdensome. The CTE/KDE approach in the final rule is generally 
consistent with approaches taken by existing traceability programs, 
which we think will assist with implementation. Where appropriate and 
possible, we have revised or deleted proposed requirements to avoid 
unnecessary burden, provided additional opportunities for flexibility, 
and better aligned the requirements with current industry practices.
    (Comment 105) Some comments maintain that the rule should focus on 
key gaps in the existing traceability recordkeeping requirements in 
subpart J. One comment suggests that we amend subpart J to require 
covered entities to maintain lot code information and asks us to 
consider ways to combine the requirements of subpart J and proposed 
subpart S to enhance traceability. Some comments assert that although 
creating and maintaining traceability lot codes and linking the codes 
throughout the supply chain are needed to fill gaps we have identified 
in the subpart J requirements, we should issue guidance to address any 
other shortcomings of these requirements rather than adopt new 
requirements.
    (Response 105) We agree with the comments that the rule should 
focus on addressing important gaps in the subpart J recordkeeping 
requirements, and that is what we have done with subpart S. The 
preamble to the proposed rule cites the lack of lot codes as a key 
shortcoming of subpart J, and the final rule makes recording 
traceability lot codes and providing them to customers as part of 
certain CTEs a critical component of the subpart S requirements. The 
final rule addresses another gap in the subpart J requirements by more 
completely covering the sectors of the supply chain, from farms and 
other food producers at the beginning of the chain to RFEs and other 
entities at the end of the chain. Further, firms that are currently 
complying with subpart J recordkeeping can use those records to satisfy 
many of the subpart S requirements. Consistent with Congress' directive 
to establish additional recordkeeping requirements for traceability, 
and because the scope of subparts J and S are not the same, we 
established a new regulation. We believe that putting these 
requirements into a guidance, without also issuing a regulation, would 
not be appropriate.
    (Comment 106) Several comments specify each of the KDEs they 
believe are unnecessary or inapplicable to some or all FTL foods, 
including such KDEs as the following: the entry number for imported 
products; the category code/term, category description, brand name, 
commodity, and variety; the physical location name; location 
identifiers; the point of contact for lot code generators; the date and 
time for a CTE; location information for where the CTE occurred; and 
the name of the transporter.
    (Response 106) As stated in Response 104, we have made several 
changes to the KDEs that must be kept and provided for each CTE in the 
supply chain. We address the comments on which KDEs are appropriate and 
necessary for each CTE in the individual sections of this document 
concerning the relevant CTEs.
    (Comment 107) One comment objects to imposing different 
requirements for different CTEs under the rule.
    (Response 107) We do not believe it would be appropriate to require 
maintenance of the same KDEs for each supply chain event, as some 
information is not available at all steps in the supply chain and some 
entities are better suited than others to keep and provide information 
for certain CTEs. Consequently, the final rule tailors the KDEs that 
must be kept and provided for each CTE according to the information it 
is reasonable and appropriate for entities to maintain to facilitate 
effective traceability.
    (Comment 108) Several comments object to the proposed requirements 
to provide certain traceability information to their customers for 
certain CTEs, such as shipping. One comment asserts that the proposed 
rule would require unnecessary repeated sharing of data, rather than 
focusing on just one or a few responsible parties. One comment asserts 
that the rule necessitates that trading partners repeatedly reshare 
attributes associated with products, locations, and business entities 
instead of acknowledging that those attributes are populated by one or 
a few parties who are responsible for that data.
    (Response 108) We do not agree with the comments that it is 
unnecessary to require certain entities in the supply chain to share 
information with persons to whom they send FTL foods. As discussed more 
fully below, the final rule requires entities that engage in certain 
activities with respect to FTL foods (e.g., initial packing, receiving, 
transformation) to keep records of certain KDEs so that this 
information is available to FDA if necessary to assist in our 
investigation of a foodborne illness outbreak. To help ensure that 
these firms have the required information, the rule also requires for 
certain CTEs (e.g., shipping) that firms provide information to persons 
to whom they send the food. In many cases, firms already provide this 
information to their customers in the normal course of business, 
although perhaps not all firms provide all the KDEs specified in the 
final rule. To the extent that any of the required information is 
already being kept within a firm's record system, the firm does not 
need to duplicate these existing records

[[Page 70943]]

to satisfy the requirements under subpart S. In addition, as discussed 
below, the final rule includes changes designed to place responsibility 
for the maintenance of certain records on the entities in the supply 
chain that are best suited to the task.
    (Comment 109) Several comments suggest that FDA require firms to 
pass forward two standardized pieces of information (not specified in 
the comment) identifying the originator or creator of a product in a 
method that does not require the disclosure of confidential business 
information, rather than requiring an elaborate set of additional KDEs. 
The comments maintain that such a requirement, coupled with adequate 
enforcement of the subpart J requirements, would allow for effective 
tracking and tracing of foods on the FTL. Alternatively, the comments 
suggest that FDA allow use of a linking identifier already established 
by the receivers and shippers--such as a purchase order (PO) number, 
bill of lading (BOL), or other reference document--that links products 
being shipped to products received. The comments assert that this 
approach would be an effective alternative to a lot code-based system 
while being less cumbersome and costly to implement.
    (Response 109) We disagree with the comments to the extent that 
they suggest we are requiring unnecessary recordkeeping. As previously 
stated, we have tailored the required KDEs to specific CTEs in the 
supply chain so that the different entities in the chain can provide 
FDA with information we need to conduct an outbreak investigation 
involving an FTL food. Requiring documentation of traceability lot 
codes and related information at different stages of production and 
distribution will enable us to skip steps in the supply chain, link a 
food to the firms that have handled it, and ultimately lead us back to 
the source of the food. Relying solely on PO numbers, BOLs, and other 
reference documents to link products between each shipper and receiver 
in a supply chain would not allow us to skip steps and trace a product 
back to its source in an efficient and timely manner to mitigate 
potential foodborne illnesses. Regarding the comments' concerns about 
the disclosure of confidential commercial information, the final rule 
includes changes to proposed requirements related to points of contact 
and lot code generators to address these concerns, as discussed in 
Sections V.F.28 and V.M.2 of this document.
    (Comment 110) Several comments suggest that the KDEs focus on lot 
numbers. One comment asserts that FDA could require an endless number 
of data points, but that would not be necessary if there was a 
mandatory requirement for lot codes to be present on all forms of 
documentation that support the transaction. One comment suggests that 
the proposed timeframe and implementation process for the rule would be 
more manageable with a smaller data set transmitted between trading 
partners--the lot code tied to product and contact information for the 
brand owner--and increased flexibility on how to reach the objective. 
One comment maintains that the lot number along with the company name 
and product identification should be enough to ``unlock'' other needed 
information with the originator. Some comments maintain that the rule 
should focus on the appropriate assignment of traceability lot codes 
linked to the date of harvest and preservation of traceability lot 
codes throughout the supply chain. One comment maintains that the 
proposed rule seems to codify approaches (e.g., use of reference 
records, dates, times, product descriptions, identifiers) that have 
proven to be imperfect and cumbersome, and which the IFT in the 2012 
traceability pilot report identified as ``conditional'' data elements 
(e.g., back-up plans when the batch/lot number was not available). This 
comment maintains that the lot number is the critical data element, 
combined with information regarding the entity responsible for the lot 
number and the item description. One comment maintains that the lot 
number tied to the product and accompanied by contact information for 
the entity responsible for production (rather than handling) of that 
product is sufficient to trace products. The comment further asserts 
that if some of the information proposed to be shared between trading 
partners were instead required to be tied to the lot number/product and 
maintained by the originator, creator, or transformer, and made 
available upon written request, FDA's objectives could be met at a 
lower cost to the industry and with improved implementation and 
compliance.
    On the other hand, one comment argues that lot codes often are 
missing for produce and maintains that documents supplied with 
purchases do not contain any traceability information beyond an item's 
description, the product number/stock-keeping unit (SKU), the PO 
number, and the name of the supplier. Furthermore, the comment asserts 
that most distributors do not have the ability or capacity to record 
lot numbers, which the comment maintains would have to be read from the 
box or label and entered manually into a database.
    (Response 110) We agree with the comments asserting that lot codes 
are a critical component of effective traceability records. As stated 
in Response 345, recording traceability lot codes when handling FTL 
foods and providing the codes to supply chain partners as part of 
certain CTEs is a core component of the subpart S requirements. 
Recognizing that the absence of required lot code information is a key 
weakness of the subpart J traceability requirements, the final rule 
directs that traceability lot codes be assigned and recorded when FTL 
foods are initially packed (or, for foods obtained from a fishing 
vessel, first processed on land) or transformed, and the traceability 
lot code must be recorded at subsequent stops in the food's supply 
chain. To help ensure that entities in the supply chain can document 
the traceability lot code for the FTL foods they receive, the final 
rule requires shippers of FTL foods to provide this information to 
receivers. To help ensure that accurate traceability lot code 
information for FTL foods is maintained, the rule requires firms to 
keep records linking traceability lot codes to information on the food 
and its producer. This additional information is not meant as a ``back-
up plan,'' but instead can prove independently useful, as discussed in 
more detail below in response to comments about specific KDEs. To 
further aid traceability to the producers and manufacturers of FTL 
foods, the final rule requires firms to provide to the recipients of 
the food they ship information that enables identification of the 
source of the traceability lot code assigned to the food. In short, we 
believe the final rule appropriately makes traceability lot codes a KDE 
of critical importance to the traceability recordkeeping requirements 
in subpart S, but we also believe that the other KDEs required by 
subpart S are essential to rapid and effective traceability.
    For receivers of shipments that may be missing lot codes, Sec.  
1.1345(b) sets forth the requirements for when an FTL food is received 
from a person who is exempt from subpart S. This includes assigning a 
traceability lot code if one has not already been assigned. In a 
situation where the shipper is covered by subpart S but nonetheless 
failed to provide the required traceability lot code, we urge supply 
chain partners to work together to address such discrepancies. With 
respect to the comment that most distributors do not have the ability 
to record lot numbers,

[[Page 70944]]

we do not agree. We believe that the majority of distributors receive 
lot code information for the foods they receive and they are able to 
record this information, although they might not have the capability to 
do so electronically. Although we encourage the use of electronic 
records for traceability, the final rule does not require them.
    (Comment 111) One comment maintains that the more information and 
data that are required, the more likely there will be errors. One 
comment asserts that the rule would force use of advance shipping 
notices (ASNs) due to the complexity of operations, the number of items 
carried in facilities, and the view that manual activity is prone to 
human error.
    (Response 111) We do not agree that maintaining the records 
required under the final rule will lead to errors in recordkeeping. 
Many firms already keep all or most of the required KDEs as part of 
their existing tracing or business records. To the extent that errors 
occur, we believe that availability of the required information will 
make it more likely that FDA could nevertheless obtain the information 
needed in conducting an outbreak investigation or assisting in a 
product recall. With respect to ASNs, the final rule does not require 
the use of any particular type of reference document to meet applicable 
subpart S requirements.
    (Comment 112) One comment maintains that there is broad-based 
adoption of traceability technologies and records collection at the 
beginning of the supply chain for certain commodities. The comment 
supports requiring RFEs to capture the traceability lot code assigned 
originally to a food but not prescribing how information is shared 
through the supply chain, and asks that we reduce the number of KDEs 
that must be shared.
    (Response 112) As previously stated, we agree that traceability lot 
codes are a crucial component of this rule, including as maintained by 
RFEs for the FTL foods they receive. As discussed below, the final rule 
provides greater flexibility in how information can be shared through 
the supply chain, including with respect to information on the 
traceability lot code source for an FTL food, and streamlines and 
simplifies the KDEs required for some CTEs.
    (Comment 113) One comment asserts that required KDEs other than the 
lot code will discourage, complicate, and delay implementation of the 
rule. On the other hand, one comment maintains that when a lot code is 
available, additional KDEs, such as the physical location name and the 
time a food was shipped, received, transformed, or created, add value 
to traceability.
    (Response 113) As stated in Response 345, records of traceability 
lot codes are critical for ensuring the traceability of FTL foods. 
However, to effectively conduct investigations into foodborne illness 
outbreaks, FDA needs to be able to review other traceability 
information on foods such as shipment information and information on 
the entities that have produced and handled the foods to ensure we can 
follow the supply chain history of the product. The lot code alone 
without these additional KDEs would not provide all of the information 
necessary to determine the flow of product through sometimes 
complicated supply chains. Consequently, for CTEs involving FTL foods, 
the final rule requires firms to record the applicable traceability lot 
code for the food along with other KDEs, including essential 
information describing the product and persons who handled the product, 
such as the source of the product's traceability lot code. Sections V.I 
through V.O of this document discuss the KDEs that firms will be 
required to keep for particular CTEs under the final rule.
    (Comment 114) One comment asks that we make explicit in the rule 
that the traceability lot code requirements are data retrieval 
requirements rather than standards specifying how, where, or by whom 
traceability information must be stored and transferred. The comment 
further asks for confirmation that the subpart S requirements can be 
fulfilled by providing to FDA, in the format and timeframe requested, 
the relevant information for which a company is responsible, regardless 
of how (or where) that information is managed within a company's 
internal systems or through its relations with third-party service 
providers or supply chain partners.
    (Response 114) The final rule requires entities who perform certain 
CTEs (e.g., initial packing, shipping, receiving) with FTL foods to 
keep records of certain KDEs relevant to those events, and in some 
cases to provide certain KDEs to other entities in the food's supply 
chain. We believe that these requirements are necessary to ensure that 
adequate traceability information is available to FDA and supply chain 
entities to quickly and effectively respond to foodborne illness 
outbreaks.
    As discussed in section V.R.1 of this document, the final rule does 
not adopt standards for the format in which required information must 
be stored or shared. Under Sec.  1.1315(a)(1), a firm's traceability 
plan must include a description of the procedures used to maintain the 
records the firm is required to keep under subpart S, including the 
format and location of these records. When requested by FDA, the 
information required under subpart S must be provided to us in 
accordance with Sec.  1.1455. We agree that the record production 
requirements in Sec.  1.1455 can be fulfilled by providing to FDA the 
relevant information for which a company is responsible, regardless of 
how (or where) that information is managed within a company's internal 
systems or through its relations with third-party service providers or 
supply chain partners, as long as the requirements of Sec.  1.1455 are 
satisfied. The final rule specifies that offsite storage of records is 
permitted (see Sec.  1.1455(c)(2)), that firms may have another entity 
establish and maintain required records on their behalf (see Sec.  
1.1455(b)), and that electronic records are permitted and may include 
valid, working electronic links to the required information (see Sec.  
1.1455(a)(1)). We believe that these provisions provide the flexibility 
that the comment requests.
    (Comment 115) One comment asserts that the written order of the 
proposed requirements does not follow the logical flow of the product 
through the supply chain. As an example, the comment notes that 
shipping is the last CTE addressed in the codified even though it 
covers shipment by a farm. The comment suggests that we reorder the 
provisions to begin with origination of food (including records for 
growing and for shipping by the originator) and proceeding to the 
requirements applicable to first receivers, followed by those for 
receiving, transformation, and creation.
    (Response 115) We agree with the comment that a reordering of some 
of the proposed CTE recordkeeping requirements is appropriate. As 
stated in Response 357, the final rule begins with a reduced list of 
KDEs for activities that occur before a RAC is initially packed. Next, 
it states the requirements for the initial packing of RACs other than 
food obtained from a fishing vessel and for the first land-based 
processing of food obtained from a fishing vessel (which, as discussed 
in Response 384, have replaced the proposed requirements for first 
receivers). The final rule then specifies the requirements for the CTEs 
of shipping and receiving of FTL foods, concluding with the 
requirements applicable to transformation (which under the final rule 
includes events we called ``creation'' in the proposed rule). We 
believe this reordering more closely

[[Page 70945]]

aligns with the movement of foods through the supply chain.
6. Use of Traceability Lot Codes
    (Comment 116) Some comments assert that the industry's current 
practice of using records such as POs or BOLs allows distributors to 
sufficiently track which lots are in the shipments they receive and 
where product from that shipment goes. One comment maintains that the 
2012 IFT Final Report found that identifiers such as POs and BOLs can 
be used for tracing and suggests that such an approach would be better 
than the system in the proposed rule requiring traceability lot codes 
and many other KDEs. The comment maintains that distributors' current 
practices result in broader but more effective recalls because they 
provide greater confidence that affected products were removed. The 
comment argues that the proposed rule's focus on tracing individual 
lots of FTL foods could lead to an insufficient and prolonged product 
withdrawal, which could be a public health risk.
    (Response 116) We do not agree that the use of POs or BOLs alone, 
without inclusion of the traceability lot code and other KDEs required 
under subpart S, is sufficient to enable us to effectively and 
efficiently trace food through the supply chain. The assignment of a 
traceability lot code, combined with other identifying KDEs, 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. During an outbreak or recall event, FDA routinely requests lot 
code information from firms to effectively link movement of foods 
throughout the supply chain. The availability of traceability lot codes 
along an entire supply chain will improve our ability to identify the 
specific food involved in a contamination event and to determine the 
appropriate scope of a recall event. The accurate and timely provision 
of the traceability lot code for a product as it moves through the 
supply chain is a critical component of the subpart S requirements.
    (Comment 117) One comment maintains that maintaining traceability 
lot codes should be encouraged but not required because, according to 
the comment, experience in the meat and poultry industry shows that lot 
codes rarely narrow the scope of an outbreak to a specific lot or lots, 
since consumers generally do not have the packaging material with lot 
codes at the time of illness onset. The comment asserts that consumer 
purchase reports from retailers, which do not contain lot codes, are 
useful in outbreak investigations. The comment also maintains that most 
outbreaks with successful traceback investigations are able to identify 
a source and result in recalls with much wider scope than a single lot, 
even when lots are traceable.
    (Response 117) We disagree that entities should not be required to 
keep traceability lot codes because food packaging may not be available 
during an investigation. The reason for requiring entities, including 
RFEs and restaurants, to keep records containing the traceability lot 
code upon receipt of an FTL food is to provide a mechanism for 
determining what traceability lots were available for purchase or 
consumption during the timeframe of exposure without requiring the 
consumer to retain packaging. Once traceability lot codes that were 
available for purchase or consumption are identified, we can do a 
traceback of those lots and obtain additional information on the food, 
including ingredients and their sources.
    (Comment 118) One comment suggests that the traceability lot code 
should only be linked to the business name of the firm that originated 
the product and the date of production rather than the location of 
production. The comment maintains that this information is the most 
important to support effective traceback. The comment further suggests 
that firms should be required to link the traceability lot code to 
existing industry records to support root-cause investigations, rather 
than specifically requiring KDEs and CTEs.
    (Response 118) We do not agree that the traceability lot code, the 
business name, and the date of production alone are sufficient to 
enable effective tracing of foods, nor do we agree that linking the 
traceability lot code to existing industry records would be sufficient. 
Our experience performing traceability investigations has demonstrated 
that identifying the food and actual location of production, 
processing, or packing can be extremely challenging and time-consuming 
using only information that is maintained in accordance with current 
requirements and business practices, including in reference documents 
such as BOLs and ASNs, and we think it would continue to be challenging 
if we only required the traceability lot code to be linked to the 
business name of the originating firm and the date of production. In 
many cases, the business name of a firm may not correspond to the 
physical location address where the food was handled but to the 
headquarters address for an entity. Since some businesses may have 
multiple locations in addition to a headquarters address, linking the 
traceability lot code to the physical location where the food was 
handled is critical to ensuring timely and accurate information for 
traceback investigations. Furthermore, linking the traceability lot 
code to the other required KDEs will provide critical traceability 
information, including information about the type of food and its 
movement through the supply chain. In Section V.C.5 of this document we 
explain how we have streamlined the KDEs to include only the 
information that we think is essential to effective and efficient 
traceability.
7. Need for Flexibility
    (Comment 119) Many comments urge us to establish flexible 
requirements that can work with different types of food, firms, 
business models, and traceability approaches. One comment suggests that 
the rule should be flexible enough to accommodate industry practices 
and simple enough that it can be adopted uniformly across industry. One 
comment asserts that the rule must account for many different business 
models and supply chains involved in getting fresh produce from the 
farm to the point of service/retail, but one comment maintains that it 
is not practical or feasible to have different systems for different 
crops. Several comments ask that the rule provide additional 
flexibility to minimize the costs of compliance for smaller entities. 
One comment contends that an inflexible, labor-intensive, or one-size-
fits-all approach could be economically disastrous for small farms, 
those that prioritize diversified production, and those who are already 
participating in certifications (such as USDA organic) that require 
extensive recordkeeping. One comment asserts that although the rule 
provides strong protections from additional recordkeeping requirements 
where food is sold directly to consumers, where there are supply chain 
intermediaries, even in relatively short, low-volume supply chains, the 
rule does not offer size- and risk-appropriate flexibility.
    (Response 119) As stated in the preamble to the proposed rule, we 
believe it is consistent with best industry practice to adopt a 
recordkeeping approach for FTL foods that is based on maintaining and 
sharing relevant KDEs for the different CTEs in the supply chain. 
However, within this framework of standard requirements, the final rule 
includes provisions that take into account the different type of foods 
and supply chain entities that are subject to the subpart S 
requirements

[[Page 70946]]

and allows firms considerable flexibility in meeting those 
requirements. For example, the rule does not specify a particular 
format in which required information must be maintained and shared. 
Although we strongly encourage the use of electronic recordkeeping for 
traceability, persons subject to the rule may keep their records in 
paper or electronic form. Firms can contract with others to establish 
and maintain records required under subpart S on their behalf as long 
as the firm can provide the information to FDA in accordance with the 
rule. To protect certain confidential business information, the rule 
allows firms the flexibility to provide their customers with a 
reference to the information instead of directly identifying the 
traceability lot code source of an FTL food they handle.
    Recognizing that there are differences in the production and 
distribution of different types of foods, the final rule establishes 
separate KDE requirements for the initial packing of RACs that are not 
obtained from a fishing vessel and for the first land-based processing 
of food obtained from a fishing vessel. The final rule also exempts 
certain types of food from the scope of the subpart S requirements. In 
addition, the final rule exempts certain smaller food producers and 
smaller RFEs and other food service providers, including many farms and 
firms that are a part of short, local supply chains. Finally, the final 
rule provides flexibility to all supply chain entities by allowing them 
to rely on any records they have already created or obtained for 
business or other purposes to meet the recordkeeping requirements for 
subpart S.
8. Outcome- or Performance-Based Approach
    (Comment 120) Several comments suggest that we adopt an ``outcome-
based'' or ``performance-based'' approach to the recordkeeping 
requirements instead of what they describe as the proposed 
``prescriptive'' approach specifying particular information that must 
be maintained regarding specific events. Some comments suggest that the 
rule should regard firms as compliant if they are able to provide FDA 
with requested information (linking outgoing products to incoming 
ingredients) within a short time (e.g., 24 hours). One comment 
maintains that FDA has said tracebacks are most efficient when 
traceability information is available at the point of sale; therefore, 
the comment suggests that we focus on that objective instead of 
prescribing how information must be shared throughout the supply chain. 
One comment suggests that we consider the lessons learned from the meat 
and poultry industry's implementation of traceability programs under 
the regulation of the USDA's FSIS, which the comment maintains require 
only that establishments have procedures in place to recall products 
when needed without dictating how to achieve the result. One comment 
suggests that we consider requirements that are less prescriptive and 
can adapt to the future, including advancements in technology. One 
comment asserts that FDA's clear articulation of the objective of 
having details (including the lot number assigned to the product, the 
brand owner, and contact information for the brand owner) at the point 
of sale, without prescribing the mechanism by which that information is 
shared through the supply chain, will afford the flexibility that will 
facilitate adoption of the rule in the short term and encourage 
innovation consistent with FDA's New Era of Smarter Food Safety in the 
longer term.
    (Response 120) Although we appreciate the benefits of 
``performance-based'' approaches to regulation noted by the comments, 
we believe that the interconnected nature of effective food 
traceability and the varying levels of tracing capability throughout 
the industry require an approach for FTL foods specifying certain KDEs 
that must be kept and shared in the context of certain supply chain 
events, while allowing flexibility in how the required records are 
maintained and shared. Although we agree it is very important for FDA 
to have traceability information available at the point of sale, our 
investigations of foodborne illness outbreaks often require us to 
obtain information from other supply chain members as well. We think it 
is important for the final rule to specify the information that must be 
available to us from each point in the supply chain; otherwise, we are 
uncertain that the majority of entities subject to the rule would be 
able to provide the needed information on an FTL food and the firms 
that have produced or handled the FTL food in a timely manner.
    In addition, ``performance-based'' approaches generally work best 
when each covered entity is responsible only for information it 
generates; however, for this rule to deliver the anticipated traceback 
efficiencies and public health gains, information must not only be 
generated by individual firms, but also passed along the chain. As 
noted in the comment, it is important to have traceability information 
available at the point of sale. The rule helps to ensure that 
restaurants and RFEs have the necessary information by requiring 
entities earlier in the supply chain to provide information that will 
ultimately reach these establishments. However, as stated in Response 
460, the final rule provides flexibility in the manner in which 
information is stored and shared with others in accordance with subpart 
S requirements. Finally, we agree with the comments urging that the 
requirements be capable of being adapted to future technological 
advancements. As discussed in Section V.R.1 of this document, we are 
not mandating the use of any particular technical standards for the 
maintenance and transmission of the KDEs required under subpart S.
    (Comment 121) One comment concludes that the requirement for the 
electronic sortable spreadsheet is consistent with the recommendation 
in the 2012 IFT Final Report that FDA accept CTEs and KDEs in summary 
form.
    (Response 121) We agree that the sortable spreadsheet requirement 
is consistent with the 2012 IFT Final Report regarding pilot projects 
for improving traceability (Ref. 1).
9. Consistency With Section 204(d)(1) of FSMA
    As discussed in the following paragraphs, several comments assert 
that the proposed rule is inconsistent with specifications regarding 
the traceability recordkeeping requirements set forth in section 
204(d)(1) of FSMA.
    (Comment 122) One comment asserts that the proposed KDEs would 
include information that is not ``reasonably available,'' contrary to 
section 204(d)(1)(A) of FSMA, because fishing vessels, aquaculture 
operations, and subsequent supply chain steps do not know the final 
destination of the products due to global competition within the 
seafood industry.
    (Response 122) We disagree with the comment. Under the final rule, 
owners, operators, and agents in charge of fishing vessels are largely 
exempt from the rule with respect to FTL foods produced through the use 
of the vessel. As discussed in section V.L of this document, we believe 
that aquaculture farms and firms that conduct the initial packing of 
FTL foods from aquaculture farms will have the information needed to 
comply with relevant requirements under the rule. As discussed in 
Responses 101 and 528, the rule applies equally to both foreign and 
domestic firms, and we expect that foreign firms will be able to work 
with their supply chain partners to determine whether their products 
will be sold in the United States, as they already must do in order

[[Page 70947]]

to comply with several existing FDA regulations.
    (Comment 123) Some comments assert that the proposed rule fails to 
ensure that the public health benefits ``outweigh the cost of 
compliance'' as required by section 204(d)(1)(D) of FSMA. One comment 
maintains that this is particularly so for foodservice distributors, 
who engage in hundreds of thousands of transactions on a daily basis 
that would be subject to the rule's requirements, and therefore would 
be required to establish and maintain thousands of new records every 
day, many of which the comment asserts are not maintained under current 
practices.
    (Response 123) We disagree. Section 204(d)(1)(D) of FSMA states 
that FDA should ensure that the public health benefits of imposing 
additional recordkeeping requirements outweigh the cost of compliance 
with such requirements. As discussed in the FRIA (Ref. 16), the public 
health benefits of subpart S are expected to outweigh the costs of 
compliance with the rule. Currently, the traceability records of 
foodservice distributors are often essential to FDA's ability to 
conduct rapid and effective traceback operations. In addition, we 
believe that most foodservice distributors, like other types of supply 
chain entities subject to the final rule, generally will not have to 
establish thousands of new records but instead will be able to rely on 
records they keep in their current business practices to meet most of 
their requirements under subpart S.
    (Comment 124) Several comments assert that the proposed 
requirements are not ``scale-appropriate and practicable for facilities 
of varying sizes and capabilities with respect to costs and 
recordkeeping burdens,'' as required under section 204(d)(1)(E) of 
FSMA. Some comments maintain that FDA should not use a one-size-fits-
all approach. One comment suggests that we use the best data available 
on food production risks at different scales; some comments urge us to 
adopt requirements that are size- and risk-appropriate and practicable 
for small farms and other small food businesses. Some comments assert 
that the proposed rule does not meet the ``scale-appropriate'' 
requirement because it favors firms with long supply chains over local 
firms with short supply chains, whose operations are said to pose 
lesser safety concerns. One comment maintains that in the cases where 
there are supply-chain intermediaries--even in relatively short, low-
volume supply chains--the proposed rule does not offer size- and risk-
appropriate flexibility. One comment asserts that we overestimated the 
degree to which some farms--particularly small contract farms, which 
would have responsibilities as shippers--have ready access to computer 
spreadsheet programs and similar electronic recordkeeping technology. 
Some comments suggest that we adjust the requirements to better reflect 
the scale and short supply chains of smaller growers and food hubs. One 
comment maintains that the proposed rule is not appropriate for LRFS 
markets and supply chains.
    (Response 124) We do not agree with the comments. As stated in 
Response 107, due to the interconnected nature of traceability 
operations, establishing different requirements for different types and 
sizes of supply chain entities would be impractical and ineffective. 
Nevertheless, recognizing the different impact that the rule might have 
on different types and sizes of firms, the final rule exempts certain 
types of food from the subpart S requirements and also exempts or 
partially exempts certain smaller food producers, RFEs, and other food 
service providers, including many farms and firms that are a part of 
short, local supply chains. In addition, recognizing that smaller firms 
might not have electronic recordkeeping capability, the final rule does 
not require the use of electronic records, and it provides exemptions 
to certain smaller farms and firms from the requirement to make 
available to FDA an electronic sortable spreadsheet containing 
information on specified FTL foods under certain circumstances. We 
believe that the supply chain entities that must comply with the rule 
have the capability to do so. However, as discussed in section V.U.4 of 
this document, we anticipate that we will need to conduct different 
outreach and training activities to help different types and sizes of 
firms come into compliance with the rule. In addition, firms facing 
unique economic hardship due to the requirements may submit to FDA a 
request for a waiver of one or more of the requirements under subpart S 
(see Section V.Q of this document).
    (Comment 125) Some comments assert that the proposed rule does not 
meet Congress' directive to ``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) of FSMA). One comment maintains that the proposed rule 
would create an entirely new--and at times duplicative--recordkeeping 
system for the food industry. Some comments assert that there is 
overlap between the proposed requirements and the existing traceability 
recordkeeping requirements in subpart J, and request that FDA not 
create situations where firms need to keep duplicative records for 
subparts S and J. One comment asserts that FDA and NOAA already require 
seafood companies to capture the same or similar KDEs for harvesting 
and importing--KDEs the comment maintains the rule would not accept. 
The comment claims that without the flexibility to use different KDEs 
that provide data comparable to that contained in the acceptable 
records, companies would be compelled to maintain and report multiple 
records containing the same or virtually the same information.
    (Response 125) We disagree with the comments. The final rule 
specifies that firms are not required to duplicate existing records 
(such as those kept in the ordinary course of business or maintained to 
comply with other regulations) if they contain the information required 
by subpart S, and firms may supplement any such existing records as 
necessary to include all required information. For some firms, the 
records they maintain to comply with subpart J contain much of the 
information that is required under subpart S, and these firms will not 
need to duplicate these records to comply with subpart S. Similarly, if 
a firm that handles seafood keeps records required by FDA or NOAA that 
include information required under subpart S, it will not need to 
duplicate those records to meet subpart S requirements.
    (Comment 126) One comment asserts that there is duplication in the 
proposed requirements to establish and maintain reference record types 
and reference record numbers for several CTEs.
    (Response 126) We do not agree that the requirements in the final 
rule to document the reference document type and number applicable to a 
tracking event require maintenance of duplicate records. If the 
reference document type and number are already present in the firm's 
records for the relevant CTE--for example, if they are indicated on the 
reference document itself and the firm maintains the reference document 
to meet the requirements of the rule--then the firm would not be 
required to make a duplicate record that contains the reference 
document type and number.
    (Comment 127) One comment asserts that by requiring the collection 
of highly detailed data linked to the lot code and available in other 
records, FDA has proposed a duplicative, burdensome system. The comment 
maintains that the duplicative nature is evident in requiring the 
creation of individual pieces of information linked to the lot

[[Page 70948]]

code and requiring a link to identify the underlying records containing 
information that must be linked to the lot code.
    (Response 127) We disagree. The final rule does not require firms 
to create additional, duplicative documents for the sole purpose of 
linking the KDEs to the relevant traceability lot code. For firms that 
maintain paper records, one way such linkage may be achieved would be 
by having the traceability lot code appear on the reference documents 
the firm keeps to document the required KDEs. For firms that maintain 
records electronically, linkage could be achieved simply by including 
the traceability lot code in the same row of a spreadsheet or database 
that documents the required KDEs for a tracking event. Regardless of 
whether the records are kept on paper or electronically, the rule does 
not require creation or maintenance of duplicate records.
    (Comment 128) Some comments support the rule's flexibility 
regarding the ways in which a traceability lot code may be linked to 
other data elements.
    (Response 128) We believe that the final rule allows for 
flexibility and accommodates current business practices while ensuring 
that entities subject to the rule remain responsible for recordkeeping 
requirements to facilitate traceback during an outbreak investigation.
    (Comment 129) One comment asserts that the proposed rule is 
inconsistent with the requirement in section 204(d)(1)(F) of FSMA to 
``minimize the number of different recordkeeping requirements for 
facilities that handle more than 1 type of food.'' The comment asserts 
that passing forward KDEs from a shipper to a receiver will create 
demands for multiple different record formats based on unique business 
systems, resulting in an ever-increasing number of differing 
traceability data requirements.
    (Response 129) We disagree. In general, the recordkeeping 
requirements of the final rule are not specific to the type of FTL food 
that is handled (although slightly different KDEs are required for the 
initial packing of a RAC not obtained from a fishing vessel compared to 
those required for the first land-based processing of a food obtained 
from a fishing vessel, and initial packers of sprouts must keep 
additional information regarding the seeds used for sprouting). Because 
the rule does not specify a particular form in which required records 
must be maintained or provided, it is possible that different firms may 
ask their suppliers to provide required information in different 
formats. However, we think the benefits of giving firms flexibility 
regarding how they maintain and share information--which many comments 
emphasize as important--outweigh the potential issues that could arise 
from different customers requesting records in different formats. We 
encourage supply chain partners to work together to harmonize how best 
to share the required information to minimize issues related to 
multiple record formats.
    (Comment 130) One comment asserts that the proposed rule runs afoul 
of the requirement in section 204(d)(1)(G) of FSMA that this regulation 
``to the extent practicable, not require a facility to change business 
systems to comply. . . .'' The comment contends that the proposed rule 
would force seafood businesses to revise their current systems for 
shipping and receiving documents to capture, maintain, and manage the 
required information. The comment asserts that some companies will have 
no choice but to incorporate tandem codes (the new traceability lot 
code and the conventional inventory code) even though these codes 
capture almost exactly the same information.
    (Response 130) We disagree with the comment. As stated in Response 
460, although the rule requires maintenance of certain KDEs for 
particular CTEs, it provides flexibility as to the form of the records 
in which the required information is kept. Because not all firms 
currently keep all of the information required under the final rule, we 
anticipate that firms may make changes to their traceability operations 
to come into compliance with the subpart S requirements. However, the 
rule does not mandate a change in business systems, and in many cases 
we think that relatively small changes to existing business systems 
will be sufficient to allow firms, including those that handle seafood 
products on the FTL, to comply with subpart S. With respect to the 
claim that firms will need to establish ``tandem'' lot codes because 
the conventional inventory code and the traceability lot code might 
reflect different information, we note that the traceability lot code 
itself does not have to incorporate all required KDE information, such 
as in bar code form. Instead, the final rule requires firms to keep 
records that link the traceability lot code for an FTL food to the 
other KDEs required for the relevant CTE (e.g., initial packing, 
transforming). Therefore, firms should not have to change their current 
lot codes or create separate traceability lot codes solely because a 
traceability lot code must be linked to other KDEs for an event. Any 
type of lot code that an industry or firm currently utilizes can be 
used as the ``traceability lot code'' as long as it is passed through 
the supply chain and is only changed in the circumstances specified in 
the rule.
    (Comment 131) Some comments contend that the proposed rule violates 
the prohibition in section 204(d)(1)(L)(i) of FSMA that the rule must 
not require ``a full pedigree, or a record of the complete previous 
distribution history of the food from the point of origin of such food. 
. . .'' One comment asks that the final rule delete all recordkeeping 
requirements that the comment asserts would require a full pedigree or 
distribution history of the food, including proposed Sec. Sec.  
1.1335(f) and 1.1350(a)(4), which concern requirements to maintain 
records identifying the traceability lot code generator when receiving 
and shipping an FTL food.
    (Response 131) We do not agree that the rule requires entities to 
document a full pedigree for FTL foods they handle. Neither the 
proposed rule nor this final rule would require a full pedigree or a 
record of the complete previous distribution history of the food from 
the point of origin of such food. Although the final rule includes 
requirements for certain KDEs to be passed through the supply chain, 
including the location description of the traceability lot code source 
or a traceability lot code source reference, this does not constitute a 
requirement to maintain or provide a full pedigree of the food or a 
record of its complete previous distribution history from the point of 
origin.
10. Focus and Purpose of the Regulation
    (Comment 132) Comments express different views on what should be 
the focus of the rule. One comment asserts that FDA should focus on 
outbreak prevention rather than response. One comment maintains that 
the rule should focus on helping FDA conduct supply chain tracebacks to 
a specific business in a timely manner, instead of issuing overly broad 
outbreak statements. Some comments assert that many of the proposed 
requirements are intended to help FDA conduct root-cause investigations 
of outbreaks rather than facilitate effective traceback. On the other 
hand, some comments express support for the use of data generated from 
tracing to advance understanding of root causes of foodborne illness 
outbreaks.
    (Response 132) Congress stated that the goal of this rulemaking is 
to rapidly and effectively identify recipients of a food to prevent or 
mitigate a foodborne

[[Page 70949]]

illness outbreak and to address credible threats of serious adverse 
health consequences or death. The final rule is therefore designed to 
help FDA respond more quickly and effectively once an outbreak or 
contamination event is identified, rather than to prevent contamination 
(which is the focus of several other FSMA regulations, including the 
produce safety regulation and regulations on preventive controls for 
human and animal foods). As stated in the preamble to the proposed 
rule, the purpose of the subpart S requirements is to reduce the harm 
to public health caused by foodborne illness outbreaks by enabling 
faster traceback and traceforward operations to identify the source of 
outbreaks and more quickly remove contaminated foods from the 
marketplace. In addition, the rule will benefit industry by helping to 
narrow the scope of necessary recall actions. In the preamble to the 
proposed rule, we also noted that being able to more quickly identify 
the source of a contaminated product can help us conduct more timely 
root-cause analysis, which could produce information that aids our 
understanding of how contamination may have occurred and help prevent 
future outbreaks. Thus, although facilitating root-cause analysis is 
not the principal focus of the rule, we can improve the safety of the 
food supply by using information needed to conduct efficient traceback 
operations to understand and address the causes of foodborne illness.
    (Comment 133) One comment maintains that the rule should focus on 
what is essential for tracing food products rather than on supply chain 
transparency, which the comment states is a business benefit and is not 
necessary for food safety.
    (Response 133) We disagree with the comment to the extent that it 
implies that the rule is focused on supply chain transparency rather 
than traceability. The rule is designed to enable faster and more 
efficient traceback and traceforward of FTL foods in response to 
foodborne illness outbreaks. While the rule requires disclosure of 
traceability information, it does so in the interest of promoting 
better traceability, not to increase supply chain transparency. As 
discussed later in this document, the final rule includes changes to 
the proposed requirements that will enable firms to protect the 
confidentiality of certain information.
    (Comment 134) Some comments suggest that the proposed rule is 
improperly focused on establishing chain of custody for enforcement 
purposes at the expense of rapid identification of the source of 
outbreaks.
    (Response 134) We disagree. As previously stated, as directed by 
Congress, the rule is intended to help us more quickly and efficiently 
identify the source of a contaminated FTL food in an investigation into 
a foodborne illness outbreak, which will reduce harm to consumers and 
economic loss to industry. Requirements such as those concerning 
documentation of the immediate previous source or the immediate 
subsequent recipient of a food are designed to help us more rapidly 
identify the source of an outbreak and remove all contaminated food 
from the marketplace, not to help us prepare an enforcement action. 
Although it is possible that information maintained in accordance with 
this rule and reviewed by FDA in an outbreak investigation (or to 
address credible threats of serious adverse health consequences or 
death resulting from foods being adulterated or misbranded) might be 
relevant in a subsequent enforcement action regarding the production or 
distribution of contaminated food, the subpart S requirements were not 
designed to establish chain of custody as an enforcement tool.
    (Comment 135) One comment expresses concern that it is still taking 
too long to identify outbreaks and collect and analyze the 
epidemiological information needed to begin the traceback process, 
though the comment maintains that this is because of factors outside 
FDA's control. One comment states that its understanding is that, while 
it is not specifically addressed in the proposed rule, FDA will use 
traceback results to verify or challenge the assumptions of the 
epidemiological investigation.
    (Response 135) As with all of our investigations into foodborne 
illness outbreaks, we will continue to work closely with the CDC to 
identify the source of outbreaks involving foods and prevent additional 
illnesses.
    (Comment 136) One comment suggests that we consider an approach 
that focuses on foods for which the maintenance of detailed 
traceability records would provide a public health benefit.
    (Response 136) As directed by Congress, we have developed 
traceability recordkeeping requirements for foods that, in accordance 
with the risk factors specified in section 204(d)(2)(A) of FSMA, we 
have designated for inclusion on the FTL. The FTL consists of foods for 
which we have concluded that additional traceability recordkeeping 
requirements are needed to better protect the public health.
    (Comment 137) Some comments ask that we state which specific 
aspects of the outbreak investigation process will be improved by the 
rule and those not affected.
    (Response 137) In the preamble to the proposed rule, we discussed 
several aspects of our investigations into foodborne illness outbreaks 
that we believe will be aided by having access to the additional 
traceability information required under the proposed rule, such as 
speeding up an investigation by obtaining more accurate and detailed 
information on a food at an RFE, improving our ability to solve 
outbreaks linked to multi-ingredient foods (by making it less 
burdensome to obtain records for multiple commodities), more quickly 
determining the breadth and number of potentially contaminated products 
(possibly narrowing the scope of recall), and being able to more 
quickly notify the public of potentially contaminated food in the 
marketplace. We believe that this rule will improve many of the 
significant steps of a traceback investigation.
    (Comment 138) Some comments assert that the rule should focus more 
on RFEs than other entities in the supply chain. One comment maintains 
that restaurants, caterers, salad bars and delis within a retail 
operation, and wholesalers are the sectors of the food industry that 
have been the least likely to keep the product-level documentation 
necessary for assisting in a quick response to food safety events. One 
comment asserts that barriers to efficient traceback investigations are 
most often due to deficiencies at the retailer and food service level, 
but expresses concern that FDA's proposed solution is overly broad in 
its proposed remedies. One comment expresses support for FDA being able 
to ``skip steps'' (points in a supply chain that do not transform or 
create products, such as distributors) during an outbreak 
investigation, but states that this would only be possible if the point 
of sale or service can provide FDA with the lot number as assigned by 
the originator, transformer, or creator of the food, along with the 
item description and contact information for the entity responsible for 
that lot number. The comment maintains that the economic burden 
associated with the rule can be lessened, without compromising FDA's 
ability to conduct a traceback, by focusing additional recordkeeping 
requirements at the RFE and points of transformation, and not at supply 
chain entities who do not transform or sell/serve product directly to 
consumers.

[[Page 70950]]

    (Response 138) We do not agree with the comments with respect to 
limiting additional recordkeeping requirements only at RFEs and points 
of transformation. Although the FTL recordkeeping requirements apply to 
RFEs (except those exempt from the rule, e.g., due to their smaller 
size), they are not the only supply chain entities from which FDA needs 
to obtain information during a foodborne illness outbreak 
investigation. As the comments assert, and as we discussed in the 
preamble to the proposed rule, having RFEs keep the traceability 
information required under subpart S will greatly benefit our ability 
to conduct effective traceback operations and identify the source of 
contaminated food. Nevertheless, for the FTL recordkeeping requirements 
to provide the enhanced traceability they are designed to achieve, they 
need to encompass farms, manufacturers, distributors, and other 
entities in the supply chains for FTL foods.
11. Use of Other Information Available to FDA
    (Comment 139) Several comments suggest that in developing and 
implementing these traceability recordkeeping requirements, FDA should 
rely on information that is in existing Agency databases. One comment 
suggests that the databases maintained to support the food facility 
registration, prior notice, and import entry processes have some of the 
same information the proposed rule would require, and asks that the 
Agency explore how to use this information rather than requiring the 
supply chain to report duplicate information. Similarly, one comment 
requests that we assess whether information in the registration 
database and traceability records that are already maintained could be 
leveraged to assist with outbreak investigations to limit the KDEs 
required under the rule. This comment suggests that we assess whether a 
subset of the information provided by a facility every 2 years when it 
registers, including facility address and emergency contact 
information, could satisfy any of the proposed KDE requirements, 
including the requirement for receivers and shippers to maintain and 
send information on the lot code generator. Noting that registered 
facilities must provide a Data Universal Numbering System (DUNS) number 
when they register, the comment asks that we determine if the DUNS 
number provides access to any required tracing information.
    (Response 139) We acknowledge that some of the information required 
under subpart S might also be submitted to FDA to comply with other 
regulatory requirements, such as those concerning food facility 
registration, prior notice, and import entry. However, at present the 
databases containing this information have considerable unvalidated 
information and multiple entries for the same location. Given that 
accurate and up-to-date information about specific transactions is 
critical during a traceback investigation, it is difficult to rely on 
these data sources for contact information and for conducting traceback 
operations when investigating foodborne illness outbreaks. However, as 
previously stated, the final rule allows firms to use existing records 
(whether created in the normal course of business, to meet other 
regulatory requirements, or for any other purpose) to meet their 
subpart S requirements as long as the records contain the required 
information--in other words, firms will not have to create duplicate 
records. It is likely that many firms will be able to rely on some of 
the information they submit to FDA for other regulatory purposes to 
also meet their recordkeeping requirements under subpart S, which 
should lessen the recordkeeping burden posed by the new requirements.
    (Comment 140) One comment asks that FDA consider how to collaborate 
with other government agencies such as the NOAA National Marine 
Fisheries Service, which has databases containing domestic vessel 
identification and fishing permit information as well as federally 
collected harvest information reported by the Seafood Dealer Receiver.
    (Response 140) Although FDA coordinates with other Federal 
agencies, including NOAA, where appropriate, section 204(d) of FSMA 
directs us to establish recordkeeping requirements for foods on the 
FTL, which include certain seafood products (e.g., finfish, 
crustaceans). Therefore, persons who manufacture, process, pack, or 
hold seafood that is on the FTL are subject to certain recordkeeping 
requirements (except that, as discussed later in this document, raw 
bivalve molluscan shellfish is exempt from the rule, and a partial 
exemption applies for food obtained from a fishing vessel). 
Nevertheless, under the final rule, firms may use records they maintain 
to meet requirements under NOAA or other regulations to meet their 
subpart S requirements (i.e., they will not have to maintain duplicate 
records). Note also that, as discussed in Response 266, the final rule 
does not include the proposed requirement to keep a record of the 
vessel identification number or license number for a fishing vessel 
used to produce an FTL food.
    (Comment 141) One comment encourages FDA to gather additional sales 
and inventory data not included within the scope of this rule to help 
focus the date range of requested records. The comment states that, in 
the proposed rule, FDA encourages RFEs to share data that can help 
identify consumer purchases, and the comment asserts that industry-led 
leafy green traceability pilot programs have demonstrated that varying 
kinds of data exist that can help narrow the scope of a records 
request.
    (Response 141) We will use any information available to us to help 
us narrow the time period for traceability records for possibly 
contaminated FTL foods we might request to see in an outbreak 
investigation. As stated in the preamble to the proposed rule, if an 
RFE has consumer purchase data or other potentially relevant data not 
required under subpart S that they are willing to share with us, we 
will try to use such data to help us narrow the scope of our 
traceability records request.
12. Consumer Concerns
    (Comment 142) One comment expresses concern about how the rule 
might affect consumers' ability to identify foods (such as during an 
outbreak). The comment asks how a consumer could identify what item was 
involved once a food was purchased from a store. The comment states 
that some of items posing the greatest concern are items bought from a 
bin of items or from a shelf with bulk produce where lots can be 
combined, which the comment maintains would necessitate guesswork on 
behalf of the consumer.
    (Response 142) The final rule does not establish any requirements 
for consumers, nor does it require RFEs to keep records regarding sales 
they make to consumers. However, if consumers believe they have 
purchased food that caused illness, we encourage them to contact their 
local or State health department or FDA and provide whatever 
information they have regarding the food and illness experienced so 
that government officials can investigate the potential contamination. 
In the event of a recall, the information disseminated to consumers is 
generally tailored to assist them in identifying the items that have 
been recalled (e.g., by stating the places where the food was sold, the 
brand names it was sold under, pictures of the recalled product, and 
any lot information that appeared on the consumer packaging).

[[Page 70951]]

13. Relationship to Subpart J Requirements
    (Comment 143) One comment suggests that we consider ways to combine 
the traceability recordkeeping requirements in subpart J with the 
proposed subpart S requirements to enhance traceability. The comment 
notes that although FDA has the authority under the Bioterrorism Act to 
impose recordkeeping requirements on distributors, importers, and 
transporters (among other entities), these entities are not required to 
maintain lot code information under subpart J.
    (Response 143) As specified in section 204(d) of FSMA, the subpart 
S requirements apply only to persons that manufacture, process, pack, 
or hold foods the Agency has designated for inclusion on the FTL. Such 
persons include food distributors (because they hold food) and some 
importers (if they take physical possession of the food they import). 
As stated in the preamble to the proposed rule, we have exempted 
transporters from subpart S because in our outbreak investigations we 
generally are able to obtain the traceability information we need from 
others in the supply chain, and if necessary we can review records that 
transporters must keep in accordance with subpart J. As stated in the 
preamble to the proposed rule, we encourage all entities in the supply 
chain to maintain lot code information for all foods they handle to 
improve traceability.
14. Effect on Different Supply Chain Entities
    (Comment 144) One comment asks that we consider structuring the 
rule by including provisions specific to different sectors of the 
industry and that we use terminology consistent with that used in the 
different industry sectors. The comment maintains that the words 
``originate, transform, or create'' are unnecessarily confusing for the 
produce growing industry.
    (Response 144) We decline to establish different recordkeeping 
requirements with different terminology for each of the many different 
sectors of the food industry. Instead, for most CTEs, the final rule 
specifies one set of KDEs that are appropriate and relevant for all 
industry sectors. The KDEs required in the final rule for each CTE are 
KDEs which will facilitate tracing of food, regardless of the type of 
food or sector of the industry. One exception is for certain provisions 
concerning seafood obtained from a fishing vessel, because of the 
difference between growing or manufacturing foods on land and 
harvesting food from bodies of water. Another exception is for sprouts, 
which have unique food safety concerns related to the use of seeds for 
sprouting.
    As stated in Response 104, we have made several changes to simplify 
and streamline the proposed requirements. These changes include 
deleting the terms ``originating'' and ``originator,'' and deleting the 
``creation'' CTE and merging the proposed requirements for creation 
with the requirements for transformation.
    (Comment 145) Some comments express concern about the effect of the 
rule on particular food industry components. For example, one comment 
maintains that the rule might have a disproportionate impact on 
traditional cheese production, distribution, and sale, and increase the 
cost of artisanal products.
    (Response 145) We have put in place a set of requirements that is 
flexible so that entities of any size are able to comply with the final 
rule to more efficiently and effectively trace potentially contaminated 
food through the supply chain to protect public health. However, we 
understand that small operations may be particularly burdened by the 
provisions of the rule. Therefore, the final rule provides exemptions 
from some or all of the provisions of subpart S for certain smaller 
operations and in certain short supply chain situations, as discussed 
in sections V.E.2 and V.E.3, respectively, of this document.
    (Comment 146) One comment expresses concern about the effect of the 
rule on foodservice distributors. The comment maintains that 
foodservice distributors' ability to comply with the rule will be 
highly dependent on whether upstream suppliers provide the records 
necessary to facilitate compliance. The comment says that distributors' 
customers often choose the suppliers from which the distributors must 
source their products, leaving the distributors with limited leverage 
to require that suppliers provide the required records. The comment 
adds that distributors often must use multiple suppliers for the same 
product, which requires the use of different procurement methods that 
can impact the records distributors would have to keep for each product 
and how they would need to be transmitted. The comment maintains that 
accounting for the regulated status of each product would thus require 
a case-by-case analysis of both the products being received and the 
characteristics of individual suppliers, including an assessment of 
whether specific products or suppliers are wholly or partially exempt 
from the rule. The comment further states that these assessments likely 
would also vary depending on the sourcing of the product, which can 
change on a regular basis due to activities by distributors or 
suppliers.
    (Response 146) The final rule requires a firm that ships an FTL 
food to provide certain KDEs to the next entity in the supply chain. 
Regardless of how many different firms might supply a foodservice 
distributor with the same FTL food, all of these suppliers will need to 
provide the same set of KDEs to the distributor. We understand that if 
an entity is receiving a food from an exempt firm, the shipment might 
not be accompanied by the records required under subpart S. Therefore, 
we have modified the requirements in the final rule for the receiver of 
a food from an exempt firm so that receivers can still comply with 
their obligations under the rule. The final rule requires firms, as 
part of their traceability plans, to be able to identify the FTL foods 
they handle; this will help ensure that firms keep and provide (to 
their supply chain partners) the required KDEs in accordance with the 
rule. If suppliers comply with their subpart S requirements, 
foodservice distributors will have the information they need to meet 
their requirements as receivers and subsequent shippers of the foods.
    (Comment 147) One comment asks FDA to ensure that the final rule 
can easily integrate with a farm's existing food safety protocols.
    (Response 147) The subpart S requirements applicable to farms, 
primarily the requirement to maintain a traceability plan (including a 
farm map) as stated in Sec.  1.1315, can be incorporated into a farm's 
existing food safety operations, including any existing tracing 
protocols the farm may have in place. Similarly, for farms that are 
engaged in harvesting, cooling, and initial packing activities as 
defined in the final rule, the applicable subpart S requirements will 
not conflict with the protocols the farms are following to comply with 
the produce safety regulation or other food safety regulations.
15. Requests To Exempt Certain Foods or Align the Subpart S 
Requirements With Existing Regulations
    (Comment 148) Several comments ask that we align the rule's 
requirements for seafood with the requirements in the Seafood Import 
Monitoring Program (SIMP) and other programs to avoid duplication and 
allow companies to use the information they maintain under those 
programs to meet their requirements under the traceability rule. One 
comment asks that we examine

[[Page 70952]]

areas within the proposed requirements that overlap with existing data 
collection efforts (e.g., SIMP and FDA's seafood hazard analysis 
critical control point (HACCP) regulation (part 123)). The comment 
asserts that, where possible, data collection across these programs 
(and between government agencies) should be streamlined and made 
interoperable to reduce the reporting burden and remove unnecessary 
duplication. One comment asks that we align the KDEs and CTEs with 
SIMP, including the traceability lot code, International Fisheries 
Trade Permit, International Maritime Organization (IMO) number, and 
species identity. One comment asserts that where the KDEs required 
under this rule overlap with information collected under other 
requirements (such as SIMP and the NOAA 370 Form), alignment would 
improve efficiency and cost-effectiveness of compliance. One comment 
asserts that because robust traceability requirements exist for many 
species, exemptions from or alignment of the rule to other food or 
seafood traceability regulations will be necessary to minimize 
duplication of recordkeeping requirements. Some comments suggest that 
we align the requirements in the rule applicable to seafood with the 
Global Dialogue on Seafood Traceability (GDST); another comment asserts 
that the emphasis on event-based traceability in the proposed rule is 
similar to the approach taken in the GDST. One comment maintains that 
seafood exporters should be permitted to use existing documentation and 
the systems already in place to meet the traceability requirements. One 
comment states that commercial trip tickets, broken out by species, 
follow the product from the vessel to the dealer and should adequately 
cover traceability requirements for that portion of the supply chain as 
well as at the processor level.
    (Response 148) We agree with the comments that persons who 
manufacture, process, pack, or hold seafood that is on the FTL should 
be allowed to use information they maintain for other regulatory 
purposes to meet applicable requirements under subpart S. Under Sec.  
1.1455(f), firms may use existing records if they contain information 
required to be kept under subpart S, so those in the seafood industry 
will not need to duplicate these records to comply with the final rule. 
With respect to requirements under SIMP, we agree there is some 
alignment with the traceability recordkeeping requirements under 
subpart S, which should result in entities in the seafood industry 
having to create fewer records to comply with subpart S than would 
otherwise be required.
    (Comment 149) One comment suggests that the KDEs that are recorded 
for imported seafood should also be reported to regulators. The comment 
maintains that the architecture for a database for importers to report 
the KDEs required by the rule is already in place as a result of SIMP 
through the International Trade Data System (ITDS) and the Automated 
Commercial Environment portal.
    (Response 149) We do not agree with the comment. The final rule 
requires persons who manufacture, process, pack, or hold FTL foods to 
maintain KDEs related to particular tracking events for review by FDA 
upon request. As discussed in Response 466, FDA investigators may 
request the records required under subpart S under a range of 
circumstances, including during routine inspections and in the event of 
an outbreak investigation, recall, or other threat to public health. We 
do not believe it is necessary to also require firms to routinely 
report the required KDEs for any FTL foods, whether of foreign or 
domestic origin.
    (Comment 150) One comment asks how the rule relates to certificate 
of catch requirements for wild-caught seafood.
    (Response 150) The final rule establishes recordkeeping 
requirements to effectively and efficiently trace food products 
throughout the supply chain. To the extent catch certificates contain 
information required by this subpart, those existing records can be 
used to comply with the final rule.
    (Comment 151) One comment maintains that for farms that are 
certified organic, the organic production records coupled with the name 
of the farm should provide enough traceability for responding to 
outbreaks because these farms are already required to track which field 
a product was harvested from, the date it was harvested, and other 
information.
    (Response 151) We disagree. The USDA National Organic Program does 
not require all the KDEs required under the final rule to effectively 
and efficiently trace food through the supply chain. However, any 
existing records that an organic farm may keep under the National 
Organic Program (or other certification program) that contain 
information required by subpart S, such as the field where product was 
harvested or the date of harvest, can be used for compliance with the 
final rule. Duplicate records would not need to be kept, which would 
reduce the burden on these farms.
16. Requests for Issuance of a Supplemental Proposed Rule
    (Comment 152) Several comments ask that we issue a revised or 
supplemental proposed rule to give the public an opportunity to 
consider changes to the proposed requirements, which the comments 
expect to be significant. One comment notes that FDA issued revised 
proposed rules in more than one major FSMA rulemaking. Some comments 
assert that, because fundamental changes to the proposed rule's basic 
framework might be needed, providing notice and comment for a revised 
proposal is necessary under the Administrative Procedure Act (APA) to 
avoid concerns that the final rule might not be a ``logical outgrowth'' 
of the proposed rule. One comment asserts that, due to numerous ``legal 
issues'' with the proposed rule and purported flaws with the proposed 
rule's economic impact assessment, FDA must issue a revised proposed 
rule that meets the requirements of the FD&C Act, the Regulatory 
Flexibility Act, and the APA. One comment maintains that compliance 
with the consent decree in U.S. District Court applicable to the 
rulemaking cannot be at the expense of other applicable legal 
requirements, including the APA and section 204 of FSMA.
    (Response 152) We do not agree that it is necessary to issue a 
revised or supplemental proposed rule before issuing a final rule. The 
APA does not require the issuance of a revised or supplemental rule 
with respect to this rulemaking, and although FDA did take such action 
in some other FSMA rulemakings, it is not the Agency's common practice 
to issue revised or supplemental proposed rules. As previously 
discussed, the final rule contains several changes to the proposed rule 
in response to comments we received. However, we have not substantially 
altered the basic framework and approach set forth in the proposed 
rule, and we believe the changes we have made to the proposed 
requirements are logical outgrowths of the proposed rule. Throughout 
this document we will explain the changes, including how they relate to 
what was proposed.

D. Scope (Sec.  1.1300)

    We proposed to specify (in Sec.  1.1300) that, except as specified 
otherwise in subpart S, the requirements would apply to persons who 
manufacture, process, pack, or hold foods that appear on the list of 
foods for which additional

[[Page 70953]]

traceability records are required in accordance with section 204(d)(2) 
of FSMA, i.e., the FTL. Proposed Sec.  1.1300 also stated that we will 
publish the FTL on our website in accordance with section 204(d)(2)(B) 
of FSMA.
    On our own initiative, we have added our website, ``www.fda.gov,'' 
to proposed Sec.  1.1300, as we do not expect the website to change. We 
are finalizing the remainder of Sec.  1.1300 as proposed. We respond to 
the comments on proposed Sec.  1.1300 in the following paragraphs.
    (Comment 153) One comment recommends that FDA replace the term 
``person'' with the term ``business entity.''
    (Response 153) We decline to make this change. The final rule 
defines ``person'' as it is defined in section 201(e) of the FD&C Act 
(21 U.S.C. 321(e)) as well as in subpart J, i.e., as including an 
individual, partnership, corporation, and association. We believe this 
appropriately specifies the entities who are covered under the final 
rule.
    (Comment 154) A few comments recommend that FDA replace the term 
``person'' with the term ``facility'' as defined in section 415(c)(1) 
of the FD&C Act (21 U.S.C. 350d(c)(1)). The comments assert that 
because Congress directed FDA (in section 204(d)(1) of FSMA) to 
establish additional recordkeeping requirements for ``facilities'' that 
manufacture, process, pack, or hold certain foods, the rule should 
apply only to facilities as that term is defined in section 415(c)(1) 
of the FD&C Act. Several comments maintain that farms, ``farm mixed-
type facilities,'' restaurants, and other RFEs should not be subject to 
the rule, asserting that they are not facilities, they are not 
mentioned in section 204(d), and they have been excluded from the term 
``facility'' in section 415(c)(1) of the FD&C Act. Some comments 
maintain that applying the rule only to facilities would be consistent 
with other FSMA regulations. Several comments assert that entities that 
are not subject to FDA's food facility registration requirements in 
part 1, subpart H, such as farms and grocery stores, should be exempt 
from the final rule.
    (Response 154) As we stated in the preamble to the proposed rule, 
although section 204(d)(1) of FSMA refers to ``facilities'' that 
manufacture, process, pack, or hold food, Congress clearly intended 
that these traceability recordkeeping requirements would apply to some 
entities that are not required to register with FDA as ``facilities'' 
under section 415 of the FD&C Act, such as grocery stores (see 85 FR 
59984 at 59995; see also Response 156 regarding application of the rule 
to farms). Because Congress did not intend that the traceability 
requirements would apply only to facilities required to register with 
FDA, it is not necessary to limit the scope of the rule to 
``facilities'' as that term is defined in section 415(c)(1) of the FD&C 
Act. The fact that certain other FSMA regulations and the registration 
requirements in subpart H apply only to facilities is not relevant, as 
those regulations were promulgated under different legal authorities 
than subpart S and were established to address concerns different from 
enhancing food traceability. As discussed elsewhere in this document, 
each point in the supply chain is important for effective traceability, 
and farms, restaurants, and RFEs are all important sources of 
traceability information. Therefore, under Sec.  1.1300 of the final 
rule, the subpart S requirements apply not just to ``facilities'' that 
manufacture, process, pack, or hold FTL foods, but to all ``persons'' 
who do so. This includes, except where an exemption applies, farms, 
restaurants, RFEs, and other persons engaged in the manufacture, 
processing, packing, or holding of FTL foods.
    (Comment 155) One comment asks that we define the role of persons 
who own food but do not manufacture, process, pack, or hold the food.
    (Response 155) The final rule covers persons who manufacture, 
process, pack or hold an FTL food. Therefore, as discussed in the 
preamble to the proposed rule (see 85 FR 59984 at 60000), persons who 
own an FTL food but do not manufacture, process, pack, or hold the food 
are not subject to the rule. As described in Response 465, persons 
subject to the rule may enter into agreements with other persons to 
maintain required records on their behalf.
    (Comment 156) One comment asserts that FDA does not have authority 
to regulate farms in general and suggests that we work with farms and 
farm groups to build electronic recordkeeping capacity on a voluntary 
basis.
    (Response 156) We disagree with the comment. By referencing farms 
in several instances in section 204(d) of FSMA, Congress clearly 
contemplated that the additional traceability recordkeeping 
requirements it directed FDA to establish would apply to farms. For 
example, section 204(h) states that FDA shall issue an SECG setting 
forth in plain language the requirements of subpart S ``in order to 
assist small entities, including farms and small businesses, in 
complying with the recordkeeping requirements.''
    Farms are subject to the requirements in the final rule if they 
manufacture, process, pack, or hold foods on the FTL. The final rule 
provides exemptions (in Sec.  1.1305) from the subpart S requirements 
for certain small producers, including certain produce farms and egg 
farms. For farms that are not exempted, the specific requirements 
applicable to them under the final rule would depend on the activities 
of the farm. All entities that are covered by the rule must maintain a 
traceability plan, and under Sec.  1.1315(a)(5), for farms that grow or 
raise an FTL food (with the exception of egg farms), that traceability 
plan will be required to include a farm map showing the areas in which 
they grow or raise FTL foods. Farms that harvest or cool covered foods 
prior to initial packing will be required to keep and provide a 
streamlined set of KDEs that is set forth in Sec.  1.1325, but they 
will not be required to adhere to the shipping and receiving KDE 
requirements for any movement of the food that happens before it is 
initially packed. Farms that perform initial packing of covered foods 
will be subject to the requirements in Sec.  1.1330, and will also be 
required to keep and provide shipping KDEs relating to the shipment of 
food that happens after the food is initially packed. As discussed in 
Section V.U.5 of this document, we intend to work with farms and farm 
groups to help them understand and come into compliance with the 
subpart S requirements that apply to them.

E. Exemptions (Sec.  1.1305)

    We proposed to establish several exemptions and partial exemptions 
to the FTL traceability recordkeeping requirements for certain types of 
foods and certain types of persons who manufacture, process, pack, or 
hold FTL foods. In response to comments, we have made several changes 
to the exemptions and added certain exemptions.
1. General
    (Comment 157) Some comments note that section 204(d)(6)(E) of FSMA 
allows FDA, by notice in the Federal Register, to identify food 
commodities for which application of the product traceability 
requirements is not necessary to protect the public health. The 
comments suggest that rather than using the proposed waiver, exemption, 
or modified requirements provisions, we should exempt products through 
the rulemaking process to clearly identify the exempted commodities and 
ensure that all steps in the food chain have an equal understanding of 
what products

[[Page 70954]]

are and are not required to comply throughout the supply chain.
    (Response 157) In response to comments, we have provided additional 
exemptions in Sec.  1.1305 of the final rule, such as an exemption for 
certain raw bivalve molluscan shellfish (see Section V.E.7 of this 
document) and an exemption for persons who handle FTL foods during or 
after the time when the food is within the exclusive jurisdiction of 
the USDA (see Section V.E.8 of this document). We have also provided 
additional clarifications and descriptions for the commodities on the 
FTL. For some commodities we have added examples of foods that are and 
are not considered part of that commodity designation on the FTL. We 
believe these clarifications and examples will help stakeholders better 
understand the foods under each commodity that are covered by the rule.
    In keeping with section 204(d)(6)(E) of FSMA, the final rule 
includes provisions under which persons may request an exemption from 
(or modification of) the subpart S requirements (see Sec. Sec.  1.1360 
through 1.1400). The final rule also includes provisions under which 
persons may request a waiver of subpart S requirements (see Sec. Sec.  
1.1405 through 1.1450), in accordance with section 204(d)(1)(I) of 
FSMA. Under these provisions, citizen petitions requesting modified 
requirements or exemptions would be made public, as would citizen 
petitions requesting waivers for types of entities. Stakeholders will 
have an opportunity to submit comments on such citizen petitions. 
Similarly, these final rule provisions state that should FDA decide on 
its own initiative to consider adopting modified requirements, granting 
an exemption, or waiving subpart S requirements, we will publish a 
notice in the Federal Register and provide an opportunity for 
stakeholders to submit comments. In any of these circumstances, after 
consideration of any timely submitted comments, we will publish a 
notice in the Federal Register setting forth any modified requirements 
or exemptions that we ultimately decide to grant for certain foods or 
types of entities, or any requirements we ultimately decide to waive 
for certain types of entities, so that all stakeholders will be aware 
of any changes to covered foods or types of covered entities. 
Therefore, we do not believe it is necessary to address requests for 
waivers or exemptions through notice-and-comment rulemaking.
    (Comment 158) Some comments assert that small businesses should be 
exempt from the subpart S requirements, maintaining that they would not 
be able to comply, including because they lack electronic capabilities, 
and would be forced to shut down. The comments maintain that the 
industry is already overburdened, and the proposed requirements are 
unrealistic and would cause extreme hardship. Some comments state that 
FDA should use thresholds for exemption from other FSMA rules or those 
set by the Small Business Administration (SBA). Some comments request 
that we provide additional flexibilities in the final rule for small 
businesses. The comments claim that small and medium-sized companies do 
not have the resources available to comply with the rule compared to 
large businesses.
    (Response 158) We agree with the importance of reducing the burden 
of the final rule, where possible and appropriate, on businesses that 
may have fewer resources to apply to complying with the requirements of 
the regulation, while minimizing the additional health risk caused by 
exposure to products that would otherwise be covered by the regulation. 
The final rule provides a full exemption for certain small produce 
farms (Sec.  1.1305(a)(1)), specifically farms that are exempt under 
Sec.  112.4(a) (21 CFR 112.4) in the produce safety regulation, and 
produce farms with an average annual sum of the monetary value of their 
sales of produce and the market value of produce they manufacture, 
process, pack, or hold without sale (e.g., held for a fee) during the 
previous 3-year period of no more than $25,000 (on a rolling basis), 
adjusted for inflation using 2020 as the baseline year for calculating 
the adjustment. The final rule also fully exempts 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 (see Sec.  1.1305(a)(2)). 
Another full exemption is provided for certain producers of RACs other 
than produce or shell eggs (e.g., aquaculture operations) when the 
average annual sum of the monetary value of their sales of RACs and the 
market value of the RACs they manufacture, process, pack, or hold 
without sale (e.g., held for a fee) during the previous 3-year period 
is no more than $25,000 (on a rolling basis), adjusted for inflation 
using 2020 as the baseline year for calculating the adjustment (see 
Sec.  1.1305(a)(3)). In addition to these full exemptions for certain 
small producers, the final rule also exempts farms whose average annual 
sum of the monetary value of their sales of RACs and the market value 
of RACs they manufacture, process, pack, or hold without sale (e.g., 
held for a fee) during the previous 3-year period is no more than 
$250,000 (on a rolling basis), adjusted for inflation using 2020 as the 
baseline year, from the requirement to provide an electronic sortable 
spreadsheet containing traceability information FDA may request in 
certain circumstances (Sec.  1.1455(c)(3)(iii)(A)).
    As discussed below, the final rule also includes other exemptions 
that would exclude certain foods that farms produce from the coverage 
of the rule, including, but not limited to, exemptions or partial 
exemptions for the following: food sold directly to consumers (Sec.  
1.1305(b)); food in farm to institution programs (Sec.  1.1305(l)); 
certain foods produced and packaged on a farm (Sec.  1.1305(c)); foods 
that receive certain types of processing (Sec.  1.1305(d)); produce 
that is rarely consumed raw (Sec.  1.1305(e)); certain raw bivalve 
molluscan shellfish (Sec.  1.1305(f)); and certain commingled RACs 
(Sec.  1.1305(h)). The final rule imposes less burdensome requirements 
on farms than under the proposed rule, including reduced requirements 
for documentation of growing foods and elimination of proposed 
requirements for farms to keep and send shipping KDEs for foods that 
have not yet been initially packed. Furthermore, we will provide 
education, training, and technical assistance to farmers to help them 
understand and come into compliance with the new traceability 
recordkeeping requirements.
    The final rule fully exempts small RFEs and restaurants with an 
average annual monetary value of food sold or provided during the 
previous 3-year period of no more than $250,000 (on a rolling basis), 
adjusted for inflation using 2020 as the baseline year for calculating 
the adjustment (Sec.  1.1305(i)), and also exempts RFEs and restaurants 
with an average annual monetary value of food sold or provided during 
the previous 3-year period of no more than $1 million (on a rolling 
basis), adjusted for inflation using 2020 as the baseline year for 
calculating the adjustment, from the sortable spreadsheet requirement 
(Sec.  1.1455(c)(3)(iii)(B)). The final rule also includes a partial 
exemption for RFEs and restaurants for food that is purchased directly 
from a farm (Sec.  1.1305(j)).
    The final rule does not fully exempt from the subpart S 
requirements any businesses in the middle of the supply chain, such as 
packers, manufacturers, and distributors. We believe that exempting 
such firms could result not only in the unavailability of traceability

[[Page 70955]]

information at those specific firms, but also in a failure to pass 
along critical traceability information (such as information relating 
to the traceability lot code), which would affect subsequent supply 
chain members and would therefore have a broad impact on the 
effectiveness of the rule. However, as discussed in Section V.R.3 of 
this document, the final rule exempts businesses in the middle of the 
supply chain (i.e., that are neither farms nor restaurants/RFEs) whose 
average annual sum of the monetary value of their sales of food and the 
market value of food they manufacture, process, pack, or hold without 
sale (e.g., held for a fee) during the previous 3-year period is no 
more than $1 million (on a rolling basis), adjusted for inflation using 
2020 as the baseline year, from the sortable spreadsheet requirement 
(Sec.  1.1455(c)(3)(iii)(C)).
    In accordance with section 204(h) of FSMA, we will be issuing an 
SECG specifically aimed at assisting affected small businesses in 
complying with the requirements of this rule. In addition, we may issue 
other guidance documents to help smaller entities and all persons 
subject to the FTL recordkeeping requirements understand and meet the 
requirements applicable to them.
    (Comment 159) Some comments argue that the rule should not require 
businesses to maintain traceability records or create a lot code for 
any exempt product.
    (Response 159) We agree with the comments. When a food is fully 
exempt from the rule, firms will not be required to maintain subpart S 
records relating to that food. However, firms that are subject to the 
subpart J regulation must keep records as required under that subpart. 
We also note that, as a best practice, we believe that firms should 
maintain some form of traceability records for all foods that they 
handle, regardless of whether they are legally required to do so.
    (Comment 160) Some comments contend that small dealer operations 
that sell only to restaurants, farmers markets, or retail operations 
(as opposed to selling to secondary dealers) should be exempt from the 
rule as there is only one transaction to trace back in these 
circumstances. The comments assert that requiring the creation of lot 
codes for a one-step transaction does not improve the ability to 
perform traceback or traceforward. The comments further maintain that 
it is only when a product goes from the primary dealer to a secondary 
dealer that the requirement for the creation of a lot code should 
apply.
    (Response 160) We understand the word ``dealers'' to mean 
distributors in the context of the comment, and we decline to exempt 
from the rule small dealers that do not sell to secondary dealers. 
Records of sales from dealers to restaurants, farmers markets, and 
retail operations are necessary to tracing potentially contaminated 
product and acting quickly to reduce the impact of foodborne outbreaks. 
However, as discussed in Section V.R.6 of this document, these small 
dealers may rely on records they already keep (e.g., in the course of 
business or to comply with other legal requirements, such as the 
subpart J regulation) to meet applicable requirements under subpart S. 
Further, dealers will only need to create a traceability lot code if 
they receive an FTL food that does not already have a traceability lot 
code because the entity they received it from was exempt from the rule. 
We also note that small dealers may be exempt from the sortable 
spreadsheet requirement if they are sufficiently small to be below the 
$1 million ``ceiling'' in Sec.  1.1455(c)(3)(iii)(C).
    (Comment 161) Some comments recommend that we provide additional 
clarification for each exemption to emphasize that they are only 
applicable to foods on the FTL. For example, the comments suggest 
rephrasing the title of proposed Sec.  1.1305(a) to read ``Exemptions 
for small originators of food on the FTL'' instead of ``Exemptions for 
small originators.''
    (Response 161) We decline to make this change as unnecessary. Under 
Sec.  1.1300 of the final rule, subpart S applies to persons who 
manufacture, process, pack, or hold FTL foods. As subpart S does not 
apply to any foods not on the FTL, we believe it is unnecessary to 
state that each individual exemption concerns only FTL foods.
    (Comment 162) Some comments maintain that the exemptions specified 
in the proposed rule are too broad and recommend that FDA eliminate 
exemptions from the rule. The comments suggest that end-to-end 
traceability is best accomplished by maximizing participation 
throughout the supply chain and limiting exemptions wherever possible. 
Some comments recommend that we reconsider all proposed full or partial 
exemptions that are not expressly required by FSMA to best strike a 
balance between protecting public health and reducing the burden on 
small businesses. These comments suggest that in lieu of providing full 
or partial exemptions, we should provide technical assistance to assist 
firms in developing traceability systems and work with companies to 
develop affordable traceability programs. Some comments recommend that 
if the final rule includes exemptions, we should clarify for the public 
which entities are exempt from the rule.
    (Response 162) We do not agree with the comments that we should 
eliminate some or all of the proposed exemptions. As some comments 
note, Congress directed us to establish certain exemptions from the 
additional traceability recordkeeping requirements; therefore, the 
final rule must include these exemptions. The several exemptions we 
proposed on our own initiative reflect our thinking that applying the 
subpart S requirements to certain persons or foods would not be 
appropriate for various reasons. For example, in the preamble to the 
proposed rule (85 FR 59984 at 59995), we discussed the proposed 
exemption in Sec.  1.1305(a) for certain types of small or very small 
farms. 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, we considered that covering these small farms would produce 
little measurable public health benefit. Similarly, in Sec.  1.1305(k), 
we proposed to exempt transporters from this rule because we found 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 (85 FR 59984 at 59999). 
We continue to believe that the exemptions we proposed on our own 
initiative are appropriate to maintain, for the reasons described in 
the proposed rule and as discussed below. Furthermore, as discussed 
above and below, the final rule includes other exemptions not included 
in the proposed rule. We intend to provide outreach and assistance to 
help all firms subject to the rule to come into compliance with the 
applicable requirements.
    Regarding the comments asking that we clarify for the public which 
particular entities are not subject to the rule, we intend to provide 
outreach and education to ensure that all affected entities understand 
the subpart S exemptions. However, it would not be feasible for us to 
list specific exempt firms by name because we do not have access to the 
relevant information (e.g., annual sales data) that would allow us to 
create a comprehensive list of exempt firms. Furthermore, because some

[[Page 70956]]

exemptions in Sec.  1.1305 are specific to certain foods, some firms 
might be covered by the rule but exempt with respect to certain FTL 
foods they handle. We encourage exempt entities and firms selling 
exempt foods to provide information about their exempt status to 
downstream entities in the supply chain.
    (Comment 163) Some comments request clarification on whether there 
are additional regulations in place to ensure the safety of products 
that are otherwise exempt from this rule. The comments note particular 
concern regarding foods that receive a kill step and whether there are 
requirements to ensure that a kill step is appropriately applied. 
Additionally, the comments question whether, in the case of an outbreak 
associated with foods that are otherwise exempt from this rule, 
information on those foods will be available to FDA promptly.
    (Response 163) In recent years FDA has established several 
regulations implementing FSMA that are aimed at ensuring the safety of 
the food supply. These include regulations on the following: Standards 
for the Growing, Harvesting, Packing, and Holding of Produce for Human 
Consumption (80 FR 74354, November 27, 2015) (part 112); Current Good 
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive 
Controls for Human Food (80 FR 55908, September 17, 2015) (part 117); 
Foreign Supplier Verification Programs for Importers of Food for Humans 
and Animals (80 FR 74226, November 27, 2015) (part 1, subpart L); and 
Sanitary Transportation of Human and Animal Food (81 FR 20092, April 6, 
2016)) (21 CFR part 1, subpart O). Other FDA regulations concerning 
food safety have been adopted in final rules, including the following: 
Hazard Analysis and Critical Control Point (HAACP) Procedures for the 
Safe and Sanitary Processing and Importing of Juice (66 FR 6138, 
January 19, 2001) (21 CFR part 120); Procedures for the Safe and 
Sanitary Processing and Importing of Fish and Fishery Products (60 FR 
65096, December 18, 1995) (part 123; see also Sec. Sec.  1240.3 and 
1240.60); Prevention of Salmonella Enteritidis in Shell Eggs During 
Production, Storage, and Transportation (74 FR 33030, July 9, 2009) (21 
CFR part 118); and Manufacture and Processing of Thermally Processed 
Low-Acid Foods Packaged in Hermetically Sealed Containers (38 FR 12716, 
May 14, 1973) (part 113). Many of these regulations contain provisions 
related to the application of a ``kill step'' to foods to control for 
certain hazards. Entities required to comply with these food safety 
regulations are also subject to FDA inspection and oversight. In 
addition to these and other final rules we have issued to help ensure 
food safety, we note that all food remains subject to the adulteration 
provisions of the FD&C Act.
    As previously discussed, in 2004 we adopted the subpart J 
traceability recordkeeping requirements (see 69 FR 71562), which 
require persons (with some exceptions, including farms and restaurants) 
who manufacture, process, pack, transport, distribute, receive, hold, 
or import food to establish and maintain certain records. The subpart J 
requirements were designed to allow us to identify the immediate 
previous sources and immediate subsequent recipients of food, helping 
to facilitate our ability to quickly notify consumers and/or facilities 
that might be affected by a foodborne illness outbreak. The subpart J 
requirements apply to all foods, not just those on the FTL; and in some 
cases they apply to entities that are not covered by subpart S. 
Furthermore, in situations where FDA has a reasonable belief that an 
article of food is adulterated and presents a threat of serious adverse 
health consequences or death to humans or animals, section 414(a) of 
the FD&C Act requires firms to provide us with access to all relevant 
records relating to such food (and to any other food that we reasonably 
believe to be similarly affected). In addition, section 204(f) of FSMA 
requires farms to provide us with information identifying potential 
immediate recipients (other than consumers) of foods, in certain 
situations relating to an active investigation of a foodborne illness 
outbreak. Therefore, even in the case of an outbreak associated with 
foods that are exempt from this rule, various mechanisms exist that 
will help us promptly gain access to information regarding the affected 
foods.
2. Exemptions for Certain Small Producers
    We proposed to exempt from the FTL traceability requirements 
certain small produce farms, small producers of shell eggs, and other 
small producers of food, given the relatively low volume of food 
produced by these small entities and the fact that subsequent persons 
in the supply chain would have to keep records on the foods produced by 
these entities.
    Under proposed Sec.  1.1305(a)(1), the rule would not apply to 
farms or the farm activities of farm mixed-type facilities with respect 
to the produce they grow, when the farm is not a covered farm under the 
produce safety regulations in accordance with Sec.  112.4(a) (which 
concerns farms with no more than $25,000 in annual sales of produce). 
In proposed Sec.  1.1305(a)(2), we specified that the rule 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 exemption is consistent with the regulations on shell egg 
production, storage, and transportation (see Sec.  118.1(a) (21 CFR 
118.1(a))). Finally, under proposed Sec.  1.1305(a)(3), the rule 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. We stated that this exemption 
would apply to, among others, small aquaculture farms and small farms 
that grow non-produce foods that might be on the FTL in the future.
    In response to comments, we are making minor changes and 
clarifications to these proposed exemptions for certain small producers 
of FTL foods. These changes are discussed in more detail in the 
paragraphs below.
    (Comment 164) Some comments support the proposed exemptions for 
small produce and egg farms. The comments state that the proposed 
exemptions for smaller farms will hopefully encourage participation 
without imposing a financial burden on them. One comment maintains that 
the exemption for small farms could lessen the potential for the new 
traceability requirements to adversely affect farms and producers with 
sustainable practices. Some comments state they are relieved that small 
farms that are already covered by local and State tracing regulations 
would not be subject to increased labor and technology burdens under 
the rule.
    On the other hand, some comments maintain that the subpart S 
requirements should cover all farms, without exemption or partial 
exemption. The comments assert that having exemptions would mean that 
comprehensive and consistent traceability records would not be 
available to FDA to track foodborne illness, including to small farms 
that might be considered safer than others. The comments maintain that 
small farms are less likely to prioritize food safety and less likely 
to be monitored by FDA and the USDA. The comments therefore assert that 
a comprehensive food safety system should consider potential food 
safety hazards at the farm level, including small farms.

[[Page 70957]]

    (Response 164) We agree with the comments on the importance of 
adopting comprehensive and consistent recordkeeping requirements to 
enable us to trace products associated with foodborne illness outbreaks 
involving FTL foods and act quickly to reduce the impact of these 
outbreaks. However, we believe it is important to reduce the burden, 
where appropriate, on farms and other businesses that may have fewer 
resources to apply to complying with the requirements of the rule, 
while minimizing any additional health risk that might result from 
exempting entities from the regulation. When we consider a small 
business exemption from a regulation, we attempt to determine a small 
business ``ceiling'' that gives relief to businesses with fewer 
available resources without inordinately affecting public health. 
Having carefully considered the risk to consumers posed by FTL foods 
from small farms, we conclude that the farms below the size ceiling set 
forth in Sec.  1.1305(a) of the final rule do not contribute 
significantly to the volume of produce in the marketplace that could 
become contaminated. 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 producers would have little 
measurable public health benefit.
    (Comment 165) Some comments state that the rule violates the small 
farms and small business protections in FSMA, citing the definition of 
a small farm in the produce safety regulation and the qualified 
exemption for certain farms under that rule.
    (Response 165) We disagree with the comments. We issued the produce 
safety regulation in accordance with section 105 of FSMA (which created 
section 419 of the FD&C Act (21 U.S.C. 350h)), while we are issuing 
these subpart S requirements in accordance with section 204(d) of FSMA. 
Section 204(d) of FSMA does not require us to create the same 
exemptions from the subpart S requirements as are included in the 
produce safety regulation or any other FSMA regulation, including with 
respect to how ``small'' entities are defined. We believe that the 
scope of the exemption for certain small producers in Sec.  1.1305(a) 
of the final rule is consistent with the purposes of the subpart S 
requirements as well as with section 204(d)(1)(E) of FSMA, which 
specifies that the recordkeeping requirements for FTL foods must be 
scale-appropriate and practicable for facilities of varying sizes and 
capabilities.
    (Comment 166) Several comments ask us to raise the sales ceiling 
for eligibility for the exemptions for small farms in proposed Sec.  
1.1305(a). The comments assert that such increases are appropriate due 
to the relatively small percentage of farms that would be eligible for 
the proposed exemptions and the economic burden of compliance with the 
rule. The comments suggest increasing the ceiling to $1 million or even 
$3 million in average annual monetary value of sales. Some comments 
state that while they support the exemption for small farms, they also 
have concerns about the burden of the rule on mid-size farms, and 
therefore request an exemption for medium to large farms that sell food 
to aggregators for redistribution. Some comments recommend matching the 
ceilings to those in other FSMA regulations and in SBA classifications, 
including the $250,000 threshold used to extend the compliance date for 
``very small businesses'' in the produce safety regulation, the 
threshold used for ``qualified exempt farms'' that are eligible for 
modified requirements under the produce safety regulation, and the $1 
million threshold used to extend the compliance date for ``very small 
businesses'' in the regulation on preventive controls for human food. 
Some comments recommend a non-monetary threshold, specifically one 
based on full-time equivalent employees (FTEs).
    (Response 166) After careful consideration of the comments, we 
conclude it is appropriate to essentially retain in the final rule the 
proposed sales ceilings for certain small produce farms, certain egg 
producers, and certain other small producers of RACs. As discussed 
below in Section V.F.24 of this document, we have removed the term 
``originators'' from this rule, which is why the exemption in Sec.  
1.1305(a)(3) is now titled as relating to ``[c]ertain other producers 
of raw agricultural commodities.'' However, we have made the following 
slight adjustments and clarifications.
    We have added Sec.  1.1305(a)(1)(ii), which states that subpart S 
does not apply to produce farms when the average annual sum of the 
monetary value of their sales of produce and the market value of 
produce they manufacture, process, pack, or hold without sale (e.g., 
held for a fee) during the previous 3-year period is no more than 
$25,000 (on a rolling basis), adjusted for inflation using 2020 as the 
baseline year for calculating the adjustment. Although this exemption 
is a subset of produce farms that are exempt under Sec.  
1.1305(a)(1)(i) (which exempts farms that are not covered by the 
produce safety regulation due to their size), we wanted to ensure that 
our exemption for produce farms was consistent with our exemption for 
other small producers in Sec.  1.1305(a)(3), while still retaining 
Sec.  1.1305(a)(1)(i) to provide clarity that any farms that are exempt 
under Sec.  112.4(a) of the produce safety regulation are exempt from 
this regulation as well.
    We have made minor modifications to the exemption in proposed Sec.  
1.1305(a)(3), which are also reflected in the new Sec.  
1.1305(a)(1)(ii) (when applicable). We have changed the baseline year 
for calculating the inflation adjustment from 2019 to 2020 because 2020 
coincides with data and estimates of the impacts of the final rule in 
the FRIA (Ref. 16). And while the exemption in proposed Sec.  
1.1305(a)(3) was based on the average annual monetary value of food 
sold, the final rule exemption is based on the average annual sum of 
the monetary value of a producer's sales of RACs and the market value 
of the RACs they manufacture, process, pack, or hold without sale 
(e.g., held for a fee). This change encompasses two decisions: A 
decision to look only at RACs, rather than all foods, in calculating 
the eligibility ceiling; and a decision to consider the value of food 
that is handled without sale, in addition to the value of sales.
    Regarding the first decision, we now use only the value of RACs, 
rather than all foods, in calculating the eligibility ceiling. This 
provides greater clarity and creates a standard of eligibility for the 
exemption that is parallel to the standard in Sec.  1.1305(a)(1), which 
relates to the value of produce sold (or held without sale) by a 
produce farm. The word ``originator'' in proposed Sec.  1.1305(a)(3) 
referred to a producer of RACs, and implied that the ``food sold'' 
under that provision would be RACs, but the provision was not explicit 
on that point. For greater clarity in the final rule, and in light of 
the fact that a producer of RACs might also sell other products that 
are not RACs (and that we do not intend to be taken into account in 
calculating eligibility for the exemption), we are stating explicitly 
in the final rule that the eligibility ceiling is tied to the value of 
RACs sold (or held without sale, as discussed below).
    Regarding the second decision, we have added the market value of 
RACs manufactured, processed, packed, or held without sale to the 
calculation of the eligibility ceiling to create an exemption standard 
that can be used by farms and other producers that hold

[[Page 70958]]

food but do not always sell it. We are aware of the complex business 
relationships that exist at the start of the supply chain, and we 
therefore wanted to create a standard that encompassed entities that 
perform services for a fee, rather than engaging directly in the sale 
of food.
    The thresholds in Sec.  1.1305(a) provide appropriate relief to 
small produce farms, small egg farms, and small producers of other 
RACs, and are consistent with similar exemptions for small farms in 
other food safety regulations, such as the produce safety regulation 
and the shell egg safety regulation (part 118 (21 CFR part 118)). The 
exemptions for small farms and producers in Sec.  1.1305(a) of the 
final rule exempt roughly 63 percent of produce farms that would 
otherwise be subject to the subpart S requirements and roughly 1 
percent of covered sales. Also exempted are 98 percent of shell egg 
producers (roughly 1 percent of covered sales) and 40 percent of 
aquaculture operations (roughly 3 percent of covered sales) (Ref. 16)). 
Aquaculture operations are currently the only type of operation 
affected by Sec.  1.1305(a)(3), because all of the RACs currently on 
the FTL are either produce, eggs, or seafood (and fishing vessels have 
a separate exemption in Sec.  1.1305(m)).
    We considered other suggestions for sales volume ceilings for 
eligibility for the small produce farm exemption from the rule, 
including a threshold tied to the definition of ``very small business'' 
in the produce safety regulation, $250,000, which was used in that rule 
to provide an extended compliance date for farms that met that 
threshold; and various thresholds up to $1 million. Produce farms with 
no more than $250,000 in annual sales account for nearly 86 percent of 
covered farms and 6 percent of covered RAC sales in the United States, 
while produce farms with no more than $1 million in annual sales 
account for more than 93 percent of covered produce farms and more than 
13 percent of covered RAC sales. We conclude that neither of these 
cutoffs would be appropriate to use for the small produce farm 
exemption in Sec.  1.1305(a)(1) because they would result in exemption 
of a significant portion of the covered market from the subpart S 
recordkeeping requirements, which would inhibit our ability to conduct 
efficient and thorough tracebacks to protect public health.
    For similar reasons, we considered and rejected the possibility of 
basing eligibility for the small produce farm exemption on FTEs or SBA 
size standards. Extremely wide variation in revenues earned at any FTE 
level due to differences in business practices, automation, and other 
factors make FTEs a less accurate indicator of the true size, 
viability, and public health impact of businesses than measures based 
on sales. For produce farms, SBA standards define small businesses as 
those with no more than $1 million in annual sales, a volume that, if 
adopted as the ceiling for eligibility for the small produce farm 
exemption, would have a significant impact on our ability to conduct 
effective tracebacks and protect public health.
    We considered and rejected basing eligibility for the small farm 
exemption on the definition of a ``qualified exempt'' farm, defined in 
the produce safety regulation (Sec.  112.5 (21 CFR 112.5)) as a farm 
with less than $500,000 rolling annual average in food sales, with more 
than 50 percent of their food sold to qualified end users (consumers or 
retailers located in the same State or not more than 275 miles away). 
While nearly 10 percent of produce production fits into this category, 
less than 20 percent of all produce farms fall under this definition. 
Further, some of the farms that fit this definition make nearly 
$500,000 in annual revenue, produce a relatively large volume of food, 
and could sell half of their production into large market supply 
chains. Exempting such farms could have a significant impact on our 
ability to conduct effective tracebacks and protect public health, 
while simultaneously providing less relief for the very smallest farms. 
The exemption in the final rule covers more than 60 percent of produce 
farms, while an exemption based the produce safety regulation's 
``qualified exempt'' threshold would cover less than 20 percent of all 
produce farms.
    (Comment 167) One comment suggests that diversified produce farms 
may not be eligible for exemption due to the aggregate value of all 
produce grown on such farms, regardless of the value of FTL foods 
grown. The comment asserts that the inclusion of non-produce sales in 
the exemption calculation penalizes diversified farming operations. 
Additionally, the comment maintains that the proposed rule would 
require adoption of new traceability practices for either all crops, 
whether they are covered or not, or just a portion of the crops grown 
and covered by the rule. The comment asserts that either solution would 
create incremental expense not experienced by larger-scale farming 
operations that only grow FTL foods or grow food in such large 
quantities that they can dedicate resources and develop procedures for 
those operations that are covered. The comment therefore recommends 
calculating the small produce farm exemption based only on sales of FTL 
foods.
    (Response 167) We disagree with the comment. We conclude that 
including all produce sales, rather than just sales of produce on the 
FTL, in determining eligibility for the small produce farm exemption 
provides a more accurate measure of a farm's financial ability to meet 
the traceability recordkeeping requirements under the rule. 
Consequently, if a diversified farming operation has annual produce 
sales of more than $25,000, it is more likely to have the resources 
with which to comply with the applicable subpart S requirements, and it 
is appropriate that it not be exempt from the rule.
    (Comment 168) Some comments assert that the rule will hurt local, 
regenerative farming that is environmentally friendly. One comment 
maintains that the rule will reduce options to buy from small farms and 
force firms to buy from large farms that have a big carbon footprint 
through scale and shipping and are harmful to the environment.
    (Response 168) We disagree that the rule will significantly harm 
local regenerative farm practices or significantly reduce options to 
buy from small farms. We note that in addition to the exemption for 
small produce farms in Sec.  1.1305(a)(1), there are several other 
exemptions discussed below that may apply to sales of food by and from 
local, regenerative farms and other smaller farms. Furthermore, as 
discussed in section V.J of this document, the final rule reduces and 
streamlines the recordkeeping requirements for covered farms.
    (Comment 169) One comment asserts that the proposed requirements 
will disrupt tracing programs already in place on small, diverse farms.
    (Response 169) We disagree. We understand that farms employ a wide 
variety of tracing programs depending on size, crop mix, season, 
location, technology, and business models/agreements, and we are 
adopting requirements that include traceability information that is 
typically part of existing traceability programs. To the extent that 
entities with existing traceability programs already generate some or 
all of the information they are required to maintain under this rule, 
they may use that information to comply.
    (Comment 170) Some comments request that FDA exempt small and 
midsized farms from ``computerized tracking'' to allow flexibility and 
that, in

[[Page 70959]]

general, FDA should streamline requirements for small farms.
    (Response 170) The rule does not require electronic recordkeeping. 
The only subpart S requirement with an electronic component is the 
requirement to make available to FDA an electronic sortable spreadsheet 
in certain circumstances (Sec.  1.1455(c)(3)). As discussed in more 
detail in Response 470, the final rule exempts farms from this sortable 
spreadsheet requirement if they have average annual sales of $250,000 
or less (Sec.  1.1455(c)(3)(iii)(A)). The final rule also includes 
several full and partial exemptions that may apply to small farms or to 
certain foods produced on farms, as discussed in Response 158. 
Moreover, the final rule simplifies the recordkeeping requirements 
applicable to farms in general, as discussed in Response 156.
    (Comment 171) One comment questions how downstream users will be 
able to identify exempt product, and asks whether an exemption form 
will be provided to the distributor. The comment questions whether food 
from an exempt farm is exempt throughout the supply chain. One comment 
supports the proposed exemption of small shell egg producers but 
maintains that it should apply throughout the supply chain. Some 
comments maintain that the requirements for receivers to collect 
information such as lot code, location identifier and location 
description of the originator, and the place where the food was packed 
and cooled would cause difficulty for both the receivers and exempt 
originators. The comments maintain that receivers of a listed food will 
require information from the small originator to satisfy their 
requirements to send information to subsequent receivers. But the 
comments assert that receivers will have no way of knowing whether the 
originator is a small originator without receiving this information 
from the originator, and they argue that taking the steps necessary to 
demonstrate the application of the exemption would eliminate any 
benefit from the exemption. Therefore, the comments ask that the rule 
not require lot codes or record generation for any exempt food.
    (Response 171) Farms that qualify for the exemption in Sec.  
1.1305(a)(1), (a)(2), or (a)(3) are fully exempt and do not have to 
keep any records to comply with the rule. However, foods on the FTL 
produced by exempt farms are not exempt throughout the supply chain, 
nor are distributors who receive food from exempt farms. Section 
1.1330(c) sets forth the records that persons must keep if they 
initially pack a food received from an exempt farm. Similarly, Sec.  
1.1345(b) sets forth the records a person must keep if they receive 
food from an exempt entity. These requirements are limited to 
information a person would be reasonably expected to know based on 
information that is likely provided during the normal course of 
business. An exempt farm is not expected to provide a traceability lot 
code; the traceability lot code would be assigned by the initial packer 
(if they are covered by the rule) or by the person who receives the 
food from the exempt farm, in accordance with Sec.  1.1345(b)(1).
    We anticipate that supply chain partners will be able to 
communicate about whether or not they are exempt, and we are not 
placing any requirements on exempt entities regarding the nature of 
such communications.
    (Comment 172) One comment states that FDA should clarify and define 
``other originators of food'' in proposed Sec.  1.1305(a)(3). The 
comment maintains that the term could be interpreted as including all 
food originators, including shell egg producers that were not exempt 
because they had more than 3,000 laying hens. One comment states that 
they understand ``other originators of food'' to include aquaculture.
    (Response 172) We have revised the heading for the exemption in 
Sec.  1.1305(a)(3) to state that it applies to certain other producers 
of RACs, instead of certain other originators of food. By ``other 
producers of raw agricultural commodities,'' we mean producers of 
covered RACs that are not produce or eggs, which are discussed in Sec.  
1.1305(a)(1) and (a)(2), respectively. Such other producers of RACs 
would include producers of seafood and any other non-produce, non-egg 
RACs that may someday be on the FTL. We have added the phrase ``(e.g., 
aquaculture operations)'' to help clarify the meaning of ``other 
producers of raw agricultural commodities.''
3. Exemption for Farms Regarding Food Sold Directly to Consumers
    In accordance with section 204(d)(6)(H) and (I) of FSMA, we 
proposed to exempt farms from the 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)). These direct-to-consumer sales by farms include 
applicable sales at farmers' markets, roadside stands, over the 
internet, and through community-supported agriculture (CSA) programs. 
The final rule retains this exemption and expands it to include food 
that is donated directly to a consumer.
    (Comment 173) Some comments suggest that we clarify or expand the 
term ``agent in charge of the farm'' to include all farm employees or 
other individuals the farm has authorized to make sales on its behalf.
    (Response 173) In the context of this exemption, the phrase ``agent 
in charge of the farm'' may be anyone employed by the farm who is 
authorized to sell food on behalf of the farm.
    (Comment 174) Some comments suggest that farms that share or trade 
crops with other local farms for the purpose of adding variety to their 
farm stand or CSA box should be exempt from the rule.
    (Response 174) We disagree with the comments. Consistent with 
section 204(d)(6)(H) and (I) of FSMA, the exemption in Sec.  1.1305(b) 
is limited to farms that sell or donate the food produced on their own 
farm directly to a consumer. The value of traceability records in such 
a circumstance is limited because the food moves directly from the farm 
that grew it to the consumer. When a farm uses a CSA or a farm stand to 
sell the food produced on their own farm directly to consumers, the 
farm will be eligible for the exemption. But when the food was produced 
on another farm, and was obtained by the farm that runs the CSA or farm 
stand via sharing, trading, or selling, the exemption does not apply.
    However, we note that most CSAs and farm stands will meet the 
definition of a ``retail food establishment'' under Sec.  1.1310. 
Therefore, a CSA or farm stand could be eligible for the partial 
exemption in Sec.  1.1305(j) for RFEs that purchase food directly from 
the farm that produced the food (see Section V.E.11 of this document). 
Furthermore, as discussed in Section V.E.10 of this document, an RFE or 
restaurant will be exempt from the rule under Sec.  1.1305(i) if the 
average annual sum of the monetary value of their sales of food and the 
market value of food they manufacture, process, pack, or hold without 
sale (e.g., held for a fee) during the previous 3-year period was no 
more than $250,000 (on a rolling basis), adjusted for inflation using 
2020 as the baseline year for calculating the adjustment. This may 
include many CSAs and farm stands.
    (Comment 175) Some comments request that all small farms be exempt, 
not only those that sell food directly to the consumer. The comments 
assert that only ``hobby''-type farms that do not rely on food sales to 
make a living can operate with only direct-to-consumer

[[Page 70960]]

sales. The comments maintain that even most farms that primarily sell 
direct to consumers sell some of their products through wholesalers, 
and that the paperwork for that portion of their sales would be too 
burdensome.
    (Response 175) We understand that the exemption for direct-to-
consumer sales in Sec.  1.1305(b) will not fully exempt most farms from 
the rule because farms that sell some product directly to consumers 
also sell some of their product through wholesalers. However, as 
discussed above, the final rule provides a complete exemption for 
certain small producers (including farms) in Sec.  1.1305(a). There are 
also other full and partial exemptions that may apply to many small 
farms. Furthermore, as discussed below, the revised KDEs in the final 
rule impose less of a burden than the proposed rule did on many farm 
activities.
4. Inapplicability to Certain Food Produced and Packaged on a Farm
    Consistent with section 204(d)(6)(B) of FSMA, we proposed to 
provide that the FTL 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, 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)).
    We further proposed that, upon request, FDA would waive the 
requirement 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)).
    On our own initiative, we have slightly revised the provision 
concerning waiving the requirement to provide a business phone number 
to accommodate a religious belief, to align with the text of similar 
language in Sec.  1.1455(c)(3)(iv) concerning a request for a sortable 
electronic spreadsheet under certain circumstances. Thus, Sec.  
1.1305(c)(2) of the final rule states, in part, that we 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. 
We are finalizing the remainder of Sec.  1.1305(c) as proposed. We 
respond to the comments on proposed Sec.  1.1305(c) in the following 
paragraphs.
    (Comment 176) Some comments express general support for the 
exemption for foods that are compliant with packaging and labeling 
requirements. However, some comments maintain that the exemption is too 
narrow, and some ask that FDA reconsider or delete the restrictions on 
packaging in this exemption. Some comments assert that the proposed 
rule requires firms to use plastic sealed packaging to qualify for the 
exemption for identity-preserved food in proposed Sec.  1.1305(c), in 
violation of FSMA. One comment contends that FSMA does not require new 
packaging guidelines, while other comments assert that FSMA 
specifically exempts certain identity-preserved foods and that there 
should be no additional requirements on such foods.
    Some comments maintain that meeting the packaging requirements 
would not be feasible for most smaller farms or even mid-size farms. 
Some comments assert that the requirements only make sense for large, 
national producers and the exemption does not benefit small, local 
farms. Some comments maintain that the requirements may cost them 
business and that it will be difficult to sustain environmentally 
friendly niche markets. The comments state that some customers do not 
want food in plastic packaging and that some may even have an allergy 
to such packaging. Some comments contend that the required packaging is 
expensive and resource-intensive, and would require investment in 
expensive equipment and processes. One comment asserts that the 
requirements will lead to an increase in production costs and to high 
food prices.
    (Response 176) We appreciate the support that some comments 
expressed for this exemption. Regarding some comments' assertions that 
Sec.  1.1305(c) imposes packaging requirements that are not feasible 
for all farms, we note that this provision does not establish packaging 
requirements for farms; instead, it sets forth an exemption for foods 
that are packaged and labeled in a certain way. Farms that do not 
package and label their foods in this way are not in violation of 
subpart S; they simply are not eligible for this exemption.
    Regarding some comments' assertions that the requirements are in 
violation of FSMA, we conclude that the requirements to meet the 
exemption in Sec.  1.1305(c) are appropriate and fully consistent with 
section 204(d)(6)(B) of FSMA, which stipulates that packaging/labeling 
that qualifies for the exemption should preserve the identity of the 
farm that grew the product for purposes of traceability and also 
maintain the integrity of the product and prevent subsequent 
contamination or alteration of the product. The exemption is written as 
narrowly as it is to ensure that all of these conditions are met (see 
Response 178 regarding clamshell packaging).
    (Comment 177) One comment requests that FDA clarify the meaning of 
product ``integrity.'' The comment asserts that Congress was referring 
to packaging that maintains the food as a distinct unit rather than 
packaging that prevents exposure to the environment, adding that all 
produce is packaged in breathable packaging to prevent deterioration. 
Some comments assert that the consideration should be traceability 
(i.e., exposure of the product to the environment is irrelevant), and 
as long as packaging and labeling is identity-preserving, it should be 
allowed under the exemption, and additional packaging requirements 
should be kept to a minimum. One comment suggests the exemption be 
revised to refer to packaging that maintains the integrity of the lot 
identity of the product and prevents subsequent alteration of the lot 
identification of the product.
    (Response 177) We agree that maintaining the food as a distinct 
unit and labeling the food so that the farm's identity is preserved to 
aid in traceability are both important considerations for this 
exemption. However, they are not the only considerations, and we 
disagree with the assertion that exposure to the environment is 
irrelevant. Section 204(d)(6)(B)(i) of FSMA specifies that the 
packaging must prevent subsequent contamination or alteration of the 
product. As discussed in Response 178, plastic clamshells and other 
vented packaging will not necessarily prevent subsequent contamination.
    Regarding the comment about lot identity, section 204(d)(6)(B)(i) 
of FSMA does not require that food be labeled to identify the lot 
number in order to receive this exemption, and we have not included 
such a requirement in the final rule. However, we agree that it is a 
good practice, when possible, for foods to be labeled with information 
regarding the lot number.
    (Comment 178) Some comments suggest that FDA allow the exemption in 
Sec.  1.1305(c) to apply to foods packed in cardboard and clamshell 
packing with holes. The comments assert that

[[Page 70961]]

the preamble to the proposed rule incorrectly states that vented 
clamshells do not maintain the integrity of the product they contain. 
Some comments request information on the contamination risks for food 
in clamshells or bags with holes when that product is protected by an 
outer container (cardboard box) and shipped directly to a retailer, and 
they question how plastic packaging prevents contamination.
    (Response 178) As stated in the proposed rule, 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 because such packaging does not necessarily 
maintain the product's integrity and prevent subsequent contamination 
and alteration. None of the comments presented information or arguments 
that caused us to revise our understanding of this issue. Although 
environmental exposure to produce packaged in vented clamshells or bags 
with holes would be less than when produce is packed without packaging 
in open crates, vented packaging can subject produce to contamination 
in many ways, including from condensate in aerosols carried by the air 
handling system, moisture dripping onto containers, particulates blown 
through the facility by the air handling system, fingers of handlers 
during handling of the packages, objects that may be inadvertently 
inserted through the vents, and pests that can access the produce 
through the vents. In contrast, sealed plastic packaging that remains 
sealed throughout the supply chain will prevent contamination that 
could occur through the vectors described above. Therefore, while 
plastic clamshells and other vented packaging could maintain identity 
preserving labeling through the supply chain, such packaging would not 
necessarily maintain the integrity of the product and prevent 
subsequent contamination, as required by the statute.
    (Comment 179) Some comments assert that the required packaging is 
environmentally damaging and wasteful, and that the rule creates a bias 
towards expensive, environmentally damaging packaging. Some comments 
ask if FDA has considered the environmental impacts of the packaging 
requirements. Some comments assert that individual item plastic 
packaging is expensive and wasteful and that some commonly used 
recyclable packaging will not be permitted under the proposed 
exemption.
    (Response 179) As discussed in Response 176, this provision does 
not establish a packaging requirement for farms; instead, it sets forth 
one of several exemptions from the rule applicable to certain foods or 
supply chain entities. Thus, Sec.  1.1305(c) does not require farms to 
change how they package their food.
    Regarding the comment asking if we have considered the 
environmental impact of Sec.  1.1305(c), as discussed in the 
Categorical Exclusion Memorandum (Ref. 24) stating why neither an 
environmental assessment (EA) nor an environmental impact statement 
(EIS) is required for this rulemaking (see Section VIII of this 
document), we think it is very unlikely that a significant number of 
farms would change their packaging procedures just to avoid the subpart 
S traceability recordkeeping requirements by making themselves eligible 
for the exemption in Sec.  1.1305(c). The final rule provides full and 
partial exemptions for certain farms, as well as a number of exemptions 
for certain foods produced on farms (see Response 158). In addition, 
the final rule imposes less burdensome requirements on farms than under 
the proposed rule, including the elimination of proposed requirements 
that would have required growers to maintain KDEs regarding the growing 
of individual lots of food and that would have required the maintenance 
of shipping and receiving KDEs before the initial packing of a food. 
Therefore, we anticipate that most farms that are subject to the rule 
will not conclude that the burden of compliance is so great that they 
must significantly change their operations for certain foods just to 
avoid having to keep the required traceability records. We also note 
that changes to a farm's packaging procedures can themselves be costly 
and resource-intensive, and might not be feasible for many types of 
foods. We therefore do not expect the final rule to result in a 
significant number of farms changing their practices in ways that could 
cause environmental damage so as to avoid coverage under this rule.
    (Comment 180) Many comments support the exemption for products 
packaged on a farm where the identity of the product is maintained on 
the packaging all the way to the consumer, as long as the packaging 
maintains the integrity of the product. Most of these comments also 
request that these products be exempted throughout the supply chain. 
The comments maintain that entities downstream in the supply chain from 
the farm will have no way of knowing some of the traceability 
information (e.g., the traceability lot code) unless the farm provides 
the information. The comments assert that this would negate the 
exemption and could cause firms to avoid buying from these farms. The 
comments also maintain that buyers will ask non-farm entities to have 
all of the farm-level information required by the rule if these 
identity-preserved products are not exempt throughout the supply chain, 
and claim that having to provide this information would drive some 
small value-added farm operations out of business. Some comments assert 
that Congress intended that these identify-preserved farm products 
would retain their exemption throughout the supply chain. Some comments 
maintain that distributors and retailers should not have to make 
decisions about whether the farm-identity information on the packaging 
and the packaging complies with the exemption criteria in Sec.  
1.1305(c).
    (Response 180) We agree with the comments that products qualifying 
for the exemption in Sec.  1.1305(c) are exempt throughout the entire 
supply chain. This is why the provision states that ``[t]his subpart 
does not apply to food'' that meets the relevant criteria for the 
exemption. We believe that products qualifying for this exemption will 
be relatively easy to identify as they move through the supply chain. 
This can be accomplished through visual inspection or, if that is not 
sufficient, through communication with the supplier. Though not 
required by the rule, we encourage persons selling foods qualifying for 
this exemption to provide information about their exempt status to 
downstream entities in the supply chain.
    (Comment 181) One comment states that the proposed requirement in 
Sec.  1.1305(c)(1) that the packaging remain in place until the food 
reaches the consumer is beyond the scope of FSMA. The comment maintains 
that some products are labeled but not packaged at all once the store 
displays them, and these products should still be exempt.
    (Response 181) While section 204(d)(6)(B) of FSMA does not specify 
that the packaging must remain in place until the food reaches the 
consumer, the provision requires that packaging must maintain the 
integrity of the product and prevent subsequent contamination or 
alteration of the product. If the packaging is removed before the 
product reaches the consumer, the integrity of the product might not be 
maintained, and contamination or alteration could occur. This is the 
case even if the food is still labeled with the required information 
regarding the farm where it was produced and packaged. Therefore, to 
effectively implement Congress's

[[Page 70962]]

intent to exempt only those products whose packaging maintains the 
integrity of the product and prevents subsequent contamination or 
alteration of the product, Sec.  1.1305(c)(1) of the final rule 
requires that, to be eligible for this exemption, the packaging of the 
food must remain in place until the food reaches the consumer.
5. Exemptions and Partial Exemptions for Foods That Will Receive 
Certain Types of Processing
    We proposed to exempt from the FTL traceability recordkeeping 
requirements produce and shell eggs that receive certain types of 
processing. Under proposed Sec.  1.1305(d)(1), the requirements would 
not apply to produce that receives commercial processing that 
adequately reduces the presence of microorganisms of public health 
significance, provided the conditions in Sec.  112.2(b) in the produce 
safety regulation are met. Under proposed Sec.  1.1305(d)(2), the rule 
would not apply to shell eggs when all the eggs produced at a 
particular farm receive a treatment (as defined in Sec.  118.3 (21 CFR 
118.3)) in accordance with Sec.  118.1(a)(2) of the shell egg 
regulation.
    In a separate section (proposed Sec.  1.1355), we proposed to 
specify that if a person applied a kill step to an FTL food, the rule 
would not apply to the person's subsequent shipping of the food, 
provided that the person maintained a record of application of the kill 
step. We further proposed that if a person received an FTL food that 
had been subjected to a kill step, the rule would not apply to that 
person's receipt or subsequent transformation and/or shipping of the 
food.
    As discussed in the following paragraphs, we have decided to move 
these provisions regarding kill steps to the exemptions section of the 
subpart S regulations. It is set forth in Sec.  1.1305(d) as a partial 
exemption for food that a person subjects to a kill step, provided that 
the person maintains a record of the application of the kill step 
(Sec.  1.1305(d)(3)(ii)), and as a full exemption for food received 
that has previously been subjected to a kill step (Sec.  1.1305(d)(5)). 
We have also added a partial exemption to Sec.  1.1305(d) for food that 
will be subjected to a kill step in the future, provided that shippers 
and receivers of the food enter into written agreements stating that 
the kill step will be applied by the receiver or an entity in the 
supply chain (other than an RFE or restaurant) subsequent to the 
receiver (Sec.  1.1305(d)(6)).
    We received comments that have persuaded us to add a partial 
exemption for foods that in the future will be changed such that they 
are no longer on the FTL (Sec.  1.1305(d)(6)). For example, as 
discussed in Response 30, fresh spinach is on the FTL but frozen 
spinach is not on the list. Under the final rule, fresh spinach that is 
going to be frozen can be exempt from the rule even while it is still 
fresh, provided that shippers and receivers of the fresh spinach enter 
into written agreements stating that the spinach will be frozen by the 
receiver or an entity in the supply chain (other than an RFE or 
restaurant) subsequent to the receiver. This exemption is included 
alongside the exemption for food that will receive a kill step in Sec.  
1.1305(d)(6) of the final rule. The comments that prompted the addition 
of this partial exemption are discussed below.
    (Comment 182) One comment opposes the commercial processing 
exemption for produce. The comment asserts that if we maintain the 
exemption in the final rule, the exemption should not apply until the 
adequacy of commercial processes are verified and ``cross-scope'' 
inspection processes are clarified. Other comments request 
clarification on the types of commercial processing that would be 
covered under proposed Sec.  1.1305(d)(1).
    (Response 182) Under Sec.  1.1305(d)(1) of the final rule, subpart 
S does 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 regulation are met for the produce. As discussed in 
the proposed rule (see 85 FR 59984 at 59996), 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 regulation), it is not necessary to apply the additional 
recordkeeping requirements to this food. Section 112.2(b)(1) explains 
that examples of commercial processing that adequately reduces the 
presence of microorganisms of public health significance are processing 
in accordance with the requirements of 21 CFR parts 113, 114, or 120 
(parts 113, 114, or 120); treating with a validated process to 
eliminate spore-forming microorganisms (such as processing to produce 
tomato paste or shelf-stable tomatoes); and processing such as 
refining, distilling, or otherwise manufacturing/processing produce 
into products such as sugar, oil, spirits, wine, beer, or similar 
products.
    (Comment 183) One comment recommends that we include the kill step 
exemption with other exemptions in proposed Sec.  1.1305.
    (Response 183) We agree with the comment, and because application 
of a kill step involves certain types of processing, we have moved the 
expanded kill step provisions to the exemptions and partial exemptions 
for foods that receive certain types of processing in Sec.  1.1305(d) 
of the final rule.
    (Comment 184) Many comments express support for the proposed kill 
step exemption. One comment maintains that if an establishment 
improperly performed the kill step for a food there would be 
insufficient traceability for those food products.
    (Response 184) As discussed above, the final rule retains the 
proposed rule's approach to foods that receive or have received a kill 
step, and adds a partial exemption for foods that will receive a kill 
step in the future. The final rule defines ``kill step'' to mean 
``lethality processing that significantly minimizes pathogens in a 
food'' (Sec.  1.1310). We think these exemptions and partial exemptions 
are appropriate because applying a kill step to a food significantly 
minimizes the presence of pathogens in the food, thus reducing the risk 
posed by the food and reducing the likelihood that the food would be 
involved in an outbreak, which in turn reduces the need for further 
tracing of that food. Application of a kill step generally occurs in 
accordance with other FDA regulations, such as those concerning 
preventive controls for human food and LACF, which reduces the 
likelihood that a kill step would be improperly performed. We note 
that, if an outbreak were to occur in a food that was fully or 
partially exempt under these provisions, various mechanisms exist that 
would help FDA gain access to information regarding the affected foods, 
as discussed in Response 163.
    (Comment 185) Several comments request clarification of the 
definition of ``kill step'' and the use of the phrase ``significantly 
minimizes,'' asking whether a log reduction is necessary to 
significantly minimize pathogens. Several comments ask that we align 
the definition of kill step with the seafood HACCP, preventive controls 
for human food, and LACF regulations, or whether food processed under 
those regulations would be considered kill steps. Several comments ask 
whether certain processes, such as freezing, individually quick 
freezing (IQF), drying, ozonated water, or ultraviolet (UV) light, 
would be considered kill steps. One comment asks whether product 
formulation, such as a product's pH level, water activity level, or use 
of certain preservatives could be considered kill steps, particularly 
for cheese. Several

[[Page 70963]]

comments ask whether cooking or shucking molluscan shellfish under the 
Interstate Shellfish Sanitation Conference (ISSC) Model Ordinance would 
count as kill steps. Another comment asks us to identify the kill step 
for products with multiple cooking steps, such as steaming crabs to 
pick crabmeat, pre-cooking raw tuna before canning, or post-harvest 
processing of molluscan shellfish. Some comments ask that we provide a 
list of approved kill steps.
    (Response 185) As discussed in Section V.F of this document, in the 
final rule we are defining ``kill step'' as lethality processing that 
significantly minimizes pathogens in a food. We added the term 
``lethality'' to the proposed definition to clarify that a kill step 
involves ``lethality processing,'' where the processing is robust 
(significantly minimizes pathogens in a food) and not something that 
simply reduces pathogens (e.g., a washing process). It is possible to 
reduce or minimize pathogens in other ways, such as filtration, but we 
would not consider that a kill step because it is not a lethality 
processing. We are not requiring a specific log reduction for a kill 
step as this depends on many factors, such as the food, the process, 
the pertinent pathogen, the prevalence and concentration of a pathogen, 
and other factors. Examples of kill steps include cooking, 
pasteurization, other heat treatments, high-pressure processing, and 
irradiation, as long as those processes are conducted in a manner that 
results in a lethality treatment that significantly minimizes the 
pertinent pathogen.
    Under this definition of ``kill step,'' processes such as freezing, 
IQF, drying, ozonated water, or UV light generally would not be 
considered kill steps because those processes usually would not involve 
a lethality step that significantly minimizes pathogens. Similarly, 
controlling hazards via a product's pH level, water activity level, use 
of certain preservatives, or other types of product formulation 
generally would not be considered kill steps. While those activities 
may control the growth of the pathogen, they usually would not be 
applied as kill steps.
    Regarding the application of specific other FDA regulations, any 
LACF that has been processed to commercial sterility in accordance with 
part 113 will have received a kill step as that term is defined in 
subpart S. Any lethality step that has been validated to significantly 
minimize or prevent a pathogen in accordance with the preventive 
controls regulation would also be considered a kill step. While we 
anticipate that in many cases a kill step will be performed in a 
facility that is subject to the preventive controls regulation, the 
LACF regulation, or both, we recognize that this will not always be the 
case. (For example, many manufacturing facilities are not subject to 
the LACF regulation, and a very small manufacturing facility might be 
exempt from the preventive controls regulation but subject to subpart 
S.) Any lethality processing that significantly minimizes pathogens in 
a food will be considered a kill step for the purposes of subpart S, 
regardless of whether it is performed in a facility that is subject to 
these other FDA regulations.
    The seafood HACCP regulation requires seafood processors to control 
for certain hazards, and in certain cases, this means processors need 
to apply a lethality or kill step as a control. The Fish and Fishery 
Products Hazards and Controls Guidance provides information regarding 
control of pathogens through techniques such as cooking or 
pasteurization, with the goal of either eliminating pathogenic bacteria 
of public health concern or reducing their numbers to acceptable 
levels. This information could be used to inform a determination of 
whether or not a specific technique constituted a kill step as that 
term is defined in subpart S.
    Regarding the comment that asked about cooking or shucking 
molluscan shellfish under the ISSC Model Ordinance, as discussed in 
Section V.E.7 below, the final rule exempts raw bivalve molluscan 
shellfish that are covered by the requirements of the NSSP; subject to 
the requirements of part 123, subpart C, and Sec.  1240.60; or covered 
by a final equivalence determination by FDA for raw bivalve molluscan 
shellfish.
    For products that receive multiple cooking steps, once the food 
undergoes lethality processing that significantly minimizes pathogens 
in the food, we will regard the food as having received a kill step. 
Finally, because whether a process would be considered a kill step 
depends on the application of the process to a specific food, we 
decline to provide a list of approved kill steps.
    Some manufacturing processes can change the form of a food such 
that it is no longer on the FTL. In those situations, subpart S would 
no longer apply to the food under Sec.  1.1305(d)(4) of the final rule, 
even if the manufacturing process did not constitute a kill step. For 
example, fresh spinach is on the FTL, but frozen spinach is not. Frozen 
spinach is therefore not covered by the subpart S requirements, even 
though freezing is not a kill step.
    (Comment 186) Some comments ask for clarity about how the kill step 
provision would apply to specific commodities such as fresh produce. 
One comment asks how the kill step exemption would apply to finfish and 
other seafood since the kill step would not eliminate or reduce fish 
and other seafood-associated toxins such as histamine or ciguatoxin. 
One comment asks whether application of a kill step would affect 
whether a food was covered by the rule or not.
    (Response 186) If a kill step is applied to an FTL food, then the 
food is partially exempt from the subpart S requirements under Sec.  
1.1305(d) of the final rule. The person applying the kill step would 
need to keep receiving records and a record of the application of the 
kill step, but they would not need to keep transformation records or 
shipping records related to the food that received the kill step. 
Subsequent entities in the supply chain would not need to keep records 
for that food. As discussed in Response 196, an additional partial 
exemption would be available if it is known in advance that the food 
will be subjected to a kill step.
    As previously stated, we are defining ``kill step'' to mean 
lethality processing that significantly minimizes pathogens in a food. 
Histamine and ciguatoxin are not pathogens; they are toxins, and we 
agree with the comment that toxins are not controlled by the 
application of lethality processing. Processes such as cooking will 
constitute a kill step in situations where the relevant hazard relates 
to pathogens, provided that the cooking is sufficient to constitute 
lethality processing that significantly minimizes the pathogens in the 
food. But with respect to a food that is associated with histamine or 
ciguatoxin as a hazard--which is the case for some of the foods 
currently on the FTL, as discussed below--cooking would not affect the 
toxin and would not constitute a kill step. In general, cooking and 
other lethality treatments do not significantly minimize non-
microbiological hazards, nor do they affect the toxins from 
microbiological hazards that cause foodborne illness through the 
formation of a heat-stable toxin in food, such as Staphylococcus aureus 
and Bacillus cereus.
    For each of the commodities on the FTL, there are one or more 
associated commodity-hazard pairs that drive the commodity risk score 
and lead to the commodity being included on the FTL (see Refs. 10 and 
15). Of the foods currently on the FTL, there are only two commodities 
with such commodity-hazard pair(s) for which the associated hazards 
include toxins: Finfish,

[[Page 70964]]

histamine-producing species, and Finfish, species potentially 
contaminated with ciguatoxin. Because the acute chemical toxins are not 
eliminated by thermal processes, cooking these commodities does not 
constitute a kill step. But for all of the other commodities currently 
on the FTL, including seafood products on the FTL that are not in 
either of these commodities, cooking would be considered a kill step as 
long as the product is cooked sufficiently to constitute lethality 
processing that significantly minimizes the pathogens in the food.
    As discussed in Section V.T of this document, we plan to 
periodically review and update the FTL using the procedures set forth 
in Sec.  1.1465. As a result of this process, it is possible that the 
commodity-hazard pairs(s) that lead to a commodity being on the FTL 
could change. In such cases, the determination of whether cooking is 
considered a kill step would be re-evaluated and could change, 
depending on whether the associated hazards include an acute chemical 
toxin or a microbiological hazard that produces a heat-stable toxin in 
food. Similarly, if new commodities are added to the FTL in the future, 
we would evaluate the hazards associated with each new commodity to 
determine whether cooking would be considered a kill step for that 
commodity. As discussed above, currently the only commodities on the 
FTL for which cooking (or other lethality processing) is not considered 
a kill step are Finfish, histamine-producing species, and Finfish, 
species potentially contaminated with ciguatoxin. This can only change 
as a result of updates to the FTL that are carried out using the 
procedures in Sec.  1.1465; and if it does change, we will communicate 
clearly about which commodities on a revised FTL are in this situation.
    As discussed in Responses 27 and 185, some manufacturing processes 
can change the form of a food such that it is no longer on the FTL. In 
those situations, subpart S would no longer apply to the food, even if 
the manufacturing process did not constitute a kill step. For example, 
canned tuna is in the commodity ``canned seafood,'' which is not on the 
FTL. Canned tuna has tuna as an ingredient, but not in any of the forms 
(``fresh'' or ``frozen'') in which tuna appears on the FTL. Canned tuna 
is therefore not on the FTL and is not covered by the subpart S 
requirements, even though the canning process does not constitute a 
kill step for histamine, which is a hazard among the commodity-hazard 
pairs that lead to Finfish, histamine-producing species (e.g., tuna), 
being included on the FTL. In many cases, the inquiry into whether or 
not a process constitutes a kill step will not be relevant, because the 
same process will have changed the food into a form that is not on the 
FTL.
    (Comment 187) Some comments assert that in addition to the proposed 
exemption associated with a ``kill step,'' products covered under the 
LACF and acidified foods (AF) regulations (parts 113 and 114, 
respectively) should be exempt from other recordkeeping requirements in 
the proposed rule. The comments state that the processes required in 
parts 113 and 114 exceed the exemption requirements included in 
proposed Sec.  1.1305(d). In addition, the comments maintain that those 
regulations require that the products be marked with a permanent code 
on their containers and that records be maintained for 3 years. The 
comments also propose that subpart S be modified to include provisions 
for identifying foods intended to undergo LACF or AF processes.
    (Response 187) As discussed in Response 7, the RRM-FT uses a 
categorization scheme that classifies FDA-regulated foods into 47 
commodity categories. Within each commodity category, the RRM-FT 
identifies individual commodities. Two of the 47 commodity categories 
apply to products covered under the LACF and AF regulations: 
``Acidified/LACF--Baby (Infant and Junior) Food Products'' and 
``Acidified/LACF--NEC.'' These two commodity categories are associated 
with eight different commodities: baby food; canned broth, chicken or 
beef; canned fruits and vegetables; canned seafood; cheese sauce 
(shelf-stable); diet and nutritional drinks (shelf-stable); milk 
(shelf-stable, not condensed); and soups (canned). None of these 
commodities had a risk score high enough to be included on the FTL. 
Therefore, there are currently no products covered under the LACF and 
AF regulations on the FTL, and such products are therefore not 
currently subject to the final rule.
    We agree it is helpful to identify foods that are intended to 
undergo processes that would either constitute a kill step or change 
the food such that it is no longer on the FTL (or both). Therefore, as 
discussed in Response 196, Sec.  1.1305(d)(6) of the final rule 
provides a partial exemption for foods that will be subjected to a kill 
step by an entity other than an RFE, restaurant, or consumer, or that 
will be changed by an entity other than an RFE, restaurant, or consumer 
such that the food is no longer on the FTL, provided that shippers and 
receivers of the food enter into written agreements stating that the 
food will receive a kill step or be changed such that it is no longer 
on the FTL. This partial exemption can be used when it is known that an 
FTL food will ultimately undergo processing under the LACF or AF 
regulations, and will therefore no longer be on the FTL.
    (Comment 188) Some comments state that pasteurized crabmeat should 
be exempt from subpart S because, in manufacturing the finished 
product, the crabs must be cooked twice, first to allow removal of the 
meat from the shell, and then a second time to pasteurize the finished 
product. The reasons provided in the comment for the requested 
exemption include that the second ``kill step'' was comparable to the 
processes that allow for exemption of produce and egg products under 
proposed Sec.  1.1305(d); that the seafood HACCP regulation requires 
the maintenance of records for those products for 2 years; that the 
seafood HACCP regulation requires processors to address all food safety 
hazards, including hazards introduced from the growing environment; and 
finally that the crabmeat is separated from the viscera, which 
eliminates the need for traceback to the harvest environment.
    (Response 188) We agree that the cooking or pasteurization of 
crabmeat products meets the definition of a kill step, provided that it 
is done in a way that constitutes lethality processing that 
significantly minimizes pathogens in the food. The exemptions in Sec.  
1.1305(d) relating to the application of a kill step are therefore 
applicable to cooked or pasteurized crabmeat products.
    (Comment 189) Some comments request that surimi analogue be 
considered exempt from the rule. The comments maintain that exemption 
would be appropriate because the process requires that the finished 
product be cooked twice during production and the second pasteurization 
process is comparable to the exemption requirements in Sec.  1.1305(d) 
for produce and egg products, and the seafood HACCP regulation requires 
the processor to address all food safety hazards associated with the 
analogue and to maintain HACCP records for 2 years.
    (Response 189) We do not think it is appropriate to exempt surimi 
analogue from the rule. Surimi analogue is a paste that is usually made 
from fish. As with any food, if surimi analogue contains an FTL food as 
an ingredient, it will be on the FTL (provided the FTL ingredient 
remains in the same form in which it appears on the FTL).

[[Page 70965]]

    However, the final rule provisions relating to kill steps would 
apply to surimi analogue just as they do to other foods. Surimi 
analogue and its FTL ingredients therefore could be eligible for the 
full and partial exemptions related to kill steps in Sec.  
1.1305(d)(3), (d)(5), and (d)(6), if the relevant conditions are met.
    (Comment 190) Some comments recommend that seafood that has 
undergone a cooking process (e.g., cooking, pasteurization, hot smoke) 
should not be considered ``high risk'' under the rule. The comments 
maintain that the seafood HACCP requirements and other regulatory 
controls are sufficient to ensure the safety of these products.
    (Response 190) Thermal processes intended to eliminate or 
significantly minimize pathogens meet the definition of a kill step. 
This is true of cooking in many contexts. However, as discussed in 
Response 186, cooking does not significantly minimize toxins such as 
histamine and ciguatoxin. Cooking a product does not constitute a kill 
step for foods on the FTL when acute chemical toxins or microbiological 
hazards that produce heat-stable toxins are determined to be among the 
commodity-hazard pair(s) that drive the commodity risk score and lead 
to the commodity being included on the FTL. Of the foods currently on 
the FTL, there are two commodities with such commodity-hazard pair(s) 
for which the associated hazards include toxins: Finfish, histamine-
producing species, and Finfish, species potentially contaminated with 
ciguatoxin. Because the acute chemical toxins in these types of finfish 
are not eliminated by thermal processes, cooking or other thermal 
processing of these commodities does not constitute a kill step. But 
for seafood products on the FTL that are not in either of these 
commodities, cooking or other thermal processing would be considered a 
kill step as long as the product is cooked sufficiently to constitute 
lethality processing that significantly minimizes the pathogens in the 
food.
    As discussed in Response 73, smoked finfish (including both hot and 
cold smoked finfish) is a commodity that was identified for inclusion 
on the FTL due to its risk score. Therefore, hot smoked finfish is 
covered by the subpart S requirements, and the hot smoking itself 
cannot be considered a kill step.
    Notwithstanding the fact that other regulations are in place for 
food safety, Congress instructed FDA to create a list of foods for 
which additional recordkeeping requirements would be appropriate and 
necessary to protect the public health, with the goal of improving 
traceability. While the seafood HACCP regulations are intended to 
ensure the safety of seafood products, the purpose of this final rule 
is to improve traceability in the event of a foodborne illness outbreak 
involving foods on the FTL. The seafood commodities on the FTL are on 
the list because they have a risk score that meets the threshold for 
the FTL. Consequently, persons who manufacture, process, pack, or hold 
seafood products on the FTL must comply with the subpart S 
requirements, unless an exemption applies.
    (Comment 191) Many comments maintain that downstream entities may 
not know whether a kill step was applied to a particular food and that 
distributors and retailers may not be able to create different systems 
for receiving foods on the FTL and foods not on the FTL. But some 
comments suggest that requiring shippers to communicate to receivers 
that a food has undergone a kill step would still require 
recordkeeping, resulting in this not being a true exemption. A few 
comments request that FDA specify that downstream entities could rely 
in good faith on the absence of subpart S records as an indication that 
a kill step was applied. Some comments suggest that FDA exercise 
enforcement discretion for those downstream entities that rely in good 
faith on upstream entities to determine whether a product received a 
kill step. One comment suggests that if the shipper does not provide 
subpart S records, the receiver should be able to assume the records 
are not required as long as the receiver does not have affirmative 
knowledge that the food should be covered by the rule and the shipper 
has provided a guaranty that it will provide traceability information 
when required.
    A few comments ask us to require the person who applied the kill 
step to provide a statement to subsequent entities in the supply chain 
that a kill step had been applied. One comment asks that we require 
anyone who received a food to which a kill step has been applied to 
maintain lot-based traceability linking back to the entity that applied 
the kill step.
    (Response 191) As discussed in Response 196, a person who applies a 
kill step must maintain a record of the kill step, but they are not 
required to keep records relating to the transformation or subsequent 
shipping of the food. Under Sec.  1.1305(d)(5), subpart S does not 
apply to food a person receives that has previously been subjected to a 
kill step. As discussed above, we think these exemptions are 
appropriate in light of the reduced risk associated with foods that 
have received a kill step.
    We have not included a requirement for the person applying the kill 
step to notify downstream entities that a kill step has been applied, 
and we also decline to require subsequent entities to maintain 
traceability records for products to which a kill step has been 
applied. Receivers should not assume (in the absence of other evidence) 
that just because they receive a product without subpart S records from 
the shipper of the food that a kill step was applied. Persons covered 
by the rule are responsible for knowing whether they need to keep 
subpart S records. In cases where it is not clear whether a kill step 
has been applied, firms should work with their suppliers to communicate 
about the status of the product. If entities in a particular supply 
chain wish to have documentation of a kill step, they can work that out 
with their supply chain partners. As discussed previously, we encourage 
persons selling exempt foods to provide information about their exempt 
status to downstream entities in the supply chain.
    (Comment 192) A few comments request that FDA also provide an 
exemption for foods that will receive a kill step from the consumer. 
The comments argue that these foods are less likely to result in a 
foodborne illness outbreak, making additional recordkeeping 
requirements for traceability unnecessary.
    (Response 192) We decline to provide an exemption for FTL foods for 
which the consumer will apply a kill step. The kill step exemption in 
the final rule applies only to foods to which a kill step is applied by 
a commercial entity, and the entity applying the kill step must 
maintain a record of the application of the kill step. We anticipate 
that entities applying a kill step will primarily include 
manufacturers/processors producing food under existing regulations, 
such as the preventive controls, LACF, and seafood HACCP regulations. 
Those regulations include additional provisions to ensure that a kill 
step was applied adequately. Consumers may not apply an adequate kill 
step in the home or may not follow the cooking instructions; they also 
might not apply a kill step at all, depending on the nature of the 
food.
    (Comment 193) One comment suggests that the requirement to identify 
a list of FTL foods to be shipped should not include foods that will 
receive a kill step.

[[Page 70966]]

    (Response 193) As discussed in Section V.G of this document, the 
final rule omits the proposed requirement to maintain a list of FTL 
foods shipped.
    (Comment 194) One comment suggests that we revise the definition of 
the ``Food Traceability List'' to make clear that if a food on the FTL 
receives a kill step, it is not covered by the rule.
    (Response 194) We decline to revise the definition of ``Food 
Traceability List'' as suggested. Instead, as discussed above, the 
final rule provides a complete exemption for food a person receives 
that has previously been subjected to a kill step, as well as partial 
exemptions for food a person subjects to a kill step and food that will 
be subjected to a kill step in the future. We think these exemptions 
provide an appropriate level of traceability for these foods, while 
taking into account the reduced risk associated with these foods.
    We note that in some cases, the application of a kill step 
coincides with a food being changed such that it is no longer on the 
FTL. For example, as discussed in Response 30, fresh spinach is on the 
FTL because it is part of the commodity ``leafy greens,'' but canned 
spinach is not on the FTL because it is part of the commodity ``canned 
fruits and vegetables.'' Moreover, the fact that canned spinach 
contains spinach as an ingredient does not place it on the FTL, because 
the spinach is not in the same form (``fresh'') in which it appears on 
the FTL. The canning process (and related cooking) constitutes a change 
to the food such that it is no longer on the FTL; consequently, canned 
spinach is not covered by the rule. It therefore might not be necessary 
to inquire whether the canned food received a kill step, though we note 
that the processes associated with making canned spinach under the LACF 
regulation do constitute a kill step.
    (Comment 195) Some comments suggest that we should exempt dietary 
supplements and dietary ingredients from the rule because dietary 
ingredient manufacturing involves steps to reduce the presence of 
microorganisms of public health significance.
    (Response 195) We decline to exempt dietary supplements or dietary 
ingredients from the rule. As discussed in Response 78, dietary 
supplements are a separate commodity in the Model and they do not have 
a risk score high enough to merit inclusion on the FTL. However, if a 
dietary supplement uses an ingredient that is on the FTL, and that 
ingredient is in the same form in which it appears on the FTL (e.g., 
``fresh''), then the dietary supplement would be covered by the rule. 
For example, some refrigerated dietary supplements contain fresh herbs 
and are therefore on the FTL and covered by the rule.
    (Comment 196) Multiple comments assert that, in addition to 
providing a partial exemption for foods that receive a kill step, we 
should also exempt, throughout the supply chain, foods that will 
receive a kill step in the future. The comments argue that because a 
kill step will be applied, there is no public health benefit to 
requiring additional traceability records for those foods. The comments 
also suggest that receiving and transformation records, including 
maintaining a lot code, should not be required for foods that will 
receive a kill step in the future. The comments note that we already 
allow for an exemption for certain produce and eggs that will receive 
commercial processing in the future.
    (Response 196) We agree with the comments that full traceability 
records are not necessary for foods that will receive a kill step in 
the future. Under the final rule, once it becomes known that an FTL 
food will receive a kill step in the future, the food becomes eligible 
for the partial exemption in Sec.  1.1305(d)(6), provided that written 
agreements are in place, as described below, to indicate the intent 
that the food will be subjected to a kill step. The person who applies 
the kill step would still need to maintain a record of the kill step, 
as specified in Sec.  1.1305(d)(3)(ii); however, because of the 
existence of the written agreement, the person applying the kill step 
would not need to keep receiving records for the food, as specified in 
Sec.  1.1305(d)(3)(i). (Furthermore, as discussed in the introduction 
to Section V.E.5 of this document, the person who applies a kill step 
is never required to keep transformation or shipping records relating 
to the food, provided they maintain a record of the kill step.) If the 
entity applying the kill step does not have a written agreement in 
place with the shipper of the food, the entity must maintain receiving 
records for the food, as stated in Sec.  1.1305(d)(3)(i). Once the kill 
step has been applied, subsequent entities who receive the food would 
not need to keep subpart S records for the food, as specified in Sec.  
1.1305(d)(5).
    To ensure that a kill step will be applied, Sec.  1.1305(d)(6) of 
the final rule requires, for the exemption to apply, that the shipper 
and receiver of the FTL food enter into a written agreement stating 
that a kill step will be applied to the FTL food by an entity other 
than an RFE, restaurant, or consumer. The written agreement can either 
specify that the receiver will apply a kill step, or that the receiver 
will only ship the food to another entity that agrees, in writing, that 
it will either apply a kill step or enter into a similar written 
agreement with the subsequent receiver stating that a kill step will be 
applied to the food. The food might move through several steps in the 
supply chain before it reaches the entity that applies the kill step, 
and the first shipper might not be aware of who will eventually apply 
the kill step. However, for each shipping event that is covered by a 
written agreement between the shipper and the receiver, there must be a 
shared understanding that the food will eventually be subjected to a 
kill step by an entity that is not an RFE, restaurant, or consumer. 
RFEs, restaurants, and consumers are not included because we expect the 
kill step to be applied under controlled conditions, which may not 
always be the case in a retail food setting or in the home. As 
discussed in Response 185, we anticipate that entities applying a kill 
step will primarily be manufacturers/processors producing food under 
existing regulations, such as those on preventive controls, LACF, and 
seafood HACCP, which will help ensure that the kill step is applied 
adequately.
    As specified in Sec.  1.1305(d)(6)(iii), a written agreement under 
these provisions must include the effective date, printed names and 
signatures of the persons entering into the agreement, and the 
substance of the agreement. We consider electronic signatures to meet 
the signature requirement of this provision, and another entity (e.g., 
corporate headquarters) may sign the agreement on behalf of a shipper 
or receiver provided the agreement is specific to the shipper and 
receiver. To ensure the agreement reflects the current understanding 
between the parties, the written agreement must be renewed at least 
once every 3 years, as set forth in Sec.  1.1305(d)(6)(iv). That 
provision also specifies that the written agreement must be maintained 
by both parties for as long as it is in effect.
    We are providing flexibility for written agreements to be entered 
into in a variety of ways, depending on the business practices of the 
supply chain partners. The written agreement can be a new agreement 
developed for the purposes of this regulation or it can be written into 
existing contracts or other documents between the shipper and receiver. 
The written agreement can be written to cover the FTL food on a per-
lot, per-shipment, or other basis (e.g., all products the shipper 
provides to the receiver will receive a kill step), depending on what 
makes the most sense for the shipper and receiver.

[[Page 70967]]

However, the written agreement must represent the current understanding 
of the parties. If circumstances change such that the substance of the 
written agreement is no longer accurate, the agreement must be updated 
even if the 3 years has not expired. As with all records required under 
subpart S, written agreements must be provided to FDA upon request in 
accordance with Sec.  1.1455(c).
    This approach aligns with our exemptions in Sec.  1.1305(d)(1) and 
(2) for produce that is eligible for the commercial processing 
exemption under Sec.  112.2(b) of the produce safety regulation, and 
for shell eggs when all eggs produced at a particular farm will receive 
a treatment. We agree with the comments that it makes sense to add this 
new partial exemption to broaden the situations in which the 
recordkeeping burden can be reduced due to advance knowledge that a 
food will receive a kill step. This new partial exemption is available 
in situations that are not covered by the two other exemptions in Sec.  
1.1305(d), including situations where it does not become known that the 
food will receive a kill step until after it leaves the farm or other 
point of origination.
    As discussed in Response 194, the partial exemption in Sec.  
1.1305(d)(6) is available not only to food that will receive a kill 
step, but also to food that will be changed such that it is no longer 
on the FTL.
    (Comment 197) One comment requests that FDA expand the kill step 
exemption to include FTL foods that received a kill step in compliance 
with the preventive controls for human food regulation in part 117, 
subpart C (21 CFR part 117, subpart C), or related regulations. The 
comment argues that this would be consistent with the commercial 
processing exemption for produce in the proposed rule and would exclude 
foods that will be prepared under food safety plans that require a kill 
step, either through processing or validated cooking instructions to 
the consumer.
    (Response 197) As discussed above, we are providing a set of full 
and partial exemptions relating to foods that receive a kill step. Such 
kill steps will often, though not always, be applied in facilities that 
are subject to the preventive controls regulation. We are not exempting 
FTL foods for which the consumer is expected to apply a kill step, as 
discussed in Response 192.
6. Exemption for Produce That Is Rarely Consumed Raw
    We proposed to exempt from subpart S produce that is listed as 
rarely consumed raw (RCR) in Sec.  112.2(a)(1) of the produce safety 
regulation (proposed Sec.  1.1305(e)). We stated that due to the lesser 
risk to public health posed by such produce (as reflected in its being 
exempt from the produce safety regulation), it was not necessary to 
apply the additional recordkeeping requirements to these foods. The 
final rule maintains this exemption in Sec.  1.1305(e).
    (Comment 198) Some comments support exemption of produce that is 
rarely consumed raw. Some comments also suggest revisiting the RCR list 
and request that we evaluate a broader range of crops than the 
commodities found in the National Health and Nutrition Examination 
Survey, What We Eat in America (NHANES/WWEIA) dataset. One comment 
suggests exemption of foods that contain an ingredient that is on the 
FTL if the food is rarely consumed raw (even if the food is not listed 
on the RCR list in Sec.  112.2(a)(1)), for example, frozen pizza 
containing an ingredient on the FTL. One comment requests that we apply 
our exemption for RCR produce to all foods on the FTL that are rarely 
consumed raw. The comment asserts that this would reduce the number of 
foods covered by the FTL that have never been associated with a 
foodborne illness outbreak. The comment maintains that because foods 
like frozen pizza are usually cooked by the consumer before being 
consumed, they should not be covered. Other comments maintain that most 
seafood should not be covered by the rule because it is cooked before 
consumption.
    (Response 198) Produce that is on the RCR list as not covered under 
the produce safety regulation in Sec.  112.2(a)(1) is exempt from the 
subpart S requirements under Sec.  1.1305(e). Reevaluation of the RCR 
list is beyond the scope of this rulemaking. The RCR list is an 
exhaustive list containing fruits and vegetables that are almost always 
cooked before being consumed. The list was developed using national 
food survey data from the NHANES/WWEIA that was conducted in 
partnership between the U.S. Department of Health and Human Services 
(HHS) and the USDA. NHANES/WWEIA examines a nationally representative 
sample of about 5,000 persons each year located across the country. The 
sample is selected to represent the U.S. population of all ages. More 
information, data, and other details about how the RCR list was 
developed are available in the final rule establishing the produce 
safety regulation (80 FR 74353).
    As discussed in Response 192, we are not creating a broader 
exemption to the subpart S requirements for foods that are expected to 
receive a consumer kill step. We also decline to create a ``rarely 
consumed raw'' exemption for non-produce foods. As discussed above, FDA 
developed an exhaustive list of produce that is designated as RCR in 
the produce safety regulation, and those products are exempt from the 
subpart S requirements. However, we have not developed an exhaustive 
list for other types of foods, such as frozen pizza or specific types 
of finfish, that are rarely consumed raw, and it would not be feasible 
to do so at this time. Moreover, although the Agency determined in the 
produce safety regulation that there was relatively low risk associated 
with produce that is rarely consumed raw, it does not necessarily 
follow that this is the case for non-produce items that are rarely 
consumed raw. Shell eggs are not intended to be consumed raw, and 
indeed for many years FDA has required that all shell eggs be labeled 
with safe handling instructions requiring that they be cooked 
thoroughly (see 21 CFR 101.17(h)). However, subsequent to the issuance 
of that regulation, shell eggs were nonetheless involved in numerous 
foodborne illness outbreaks. Furthermore, as discussed above, many 
types of seafood are associated with hazards that are not addressed by 
cooking. These are some of the complexities that have led us to decide 
not to identify and exempt a list of non-produce items that are rarely 
consumed raw.
    The coverage of seafood on the FTL is discussed in several 
responses in this document. We note that ``Pizza (Frozen)'' is a 
commodity that was evaluated by the Model, and it did not receive a 
risk score high enough to be on the FTL. And because all of its 
ingredients are frozen, a frozen pizza could only be on the FTL if it 
contained an FTL ingredient that is on the FTL in its frozen form 
(e.g., finfish).
    (Comment 199) Some comments maintain that the majority of seafood 
products are cooked prior to consumption and are rarely consumed raw 
(e.g., shrimp, lobster, crab, crayfish), yet the exemption in proposed 
Sec.  1.1305(e) only addresses produce that is rarely consumed raw. 
Some comments further maintain that NHANES did not accurately capture 
consumption patterns of shrimp and the extent to which shrimp is 
consumed cooked or raw. The comments suggest opening a public comment 
period for stakeholders to help identify seafood products that are 
rarely consumed raw

[[Page 70968]]

and develop a list similar to that for produce in part 112.
    (Response 199) As discussed above, we decline to identify and 
exempt seafood products that are rarely consumed raw. Under the seafood 
HACCP regulations, the identification of products that will be cooked 
before consumption occurs during the individual processor's hazard 
analysis where hazards and controls are identified. In the absence of 
an RCR list identifying specific species of seafood that are unlikely 
to be consumed raw, the Model identified seafood commodities (e.g., 
several finfish commodities and crustaceans) as having a risk score 
that meets the criteria for the FTL based on data related to 
consumption and six other criteria (Ref. 10), which resulted in those 
foods being included on the FTL. Further, we believe NHANES is 
currently the best data source available for estimating consumption 
across the commodities in the RRM-FT, including the commodity 
``Crustaceans,'' which includes shrimp. The RRM-FT does not consider 
consumer cooking because the commodity in the Model is defined as foods 
available for purchase by the consumer. Therefore, we used data from 
NHANES regardless of whether the product is consumed cooked or raw by 
the consumer to score Criterion 6 (Consumption) for ``Crustaceans.''
7. Exemption for Raw Bivalve Molluscan Shellfish
    The proposed rule did not include an exemption for molluscan 
shellfish. However, we received many comments requesting such an 
exemption. In response to the comments, the final rule includes an 
exemption for certain raw bivalve molluscan shellfish, as discussed in 
the following paragraphs.
    (Comment 200) One comment maintains that although existing 
regulations applicable to shellfish are adequate, application of the 
rule to shellfish could produce potential benefits. On the other hand, 
several comments ask that we exempt from the rule shellfish that is 
subject to the NSSP. Several comments compare the existing raw 
molluscan shellfish safety and traceability requirements to the 
proposed rule and ask that we exempt raw molluscan shellfish from the 
rule. One comment maintains that current Louisiana laws and regulations 
cover most of the proposed requirements for the shellfish industry 
operating in accordance with the NSSP requirements. Some comments 
assert that there are conflicts between the proposed rule and the 
requirements in the seafood HACCP regulation and the NSSP Model 
Ordinance (recognized by the ISSC), and maintain that the information 
required by the proposed rule should already be contained in records 
required by the NSSP. The comments maintain that the current NSSP 
requirements and local laws regarding traceability and recordkeeping 
require traceability back to harvesters and harvest waters, adding that 
processors also must meet the requirements of the NSSP Guide for the 
Control of Molluscan Shellfish (NSSP Guide) and the seafood HACCP 
regulation to address food safety hazards associated with raw molluscan 
shellfish. The comments assert that adding the subpart S requirements 
would cause financial burdens and further confuse the regulatory 
environment. One comment asserts that not granting a ``waiver'' for 
shellfish would establish dual conflicting traceability requirements. 
One comment maintains that if FDA thinks different traceback 
information is needed for raw molluscan shellfish, we should use the 
process for making changes to the NSSP through the ISSC. However, one 
comment asserts that changes to the NSSP Guide or additional, redundant 
requirements would cause confusion in both the regulatory community and 
the shellfish industry. Many of the comments maintain that the proposed 
traceability requirements would not provide any additional safety 
benefits regarding raw molluscan shellfish. One comment suggests the 
use of State-designated harvest areas and NSSP lease numbers as harvest 
locations. One comment suggests that the rule specifically exempt 
``shellfish harvesters and dealers that are regulated pursuant to the 
National Shellfish Sanitation Program and are listed on the Interstate 
Certified Shellfish Shippers List published by the U.S. Food and Drug 
Administration.''
    (Response 200) We recognize that the NSSP is a longstanding, well-
established Federal-State cooperative program for the sanitary control 
of shellfish produced and sold for human consumption with broad 
participation from agencies from shellfish-producing and non-producing 
States, FDA, the Environmental Protection Agency (EPA), NOAA, foreign 
governments, and the shellfish industry. Specifically, the NSSP 
provides a broad framework of raw molluscan shellfish sanitation 
standards through the NSSP Guide. The NSSP Guide contains within it all 
relevant federal requirements concerning, among other things, current 
good manufacturing practice (CGMP), hazard analysis and HACCP plans, 
recordkeeping, sanitation control procedures, and the restriction of 
interstate transport of shellfish in an insanitary manner. Importantly, 
the NSSP Guide also allow products in the program to be traced from 
harvest to retail. We conclude that applying the requirements of this 
rule to such molluscan shellfish covered by NSSP would be unnecessary 
and duplicative in light of those existing controls.
    Further, we recognize that under the seafood HACCP regulations, 
processors of fishery products that meet the definition of ``molluscan 
shellfish'' in Sec.  123.3(h) (21 CFR 123.3(h)) are required by subpart 
C of part 123 to maintain records documenting certain required 
traceability information relating to the shellstock. Additionally, 
Sec.  1240.60 requires that shipments of molluscan shellstock or 
containers of shucked molluscan shellfish be accompanied by tags, 
labels, BOLs, or similar shipping documents that bear certain required 
traceability information. Therefore, we conclude that applying the 
requirements of this rule to raw bivalve molluscan shellfish that is 
subject to the requirements of part 123, subpart C, and Sec.  1240.60 
would be unnecessary and duplicative in light of those existing 
controls.
    We also recognize that there are raw bivalve molluscan shellfish 
that are covered by a final equivalence determination by FDA, meaning 
that FDA has found that a foreign country has adopted and implemented a 
system of food safety control measures for raw bivalve molluscan 
shellfish that provides at least the same level of sanitary protection 
as comparable food safety measures in the United States (i.e., those 
applied through the NSSP and those required by subpart C of part 123 
and Sec.  1240.60). We therefore conclude that applying the 
requirements of this rule to raw bivalve molluscan shellfish that are 
covered by a final equivalence determination by FDA would be 
unnecessary and duplicative.
    Therefore, Sec.  1.1305(f) of the final rule provides that the 
subpart S requirements do not apply to raw bivalve molluscan shellfish 
that are covered by the requirements of the NSSP; subject to the 
requirements of part 123, subpart C, and Sec.  1240.60; or covered by a 
final equivalence determination by FDA for raw bivalve molluscan 
shellfish. This exemption holds throughout the supply chain, including 
subsequent receivers of raw bivalve molluscan shellfish.
    (Comment 201) One comment asserts that the State of Louisiana 
regulates oyster harvesting, including traceability requirements that 
require oyster tags to

[[Page 70969]]

be kept for 90 days. The comment maintains that the Louisiana 
recordkeeping requirements (including those concerning commercial trip 
tickets, oyster tags, and time-temperature logs) help ensure that 
oysters are tracked from harvest to consumption to protect the public 
health. The comment asserts that these traceability requirements cover 
the goals of the proposed rule.
    (Response 201) As stated in Response 200, raw bivalve molluscan 
shellfish covered by the requirements of the NSSP are exempt from 
subpart S under Sec.  1.1305(f). Through their participation in the 
NSSP and membership in the ISSC, States such as Louisiana have agreed 
to adopt the NSSP Model Ordinance into State law and enforce NSSP 
requirements for the sanitary control of molluscan shellfish.
    (Comment 202) One comment recommends that all shellfish harvesters 
and shellfish farmers be exempt from the requirement to create lot 
codes and instead, the comment asserts, they should keep records under 
Sec.  1.337, consistent with existing subpart J requirements. The 
comment asserts that asking each shellfish harvester and shellfish 
farmer to register with FDA is duplicative because they already have to 
be licensed by their State shellfish control authorities.
    (Response 202) Under Sec.  1.1305(f), and as stated in Response 
200, subpart S does not apply to raw bivalve molluscan shellfish that 
are covered by the requirements of the NSSP; subject to the 
requirements of part 123, subpart C, and Sec.  1240.60; or covered by a 
final equivalence determination by FDA for raw bivalve molluscan 
shellfish. However, we decline the recommendation to exempt all 
shellfish harvesters and shellfish farmers from the requirement to 
assign traceability lot codes. The FTL contains types of shellfish that 
are not molluscan shellfish (specifically crustaceans, including, but 
not limited to, shrimp, crab, lobster, and crayfish) and that are 
therefore not exempt under Sec.  1.1305(f), and for those types of 
shellfish, the requirement to assign traceability lot codes is the same 
as for any other food on the FTL. Shellfish harvesters and shellfish 
farmers that initially pack a RAC (other than a food obtained from a 
fishing vessel), perform the first land-based processing of a food 
obtained from a fishing vessel, or transform a food would be required 
to assign traceability lot codes in accordance with Sec.  1.1320.
    This rule does not establish a requirement for shellfish harvesters 
and farmers to register with FDA. Food facility registration is 
addressed in subpart H. We note that subpart H does not apply to farms 
(see Sec.  1.226(b) (21 CFR 1.226(b)) or to certain fishing vessels 
(see Sec.  1.226(f)).
    (Comment 203) One comment asks if the proposed traceability lot 
code would be required to travel with oysters after they are shucked. 
The comment mentions that the shellfish industry commonly commingles 
shellfish based on grade and order, and maintains that requiring a 
vessel-specific traceability lot code would be burdensome. One comment 
asks FDA to clarify if receiver requirements would apply to a shucker 
of raw molluscan shellfish destined for a restaurant.
    (Response 203) As stated in Response 200, subpart S does not apply 
to raw bivalve molluscan shellfish that are covered by the requirements 
of the NSSP; subject to the requirements of part 123, subpart C, and 
Sec.  1240.60; or covered by a final equivalence determination by FDA 
for raw bivalve molluscan shellfish. This exemption applies throughout 
the supply chain, including subsequent receivers, shippers, and 
transformers of the shellfish. Therefore, a traceability lot code will 
not be required to travel with oysters (or other raw bivalve molluscan 
shellfish) after they are shucked, and receiver requirements will not 
apply to apply to a shucker of raw bivalve molluscan shellfish destined 
for a restaurant.
    Regarding the comment's observation that all shellfish, not 
specifically oysters, are commonly commingled, we note that not all 
shellfish are exempt, as discussed in more detail in Response 202 
above. Specifically, the FTL also includes crustacean shellfish, which 
are not exempt under Sec.  1.1305(f). For crustacean shellfish, the 
requirement to assign traceability lot codes is the same as for any 
other food on the FTL. As discussed in Section V.E.9 of this document, 
some seafood will be able to meet the definition of ``commingled raw 
agricultural commodity'' in this rule and will therefore be eligible 
for the partial exemption in Sec.  1.1305(h).
8. Exemption for Persons Who Manufacture, Process, Pack, or Hold 
Certain Foods Subject to USDA Regulation
    Although the proposed rule did not include an exemption for foods 
that are subject to regulation by the USDA, in response to a comment, 
the final rule specifies that the subpart S requirements do not apply 
to persons who manufacture, process, pack, or hold FTL foods during or 
after the time when the food is within the USDA's exclusive 
jurisdiction, as discussed in the following paragraphs.
    (Comment 204) One comment asks whether facilities regulated by the 
USDA's FSIS are covered by the rule.
    (Response 204) Facilities that are exclusively regulated by FSIS 
are not covered by this rule. See Response 83 for further discussion of 
Sec.  1.1305(g), which states that the subpart S requirements do not 
apply to persons who manufacture, process, pack, or hold food on the 
FTL during or after the time when the food is within the exclusive 
jurisdiction of the USDA under the Federal Meat Inspection Act (21 
U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 
et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.). 
If FDA and FSIS share joint regulatory oversight of a particular 
facility, FTL foods produced under exclusive FSIS oversight in that 
facility would not be covered by the final rule.
    The requirements of subpart S apply to FTL foods that have not yet 
arrived at a facility where they will be exclusively regulated by FSIS. 
For example, if an FDA-regulated facility sends an FTL food to a 
facility where it will be exclusively regulated by FSIS, the shipper 
must maintain the required shipping KDEs and provide the required KDEs 
to the FSIS facility in accordance with Sec.  1.1340 of the final rule. 
This will help ensure that the FSIS facility has a record of the 
shipment of the food in the event a traceback of the food products is 
necessary. However, neither the FSIS facility nor any subsequent 
entities in the food's supply chain would be required to keep subpart S 
records for the food.
9. Partial Exemption for Commingled Raw Agricultural Commodities
    In accordance with section 204(d)(6)(D) of FSMA, we proposed to 
partially exempt certain commingled RACs from subpart S (proposed Sec.  
1.1305(f)). For purposes of the partial exemption, and in keeping with 
Congress's language in section 204(d)(6)(D) of FSMA, we proposed to 
define ``commingled raw agricultural commodity'' as any commodity that 
is combined or mixed after harvesting but before processing, except 
that the term 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.  1.1305(f)(1)). As a result, the proposed exemption would not 
apply to produce subject to the produce safety regulation. Also in 
keeping with section 204(d)(6)(D) of FSMA, the proposed rule

[[Page 70970]]

stated that the term ``processing'' 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)). In the preamble to the proposed rule, we 
stated that for the purposes of this definition of ``commingled raw 
agricultural commodity,'' a commodity would be regarded as combined or 
mixed before processing only when the combination or mixing involved 
food from different farms (see 85 FR 59984 at 59996).
    Also, in keeping with section 204(d)(6)(D) of FSMA, proposed Sec.  
1.1305(f)(2) specified that, with respect to a commingled RAC that 
receives the exemption in proposed Sec.  1.1305(f)(1), if a person who 
manufactures, processes, packs, or holds such commingled RAC is 
required to register with FDA under section 415 of the FD&C Act in 
accordance with subpart H with respect to the relevant RAC, such person 
must maintain records (for 2 years) identifying the immediate previous 
source of such RAC and the immediate subsequent recipient of such food 
in accordance with the subpart J traceability requirements in 
Sec. Sec.  1.337 and 1.345.
    As discussed in the following paragraphs, consistent with changes 
we are making in response to comments in Section V.E.5 of this document 
to exempt foods that will be subjected to a kill step (see Response 
196), we are expanding the partial exemption for commingled RACs to 
include RACs that will become commingled in the future, provided that 
there is a written agreement in place between the shipper and receiver 
of the RAC, as specified in Sec.  1.1305(h)(2) of the final rule. In 
response to comments, we have made other minor changes to the proposed 
partial exemption for commingled RACs and to the definition of 
``commingled raw agricultural commodity,'' as discussed in the 
following paragraphs.
    (Comment 205) One comment suggests expanding the proposed 
definition of ``commingled raw agricultural commodity'' to include bulk 
and commingled ingredients after they are first combined and 
subsequently transformed.
    (Response 205) We decline to make this change to the proposed 
definition of ``commingled raw agricultural commodity.'' In section 
204(d)(6)(D)(ii)(I) of FSMA, Congress defined ``commingled raw 
agricultural commodity'' for purposes of this partial exemption as any 
commodity that is combined or mixed after harvesting but before 
processing. We incorporated this definition in proposed Sec.  
1.1305(f)(1), and we continue to incorporate it in the final rule, 
although we have moved it to the ``Definitions'' section of subpart S 
(Sec.  1.1310). We conclude that it would not be appropriate to broaden 
the scope of the exemption to include RACs that are commingled after 
processing, as the comment appears to suggest, because this would 
result in more FTL foods for which subpart S traceability records would 
not be available in the event of a foodborne illness outbreak involving 
such a food. However, we note that the partial exemption applies to 
commingled RACs as they move through the supply chain. Therefore, to 
the extent that the comment is suggesting that commingled RACs should 
continue to be exempt after they are shipped by the entity that 
performed the commingling, this is already part of the stated 
exemption.
    We note that although farms and firms are not required to keep 
subpart S records for commingled RACs exempted under Sec.  1.1305(h), 
maintaining traceability records as a best practice can be beneficial 
in the event that a traceback or recall is required.
    (Comment 206) One comment requests that we clarify how the 
commingled RAC exemption will apply to eggs. The comment asks whether 
eggs from separate farms under different company management, commingled 
before packing, are eligible for the exemption. The comment also asks 
whether, if a processor uses eggs grown on his farm and mixes them with 
eggs from another farm that are exempted under this commingled RAC 
exemption, the exemption extends to the processor's mixed eggs.
    (Response 206) In the preamble to the proposed rule (85 FR 59984 at 
59997), we stated that we would consider commingled shell eggs to be 
eggs from separate farms under different company management that are 
physically mixed before packing, while packed eggs that are from a 
single farm or from separate farms under the same management would not 
be considered commingled shell eggs. Therefore, if a processor mixes 
eggs collected on her farm with eggs from another farm under different 
company management, and she does so before packing the eggs, the eggs 
so combined would be eligible for the exemption in Sec.  1.1305(h). 
This is true regardless of whether the eggs from the other farm were 
already considered to be exempt under this provision.
    Although we believe it is likely that most people would understand 
the phrase ``different farms'' to mean farms under different company 
management, because there are many different business models for farms, 
we believe the definition should provide greater clarity on the meaning 
of ``different farms.'' Therefore, the final rule's definition of 
``commingled raw agricultural commodity'' specifies that a commodity is 
``combined or mixed'' only when the combination or mixing involves food 
from different farms under different company management (except with 
respect to food obtained from a fishing vessel, as discussed in 
Response 208).
    (Comment 207) One comment asks FDA to clarify situations under 
contract manufacturing with regard to egg production, specifically in-
line production (when the henhouse and shell egg processing plant are 
on the same site) and off-line production (when a shell egg processing 
plant receives eggs from nearby farms). The comment states that the 
farms may be under the same ownership as the shell egg processing 
plant, or the shell egg processing plant may own the laying hens but 
not the land or the site. The comment maintains that if a farm is 
operating a shell egg processing plant, the records of contract farms 
must be sent to the immediate subsequent recipients (retail grocery 
store or food service company) of eggs, because the eggs in question 
will have ``originated'' on the contract farms, since the originator is 
where the eggs are harvested. The comment maintains that in the off-
line setting, the shell egg processing plant would have to provide 
records to immediate subsequent recipients (customers). However, the 
comment does not believe that this information is relevant or needs to 
be passed along to the customers, because the processing plant will 
have those records.
    (Response 207) As discussed above, when eggs from different farms 
under different company management are combined or mixed before they 
are processed, they are eligible for the partial exemption under Sec.  
1.1305(h). Therefore, in the off-line production systems described in 
the comment, if the eggs come from different farms under different 
company management and they are combined or mixed at the processing 
plant before they are processed, they would be eligible for the partial 
exemption. For the in-line production systems described in the comment, 
if the eggs being processed are all from the same farm, then they are 
not eligible for the partial exemption.
    For eggs that are not subject to the partial exemption, the 
requirements of subpart S would apply. As described in Response 271, 
the final rule does not use the concept of ``origination'' that is

[[Page 70971]]

mentioned in the comment. Sections V.J and V.K of this document discuss 
how the revised KDEs apply to RACs such as eggs. We do not agree that 
sending traceability information through the supply chain is 
unnecessary in situations where the processing plant maintains the 
records. Traceback often begins at RFEs or restaurants, and it is 
important for those entities to have the relevant traceability records.
    (Comment 208) Some comments suggest that the partial exemption for 
commingled RACs should apply to seafood. The comments maintain that 
commingling of seafood occurs at different stages after harvesting and 
before processing. The comments assert that the originating source may 
not be a farm but a landing source that might range from several docks 
to fishing vessels. The comments ask whether products produced by 
factory trawlers and at-sea processing vessels that harvest and process 
the fish will be eligible for the partial exemption.
    (Response 208) The preamble to the proposed rule did not discuss 
application of the partial exemption for commingled RACs to commingled 
seafood, and we agree with the comments that we should provide clarity 
on this matter. We further agree that some seafood will be able to meet 
the definition of ``commingled raw agricultural commodity'' in this 
rule and will therefore be eligible for the partial exemption in Sec.  
1.1305(h). For seafood that is not obtained from a fishing vessel 
(e.g., seafood that is farmed in an aquaculture operation), the 
application of the partial exemption would be similar to what is 
described above for eggs.
    We conclude that we should modify the definition of ``commingled 
raw agricultural commodity'' as it applies to food obtained from a 
fishing vessel to reflect the unique circumstances of such food, 
including the fact that fishing vessels are partially exempt from the 
rule under Sec.  1.1305(m). Therefore, we have revised the definition 
of ``commingled raw agricultural commodity'' to specify that for food 
obtained from a fishing vessel, a commodity is ``combined or mixed'' 
only when the combination or mixing involves food from different 
landing vessels and occurs after the vessels have landed. We believe 
that the requirement that the combination or mixing involve food from 
different landing vessels and occur after the vessels have landed 
generally parallels the requirement that the combination or mixing of a 
RAC not obtained from a fishing vessel must involve food from different 
farms under different company management. Applying this revised 
definition of ``commingled raw agricultural commodity'' to the comment 
concerning products produced by factory trawlers and at-sea processing 
vessels, we note that the seafood would not be subject to the partial 
exemption for commingled RACs if the combination or mixing of the 
seafood occurs before the vessels have landed. We recognize that 
commingling of seafood often occurs on fishing vessels prior to 
landing. However, fishing vessels are exempt from subpart S under Sec.  
1.1305(m) and therefore are not required by this rule to keep records 
of any commingling or processing that occurs on the fishing vessel. 
Under this regulation, the chain of traceability records for food 
obtained from a fishing vessel does not begin until the vessel lands, 
as described in Section V.L of this document. Therefore, for food 
obtained from a fishing vessel, we have defined commingling to mean the 
combining or mixing of food from different landing vessels that occurs 
after the vessels have landed. See Response 385 for an explanation of 
how the first land-based processor of food obtained from a fishing 
vessel would record KDEs, such as the harvest date range and locations, 
in situations where the food was caught by different vessels and 
combined onto a single vessel before coming to land.
    (Comment 209) One comment maintains that spices are consolidated/
commingled at various steps in the supply chain before processing and 
therefore should be eligible for the partial exemption for commingled 
RACs.
    (Response 209) ``Spices'' is a commodity that was considered in the 
Model but that did not receive a high-enough risk score to be included 
on the FTL; therefore, spices are not currently subject to the rule. If 
spices were to be added to the FTL in the future, any spices that met 
the definition of a commingled RAC would be eligible for the partial 
exemption. We note that herbs are distinct from spices, and herbs are 
explicitly covered by the produce safety regulation (see Sec.  
112.1(b)(1) (21 CFR 112.1(b)(1)). Therefore, herbs--such as fresh 
herbs, which are currently on the FTL--are not eligible for the partial 
exemption for commingled RACs.
    (Comment 210) Some comments suggest that we establish a partial 
exemption for commingled RACs (other than fruits and vegetables that 
are subject to the produce safety regulation) such as grains and 
oilseeds that are not currently on the FTL but could be added to the 
list in the future.
    (Response 210) We do not think it is necessary to adopt a specific 
exemption for grains, oilseeds, and other potentially commingled RACs 
that are not on the FTL but could be added to the FTL in a future 
update of the list. If a RAC not on the FTL is added to the FTL in the 
future, and if that RAC is not subject to the produce safety 
regulation, a mixture or combination of that RAC that met the 
definition of a commingled RAC would be eligible for the partial 
exemption at that time.
    On our own initiative, we are revising the partial exemption for 
commingled RACs to extend it to RACs that that will become commingled 
RACs in the future, provided that there is a written agreement in place 
between the shipper and receiver of the RAC, as specified in Sec.  
1.1305(h)(2) of the final rule. We are making this revision to be 
consistent with changes we are making to proposed Sec.  1.1305(d) to 
provide for an exemption for food that will be subjected to a kill step 
or that will be changed such that the food is no longer on the FTL (see 
Section V.E.5 of this document). As with food that will become exempt 
because a kill step will be applied, or because the food will be 
changed so that it is no longer an FTL food, we conclude that it is not 
necessary to apply the subpart S requirements to food that will become 
partially exempt as a commingled RAC, and we think that written 
agreements can be used to ensure that supply chain partners share the 
expectation that the RAC will be commingled before it is processed. 
Therefore, Sec.  1.1305(h)(2)(i)-(ii) of the final rule provides that, 
except as specified in Sec.  1.1305(h)(3), subpart S does not apply to 
a RAC that will become a commingled RAC provided that: there is a 
written agreement between the shipper of the RAC and the receiver 
stating that the receiver will include the commodity as part of a 
commingled RAC; or there is a written agreement between the shipper of 
the RAC and the receiver stating that an entity in the supply chain 
subsequent to the receiver will include the commodity as part of a 
commingled RAC and that the receiver will only ship the RAC to another 
entity that agrees, in writing, it will either include the RAC as part 
of a commingled RAC or enter into a similar written agreement with the 
subsequent receiver stating that the RAC will become part of a 
commingled RAC.
    The written agreement must include the effective date, printed 
names and signatures of the persons entering into the agreement, and 
the substance of the agreement (Sec.  1.1305(h)(2)(iii)), and it must 
be maintained by both parties for as long as it is in effect and 
renewed at

[[Page 70972]]

least once every 3 years (Sec.  1.1305(h)(2)(iv)). As discussed in 
Response 196, we are providing flexibility for written agreements to be 
entered into in a variety of ways, depending on the business practices 
of the supply chain partners. The discussion in Response 196 regarding 
that flexibility in the context of Sec.  1.1305(d)(3) also applies to 
written agreements under Sec.  1.1305(h)(2).
    Because the definition of commingled RAC only applies when the 
commodity is combined or mixed after harvesting but before processing, 
the partial exemption in Sec.  1.1305(h)(2) is only available in 
situations where the RAC is moving through the supply chain without 
having yet been processed by anyone in the supply chain, and with the 
intent that it will be combined or mixed before being processed. Once 
that combining or mixing occurs, the partial exemption in Sec.  
1.1305(h)(1) applies.
    We did not receive any comments on proposed Sec.  1.1305(f)(2), 
which specified that with respect to a commingled RAC that receives the 
exemption in proposed Sec.  1.1305(f)(1), if a person who manufactures, 
processes, packs, or holds such commingled RAC is required to register 
with FDA as a food facility with respect to activities concerning the 
applicable RAC, such person must maintain records (for 2 years) 
identifying the immediate previous source of such RAC and the immediate 
subsequent recipient of such food in accordance with Sec. Sec.  1.337 
and 1.345 of subpart J. This language, which is based on section 
204(d)(6)(F) of FSMA, has been retained in the final rule as Sec.  
1.1305(h)(3). Because we have added the partial exemption for RACs that 
will become commingled RACs in Sec.  1.1305(h)(2) of the final rule, we 
have expanded Sec.  1.1305(h)(3) to specify that the requirement for 
registered facilities to record the immediate previous source and 
immediate subsequent recipient of the commingled RAC applies with 
respect to a commingled RAC that receives either of the exemptions in 
Sec.  1.1305(h)(1) or (h)(2). This will ensure that when a RAC is 
exempt from the subpart S requirements either because it has already 
been commingled or because it will be commingled in the future, some 
amount of traceability records will still be available from entities 
that are required to register under subpart H.
10. Exemption for Small RFEs and Restaurants
    In Sec.  1.1305(g) of the proposed rule, we presented the option of 
adopting either a full exemption or a partial exemption from the 
proposed subpart S requirements for RFEs that employ 10 or fewer FTE 
employees. Option 1 would completely exempt from subpart S RFEs that 
employ 10 or fewer FTEs (the number of FTEs would be based on the 
number of such employees at each RFE and not the entire business). 
Option 2 would only exempt such RFEs from 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 subpart S (for the foods 
and date ranges specified in FDA's request).
    In response to comments, we are establishing a full exemption from 
subpart S for certain small RFEs, creating an exemption from the 
electronic sortable spreadsheet requirement for larger but still 
relatively small RFEs, and making several other changes regarding the 
proposed exemption for small RFEs, as discussed in the following 
paragraphs.
    (Comment 211) Some comments voice support for Option 1 in proposed 
Sec.  1.1305(g), which would provide a full exemption from the rule for 
RFEs with 10 or fewer FTEs. These comments maintain that requiring 
small RFEs to comply with the rule would be an undue burden, as many of 
these entities have few resources; that tracebacks rarely affect small 
retailers; that complying with the rule would be costly and infeasible 
for these entities; that there is no need for the regulation to apply 
to small retailers; and that small retailers in particular should 
receive a full exemption as many of them have been heavily affected by 
the COVID-19 pandemic. Some comments maintain that small convenience 
stores in particular should be eligible for this exemption because they 
would not be able to comply with the rule due to increased costs 
associated with equipment, maintenance, and labor.
    On the other hand, some comments support Option 2, which would only 
exempt small RFEs from the sortable spreadsheet requirement in proposed 
Sec.  1.1455(b)(3). These comments maintain that requirements for small 
RFEs to comply with the sortable spreadsheet requirements would be 
unduly burdensome and effectively require the use of electronic records 
in violation of section 204(d)(1)(C) and (E) of FSMA. In support of 
Option 2, some comments assert that this option provides the 
appropriate balance between maintaining a diverse market and achieving 
widespread adoption of traceability standards, and that small 
businesses still have the ability to impact public health, particularly 
in rural communities where they may be the sole source of food. These 
comments also suggest that compliance with the other subpart S 
requirements would not require too much effort for these entities, and 
that records besides the sortable spreadsheet would still be necessary 
if an outbreak is associated with a small retailer. Further, some 
comments suggest that with improvements in technology, there is the 
potential for large businesses to be run with fewer FTEs, which would 
make more firms eligible for the proposed exemption.
    Some comments suggest that FDA consider another option, in which 
small RFEs would be required to provide to FDA, within 24 hours, 
records relating to the receipt of a product if they were unable to 
provide the traceability lot code for the product. The comments suggest 
that this option would limit the recordkeeping burden on small RFEs 
while still enabling FDA to readily access traceability information 
when needed.
    (Response 211) We acknowledge that many small RFEs may have limited 
resources with which to comply with the FTL traceability recordkeeping 
requirements. In addition, and as stated in the preamble to the 
proposed rule (85 FR 59984 at 59997), we recognize that because smaller 
RFEs 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. Moreover, because many of the foods sold at small RFEs are 
nationally distributed and are also sold at larger RFEs, 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.
    However, we also recognize that in some cases, it might be helpful 
to traceback efforts for smaller RFEs to have traceability records in 
place, particularly if the establishments are associated with an 
outbreak. Keeping small RFEs within the scope of the rule but exempting 
them from the requirement to provide FDA with an electronic sortable 
spreadsheet containing requested traceability information would reduce 
their burden of complying with the subpart S requirements while still 
providing the Agency with access to tracing information when 
investigating foodborne illness outbreaks involving listed foods 
received by such RFEs.
    We decline to adopt the approach suggested by comments that would 
allow small RFEs to provide, within 24 hours, records relating to 
receipt of a

[[Page 70973]]

product if they were unable to provide the traceability lot number for 
the product. We note that receiving records maintained by RFEs should 
already contain the traceability lot code, and commenters did not 
provide a reason why small RFEs might then be unable to provide that 
information upon request. Therefore, it is unclear why, if small RFEs 
would already have this information, it would not be appropriate to 
require them to make this information available to us. Moreover, having 
access to both the traceability lot code and the KDEs containing 
information on the food and its handlers is essential to conducting 
fast and efficient traceback operations. For these reasons, we decline 
to adopt the suggested alternative requirements.
    Having carefully considered the comments regarding the proposed 
options for exemption of small RFEs, we conclude that it is appropriate 
to establish a full exemption for certain small RFEs and restaurants 
(in Sec.  1.1305(i) of the final rule) and an exemption from the 
electronic sortable spreadsheet requirement for larger but still 
relatively small RFEs and restaurants (in Sec.  1.1455(c)(3)(iii)(B)). 
The eligibility ceilings for these exemptions for small RFEs and 
restaurants are discussed in response to the comments below.
    We note that while proposed Sec.  1.1305(g) only mentioned RFEs, 
the exemptions in Sec. Sec.  1.1305(i) and 1.1455(c)(3)(iii)(B) of the 
final rule refer to both RFEs and restaurants. As discussed in Section 
V.F of this document, we have removed restaurants from the definition 
of ``retail food establishment'' in the final rule, and we have instead 
added a separate definition for the term ``restaurant.'' Therefore, in 
places where the proposed rule only used the term RFE (which 
encompassed restaurants), we are now using the phrase ``RFEs and 
restaurants.''
    (Comment 212) Some comments support basing the exemption for small 
RFEs on the number of FTEs, particularly if based, as proposed, on the 
number of FTEs at each establishment and not the entire business. Some 
comments request clarification on the methodology used to equate part-
time employees to FTEs, while other comments ask that we define or 
provide a reference for the term ``full-time equivalent employee.'' 
Other comments assert that a ceiling of fewer than 10 FTEs would cover 
only a very small portion of the industry and would detract from RFEs 
focusing on food safety. These comments also suggest that the 10-FTE 
ceiling seems arbitrary when supply chains are similar across RFEs, 
regardless of how many FTEs they have. Some comments recommend raising 
the ceiling so that RFEs with more FTEs would be eligible for the 
proposed exemption, such as by using the Organization for Economic 
Cooperation and Development (OECD) ceiling for ``small business'' of 
fewer than 49 FTEs. Other comments suggest adopting an alternate 
standard for the RFE exemption, such as one that aligns with FDA's menu 
labeling regulation, which only covers restaurants and similar RFEs 
that are part of a chain with 20 or more locations (see 21 CFR 
101.11(a)). These comments suggest that using this standard would be 
easier for industry to understand, as they should already be familiar 
with it. However, the comments maintain that labeling and food safety 
regulations may differ in approach and therefore might not be directly 
applicable to each other.
    Some comments suggest other eligibility standards, such as those 
based on annual sales, volume of product sold, or how many customers an 
RFE serves. Some comments suggest that an income-based standard would 
be more appropriate than one based on number of FTEs, as new 
technologies and automation may reduce the number of employees needed. 
The comments also claim that use of an income-based standard is a good 
proxy for volume of food produced as well as an RFE's ability to comply 
with the rule. Some comments suggest adopting thresholds used 
elsewhere, such as those used in certain rules issued under FSMA that 
consider ``very small businesses'' to be those with less than $1 
million in annual food sales, or an SBA standard (less than $7.5 
million in annual receipts). However, some comments assert that the 
vast majority of retailers have receipts totaling less than $7.5 
million, and that these retailers are responsible for greater than 40 
percent of food sales.
    Some comments suggest adding an income-based ceiling to the 
proposed threshold of fewer than 10 FTEs to keep the exemption narrow. 
Other comments suggest that all RFEs should be exempt; still others 
simply request that the exemptions for RFEs be size- and risk-
appropriate.
    (Response 212) We recognize that variation in revenues earned at 
any FTE level, due to differences in business practices, automation, 
and other factors, can make the number of FTEs a firm has an unreliable 
indicator of the true size and viability of the business. Further, the 
variation in revenues and production capacity at any FTE level make the 
number of FTEs an unreliable indicator of the public impact of a size-
based exemption. We decline the suggestion of some comments that the 
small RFE eligibility standard be based on the number of customers 
served, as we believe that this too may not be an accurate indicator of 
the true size of the business. In addition, we believe that use of the 
standard from the menu labeling regulation is not appropriate for this 
rule because doing so would exempt a large portion of the food supply 
(likely over 99 percent of restaurants) and significantly affect FDA's 
ability to conduct a traceback in the event of an outbreak.
    Having considered the suggestions provided in the comments, we 
conclude that it is appropriate to adopt an eligibility standard for 
small RFEs and restaurants that is based on the average annual monetary 
value of food sold or provided by the business. Annual sales are used 
in several other regulations issued under FSMA, and we consider them to 
be a valid indicator of a firm's available resources to comply with the 
rule as well as the volume of product contributed to the marketplace 
that could become contaminated. We include the value of food provided 
to capture food that may be provided as part of a service, but not 
specifically sold to a consumer. For example, the value of food 
provided may be included in the price of an overnight stay at a 
hospital or included in the price of membership of a club that serves 
food, but not specifically broken out in billing for those services.
    Regarding the appropriate limit for annual sales for determining 
eligibility for exemptions for small RFEs and restaurants, we 
considered various options, including $100,000, $250,000, $500,000, and 
$1 million. We estimate that a $1 million threshold would cover 50 
percent of RFEs and 6 percent of RFE sales; a $500,000 threshold would 
cover 36 percent of RFEs and 3 percent of RFE sales; a $250,000 
threshold would cover 19 percent of RFEs and 1 percent of RFE sales; 
and a $100,000 threshold would cover 8 percent of RFEs and less than 1 
percent of RFE sales. We do not believe a $500,000 or $1 million 
ceiling would be appropriate for a full exemption because they would 
exempt a significant portion of RFEs and restaurants from the 
requirements to keep records necessary to help ensure effective 
traceability of FTL foods, significantly affecting our ability to 
conduct fast, efficient, and thorough traceback investigations. For 
this same reason, we decline to adopt an eligibility ceiling of $7.5 
million (as used in certain SBA regulations).
    We conclude that a $250,000 ceiling for annual sales is appropriate 
for a full exemption for RFEs and restaurants

[[Page 70974]]

from the subpart S requirements, as it balances our need to be able to 
conduct effective traceback with providing relief for small entities 
that make up a small portion of total RFEs and restaurants. As 
discussed above, the value of food in the final rule includes the value 
of food provided to consumers (as well as the value of food sold), to 
capture the value of food that is provided as part of a service but not 
specifically sold to a consumer. Therefore, Sec.  1.1305(i) of the 
final rule provides that subpart S does not apply to RFEs and 
restaurants with an average annual monetary value of food sold or 
provided during the previous 3-year period of no more than $250,000 (on 
a rolling basis), adjusted for inflation using 2020 as the baseline 
year for calculating the adjustment.
    However, while we conclude that it would not be appropriate to 
provide a full exemption to RFEs and restaurants with more than 
$250,000 in annual sales, we conclude that it would be appropriate to 
reduce the burden of the rule on establishments that are somewhat 
larger but still relatively small. Therefore, Sec.  
1.1455(c)(3)(iii)(B) of the final rule exempts RFEs and restaurants 
with food revenues of no more than $1 million from the requirement to 
provide to FDA in certain circumstances an electronic sortable 
spreadsheet containing requested traceability information. The 
electronic sortable spreadsheet requirement and the exemptions from 
this requirement are discussed in Section V.R of this document.
    (Comment 213) Some comments maintain that the rule would overburden 
small cottage food producers, would be difficult for them to comply 
with, would cause businesses to close, and would hinder small 
businesses from starting up. Some comments contend that the rule will 
create particular difficulties for certain small cottage producers, 
such as bakers tracking ingredients like eggs. Some comments suggest 
that if FDA considers exemptions for small RFEs with fewer than 10 
FTEs, the Agency should also consider an exemption for small cottage 
producers. Some comments state that they are very small businesses, 
some are single-person operations, and some make less than $20,000 per 
year in revenue. Some comments maintain that their small cottage 
businesses are already covered by State cottage business laws and that 
FDA should defer to these State regulations. One of these comments 
asserts that the burden of ensuring traceability should be on the 
supplier to keep records of the persons to whom they sell their food.
    Some comments suggest that FDA reconsider the small business size 
thresholds for cottage food producers. Some comments suggest that small 
cottage producers should be exempt if they make less than $100,000 in 
annual revenue and are covered by their State cottage business laws; 
other comments maintain that the rule will be overly burdensome on any 
business making less than $50,000 in annual revenue.
    Some comments assert that cottage food producers with short, local 
supply chains are not a food safety risk and are easy to trace, while 
large, conventional producers are the ones that pose a food safety 
risk. Some comments claim that baked goods are not risky.
    (Response 213) FDA agrees with the importance of reducing the 
burden, where appropriate, on businesses that may have fewer resources 
to apply to complying with the requirements of the regulation, while 
minimizing the additional health risk caused by exposure to products 
that would otherwise be covered by the regulation. As discussed in 
Response 212, the final rule fully exempts small RFEs and restaurants 
making no more than $250,000 in annual sales (Sec.  1.1305(i)), and 
also exempts RFEs and restaurants with no more than $1 million in 
annual sales from the requirement to provide an electronic sortable 
spreadsheet containing traceability information FDA may request in 
certain circumstances (Sec.  1.1455(c)(3)(iii)(B)). Because most State 
cottage food programs set a ceiling for participation at no more than 
$50,000 in annual sales, we believe most cottage food producers will be 
fully exempt from this rule.
    (Comment 214) Some comments request clarification on whether farms 
with fewer than 10 FTEs are eligible for the proposed exemption for 
RFEs in Sec.  1.1305(g). The comments maintain that eligibility should 
be based on the nature of the supply chain, and that farms that sell 
directly to consumers but also through short, local supply chains 
should be exempt. Other comments assert that appropriate treatment of 
RFEs under subpart S is important for farms because many farms sell 
their produce to RFEs such as grocery stores.
    (Response 214) Section 1.1310 of the final rule defines ``retail 
food establishment,'' in part, as an establishment that sells food 
products directly to consumers as its primary function. The definition 
further states that 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. Sale of food directly to consumers can include 
sale of food by a farmer at a roadside stand, farmers' market, or CSA. 
In addition, the definition states that a ``retail food establishment'' 
includes certain farm-operated businesses selling food directly to 
consumers as their primary function, with ``farm-operated business'' 
meaning a business that is managed by one or more farms and conducts 
manufacturing/processing not on the farm(s). If a farm meets the 
definition of ``retail food establishment'' in Sec.  1.1310 and meets 
the criteria for an exemption for RFEs in Sec.  1.1305(i) or Sec.  
1.1455(c)(3)(iii)(B), it would be eligible for such exemption. 
Moreover, as previously discussed, under Sec.  1.1305(b) of the final 
rule, the subpart S requirements do not apply to a farm with respect to 
food produced on the farm that is sold or donated directly to a 
consumer by the owner, operator, or agent in charge of the farm.
    (Comment 215) One comment asserts that restaurants and RFEs that 
only receive food should not have to maintain traceability records. The 
comment claims that logistics is not a core business function of 
restaurants or RFEs and that those businesses are not equipped to scan 
or manually enter data for each delivery. The comment maintains that 
including these entities in the final rule would result in significant 
cost, training, and equipment needs.
    (Response 215) We do not agree. RFEs and restaurants are often our 
first point of contact in an outbreak, recall, or other situation 
requiring fast, efficient traceback. They frequently serve as the first 
point in the supply chain to provide the traceability information 
needed by FDA investigators to launch a traceback investigation. Having 
traceability records at these establishments linking the food they sell 
to the previous link in the supply chain and ultimately the source of 
the food is necessary for effective traceback and the protection of 
public health (Ref. 25). However, as previously stated, we recognize 
the importance of reducing the burden of the rule, where appropriate, 
on businesses that may have fewer resources to apply to complying with 
the rule, while minimizing the additional health risk caused by 
exposure to products that would otherwise be covered by the regulation. 
Consequently, as discussed above, the final rule includes several full 
or partial exemptions from the rule for certain restaurants and RFEs.
    (Comment 216) Some comments suggest that the Agency incorporate

[[Page 70975]]

additional flexibilities into the rule specifically for the airline 
catering industry. The comments suggest that one way of doing so would 
be to amend the definitions of ``retail food establishment'' and 
``shipping'' to state that airline caterers are considered RFEs and 
specify that they do not engage in shipping when they send foods to 
airline customers for consumption by passengers. Alternatively, the 
comments suggest that we add a partial exemption to the rule specifying 
that entities that prepare foods for airlines that are intended for 
immediate consumption by passengers would not have to maintain 
transformation, creation, or shipping KDEs, but would only be required 
to maintain receiving KDEs and traceability program records.
    (Response 216) We decline to redefine ``retail food establishment'' 
to include airline caterers. As previously stated, we proposed to 
define ``retail food establishment'' as it is defined in the food 
facility registration regulation (Sec.  1.227 (21 CFR 1.227)), i.e., an 
establishment whose primary function is to sell food products directly 
to consumers from that establishment. Most airline caterers prepare 
meals and other foods for sale to airlines, rather than directly to 
consumers. Because airline caterers generally are not RFEs but 
manufacturers/processors subject to the regulations on preventive 
controls for human food in part 117, we find no basis for regarding 
them as RFEs for purposes of the subpart S traceability recordkeeping 
requirements. For this reason, we also conclude that it would not be 
appropriate to provide that airline caterers do not engage in 
``shipping'' as defined in the rule when they send foods to airlines 
for consumption by passengers. As discussed in Section V.E of this 
document, the definition of ``shipping'' states, in part, that shipping 
does not include the sale or shipment of a food directly to a consumer; 
however, most airline caterers do not sell food directly to consumers. 
To the extent an airline caterer meets the definition of an RFE, the 
traceability recordkeeping requirements for an RFE will apply. Some 
airline caterers might be eligible for the exemption (discussed in 
Section V.R.3 of this document) under which entities other than farms, 
RFEs, or restaurants with no more than $1 million in annual sales would 
not be required to provide to FDA, under certain circumstances, an 
electronic sortable spreadsheet containing requested traceability 
information (Sec.  1.455(c)(3)(iii)(C)).
    (Comment 217) Some comments ask FDA to clarify that RFEs need only 
keep invoices/receipts, not full traceability logs, to document receipt 
of FTL foods. The comments assert that it would be an unrealistic and 
unnecessary burden for small RFEs to keep copies or records 
establishing where FTL foods were purchased for 180 days.
    (Response 217) As discussed in Response 211, the final rule exempts 
small RFEs and restaurants from the subpart S requirements. With 
respect to larger RFEs and restaurants that are not exempt from the 
rule, the rule does not require firms to maintain a ``traceability 
log'' for their handling of FTL foods. Instead, firms will need to 
establish and maintain a traceability plan in accordance with Sec.  
1.1315, and they will need to keep certain KDEs associated with CTEs, 
which in the case of RFEs and restaurants generally will be the KDEs 
associated with receiving in Sec.  1.1345. As with other types of 
supply chain entities subject to the rule, we anticipate that RFEs and 
restaurants will be able to rely on records they already use to meet 
most of their requirements under subpart S. In addition, as discussed 
in Section V.N of this document, almost all of the receiving KDEs that 
RFEs and restaurants are required to maintain under Sec.  1.1345 are 
KDEs that their suppliers will be required to send them under Sec.  
1.1340(b).
    In general, all subpart S records must be maintained for 2 years 
(see Sec.  1.1455(d)). However, as discussed below, when an RFE or 
restaurant purchases food directly from the farm where it was produced, 
they are only required to maintain a record documenting the name and 
address of the farm that was the source of the food, and they must 
maintain that record for only 180 days.
11. Partial Exemption for RFEs and Restaurants Purchasing Food Directly 
From a Farm
    In addition to the full or partial exemption for small RFEs in 
proposed Sec.  1.1305(g), in accordance with section 204(d)(6)(G) of 
FSMA, we proposed to adopt a partial exemption from the subpart S 
requirements for all RFEs when they receive FTL foods directly from a 
farm. Proposed Sec.  1.1305(h)(1) provided that subpart S would not 
apply to an RFE with respect to foods on the FTL that are produced on a 
farm (including foods produced and packaged on the farm) and sold 
directly to the RFE 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 an RFE purchased an FTL food directly 
from the owner, operator, or agent in charge of a farm, the RFE 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, RFEs 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 proposed to broaden the application 
of this partial exemption to include all RFEs purchasing food directly 
from farms.
    (Comment 218) Some comments ask whether the partial exemption for 
RFEs purchasing directly from a farm would include food that first goes 
through a broker, warehouse, or distribution center that is part of the 
RFE's network. Some comments maintain that the partial exemption should 
apply to food purchased by a broker if the food is shipped directly 
from the farm to the RFE. Some comments assert that the exemption 
should apply to food shipped directly from the farm to the RFE even 
when the purchasing entity is the RFE's parent company.
    (Response 218) We do not agree with the comments. The intent of the 
partial exemption is to reduce the number of records required for 
direct sales of FTL foods from farms to RFEs or restaurants, for which 
the supply chain is extremely simple, covering a single transaction. 
This direct connection between a farm and an RFE or restaurant is not 
present when: (1) an FTL food is shipped to a broker, warehouse, or 
distribution center before being sent to the RFE, even if such entity 
is in the same corporate structure as the RFE; or (2) a broker or the 
RFE's parent company buys the food and arranges for its shipment from 
the farm to the RFE. Therefore, the exemption does not apply to food 
purchased by a broker or parent company even if the food is shipped 
directly from a farm to an RFE or restaurant, even if no third party 
ever takes physical possession of the food. Similarly, the exemption 
does not apply to food that is not shipped directly from the farm 
growing the food to the RFE making the purchase, e.g., food that goes 
through a broker, a warehouse, or a distribution center, even if these 
entities are part of the parent company. To make this clear, Sec.  
1.1305(j)(1) of the final rule states that except as specified in Sec.  
1.1305(j)(2), subpart S does not apply to an RFE or restaurant with 
respect to a food that is produced on a farm (including food produced 
and packaged on the farm) and is both sold and shipped directly to the 
RFE or restaurant by the owner, operator, or

[[Page 70976]]

agent in charge of that farm. Section 1.1305(j)(2) provides that when 
an RFE or restaurant purchases a food directly from a farm in 
accordance with Sec.  1.1305(j)(1), the RFE or restaurant must maintain 
a record documenting the name and address of the farm that was the 
source of the food. Section 1.1305(j)(2) further specifies that the RFE 
or restaurant must maintain such a record for 180 days, as we had 
proposed. Throughout Sec.  1.1305(j), and consistent with the rest of 
the final rule as discussed in Response 285, we refer to both RFEs and 
restaurants, as opposed to using RFE as an umbrella term that 
encompasses restaurants, as was done in the proposed rule.
    (Comment 219) Some comments request clarification on whether the 
partial exemption for RFEs that receive FTL foods directly from a farm 
includes e-commerce sales.
    (Response 219) The partial exemption in Sec.  1.1305(j) applies any 
time food is produced on a farm and then sold and shipped directly to 
an RFE or restaurant by the owner, operator, or agent in charge of that 
farm. Whether or not the sale was made online is not relevant as long 
as the conditions of Sec.  1.1305(j) are met. For example, when a farm 
sells its food directly to an RFE through the farm's website, the RFE 
could be eligible for the exemption as long as they bought the food 
directly from the farm (through the farm's website) and the food was 
shipped directly to the RFE by the farm.
    (Comment 220) Some comments suggest that in addition to requiring 
RFEs under the partial exemption to maintain the name and address of 
the farm that sold the food, the RFEs should be required to maintain 
the lot code and harvest or pack date associated with the food, because 
the comments assert that this information is the most important to have 
for traceability purposes.
    (Response 220) We decline to make this change because section 
204(d)(6)(G) of FSMA requires that if food is sold directly from a farm 
to a grocery store, the grocery store must not be required to maintain 
records other than those documenting the farm that was the source of 
the food. (As previously discussed, we have broadened this partial 
exemption to apply to all RFEs and restaurants.)
    (Comment 221) Some comments request that we expand this partial 
exemption so that it would also apply to RFEs that purchase wild-caught 
American shrimp directly from local processors. The comments also 
suggest that the processors themselves be eligible for the partial 
exemption.
    (Response 221) We decline to make this change. We conclude that it 
would not be appropriate to expand the partial exemption for RFEs and 
restaurants purchasing food directly from a farm to apply to RFEs and 
restaurants that receive food from entities other than farms, such as 
shrimp processors, or to such other entities themselves. The intent of 
the partial exemption is to reduce the number of records required when 
FTL foods are sold and shipped directly from the producing farms to an 
RFE or restaurant. In such a situation, the supply chain is extremely 
simple, covering a single transaction. This direct connection between a 
farm and an RFE or restaurant is not present when the food moves 
through a processor.
12. Partial Exemption for RFEs and Restaurants Making Certain Purchases 
From Another RFE or Restaurant
    In response to comments expressing concerns about application of 
the subpart S requirements to certain purchases of food by RFEs from 
other RFEs, we are adopting a partial exemption as discussed in the 
following paragraphs.
    (Comment 222) Some comments ask that we clarify what RFEs should do 
if they purchase a listed food from a grocery store or another RFE that 
does not provide the KDEs required under the proposed rule. One comment 
asks whether RFEs will be considered to be in compliance with the rule 
if they keep receipts or invoices for these purchases. Some comments 
maintain that there is no batch level data available for RFEs that make 
``cash and carry'' purchases from other RFEs.
    (Response 222) Under the final rule, RFEs and restaurants that 
receive food (under the definition of ``receiving'' in Sec.  1.1310) 
are required to keep receiving records under Sec.  1.1345 unless they 
are exempt. However, we recognize that RFEs, and particularly 
restaurants, may purchase foods on the FTL on an ad hoc basis to meet 
immediate operational needs when they run out of an item purchased from 
a regular supplier. We recognize that it might not be feasible for RFEs 
or restaurants to keep the full ``receiving'' records of such purchases 
in accordance with Sec.  1.1345 of the final rule (see Section V.N of 
this document). It also might not be feasible for the RFE or restaurant 
that makes the sale to keep and send shipping records under Sec.  
1.1340, especially if the sale happens under circumstances where it may 
seem like the purchaser is a consumer. Therefore, Sec.  1.1305(k)(1) of 
the final rule provides that, except as specified in Sec.  
1.1305(k)(2), subpart S does not apply to either entity when a purchase 
is made by an RFE or restaurant from another RFE or restaurant, when 
the purchase occurs on an ad hoc basis outside of the buyer's usual 
purchasing practice (e.g., not pursuant to a contractual agreement to 
purchase food from the seller).
    Instead of the receiving KDEs required under Sec.  1.1345, when an 
RFE or restaurant purchases an FTL food on an ad hoc basis from another 
RFE or restaurant in accordance with Sec.  1.1305(k)(1), the RFE or 
restaurant that makes the purchase must maintain a record (such as a 
sales receipt) documenting the name of the product purchased, the date 
of purchase, and the name and address of the place of purchase (Sec.  
1.1305(k)(2)).
    We conclude that, in these circumstances, this information would be 
adequate to enable us to conduct an effective traceback of such a 
product. As with other subpart S recordkeeping requirements, RFEs and 
restaurants may keep the required information on such purchases in any 
records they choose, including paper receipts.
    This partial exemption in Sec.  1.1305(k) does not exempt RFEs and 
restaurants from the subpart S requirements when an RFE or restaurant 
purchases food from another RFE or restaurant as part of the buyer's 
usual purchasing practice, as opposed to on an ad hoc basis. For an ad 
hoc purchase of the sort that would be eligible for this partial 
exemption, the purchase is generally made through the means utilized by 
consumers (e.g., through a check-out line), under circumstances where 
the selling RFE or restaurant might assume that the purchaser is a 
consumer. When a contractual relationship exists in which one RFE or 
restaurant serves as a regular commercial supplier for another RFE or 
restaurant, such purchases would be outside the scope of the partial 
exemption in Sec.  1.1305(k).
13. Partial Exemption for Farm to School and Farm to Institution 
Programs
    Having consulted with USDA in accordance with section 204(d)(6)(A) 
of FSMA, we proposed to establish 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. Proposed Sec.  1.1305(i)(1) would have provided that, 
except as specified in proposed 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 (Pub. L. 116-94) or Section 4 of the Child Nutrition 
Act of 1966 (Pub. L. 111-296), or any other entity conducting a farm to 
school or farm to institution program, with respect to a

[[Page 70977]]

food 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 
directly from a farm in accordance with (i)(1), 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) specified that the 
school food authority or relevant food procurement entity must maintain 
such records for 180 days, the same retention period that we proposed 
for records maintained under the partial exemption for RFEs purchasing 
food directly from a farm in proposed Sec.  1.1305(h).
    (Comment 223) Some comments support the partial exemption for 
entities conducting farm to school or farm to institution programs. 
Other comments oppose the exemption, maintaining that the exemption 
would not be protective of public health because these programs move 
large volumes of food to vulnerable populations. The comments provide 
examples of food banks that hand out food in parking lots or community 
centers that they maintain are not designed to allow for safe handling 
and storage of food.
    (Response 223) As discussed in the preamble to the proposed rule, 
having consulted with the USDA in accordance with section 204(d)(6)(A) 
of FSMA, we believe it is appropriate to adopt this partial exemption 
from the subpart S requirements for farm to school and farm to 
institution programs, to avoid placing undue burdens on these programs. 
While we disagree with comments suggesting that the partial exemption 
for farm to school and farm to institution programs is inappropriate, 
we recognize the potential that food supplied through such programs can 
play a role in foodborne illness. It is because of this that, rather 
than fully exempt such programs from the rule, we have established a 
partial exemption for such programs. Section 1.1305(l)(1) of the final 
rule states that, except as specified in Sec.  1.1305(l)(2), subpart S 
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 or donated to the school or 
institution. Under Sec.  1.1305(l)(2), when a school or institution 
conducting a farm to school or farm to institution program obtains a 
food from a farm in accordance with Sec.  1.1305(l)(1), the school food 
authority or relevant food procurement entity must maintain a record 
(for 180 days) documenting the name and address of the farm that was 
the source of the food. We believe this partial exemption adequately 
protects public health while not placing undue burden on such programs, 
in accordance with section 204(d)(6)(A) of FSMA.
    (Comment 224) Some comments recommend expanding the partial 
exemption in proposed Sec.  1.1305(i) to include food that is donated 
by a farm to a school or institution. Other comments ask whether the 
proposed exemption would include food that is sold to schools or 
institutions through distributors. Other comments suggest that food 
hubs and other aggregators who work with small farms are a vital link 
in the farm to institution supply chain, often working with very small 
farms to aggregate their product into large enough quantities to meet 
the needs of large institutional kitchens, and should also be exempt; 
these comments maintain that if the food hubs or aggregators are 
required to comply, their recordkeeping burden will essentially force 
the small farms to comply with the requirements as well. Others suggest 
that if food hubs are required to comply with the proposed 
requirements, they may cease providing products on the FTL to avoid 
recordkeeping required by the rule.
    (Response 224) We recognize that farm to school and farm to 
institution programs may receive food through a variety of means, 
including via sales or donations, and that this food may be received by 
such institutions either directly or indirectly (e.g., through entities 
such as brokers, buyers, or school procurement entities). Accordingly, 
we have revised the partial exemption to specify, in Sec.  
1.1305(l)(1), that it applies when food is sold ``or donated'' to a 
school or institution, and that it does not require that a food be sold 
``directly'' from a farm to a school or institution, as had been stated 
in the proposed rule. To align with this change, we have revised the 
partial exemption to state, in Sec.  1.1305(l)(2), that a school food 
authority or relevant food procurement entity must maintain a record 
documenting the name and address of the farm that was the source of the 
food when a school or institution conducting a farm to school or farm 
to institution program ``obtains a food'' (rather than ``purchases a 
food directly'') from a farm in accordance with Sec.  1.1305(l)(1).
14. Partial Exemption for Food Obtained from Fishing Vessels
    In accordance with section 204(d)(6)(C) of FSMA, we proposed to 
adopt a partial exemption from the proposed traceability recordkeeping 
requirements for fishing vessels. Proposed Sec.  1.1305(j)(1) provided 
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, we proposed to 
define ``fishing vessel'' 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 (proposed Sec.  1.1310). Under this 
partial exemption, activities of fishing vessels such as harvesting, 
transporting, heading, eviscerating, and freezing fish generally would 
not be subject to the proposed recordkeeping requirements.
    Under the proposed 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). In the 
preamble to the proposed rule, we stated that 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 ``until such time as 
the food is sold by the owner, operator, or agent in charge of such 
fishing vessel.'' We stated that 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 believed it was 
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) specified that if the

[[Page 70978]]

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 the requirements of 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) (21 CFR 1.327(c)). Affected fishing 
vessels would be required to maintain such records for 2 years.
    We have made clarifying changes to this partial exemption, as 
discussed in the following paragraphs.
    (Comment 225) Some comments assert that owners, operators, and 
agents of fishing vessels should not be exempt from the rule. The 
comments maintain that these entities are best placed to maintain 
accurate records of the relevant KDEs, that these entities might 
already be required to keep such records under national/regional catch 
documentation schemes, and that excluding them risks having inaccurate 
data later in the supply chain. One comment contends that the exemption 
would allow unsafe and illegal seafood to enter the supply chain 
because as supply moves between vessels there is opportunity for 
laundering of unsafe and illegal catches.
    (Response 225) Section 204(d)(6)(C) of FSMA states that with 
respect to a food that is produced through the use of a fishing vessel, 
the recordkeeping requirements under this rulemaking shall, until such 
time as the food is sold by the owner, operator, or agent in charge of 
the fishing vessel, be limited to the requirement that entities who 
register with FDA under subpart H must maintain records identifying the 
immediate previous source and the immediate subsequent recipient of 
such food. As discussed in the preamble to the proposed rule (85 FR 
59984 at 59999), we therefore 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 for the requirement 
to keep certain one-up, one-back records. Section 1.1305(m)(1) of the 
final rule therefore states that with respect to a food that is 
obtained from a fishing vessel, subpart S does not apply to the owner, 
operator, or agent in charge of the fishing vessel, except as specified 
in Sec.  1.1305(m)(2). Section 1.1305(m)(1) further states that, except 
as specified in Sec.  1.1305(m)(2), subpart S does not apply to persons 
who manufacture, process, pack, or hold the food until such time as the 
food is sold by the owner, operator, or agent in charge of the fishing 
vessel. This language is meant to clarify the application of the 
partial exemption in situations where the food is still owned by the 
owner, operator, or agent in charge of the fishing vessel, but it is 
being handled by a different entity.
    Section 1.1305(m)(2) provides that, with respect to any person who 
receives the partial exemption in Sec.  1.1305(m)(1), if such person is 
required to register with FDA under section 415 of the FD&C Act, 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. We note that the proposed rule used both the 
phrase, ``food obtained from a fishing vessel,'' and the phrase, ``food 
produced through a fishing vessel.'' In the final rule, for uniformity 
and clarity, we use only the phrase, ``food obtained from a fishing 
vessel.''
    We believe that the records that the first land-based receiver of 
an FTL food obtained from a fishing vessel must keep under Sec.  1.1335 
of the final rule (discussed in Section V.L of this document) should 
help ensure adequate traceability of food obtained from fishing 
vessels. In situations where the first land-based receiver is partially 
exempt from subpart S under Sec.  1.1305(m), we believe that any 
records required to be kept under Sec.  1.1305(m)(2), in combination 
with the records that the first non-exempt receiver will be required to 
maintain under Sec.  1.1345(b), should help ensure adequate 
traceability of the food.
    Regarding the comment about laundering of unsafe and illegal 
catches, we agree that this is an important concern, but it is outside 
the scope of this rulemaking, especially in light of the partial 
exemption Congress required us to provide for fishing vessels. However, 
fishing vessels must comply with all of the laws and regulations that 
apply to them, including any laws and regulations aimed at combating 
such practices.
    (Comment 226) One comment supports the proposed partial exemption 
for fishing vessels and regards the proposed rule's interpretation of 
section 204(d)(6)(C) of FSMA to be reasonable and consistent with 
Congressional intent. Some comments state that although fishing vessels 
that are not required to register with FDA would be fully exempt, they 
ask that we adopt an exemption for food sold directly to consumers from 
fishing vessels, including food sold by fishermen who are specifically 
licensed to sell their own catch directly to consumers by a ``fresh 
product license'' or other authority, mirroring the exemption in 
proposed Sec.  1.1305(b) for farms that sell food directly to 
consumers, suggesting that section 204(d)(6)(E) of FSMA gives us the 
authority to exempt entities when application of the subpart S 
requirements is not necessary to protect the public health.
    (Response 226) We appreciate the support for the proposed partial 
exemption for fishing vessels as being consistent with Congressional 
intent. We do not think the proposed modification to Sec.  1.1305(b) is 
necessary. As drafted, Sec.  1.1305(b) exempts farms with respect to 
food they produce that they sell directly to the consumer. Without this 
exemption, farms may otherwise be required to keep various subpart S 
records relating to such food, such as records relating to the 
harvesting of the food. In contrast, under Sec.  1.1305(m)(1), the 
owner, operator, or agent in charge of a fishing vessel is already 
exempt from the subpart S requirements. An additional exemption for 
this specific circumstance is therefore unnecessary. While it is true 
that some owners, operators, or agents in charge of fishing vessels may 
be required to keep records identifying the immediate subsequent 
recipient of a food in accordance with Sec.  1.345 (see Sec.  
1.1305(m)(2)), we note that Sec.  1.345 does not apply to persons who 
distribute food directly to consumers (see Sec.  1.327). Therefore, 
even without a modification of Sec.  1.1305(b), it is already the case 
that under subpart S the owner, operator, or agent in charge of a 
fishing vessel is not required to keep any records with respect to food 
obtained from a fishing vessel that such person sells or donates 
directly to a consumer.
    (Comment 227) Some comments state that FDA should treat wild and 
farmed shellfish production the same. The comments maintain that many 
individuals participate in both sectors and would be confused by the 
different requirements. The comments also maintain that most dealers 
also purchase both wild and farmed shellfish. One comment states that 
the

[[Page 70979]]

rule should regulate shellfish harvesters and shellfish farmers the 
same as it regulates fishing vessels (i.e., partially exempt).
    (Response 227) We note that qualifying raw bivalve molluscan 
shellfish are exempt from the requirements of the final rule as 
discussed in Response 200. The exemption applies to both wild-caught 
and aquacultured raw bivalve molluscan shellfish.
    Regarding other shellfish, we are unable to impose the requirements 
that apply to farmed shellfish on fishing vessels that harvest 
shellfish because, as discussed in Response 225, Congress required us 
to create a partial exemption for the owners, operators, and agents in 
charge of fishing vessels (see section 204(d)(6)(C) of FSMA). And we 
decline to extend this partial exemption for owners, operators, or 
agents in charge of fishing vessels to farmed shellfish because, as 
discussed in Response 97, we think that coverage of farms is important 
to effective traceability. We acknowledge that an entity that receives 
both food produced on farms and food obtained from fishing vessels will 
have to identify as either an initial packer (for food produced on 
farms) or first land-based receiver (for food obtained from a fishing 
vessel) for the relevant transactions and comply with the applicable 
recordkeeping requirements. But we note that although the requirements 
for initial packer and first land-based receiver are different, the 
requirements through the rest of the supply chain for food from either 
type of entity are the same.
    (Comment 228) One comment asserts that there should be no new 
records required for wild-caught domestic shrimp vessels as many of 
these vessels already must register with FDA as food facilities and 
keep one-up, one-back traceability records under subpart J.
    (Response 228) To the extent that vessels engaged in catching 
shrimp are ``fishing vessels'' as defined in Sec.  1.1310, they will 
not be subject to any subpart S requirements unless they are registered 
food facilities, in which case they would be required to maintain 
records identifying the immediate previous source and immediate 
subsequent recipient of the shrimp they catch in accordance with 
Sec. Sec.  1.337 and 1.345 of subpart J (see Sec.  1.1305(m), as 
further explained in Response 225). If the vessel is already keeping 
subpart J records, those records can be used to comply with Sec.  
1.1305(m)(2). As stated in Sec.  1.1455(f), an entity does not need to 
duplicate existing records that it has if they contain the information 
required under subpart S.
    (Comment 229) One comment asserts that the requirements for first 
receivers (under proposed Sec.  1.1330) could be read as functionally 
nullifying the proposed exemption for fishing vessels. The comment 
suggests that to avoid this, the rule must not require that a 
traceability lot code be associated with fishing events by fishers, but 
the first receiver of such food from a fisher might need to assign a 
traceability lot code. The comment maintains that the GDST standards 
encourage the assignment of lot codes to fishing events by fishers, but 
the ISSC's implementation guidelines recognize that this might not be 
possible for at least several years. Therefore, the comment suggests 
that FDA encourage lot code assignment at the vessel level as a best 
practice.
    (Response 229) For clarity we have changed the name of the ``first 
receiver'' of food obtained from a fishing vessel to the ``first land-
based receiver,'' which we have defined to mean the person taking 
possession of a food for the first time on land directly from a fishing 
vessel (Sec.  1.1310). Section 1.1335 sets forth the records that a 
person must keep if they are the first land-based receiver. These 
requirements have been modified from what the proposed rule would have 
required for first receivers of food obtained from fishing vessels, and 
are limited to information that a person would reasonably be expected 
to know based on information that is likely provided during the normal 
course of business. The fishing vessel is not expected to provide a 
traceability lot code; the traceability lot code would be assigned by 
the first land-based receiver in accordance with Sec.  1.1320(a). If 
the first land-based receiver is exempt, the traceability lot code 
would be assigned by the first non-exempt receiver of the food in 
accordance with Sec.  1.1345(b)(1) (unless that entity is an RFE or 
restaurant).
    (Comment 230) Some comments ask whether the definition of fishing 
vessel includes boat tenders that catch and offload fish to another 
fishing vessel. Specifically, the comments ask whether the definition 
includes tender vessels, carrier vessels, or mother ships. One comment 
maintains that boat tenders are used in many seafood harvest situations 
and are an extension of the fishing vessel that is exempt under the 
proposed rule. The comment also asks FDA to clarify whether the 
proposed definition of ``first receiver'' includes ``over the dock 
transfers.''
    (Response 230) Any vessel that meets the definition of ``fishing 
vessel'' in Sec.  1.1310 is subject to the partial exemption in Sec.  
1.1305(m). In situations where a tender vessel catches fish and 
offloads the fish to a carrier vessel or mother ship, all of the 
vessels involved in the transaction would be partially exempt under 
Sec.  1.1305(m), as long as they meet the definition of a ``fishing 
vessel.'' Regarding the comment that asks us to clarify the definition 
of ``first receiver'' in relation to ``over the dock transfers,'' as 
discussed in Response 385, the final rule omits the proposed first 
receiver requirements and includes requirements for the first land-
based receiver of food obtained from a fishing vessel. It is unclear 
what ``over the dock transfer'' means in the context of the subpart S 
requirements. If a transfer takes place between two fishing vessels, 
then each fishing vessel would be eligible for the partial exemption in 
Sec.  1.1305(m), meaning the only records they might be required to 
keep would be the records described in Sec.  1.1305(m)(2), if 
applicable. However, if ``over the dock transfer'' refers to a transfer 
and sale from the owner, operator, or agent in charge of a fishing 
vessel to a separate land-based entity, then the land-based entity 
would be the first land-based receiver of the food and would have to 
keep the records required under Sec.  1.1335.
15. Exemption for Transporters
    We proposed to exempt transporters of food from the proposed 
traceability recordkeeping requirements (proposed Sec.  1.1305(k)). We 
proposed 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).
    (Comment 231) Some comments assert that the proposal to exempt 
transporters is contrary to language in section 204(d) of FSMA, 
suggesting that a person who has ``possession, custody, or control'' of 
food (under the proposed definition of ``transporter'') would also be a 
person who ``holds'' the food under the statute. Other comments 
maintain that transporters should not be exempt because although they 
present a lower risk of contamination, information on when and how food 
is transported is still important to have. These comments suggest that 
including transporters in the rule would create added benefits and 
would facilitate outbreak investigations. Some comments suggest that 
the Agency should acknowledge that food may become contaminated during 
transport, referencing the recordkeeping requirements already in place 
under the sanitary transportation regulation (part 1, subpart O). Some 
comments request that transporters be exempt from the final rule 
because they believe that information from

[[Page 70980]]

transporters is not necessary for traceability purposes. The comments 
state that transporters are subject to subpart J, so if certain foods 
are exempt from this rule, transporters would still have to maintain 
subpart J records for those foods. Some comments request clarification 
of requirements for transporters in fish supply chains.
    (Response 231) We acknowledge that food can become contaminated 
during transportation, which is why in the final rule on ``Sanitary 
Transportation of Human and Animal Food'' (81 FR 20092) we established 
requirements for shippers, loaders, carriers by motor vehicle and rail 
vehicle, and receivers engaged in the transportation of food, including 
food for animals, to use sanitary transportation practices to ensure 
the safety of the food they transport. As the comments state, the 
sanitary transportation regulation includes recordkeeping requirements 
for certain entities subject to the regulation, though we note that 
these recordkeeping requirements focus on ensuring the use of sanitary 
practices during transportation, not on traceability.
    As discussed in the preamble to the proposed rule (85 FR 59984 at 
59999), we believe that transporters should be exempt from the subpart 
S requirements 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. Thus, the final rule maintains this exemption for 
transporters of food (Sec.  1.1305(n)). Additionally, we have removed 
from the final rule the proposed requirements that (1) persons who 
receive listed foods keep a record of the name of the transporter who 
delivered the food (proposed Sec.  1.1335(h)) and (2) persons who ship 
listed foods keep a record of the name of the transporter who 
transported the food from the shipper (proposed Sec.  1.1350(a)(8)), as 
discussed in Section V.M of this document.
    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. We note that in many cases, 
the shipper or receiver will have this information as a result of the 
subpart J requirements.
    Regarding the comments suggesting that the proposed exemption for 
transporters is contrary to the language in the statute, the proposed 
rule included several full and partial exemptions from the subpart S 
requirements, including some specified by Congress and some we proposed 
on our own initiative, including the exemption for transporters. It is 
within our rulemaking authority to create exemptions beyond what 
Congress specified. For the reasons stated above, we conclude that 
exempting transporters is an appropriate exercise of our authority to 
implement section 204(d) of FSMA.
16. Exemption for Nonprofit Food Establishments
    We proposed in Sec.  1.1305(l) 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 proposed to define a 
nonprofit food establishment as in subpart J (Sec.  1.328 (21 CFR 
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 definition further stated that the term ``nonprofit food 
establishment'' includes central food banks, soup kitchens, and 
nonprofit food delivery services. In addition, to be considered a 
nonprofit food establishment, we proposed that 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)).
    Although we received comments concerned that the definition of 
``nonprofit food establishment'' used for this exemption was not broad 
enough, we are finalizing the exemption as proposed, for the reasons 
stated below.
    (Comment 232) Some comments support the proposed exemption for 
nonprofit food establishments. Some comments suggest that FDA exempt 
other nonprofits aside from those that meet the terms of section 
501(c)(3) of the Internal Revenue Code, such as food hubs and 
businesses with section 501(c)(4), (c)(5), or (c)(6) status. The 
comments maintain that numerous nonprofit food hubs and businesses are 
organized under other nonprofit statuses and consequently should also 
be exempt under the final rule. Some comments assert that the language 
in FSMA means that the rule should only apply to facilities, and that 
therefore FDA should exempt all nonprofit food establishments in which 
food is prepared for or served directly to the consumer.
    (Response 232) As discussed in the preamble to the proposed rule 
(85 FR 59984 at 59999), and as finalized in Sec.  1.1305(o), we are 
exempting nonprofit food establishments from the rule consistent with 
their exclusion from the subpart J regulation. The definition of 
``nonprofit food establishment'' that we proposed and are adopting in 
Sec.  1.1310 of the final rule is consistent with the definitions used 
in subpart J (Sec.  1.328) and the facility registration regulation 
(Sec.  1.227), both of which are limited to establishments that meet 
the terms of 26 U.S.C. 501(c)(3). It is not readily apparent from the 
comments which entities covered under this rulemaking have section 
501(c)(4), (c)(5), or (c)(6) status. Moreover, we are not aware of any 
particular challenges regarding compliance with subpart S that are 
faced by entities with section 501(c)(4), (c)(5), or (c)(6) status. 
Therefore, we conclude that it is not necessary to revise the 
definition of nonprofit food establishment for the purposes of the 
subpart S requirements.
    However, we note that the rule includes procedures for requesting a 
waiver of one or more of the subpart S requirements for an individual 
entity or a type of entity on the grounds that having to meet the 
requirements would result in an economic hardship, due to the unique 
circumstances of the individual entity or type of entity (see 
Sec. Sec.  1.1405 through 1.1450, as discussed in Section V.Q of this 
document). Establishments with status under a different section of 
section 501(c) might wish to submit a request for a waiver if they 
believe that application of the subpart S requirements to them would 
result in an unusual economic hardship, and that the conditions set 
forth in Sec.  1.1405 are met.
    As discussed in Response 154, we do not agree that Congress's use 
of the word ``facility'' prevents subpart S from applying to entities 
that provide food to consumers.
    (Comment 233) One comment requests clarification on whether 
shippers who supply food to exempt nonprofits would have to follow the 
requirements of the rule, maintaining that to do so would not have any 
public health benefit because the nonprofit would not be required to 
maintain records under the rule.
    (Response 233) The exemption for nonprofit food establishments in 
Sec.  1.1305(o) applies only to the nonprofit food establishment and 
not to any other entities within the supply chain that supply food to 
them. We do not agree that there would be no benefit to requiring 
shippers who supply food to nonprofits to maintain records, as we 
continue to believe that having entities maintain records up to receipt 
by the nonprofit is appropriate to help ensure the traceability of 
potentially contaminated food. However, we note that the definition of 
shipping in Sec.  1.1310 does not include the donation

[[Page 70981]]

of surplus food. Therefore, if a shipper is donating surplus food to a 
nonprofit food establishment (or other entity), they would not be 
required to keep records of the shipment of the donated food.
    (Comment 234) One comment requests clarification on how the 
requirements would apply to participants in the ``food recovery 
system,'' especially nonprofit organizations, maintaining that onerous 
requirements might drive people away from participating in food 
recovery efforts.
    (Response 234) If an organization participating in the ``food 
recovery system'' meets the definition of ``nonprofit food 
establishment'' in Sec.  1.1310 of the final rule, it would be exempt 
from the rule. The comment did not provide information as to what kinds 
of entities, other than nonprofit organizations, might be involved in 
the food recovery system, and we are unable to determine whether there 
are other entities involved in food recovery that would otherwise be 
exempt from this rule. However, such entities might be eligible for 
exemptions or partial exemptions under other provisions of the final 
rule. Also, as discussed in Section V.Q of this document, the rule 
includes procedures for requesting a waiver of one or more of the 
subpart S requirements for an individual entity or a type of entity on 
the grounds that having to meet the requirements would result in an 
economic hardship, due to the unique circumstances of the individual 
entity or type of entity (see Sec. Sec.  1.1405 through 1.1450).
17. Exemption for Persons Who Manufacture, Process, Pack, or Hold Food 
for Personal Consumption
    We proposed that subpart S would not apply to persons who 
manufacture, process, pack, or hold food for personal consumption 
(proposed Sec.  1.1305(m)). In the preamble to the proposed rule, we 
noted that 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 ``potluck'' 
dinner with friends) to qualify for this exemption (see 85 FR 59984 at 
59999, citing 69 FR 71562 at 71579). We received no comments on this 
provision and we are finalizing the exemption as proposed in Sec.  
1.1305(p) of the final rule.
18. Exemption for Certain Persons Who Hold Food on Behalf of Individual 
Consumers
    We proposed (in Sec.  1.1305(n)) that subpart S would not apply to 
persons who hold food on behalf of specific individual consumers, 
provided that such persons are not parties to the transaction involving 
the food they hold and are not in the business of distributing food. 
The preamble to the proposed rule stated that the proposed 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 FTL 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 85 FR 59984 at 59999). We received no comments 
on this provision and are finalizing the exemption as proposed under 
Sec.  1.1305(q) of the final rule.
19. Exemption for Food for Research or Evaluation
    As discussed in the following paragraphs, we received comments that 
have prompted us to add an exemption from the subpart S requirements 
for food used in research or evaluation.
    (Comment 235) Some comments suggest we establish an additional 
exemption for food for research and development purposes. Some 
commenters request a full exemption and others note that it should be 
similar in scope to the exemption for food for research and development 
purposes under the FSVP regulation (see 21 CFR 1.501(c)). These 
comments assert that food for research and development purposes poses a 
low risk to public health, is subject to the one-up, one-back 
requirements of subpart J, and is not intended for retail sale or 
otherwise distributed to the public.
    (Response 235) We agree with the comments that food for research or 
evaluation generally should be exempt, provided that certain conditions 
similar to those in the FSVP regulation are met. We conclude that the 
risk of a foodborne illness outbreak arising from use of food in 
research or evaluation is low. Therefore, Sec.  1.1305(r) of the final 
rule provides that subpart S does not apply to food for research or 
evaluation use, provided such food (1) is not intended for retail sale 
and is not sold or distributed to the public; and (2) is accompanied by 
the statement ``Food for research or evaluation use.''
20. Other Requests for Exemption
    We received several comments requesting that we exempt other 
persons or foods from the subpart S requirements. We discuss these 
comments in the following paragraphs.
a. Certain Foods
    (Comment 236) Some comments assert that the rule is unnecessary for 
tracing of seafood. Some comments maintain that there are existing 
traceability requirements for certain seafood species and request that 
such seafood be exempted from the rule.
    (Response 236) We do not agree that the rule is unnecessary for 
tracing of seafood. Based on the data in the Model, the risk scores for 
certain seafood commodities result in those foods being placed on to 
the FTL and covered by the final rule. Except with respect to raw 
bivalve molluscan shellfish (discussed in Section V.E.7 of this 
document), we are not aware of existing traceability requirements 
applicable to seafood that will ensure a comparable level of 
traceability as outlined in the final rule.
    (Comment 237) One comment suggests that shrimp processors that have 
gained certification through a third-party inspection should be exempt 
from additional traceability requirements.
    (Response 237) We disagree with the comment. The certification to 
which the comment refers generally concerns compliance with applicable 
manufacturing/processing regulations, such as those concerning HACCP or 
CGMP, which do not necessarily address traceability. Therefore, we do 
not believe it would be appropriate to exempt shrimp processors that 
obtain such certification from the subpart S requirements.
    (Comment 238) One comment suggests that a blue crab processor or 
dock that holds either a Marine Stewardship Council (MSC) or Gulf 
United for Lasting Fisheries-Responsible Fisheries Management 
(G.U.L.F.-RFM) sustainability certification should be exempt from the 
rule. The comment asserts that any processor or dock that sells 
processed or live crab product using one of these certifications is 
required to have undergone a chain of custody inspection and 
demonstrate the capability to trace the product back to its origin. The 
comment maintains that under these certifications, crab transport 
crates are labeled with the fisherman's license and name, and that, 
combined with trip tickets, this allows crabs to be tracked from vessel 
to dealer and often to processor.
    (Response 238) The comment did not provide specific information 
about the traceability aspects of these programs, and we do not have 
information to establish that they have sufficient traceability 
requirements to ensure the effective and efficient tracing of food 
through the supply chain. However, any

[[Page 70982]]

existing records kept under these programs that contain information 
required by subpart S can be used for compliance with the final rule. 
Duplicate records would not need to be kept, which would reduce the 
burden on entities with those certifications.
b. Food Hubs
    (Comment 239) Some comments request that FDA exempt food hubs from 
the regulation due to the additional burden the regulation would pose 
and the role that food hubs have played during the COVID-19 pandemic.
    (Response 239) We decline to establish an exemption for food hubs. 
The term ``food hub'' covers a wide range of business models and 
functions. Food hubs that pack and hold RACs are covered by the 
``farm'' definition in the final rule if the farms that grow, harvest, 
and/or raise the majority of the RACs packed and/or held by the food 
hub own, or jointly own, a majority interest in the food hub. Some food 
hubs may conduct activities that transform RACs into processed food. 
Some food hubs have a farm-to-business/institution/retail model (e.g., 
selling to food cooperatives, grocery stores, institutional foodservice 
companies, and restaurants), while others have a farm-to-consumer model 
(i.e., selling directly to the consumer, such as through a CSA 
program), and some are hybrids that sell to both businesses and 
consumers. Some food hubs provide value added services such as fresh-
cut operations. Given the diverse range of activities conducted by food 
hubs, we conclude that it is not appropriate to create a blanket 
exemption for all food hubs. However, depending on the activities they 
conduct, individual food hubs might meet the criteria for one or more 
of the exemptions provided in the final rule.
c. Third-Party Cold Storage Facilities
    (Comment 240) Some comments request that certain facilities be 
exempt from the final rule under section 204(d)(6)(E) of FSMA, which 
allows FDA to provide modified requirements or an exemption from 
subpart S for a food or type of facility when the Agency determines 
that additional records are not necessary to protect public health. 
These comments assert that we should grant exemptions for third-party 
cold storage facilities where the customers, including manufacturers, 
maintain ownership of the food and are responsible for the records, 
provided the food continues to be owned by the entity that shipped the 
food to the third-party facility. The comments assert that additional 
records are not needed to protect public health in this situation and 
would create a significant burden for the third-party cold storage 
facilities.
    (Response 240) We decline to establish an exemption for third-party 
cold storage facilities. In general, we believe it is necessary for 
effective traceability to require entities that physically hold an FTL 
food at a location, including third-party cold storage facilities, to 
keep records to facilitate traceback and traceforward to other entities 
in the food's supply chain. As discussed in Section V.F of this 
document, the definition of ``holding'' in Sec.  1.1310 of the final 
rule states that holding facilities could include cold storage 
facilities. However, as discussed in Section V.R of this document, such 
storage facilities may enter into an agreement with another party, such 
as the owner of the FTL food, to keep records on behalf of the storage 
facility.
d. Third-Party Logistics Providers
    (Comment 241) One comment asserts that third-party logistics 
providers should not be covered by the rule because agreements between 
such providers and food companies might need to be very complex, which 
could lead some providers to decide not to receive or ship FTL foods. 
The comment maintains that this could hurt small businesses who rely on 
third-party logistics providers to grow their businesses.
    (Response 241) We decline to establish an exemption for third-party 
logistics providers. Regardless of agreements in place between third-
party logistics providers and food companies, if the third-party 
logistics provider is an entity that manufactures, processes, packs, or 
holds a food on the FTL, subpart S records are needed to ensure 
traceability is maintained and unbroken between supply chain partners. 
As discussed in Response 259, persons who do not physically possess 
food are not engaged in ``holding'' within the meaning of this final 
rule. Thus, if a third-party logistics provider does not take physical 
possession of the food, it would not be subject to the rule.
e. Small Wholesalers
    (Comment 242) Some comments ask whether there is an exemption for 
very small wholesalers. The comments note that while there is an 
exemption for small retailers, there is no mention of wholesalers. The 
comments ask that if small and very small wholesale operations are 
covered by the rule, FDA should provide further guidance as to how 
these firms can comply in a way that aligns with their fiscal 
limitations.
    (Response 242) While we understand the concerns of small 
wholesalers about the potential financial impact of compliance with the 
rule, we also recognize that it is necessary to ensure that essential 
traceability information is kept and passed forward along the entire 
supply chain. We conclude that if small wholesalers were exempt from 
the rule, there might be significant gaps in the tracing information 
available at critical points throughout the distribution chain. Small 
RFEs and restaurants are at the end of the distribution chain, while 
small producers are typically at the beginning of the distribution 
chain, which means that the exemptions in Sec.  1.1305(a) and (i) do 
not create gaps in the distribution chain. An exemption for small 
wholesalers, however, would create a gap in the middle of the 
distribution chain. Therefore, we decline to adopt a full exemption for 
small wholesalers (or for any small entities not at either end of the 
supply chain). However, as discussed in Response 470, the final rule 
provides some relief to small wholesalers and other small entities in 
the middle of the supply chain by exempting them from the requirement 
to provide an electronic sortable spreadsheet containing requested 
tracing information under certain circumstances.
    As previously stated, in accordance with section 204(h) of FSMA, we 
will be issuing an SECG specifically aimed at assisting affected small 
businesses in complying with the requirements of this rule. In 
addition, we may issue other materials to help smaller entities and all 
persons subject to the FTL recordkeeping requirements understand and 
meet the requirements applicable to them.
f. Intracompany Shipments
    (Comment 243) Some comments suggest that intracompany shipments 
should be exempt from the rule, maintaining that keeping records of 
such shipments is not necessary to protect public health and would 
create a significant burden. Some comments suggest that FDA revise the 
definitions of ``shipping'' and ``receiving'' to expressly exclude 
shipments between shippers and receivers that are under the ownership 
or operational control of a single company. These comments maintain 
that data related to internal movement of food products between 
locations under the same ownership would fail to add value, cause 
delays in providing critical traceability information to FDA, and be 
overly burdensome. Noting that we proposed to define ``receiving'' as 
an event in a

[[Page 70983]]

food's supply chain in which a food is received by a customer (other 
than a consumer) at a defined location after being transported from 
another defined location, the comments assert that intracompany 
movements do not involve a ``customer'' because the typical industry 
understanding of ``customer'' means the purchaser of the food. The 
comments also maintain that companies already have appropriate internal 
controls and recordkeeping requirements in place for traceability of 
food that moves within a company. In addition, the comments assert that 
each CTE will trigger voluminous records and that exempting 
intracompany movement of FTL foods will significantly reduce the burden 
of the rule.
    (Response 243) We decline to exempt intracompany shipments from the 
subpart S requirements. We conclude that effective traceability 
requires that records be kept when a product changes physical location, 
regardless of whether the shipper and receiver are under the ownership 
or operational control of the same company as in intracompany shipment 
(as the comments have described that term). Therefore, as discussed 
more fully in Section V.F of this document, we have revised the 
definition of ``shipping'' to specify that it includes sending an 
intracompany shipment of food from one location at a particular street 
address of a firm to another location at a different street address of 
the firm; we have added a similar clarification to the definition of 
``receiving.'' However, we note that movement of a product within a 
particular location of a firm (i.e., at a particular street address) 
does not constitute ``shipping'' or ``receiving'' under the final rule.
g. Cross-Docking
    (Comment 244) Some comments suggest that we provide an exemption 
for cross-docking activities and describe cross-docking as when a 
pallet of food products is sent from a firm through a distribution 
center or cross-docker and then sent on to the next point in the supply 
chain. The comments maintain that during cross-docking, a product 
passes over a loading dock from one transporter to another without 
being held at the cross-docking facility for an appreciable amount of 
time, and the product is held under procedures that maintain essential 
transportation conditions, such as temperature. The comments maintain 
that the food is not entered into the inventory of the distribution 
center or cross-docker, and that the shipping records for such food are 
primarily paper invoices. The comments assert that shipping and 
receiving requirements should not apply to food that is shipped in this 
way and request clarity regarding the common logistical practice of 
``cross-docking'' and whether it is covered under subpart S.
    (Response 244) We do not think it is necessary to exempt cross-
docking activities from the subpart S requirements. The final rule 
defines shipping to mean an event in a food's supply chain in which a 
food is arranged for transport (e.g., by truck or ship) from one 
location to another location. Records must be kept regarding both 
locations, i.e., the location where the shipping event began and the 
location where it ended (i.e., where the food was received). It is not 
necessary to have records of the route the food took, including any 
instances where it may have been moved from one carrier to another. 
Thus, in a cross-docking situation where food is arranged for transport 
from point A to point B, but it is briefly placed on a loading dock at 
point X in order to be transferred from one truck to another truck, we 
would not consider the food to have been shipped to point X (or to have 
been received at point X). Thus, no records would need to be kept 
regarding point X; the required shipping and receiving records would 
reflect that the food was shipped from point A and received at point B. 
A full discussion of the requirements applicable to the shipping (under 
Sec.  1.1340) and receiving (under Sec.  1.1345) of FTL foods is set 
forth in Sections V.M and V.N, respectively, of this document.
    We recognize that questions might arise in situations where food is 
arranged for transport from point A to point B, with an understanding 
that there will be an intermediary step during which the food is held 
at point X for a period of time. To determine whether the food was 
received at point X (and then subsequently shipped to point B), we 
would consider factors such as how long the food was held at point X, 
whether it was held there under temperature-controlled conditions that 
differ from transportation conditions, and whether it was taken into 
inventory at point X.

F. Definitions (Sec.  1.1310)

    We proposed to codify definitions of several terms we use in the 
subpart S traceability recordkeeping regulation (proposed Sec.  
1.1310). As discussed in the following paragraphs, we have revised 
several of the proposed definitions in response to comments we 
received, and we have added and deleted definitions in accordance with 
other changes to the proposed requirements we are making in the final 
rule.
    (Comment 245) Several comments request that we ensure that 
definitions of terms used in the subpart S are consistent with the 
definitions of those terms in other FSMA regulations.
    (Response 245) We agree that the definitions should be aligned as 
much as possible. In most cases, the definitions used in the final rule 
are identical to the definitions in other FDA regulations, including 
other FSMA regulations. To the extent there are minor differences in 
certain definitions, we discuss them in response to the comments below.
1. Category
    We proposed to define ``category'' to mean 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. We did not receive any comments on the 
definition of ``category.'' The term ``category'' is not included in 
the final rule as it was a component of the definition of 
``traceability product description,'' which we have also deleted (see 
Response 299 regarding deletion of the term ``traceability product 
description'').
2. Commingled Raw Agricultural Commodity
    Although the proposed rule included a definition of ``commingled 
raw agricultural commodity'' within the text of the partial exemption 
for commingled RACs (proposed Sec.  1.1305(f)), we have revised the 
definition and moved it to the definitions section of the final rule 
(Sec.  1.1310). In accordance with section 204(d)(6)(D) of FSMA, we 
proposed to define ``commingled raw agricultural commodity'' as 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 
RACs to which the standards for the growing, harvesting, packing, and 
holding of produce for human consumption in part 112 apply. We further 
stated that for the purpose of this definition, a commodity is 
``combined or mixed'' only when the combination or mixing involves food 
from different farms; in addition, the term ``processing'' would mean 
operations that alter the general state of the commodity, such as 
canning, cooking, freezing, dehydration, milling, grinding, 
pasteurization, or homogenization.
    As discussed in Response 206, we have revised the definition of

[[Page 70984]]

``commingled raw agricultural commodity'' to specify that a commodity 
is ``combined or mixed'' only when the combination or mixing involves 
food from different farms under different company management, 
consistent with the statement in the preamble to the proposed rule that 
we would not consider packed eggs that are from a single farm or 
separate farms under the same management to be commingled shell eggs 
(see 85 FR 59984 at 59997). In addition, as discussed in Response 208, 
we have revised the definition of ``commingled raw agricultural 
commodity'' to specify that, for food obtained from a fishing vessel, a 
commodity is ``combined or mixed'' only when the combination or mixing 
involves food from different landing vessels and occurs after the 
vessels have landed. We are finalizing the remainder of the definition 
of ``commingled raw agricultural commodity'' as proposed.
3. Cooling
    We proposed to define ``cooling'' to mean active temperature 
reduction of a food using hydrocooling, icing, forced air cooling, 
vacuum cooling, or a similar process, either before or after packing. 
We have modified the definition of ``cooling'' for clarity as explained 
below.
    (Comment 246) One comment asks FDA to confirm that re-cooling is 
considered part of cooling under the rule.
    (Response 246) We recognize that cooling of food can take place at 
multiple points along the supply chain. To more precisely specify the 
entities required (under Sec.  1.1325 of the final rule) to keep 
certain records of cooling that occurs before a RAC is initially 
packed, we have revised the definition to refer to active temperature 
reduction of a RAC, rather than a ``food.'' Under this revised 
definition, re-cooling would be considered ``cooling'' if the food in 
question was still a RAC, and if the other elements of the definition 
were met. In addition, we have clarified that ``cooling'' does not 
include icing of seafood, because seafood is generally iced to maintain 
product quality during holding rather than to reduce the temperature of 
the food.
4. Creating
    We proposed to define ``creating'' to mean making or producing a 
food on the FTL (e.g., through manufacturing or processing) using only 
ingredient(s) that are not on the FTL. The definition further stated 
that ``creating'' does not include originating or transforming a food. 
As explained below, we have removed this term from the final rule.
    (Comment 247) As part of requests for FDA to align the final rule 
with industry traceability standards, some comments request that the 
Agency use the International Organization for Standardization (ISO)/
International Electrotechnical Commission (IEC) 19987 and 19988 
standard term of ``commissioning'' instead of the proposed ``growing'' 
and ``creating'' terms. Other comments assert that the terms 
``creating'' and ``transforming'' are confusing, as they are 
essentially the same thing.
    (Response 247) We agree that the term ``creating'' appears to have 
caused some confusion, based on comments. In the final rule, we have 
removed the term ``creating'' and merged the concept and definition of 
``creating'' with the concept and definition of ``transformation.'' 
Thus, the final rule defines ``transformation'' in part as an event in 
a food's supply chain that involves manufacturing/processing a food or 
changing a food (e.g., by commingling, repacking, or relabeling) or its 
packaging or packing, when the output is a food on the FTL. This 
definition encompasses both ``transformation'' and ``creating'' as 
those terms were defined in the proposed rule. While we appreciate the 
value of industry standards for traceability, we decline to use the 
term ``commissioning'' in the final rule, as we believe it is not 
needed. We believe that the concept of ``transformation'' as defined in 
the final rule is widely used in industry and, because it streamlines 
two concepts into one, should reduce potential confusion. We also do 
not believe it would be appropriate to combine the ``growing'' activity 
(there was no proposed definition of ``growing'') into the 
``transformation'' definition because we conclude it is more consistent 
with the framework of the FTL traceability rule to focus the concept of 
``transformation'' primarily on manufacturing/processing and related 
activities.
5. Critical Tracking Event
    We proposed to define ``critical tracking event'' to mean 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 did not receive any comments on the definition 
of ``critical tracking event.'' In the final rule, we have modified the 
definition of ``critical tracking event'' to align with other changes 
to the proposed codified provisions. In response to comments, the CTEs 
in the final rule consist of harvesting, cooling (before initial 
packing), initial packing of RACs other than food obtained from a 
fishing vessel, first land-based receiving of food obtained from a 
fishing vessel, shipping, receiving, and transformation (see Sections 
V.H through V.O of this document for a discussion of changes to the 
CTEs). As a result of these changes, we define ``critical tracking 
event'' in the final rule as an event in the supply chain of a food 
involving the harvesting, cooling (before initial packing), initial 
packing of a RAC other than a food obtained from a fishing vessel, 
first land-based receiving of a food obtained from a fishing vessel, 
shipping, receiving, or transformation of the food.
6. Farm
    We proposed to define ``farm'' as it is defined in Sec.  1.328. The 
definition further stated that, 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. We have retained this definition in the final rule.
    (Comment 248) One comment asks whether oyster leaseholders are 
considered farms.
    (Response 248) The definition of ``farm'' in Sec.  1.328 states 
that, among other things, a farm is an operation under one management 
in one general (but not necessarily contiguous) physical location 
devoted to the growing of crops, the harvesting of crops, the raising 
of animals (including seafood), or any combination of these activities. 
Therefore, if an oyster leasehold is used for the raising of seafood, 
it is a farm for the purposes of this rule.
    (Comment 249) One comment requests that FDA clearly state that 
aquaculture operations are farms, and asks that we require that growing 
area coordinates or the equivalent be maintained for aquaculture farms, 
not just harvest information.
    (Response 249) As discussed above, operations devoted to the 
raising of seafood, such as aquaculture operations, are farms. As 
discussed in Response 328, the final rule requires that aquaculture 
farms maintain a farm map showing the areas in which they raise FTL 
foods, and the map must show the location and name of each container 
(e.g., pond, pool, tank, cage) in which the seafood is raised, 
including geographic coordinates and any other information needed to 
identify the location of each container (see Sec.  1.1315(a)(5) and 
(a)(5)(ii)). As discussed in Section V.J of this document, persons who 
harvest an aquacultured food are required to keep (among other KDEs) 
information

[[Page 70985]]

identifying where the food was harvested (see Sec.  1.1325(a)(1)(vi)). 
Similarly, as discussed in Section V.K of this document, persons who 
initially pack an aquacultured food must also keep this information 
(see Sec.  1.1330(a)(6)).
    (Comment 250) Several comments request that we update the 
definition of ``farm'' in this rulemaking or update it elsewhere before 
finalizing the rule. These comments suggest that there is a need for a 
revised and clear definition of ``farm'' that is consistent across all 
the FSMA rulemakings. One comment maintains that the question of how to 
handle intracompany shipments is complicated by the fact that the 
definition of farm in Sec.  1.328 does not clearly define whether an 
operation is one farm or multiple farms.
    (Response 250) We agree that, to the extent possible, the 
definition of ``farm'' in the subpart S food traceability regulation 
should be consistent with other FDA regulations, including other FSMA 
rules. The final rule defines ``farm'' to mean farm as defined in Sec.  
1.328, except that 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. By referencing the farm definition in Sec.  1.328, we are 
aligning our definition not only with subpart J (which is where Sec.  
1.328 appears), but also with several regulations that have adopted the 
identical farm definition, including the food facility registration 
regulation (see Sec.  1.227), the produce safety regulation (see Sec.  
112.3), and the preventive controls for human food regulation (see 21 
CFR 117.3). We think it is appropriate for the farm definition in the 
food traceability regulation to include additional language about egg 
farms so that our rule is also aligned with the definition of ``farm'' 
in the egg safety regulation (see Sec.  118.3).
    As discussed in the January 2018 document, ``Guidance for Industry: 
Policy Regarding Certain Entities Subject to the Current Good 
Manufacturing Practice and Preventive Controls, Produce Safety, and/or 
Foreign Supplier Verification Programs,'' FDA intends to initiate a 
future rulemaking related to farm activities, which may change the farm 
definition that is used in those three FSMA regulations (which is 
identical to the farm definition used in this final rule). If the 
definition of ``farm'' in Sec.  1.328 is revised through that separate 
rulemaking, those revisions will be incorporated into the subpart S 
food traceability regulation, because our definition of ``farm'' 
directly references Sec.  1.328.
7. First Land-Based Receiver
    We are adding a definition of ``first land-based receiver'' to the 
final rule to clarify the scope of changes we have made concerning 
recordkeeping requirements for the first land-based receiver of food 
obtained from a fishing vessel (see Section V.L of this document). For 
the purposes of subpart S, ``first land-based receiver'' means the 
person taking possession of a food for the first time on land directly 
from a fishing vessel.
8. First Receiver
    We proposed to define ``first receiver'' as the first person (other 
than a farm) who purchases and takes physical possession of a food on 
the FTL that has been grown, raised, caught, or (in the case of a non-
produce commodity) harvested. Because we have deleted from the rule the 
proposed requirements applicable to the first receiver of an FTL food 
(see Section V.K of this document), we are also deleting the definition 
for ``first receiver.''
    (Comment 251) One comment asks that we include a definition of a 
``first shipper'' to allow the first receiver to know what data must be 
sent with each shipment.
    (Response 251) Because we have deleted the proposed requirements 
that would have applied to first receivers, there is no need to define 
``first shipper.''
    (Comment 252) One comment asks that the first receiver definition 
be amended to include fresh produce packinghouses because they maintain 
many of the first receiver KDEs linked to a lot code assigned by the 
packinghouse at the time of packing. The comment contends that growers 
are comfortable with packers maintaining this information on their 
behalf.
    (Response 252) As previously stated, the final rule deletes the 
proposed requirements for first receivers, so there is no need to 
revise the definition as suggested. However, in response to comments, 
we have replaced the requirements for first receivers with requirements 
for persons who either (1) perform the initial packing of a RAC other 
than a food obtained from a fishing vessel or (2) are the first land-
based receiver of a food obtained from a fishing vessel (see Sections 
V.J and V.K of this document). As discussed below, ``initial packing'' 
is defined as packing a RAC (other than a food obtained from a fishing 
vessel) for the first time. Under Sec.  1.1330 of the final rule, an 
entity (such as a produce packinghouse) that initially packs a RAC not 
obtained from a fishing vessel must assign a traceability lot code and 
maintain harvest and (when applicable) cooling KDEs, among others, 
linked to the traceability lot code.
    (Comment 253) One comment requests that we clarify situations when 
an RFE might meet the definition of a ``first receiver,'' such as when 
an RFE purchases from a vendor that received food from a farm.
    (Response 253) As previously stated, we have deleted the proposed 
requirements for first receivers of FTL foods. We have replaced the 
first receiver concept with the concepts of initial packing (for RACs 
not obtained from a fishing vessel) and first land-based receiving (for 
food obtained from a fishing vessel). We think it is unlikely that an 
RFE or restaurant would engage in the initial packing of a food. We 
also do not think that most RFEs or restaurants would be the first 
land-based receiver of a food obtained from a fishing vessel, although 
there are situations where this might be the case. In most 
circumstances we anticipate that the only CTE performed by an RFE or 
restaurant would be receiving.
    (Comment 254) One comment expresses concern that the inclusion of 
ownership in the proposed definition of ``first receiver'' would create 
confusion with FDA's definition of ``secondary activities farm'' in the 
produce safety regulation.
    (Response 254) Because the final rule does not include requirements 
for first receivers, this should eliminate any possible confusion of 
the term ``first receiver'' with definitions of terms in other 
regulations. We also note that the definitions of ``initial packing'' 
and ``first land-based receiver'' (which define the events that 
replaced the first receiver CTE) do not include ownership of the food 
as part of the definition.
    (Comment 255) One comment requests that FDA define ``non-farm 
entity,'' which is a phrase we used in the preamble to the proposed 
rule to explain the proposed definition of ``first receiver.''
    (Response 255) Because the final rule does not include requirements 
for ``first receivers,'' there is no need to clarify the meaning of 
``non-farm entity.''
9. Fishing Vessel
    We proposed 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 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,

[[Page 70986]]

preparation, supply, storage, refrigeration, transportation, or 
processing. On our own initiative, we have added text at the end of the 
definition stating that the definition is as set forth in the Magnuson-
Stevens Fishery Conservation and Management Act, 16 U.S.C. 1802(18), 
which is the definition for ``fishing vessel'' specified in section 
204(d)(6)(C) of FSMA.
    (Comment 256) One comment requests that we revise the definition of 
``fishing vessel'' to include aquaculture farm vessels or trucks, 
because shellfish farms do not use boats to access their farms. The 
comment maintains that the Magnuson-Stevens Act definition of ``fishing 
vessel'' does not apply to aquaculture.
    (Response 256) We decline to make this change. Section 204(d)(6)(C) 
of FSMA requires a partial exemption for ``fishing vessel'' as that 
term is defined in section 3(18) of the Magnuson-Stevens Fishery 
Conservation and Management Act. If a conveyance used on an aquaculture 
farm does not meet this definition, it would not be considered a 
``fishing vessel'' for the purposes of subpart S.
10. Food Traceability List
    We proposed to define ``Food Traceability List'' to mean 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 stated that the term ``Food Traceability List'' 
includes both the foods specifically listed and foods that contain 
specifically listed foods as ingredients. We did not receive any 
comments on the proposed definition, but we received several comments 
asking whether certain foods were on the FTL, some of which indicated 
confusion with how the FTL was defined. We are revising the definition 
in the final rule for clarity, consistent with determinations we have 
made regarding the description of foods on the FTL (see Response 27). 
Therefore, the final rule defines ``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, and further states that the term ``Food Traceability List'' 
includes both the foods specifically listed and foods that contain 
listed foods as ingredients, provided that the listed food that is used 
as an ingredient remains in the same form (e.g., fresh) in which it 
appears on the list.
11. Growing Area Coordinates
    We proposed 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.
    (Comment 257) One comment requests that the final rule emphasize 
that the term ``growing area coordinates'' applies to where a food was 
both grown and harvested.
    (Response 257) Because growing area coordinates was one of the KDEs 
we proposed to require for the CTE of growing an FTL food, and the 
final rule deletes the proposed CTE for growing of foods (see Section 
V.J of this document), we are also deleting the definition of ``growing 
area coordinates.'' As discussed in Section V.G of this document, the 
final rule instead requires certain farms to keep, as part of their 
traceability plan, a farm map showing the location and name of each 
field (or other growing area) in which an FTL food is grown, including 
geographic coordinates and any other information needed to identify the 
location of each field or growing area. As discussed in Section V.J of 
this document, harvesters of produce covered by the rule also will be 
required to keep, among other KDEs, the name of the field or growing 
area from which the food was harvested (which must correspond to the 
name used by the grower), or other information identifying the harvest 
location at least as precisely as the field or other growing area name. 
Similar requirements apply to aquacultured food, as discussed in 
Section V.J.
12. Harvesting
    We proposed to define ``harvesting'' to mean activities of farms 
and farm mixed-type facilities that are traditionally performed on 
farms for the purpose of removing RACs from the place they were grown 
or raised and preparing them for use as food. The definition further 
stated that ``harvesting'' is limited to activities performed on RACs, 
or on processed foods created by drying/dehydrating a RAC without 
additional manufacturing/processing, on a farm. The proposed definition 
went on to state that ``harvesting'' does not include activities that 
transform a RAC into a processed food as defined in section 201(gg) of 
the FD&C Act, and provided examples of harvesting, including cutting 
(or otherwise separating) the edible portion of the RAC from the crop 
plant and removing or trimming part of the RAC (e.g., foliage, husks, 
roots, or stems). Additional examples of harvesting in the proposed 
definition included 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 RACs grown on a farm.
    (Comment 258) Several comments state that the proposed definition 
of ``harvesting'' does not include ``cooling,'' unlike the definition 
of ``harvesting'' in other FSMA regulations. The comments ask that we 
include ``cooling'' in the definition of ``harvesting'' to make the 
definition consistent with the other FSMA regulations.
    (Response 258) We agree that it is important to maintain 
consistency in definitions, when possible, in situations where the same 
term is defined in multiple FDA regulations. Because of this, we have 
aligned many of the subpart S definitions with Sec.  1.227, which is a 
provision with which many other FSMA rules have also aligned their 
definitions. We are therefore revising the definition of ``harvesting'' 
in the final rule so that it is the same as the definition in Sec.  
1.227. We had proposed not to include ``cooling'' in the definition 
because the rule includes KDEs related to cooling and we believed it 
would be helpful to distinguish cooling from harvesting. However, to 
maintain consistency across FDA regulations, the final rule includes 
cooling in ``harvesting,'' while maintaining separate KDEs for the two 
different events of harvesting and cooling. As discussed above, the 
final rule continues to include a definition of ``cooling,'' to clarify 
the application of the KDEs that relate to cooling. When a person 
performs ``cooling'' as defined in the final rule and that person does 
not otherwise perform any activities associated with harvesting, they 
would not be required to maintain the harvesting KDEs in Sec.  
1.1325(a). If applicable, such a person would be required to maintain 
the cooling KDEs in Sec.  1.1325(b).
    In accordance with finalizing the definition of ``harvesting'' as 
it appears in Sec.  1.227, we are removing from the proposed definition 
a few of the additional examples of harvesting that we had proposed to 
include, specifically ``collecting eggs, taking of fish and other 
seafood in aquaculture operations, [and] milking.'' We continue to 
consider these activities to be harvesting activities, even though we 
are removing them from the definition for the sake of consistency. 
Other than the removal of these additional examples and the

[[Page 70987]]

addition of ``cooling'' to the list of additional examples, the 
remainder of the proposed definition of ``harvesting'' was already 
identical to the definition in Sec.  1.227.
13. Holding
    We proposed to define ``holding'' to mean storage of food and 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 RACs 
when the drying/dehydrating does not create a distinct commodity (such 
as drying/dehydrating hay or alfalfa)). The definition further stated 
that ``holding'' also includes activities performed as a practical 
necessity for the distribution of that food (such as blending of the 
same RAC and breaking down pallets) but does not include activities 
that transform a RAC into a processed food as defined in section 
201(gg) of the FD&C Act. The proposed definition notes that holding 
facilities include warehouses, cold storage facilities, storage silos, 
grain elevators, and liquid storage tanks.
    (Comment 259) One comment asks that we confirm that the definition 
of ``holding'' requires physical possession of food and expresses 
support for that definition.
    (Response 259) We confirm that the definition of ``holding'' 
requires physical possession of the food. However, to ensure that 
``holding'' is defined consistently in FDA regulations, we are not 
adding this clarification to the text of the definition. The final rule 
maintains the same definition of ``holding'' that we proposed with one 
edit (explained below), which makes the definition in the final rule 
identical to that in Sec.  1.227 and consistent with other FDA 
regulations, including the FSMA regulations.
    (Comment 260) Some comments assert that the ``exemption'' of 
brokers and importers who do not physically possess FTL foods will 
complicate successful implementation of the rule. The comments do not 
believe that most importers also hold food, and they maintain that, in 
FSMA's FSVP provisions, Congress recognized the need to hold importers 
accountable for the safety of the foods they import, regardless of 
whether they take physical possession of the food. The comments 
maintain that importers should retain and share with key partners 
essential traceability data to enable FDA to access the lot number and 
necessary information at the point of sale. The comments also state 
that, in the sanitary transportation regulation, freight brokers are 
identified as a type of ``shipper'' that is subject to that regulation. 
The comments assert that because other FSMA regulations recognize the 
role that importers and brokers play in food safety, importers and 
brokers should not be excluded from the subpart S requirements.
    A few comments urge FDA to ensure that brokers and importers help 
facilitate compliance for other entities in the supply chain. The 
comments acknowledge that brokers may not hold the food and therefore 
would not be covered by the rule, but the comments maintain that such 
brokers may still possess relevant information for traceability. The 
comments also question whether excluding such brokers from the rule 
would place an unfair burden on manufacturers to ensure that 
information is shared across the supply chain if the broker is the 
entity that moves the food.
    (Response 260) Section 204(d)(1) of FSMA directs FDA to establish 
recordkeeping requirements for facilities that manufacture, process, 
pack, or hold foods for which we have determined that the additional 
requirements are appropriate and necessary to protect the public 
health. As discussed in the preamble to the proposed rule (85 FR 59984 
at 60000), we believe that persons who do not physically possess food 
are not engaged in holding of food within the meaning of the rule. This 
means, for example, that a person who coordinates the import of a FTL 
food but never takes physical possession of the food would not be 
subject to the rule, while a person who imports a listed food and 
physically possesses the food would be subject to the rule unless an 
exemption applies. 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. Although, 
as noted by the comments, brokers and importers that do not physically 
possess food are subject to other FSMA regulations, the inapplicability 
of the subpart S requirements to such firms does not constitute a 
conflict, as the different regulations serve different food safety 
purposes and are based on different statutory authorities. Given the 
many different business models and persons that may be involved within 
a supply chain, we encourage all supply chain partners to work together 
to provide the required information to each other to ensure end-to-end 
traceability.
    We also note that entities that are covered by the rule may 
designate entities that are not covered, such as importers or brokers 
who do not hold the food, to maintain traceability records on behalf of 
the covered entity (see Sec.  1.1455(b)). However, the covered entity 
would remain responsible for ensuring that the subpart S requirements 
are met for the FTL foods that they manufacture, process, pack, or 
hold.
    (Comment 261) One comment notes that the proposed definition of 
``holding'' omits the word ``could'' from the statement in the 
definition of ``holding'' in the preventive controls regulation that 
``[h]olding facilities could include warehouses, cold storage 
facilities, storage silos, grain elevators, and liquid storage tanks.'' 
The comment asks if the omission was intended to convey a different 
meaning.
    (Response 261) We did not intend to convey a different meaning of 
``holding'' from that in the preventive controls regulation. To ensure 
that we are defining ``holding'' consistently, the final rule specifies 
that holding facilities ``could include'' warehouses, cold storage 
facilities, storage silos, grain elevators, and liquid storage tanks.
    (Comment 262) One comment requests that we replace the example of 
``drying/dehydrating hay or alfalfa'' in the definition of ``holding'' 
with an example that is relevant to the current list of FTL foods.
    (Response 262) We disagree with the comment that we should delete 
the example of drying/dehydrating hay or alfalfa from the definition of 
``holding'' in the final rule. As noted above, we believe it is 
important to maintain consistency with definitions that are common 
across various FDA regulations (including the FSMA regulations); 
therefore, we are finalizing the definition of ``holding'' as it 
appears in Sec.  1.227.
    (Comment 263) One comment asks whether the definition of holding 
includes holding of live animals, such as lobsters in a lobster pond.
    (Response 263) Crustaceans such as lobsters are included on the FTL 
and are therefore covered by the final rule. Because ``holding'' means 
storage of food, including activities performed incidental to storage 
of a food, holding crustaceans such as lobsters in ponds or other 
containers is ``holding'' under the final rule.
    (Comment 264) One comment requests that we clarify the difference 
between drying alfalfa and drying raisins, and asks why drying alfalfa 
is considered a harvesting activity while drying raisins is considered 
a manufacturing/processing activity.
    (Response 264) We regard the drying of hay and alfalfa as a holding 
activity (rather than a ``harvesting'' activity as

[[Page 70988]]

the comment asserts) because the drying is done to effectuate the safe 
storage of hay/alfalfa and is not a process that transforms the hay/
alfalfa into a distinct commodity. The drying of grapes into raisins is 
considered a manufacturing/processing activity because the process 
transforms the grapes (a RAC) into a distinct commodity (raisins), 
which is not a RAC.
14. Initial Packing
    We are adding a definition of ``initial packing'' to clarify the 
scope of the CTE for the initial packing of a food, as discussed in 
Section V.K of this document. The final rule defines ``initial 
packing'' to mean packing a RAC (other than a food obtained from a 
fishing vessel) for the first time.
15. Key Data Element
    We proposed to define ``key data element'' to mean information 
associated with a CTE for which a record must be established and 
maintained in accordance with this subpart. We did not receive any 
comments on this definition. On our own initiative, we are revising the 
definition to specify that a KDE is information associated with a CTE 
for which a record must be maintained ``and/or provided'' in accordance 
with subpart S, to reflect that certain KDEs must be provided to other 
supply chain entities as well as maintained. Also on our own 
initiative, we removed ``established and'' in the phrase ``for which a 
record must be established and maintained in accordance with this 
subpart,'' because in some situations an entity might receive the 
relevant record from a supply chain partner (e.g., the shipper), rather 
than establish a new record.
16. Kill Step
    We proposed to define ``kill step'' to mean processing that 
significantly minimizes pathogens in a food. We did not receive any 
comments on this definition, but we received questions about what 
constitutes a kill step, some of which indicated confusion about how to 
apply the definition. As discussed in Section V.B of this document, we 
have added the word ``lethality'' before ``processing'' in the 
definition to clarify that the processing must be robust and not 
something that simply reduces pathogens (e.g., a washing process).
17. Location Description
    We proposed to define ``location description'' to mean 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.
    (Comment 265) Several comments state that requiring both a 
``physical location name'' and a ``physical location description'' is 
confusing. The comments maintain that a physical location description 
typically means a complete physical address and other key contact 
information; another comment states that ``location description'' 
should be defined as the business name, phone number, and physical 
address. Some comments request that we clarify which KDEs are required 
for a location description; several other comments suggest that we 
allow flexibility in how an entity's location is communicated.
    (Response 265) We agree that the proposed definition of ``location 
description'' was somewhat unclear. To address this, we have deleted 
``physical location name'' from the definition and removed the word 
``primary'' preceding ``phone number'' as it was not adding clarity. We 
also removed the phrase ``complete physical address'' from the 
beginning of the definition because it was redundant with the 
information that followed. The revised definition also specifies that 
the key contact information should be for the location where a food is 
handled (as opposed to the address of the corporate headquarters of a 
brand owner or parent company), because that is the information that is 
most useful during a traceback investigation. The final rule therefore 
defines ``location description'' to mean key contact information for 
the location where a food is handled, specifically the business name, 
phone number, physical location address (or geographic coordinates), 
and city, state, and zip code for domestic locations and comparable 
information for foreign locations, including country.
    We are providing flexibility in allowing a physical location 
address or geographic coordinates. However, there is only so much 
flexibility we can allow in the location description because it is 
important for the location description to be a complete set of 
information to allow us to quickly identify, during an outbreak of 
foodborne illness, the physical location of the entity that handled the 
FTL food, as well as to have an accurate phone number that will allow 
us to contact that location quickly.
    (Comment 266) One comment maintains that, for fishing vessels, 
location description is not a KDE used by other traceability programs 
and should be changed to vessel flag state. Another comment says that 
location description is a confusing term with respect to fishing 
vessels because it could include the vessel identification number, 
license number, name of vessel, and country in which the vessel is 
licensed. The comment also asks why a point of contact is needed and 
suggests that this KDE be optional for fishing vessels.
    (Response 266) The final rule omits from the definition of 
``location description'' the proposed text on what the definition meant 
specifically for fishing vessels. Instead, Sec.  1.1335 of the final 
rule specifies that if a person is the first land-based receiver of a 
food that was obtained from a fishing vessel, the only location 
description record the person must maintain is the location description 
for itself, which also serves as the traceability lot code source for 
the food, since the first land-based receiver must assign a 
traceability lot code to the food (see Section V.H of this document). 
We have removed requirements to maintain records related to the 
identity of the fishing vessel, such as the country of license of the 
vessel and a point of contact for the vessel (which we had proposed as 
part of the location description) and the vessel identification number 
(which we had proposed as part of the location identifier), to simplify 
the requirements of the final rule, as we have determined that this 
information is not essential for traceability under subpart S. However, 
the first land-based receiver of a food obtained from a fishing vessel 
must maintain a record of the harvest date range and location for the 
trip during which the food was harvested because it may be important to 
know where the fish was caught for traceability purposes in the event 
of an outbreak of foodborne illness.
18. Location Identifier
    We proposed to define ``location identifier'' to mean 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. To avoid potential confusion regarding this term, we 
have deleted it from the rule, as discussed in response to the comments 
below.

[[Page 70989]]

    (Comment 267) Several comments maintain that including both a 
location description and location identifier for an entity is redundant 
and that use of the term ``identifier'' is confusing, offers more 
detail than is necessary, and could be difficult to obtain, while other 
comments suggest that either location description or location 
identifier but not both should be required. One comment maintains that 
having both a location description and a location identifier could be 
confusing to FDA during an investigation. One comment suggests allowing 
for flexibility for the location identifier, with options to provide a 
name and physical location or a unique identifier, potentially using 
the last 5 to 6 digits of the FDA registration number. However, one 
comment suggests that FDA facility registration numbers should not be 
used as a location identifier. One comment suggests that FDA assign 
location identifiers for all establishments that produce, transform, 
package, or label foods covered by this rule. Finally, some comments 
state that location identifiers are not commonly used in business at 
all or are not commonly used to refer to the physical location of 
production; instead, the comments maintain that a location identifier 
often refers to a commercial location such as headquarters, sales, or 
customer service locations.
    (Response 267) We recognize that the proposed requirements to keep 
both a ``location description'' and a ``location identifier'' for an 
entity were confusing to many commenters. Therefore, we have removed 
the requirement to keep a ``location identifier'' and deleted the 
definition of ``location identifier'' from the final rule. We conclude 
that the information specified in the definition of ``location 
description'' is adequate to identify where an entity is physically 
located, and comments indicate that some covered entities do not 
currently use location identifiers. Businesses that use location 
identifiers, such as to differentiate between intracompany locations 
(e.g., store numbers), may choose to include that information as part 
of their location description. This could be done either by adding it 
to the required information or by using it as a shorthand for some or 
all of the required information, provided that a glossary or key is 
maintained (and, if necessary, shared) to indicate the complete 
physical address and other required information relating to the 
specific location.
    (Comment 268) Several comments recommend expanding the definition 
of ``location identifier'' to include the GS1 Global Location Number 
(GLN). According to comments, the GLN has wide global acceptance and is 
endorsed by the FAO. Comments suggest adopting the GLN as the location 
identifier, maintaining that the GLN better identifies fishing vessels 
and that it would be useful for identifying packing and cooling 
locations. On the other hand, one comment supports the definition of 
``location identifier'' for fishing vessels as proposed.
    (Response 268) We have deleted the proposed requirement to maintain 
a location identifier (including, where applicable, a fishing vessel 
identifier) for all CTEs. Consequently, we have also deleted the 
definition of ``location identifier.'' However, businesses that use 
GLNs may choose to include that information as part of their location 
description. This could be done either by adding it to the required 
information or by using it as a shorthand for some or all of the 
required information, provided that a glossary or key is maintained 
(and, if necessary, shared) to indicate the complete physical address 
and other required information relating to the specific location.
19. Lot
    We proposed to define ``lot'' to mean the food produced during a 
period of time at a single physical location and identified by a 
specific code. The proposed definition further stated that a lot may 
also be referred to as a batch or production run. As discussed below, 
we are deleting this definition to avoid possible confusion with the 
term ``traceability lot.''
    (Comment 269) Several comments express confusion about the 
difference between ``lot'' and ``traceability lot,'' maintaining that 
the need for two terms was unclear. (As discussed below, we proposed to 
define ``traceability lot'' as a lot of food that has been originated, 
transformed, or created.) Some comments recommend that FDA should 
define ``lot'' by using current industry terminology to better align 
with currently used processes and standards, and remove new terms that 
are causing confusion, such as ``traceability lot.''
    (Response 269) We agree there was potential for confusion between 
the terms ``lot'' and ``traceability lot.'' We have deleted the 
definition of ``lot'' from the final rule. Because the rule is focused 
on keeping and providing to subsequent supply chain entities the 
traceability lot code, which applies to a ``traceability lot'' of an 
FTL food, we conclude that it is not necessary to have an additional 
definition for ``lot.'' Regarding consensus terminology, we have 
reviewed traceability standards and initiatives both domestically and 
internationally and we are not aware of a consensus definition of 
``lot.'' For the purposes of subpart S, we think the important thing is 
to have a shared understanding of the term ``traceability lot,'' the 
definition of which is discussed below. Businesses may choose to assign 
additional lot codes that are internal to their operations, but such 
practices are beyond the scope of this rule and therefore do not 
require a definition of ``lot.''
20. Manufacturing/Processing
    We proposed to define ``manufacturing/processing'' to mean making 
food from one or more ingredients, or synthesizing, preparing, 
treating, modifying, or manipulating food, including food crops or 
ingredients. The proposed definition further stated that examples of 
manufacturing/processing activities include baking, boiling, bottling, 
canning, cooking, cooling, cutting, distilling, drying/dehydrating RACs 
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. Finally, the proposed definition noted 
that, for farms and farm mixed-type facilities, manufacturing/
processing does not include activities that are part of harvesting, 
packing, or holding. We did not receive any comments on this definition 
and are finalizing it as proposed, which is identical to the definition 
in Sec.  1.227.
21. Mixed-Type Facility
    We proposed to define ``mixed-type facility'' to mean 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 definition further 
states that 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. We did not receive any comments on the definition of 
``mixed-type facility'' and are finalizing it as proposed, which is 
identical to the definition in Sec.  1.227.
22. Nonprofit Food Establishment
    We proposed to define ``nonprofit food establishment'' to mean a 
charitable entity that prepares or serves food directly to the consumer 
or

[[Page 70990]]

otherwise provides food or meals for consumption by humans or animals 
in the United States. The definition further stated that the term 
includes central food banks, soup kitchens, and nonprofit food delivery 
services and notes that 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.
    (Comment 270) One comment asks whether hospitals and nursing homes 
are considered nonprofit food establishments.
    (Response 270) Hospitals and nursing homes are nonprofit food 
establishments under the rule (and thus would be exempt from subpart S 
under Sec.  1.1305(o)) if they meet the definition of ``nonprofit food 
establishment'' that we proposed and are finalizing, i.e., they are a 
charitable entity that prepares or serves food directly to consumers or 
otherwise provides food or meals for consumption by humans or animals 
in the United States, and they meet the terms of section 501(c)(3) of 
the U.S. Internal Revenue Code. Hospitals and nursing homes that are 
not nonprofit food establishments might be eligible for other 
exemptions or partial exemptions, such as the exemption for small RFEs 
and restaurants in Sec.  1.1305(i).
23. Originating
    We proposed 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. As explained below, we have removed this term from 
the final rule.
    (Comment 271) One comment asks that we replace ``growing'' with 
``harvesting'' in the definition of ``originating.'' The comment 
maintains that traceability lot codes normally are not assigned to food 
before it is harvested.
    (Response 271) We agree that traceability lot codes usually are not 
assigned to a food until after it is harvested, and we have made 
several changes to the rule to reflect this, including adoption of 
requirements applicable to the initial packer of a food not obtained 
from a fishing vessel and the first land-based receiver of a food 
obtained from a fishing vessel (see Sec. Sec.  1.1330 and 1.1335). As a 
result of these and other changes, the final rule no longer includes 
requirements concerning originators or originating of foods, and we are 
deleting the definition of ``originating.''
24. Originator
    We proposed to define ``originator'' to mean a person who grows, 
raises, or catches a food, or harvests a non-produce commodity. We did 
not receive any comments on this definition. Consistent with the 
deletion of the term ``originating,'' we are deleting the definition of 
``originator'' from the rule.
25. Packing
    We proposed to define ``packing'' to mean placing food into a 
container other than packaging the food, including 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 not including activities 
that transform a RAC, 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. 
The proposed definition was identical to the definition in Sec.  1.227. 
We are finalizing the definition of ``packing'' as proposed, except 
that we are deleting the reference to the definition of ``raw 
agricultural commodity'' in section 201(r) of the FD&C because we are 
adding a definition of ``raw agricultural commodity'' to the rule, 
stating that the term means ``raw agricultural commodity'' as defined 
in section 201(r) of the FD&C Act. We note that, in general, packing 
means putting a product into a container that is distributed in 
commerce (e.g., packing clamshell containers into a cardboard box for 
shipment), and does not include placing a product into a temporary 
container to move it, such as from a field to a packinghouse.
    (Comment 272) Some comments state that the proposed definition of 
``packing'' conflicts with practices used for seafood, especially 
molluscan shellfish. The comments maintain that activities such as 
sorting and culling are associated with harvesting for seafood, 
particularly molluscan shellfish. The comments ask that we revise the 
definition of ``packing'' to focus on activities associated with the 
first receiver KDEs to be more consistent with the seafood HACCP 
regulation.
    (Response 272) We understand that industries handling different FTL 
foods sometimes use the same terms differently. The definition of 
``packing'' we proposed is used in other FDA regulations, and we are 
finalizing it as proposed (except for the small edit described above, 
which matches other FSMA regulations that also define ``raw 
agricultural commodity'' separately) for consistency with those 
regulations. In response to comments, the final rule deletes proposed 
requirements associated with the first receiver of an FTL food; KDEs 
related to packing will need to be kept when an entity performs the 
initial packing of a RAC (other than a food obtained from a fishing 
vessel) (see Section V.K of this document). As the comment mentions 
molluscan shellfish, we note that the final rule includes an exemption 
for certain raw bivalve molluscan shellfish (Sec.  1.1305(f)).
26. Person
    We proposed to define ``person'' as it is defined in section 201(e) 
of the FD&C Act, i.e., as including an individual, partnership, 
corporation, and association. We are finalizing the definition of 
``person'' as proposed.
    (Comment 273) Some comments request that we reconsider using 
``person'' to describe both people and companies. One comment asks how 
``person'' applies to multi-location corporations.
    (Response 273) We decline to revise the definition of ``person,'' 
which is a term and definition used in the subpart J regulation and 
throughout the FD&C Act. Because persons who manufacture, process, 
pack, or hold FTL foods under Sec.  1.1300 of the final rule could 
include both individuals and companies, it is appropriate that the 
definition include individuals along with partnerships, corporations, 
and associations. Multi-location corporations might have different 
corporate structures and practices, and the final rule includes 
flexibility to account for this fact. For example, a multi-location 
corporation may choose to maintain all of the required records 
associated with its various branches in a central location, as long as 
such records can be provided to FDA within 24 hours of request for 
official review (see Sec.  1.1455(c)(2)). We also note that, as 
discussed in Response 276, the final rule specifies that ``shipping'' 
includes sending an intracompany shipment of food from one location at 
a particular street address of a firm to another location at a 
different street address of the firm.
27. Physical Location Name
    We proposed to define ``physical location name'' to mean the 
word(s) used to identify the specific physical site of a business 
entity where a particular critical tracking event occurs. The 
definition further stated that a physical location name might be the 
same as an entity's business name if the entity has only one physical 
location. We did not receive any comments on

[[Page 70991]]

this definition, but we received comments about the proposed definition 
of ``location description,'' which included the phrase ``physical 
location name.'' As discussed previously, we have deleted ``physical 
location name'' as a component of ``location description'' and are 
therefore deleting the definition of ``physical location name'' from 
the rule.
28. Point of Contact
    We proposed 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 explained below, we have made changes to the 
definition of ``point of contact'' in response to comments.
    (Comment 274) Many comments express concern about proposed 
provisions requiring the identification of a point of contact. Some 
comments maintain that, with employee turnover rates, requiring an 
individual's name for the point of contact would increase costs and 
paperwork burden, introduce an opportunity for updating errors, and 
create privacy issues in sharing the information. Some comments 
maintain that requiring names and phone numbers of points of contact to 
be passed through the entire chain puts individuals at unnecessary risk 
for the compromise of their privacy, and could potentially make them an 
information target for a criminal organization and raise liability 
concerns if such an individual is targeted for information after a data 
breach of information stored by a downstream entity. Some comments 
acknowledge the importance of maintaining a record of the point of 
contact but maintain that this information is not currently 
communicated within most of the produce industry, and the comments 
request guidance on feasible options to demonstrate compliance with 
this requirement. Many comments oppose the proposed requirements to 
provide a point of contact for the lot code generator, stating that 
sharing this information may disclose confidential information about a 
firm's suppliers. Some comments ask that we provide additional 
justification to explain the benefit of including a point of contact 
requirement, asserting that it is unnecessary to have the name of the 
individual responsible for a covered entity's traceback program for FDA 
to perform an efficient traceback. Other comments ask that we provide 
more flexibility to allow firms to determine the best way to provide 
information on the designated point of contact. These comments 
recommend changing the definition of ``point of contact'' to allow for 
reference to a job title or a more general reference to a responsible 
individual, rather than stating an individual's name.
    (Response 274) We appreciate the comments' concerns about the 
privacy of individuals serving as a firm's point of contact. To address 
these privacy concerns, we have deleted proposed requirements for firms 
to provide point of contact information to other entities in the supply 
chain. In the final rule, the only requirements regarding a point of 
contact are in the traceability plan (which is not shared with other 
entities in the supply chain) (Sec.  1.1315(a)(4)) and in the 
procedures for requesting a waiver for an individual entity (Sec.  
1.1415(a)).
    To further address the concerns raised in the comments, we have 
revised the definition of ``point of contact'' to mean an individual 
having familiarity with an entity's procedures for traceability, 
including their name and/or job title, and phone number. We conclude 
that providing a job title in place of (or in addition to) an 
individual's name allows firms to provide essential point of contact 
information without infringing on the privacy of employees and provides 
flexibility for firms to decide how best to identify the individual or 
individuals who have familiarity with the firm's procedures for 
traceability.
    On our own initiative, we have removed the proposed requirement to 
provide the email address and Fax number for the point of contact. The 
proposed requirement was to provide these pieces of information ``if 
available,'' and we determined that neither was necessary. When 
reaching out to a point of contact, we will generally do so by phone, 
and at that point we can get any other contact information that is 
needed.
    (Comment 275) Several comments recommend that the rule provide 
flexibility in the number of points of contact a firm can provide to 
fulfill a point of contact requirement, noting that some covered 
entities may have an entire team of people tasked with this 
responsibility.
    (Response 275) We agree with the comments. As stated above, we are 
revising the definition of ``point of contact'' to allow for the use of 
job titles in place of (or in addition to) an individual's name. As 
noted in Response 450, we have deleted as unnecessary the use of 
``(s)'' (indicating pluralization of terms as applicable) from all 
provisions in which we had proposed to include it (except with respect 
to the definition of ``retail food establishment,'' where we have 
retained it so that the definition is the same as in other FDA 
regulations).
29. Produce
    We proposed to define ``produce'' as it is defined in Sec.  112.3 
in the produce safety regulation. We did not receive any comments on 
this definition and are finalizing it as proposed.
30. Product Description
    We are deleting the proposed definition of ``traceability product 
description'' and replacing it with a definition of ``product 
description.'' The final rule defines ``product description'' to mean a 
description of a food product, which includes the product name 
(including, if applicable, the brand name, commodity, and variety), 
packaging size, and packaging style. The definition further states that 
for seafood, the product name may include the species and/or acceptable 
market name. We discuss comments on the proposed definition of 
``traceability product description''--which are relevant to the 
definition of ``product description''--in Response 299.
31. Raw Agricultural Commodity
    For clarity in understanding certain provisions of subpart S that 
include the term ``raw agricultural commodity,'' we are adding a 
definition of the term identical to that found in other FDA 
regulations, including the produce safety regulation. Thus, ``raw 
agricultural commodity'' means ``raw agricultural commodity'' as 
defined in section 201(r) of the FD&C Act.
32. Receiving
    We proposed 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. As discussed below, we are making 
several changes to the definition of ``receiving'' in response to 
comments.
    (Comment 276) One comment supports specifying that ``receiving'' 
only involves receipt of food by a ``customer'' other than a consumer. 
On the other hand, several comments recommend changing ``customer'' to 
``received by a different facility'' in the receiving definition. The 
comments maintain that the proposed rule's inclusion of ``customer'' in 
the definition of ``receiving'' makes it unclear whether the rule 
applies to shipments among different locations under a single corporate 
umbrella. One comment supports requiring records of intracompany 
movements under the

[[Page 70992]]

rule. The comment describes shipments of foods on the FTL from a 
retailer's distribution center to the retailer's stores, which the 
comment asserts might be excluded under the proposed rule because the 
ownership of the food does not change and the receiver is not a 
``customer.'' The comment claims that this would create a serious gap 
in traceability. To avoid this potential, the comment recommends 
revising the definition of ``receiving'' to clarify that product 
movement is between distinct or noncontiguous physical locations, 
regardless of ownership.
    Conversely, several comments request that FDA exempt from the final 
rule intracompany shipments of food, such as shipments between 
manufacturers and internal warehouses and shipments between 
manufacturers and third-party warehouses under the same company's 
control. The comments assert that intracompany shipments do not provide 
necessary traceback information because the records do not contain 
either the supplier or the customer of the food. Further, the comments 
state that additional recordkeeping is not needed for intracompany 
movements because they would already be captured in a company's one-up, 
one-back records because, according to the comments, subpart J has a 
relevant exemption that is narrowly focused on vertically integrated 
companies. A few of the comments request that food transported between 
facilities owned or controlled by the same company be excluded from 
maintaining shipping and receiving records, provided a record is 
maintained of all locations where the product was stored or produced. 
The comments argue that recordkeeping would be challenging due to the 
frequency of intracompany movement of food, would require entities to 
maintain redundant records, and would force companies to maintain 
electronic recordkeeping. Another comment asserts that a new 
traceability lot code should not be required when an ingredient is 
transferred from one site to another within the same company. One 
comment recommends that the final rule exclude movements between 
entities that are ``under the ownership or operational control of a 
single legal entity which may establish and maintain traceability 
records in conformance with common, integrated, written procedures,'' 
to be consistent with the sanitary transportation of human and animal 
food regulation exemption for intracompany food shipments.
    (Response 276) We decline to exempt intracompany shipments from the 
final rule. We generally agree with the comments that are concerned 
that failure to record certain intracompany movements of food could 
create the potential for gaps in traceability, and we have revised the 
definition of ``receiving'' to address this concern. First, we have 
deleted the reference to ``customer'' so that receiving is now defined 
as an event in a food's supply chain in which a food is received by 
someone other than a consumer after being transported (e.g., by truck 
or ship) from another location. Second, we have added to the definition 
a statement that receiving includes receipt of an intracompany shipment 
of food from one location at a particular street address of a firm to 
another location at a different street address of the firm. Under the 
revised definition, the example provided in the comment of movement of 
an FTL food between a retailer's distribution center to the retailer's 
stores would be considered a receiving event at the stores. If this 
were not the case, FDA would not be able to determine precisely which 
traceability lot codes were available for purchase at an RFE during a 
timeframe of interest. We would need to rely on receiving records at 
the distribution center and the firm's inventory practices, which might 
significantly expand the number of suspect traceability lot codes to be 
traced, increasing investigation time and reducing effectiveness.
    Contamination of foods may occur at any point in the supply chain, 
including warehouses. Therefore, records of intracompany movements 
between warehouses are important for traceability and may help identify 
where contamination occurred. Relying on a firm's business practices, 
as some comments propose, rather than the KDEs required by the final 
rule may reduce traceback effectiveness and increase investigation 
time.
    Movement of a food within a single location (at a particular street 
address) of a firm does not constitute receiving. Examples of movements 
within a location that would not be considered receiving events include 
the following: (1) moving received foods from the loading dock to the 
warehouse; (2) moving ingredients from storage to processing; and (3) 
moving foods from processing to the warehouse or shipping dock. 
Intracompany movements of ingredients would not require a new 
traceability lot code (Sec.  1.1320 describes the situations in which a 
traceability lot code must be assigned).
    The final rule does not prescribe how firms should maintain 
records, only what information should be maintained. Electronic records 
of intracompany shipments are not required. Further, firms do not need 
to duplicate existing records, if those records contain some or all of 
the required information (Sec.  1.1455(f)); in addition, firms do not 
need to keep all of the required information in a single set of records 
(Sec.  1.1455(g)).
    Finally, the goals of the food traceability regulation are 
different from the goals of the sanitary transportation regulation. 
Knowing where food has been is important for traceability. Therefore, 
we are not providing an exemption for intracompany food shipments.
    (Comment 277) Comments in favor of excluding cross-docking from the 
rule argue in favor of including the word ``customer'' in the 
definition of ``receiving'' so as to exclude the cross-docking 
facility, which is not a ``customer.''
    (Response 277) We have removed the word ``customer'' from the 
definition of ``receiving'' (see Response 276). We discuss handling of 
cross-docking under the final rule in Section V.E.20.g of this document 
and Response 244.
    (Comment 278) One comment seeks clarification on whether the term 
``receiving'' would apply to transporting RACs from the orchard or 
field to the packinghouse, because the grower often maintains ownership 
of the food and therefore there is no ``customer.''
    (Response 278) While the term ``receiving'' as defined in subpart S 
could include movement of RACs from an orchard or field to a 
packinghouse at a different physical address, we have excluded such 
movements from the receiving CTE in the final rule. As discussed in 
Section V.N.3 of this document, Sec.  1.1345(c) of the final rule 
specifies that Sec.  1.1345 (concerning records to kept when receiving 
a food) does not apply to receipt of a food that occurs before the food 
is initially packed (if the food is a RAC not obtained from a fishing 
vessel) or to the receipt of a food by the first land-based receiver 
(if the food is obtained from a fishing vessel).
    (Comment 279) One comment asks that we not consider receipt of a 
product at a third-party warehouse under the control of a given 
manufacturer to be a ``receiving'' event, maintaining that a 
requirement that the third-party warehouse assign a new traceability 
lot code when receiving an FTL food would not lead to efficient 
tracing.
    (Response 279) We do not agree that receipt of an FTL food by a 
third-party warehouse should not be a ``receiving'' event. We conclude 
that having the third-party warehouse keep a record of its receipt of 
the food is necessary to ensure adequate traceability of the food.

[[Page 70993]]

However, we agree that the third-party warehouse should not assign a 
new traceability lot code to the food. The third-party warehouse's 
receipt of the food at its physical site would constitute ``receiving'' 
and would therefore be subject to the requirements in Sec.  1.1345. 
However, a firm that receives an FTL food and only holds it at a 
location (and perhaps subsequently ships it from that location) 
generally may not give the food a new traceability lot code. The 
circumstances in which a firm may assign a traceability lot code are 
limited (see Sec.  1.1320), and a firm may not assign a traceability 
lot code solely due to its receipt of a food unless it receives a food 
that has no traceability lot code from an entity that is exempt from 
the rule (see Sec.  1.1345(b)(1)).
33. Reference Document
    In partial response to comments about the proposed definition of 
``reference record,'' which is discussed below, we are deleting that 
term from the rule and we are adding a definition of ``reference 
document.'' The final rule defines ``reference document'' to mean a 
business transaction document, record, or message, in electronic or 
paper form, that may contain some or all of the KDEs for a CTE in the 
supply chain of a food. The definition further states that a reference 
document may be established by a person or obtained from another 
person. The definition also states that reference document types may 
include, but are not limited to, BOLs, POs, ASNs, work orders, 
invoices, database records, batch logs, production logs, field tags, 
catch certificates, and receipts.
34. Reference Document Number
    Consistent with the change from ``reference record'' to ``reference 
document,'' we are deleting the proposed definition of ``reference 
record number'' as described below, and adding a definition of 
``reference document number'' to mean the identification number 
assigned to a specific reference document. The proposed definition of 
``reference record number'' had included similar language and had also 
provided the examples of a PO number, BOL number, or work order number. 
We have deleted these examples from the definition of ``reference 
document number'' because examples of reference documents are provided 
in the definition of ``reference document.'' We note that, in addition 
to being KDEs for certain CTEs, reference document numbers might be 
used in an electronic sortable spreadsheet requested by FDA in 
accordance with Sec.  1.1455(c)(3) to indicate the particular reference 
documents that contain information included in the spreadsheet.
35. Reference Record
    We proposed 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 further stated that types of reference records include, but 
are not limited to, BOLs, POs, ASNs, work orders, invoices, batch logs, 
production logs, and receipts.
    As discussed above, in the final rule we are replacing the term 
``reference record'' with ``reference document.'' We are also changing 
the definition in response to comments, as discussed below.
    (Comment 280) One comment suggests adding ``movement documents'' to 
the definition's list of types of reference records to provide 
flexibility to allow companies to use existing records to meet the 
requirements of the rule.
    (Response 280) We decline to make this change because we are not 
certain that ``movement document'' is a widely used term in the food 
industry. However, the list of types of reference documents in the 
definition of ``reference document'' is non-exclusive, and firms may 
use a movement document or any other type of document as a reference 
document under the rule.
    (Comment 281) One comment states that the proposed definition of 
``reference record'' may preclude commonly used data exchange standards 
from GS1, including the Global Data Synchronization Network (GDSN), 
Electronic Product Code Information Services (EPCIS), and Electronic 
Data Interchange (EDI). The comment asserts in this regard that section 
204(d) of FSMA requires FDA to adopt approaches that are 
``practicable'' and ``reasonably available and appropriate.''
    (Response 281) We do not agree that the definition of ``reference 
document'' (previously ``reference record'') precludes the use of GS1-
related documents as reference documents. As previously stated, the 
definition's listing of types of documents that can serve as reference 
documents is not exhaustive. Moreover, in changing from the term 
``reference record'' to ``reference document,'' we have revised the 
definition to make clear that a reference document may be a business 
transaction document, record, or message, and may be in electronic or 
paper form; the definition also specifies that a person subject to the 
rule may establish a reference document or use one that has been 
provided to them by someone else. As discussed in Section V.R of this 
document, the final rule neither prescribes nor excludes the use of 
specific technologies for maintaining required records or providing 
required information to subsequent recipients.
36. Reference Record Number
    We proposed to define ``reference record number'' as the 
identification number assigned to a reference record, such as a PO 
number, BOL number, or work order number. We received no comments on 
the definition but have replaced the term ``reference record number'' 
with ``reference document number'' in the final rule, and have revised 
the definition as described above.
37. Restaurant
    We are adding a definition of ``restaurant'' as it is defined in 
the food facility registration regulation (Sec.  1.227). The definition 
states that ``restaurant'' means a facility that prepares and sells 
food directly to consumers for immediate consumption. The definition 
further states that ``restaurant'' does not include facilities that 
provide food to interstate conveyances, central kitchens, and other 
similar facilities that do not prepare and serve food directly to 
consumers. The definition also specifies that the following are 
restaurants: (1) entities in which food is provided to humans, such as 
cafeterias, lunchrooms, cafes, bistros, fast food establishments, food 
stands, saloons, taverns, bars, lounges, catering facilities, hospital 
kitchens, day care kitchens, and nursing home kitchens; and (2) pet 
shelters, kennels, and veterinary facilities in which food is provided 
to animals.
    See our responses to the comments on the proposed definition of 
``retail food establishment'' for an explanation of the addition of a 
definition for ``restaurant.''
38. Retail Food Establishment
    We proposed to define ``retail food establishment'' as it is 
defined in the food facility registration regulation (Sec.  1.227), 
i.e., as an establishment that sells food products directly to 
consumers as its primary function. The definition further specified 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 it manufactures, processes, packs, or holds, directly to 
consumers;

[[Page 70994]]

     an RFE'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; and
     a ``retail food establishment'' also includes certain 
farm-operated businesses selling food directly to consumers as their 
primary function.
    The proposed definition of ``retail food establishment'' further 
specified 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 CSA program. 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 proposed definition further stated 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 specified with respect to sale of food directly to 
consumers from an establishment located on a farm.
    The proposed definition further stated that for the purposes of the 
definition, ``farm-operated business'' means a business that is managed 
by one or more farms and conducts manufacturing/processing not on the 
farm(s).
    We are finalizing the definition of ``retail food establishment'' 
without change.
    (Comment 282) One comment asks if retail chains with in-store food 
production meet the definition of an RFE under subpart S.
    (Response 282) If a retail chain store sells food products directly 
to consumers as its primary function, then it meets the definition of 
``retail food establishment.'' We are aware that many RFEs, such as 
grocery stores, have in-store food production. As discussed in Section 
V.O.3 of this document, Sec.  1.1350(c) of the final rule provides that 
the recordkeeping requirements for the transformation of foods do not 
apply to RFEs and restaurants with respect to foods they do not ship 
(e.g., foods they sell or send directly to consumers).
    (Comment 283) One comment asks whether CSA programs are included in 
the definition of ``retail food establishment.''
    (Response 283) The definition of ``retail food establishment'' 
specifies that a ``retail food establishment'' includes certain farm-
operated businesses selling food directly to consumers as their primary 
function. The definition of ``retail food establishment'' 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 through a CSA program, and 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 through a 
CSA. The definition further states that a 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.
    (Comment 284) One comment asks whether the definition of ``retail 
food establishment'' includes distribution centers.
    (Response 284) If a distribution center sells food products 
directly to consumers as its primary function and otherwise meets the 
above-stated definition of ``retail food establishment,'' it would be 
an RFE for purposes of the subpart S requirements. However, we believe 
it is likely that many distribution centers would not meet this 
definition because most function to distribute food to wholesale or 
retail locations as a primary function, rather than sell food directly 
to consumers.
    (Comment 285) Many comments request clarification about whether 
restaurants are included in the definition of ``retail food 
establishment.'' Several comments recommend including restaurants, 
online food retailers, and meal kit delivery companies in the 
definition of ``retail food establishment,'' noting that we said in the 
preamble to the proposed rule that we consider those operations to be 
RFEs. The comments also note that the FDA Food Code includes 
restaurants in the definition of ``food establishment,'' and maintain 
that including restaurants in the definition of ``retail food 
establishment'' would be consistent with the retail model code. Some 
comments assert that issues have arisen in successfully tracing product 
in the ``last mile,'' which includes many types of retail operations, 
and therefore maintain that it is critical to include such operations 
in the definition of ``retail food establishment.''
    (Response 285) We agree that it is important for restaurants to be 
covered by subpart S, and we recognize that many commenters were 
confused by the fact that restaurants were not mentioned in the 
codified of the proposed rule. However, we decline to add restaurants 
to the definition of a ``retail food establishment.'' We note that 
``restaurant'' is a term that is defined separately from ``retail food 
establishment'' in the food facility registration regulation (see Sec.  
1.227), and that it is also independently defined in subpart J (see 
Sec.  1.328). Therefore, to be consistent with other FDA regulations, 
we are adding a definition of restaurant to Sec.  1.1310 (as described 
above), and we are maintaining the proposed definition of ``retail food 
establishment.'' We think this will achieve the clarity that commenters 
sought regarding the application of subpart S to restaurants. The final 
rule applies relevant provisions such as exemptions and CTE 
requirements to both RFEs and restaurants in exactly the same manner, 
using the phrase ``retail food establishments and restaurants.''
    As noted in the comment, the definition of ``food establishment'' 
in the FDA Food Code is different from the definition of ``retail food 
establishment'' used in Sec.  1.227. We are considering how to address 
this difference, but in the meantime we conclude that it is appropriate 
to align subpart S with the existing definitions of ``retail food 
establishment'' and ``restaurant'' in other FDA regulations.
    Regarding the request to add online food retailers and meal kit 
delivery companies to the definition of ``retail food establishment,'' 
we have concluded that this revision is not necessary. We note that the 
definition already explicitly addresses sales from establishments 
located on farms and sales by farm-operated businesses on direct-to-
consumer sales platforms, including door-to-door sales and mail,

[[Page 70995]]

catalog, and internet order, including online farmers' markets and 
online grocery delivery (see above and at Sec.  1.1310). More 
generally, facilities that sell food directly to consumers via the 
internet or mail-order may be RFEs, provided they meet the other 
criteria of the ``retail food establishment'' definition in Sec.  1.227 
(see Ref. 26).
39. Shipping
    We proposed 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. The 
definition further stated that shipping does not include the sale or 
shipment of a food directly to a consumer or the donation of surplus 
food. As explained below, we have changed the definition of 
``shipping'' in the final rule.
    (Comment 286) A comment requests that we clarify the definition of 
shipping and revise it to include the idea that it is movement of food 
from a defined location to a customer, similar to the proposed 
definition of ``receiving.''
    (Response 286) We decline to make this change. As stated in 
Response 276, we have deleted the reference to a ``customer'' in the 
definition of ``receiving'' because it caused confusion with respect to 
the application of the receiving CTE requirements to intracompany 
shipments. Consequently, we conclude that it would not be appropriate 
to add a similar reference to a ``customer'' in the ``shipping'' 
definition. We also revised the definition of ``shipping'' to reflect 
changes we are making to CTE requirements, including deletion of the 
proposed requirements for the first receivers of FTL foods. Thus, the 
revised definition specifies that ``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 one location to another location. Finally, 
consistent with another change we made to the definition of 
``receiving'' concerning intracompany shipments, we have revised the 
definition of ``shipping'' to specify that it includes sending an 
intracompany shipment of food from one location at a particular street 
address of a firm to another location at a different street address of 
the firm.
    (Comment 287) One comment asks that we clarify whether retailers 
who donate food need to capture traceability information.
    (Response 287) The definition of ``shipping'' in Sec.  1.1310 
specifically states that shipping does not include the donation of 
surplus food. Therefore, retailers who donate food do not need to 
document any traceability information relating to the donation. 
However, they may need to document information relating to their 
receipt of the food, unless another exemption applies.
    (Comment 288) One comment seeks clarification that shipping CTE 
requirements do not apply to RACs shipped from the field or orchard to 
the packinghouse.
    (Response 288) As discussed in Section V.M.3 of this document, the 
shipping CTE requirements do not apply to shipment of a RAC that occurs 
before the RAC is initially packed (see Sec.  1.1340(c)).
    (Comment 289) Some comments ask that we use consumer data and 
reviews to help us conduct outbreak investigations. One comment 
suggests that all food industry and regulated partners be required to 
submit customer loyalty information and/or credit card information to 
assist in the notification of customers who have purchased products 
involved in outbreak investigations. One comment expresses concern that 
we have substantially downplayed the utility of consumer-specific data. 
The comment asserts that tracking lot numbers purchased by individual 
consumers is not currently practical but asks that we encourage 
industry, both conventional and e-commerce, to capture and voluntarily 
submit consumer-specific data, such as customer loyalty or credit card 
information. The comment asks that firms that currently maintain this 
information not be inadvertently penalized or disproportionately 
targeted because they have this information.
    (Response 289) As stated in the preamble to the proposed rule (85 
FR 59984 at 59992), we support efforts by retailers to identify and 
provide us with anonymized consumer purchase data during our 
investigations into foodborne illness outbreaks. We agree that such 
information can be very helpful in narrowing the scope of an 
investigation and more quickly identifying the source of contamination. 
We do not target or penalize firms that maintain this information; 
rather, we encourage firms to make available any relevant consumer data 
they might have. However, as stated in the preamble to the proposed 
rule (85 FR 59984 at 60003), we believe that it would be too burdensome 
to require retail facilities to keep traceability records of sales to 
consumers, and we conclude that it not essential that we have access to 
such records to effectively respond to threats to public health posed 
by outbreaks. Therefore, the final rule does not require records of 
sales to consumers. A sale of an FTL food to a consumer does not 
constitute a shipping event (even if the sale involves transport of the 
food, as with sales made over the internet), because the definition of 
``shipping'' in Sec.  1.1310 specifies that shipping does not include 
the sale or shipment of a food directly to a consumer.
40. Traceability Lot
    We proposed to define ``traceability lot'' as a lot of food that 
has been originated, transformed, or created. As explained below, we 
have revised the definition of ``traceability lot'' to align with 
changes we have made to the proposed CTE requirements.
    (Comment 290) Some comments suggest that the definition of 
``traceability lot'' is easily confused with the definition of ``lot.'' 
The comments express concern that the recordkeeping requirements will 
be overly burdensome if FDA is not specific about the expectations for 
maintaining records based on a lot or traceability lot of an FTL food.
    (Response 290) We recognize that proposing separate definitions for 
``lot'' and ``traceability lot'' caused confusion among many 
commenters. We have therefore deleted the definition of ``lot'' from 
the rule and changed the definition of ``traceability lot'' to refer to 
either a batch or lot of food. We have also revised the definition to 
align with changes to the rule regarding when a traceability lot code 
must be assigned (see Sec.  1.1320). The revised definition states that 
a traceability lot is a batch or lot of food that has been initially 
packed (for RACs other than food obtained from a fishing vessel), 
received by the first land-based receiver (for food obtained from a 
fishing vessel), or transformed.
    (Comment 291) One comment asks how many fish from multiple fishing 
vessels can be used in one finished-product lot. Several comments 
request guidance on how a lot should be created to encourage uniformity 
across industry.
    (Response 291) The rule places no limits on how much of an FTL food 
can be put into a lot, or how many different sources (including 
different fishing vessels) the food can be from. (See Section V.E.9 of 
this document for a discussion of commingling RACs, including RACs 
obtained from fishing vessels.) We believe industry should have the 
flexibility to determine how to create traceability lots in a manner 
that works best for their operations. This approach is consistent with 
the approach to the creation of lots under the regulation on preventive 
controls for human food.

[[Page 70996]]

41. Traceability Lot Code
    We proposed to define ``traceability lot code'' as a descriptor, 
often alphanumeric, used to identify a traceability lot.
    (Comment 292) Several comments suggest that the term ``traceability 
lot code'' be replaced by another phrase to indicate its special status 
and avoid use of the word ``lot,'' maintaining that the concept of 
``lot'' already has varied usage and might cause confusion. One comment 
suggests using the term ``traceability code'' instead of ``traceability 
lot code.''
    (Response 292) We disagree with the comments. The traceability lot 
code, assigned to a traceability lot of a food on the FTL, is the key 
to the subpart S traceability framework because it is the piece of 
information to which the other KDEs for a traceability event are 
linked. While we are providing flexibility for industry to determine 
how to create traceability lots in a way that work best for their 
operations, we think that the concept of a ``lot'' is well understood 
within industry (as is the concept of lot-based traceability), and we 
want our terminology to communicate that the traceability lot code is 
assigned to a specific lot (i.e., the traceability lot) of the food. 
Therefore, we believe it is important to retain the reference to a 
``lot'' in the definition. In addition, to improve a traceability lot 
code's ability to help identify a particular FTL product, and in 
response to comments suggesting that the traceability lot code be 
globally unique (see Response 507), we have revised the definition of 
``traceability lot code'' to state that it is a descriptor, often 
alphanumeric, used to uniquely identify a traceability lot within the 
records of the traceability lot code source (i.e., the place where the 
traceability lot code was assigned to a food).
    (Comment 293) One comment requests that we clarify that a lot code, 
batch code, or production code for a food on the FTL can be the 
traceability lot code if it meets the definition of a traceability lot 
code.
    (Response 293) We agree that a lot code, batch code, or other 
production code for an FTL food could be used as a traceability lot 
code if it meets the definition of ``traceability lot code'' stated 
above.
    (Comment 294) One comment suggests that the definition of 
``traceability lot code'' account for the activity of harvesting, as 
lots are identified when a product is harvested.
    (Response 294) We decline to make this revision. We acknowledge 
that lots are sometimes identified at the point of harvesting; however, 
we received several comments stating that RACs are most often assigned 
lot codes at initial packing. Therefore, Sec.  1.1320 of the final rule 
requires that a traceability lot code be assigned when a person 
initially packs a RAC other than a food obtained from a fishing vessel, 
performs the first land-based receiving of a food obtained from a 
fishing vessel, or transforms a food. Under the final rule, lot-based 
recordkeeping is not required at harvest or at any point before the 
initial packing (or first land-based receiving) of a RAC. This topic is 
further discussed in Section V.J of this document.
    (Comment 295) One comment recommends that we consider FDA 
Establishment Identifier numbers, Food Facility Registration Numbers, 
or DUNS numbers as alternatives to traceability lot codes under the 
subpart S requirements.
    (Response 295) As previously stated, a traceability lot code is a 
descriptor that must uniquely identify a traceability lot within the 
records of the traceability lot code source. If a firm chooses to 
create traceability lot codes incorporating numbers assigned by FDA or 
DUNS, they may do so, provided the resulting code meets the definition 
of a ``traceability lot code,'' including that the code uniquely 
identifies a particular lot within the firm's tracing records.
42. Traceability Lot Code Generator
    We proposed to define ``traceability lot code generator'' as the 
person who assigns a traceability lot code to a product. We received 
several comments expressing confusion about the concept of a 
``generator'' of a traceability lot code and concern about providing 
information identifying the traceability lot code generator to 
customers (see Response 412). As explained below, for clarity in the 
final rule, we have replaced the term ``traceability lot code 
generator'' with the term ``traceability lot code source.''
    (Comment 296) Several comments maintain that the proposed rule puts 
too much emphasis on the traceability lot code generator and suggest 
that there is confusion around capturing information about the 
``person'' that assigned the traceability lot code to a product.
    (Response 296) We agree that, with respect to the assignment of 
traceability lot codes, the focus for traceability should be on the 
place where the code was assigned, rather than the specific individual 
or entity who assigned the code. Because the traceability lot code is 
an integral component of the subpart S traceability requirements, it is 
important to document the physical location where the traceability lot 
code for an FTL food was assigned. During outbreak situations, this 
will allow FDA to more quickly identify this location and prioritize 
where we need to collect tracing data, which in turn will help us more 
quickly identify the origin of contaminated food. Therefore, we 
conclude that it is appropriate to replace the term ``traceability lot 
code generator'' with ``traceability lot code source,'' which we define 
as the place where a food was assigned a traceability lot code. Unless 
the relevant entity is exempt from the rule, the traceability lot code 
source will be the place where the food was initially packed (for RACs 
not obtained from a fishing vessel), received by the first land-based 
receiver (for food obtained from a fishing vessel), or transformed.
    (Comment 297) One comment requests clarity about who is considered 
the traceability lot code generator in situations of contract 
manufacturing. Specifically, the comment asks whether the contract 
manufacturer or the entity that initiated the contract should be 
regarded as the traceability lot code generator.
    (Response 297) As discussed above, in the final rule we have 
replaced the term ``traceability lot code generator'' with the term 
``traceability lot code source.'' If the contract manufacturer made the 
FTL product at their facility, that facility would be the traceability 
lot code source for the food, consistent with the definition of 
``traceability lot code source'' stated above (which refers to the 
``place'' where a traceability lot code was assigned).
    (Comment 298) Some comments maintain that for businesses that use 
random number generators to assign lot codes, a requirement to name the 
individual who assigned a traceability lot code would be superfluous.
    (Response 298) As previously stated, we agree that it is 
unnecessary to keep a record of the identity of the individual who 
assigned a traceability lot code to the food. Instead, firms must 
document the place where the traceability lot code was assigned, i.e., 
the traceability lot code source.
43. Traceability Lot Code Source
    As stated above, we are replacing the term ``traceability lot code 
generator'' with the term ``traceability lot code source.'' The final 
rule defines ``traceability lot code source'' to mean the place where a 
food was assigned a traceability lot code. Unless the relevant entity 
is exempt from the rule, this will be the place where the food was 
initially packed (for RACs not obtained from a fishing vessel), first 
processed on land

[[Page 70997]]

(for food obtained from a fishing vessel), or transformed.
44. Traceability Lot Code Source Reference
    We are adding a definition of ``traceability lot code source 
reference.'' The final rule defines ``traceability lot code source 
reference'' to mean an alternative method for providing FDA with access 
to the location description for the traceability lot code source as 
required under subpart S. The definition goes on to state that examples 
of a traceability lot code source reference include, but are not 
limited to, the FDA Food Facility Registration Number for the 
traceability lot code source or a web address that provides FDA with 
the location description for the traceability lot code source. If a 
firm uses a web address as the traceability lot code source reference, 
the associated website may employ reasonable security measures, such as 
only being accessible to a government email address, provided FDA has 
access to the information at no cost and without delay. We are adding 
this definition and provisions concerning the use of traceability lot 
code source references in response to comments expressing concern about 
data privacy associated with the provision of information on the 
traceability lot code generator (now the traceability lot code source) 
(see Section V.M of this document).
45. Traceability Product Description
    We proposed to define ``traceability product description'' as a 
description of a food product typically used commercially for 
purchasing, stocking, or selling, and as including the category code or 
term, category name, and trade description. The definition further 
stated 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. As previously stated, we are deleting the term 
``traceability product description'' and replacing it with the term 
``product description.'' In response to the comments on the proposed 
definition of ``traceability product description,'' we made changes 
that are incorporated into the definition of ``product description'' in 
the final rule.
    (Comment 299) Several comments urge FDA to simplify the 
requirements for the traceability product description. The comments 
suggest that the traceability product description is unnecessary for 
tracing, contains information not currently used, and is redundant and 
irrelevant to food traceability. One comment suggests that category 
code or term and category name (which are part of the proposed 
definition of ``traceability product description'') should be optional. 
This comment recommends that much of the information under a 
traceability product description be required only as applicable.
    (Response 299) We agree that not all of the information included in 
the proposed definition of ``traceability product description'' is 
needed, and we have simplified the definition of ``product 
description'' in the final rule. As discussed below, we have removed 
the requirement for information on ``category'' as part of the product 
description and we have removed the distinction between information 
needed for single-ingredient products and multi-ingredient products. To 
address differences between these types of products, the definition of 
``product description'' in the final rule specifies that the product 
name includes the brand name, commodity, and variety ``if applicable'' 
(because, for example, a multi-ingredient product might not have a 
commodity or variety name).
    Although we have simplified the information required under a 
product description, we do not agree that information fully describing 
an FTL product is irrelevant to tracing, because it provides 
information we need to be able to conduct traceback investigations and 
accurately identify the source of contaminated food. Therefore, the 
final rule includes requirements to keep a record of the product 
description as one of the KDEs for several traceability events. The 
final rule uses the term ``product description'' rather than 
``traceability product description'' to eliminate potential confusion 
regarding the use of a new term. The final rule defines ``product 
description'' to mean a description of a food product and to include 
the product name (including, if applicable, the brand name, commodity, 
and variety), packaging size, and packaging style. The definition 
further states that for seafood, the product name may include the 
species and/or acceptable market name.
    (Comment 300) Some comments recommend adding the GS1 Global Trade 
Item Number (GTIN) to the traceability product description and seek 
clarification of the concept of ``category'' as a component of the 
description.
    (Response 300) Having reconsidered the components of the proposed 
definition of ``traceability product description,'' we conclude that it 
is not necessary to include a product's category code/term or category 
name as part of a product description. Regarding the suggestion to add 
a GTIN to the product description, we do not believe that would be 
appropriate because GTINs are not universally used in the food 
industry. However, a firm that uses GTINs may choose to include that 
information as part of their product description. This could be done 
either by adding it to the required information, or by using it as a 
shorthand for some or all of the required information, provided that a 
glossary or key is maintained (and, if necessary, shared) to indicate 
the full product description that corresponds to the GTIN.
46. Traceability Product Identifier
    We proposed 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 
explained below, we are deleting this definition from the final rule.
    (Comment 301) One comment requests examples of the traceability 
product identifier and asks if we meant numbers such as a GTIN or an 
Internal Item Number. The comment asserts that the need for uniqueness 
would be a concern, particularly to prevent duplication with 
traceability product identifiers assigned by other covered entities.
    (Response 301) The final rule does not include a definition of 
``traceability product identifier'' because we have deleted the 
proposed requirements to establish a product identifier for an FTL food 
for certain CTEs. In the proposed rule, we included a traceability 
product identifier, along with the traceability product description, as 
important descriptive information for FTL foods to help us during 
tracebacks, because different firms often use different names for the 
same product (e.g., ``Maradol papayas'' instead of ``papayas''). 
However, in response to comments requesting that we simplify the KDEs, 
we conclude that it is not necessary to require firms to keep a product 
identifier for a food to ensure that there is adequate information for 
efficient traceability (see Section V.M.1 of this document).
    (Comment 302) One comment asks that we revise the definition of 
traceability product identifier to allow covered entities to describe 
the relationship between different packaging configurations of the same 
product. The comment maintains that current industry standards enable 
firms to declare a relationship between

[[Page 70998]]

consumer-ready packaging and higher levels of packaging used to 
transport the consumer-ready packages through the supply chain to RFEs. 
The comment asserts that this ability to determine the parent/child 
relationship between product identifiers is important for tracking the 
movement of products.
    (Response 302) As previously stated, we have deleted the proposed 
requirements to keep a record of the traceability product identifier 
for FTL foods. However, if the product hierarchy described in the 
comment is an important component of a firm's traceability records, the 
firm may wish to include product identifier information as part of the 
product descriptions it keeps for FTL foods the firm handles.
    (Comment 303) One comment maintains that for molluscan shellfish 
the unique product identifier would be the same as the product 
description.
    (Response 303) As stated in Response 301, we have deleted the 
definition of traceability product identifier as well as all of the 
proposed requirements to keep a record of a product identifier. We also 
note that, as discussed in Section V.E.7 of this document, the final 
rule exempts certain raw bivalve molluscan shellfish from the subpart S 
requirements.
47. Transformation
    We proposed to define ``transformation'' as an event in a food's 
supply chain that involves changing a food on the FTL, 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 further stated that transformation does 
not include the initial packing of a single-ingredient food or creating 
a food. In the final rule, we have combined the proposed CTEs of 
``transformation'' and ``creating'' into a single ``transformation'' 
CTE and revised the definition of ``transformation'' accordingly, as 
discussed in response to the following comments.
    (Comment 304) One comment maintains that the proposed definition of 
``transformation'' is well defined and aligns with current industry 
practices. However, several comments recommend that we recognize that 
creation and transformation are essentially the same and that any 
differentiation is based solely on whether the foods used are on the 
FTL. These comments maintain that, with respect to the requirements for 
traceability lot code assignment and linkage, having to differentiate 
between creation and transformation could become complex for processors 
that have multiple manufacturing steps within their facilities that 
result in different products. These comments assert that current 
industry traceability standards designate all such activities as 
``transformation.''
    (Response 304) We conclude that it is appropriate to use the term 
``transformation'' to cover both the activities we described in the 
proposed definition of that term as well as the activities described in 
the proposed definition of ``creating'' (see Section V.O of this 
document). Therefore, the final rule defines ``transformation'' as an 
event in a food's supply chain that involves manufacturing/processing a 
food or changing a food (e.g., by commingling, repacking, or 
relabeling) or its packaging or packing, when the output is a food on 
the FTL. The definition further states that transformation does not 
include the initial packing of a food or activities preceding that 
event (e.g., harvesting, cooling). We conclude that this revised 
definition of ``transformation'' more closely aligns with current 
industry practices while helping to ensure that firms understand the 
recordkeeping requirements applicable to transformation activities.
    (Comment 305) Several comments state that farms often repack 
produce from within the same lot and request that such repacking be 
excluded from the definition of ``transformation.'' The comments 
further ask that FDA clarify that repacking only takes place at 
``facilities'' and not at ``farms.''
    (Response 305) We decline to make the changes requested by the 
comments. Repacking whole fresh produce within one traceability lot is 
considered transformation under subpart S. Repacking whole fresh 
produce may introduce contamination, whether the repacking is done at a 
facility or a farm. (Though as previously stated, transformation does 
not include the initial packing of a RAC.) At the repacking stage, the 
traceability lot code can be changed or the traceability lot code of 
the original lot can be retained, but a new traceability lot code 
source would be required to identify the repacker, and the KDEs 
identified in Sec.  1.1350 would need to be maintained.
    (Comment 306) One comment asks FDA to reconsider treating 
repackaging of molluscan shellfish as a transformation event. The 
comment suggests that repackaging could involve dividing a traceability 
lot into smaller traceability lots. The comment asserts that applying 
transformation recordkeeping requirements to repackaging would impose a 
significant recordkeeping burden and impair traceability by introducing 
potential errors.
    (Response 306) We decline to revise the definition of 
``transformation'' as requested. We consider repackaging (and 
repacking) to be transformation events under subpart S because 
repackaging and repacking may introduce contamination, and because in 
many situations they have the potential to impede traceability by 
dividing one lot into several lots, or by commingling lots. Regarding 
the repackaging of molluscan shellfish (most of which are likely exempt 
from the rule under Sec.  1.1305(f)), a traceability lot code could 
have been assigned by the initial packer or first land-based receiver 
of the shellfish at one facility and then again during repacking at 
another facility, in accordance with Sec.  1.1320 of the final rule. At 
the repacking stage, the traceability lot code can be changed or the 
traceability lot code of the original lot can be retained (assuming 
there has been no commingling of lots), but a new traceability lot code 
source would be required to identify the repacker. If the second 
facility was not identified as the traceability lot code source for the 
repackaged product, an investigator might initially miss a potentially 
important node in a traceback investigation.
    (Comment 307) One comment asks whether transformation KDEs are 
required following the breaking of a master case of product into 
smaller units, which the comment maintains is a common practice during 
foodservice distribution.
    (Response 307) We understand that the breaking of a master case 
into smaller units is a common practice during food distribution. The 
breaking of a master case during foodservice distribution does not 
necessarily constitute transformation. If, as part of the breaking of 
the master case, the product is repacked or repackaged, then this would 
constitute transformation, as described in Response 305. However, if a 
distributor or other entity is simply breaking a master case (e.g., a 
pallet containing 20 individual cases) into separate shipments (e.g., 4 
shipments of 5 cases each), this would not constitute transformation. 
In this instance, the distributor would only need to follow the 
requirements for shipping and receiving under Sec. Sec.  1.1340 and 
1.1345, respectively. Because no transformation event has occurred, the 
distributor would not keep transformation records under Sec.  1.1350, 
nor would they assign a traceability lot code or become the 
traceability lot code source. If the pallet

[[Page 70999]]

contained cases associated with different traceability lot codes, the 
shipping records would use those traceability lot codes to indicate 
which traceability lots were shipped to which location.
    (Comment 308) One comment expresses concern that changing a food 
label is within the definition of ``transformation.'' The comment 
supports a narrow interpretation of the changes to food labels that are 
regarded as transformation and maintains that changing the brand on a 
label should not be considered transformation.
    (Response 308) We disagree with the comment. The final rule 
specifies that the brand name (if any) is a component of the product 
description of an FTL food, and changing a brand name on labeling would 
be transformation under the rule. We believe that including 
``relabeling'' in the definition of ``transformation'' is consistent 
with current practice in much of the industry, for example for entities 
following the Produce Traceability Initiative (PTI) or GS1 GTIN 
standards.
48. Transporter
    We proposed 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. 
We did not receive any comments on this definition and are finalizing 
it as proposed.
49. Vessel Identification Number
    We proposed 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. As discussed in Response 388, we are 
deleting proposed requirements to record the vessel identification 
number at certain CTEs, so we are deleting the definition of ``vessel 
identification number'' from the rule.
    (Comment 309) One comment maintains that for molluscan shellfish, 
the rule should use the aquaculture lease number instead of the vessel 
identification number. The comment further states that aquaculture 
farms and wild harvesters of molluscan shellfish do not use boats, and 
that the harvest area or lease number would provide more useful 
information.
    (Response 309) As discussed in Section V.E.7 of this document, the 
final rule exempts from subpart S raw bivalve molluscan shellfish that 
are covered by the requirements of the NSSP, subject to the 
requirements of part 123, subpart C, and Sec.  1240.60, or covered by a 
final equivalence determination by FDA for raw bivalve molluscan 
shellfish. For molluscan shellfish that are subject to subpart S, the 
final rule has no requirements to maintain a record of the vessel 
identification number.
    (Comment 310) One comment agrees with the proposed definition of 
``vessel identification number.'' One comment asks for clarification 
whether vessel identification numbers assigned by agencies other than 
the International Maritime Organization meet the requirements of the 
rule.
    (Response 310) As stated above, because the final rule contains no 
requirements for the maintenance of vessel identification numbers, we 
are deleting the definition of ``vessel identification number'' from 
the rule.
50. You
    We proposed to define ``you'' to mean a person subject to subpart S 
under Sec.  1.1300. We did not receive any comments on this definition 
and have finalized it as proposed.
51. Comments Requesting Additional Definitions
    We received comments requesting that the rule include definitions 
for additional terms. We decline to add these definitions, for the 
reasons set forth below.
    (Comment 311) One comment asks that we provide additional clarity 
around use of the term ``broker'' in the rule. The comment maintains 
that use of the term ``broker'' is confusing because food brokers and 
customs brokers serve different functions.
    (Response 311) Because the final rule does not include the word 
``broker,'' there is no need to specify a definition of the term. The 
preamble to the proposed rule (85 FR 59984 at 60000) only mentioned 
brokers in the context of saying that 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. 
This was just one example of how a person who does not take physical 
possession of an FTL food is not engaged in the holding of the food and 
therefore would not be subject to the rule.
    (Comment 312) One comment requests that we include a definition of 
``facility'' that is consistent with the definition of ``facility'' in 
other FSMA rules.
    (Response 312) We decline to define the term ``facility'' in the 
final rule. As discussed in Section V.D of this document, although 
section 204(d)(1) of FSMA refers to ``facilities'' that manufacture, 
process, pack, or hold food, the final rule is phrased in terms of 
``persons'' that manufacture, process, pack, or hold food, to avoid 
possible confusion with other uses of the term ``facilities'' in other 
FDA food regulations. Because the final rule does not include 
requirements that apply specifically to ``facilities,'' we conclude 
that it is not necessary to include a definition of ``facility'' in the 
rule.
    (Comment 313) Several comments ask for a definition and 
clarification on the meaning and application of ``fresh-cut'' regarding 
activities that are considered part of harvesting, such as trimming, 
field coring, and washing, as compared to activities that are 
considered to take place after harvesting. The comments request that we 
clarify how processing activities that result in ``fresh-cut'' produce 
differ from those that are part of traditional harvesting, such as 
trimming and cutting.
    (Response 313) Because the subpart S regulations do not refer to 
``fresh-cut'' produce, there is no need to add a definition of ``fresh-
cut'' to the rule. In the RRM-FT, we define fresh cut commodities based 
on FDA's ``Guide to Minimize Food Safety Hazards of Fresh-cut Produce: 
Draft Guidance for Industry'' (https://www.fda.gov/media/117526/download), which states that ``fresh-cut produce'' means any fresh 
fruit or vegetable or combination thereof that has been physically 
altered from its whole state after being harvested from the field. In 
addition, a description of the foods on the FTL is available on the FDA 
website to aid stakeholders in determining whether a specific food is 
covered.
    (Comment 314) Several comments request that we define the terms 
``owner,'' ``operator,'' and ``agent in charge'' or address these terms 
in guidance. One comment suggests that the rule define ``agent in 
charge'' as a person who is employed by or contracted by an entity, has 
responsibility for traceability recordkeeping, and is not necessarily 
the owner.
    (Response 314) We decline these requests. The phrase ``owner, 
operator, or agent in charge'' is statutory language (in section 
204(d)(6)(C) and (d)(6)(I)(ii) of FSMA) used in subpart S only in 
certain exemptions related to farms (Sec.  1.1305(b) and (j)) and 
fishing vessels (Sec.  1.1305(m)). Because this phrase ``owner, 
operator, or agent in charge'' is used frequently in the produce safety 
regulation, which applies to farms, and the term ``operator'' is used 
throughout FDA's ``Fish and Fishery Products Hazards and Controls 
Guidance'' (Ref. 23), we believe that the meaning of these terms is 
generally understood by

[[Page 71000]]

relevant covered entities. Therefore, we conclude that it is not 
necessary to add definitions of these terms to the rule.
    (Comment 315) Some comments request that we add a definition of 
``smoked'' to the rule.
    (Response 315) We decline this request because the word ``smoked'' 
does not appear in the subpart S regulations. In the RRM-FT, we define 
smoked finfish based on FDA's ``Fish and Fishery Products Hazards and 
Controls Guidance,'' which has the same definition for ``smoked or 
smoke-flavored fishery products'' as that in the seafood HACCP 
regulation (Sec.  123.3(s)). We believe that relevant covered entities 
understand the term ``smoked.'' In addition, a description of the foods 
on the FTL is available on the FDA website to aid stakeholders in 
determining whether a specific food is covered.
    (Comment 316) Several comments request that we define ``sprouts'' 
in the final rule.
    (Response 316) We decline to define ``sprouts'' in the final rule. 
The produce safety regulation (part 112), which includes a sprout-
specific section (subpart M), does not define the term ``sprouts.'' 
However, subpart M makes a distinction between soil- or substrate-grown 
sprouts harvested without their roots, and all other sprouts (see 21 
CFR 112.141). Therefore, we believe that sprout growers will understand 
the use of the term ``sprouts'' in this final rule. We have clarified 
in the final rule that the sprout-specific provisions of Sec.  
1.1330(b) do not apply to soil- or substrate-grown sprouts harvested 
without their roots.

G. Traceability Plan (Sec.  1.1315)

    In the provisions of proposed subpart S that are under the heading 
``Traceability Program Records,'' we proposed to require entities 
subject to the rule to keep traceability program records for the FTL 
foods they handle (proposed Sec.  1.1315), and we specified when 
entities must assign traceability lot codes to FTL foods (proposed 
Sec.  1.1320). Proposed Sec.  1.1315 stated that covered entities must 
establish and maintain records related to their traceability program. 
These records would include a description of the reference records in 
which the required information is maintained, 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 are linked (proposed Sec.  1.1315(a)(1)). We also proposed that 
required entities must establish and maintain a list of foods on the 
FTL that they ship, including the traceability product identifier and 
traceability product description for each food, and a description of 
how the entity establishes and assigns traceability lot codes to foods 
on the FTL they originate, transform, or create, as well as any 
additional information necessary to understand the data provided within 
any of the records required under subpart S, such as internal or 
external coding systems, glossaries, and abbreviations (proposed Sec.  
1.1315(a)(2) through (4)). We proposed that these traceability program 
records be retained for 2 years after their use is discontinued 
(proposed Sec.  1.1315(b)).
    To better capture the intent of this section and to align our 
approach with other FSMA regulations, we have revised Sec.  1.1315 to 
set forth the requirements for a firm's ``traceability plan.'' Rather 
than describe the reference records that a firm uses to document 
required information, revised Sec.  1.1315(a)(1) requires firms to 
describe their procedures for maintaining FTL records; and rather than 
maintaining a list of FTL foods shipped, revised Sec.  1.1315(a)(2) 
requires firms to describe their procedures for identifying FTL foods 
they handle. In alignment with other changes we are making concerning 
requirements applicable to farms, revised Sec.  1.1315(a)(5) requires 
persons who grow or raise an FTL food (other than eggs) to maintain a 
farm map as part of their traceability plan. These and other changes to 
proposed Sec.  1.1315 are discussed in response to the comments set 
forth below.
1. General
    (Comment 317) One comment asks that we require firms have a product 
tracing plan. The comment refers to the 2012 IFT Final Report (Ref. 1), 
which includes a recommendation that FDA require that each member of 
the food supply chain develop, document, and exercise a product tracing 
plan containing the following elements: identified CTEs and KDEs; 
identification of how information is recorded and linked; identified 
authorized points of contact; metrics for trace data reporting response 
times; and frequency of trace plan exercises and review. One comment 
recommends that the subtitle of ``Traceability Program Records'' 
(encompassing proposed Sec. Sec.  1.1315 and 1.1320) should be renamed 
because, according to the comment, that terminology does not align with 
language used in other FSMA regulations, such as those for allergen 
control or supply chain verification.
    (Response 317) We agree with the comments that it is appropriate 
for entities to have a traceability plan for the FTL foods they handle. 
As stated in the preamble to the proposed rule (85 FR 59984 at 60004), 
we believe it is important that firms be able to provide information on 
how they conduct their required traceability operations to help us 
understand the records we review in an outbreak investigation. To make 
this clear in the final rule, we have revised the subtitle 
``Traceability Program Records'' to ``Traceability Plan,'' and we have 
revised Sec.  1.1315(a) to state that if an entity is subject to the 
subpart S requirements, it must establish and maintain a traceability 
plan containing, as discussed below, a description of the procedures 
the firm uses to maintain its traceability records (including the 
format and location of the records), a description of the procedures 
used to identify foods on the FTL that the firm handles, a description 
of how the entity assigns traceability lot codes, a statement 
identifying a point of contact for questions regarding the traceability 
plan and records, and, if the entity grows or raises foods on the FTL 
(other than eggs), a farm map. In addition, the final rule requires 
entities to update their traceability plans as needed to ensure that 
the information provided reflects the entity's current practices and to 
ensure compliance with subpart S (see Section V.F.8 of this document). 
The previous plan must be retained for 2 years after any updates (Sec.  
1.1315(b)).
    (Comment 318) Several comments ask if the proposed traceability 
program records requirements would apply to each SKU, ingredient, or 
commodity.
    (Response 318) As stated in Response 317, Sec.  1.1315(a) of the 
final rule requires covered entities to establish and maintain a 
traceability plan containing information relating to their traceability 
procedures. Persons subject to subpart S are not required to have a 
separate plan for each food on the FTL they handle; instead, they can 
have a single plan that covers all FTL foods they handle, provided that 
the plan describes, among other things, the procedures used to maintain 
the records required to be kept for all such foods.
    (Comment 319) One comment asks how the requirement to establish and 
maintain traceability program records would be applied to foreign 
exporters and establishments.
    (Response 319) The subpart S requirements apply to all entities, 
domestic and foreign, that manufacture, process, pack, or hold foods on 
the FTL (unless an exemption applies). Thus, foreign exporters and 
other firms that manufacture, process, pack, or hold FTL foods will be 
required to maintain a traceability plan under Sec.  1.1315 of the 
final rule.

[[Page 71001]]

2. Description of Procedures Used To Maintain Records
    (Comment 320) Several comments request clarity on the requirement 
in proposed Sec.  1.1315(a)(1) to maintain a description of the 
reference records in which information required under subpart S is 
maintained. One comment supports the flexibility FDA provided in 
allowing covered entities to use whatever reference record suits their 
operations (e.g., BOLs, ASNs) rather than requiring that information be 
maintained in a particular record.
    (Response 320) As stated in section V.F.33 of this document, 
elsewhere in the final rule we have replaced the term ``reference 
record'' with ``reference document,'' which the final rule defines as a 
business transaction document, record, or message, in electronic or 
paper form, that may contain some or all of the KDEs for a CTE in the 
supply chain of a food. In addition, to address confusion about the 
meaning (in proposed Sec.  1.1315(a)(1)) of a ``description of the 
reference records'' in which a firm keeps information required under 
the rule, we conclude that the focus of a firm's traceability plan 
should be on the procedures it uses to maintain records required under 
subpart S. Therefore, we have deleted from Sec.  1.1305(a)(1) the 
proposed requirement to describe the reference records a firm uses; 
instead, Sec.  1.1305(a)(1) requires that an entity's traceability plan 
include a description of the procedures the entity uses to maintain the 
records it is required to keep under subpart S, including the format 
and location of these records. Under Sec.  1.1305(a)(1), firms will not 
need to identify each reference document it has used to record the KDEs 
of each CTE for each FTL food it handles, but rather to describe the 
general recordkeeping procedures it follows in meeting its subpart S 
requirements, including the format in which it keeps these records and 
where they are stored. Information on the format and location can 
include, for example, a description of the electronic system of FTL 
records that contains the KDEs, if that is the firm's practice. As 
another example, information on the format and location may include a 
description of the firm's receipt and storage of business documents as 
FTL records, or practice of scanning or data entry from such records 
that contain the KDEs, if that is the firm's practice.
    (Comment 321) One comment requests that the final rule clarify how 
reference records for different CTEs are linked and whether records 
must be linked electronically. The comment suggests that linking be 
defined as the ability of a covered entity to use information on one 
record to identify additional relevant records. Another comment opposes 
the proposed requirement to describe how the reference records used for 
different tracing events are linked because two firms might assign 
different lot codes to a product shipment that are not connected by 
records to the incoming product.
    (Response 321) As stated in Response 320, we are deleting the 
proposed requirement to describe reference records used and to describe 
how reference records for different tracing events are linked. The 
final rule does not require that the traceability plan include a 
description of how reference documents for different CTEs for an FTL 
food are linked. However, the provisions applicable to each CTE require 
entities to link the required KDEs for the event (including the 
traceability lot code) to the particular traceability lot. Because the 
traceability lot code is documented at each CTE, these requirements 
will enable FDA to effectively trace a specific traceability lot across 
multiple CTEs.
    Although the final rule does not define ``linking,'' we agree with 
the comment that linking can involve connecting information about a CTE 
that appears on one record with another record that contains other KDEs 
for that event or with a record that contains KDEs for the next event 
in the supply chain. For all CTEs, the final rule requires firms to 
maintain records containing and linking certain KDEs to a particular 
traceability lot. KDEs for a CTE could be ``linked'' in different ways, 
including by being listed together in single row of an electronic 
sortable spreadsheet, stored together as a record in a database, shared 
to a subsequent recipient as an electronic message, or printed on the 
same commercial document (e.g., BOL). KDEs may also be linked together 
using a common identifier on multiple records, such as the traceability 
lot code or the reference document number (e.g., a PO number attached 
to a buyer's PO; a supplier's BOL that connects to a customer's 
invoice).
3. Description of Procedures Used To Identify Foods on the Food 
Traceability List
    (Comment 322) Several comments ask that we delete the proposed 
requirement to maintain a list of foods on the FTL that a firm ships, 
asserting that meeting the requirement would require substantial time 
and resources because products and circumstances change often, which 
would necessitate frequent updating of the list. The comments also 
maintain that the list would become outdated almost immediately and 
would not be helpful to FDA in protecting public health. The comments 
further state that the list would include foods subject to a kill step 
and shipments of ingredients and semi-finished foods, all of which 
would require a burdensome case-by-case review. The comments maintain 
that in the event of a food safety investigation, firms can generate 
automated reports to gather current information about products, such as 
a list of finished goods that contain a specific ingredient. Some 
comments assert that when FDA conducts a traceforward it has already 
identified a food or foods it is investigating, making it unnecessary 
for firms to keep a list. Some comments maintain that most firms keep 
shipping records for all their products, and they ask that if the final 
rule includes this listing requirement, firms should be allowed to 
include FTL foods within their existing records, rather than create a 
separate list. One comment maintains that although they see the 
usefulness in having a master list of all the FTL foods shipped, they 
do not understand why this is essential for facilitating foodborne 
illness investigations because all shippers will be required to 
maintain and send the KDEs associated with FTL foods. The comment 
contends that it is unrealistic for entities that only receive and ship 
foods to establish this master list because they must rely on 
information provided by the previous shipper.
    Some comments ask that we exempt food service distributors, 
including fresh produce distribution centers, from the requirement to 
keep a list of FTL foods shipped. The comments maintain that the 
requirement would burden small specialty food distributors and 
ingredient distributors because distributors ship large volumes of 
product from many different firms daily. Another comment maintains that 
this requirement would impose a burden on fresh produce distribution 
centers because of the large number of listed products and the need to 
frequently change the list; one comment estimated that based on current 
practices, the FTL list could change, on average, every 3 minutes. The 
comments also maintain that requiring the traceability identifier and 
traceability product description as part of the list of FTL foods 
shipped would further increase the burden on distributors because they 
would have to maintain a list of each individual supplier for each 
covered product they ship. The comments assert that

[[Page 71002]]

maintaining the list would provide little traceability value and would 
be less relevant to distributors because they do not create or 
transform food.
    (Response 322) We agree with the comments that the requirement to 
keep a list of FTL foods shipped could be burdensome and is not 
necessary to ensure adequate traceability of these foods. Therefore, we 
are deleting the proposed requirement from the final rule. Instead, 
Sec.  1.1315(a)(2) of the final rule specifies that an entity's 
traceability plan must include a description of the procedures the 
entity uses to identify foods on the FTL that it manufactures, 
processes, packs, or holds. We conclude that this requirement will help 
us understand how a firm identifies which of the foods it handles 
require records under subpart S.
    (Comment 323) Several comments ask that we clarify how frequently 
an entity must update the list of foods on the FTL that it ships.
    (Response 323) Because we are deleting the proposed requirement to 
maintain a list of FTL foods shipped, there is no need to specify how 
frequently the list should be updated.
4. Description of How Traceability Lot Codes Are Assigned
    (Comment 324) Some comments request additional guidance on the 
creation and assignment of traceability lot codes, including more 
information about the entity that creates the code and whether the code 
will be maintained throughout the supply chain, how to identify foods 
with a traceability lot code, and how to communicate the traceability 
lot code to subsequent recipients. The comments also recommend that we 
adopt a specific format or system for use in creating and assigning 
traceability lot codes. Some comments suggest that compliance and 
enforcement will be difficult to attain if the rule allows companies to 
choose how they wish to assign traceability lot codes.
    (Response 324) We decline to specify a particular method or system 
by which firms must assign traceability lot codes, because we think it 
is appropriate for firms to have the flexibility to choose the approach 
that best suits their needs. Several food industry-supported 
traceability initiatives offer best practices and standards for 
uniquely identifying a food using a combination of a globally unique 
product identifier, firm-assigned internal lot code, and standard date 
code. This information, taken together, could be used as a traceability 
lot code, provided it meets the definition of ``traceability lot code'' 
in Sec.  1.1310 of the final rule. Because traceability lot codes are 
central to subpart S, and because we are providing flexibility 
regarding how a firm chooses to assign such codes, Sec.  1.1315(a)(3) 
requires that, for firms that assign traceability lot codes, their 
traceability plan must include a description of how they assign them.
    Although the rule allows for flexibility in the structure and 
format of traceability lot codes, Sec.  1.1320 of the final rule limits 
the circumstances under which traceability lot codes may be assigned. 
As discussed in Section V.H of this document, Sec.  1.1320(a) of the 
final rule specifies that firms must assign a traceability lot code 
when they initially pack a RAC other than a food obtained from a 
fishing vessel, perform the first land-based receiving of a food 
obtained from a fishing vessel, or transform a food. Under Sec.  
1.1320(b), except as specified otherwise in subpart S (see Sections V.H 
and V.N of this document), firms must not establish a new traceability 
lot code when they conduct other activities (e.g., shipping) for an FTL 
food.
5. Statement Identifying a Point of Contact
    (Comment 325) One comment suggests that the final rule include a 
requirement that entities have a ``qualified individual'' who can 
perform the recordkeeping activities required under the rule. The 
comment maintains that some businesses subject to the rule that create 
or transform FTL foods do not use lot coding systems and rely on the 
date the product was produced or a ``best by'' date. The comment 
maintains that for such businesses, building their first lot code will 
pose a significant challenge. But the comment notes that, unlike other 
FSMA regulations (e.g., FSVP, preventive controls for human food), the 
traceability rule has no requirement to designate a specific employee 
and level of expertise to be responsible for a firm's traceability 
system. The comment asserts that the rule constitutes the first time 
specific traceability information will be required by a regulation, 
which presents a difficult educational challenge because some firms 
already collect more information than will be required under the final 
rule, though possibly in different formats, while others will be 
starting completely from scratch. The comment also maintains that, more 
than any other FSMA rule, the compliance of downstream entities in the 
supply chain is predicated on the understanding and ability of previous 
entities in the supply chain to implement the rule, because downstream 
entities must be able to collect correct and compliant information to 
meet their own responsibilities. The comment questions how this will 
occur without a developed and standardized curriculum to ensure 
effective implementation of the requirements.
    (Response 325) We do not agree that it is necessary to codify in 
the regulation a requirement that persons subject to the final rule 
have a ``qualified individual'' with a specified level of expertise who 
has studied a standardized curriculum. We do not believe it is 
necessary to establish qualifications for individuals who conduct 
traceability operations to ensure compliance with the subpart S 
recordkeeping requirements, and developing a standardized curriculum 
would be impractical because individual firms vary widely in their 
approaches to traceability recordkeeping. However, we have revised 
Sec.  1.1315(a) to specify (in Sec.  1.1315(a)(4)) that an entity's 
traceability plan must include a statement identifying a point of 
contact for questions regarding the entity's traceability plan and 
records. As previously stated, the rule defines ``point of contact'' as 
an individual having familiarity with an entity's procedures for 
traceability, including their name and/or job title, and their phone 
number. Thus, an entity subject to subpart S must have someone 
available as a point of contact who is familiar with the firm's 
traceability plan and traceability records. This means that firms will 
have to employ or obtain the services of at least one person who 
understands how the firm conducts its internal traceability procedures, 
including how traceability information is received and/or provided to 
its supply chain partners. We conclude that this requirement to 
identify a point of contact will help ensure that traceability 
information for FTL foods is made available to FDA and other supply 
chain entities on a timely basis.
    (Comment 326) Several comments suggest that FDA can obtain 
information necessary for traceback by contacting a firm's facility 
registration contact. The comments suggest that FDA could communicate 
this expectation to industry either through guidance in support of this 
rule, guidance in support of facility registration renewal, or as part 
of the facility registration process. The comments maintain that 
contacting the facility registration contact would obviate the need for 
firms in the supply chain to provide point of contact information to 
customers, since FDA already has access to facility registration 
information.
    (Response 326) We decline to specify that a firm's point of contact 
for

[[Page 71003]]

purposes of the subpart S requirements must be its facility 
registration contact. Although facility registration data may provide 
information on points of contact for some firms subject to subpart S, 
not every covered entity is required to register with FDA as a food 
facility. For example, farms, RFEs, and restaurants are not required to 
register with the Agency. Furthermore, a firm's facility registration 
contact might not have knowledge of the firm's traceability program and 
therefore would not be best positioned to respond to questions about 
the program. As stated in Response 274, we have addressed concerns 
about the privacy of points of contact by revising the definition of 
``point of contact'' so that firms may provide the job title (instead 
of the name) of their point of contact.
6. Farm Map
    In response to comments we received about the proposed requirement 
(in Sec.  1.1325(a)) that those who grow FTL foods maintain records 
linking the traceability lot code of the food to the growing area 
coordinates for the food, we are deleting that requirement and 
replacing it with a requirement that those who grow or raise an FTL 
food (other than eggs) must include in their traceability plan a farm 
map showing the location and name of each field (or, for aquaculture 
farms, each container) in which the food on the FTL was grown or 
raised, including geographic coordinates and any other information 
needed to identify the location of each field (or, for aquaculture 
farms, each container). (As stated in Section V.F of this document, we 
had proposed to define ``growing area coordinates'' as geographical 
coordinates (under GPS or latitude/longitude) for the entry point of 
the physical location where the food was grown and harvested.) We 
discuss the farm map requirements in response to the following comments 
on the proposed requirement concerning growing area coordinates.
    (Comment 327) Many comments request the removal of growing area 
coordinates as a KDE for the growing of an FTL food. The comments 
maintain that GPS coordinates are susceptible to documentation error 
due to misplaced decimal places or other recording errors. The comments 
also assert that obtaining and maintaining growing area coordinates for 
the entrances to fields where seed for sprouting is grown would place 
an undue burden on small and mid-size farms, and ask that we clarify if 
the proposed requirement applies to operations that grow sprouts. The 
comments suggest several alternatives to the use of growing area 
coordinates, including satellite printouts, field numbers, Farm Service 
Agency records, mailing addresses, written directions, and GS1 US GLNs. 
Some comments express concerns about scalability and privacy concerns 
with the growing area coordinates requirement. A few comments seek 
clarification on whether growing area coordinates must be shared with 
trading partners.
    (Response 327) As discussed more fully in Section V.J of this 
document, we have deleted from the final rule the proposed requirements 
for persons who grow an FTL food, including the requirement to keep a 
record of the growing area coordinates for each traceability lot of an 
FTL food. However, we believe that geographic coordinates provide 
important information for identifying the location where a food is 
sourced. We also believe that geographic coordinates are accessible to 
all farms. Therefore, Sec.  1.1315(a)(5) of the final rule specifies 
that if an entity grows or raises a food on the FTL (other than eggs, 
as discussed in Response 349), its traceability plan must include a 
farm map showing the area in which the food is grown or raised. Except 
with respect to aquaculture farms (discussed in Response 328), the farm 
map must show the location and name of each field (or other growing 
area) in which a food on the FTL is grown, including geographic 
coordinates and any other information needed to identify the location 
of each field or growing area (Sec.  1.1315(a)(5)(i)). The requirement 
to maintain a farm map as specified in Sec.  1.1315(a)(5)(i) applies to 
indoor growing operations (e.g., greenhouses, hydroponic farms), as 
well as outdoor operations. We added the phrase ``or other growing 
area'' to describe situations where the location in which a food is 
grown is not a field. Like outdoor operations, indoor operations may 
consist of multiple growing areas, in which case farm maps will be 
particularly useful during an outbreak investigation to assist in 
pinpointing the area where an implicated FTL food was grown. With 
regard to the comment asking about sprout operations and sprout seed 
operations, Sec.  1.1315(a)(5)(i) applies to anyone who grows or raises 
a food on the FTL other than eggs (except it does not apply to 
aquaculture farms, which are discussed below and in Sec.  
1.1315(a)(5)(ii)). Because sprouts are on the FTL, this provision 
applies to growers of sprouts. Seeds for sprouting, however, are not on 
the FTL, so this provision does not apply to growers of seeds for 
sprouting.
    With respect to the sharing of growing area coordinates with 
trading partners, as discussed in Section V.J of this document, the 
final rule requires harvesters and coolers of FTL foods to provide to 
the initial packer of the food the location description for the farm 
where the food was harvested, which can be done by providing either the 
physical location address or geographic coordinates for the farm (in 
addition to the other information identified in the definition of 
``location description''). The final rule also requires harvesters of 
FTL produce to provide the name of the field or other growing area from 
which the food was harvested (which must correspond to the name used by 
the grower), or other information identifying the harvest location at 
least as precisely as the field or other growing area name. Because the 
field name provided to the initial packer must match the field name 
used by the grower, this requirement will allow FDA to connect the 
information we obtain from the initial packer with the farm map that 
the grower is required to maintain under Sec.  1.1315(a)(5), thus 
enabling us to identify the specific field where the produce was grown. 
We conclude that these requirements relating to the location of the 
farm where the food was harvested and the name of the field from which 
the food was harvested are essential to ensuring adequate traceability.
    (Comment 328) One comment supports the use of GPS coordinates to 
identify pond-specific harvest of fish and to identify small-scale 
aquaculture farms.
    (Response 328) We agree with the comment that this information is 
important to accurately identify and locate aquaculture operations. 
Therefore, Sec.  1.1315(a)(5)(ii) of the final rule specifies that for 
aquaculture farms, the farm map required as part of the traceability 
plan must show the location and name of each container (e.g., pond, 
pool, tank, cage) in which the seafood on the FTL is raised, including 
geographic coordinates and any other information needed to identify the 
location of each container. Use of GPS could be one way in which 
aquaculture farms could meet the requirement to document the relevant 
geographic coordinates.
    (Comment 329) One comment expresses concern over the amount of 
paperwork that would be necessary to maintain growing area coordinates 
for multiple commodities over a long period of time.
    (Response 329) As previously stated, rather than keeping records on 
the growing area coordinates for each traceability lot of FTL food 
grown, the final rule requires entities that grow or

[[Page 71004]]

raise FTL foods to keep a farm map as part of their traceability plan. 
Documenting the relevant field (or container) names and locations, 
including the geographic coordinates, on the farm map might be a one-
time event and would only need to be repeated if the field or container 
locations change, which should result in a reduced burden compared to 
the proposed requirement on growing area coordinates.
    (Comment 330) One comment suggests that we reference the GPS 
standard released in April 2020 that GPS coordinates must be accurate 
to within 5 meters (3 meters longitude and 5 meters latitude).
    (Response 330) Although we recognize the importance of the GPS in 
meeting requirements to record geographic coordinates of farms, because 
the final rule does not use the term ``global positioning system,'' 
there is no need to reference any particular GPS standard in the rule.
    (Comment 331) Some comments ask for additional clarity regarding 
how growing area coordinates would help identify fields on a farm. One 
comment states that farms may have multiple points of entry or maintain 
properties over multiple jurisdictions and suggests that physical 
location may be more useful than growing area coordinates. One comment 
maintains that the reference in the proposed rule to the geographical 
coordinates of the field entrance does not provide sufficient 
information about field location, and that without greater specificity, 
entire farms rather than individual fields might be implicated in a 
product recall. One comment asks whether a farm needs to assign names 
to each field.
    (Response 331) As previously stated, the final rule deletes the 
proposed requirement concerning growing area coordinates and replaces 
it with a requirement for farms to include farm maps in their 
traceability plans. The farm maps must show the location and name of 
each field or container in which a food on the FTL is grown or raised, 
including geographic coordinates and any other information needed to 
identify the location of each field or container. Presenting this 
information in the form of a map will provide a greater level of 
specificity and visual perspective for each field or container on the 
farm, because it will provide a fuller context to understand the size 
and location of a field or container as compared to what would be 
provided by a single set of geographic coordinates in isolation (i.e., 
not as part of a map). Additional information that may be provided, 
such as adjacent road names or other identifying information, will help 
position the farm in its geographic area and provide a better 
understanding of the farm and where foods are grown or raised than the 
physical location alone. In some cases, if the size of the farm is 
small and there are only a few adjacent fields or containers on the 
farm, it might be sufficient to specify only one set of geographic 
coordinates.
    (Comment 332) One comment maintains that tracking a lot code to a 
growing location using coordinates is complicated by transplanting.
    (Response 332) As stated in Response 327, we have deleted from the 
final rule the proposed requirement for persons who grow an FTL food to 
keep a record of the growing area coordinates for each traceability lot 
of the food. The final rule states that growers need to maintain a farm 
map showing the location and name of each field (or other growing area) 
in which food on the FTL is grown, including geographic coordinates and 
any other information needed to identify the location of each field or 
growing area. If an FTL food is initially grown in one field and then 
transplanted to another field, both fields must appear on the farm map, 
because they are both fields in which an FTL food is grown.
    As previously stated, the harvester of an FTL food must provide 
certain information to the initial packer, including the location 
description for the farm where the food was harvested and (for 
harvesters of produce) the name of the field or other growing area from 
which the food was harvested. Where transplanting had occurred, the 
harvester would only need to provide the name of the field from which 
the food was harvested (not information on previous growing locations 
of the transplanted food).
7. Deleted Requirement To Maintain Other Information Needed To 
Understand Data
    We proposed to require firms to establish and maintain, as part of 
their traceability program records, any other information needed to 
understand the data provided within any records required by subpart S, 
such as internal or external coding systems, glossaries, and 
abbreviations (proposed Sec.  1.1315(a)(4)). On our own initiative, we 
have determined that this information needed to understand data in a 
firm's records is more relevant in the context of an Agency request to 
review a firm's subpart S records than as a part of a firm's 
traceability plan. Therefore, as discussed in Section V.R of this 
document, Sec.  1.1455(c)(1) of the final rule specifies that an entity 
must make all records required under subpart S available to an 
authorized FDA representative, upon request, within 24 hours (or within 
some reasonable time to which FDA has agreed) after the request, along 
with any information needed to understand these records, such as 
internal or external coding systems, glossaries, abbreviations, and a 
description of how the records provided correspond to the information 
required under subpart S. Consistent with this determination, we have 
deleted the proposed requirement to keep records of information needed 
to understand the data in subpart S records from Sec.  1.1315.
8. Updating and Maintaining the Traceability Plan
    We proposed to require that covered entities must retain the 
records required under proposed Sec.  1.1315(a) (i.e., traceability 
program records) for 2 years after their use is discontinued (e.g., 
because the entity changes the records in which it maintains the 
required information, updates the list of foods on the FTL it ships, or 
changes its procedures for establishing and assigning traceability lot 
codes) (proposed Sec.  1.1315(b)).
    On our own initiative, we are revising Sec.  1.1315(b) to reflect 
changes made to Sec.  1.1315(a) and to make explicit what was implied 
by the parenthetical in the proposed rule, i.e., that we expect a 
firm's traceability plan to reflect its current practices. Section 
1.1315(b) of the final rule therefore states that entities must update 
their traceability plan as needed to ensure that the information 
provided reflects their current practices and to ensure that they are 
in compliance with the subpart S requirements. Consistent with the 
proposed rule, Sec.  1.1315(b) further specifies that firms must retain 
their previous traceability plan for 2 years after they update their 
plan.

H. Assignment of Traceability Lot Codes (Sec.  1.1320)

    We proposed to require entities to establish and assign a 
traceability lot code when they originate, transform, or create a food 
on the FTL (proposed Sec.  1.1320(a)). We further proposed that, except 
as specified elsewhere in subpart S, a person may not establish a new 
traceability lot code when they conduct other activities (such as 
shipping or receiving) in the supply chain for an FTL food (proposed 
Sec.  1.1320(b)). As discussed below, to align with changes we are 
making to CTE requirements, we have revised the circumstances under 
which persons are required to assign a traceability lot code, while 
making only minor changes to proposed Sec.  1.1320(b).

[[Page 71005]]

    (Comment 333) One comment recommends that we delete the requirement 
for farmers and harvesters to create lot codes. The comment maintains 
that retaining this requirement would impose financial hardship, while 
deleting it would eliminate duplication of regulations imposed by 
states. Several comments suggest that entities responsible for packing 
RACs such as produce, eggs, and seafood should be responsible for 
assigning a traceability lot code to the food. The comments maintain 
that these entities are better positioned in the supply chain to assign 
lot codes, and are more likely to have systems in place for storing 
KDEs for events like growing and harvesting.
    (Response 333) We agree with the comments that entities that pack a 
RAC for the first time generally are better positioned than growers and 
harvesters to assign a traceability lot code to the food. It is the 
packed form of the RAC that is distributed throughout the supply chain, 
and RACs often are harvested into temporary holding containers in a 
process that does not lend itself well to assigning traceability lot 
codes. In recognition of this, we have revised the proposed CTE 
requirements to delete the requirement for growers of FTL foods to 
establish a traceability lot code (see Section V.J of this document) 
and to add requirements applicable to the initial packers of RACs other 
than food obtained from a fishing vessel (see Section V.K of this 
document), including a requirement to assign a traceability lot code 
for such food. Regarding food obtained from a fishing vessel, we have 
identified the first land-based receiver of the food as the entity best 
positioned to assign a traceability lot code for the food (see Section 
V.K of this document). In accordance with these and other changes to 
the CTE requirements, Sec.  1.1320(a) of the final rule specifies that 
a person must assign a traceability lot code when they initially pack a 
RAC other than a food obtained from a fishing vessel, perform the first 
land-based receiving of a food obtained from a fishing vessel, or 
transform a food.
    (Comment 334) One comment requests that all shellfish growers and 
harvesters be exempt from the requirement to assign or keep lot codes 
because most shellfish growers and harvesters would be exempt from 
subpart S, since they produce less than $25,000 in shellfish annually.
    (Response 334) As previously discussed, Sec.  1.1305(f) of the 
final rule exempts from subpart S raw bivalve molluscan shellfish that 
are: (1) covered by the requirements of the NSSP; (2) subject to the 
requirements of part 123, subpart C, and Sec.  1240.60; or (3) covered 
by a final equivalence determination by FDA for raw bivalve molluscan 
shellfish. This means that nearly all raw bivalve molluscan shellfish 
will not be subject to the rule. However, for shellfish growers and 
harvesters that are not exempt from the rule under Sec.  1.1305(f) or 
any other exemption (e.g., the exemption for certain small producers of 
RACs other than produce or shell eggs in Sec.  1.1305(a)(3)), we 
conclude that it would not be appropriate to exempt them from the 
requirements to assign and keep lot codes as may apply to them under 
subpart S.
    (Comment 335) Several comments assert that firms should be required 
to link the incoming lot code of an FTL food to an outgoing lot code at 
every node in the distribution chain, and that each entity in the chain 
be permitted to assign their own lot code to the FTL food in accordance 
with their internal traceability protocols. Some comments maintain that 
such a system would be particularly helpful in the case of imported 
products, where it might not be known at the beginning of the supply 
chain that the product will eventually be exported to the United 
States; the comments contend that such an approach would be consistent 
with Codex recommendations regarding product tracing. The comments 
assert that this would effectively constitute ``one-up, one-back'' 
tracing via lot code.
    (Response 335) We do not agree that firms should be allowed to 
create a new traceability lot code for an FTL food whenever they deem 
it appropriate. Firms that wish to do so may assign their own internal 
lot codes to FTL foods for the purposes of internal tracing, but they 
must comply with the subpart S requirement to keep the traceability lot 
code unchanged except under specified circumstances. As discussed in 
the preamble to the proposed rule (85 FR 59984 at 60006), assigning a 
new traceability lot code for a food that has not been transformed can 
lead to confusion that can hinder traceback and traceforward efforts 
during investigation of foodborne illness outbreaks.
    The use of traceability lot codes that remain unchanged as the food 
passes through supply chain nodes such as distribution centers will 
allow us to skip these nodes, at least initially, in a traceback 
investigation and more quickly identify the firm that initially packed, 
first received on land, or transformed the food, because firms that 
receive FTL foods will be required to keep a record of the traceability 
lot code and the traceability lot code source. For these reasons, we 
conclude that it is appropriate to specify, in Sec.  1.1320(b) of the 
final rule, that new traceability lot codes must not be established 
when conducting activities other than those specified in Sec.  
1.1320(a), except as specified otherwise in subpart S. (As discussed in 
Sections V.K and V.N of this document, the final rule requires firms to 
assign a traceability lot code upon receipt of an FTL food from a 
person to whom subpart S does not apply, if one has not already been 
assigned (see Sec.  1.1345(b)).)
    As discussed in Response 525, we believe the rule conforms to the 
Codex principles for traceability (CAC/GL60-2006), and while the final 
rule goes beyond one-up, one-back tracing, this is not in conflict with 
Codex principles. Regarding the concern about imported products for 
which it might not be known at the beginning of the supply chain that 
the product will eventually be exported to the United States, as stated 
in Response 103, U.S. importers will need to work with their foreign 
suppliers to ensure they are aware of the subpart S traceability 
requirements. We note that many existing FDA regulations include 
requirements for imported foods, including requirements regarding the 
beginning of the supply chain (for example, requirements relating to 
the growing of produce in the produce safety regulation), and we 
believe it is reasonable to expect that foreign entities will be able 
to comply with the final rule. We also note that many foreign entities 
that produce food that is ultimately exported to the United States 
already have procedures in place for identifying such food, and the 
final rule provides flexibility to allow firms to rely on existing 
procedures and information to meet the rule's requirements.
    (Comment 336) One comment asserts that because supply chain systems 
are not fully interoperable, a traceability lot code designated at the 
beginning of the supply chain may not be compatible with downstream 
systems. Therefore, the comment maintains that each covered entity 
should be able to establish their own traceability lot codes, provided 
one-up, one-back traceability is maintained.
    (Response 336) We do not agree with the comment. As previously 
stated, limiting the circumstances under which a traceability lot code 
may be assigned to a product increases the chances that we will be able 
to rapidly identify and contact the source of a food when conducting an 
outbreak investigation. This use of traceability lot codes (and 
traceability lot code source information, as discussed in Section I.B 
of this

[[Page 71006]]

document) is central to subpart S because it enables traceability that 
is more efficient than what can be attained through one-up, one-back 
tracing. Allowing firms to assign new traceability lot codes to foods 
at any point in the supply chain would undermine this key element of 
subpart S and would create obstacles to efficient traceability. While 
we agree with the comment that supply chain systems are not fully 
interoperable, we do not think full interoperability is necessary to 
accommodate a variety of incoming traceability lot codes.
    (Comment 337) One comment asserts that the prohibition in proposed 
Sec.  1.1320(b) against assigning traceability lot codes other than in 
the specified circumstances violates section 204(d)(1)(E) of FSMA, 
which states that we may 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. The comment maintains 
that many covered entities have functioning, efficient traceability 
systems that assign internal lot codes to incoming product that allows 
the connection of incoming product to outgoing product, and not 
allowing the use of these systems instead of a traceability lot code 
that cannot be changed means that information must be duplicated to 
comply with the rule.
    (Response 337) We do not agree that limiting the circumstances in 
which a traceability lot code may be assigned means that firms must 
create and maintain duplicate records. Covered entities are free to 
continue to use tracing systems that assign internal lot codes to 
products as they come into their systems for internal tracing purposes, 
but they are not required to do so. To the extent that a firm chooses 
to assign internal lot codes to FTL foods they receive, and to keep 
records of those internal lot codes, the requirement to maintain the 
existing traceability lot code is not a duplication of those records.
    As previously discussed, for the rule to improve traceability as 
intended, the circumstances under which traceability lot codes may be 
assigned must be limited to allow the applicable traceability lot code 
to continue to be linked to an FTL food as the food moves through the 
supply chain, which will enable us to more quickly trace the food. We 
note that firms that assign traceability lot codes (in accordance with 
Sec.  1.1320) may opt to use their existing internal lot coding systems 
in assigning the traceability lot codes.
    (Comment 338) One comment suggests that we revise proposed Sec.  
1.1320(b) to state that a person ``shall not'' rather than ``may not'' 
establish a new traceability lot code except under circumstance stated 
elsewhere in subpart S.
    (Response 338) We agree that Sec.  1.1320(b) should be changed to 
more clearly state that assignment of a traceability lot code except 
under the specified circumstances is prohibited. Therefore, we are 
revising Sec.  1.1320(b) to state that except as specified otherwise in 
subpart S, a person ``must not'' establish a new traceability lot code 
when they conduct other activities (e.g., shipping) for a food on the 
FTL.
    (Comment 339) One comment asks that we clarify whether a new 
traceability lot code must be assigned by a third-party warehouse that 
is within the control of the manufacturer.
    (Response 339) Under Sec.  1.1320(a) of the final rule, a firm must 
assign a traceability lot code to an FTL food when it does any of the 
following: initially packs a RAC other than a food obtained from a 
fishing vessel, performs the first land-based receiving of a food 
obtained from a fishing vessel, or transforms a food. Unless the 
warehouse is engaging in one of those activities (or unless it received 
the food from an entity that is not subject to subpart S, as discussed 
in Section V.N.2 of this document), it would not be required to assign 
a traceability lot code to the food, and indeed it would not be 
permitted to do so under Sec.  1.1320(b).
    (Comment 340) Some comments suggest that the first receiver of 
shellfish (under proposed Sec.  1.1330) should assign the traceability 
lot code rather than the shellfish harvester or aquaculture farm. The 
comments assert that many shellfish harvesters and small farms are not 
computer-literate and would either not be able to comply with the 
requirement to assign a traceability lot code or would be exempt from 
the rule.
    (Response 340) We agree with the comments that harvesters of 
shellfish are often not the best-positioned entity in the supply chain 
to assign a traceability lot code. As stated above, we have deleted the 
proposed requirement for ``originators'' of FTL foods (i.e., entities 
that grow, raise, or catch a food) to assign a traceability lot code to 
the food. Instead, Sec.  1.1320(a) specifies that a traceability lot 
code must be assigned either by the initial packer, for a food not 
obtained from a fishing vessel (which could include aquacultured 
shellfish); or else by the first land-based receiver, for a food 
obtained from a fishing vessel. Note that most raw bivalve molluscan 
shellfish are exempt from subpart S (see Section V.E.7 of this 
document).
    (Comment 341) One comment asserts that the proposed KDEs would not 
be necessary if lot codes were required to be printed on all product 
packaging and related documents for every transaction. Some comments 
assert that an important precondition for the rule is the 
identification of physical product with the traceability lot code using 
industry standards such as those used in the PTI.
    (Response 341) The final rule does not require that the 
traceability lot code for a food appear on the food's labeling or 
packaging. However, we recognize the potential value of physically 
identifying foods with the traceability lot code, and we welcome the 
use of industry-supported standards and best practices, such as those 
in the PTI, in meeting subpart S requirements, including those 
regarding assignment and communication of traceability lot codes.
    (Comment 342) Many comments assert that the proposed rule would 
impose a case-level tracking requirement throughout the supply chain, 
in violation of section 204(d)(1)(L)(iii) of FSMA, because it would 
require distributors to maintain and send shipping KDEs linked to the 
specific traceability lot codes of the products in each shipment. The 
comments maintain that distributors receive shipments with multiple lot 
codes from their suppliers that would have to be tracked as they 
fulfill orders for their customers, especially in situations where a 
mixed pallet is being shipped or smaller quantities of products are 
being sold; the comments claim that tracking to the case level would be 
the only way to know the traceability lot code for each case sent to a 
customer. The comments also maintain that shipments to RFEs move not by 
an entire traceability lot, but rather by case count. The comments 
further assert that in circumstances where a pallet-level barcode with 
a case-level GTIN and applicable date and batch/lot numbers for 
products on the pallet is not available, distribution centers would 
need to break down the pallets to record the case-level information. In 
addition, the comments assert that a case-level tracking requirement is 
unnecessary because current tracing systems, which link product through 
POs, BOLs, or other reference records, is equally effective when 
conducting traceback activities. The comments also suggest that the 
proposed rule would require entities to place labels on every case, 
which they maintain would be costly. The comments contend that 
distribution centers using voice picking would not be able to track 
individual cases and

[[Page 71007]]

would need to shift to case-scanning technology. The comments also 
claim that in situations where product types are not conducive to paper 
labeling, firms may need to switch to a reusable plastic container, 
resulting in additional costs and transportation expenses. In addition, 
the comments maintain that when an RFE receives a pallet with products 
from different traceability lots, the RFE would have to keep different 
sets of KDEs for the same food item if they represent different 
traceability lots, which would create confusion and complexity. The 
comments also state that sometimes cases fall off pallets, which can 
affect traceability.
    (Response 342) We disagree with the comments that the rule requires 
case-level tracking. For each CTE performed by a covered entity, the 
final rule requires the applicable KDEs to be maintained for each 
traceability lot of an FTL food, linked with a traceability lot code. 
We have provided flexibility for how a firm identifies a traceability 
lot; a firm could define a lot as a case, a pallet, a day's production, 
or some other amount of product. We recognize that entities such as 
distribution centers are generally not allowed to assign a new 
traceability lot code under Sec.  1.1320, and therefore cannot control 
the size of the traceability lot. This can lead to situations where a 
single incoming traceability lot gets broken up and shipped to multiple 
destinations, or to multiple traceability lots being combined into a 
single pallet or a single shipment. Subpart S does not require case-
level tracking in such situations, and we think the final rule provides 
adequate flexibility for firms to decide how to manage these 
situations, depending on their individual practices.
    One reason why the rule requires KDEs in addition to the 
traceability lot code is that we recognize that in some situations, 
parts of a single traceability lot might end up in multiple places. If 
an entity such as a distribution center breaks up a single traceability 
lot and ships the product to multiple locations, each shipment will 
have its own set of KDEs associated with it, and the combination of the 
traceability lot code and the information regarding the shipping event 
(e.g., information about the food's recipient) will provide a 
sufficiently descriptive record of that event despite the fact that 
another portion of the same traceability lot (with the same 
traceability lot code) was shipped elsewhere. This approach does not 
constitute case-level tracking, because there is no requirement to have 
case identifiers to track which cases are sent to which destination. 
Conversely, if an entity such as a distribution center receives several 
small traceability lots of the same product, and therefore needs to 
combine multiple lots into a single shipment, the records for that 
shipping event would need to be specific to each traceability lot; 
however, this too does not constitute case-level tracking, because 
records would not need to be kept to uniquely identify each individual 
case. We recognize that if an entity chooses to identify a single case 
as an entire traceability lot, or to divide a traceability lot into 
single-case shipments, the result would be recordkeeping for individual 
cases. However, this would be due to the decisions made by the firm, 
not to any requirement to engage in case-level tracking.
    Regarding the statement that other tracing systems linking products 
through POs or BOLs are equally effective, we note that those systems 
can be used as long as such reference documents enable a firm to meet 
the requirements of subpart S, including linking the traceability lot 
code of an incoming FTL food to the traceability lot code of an 
outgoing FTL food. For some points in the supply chain (e.g., those 
entities performing only shipping and receiving), the traceability lot 
code will remain the same for the incoming and outgoing food.
    The final rule does not require firms to label every case of FTL 
food (with paper labels or otherwise). However, we realize that for 
some businesses, this might be the most efficient way to keep track of 
the quantity and unit of measure of a particular traceability lot that 
has been received or is being shipped to a customer. Alternate business 
practices are available, such as labeling a slot or bin in a warehouse 
with a traceability lot code if all the cases in that holding area have 
the same traceability lot code.
    As comments note, when cases lack any identifying information that 
links to a traceability lot code and there are multiple traceability 
lots of the same FTL food, such as in a warehouse, if one case falls 
off a pallet or gets separated, it could be difficult to identify which 
traceability lot the case belongs to. Individual firms can decide how 
to manage this risk. For example, a firm might take steps to prevent 
individual cases from getting accidentally separated from their 
pallets; firms might decide to label each individual case; or firms 
might decide that if a case is separated, they will perform an 
inventory of all identical product on hand to determine which 
traceability lot is missing a case.
    (Comment 343) Some comments request that FDA allow distribution 
centers to maintain and send KDEs related to multiple traceability lot 
codes on a pallet, or a new traceability lot code assigned by the 
distribution center representing the traceability lot codes on a 
pallet, rather than the exact traceability lot codes received from the 
previous source.
    (Response 343) We decline to make this change to allow distributors 
to create new traceability lot codes for foods they do not transform, 
or to create records that do not distinguish between different 
traceability lots on a pallet. Except when a distributor receives an 
FTL food from a person to whom subpart S does not apply (see Sec.  
1.1345(b)), a distributor generally would not be permitted to establish 
a new traceability lot code for a food under Sec.  1.1320(b). An 
important part of the subpart S requirements is that covered entities 
must keep a record of the traceability lot code and information on the 
traceability lot code source or a source reference for each 
traceability lot of an FTL food they handle and must pass that 
information along when they ship the food. The final rule does not 
prescribe how an entity such as a distribution center must maintain 
this information and provide it to the subsequent recipient, but it 
should be clear which traceability lots the distribution center handled 
and which specific traceability lots were included in the shipment. If 
the information maintained by the distribution center or provided to 
the subsequent recipient is ambiguous, the information provided to FDA 
may be unclear, which could slow our investigation.
    (Comment 344) Some comments ask that flexibility be incorporated 
into lot-level identification so that a packer may assign a 
traceability lot code if the grower has not done so or if a RAC is 
commingled between harvesting and processing.
    (Response 344) As previously stated, we have removed the proposed 
requirement for growers to assign traceability lot codes. Instead, 
Sec.  1.1320(a) of the final rule specifies that the initial packer of 
a RAC other than a food obtained from a fishing vessel must assign a 
traceability lot code to the newly packed food. If a RAC is commingled 
before it is initially packed, the initial packer's records will 
reflect that the traceability lot is associated with multiple fields 
and/or multiple farms, but there is no requirement to track which parts 
of the lot come from which fields or farms. If a non-produce RAC is 
commingled after harvesting and before processing, it may be partially 
exempt from subpart S under Sec.  1.1305(h) (see Section V.E.9 of this

[[Page 71008]]

document). For food obtained from a fishing vessel, see the discussion 
of commingling in Response 208; for eggs, see the discussion of 
commingling in Response 206.
    (Comment 345) One comment expresses concern that a lack of 
specificity regarding traceability lot codes and the requirement to 
pass traceability lot codes along the supply chain may prove to be 
burdensome for small entrepreneurs.
    (Response 345) We disagree with the comment. The assignment of 
traceability lot codes and the provision of these codes (along with 
other KDEs for a food) to downstream entities in the supply chain of a 
food are critical components of recordkeeping requirements that will 
enable the Agency to more swiftly and efficiently conduct product 
tracing during an investigation of a foodborne illness outbreak or a 
recall. We are uncertain as to what aspect of traceability lot codes 
the comment believes lacks specificity. We believe that the rule 
provides appropriate flexibility to firms regarding the form and 
content of traceability lot codes and the manner in which they are 
assigned to FTL foods. However, because we recognize that meeting the 
subpart S requirements may be more burdensome for smaller firms, the 
final rule includes exemptions for certain types of smaller entities, 
including small producers and small RFEs and restaurants, as discussed 
in Sections V.E and V.R.3 of this document.
    (Comment 346) One comment asks if FDA needs to be able to tie 
traceability lot codes to a specific production line or facility.
    (Response 346) The rule does not require that firms construct 
traceability lot codes such that they identify particular production 
lines or facilities. However, consistent with the definition of 
``traceability lot code,'' the traceability lot codes that a firm 
assigns must be able to uniquely identify a traceability lot within the 
firm's records. Therefore, a firm might choose to, but is not required 
to, assign traceability lot codes that reflect production on a 
particular production line or at a particular facility. Furthermore, we 
note that subpart S contains requirements relating to the traceability 
lot code source, which is the place where a food was assigned a 
traceability lot code. For many of the CTEs, records must be maintained 
that contain either the location description for the traceability lot 
code source or the traceability lot code source reference. This 
information allows FDA to identify the place where a specific 
traceability lot code was assigned, which will often be the facility 
where the food was manufactured or otherwise transformed (see Response 
265). There is no requirement that this information enable FDA to 
identify the specific production line where the food was manufactured.

I. Critical Tracking Events Framework

    At the core of the subpart S traceability recordkeeping 
requirements are provisions requiring entities that manufacture, 
process, pack, or hold FTL foods to keep and, at times, provide to 
immediate subsequent recipients of food certain information related to 
CTEs in the food's supply chain. The proposed rule included growing, 
transformation, creating, shipping, and receiving (including 
requirements for the ``first receiver'' of a food) as CTEs for which 
KDEs must be maintained. As discussed previously, we received many 
comments concerning the proposed CTEs, particularly the requirements 
associated with the first receiver CTE and which entities in the supply 
chain are best suited to assigning lot codes to FTL foods. In response 
to these comments, which we discuss below and in the following sections 
concerning specific CTEs, we have made several changes in the final 
rule to the CTE framework.
    As discussed in Section V.J of this document, many comments 
maintain that lot codes are often assigned when a harvested food is 
packed for distribution into commerce rather than during the growing 
phase. We agree and therefore have placed the responsibility for the 
assignment of traceability lot codes for RACs not obtained from a 
fishing vessel on the initial packer of such food. We are deleting 
entirely the proposed CTE for growing an FTL food, which included 
requirements to assign traceability lot codes, document growing area 
coordinates for each traceability lot, and document particular KDEs for 
sprouts. Instead, as previously discussed, the final rule requires 
persons who grow or raise an FTL food (other than eggs) to maintain, as 
part of their traceability plan, a farm map showing the area, including 
geographic coordinates, in which they grow or raise the FTL food. The 
specific information related to sprouts is now included in the 
requirements for the initial packing CTE (see Section V.K of this 
document).
    The proposed provisions for the first receiver CTE would have 
placed certain recordkeeping requirements on the first person (other 
than a farm) who purchases and takes physical possession of an FTL food 
that has been grown, raised, caught, or (in the case of a non-produce 
commodity) harvested. As previously discussed, several comments express 
confusion regarding the first receiver concept and suggest that the 
proposed first receiver requirements would make more sense as 
requirements for the person who initially packs an FTL food, because 
packers often have much of the information that would have been 
required of first receivers. Comments also indicate concern than an 
entity could be a first receiver and may not know it, including 
entities that would not typically have the required information on 
growing, harvesting, cooling, and packing, such as distributors and 
third-party warehouses.
    In response to these comments, we have replaced the proposed 
requirements of the first receiver CTE with requirements for entities 
that initially pack or (in the case of food obtained from a fishing 
vessel) perform the first land-based receiving of certain FTL foods. 
This places recordkeeping responsibilities on the entity performing a 
certain activity (e.g., initial packing) and therefore reduces 
confusion about the type of entity that is required to maintain these 
KDEs. We had proposed separate requirements for first receivers of (1) 
seafood products on the FTL obtained from a fishing vessel and (2) all 
other FTL foods. Similarly, the final rule establishes separate 
requirements for the CTE of the initial packing of RACs other than food 
obtained from a fishing vessel (Sec.  1.1330) and requirements for the 
CTE of the first land-based receiving of a food obtained from a fishing 
vessel (Sec.  1.1335).
    We also received comments requesting clarity as to what activities 
constitute ``transformation'' rather than ``creation'' of an FTL food 
and asking that the requirements for the transformation and creating 
events be combined into a single CTE. As discussed in Section V.O of 
this document, we agree with the comments and have merged the 
requirements for the creating CTE with the requirements for the 
transformation CTE in Sec.  1.1350 of the final rule. This action 
simplifies the requirements by removing the distinction between 
production of an FTL food with an ingredient(s) on the FTL (e.g., 
bagged salad) and production of an FTL food without ingredients on the 
FTL (e.g., peanut butter).
    Although the shipping and receiving CTEs in the final rule 
(Sec. Sec.  1.1340 and 1.1345, respectively) are similar to those we 
had proposed, we have made some changes to the proposed requirements 
for these CTEs. First, we have deleted from the shipping CTE the 
proposed requirement for farms to provide certain information on the 
production of a food to the immediate subsequent recipient of the food 
they ship. Instead, to ensure

[[Page 71009]]

that firms that conduct the initial packing of RACs (other than food 
obtained from fishing vessels) have this important information, we have 
adopted requirements for harvesters and coolers of such RACs to keep 
certain records of their activities and provide that information, 
including information about the farm where the food was harvested, to 
the initial packer. In addition, we have revised the shipping and 
receiving CTEs to specify that they do not apply to shipment or receipt 
of a food (if the food is a RAC not obtained from a fishing vessel) 
that occurs before the food is initially packed, or to the receipt of a 
food by the first land-based receiver of the food (if the food is 
obtained from a fishing vessel). Finally, in response to comments about 
what requirements apply when a firm receives food from an entity that 
is exempt from subpart S, we have revised the receiving CTE (as well as 
the initial packing CTE) to specify certain KDEs that must be kept when 
a receiver or initial packer receives food from a person to whom 
subpart S does not apply.
    We respond to certain general comments on the proposed CTE 
framework in the following paragraphs.
    (Comment 347) Some comments express support for FDA specifying 
KDEs.
    (Response 347) We agree with the comments that support the rule's 
framework of KDEs organized by CTEs. We believe that this framework 
forms the foundation for effective and efficient tracing and clearly 
communicates the information that FDA needs to perform such tracing.
    (Comment 348) One comment maintains that growing fresh produce in a 
controlled environment is fundamentally different than growing fresh 
produce outdoors in a field. The comment requests clarification of the 
difference between the growing, transforming, and creating CTEs for an 
indoor produce grower who grows, packs, and processes produce.
    (Response 348) We do not agree that growing produce in a controlled 
environment differs fundamentally from growing produce outdoors 
regarding the general level of safety risk or the type of recordkeeping 
requirements that are appropriate for facilitating traceability. As 
previously stated, we have incorporated the proposed requirements 
applicable to creating an FTL food into the transformation CTE in Sec.  
1.1350 of the final rule, and we have eliminated the proposed CTE for 
growing an FTL food (although, as with farms that grow produce 
outdoors, indoor produce farmers will have to establish a traceability 
plan that includes a farm map in accordance with Sec.  1.1315 of the 
final rule). If an indoor produce farmer harvests and/or cools the 
produce, the requirements in Sec.  1.1325 of the final rule will apply. 
If an indoor produce farmer packs the produce, it will be required to 
comply with the requirements applicable to initial packers under Sec.  
1.1330 of the final rule, and it would be required to maintain shipping 
records for its distribution of the packed produce in accordance with 
Sec.  1.1340. As discussed in Section V.U of this document, to help 
covered entities understand their responsibilities under the rule, we 
intend to provide communication and outreach materials that will 
provide examples of required records for different supply chain 
entities for specific FTL foods.

J. Records of Harvesting and Cooling (Sec.  1.1325)

    As discussed in Section V.I of this document, the proposed rule 
included requirements for persons who grow an FTL food to establish and 
maintain records containing and linking the traceability lot code of 
the food to the growing area coordinates for the food (proposed Sec.  
1.1325(a)). (Proposed additional requirements applicable to growers of 
sprouts are discussed in Section V.K of this document.) Proposed Sec.  
1.1350(b)(2) would have required farms to send information about the 
origination, harvesting, cooling, and packing of a food when shipping 
the food, while proposed Sec.  1.1330 would have required the first 
receivers of food to maintain a record of this information.
    In response to many comments asserting that these proposed 
requirements would impose significant recordkeeping burden on farms and 
do not align with current industry practices (including with respect to 
the assignment of lot codes), we have made several changes to the 
requirements as they relate to the information about the growing, 
harvesting, cooling, and packing of FTL foods. As previously discussed, 
we have removed the requirement for growers to assign traceability lot 
codes. Instead, the final rule specifies that traceability lot codes 
must be assigned when a food is initially packed or (in the case of 
food obtained from a fishing vessel) when it is first received on land, 
and also when the food is transformed. As previously discussed, we have 
deleted the proposed growing CTE requirements (including the 
requirement to maintain growing area coordinates for each traceability 
lot of a food) and replaced them (in part) with requirements for those 
who grow or raise an FTL food (other than eggs) to keep a farm map as 
part of their traceability plan. Under the final rule, some farms will 
only need to maintain a traceability plan and will not have additional 
KDE requirements. Finally, to ensure that the initial packer of a RAC 
has information about the farm where the RAC was grown along with 
information on the harvesting and cooling of the RAC, Sec.  1.1325 of 
the final rule establishes certain recordkeeping and sending 
requirements for persons who harvest or cool RACs, as discussed in 
response to the following comments on the growing, harvesting, and 
cooling of foods.
    (Comment 349) One comment expresses concern about the requirement 
for growers to record the growing area coordinates for each harvested 
traceability lot of food under proposed Sec.  1.1325(a). The comment 
states that its farm grows many different crops that are very near each 
other and that are rotated annually. The comment estimates that the GPS 
technology required to comply would cost $1,000 to $3,000, representing 
a significant percentage of the farm's revenue (which the comment 
states may be less than $25,000 in some years). The comment asserts 
that the growing CTE requirement is better suited for larger farms that 
do not rotate crops and have more financial resources and staff.
    (Response 349) We note initially that, as discussed in Section 
V.E.2 of this document, the final rule exempts from subpart S certain 
small producers, including produce farms that make less than $25,000 
annually in sales of produce (see Sec.  1.1305(a)). Furthermore, as 
stated above, the final rule deletes the requirements for growers in 
proposed Sec.  1.1325. Under Sec.  1.1315(a)(5) of the final rule, 
farms that grow or raise a food other than eggs are required to keep, 
as part of their traceability plan, a farm map showing (for non-
aquaculture farms) the location and name of each field (or other 
growing area) in which they grow a food on the FTL. The map must 
include geographic coordinates and any other information needed to 
identify the location of each field or growing area. In the 
circumstances described in the comment, a farm could maintain a map 
showing all the fields or growing areas on the farm and labeling them 
by name, with sufficient geographic coordinates to identify the 
location of each field or growing area. The map would not have to be 
altered to show the rotation of crops, because records maintained by 
the harvester will identify what food was harvested from a specific 
field on a specific day. Therefore, creation of the farm map could be a 
one-time action

[[Page 71010]]

unless the location or names of fields or growing areas change.
    (Comment 350) Several comments recommend that the ``growing'' 
requirements in proposed Sec.  1.1325 should be replaced with 
``harvesting'' requirements to reflect the step in the process where 
tracing begins. Alternatively, the comments suggest that harvesting 
should be a separate CTE, in addition to growing, where the lot code is 
assigned.
    (Response 350) We agree with the comments that harvesting should be 
a separate CTE, although not an event at which a traceability lot code 
should be assigned. As previously discussed, we have deleted the 
growing and first receiver CTEs. Under Sec.  1.1320(a) of the final 
rule, an entity must assign a traceability lot code when it initially 
packs a RAC other than a food obtained from a fishing vessel, performs 
the first land-based receiving of a food obtained from a fishing 
vessel, or transforms a food. We have determined that initial packers 
are better suited to assigning traceability lot codes than growers of 
RACs. However, we also believe that for initial packers to be able to 
maintain the records of harvesting and cooling of RACs that we need 
them to make available to us in an outbreak investigation, the rule 
must require that certain entities provide the initial packers with 
this information. Although the proposed rule (under Sec.  1.1350(b)(2)) 
would have required all farms to provide information to the subsequent 
receiver regarding the origination, harvesting, cooling, and packing of 
each traceability lot of food they shipped, we conclude that it is more 
appropriate and less burdensome to have harvesters and coolers provide 
information about the activities they perform to the initial packers of 
RACs. This approach also allows for flexibility to accommodate the 
varying business models and types of entities that can be involved in 
harvesting and cooling RACs before they are initially packed.
    For these reasons, Sec.  1.1325 of the final rule sets forth 
requirements for records that persons who conduct harvesting or cooling 
before initial packing must keep and provide to the initial packer. 
Section 1.1325(a)(1) specifies that for each RAC (not obtained from a 
fishing vessel) on the FTL that is harvested, the harvester must 
maintain records containing the following information: the location 
description for the immediate subsequent recipient (other than a 
transporter) of the food; the commodity and, if applicable, variety of 
the food; the quantity and unit of measure of the food (e.g., 75 bins, 
200 pounds); the location description for the farm where the food was 
harvested; for produce, the name of the field or other growing area 
from which the food was harvested (which must correspond to the name 
used by the grower), or other information identifying the harvest 
location at least as precisely as the field or other growing area name; 
for aquacultured food, the name of the container (e.g., pond, pool, 
tank, cage) from which the food was harvested (which must correspond to 
the container name used by the aquaculture farmer) or other information 
identifying the harvest location at least as precisely as the container 
name; the date of harvesting; and the reference document type and 
reference document number.
    Similarly, Sec.  1.1325(b)(1) specifies that for each RAC (not 
obtained from a fishing vessel) on the FTL that is cooled before it is 
initially packed, the cooler of the RAC must maintain records 
containing the following information: the location description for the 
immediate subsequent recipient (other than a transporter) of the food; 
the commodity and, if applicable, variety of the food; the quantity and 
unit of measure of the food (e.g., 75 bins, 200 pounds); the location 
description for where the food was cooled; the date of cooling; the 
location description for the farm where the food was harvested; and the 
reference document type and reference document number.
    In addition to these requirements to maintain certain records, 
Sec.  1.1325 of the final rule also requires harvesters and coolers to 
provide certain information to the initial packer of the RAC they 
harvest or cool. Section 1.1325(a)(2) specifies that for each RAC (not 
obtained from a fishing vessel) on the FTL that is harvested, the 
harvester must provide (in electronic, paper, or other written form) 
its business name, phone number, and the information (listed above) 
that it must keep (except for the reference document type or reference 
document number) to the initial packer of the RAC, either directly or 
through the supply chain. Similarly, Sec.  1.1325(b)(2) requires 
coolers of RACs (not obtained from a fishing vessel) to provide (in 
electronic, paper, or other written form) the information the cooler 
must keep (except for the reference document type or reference document 
number) to the initial packer of the RAC, either directly or through 
the supply chain. These provisions allow flexibility for harvesters and 
coolers to directly provide the required information to the initial 
packer or to have another entity in the supply chain, such as the farm 
where the RAC was grown, a third-party entity directing the movement of 
the RAC, or a supply chain partner who will handle the food before it 
reaches the initial packer, provide the information to the initial 
packer. However, we note that while supply chains have the flexibility 
to determine how and by whom this information is sent to the initial 
packer, it is the responsibility of harvesters and coolers to somehow 
send the information to the initial packer, and it is the 
responsibility of the initial packer to have the required information 
for each FTL food they pack.
    Consistent with these provisions requiring harvesters and coolers 
to provide certain information to the initial packers of the RACs they 
harvest or cool, we have added provisions to the shipping and receiving 
CTE requirements specifying that, for RACs not obtained from a fishing 
vessel, the shipping and receiving KDEs do not apply to any shipment or 
receipt of the food that occurs before it is initially packed. This 
means that entities that harvest or cool RACs (not obtained from a 
fishing vessel) before they are initially packed are not required to 
keep and send the shipping and receiving KDEs. We conclude that this 
approach is appropriate because the shipping and receiving KDEs are 
linked to the traceability lot code and are designed to be used for 
products that have already been assigned a traceability lot code and 
packed for commercial distribution. The separate KDEs for harvesters 
and coolers that we have established in Sec.  1.1325, and which take 
the place of the shipping and receiving KDEs for these entities, are 
better suited to the specific situation of food that has not yet been 
initially packed. Because the KDEs in Sec.  1.1325 are not tied to a 
traceability lot code, they can be organized in whatever way is 
practical for the operation, for example, on a shipment-by-shipment or 
day-by-day basis.
    (Comment 351) One comment expresses support for the fact that the 
proposed rule does not require records of recipients of a food beyond 
the immediate subsequent recipient, in accordance with section 
204(d)(1)(L)(ii) of FSMA.
    (Response 351) We agree, and the final rule also does not require 
records of recipients of a food beyond the immediate subsequent 
recipient. The harvesting and cooling CTE requirements contain the only 
provisions under which an entity would potentially have a direct 
interaction with a recipient of a food beyond the immediate subsequent 
recipient. Under Sec.  1.1325(a)(2) and (b)(2), the harvester and 
cooler of a RAC not obtained from a fishing vessel are required to 
``provide'' certain information about the

[[Page 71011]]

food to the initial packer of the food, who might not be the immediate 
subsequent recipient of the food. As discussed above, we are taking 
this approach in response to comments requesting greater flexibility 
regarding methods of exchanging information at the beginning of the 
supply chain. A food that has not yet been initially packed may, in a 
short period of time, pass through the hands of multiple entities that 
would have all been considered shippers and receivers under the 
proposed rule. We have concluded that the structure of the proposed 
rule, which involved each of these entities keeping shipping and 
receiving records and (in the case of farms) passing along information 
on the harvesting and cooling of the food, was overly prescriptive and 
burdensome, particularly because it is our understanding that the 
entities that handle a food before it is first packed will often have a 
relationship with the entity that first packs the food, even if that 
entity is not the immediate subsequent recipient. The final rule's 
requirements for harvesters and coolers would provide the requested 
flexibility. In accordance with section 204(d)(1)(L)(ii) of FSMA, Sec.  
1.1325 would not require harvesters or coolers to keep records about 
any entities (such as the initial packer) who are not the immediate 
subsequent recipient of the food. Nor would Sec.  1.1325 necessarily 
require the harvester or packer to send information directly to the 
entity that initially packs the food. As discussed above, under Sec.  
1.1325(a)(2) and (b)(2), the harvester or cooler may provide the 
information directly to the initial packer or they may elect to pass 
the relevant information through their supply chain partners (e.g., a 
harvester providing information to a cooler) until it reaches the 
initial packer.
    We also note that, although the exemptions in Sec.  1.1305(d)(6) 
and (h)(2) potentially involve a series of written agreements meant to 
ensure that a future supply chain entity will take a certain action 
(e.g., apply a kill step or commingle a RAC), these provisions do not 
require the exempt entity to know the identity of the future supply 
chain entity that will take that action, let alone to keep a record of 
who that future recipient will be. Instead, these provisions are 
structured so that each supply chain member only needs to interact with 
their immediate subsequent recipient to create the required written 
agreements.
    (Comment 352) One comment suggests that the KDEs required for the 
growing CTE include information on chemicals (e.g., pesticides) applied 
on the farm, including days, times, types, and amounts of chemicals, 
information on farm inspections, and any water testing performed on the 
farm. The comment maintains that the addition of these KDEs would be 
consistent with stricter standards that the comment asserts are needed 
to address food safety hazards at the farm level.
    (Response 352) We decline to require growers of FTL foods or any 
other entities subject to the rule to keep the suggested information on 
chemicals. Such a requirement would not be consistent with the purpose 
of the rule, which is to establish recordkeeping requirements for foods 
designated for inclusion on the FTL to help us conduct rapid and 
effective traceback when investigating foodborne illness outbreaks.
    (Comment 353) One comment asserts that although the proposed rule 
did not define ``growing,'' it appears from the preamble of the 
proposed rule that the requirement for linking the traceability lot 
code to growing area coordinates applies to produce and sprouts but not 
to aquacultured foods or foods from fishing vessels.
    (Response 353) As previously stated, we have deleted the 
recordkeeping requirements for growing an FTL food in proposed Sec.  
1.1325, which included a requirement for growers to keep a record of 
the growing area coordinates for each traceability lot of food. Under 
the final rule, a traceability lot code is not assigned for a RAC until 
the RAC is initially packed (in the case of food not obtained from a 
fishing vessel, including aquacultured seafood) or until the RAC is 
received by the first land-based receiver (for food obtained from a 
fishing vessel) (see Sec.  1.1320). In the case of produce, including 
sprouts, that traceability lot code will be linked in the initial 
packer's records to the name of the field or other growing area from 
which the food was harvested (see Sec.  1.1330(a)(5)). In the case of 
aquacultured food, the traceability lot code will be linked in the 
initial packer's records to the name of the container from which the 
food was harvested (see Sec.  1.1330(a)(6)). In both of those 
situations, the name of the field or container must correspond to the 
name used by the farmer, and the farmer is required under Sec.  
1.1315(a)(5) to maintain a farm map as part of their traceability plan, 
which must include geographic coordinates and any other information 
needed to identify the location of each field or container. This 
approach replaces the requirement in the proposed rule for the grower 
to maintain records linking each traceability lot of food to the 
growing area coordinates where the food was grown. For eggs, Sec.  
1.1315(a)(5) specifically notes that the farm map requirement does not 
apply to egg farms, and there is no obligation under Sec.  1.1330 for 
an initial packer to maintain a record of the specific poultry house or 
field where eggs were harvested. This is because, in the case of egg 
farms, we think that the information the initial packer must maintain 
under Sec.  1.1330(a)(4), identifying the location description for the 
farm where the food was harvested, is sufficient, and we do not see a 
traceability benefit to requiring more specific information about where 
a specific lot of eggs was harvested (especially in light of the fact 
that eggs are often collected from multiple poultry houses via a single 
conveyor belt that moves through all of the houses, thus making it 
impracticable to associate an egg with a specific poultry house). For 
food obtained from a fishing vessel, as discussed below, the first 
land-based receiver of the food must maintain records linking each 
traceability lot of the food to, among other things, the locations for 
the trip during which the food was caught (see Section V.L of this 
document).
    (Comment 354) One comment asks that FDA reference, in the final 
rule or a future guidance document, our ``Draft Guidance for Industry: 
Classification of Activities as Harvesting, Packing, Holding, or 
Manufacturing/Processing for Farms and Facilities'' (Ref. 27) to help 
entities subject to the subpart S requirements understand how we will 
classify certain activities of farms and facilities.
    (Response 354) We will consider whether to reference the draft 
guidance on ``Classification of Activities as Harvesting, Packing, 
Holding, or Manufacturing/Processing for Farms and Facilities'' in a 
future guidance document related to the food traceability recordkeeping 
requirements in subpart S. Section 1.1305 of the final rule defines 
``farm'' to mean ``farm as defined in Sec.  1.328'' (except for 
producers of shell eggs). As noted in Response 250, we plan to issue a 
proposed rule revising the definition of ``farm'' in several food 
safety regulations, including Sec.  1.328, and we might reissue the 
above-noted draft guidance to align with any revision of the farm 
definition we might adopt in that rulemaking. We recognize that there 
is significant interest in how the term ``farm'' is defined, and we 
will provide communications as needed to ensure that entities covered 
by subpart S have clarity on this topic as the rulemaking related to 
the farm definition proceeds.

[[Page 71012]]

    (Comment 355) One comment expresses concern about maintaining KDEs 
related to cooling foods on the FTL because cooling can occur multiple 
times and at multiple locations.
    (Response 355) We agree that foods can be cooled at multiple points 
in the supply chain, and we believe it is important to traceability to 
keep records of all of the locations where a food is held, including 
all of the locations where cooling occurs. As discussed above, Sec.  
1.1325(b) requires persons who cool a RAC (not obtained from a fishing 
vessel) before the RAC is initially packed to keep certain records and 
to provide certain information to the initial packer of the RAC. Once a 
RAC is initially packed, anyone that subsequently cools the food would 
be required to keep the KDEs applicable to shipping and receiving of 
FTL foods under Sec. Sec.  1.1340 and 1.1345, respectively.
    (Comment 356) One comment maintains that because eggs are often 
batched in lots based on weekly date of pickup and, within that large 
lot, there would be many different data points on day and time of 
cooling for the lot, requiring the transmission of this information to 
a first receiver would be burdensome for both egg producers (especially 
small ones) and first receivers. The comment suggests that compliance 
with the refrigeration requirements of the egg safety regulation (21 
CFR part 118 (part 118)) and the regulation for safe handling and 
refrigeration of eggs (21 CFR part 115 (part 115)) should be regarded 
as adequate documentation of the cooling of eggs, making additional 
records under subpart S unnecessary; alternatively, the comment 
suggests that records kept to meet the egg regulations should satisfy 
any subpart S requirements.
    (Response 356) We disagree with the suggestion that maintaining and 
providing records of cooling of eggs under subpart S is not necessary 
for traceability. However, we think that revisions we have made in the 
final rule will alleviate many of the concerns expressed in the 
comment. As previously stated, Sec.  1.1325(b) of the final rule 
requires that persons who cool RACs (including eggs) before they are 
initially packed must keep and provide to initial packers certain 
information on the cooling, including the date of cooling. Although 
proposed Sec.  1.1350(b)(2)(iv) would have required egg farms to inform 
the immediate subsequent recipient of the eggs of the time of cooling, 
the time of cooling is not a required KDE under Sec.  1.1325(b). 
Furthermore, under the final rule, egg producers are not required to 
link the Sec.  1.1325(b) KDEs on cooling to a particular traceability 
lot, as traceability lot codes are not assigned until the eggs reach 
the initial packer (see Sec.  1.1320). As discussed above, the cooling 
KDEs in Sec.  1.1325(b) can be organized in whatever way is practical 
for the operation, such as on a shipment-by-shipment or day-by-day 
basis. Finally, we agree that egg producers should be able to use 
records they keep in accordance with part 115 or part 118 to comply 
with applicable subpart S requirements (including those for cooling in 
Sec.  1.1325(b)), and this is permitted under Sec.  1.1455(f) of the 
final rule.

K. Records of Initial Packing (Sec.  1.1330)

    As previously discussed, the proposed rule included recordkeeping 
requirements applicable to the first receiver of a FTL food (proposed 
Sec.  1.1330), which the proposed rule defined as the first person 
(other than a farm) who purchases and takes physical possession of a 
food on the FTL that has been grown, raised, caught, or (in the case of 
a non-produce commodity) harvested. In addition to records of receipt, 
the proposed rule required first receivers to establish and maintain 
records 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;
     The business name, point of contact, and phone number of 
the harvester of the food, and the date(s) and time(s) of harvesting;
     The location identifier and location description of the 
place where the food was cooled, and the date and time of cooling (if 
applicable); and
     The location identifier and location description of the 
place where the food was packed, and the date and time of packing.
    We stated in the preamble to the proposed rule (85 FR 59984 at 
60008) that we were proposing these recordkeeping requirements for 
first receivers because we believed that a first receiver was the 
person best positioned to maintain comprehensive information about the 
origination and subsequent handling of a food, including information 
identifying the persons who originated, harvested, cooled, and packed 
the food. We stated that identifying the first receiver of a food as 
the first person who purchases and takes physical possession of the 
food would ensure 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.
    However, in response to many comments opposing the designation of 
``first receiving'' of a food as a CTE, we are deleting the proposed 
first receiver requirements from the final rule. Instead, we are 
establishing requirements for the initial packing of a RAC other than a 
food obtained from a fishing vessel (in Sec.  1.1330) and for the 
performance of the first land-based receiving of a food obtained from a 
fishing vessel (in Sec.  1.1335). In accordance with this change (as 
well as the deletion of the proposed CTE for growing of FTL foods, 
including sprouts), Sec.  1.1330(b) specifies the requirements 
applicable to the initial packing of sprouts (except soil- or 
substrate-grown sprouts harvested without their roots). In the 
following paragraphs, we discuss certain comments on the proposed 
requirements for first receivers as they apply to the requirements for 
initial packers, followed by a discussion of comments on the proposed 
requirements related to sprout operations.
1. Initial Packing of a RAC Other Than a Food Obtained From a Fishing 
Vessel
    (Comment 357) Several comments express opposition to the proposed 
requirements for first receivers, maintaining that the requirements are 
impractical, overly burdensome, unnecessary for traceback, confusing, 
complicated, and challenging to implement, and that the cost of keeping 
such records would exceed the benefit. Several of these comments 
include suggestions for improvements if the first receiver requirements 
are retained.
    Some comments maintain that, with respect to the produce industry, 
most of the proposed first receiver KDEs are held by the packinghouse 
where produce is initially packed and stored, but these facilities do 
not meet the definition of a first receiver, either because they do not 
purchase the produce or because they are considered farms. Other 
comments assert that the KDEs associated with the first receiver CTE 
are generally not shared between trading partners in the fresh produce 
supply chain today, so requiring such sharing would be a departure from 
existing industry event-based traceability practices. The comments 
instead ask that the rule require that traceability event-based 
information be kept by the performers of CTEs. Some comments also 
express concerns about data privacy and sharing sensitive farm 
information with parties that do not normally receive it, such as 
brokers,

[[Page 71013]]

processors, retail buyers, and even competitors. Some comments maintain 
that such data sharing would sometimes require changes to existing 
contractual provisions that restrict this type of data sharing.
    (Response 357) We agree that the proposed requirements for first 
receivers caused confusion among many commenters, might not have 
aligned with some business practices in the produce industry, and could 
have been challenging to implement in some cases. Therefore, we are 
deleting the proposed requirements for first receivers from the final 
rule. However, much of the information we had proposed to require first 
receivers to keep remains critical information for traceability. We 
agree with the comments stating that the traceability information we 
proposed to require first receivers to maintain is often kept by 
packers. Therefore, in the final rule we have replaced the proposed 
requirements for first receivers of FTL foods with requirements for the 
initial packing of a RAC (other than food obtained from a fishing 
vessel) (Sec.  1.1330) and the first land-based receiving of a food 
obtained from a fishing vessel (Sec.  1.1335).
    The KDEs that initial packers must keep under Sec.  1.1330(a) are 
similar to the KDEs that a first receiver would have had to keep as a 
receiver of an FTL food under proposed Sec.  1.1335 and as the first 
receiver of the food under proposed Sec.  1.1330. Section 1.1330(a)(1) 
of the final rule specifies that for each traceability lot of a RAC 
(other than a food obtained from a fishing vessel) on the FTL that is 
initially packed, the initial packer must maintain records containing 
the following information and linking this information to the 
traceability lot:
     The commodity and, if applicable, variety of the food 
received (Sec.  1.1330(a)(1));
     The date the initial packer received the food (Sec.  
1.1330(a)(2));
     The quantity and unit of measure of the food received 
(e.g., 75 bins, 200 pounds) (Sec.  1.1330(a)(3));
     The location description for the farm where the food was 
harvested (Sec.  1.1330(a)(4));
     For produce, the name of the field or other growing area 
from which the food was harvested (which must correspond to the name 
used by the grower), or other information identifying the harvest 
location at least as precisely as the field or other growing area name 
(Sec.  1.1330(a)(5));
     For aquacultured food, the name of the container (e.g., 
pond, pool, tank, cage) from which the food was harvested (which must 
correspond to the container name used by the aquaculture farmer) or 
other information identifying the harvest location at least as 
precisely as the container name (Sec.  1.1330(a)(6));
     The business name and phone number for the harvester of 
the food (Sec.  1.1330(a)(7));
     The date of harvesting (Sec.  1.1330(a)(8));
     The location description for where the food was cooled (if 
applicable) (Sec.  1.1330(a)(9));
     The date of cooling (if applicable) (Sec.  1.1330(a)(10));
     The traceability lot code the initial packer assigned 
(Sec.  1.1330(a)(11));
     The product description of the packed food (Sec.  
1.1330(a)(12));
     The quantity and unit of measure of the packed food (e.g., 
6 cases, 25 reusable plastic containers, 100 tanks, 200 pounds) (Sec.  
1.1330(a)(13));
     The location description for where the food was initially 
packed (i.e., the traceability lot code source), and (if applicable) 
the traceability lot code source reference (Sec.  1.1330(a)(14));
     The date of initial packing (Sec.  1.1330(a)(15)); and
     The reference document type and reference document number 
(Sec.  1.1330(a)(16)).
    Because the information that initial packers must keep under Sec.  
1.1330(a) is often shared with packers today, we do not believe that 
data privacy will be as much of a concern for producers as it was with 
the proposed requirement for farms to share information about the 
origination, harvesting, cooling, and packing of a food with a first 
receiver under proposed Sec.  1.1350(b)(2). However, we recognize that 
some changes to current practices, including to contracts, may be 
necessary for certain covered entities. With regard to comments asking 
that information be kept only by those entities that performed an 
activity and not shared with others in the supply chain, we reiterate 
that the goal of this rulemaking is to increase the efficiency of 
traceback investigations and therefore better protect public health. 
Therefore, it is critical that we are able to determine as quickly as 
possible the nodes in the supply chain where product was handled. Being 
able to access information maintained by the initial packer about what 
farm a RAC came from, who harvested it and when, and (if it was cooled) 
where and when cooling was performed will shorten the time it takes to 
perform tracebacks and, therefore, support the public health benefits 
anticipated for the rule. For this reason, as discussed in Section V.J 
of this document, Sec.  1.1325(a)(2) and (b)(2) require harvesters and 
coolers to provide initial packers with this information.
    We also note that, in the proposed rule, we used the term 
``returnable plastic containers'' as an example for unit of measure. We 
have corrected that terminology in the final rule with ``reusable 
plastic containers.''
    (Comment 358) One comment expresses concern that a requirement to 
keep first receiver KDEs would discourage direct sourcing from farms by 
RFEs and processors.
    (Response 358) As previously stated, we are deleting the proposed 
first receiver requirements, which should eliminate any concerns 
related to local sourcing posed by those requirements. We also note 
that the final rule provides a partial exemption from the subpart S 
requirements for RFEs and restaurants purchasing directly from a farm 
(Sec.  1.1305(j)) and a full exemption for small RFEs and restaurants 
(Sec.  1.1305(i)).
    (Comment 359) Some comments request information on how KDEs should 
be linked to the traceability lot code.
    (Response 359) As stated in Response 333, Sec.  1.1330(a) requires 
initial packers to maintain records that contain several KDEs 
(including the traceability lot code) and that link this information to 
a particular traceability lot of an FTL food. While the rule does not 
prescribe how this linkage must be accomplished, examples include 
placing the traceability lot code on a reference document for the 
packing of the food that contains the relevant KDEs, or keeping records 
in an electronic database that can sort data based on the traceability 
lot code and provide the KDEs related to that traceability lot. These 
are just two examples, and there are many other ways that firms might 
choose to link KDEs to individual traceability lots. As set forth in 
Sec.  1.1455(g), firms do not have to keep all of the information 
required by subpart S in a single set of records, and firms might 
maintain records for a specific traceability lot on multiple reference 
documents, provided the information can all be linked together (e.g., 
by the fact that each document contains the traceability lot code). As 
previously discussed, linking the traceability lot code with the other 
KDEs for a CTE such as initial packing will help us efficiently trace 
the movement of a product through the supply chain and appropriately 
scope any regulatory or product actions.
    (Comment 360) Some comments assert that FDA's ability to conduct 
investigations by navigating a single lot code being sent to multiple 
firms, which

[[Page 71014]]

could be a first receiver at different points in their supply chain, 
may be disrupted if or when a lot code is changed.
    (Response 360) Although we have deleted the term ``first receiver'' 
from the final rule, we agree that changes to a lot code can disrupt 
traceability. As previously stated, Sec.  1.1320(a) requires that a 
traceability lot code be assigned to an FTL food when it is initially 
packed, received by the first land-based receiver, or transformed. 
Because we conclude that changing the traceability lot code in other 
circumstances can hinder traceback efforts, Sec.  1.1320(b) generally 
prohibits establishment of a new traceability lot code when conducting 
other activities, such as shipping, with the only exceptions being for 
situations where an FTL food is received from a person to whom subpart 
S does not apply.
    (Comment 361) One comment suggests we focus on the traceability lot 
code, including a product identifier (GTIN) and internal lot code, 
rather than the product description.
    (Response 361) We agree that traceability lot codes are a 
fundamental component of the subpart S recordkeeping requirements. A 
traceability lot code may include a product identifier such as a GTIN 
and/or an internal lot code (provided the definition of ``traceability 
lot code'' in Sec.  1.1310 is met), but firms are not required to use 
GTIN or any other particular coding system or technology. On the other 
hand, we do not agree that the product description should not be part 
of the required KDEs for traceability. The final rule requires 
maintaining and providing product descriptions because they contain 
important distinguishing information about the product that can help us 
trace the correct product during a traceback.
    (Comment 362) One comment asserts that the proposed requirements 
for first receivers to maintain information on harvesting (Sec.  
1.1330(a)(2)) and packing (Sec.  1.1330(a)(4)) should be limited to 
``as applicable'' because the information may not be necessary for 
tracing purposes for first receivers of aquacultured seafood. On the 
other hand, one comment asks that packers be required to maintain 
records supporting the production of the traceability lot code, 
including the harvest location or field, harvest date, and cooling and 
packing information.
    (Response 362) We do not agree that maintenance of harvesting and 
packing information by initial packers may not be appropriate or 
relevant to tracing food, including food obtained from aquaculture 
operations. To identify the source of an FTL food, it is important to 
obtain information about where it was harvested and where it was 
initially packed. In traceback investigations, we need access to 
records documenting the movement of the food being investigated, 
particularly for locations in the supply chain where the food is 
handled in a way that could introduce contamination. Therefore, Sec.  
1.1330(a) includes requirements for initial packers to keep information 
on, among other things, the harvesting of the RAC they pack, including, 
for aquacultured food, the name of the container from which the food 
was harvested (which must correspond to the container name used by the 
aquaculture farmer) or other information identifying the harvest 
location at least as precisely as the container name (Sec.  
1.1330(a)(6)).
    (Comment 363) One comment asserts that requiring the first receiver 
of a food to maintain the location identifier and location description 
of the originator of the food is duplicative of the growing area 
coordinates tied to the lot code. Instead, the comment suggests that we 
require firms to keep the growing area coordinates and contact 
information for the originator.
    (Response 363) As stated in Response 350, we have deleted the 
proposed growing CTE, which included the requirement to document 
growing area coordinates for each traceability lot of food. Instead, a 
farm that grows or raises an FTL food (other than eggs) must maintain a 
farm map showing the location and name of each field or other growing 
area in which FTL foods are grown (or, in the case of aquaculture, the 
location and name of each container in which FTL seafood is raised), 
including geographic coordinates and any other information needed to 
identify the location of each field, growing area, or container. The 
harvester must maintain the location description for the farm from 
which the food was harvested (see Sec.  1.1325(a)). As defined in Sec.  
1.1310, the location description must include the physical location 
address or geocoordinates. (As previously discussed, we have deleted 
proposed requirements to keep location identifiers as KDEs for certain 
CTEs.) For produce, the harvester also must maintain the name of the 
field or other growing area from which the food was harvested, which 
must correspond to the name used by the grower; and for aquaculture, 
the harvester must maintain similar information relating to the 
container from which the food was harvested. Information regarding both 
the location description for the farm and the fields or containers from 
which the food was harvested is passed by the harvester to the initial 
packer, who will assign the traceability lot code to the food it packs. 
The initial packer must link that traceability lot code and the other 
KDEs (including the location description for the farm and the name of 
the field or container from which the food was harvested) to the 
relevant traceability lot.
    We do not think it is duplicative to require both a location 
description for the farm where the food was harvested and (in the case 
of produce and aquacultured seafood) the name of the field or container 
from which the food was harvested. The location description is 
important for traceability because it helps FDA contact and visit a 
farm. The field number and container number serve different 
traceability purposes because they can help narrow the scope of an 
action such as a recall. (They can also be helpful after the traceback 
for root-cause investigations.) For small farms consisting of a single 
field, the field name and farm map might not add substantially more 
detail than the location description for the farm, but in most 
situations this will not be the case. Most farms have multiple fields, 
and some farms have fields that are not at all adjacent to each other 
(in some cases they are miles apart), in which case a single location 
description for the farm would provide considerably less precise 
information about where the food was grown than a farm map combined 
with a field name. We decline to require that geographic coordinates be 
passed through the supply chain, because we received comments 
expressing privacy concerns about sharing that information. By 
requiring the harvester to pass along the field or container name, 
while allowing the geographic coordinates to remain unshared in the 
grower's traceability plan, we can achieve the necessary level of 
traceability without requiring the sharing of sensitive information.
    (Comment 364) Some comments suggest that clarity is needed 
concerning the proposed first receiver requirements to keep records 
about the harvester of the food in situations when a harvester is the 
owner of the company rather than a field employee.
    (Response 364) Under the proposed requirements, the first receiver 
would have been responsible for maintaining harvesting information on 
harvested FTL foods, including the business name, point of contact, and 
phone number of the harvester. As discussed previously, we have removed 
the proposed requirements relating to the first receiver. Under Sec.  
1.1330 of the final rule, the initial packer must keep, among other 
KDEs, the business name

[[Page 71015]]

and phone number for the harvester (Sec.  1.1330(a)(7)), which the 
harvester must provide to the initial packer in accordance with Sec.  
1.1325(a)(2). Because the final rule does not require harvesters to 
provide the initial packer with a point of contact or the name of an 
individual, this eliminates any need to distinguish between the entity 
that owns the harvesting company and a field employee.
    (Comment 365) Several comments request removal of the proposed 
requirement for first receivers to maintain dates of cooling and 
harvesting. One comment expresses support for maintaining records 
related to the date of harvesting but not the date of cooling.
    (Response 365) We decline to eliminate requirements to record the 
dates of harvesting and cooling. We believe that dates for both 
harvesting and cooling are critical for helping us determine whether 
particular products may or may not have been impacted by a 
contamination event. Because we have removed the proposed first 
receiver requirements from the final rule, requirements relating to the 
date of harvesting and cooling are now found in the harvesting and 
cooling KDEs in Sec.  1.1325, and in the initial packing KDEs in Sec.  
1.1330.
    (Comment 366) Several comments suggest that time be removed as a 
KDE from all of the CTEs where it was proposed. Some comments maintain 
that requiring firms to record the time an event occurred would create 
an unnecessary burden, would not enhance traceability, or is not 
legally permissible. One comment asserts that it is not necessary to 
know when a food was packed to perform a traceback investigation, and 
that it would make recordkeeping requirements overly burdensome to 
maintain that information. Some comments assert that documenting time 
as a KDE would be challenging due to variability as to when in the 
event the time should be identified. One comment suggested that time 
should be optional or only required if applicable. However, one comment 
claims that packers already maintain records on the date and time of 
packing, so this information could easily be shared with FDA with 
little additional burden.
    (Response 366) The proposed rule included KDEs relating to the time 
of cooling, packing, harvesting, receipt, and shipping. We agree with 
the comments asserting that the time of day when these events occurred 
is not information that is essential for effective traceability. 
Therefore, we have deleted all proposed KDEs regarding the time an 
event occurred. However, for operations that are able to keep records 
relating to time when an event occurred, we note that such records can 
be helpful during traceability, including in narrowing the scope of an 
action such as a recall. We therefore encourage the keeping of such 
records when possible, although the information is not required under 
subpart S.
    (Comment 367) One comment asserts that any firm that packs, 
packages, or ships a product should be required to maintain grower-
level records (e.g., grower/harvester, field location and/or production 
location, harvest date/time).
    (Response 367) As stated in Response 350, the final rule requires 
the initial packers of RACs on the FTL not obtained from a fishing 
vessel to maintain much of the information mentioned in the comment. 
However, once a food has been initially packed, entities other than the 
initial packer who ship the food are not required to keep such 
information. As discussed in Section V.M of this document, entities 
that ship a packed RAC (or any other FTL food) must maintain and 
provide to the immediate subsequent recipient the location description 
for the traceability lot code source or the traceability lot code 
source reference for the food, which should enable us to quickly 
identify the initial packer in the event of an outbreak. Once the 
initial packer has been identified, they can provide FDA with the type 
of grower-level information the comment discusses. We conclude that 
these requirements will allow for sufficient efficiency during 
traceback without unnecessarily burdening entities in the supply chain 
by requiring them to keep and share more information than needed.
    (Comment 368) Several comments ask that we delete requirements to 
record the location identifier and location description of where the 
food was packed. One comment asserts that it is not necessary to know 
where a food was packed in order to perform a traceback investigation, 
and maintains that keeping this information would be overly burdensome. 
Some comments suggest that location information should either be 
optional or eliminated entirely for multiple CTEs, including 
transforming, receiving (including first receiver), and creation. One 
comment asserts that location identifiers should only have to be 
maintained if they are supplied by a shipper.
    (Response 368) As previously stated, we have deleted proposed 
requirements to maintain a record of location identifiers. However, we 
do not agree that location information (in the form of location 
descriptions) is not necessary for traceability. As stated in the 
preamble to the proposed rule (85 FR 59984 at 59987), 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. 
Following the movement of a food through its supply chain, including 
events such as packing, receiving, shipping, and transforming, is an 
essential part of any traceback investigation.
    The final rule includes recordkeeping requirements for initial 
packing because packing is the point in the supply chain where RACs are 
packed into a form that can be put into distribution. Because the 
packed product often is the first form of the food that has a 
production code assigned to it, the final rule requires initial packers 
to assign a traceability lot code to the RACs they initially pack (see 
Sec.  1.1320). Given the importance of packing in defining the 
traceable product, we disagree with comments that it would be overly 
burdensome to keep and provide information on the location where a food 
was packed. Similarly, it is important to have information to identify 
the location where food was transformed, as that is another location 
where a traceability lot code must be assigned, and it is important to 
know the locations of shippers and receivers in case we need to visit 
those entities in the course of an investigation. Initially in a 
traceback, we might try to skip locations that only perform shipping 
and receiving, but we need to know those locations so that we can 
follow each physical movement of food should an investigation lead us 
to such a site. Having information on shipping and receiving locations 
is also critical in traceforward activities where we are tracking the 
movement of potentially contaminated food forward in distribution from 
the point of production.
    (Comment 369) One comment suggests that first receivers be required 
to maintain records of the quantity and unit of measure of food 
received. However, one comment suggests that it is not necessary and 
would be overly burdensome.
    (Response 369) Although we have deleted the proposed first receiver 
requirements, we believe that quantity and unit of measure are 
important KDEs for all CTEs in the final rule. These KDEs assist 
industry and the Agency in understanding and tracking how much of a 
product was harvested, cooled, packed, received, transformed, or

[[Page 71016]]

shipped as the food was handled and moved through the supply chain, as 
well as how much product would have been available for purchase in a 
given time period at RFEs and restaurants. Information on quantity and 
unit of measure is also critical when there is a need for an action, 
such as a recall, as a result of a traceback or traceforward.
    (Comment 370) One comment maintains that the send-only KDEs in 
proposed Sec.  1.1350(b)(2) effectively duplicate the KDEs kept by the 
first receiver.
    (Response 370) As previously stated, we have deleted the proposed 
requirements for first receivers. We have also deleted the requirement 
in proposed Sec.  1.1350(b)(2) that would have required all farms to 
pass certain information through the supply chain until it reached the 
first receiver. As discussed in Response 351, we conclude that it is 
more appropriate and less burdensome to have harvesters and coolers 
provide information about the activities they perform to the initial 
packers of RACs.
    More generally, we recognize that in many cases the KDEs that must 
be sent by an entity to the immediate subsequent recipient are closely 
aligned with the KDEs that the recipient is required to maintain. This 
is intentional, as it helps ensure that the entity receiving the food 
will have the information they need, that any inaccuracies in the data 
can be quickly identified, and that both entities will maintain the 
information in a similar way, which helps us link shipments to each 
other. It is this linkage in records that will allow for efficient 
tracing of product during an investigation and assist in any needed 
traceforward operations.
    (Comment 371) One comment maintains that it would be difficult for 
harvesters or initial buyers of seafood in foreign countries to 
determine if they need to comply with the first receiver requirements 
of the rule because they may not know the final destination of the 
product.
    (Response 371) As noted above, we have deleted the first receiver 
requirements, which should alleviate some of the concerns expressed in 
the comment. Nevertheless, we understand that under the final rule, 
foreign suppliers will still need to know whether their product will be 
exported to the United States. Because the rule applies to both 
domestic and imported foods on the FTL, importers and other U.S.-based 
entities will need to work with their foreign suppliers to ensure that 
they understand their responsibilities under subpart S. However, 
because many of FDA's existing food safety regulations require 
compliance from foreign suppliers, we anticipate that many foreign 
suppliers already have mechanisms in place to determine if their foods 
will be exported to the United States.
    (Comment 372) Several comments maintain that it is difficult to 
understand how the proposed first receiver requirements would apply 
under various scenarios where responsibility, ownership, and possession 
are not coincidental, such as when contract manufacturing and packing, 
consignment, brokerage, third-party logistics warehouses, co-
operatives, or consolidators are involved.
    (Response 372) As previously stated, we have deleted the proposed 
requirements for first receivers from the final rule and replaced them 
with requirements for the initial packing of a RAC (other than food 
obtained from a fishing vessel) (Sec.  1.1330) and the first land-based 
receiving of a food obtained from a fishing vessel (Sec.  1.1335). 
These requirements are not tied to ownership of the FTL food, which 
should reduce the confusion expressed in the comments. Physical 
possession of the food and performance of the activity (e.g., initial 
packing) are what determines who must comply with Sec. Sec.  1.1330 and 
1.1335, as well as with the other CTEs and KDEs in the final rule. 
Thus, for example, if a contract manufacturer performed the initial 
packing of an FTL food, it would be required to comply with the initial 
packing requirements in Sec.  1.1330. Similarly, if a third-party 
logistics warehouse received a food after it was initially packed, it 
would be subject to Sec.  1.1345 due to its taking physical possession 
of the food in receiving it. As discussed in Section V.R of this 
document, entities that are subject to the subpart S requirements are 
allowed to have another entity (such as the owner of the food) 
establish and maintain the required records on their behalf; but it is 
the entity that manufactures, process, packs, or holds the food that is 
ultimately responsible for compliance, regardless of whether or not 
they own the food.
    (Comment 373) One comment maintains that the effort to send certain 
KDEs to first receivers will be ineffectual if there is no mechanism 
for ensuring accuracy. According to the comment, because the KDEs are 
not all related to the immediate previous source of an FTL food, the 
first receiver would not be able to verify their accuracy. Some 
comments ask who will be held accountable if the data firms receive are 
not accurate. The comments maintain that in some cases the first 
receiver may not know they are the first receiver, or the shipper may 
not identify themselves as a farm, possibly leading to inadvertent non-
compliance. One comment maintains that such a situation may arise 
because shipments of the exact same product with different traceability 
lot codes could have different first receiver recordkeeping 
requirements at the same receiver, depending on the path the foods took 
to the receiver.
    (Response 373) As previously stated, we have deleted the proposed 
requirements for first receivers from the final rule, which should 
alleviate some of the concerns expressed in the comment. We believe it 
will be clear which entity in the supply chain is the initial packer or 
the first land-based receiver of an FTL food because those entities are 
performing specific activities. This is in contrast to the situation 
that would have existed under the proposed rule, in which the first 
receiver would have had to rely in part on information from their 
supplier that the supplier was a farm, which meant that they were the 
first receiver of the food.
    More generally, we agree that data accuracy is critical to 
effective tracking and tracing of food. This is a principal reason why 
the final rule requires harvesters and coolers to provide the 
applicable KDEs to the initial packer of a RAC, and why it also 
requires shippers to provide the applicable KDEs to receivers. Every 
entity that is covered by subpart S is required to accurately maintain 
and (when applicable) pass along the required information. Where there 
are concerns about data accuracy, we encourage supply chain partners to 
work together to address those concerns.
    (Comment 374) One comment states that first receivers may have 
challenges in obtaining required first receiver KDEs from ``small 
originators'' that are exempt from the rule.
    (Response 374) Although we have removed the first receiver 
requirements from the final rule, we recognize that similar concerns 
could arise for an initial packer if the harvester and/or cooler that 
would usually be required to send required information to the initial 
packer is exempt from the rule. Therefore, the initial packing 
requirements include a provision specifying the records that initial 
packers must keep when they receive a RAC from someone to whom the 
subpart S requirements do not apply. Section 1.1330(c) specifies that 
for each traceability lot of a RAC (other than a food obtained from a 
fishing vessel) on

[[Page 71017]]

the FTL that a firm initially packs that it receives from a person to 
whom subpart S does not apply, the initial packer must maintain records 
containing the following information and linking this information to 
the traceability lot:
     The commodity and, if applicable, variety of the food 
received (Sec.  1.1330(c)(1));
     The date the initial packer received the food (Sec.  
1.1330(c)(2));
     The quantity and unit of measure of the food received 
(e.g., 75 bins, 200 pounds) (Sec.  1.1330(c)(3));
     The location description for the person from whom the 
initial packer received the food (Sec.  1.1330(c)(4));
     The traceability lot code the initial packer assigns 
(Sec.  1.1330(c)(5));
     The product description of the packed food (Sec.  
1.1330(c)(6));
     The quantity and unit of measure of the packed food (e.g., 
6 cases, 25 reusable plastic containers, 100 tanks, 200 pounds) (Sec.  
1.1330(c)(7));
     The location description for where the food was initially 
packed (i.e., the traceability lot code source) and (if applicable) the 
traceability lot code source reference (Sec.  1.1330(c)(8));
     The date of initial packing (Sec.  1.1330(c)(9)); and
     The reference document type and reference document number 
(Sec.  1.1330(c)(10)).
    We think the information required under Sec.  1.1330(c) is 
information that initial packers can be reasonably expected to know in 
situations where they receive a RAC from someone who is exempt from 
subpart S. Section 1.1330(c) does not require initial packers to 
maintain records relating to information they would have needed to rely 
on the harvester or cooler to provide, such as the name of the field 
from which the food was harvested.
    (Comment 375) One comment requests clarification on how information 
will be shared downstream, specifically among firms before the first 
receiver if a lot code has not yet been assigned to the food. Some 
comments express concern about whether FDA would bring enforcement 
actions against first receivers that were not provided a traceability 
lot code.
    (Response 375) As previously discussed, the final rule deletes the 
first receiver requirements and shifts the requirement to assign a 
traceability lot code from the grower of the food to the initial 
packer. This should eliminate any concerns about what a first receiver 
(or a packer) should do if it receives a food to which a traceability 
lot code has not been assigned. Furthermore, as discussed in Section 
V.N of this document, we have created modified requirements under the 
receiving CTE for any covered entity that receives an FTL food from a 
person to whom subpart S does not apply (Sec.  1.1345(b)). In that 
circumstance, the receiver of the food must assign a traceability lot 
code if one has not already been assigned (Sec.  1.1345(b)(1)). 
However, that is the only circumstance under which someone receiving 
the food (who is not the initial packer or the first land-based 
receiver, and who is not transforming the food) may assign a 
traceability lot code to the food. In all other circumstances, a 
traceability lot code must be provided by the person who ships the 
food, and must be maintained by the person who receives the food. If a 
required KDE, such as the traceability lot code, is not provided by the 
shipper, we encourage the receiver to address this concern with the 
shipper.
    (Comment 376) One comment asserts that retailers will be challenged 
to determine if they are the first receiver when they purchase foods 
from brokers, because brokers are not covered by the rule and are not 
required to provide first receiver KDEs.
    (Response 376) Because we have deleted the proposed first receiver 
requirements, we do not believe that RFEs and restaurants that purchase 
food from brokers will be challenged in understanding their 
recordkeeping responsibilities under subpart S. In most cases, the only 
KDEs that an RFE or restaurant will be required to maintain are the 
receiving KDEs under Sec.  1.1345. RFEs and restaurants that purchase 
foods from brokers will need to work with their suppliers and/or 
brokers to ensure they receive the information provided by the shipper 
of the food in accordance with Sec.  1.1340(b) (see Section V.N of this 
document).
    (Comment 377) One comment suggests that, if FDA retains the first 
receiver requirements in the final rule, the Agency should make clear 
that covered entities may rely on other parties to establish and 
maintain records on their behalf.
    (Response 377) As previously stated, we have deleted the proposed 
first receiver requirements. We discussed in the preamble to the 
proposed rule that entities subject to the rule may have third parties 
maintain records on their behalf. However, to be more explicit in the 
final rule that covered entities may do this, we have added language to 
specify that a person subject to the rule may have another entity 
establish and maintain records required under subpart S on their 
behalf, but the person is responsible for ensuring that such records 
can be retrieved and provided onsite within 24 hours of request for 
official review (see Sec.  1.1455(b)).
    (Comment 378) One comment requests clarification on whether an egg 
processing plant that is owned by an egg farmer but not necessarily co-
located with the farm (e.g., it is separated by a few miles) would be 
the first receiver of the eggs.
    (Response 378) As previously discussed, we have deleted the 
proposed first receiver requirements and have added requirements for 
the initial packing of RACs other than food obtained from a fishing 
vessel. In the situation described in the comment, it seems likely that 
the egg farmer is the harvester of the eggs, and the egg processing 
plant is the initial packer. This is based on the activities performed 
and does not depend on ownership or location. The final rule provides 
flexibility as to how the harvester of the eggs provides the initial 
packer with the information on harvesting required under Sec.  
1.1325(a)(2). Additionally, as discussed in Response 206, if an egg 
processing plant commingles eggs from a farm it owns with eggs from 
other farms under different company management, and it does so after 
harvesting but before processing, the commingled eggs are partially 
exempt from the final rule (see Sec.  1.1305(h)).
2. Additional Records for Initial Packing of Sprouts
    In the proposed rule as part of the growing CTE, we proposed to 
require that sprout growers establish and maintain records linking the 
traceability lot code for each lot of sprouts to certain information 
about the seeds they use for sprouting (proposed Sec.  1.1325(b)). 
Specifically, we proposed to require sprout growers to establish and 
maintain records containing 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;

[[Page 71018]]

    (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.
    As discussed in the following paragraphs, in response to comments 
we have made changes to the requirements for sprout growers and we have 
moved these requirements to the CTE for initial packers, so that the 
requirements apply to initial packers of sprouts. In addition, on our 
own initiative, we have clarified that these requirements for the 
initial packers of sprouts do not apply to soil- or substrate-grown 
sprouts harvested without their roots, consistent with the types of 
sprouts that are subject to subpart M (``Sprouts'') of the produce 
safety regulation. In the preamble to the final rule adopting the 
produce safety regulation (80 FR 74353 at 74497), we stated that soil- 
or substrate-grown sprout shoots that are harvested above the soil or 
substrate line, such that their roots are not harvested for human 
consumption, do not present the same risks as other types of sprouts. 
Therefore, soil- or substrate-grown sprouts that are harvested without 
their roots are not covered by the sprout-specific provisions in 
subpart M, but are covered by the remainder of the produce safety 
regulation. Similarly, we conclude that soil- or substrate-grown 
sprouts that are harvested without their roots should not be covered by 
the sprout-specific provisions in Sec.  1.1330(b), but they are covered 
by the remainder of the requirements in subpart S.
    (Comment 379) One comment requests clarification on who is 
responsible for maintaining the proposed records of sprout growing. 
Some comments maintain that entities other than the sprout grower would 
be better positioned to establish and maintain the required KDEs. For 
example, several comments suggest that either the growers of seed for 
sprouting, the suppliers of seed for sprouting, or both should be 
required to maintain the records. A few comments assert that sprout 
growers should only be required to maintain records that trace back to 
the seed supplier, contending that the proposed requirements would 
place too great a burden on sprout growers by requiring them to have 
information to which they might not have access (e.g., information on 
seed growers). One comment suggests that the records should be 
maintained by the seed grower and seed supplier, as appropriate, and 
only be provided to the sprout grower during an investigation of an 
outbreak of foodborne illness, citing concerns related to sharing 
proprietary business information through the supply chain.
    (Response 379) As discussed above, we have revised the final rule 
so that the sprout-specific KDEs are kept by the initial packer of the 
sprouts, not the grower. (We recognize that in many cases the grower is 
also the initial packer.) We do not agree that entities such as the 
seed supplier or seed grower should be required to maintain these KDEs. 
Because sprouts are the commodity that is on the FTL, we do not think 
it is appropriate to require entities in the supply chain before the 
sprouts have been grown (e.g., seed suppliers) to maintain information 
under subpart S. However, under Sec.  1.1455(b), an initial packer of 
sprouts may arrange for a seed supplier or another entity to maintain 
information required by the rule on their behalf, as long as the 
initial packer can provide the required information to FDA within 24 
hours of a request.
    (Comment 380) Several comments express support for some or all of 
the proposed KDEs related to sprouts and seed for sprouting. However, 
one comment asserts that the proposed requirements fail to reflect the 
complexity of the international supply chain for seeds for sprouting, 
especially mung beans. The comment describes challenges associated with 
tracing mung beans grown overseas, specifically with obtaining 
information such as the location identifier and location description of 
the grower of seed for sprouting, the seed lot code assigned by the 
seed grower, and the date of seed harvesting. The comment maintains 
that tracing to the seed level would prevent importation of 
internationally sourced mung beans and suggests revising the provisions 
to require traceback of seed lots to the farm level only when such 
information is reasonably available and obtainable.
    (Response 380) We agree that some of the proposed recordkeeping 
requirements related to seed growers may be challenging for sprout 
growers to obtain and we have made changes to the requirements in the 
final rule. As previously discussed, we have deleted the proposed 
requirements for the growing and first receiver CTEs and have added 
requirements for initial packing of RACs other than food obtained from 
a fishing vessel that include specific requirements for sprout growers. 
Regarding the proposed sprout-specific requirements, we agree with the 
comments that it would be challenging for sprout growers (and initial 
packers of sprouts) to consistently obtain information related to the 
growing and harvesting of seed used for sprouting, particularly in 
situations where the seed was sourced from multiple small entities. 
Therefore, in Sec.  1.1330(b)(1) we have deleted the requirement to 
keep the seed lot code assigned by the seed grower (proposed Sec.  
1.1325(b)(1)) and are requiring information related to the location 
description for the seed grower and the date of harvesting of the seed 
(proposed Sec.  1.1325(b)(1)) only if either is available to the 
initial packer of sprouts. We deleted the requirement to maintain 
information on the seed lot code assigned by the seed grower because it 
might be especially burdensome, as there might be a considerable number 
of small farms growing seed for sprouting, which could result in having 
to record a large number of seed lot codes for a single shipment of 
seeds. However, we encourage initial packers of sprouts to maintain the 
seed lot code assigned by the seed grower, if it is available to them. 
We have changed the language relating to seed lot codes in final Sec.  
1.1330(b)(2) through (4) to better reflect the variation in industry 
practices regarding the assignment of seed lot codes. Thus, while 
proposed Sec.  1.1325(b)(2) required a record of the seed lot code 
assigned by the seed conditioner or processor, final Sec.  1.1330(b)(2) 
omits the language ``assigned by the seed conditioner or processor,'' 
in recognition of the fact that the lot code associated with the 
conditioning or processing of the seeds might not have been assigned by 
the conditioner/processor. Final Sec.  1.1330(b)(3) and (4) both 
contain language about ``any'' seed lot code that may have been 
assigned by the packinghouse (Sec.  1.1330(b)(3)), the supplier, or the 
sprouter (Sec.  1.1330(b)(4)). This revised language recognizes that 
new seed lot codes might not always be assigned by these entities; 
however, any new seed lot codes that are assigned must be maintained.
    As previously stated, we are deleting all proposed requirements 
regarding location identifier, including in proposed Sec.  1.1325(b)(1) 
through (4). We have also removed the requirement to keep information 
on volume for the description of the seeds in final

[[Page 71019]]

Sec.  1.1330(b)(5) in response to comments asking that we simplify and 
streamline the KDEs, and because we determined that this information 
was not necessary. We removed the proposed requirement to keep, for 
each lot code of seeds 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)) because the 
information necessary for traceability is captured in the KDEs required 
for the initial packer in the final rule. Finally, we added the 
requirement to keep reference document type and reference document 
number (final Sec.  1.1330(b)(7)) for the sprout-related records for 
consistency with the KDEs required for other CTEs in the final rule.
    As a result of these changes, Sec.  1.1330(b) of the final rule 
specifies that for each traceability lot of sprouts (except soil- or 
substrate-grown sprouts harvested without their roots) that is 
initially packed, in addition to maintaining the initial packing KDEs 
set forth in Sec.  1.1330(a), the initial packer must also maintain 
records containing the following information and linking it to the 
traceability lot of sprouts:
     The location description for the grower of seeds for 
sprouting and the date of seed harvesting, if either is available 
(Sec.  1.1330(b)(1));
     The location description for the seed conditioner or 
processor, the associated seed lot code, and the date of conditioning 
or processing (Sec.  1.1330(b)(2));
     The location description for the seed packinghouse 
(including any repackers), the date of packing (and of repacking, if 
applicable), and any associated seed lot code assigned by the seed 
packinghouse (Sec.  1.1330(b)(3));
     The location description for the seed supplier, any 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 
(Sec.  1.1330(b)(4));
     A description of the seeds, including the seed type or 
taxonomic name, growing specifications, type of packaging, and (if 
applicable) antimicrobial treatment (Sec.  1.1330(b)(5));
     The date of receipt of the seeds by the sprouter (Sec.  
1.1330(b)(6)); and
     The reference document type and reference document number 
(Sec.  1.1330(b)(7)).
    Other than the deletion of the location identifier KDEs and the 
changes regarding seed lot codes, the final requirements related to the 
maintenance of information concerning seed conditioning, seed 
packinghouses, and seed suppliers are the same as the proposed 
requirements. We did not receive comments indicating that this 
information would be difficult to obtain for sprout growers and we 
continue to believe this information is needed to facilitate the 
tracing of seed used for sprouting. The specific food safety concerns 
relating to sprouts (including concerns about the seeds used for 
sprouting) are discussed in the preamble to the proposed rule (see 85 
FR 59984 at 60007).
    (Comment 381) Several comments maintain that there is overlap 
between the subpart S requirements and organic certification, and one 
comment asserts that current industry best practices cover the proposed 
requirements for sprouts.
    (Response 381) As discussed in Response 119, any records that an 
organic farm may keep under the National Organic Program (or other 
certification program) that contain information required by subpart S, 
such as the field where product was harvested or the date of harvest, 
can be used to comply with this subpart. Therefore, to the extent that 
initial packers of sprouts maintain records for organic certification 
(or for any other purpose) that contain information required in Sec.  
1.1330 or other applicable subpart S requirements, they may use such 
records to meet the requirements of this rule (see Sec.  1.1455(f)).
    (Comment 382) Several comments ask whether the requirement in 
proposed Sec.  1.1325(b)(1) refers to the date of seed (for sprouting) 
harvest or the date of sprout harvest.
    (Response 382) Proposed Sec.  1.1325(b)(1) referred to the ``date 
of seed harvesting,'' by which we meant the date of harvesting of the 
seeds used for sprouting. Section 1.1330(b)(1) of the final rule 
requires initial packers of sprouts to maintain records including, 
among other information, the ``date of seed harvesting,'' if it is 
available. This refers to the harvest date for the seeds used for 
sprouting, not of the sprouts themselves. Initial packers of sprouts 
also must maintain records identifying the harvest date of the sprouts 
(Sec.  1.1330(a)(8)).
    (Comment 383) Several comments suggest adding a requirement for 
sprout growers to maintain records of seed testing results (e.g., tests 
for pathogens, germination, and/or purity).
    (Response 383) We decline to make this change because we conclude 
that a requirement for sprout operations to maintain records of seed 
testing would be beyond the scope of this rulemaking. Such records 
would not improve the efficiency of traceback for sprouts in the event 
of an outbreak of foodborne illness, which is the purpose of this 
rulemaking. However, we note that there are sprout testing requirements 
in subpart M of the produce safety regulation, including a requirement 
to establish and keep records documenting the results of all analytical 
tests conducted for purposes of compliance with subpart M (see 21 CFR 
112.150(b)(4)).
    (Comment 384) One comment disagrees with the statement in the 
preamble to the proposed rule that seeds that are primarily intended 
for livestock or field cultivation are sometimes diverted for sprouting 
for human consumption (see 85 FR 59984 at 60007). The comment maintains 
that their firm only sources seed for sprouting from growers that 
produce seed specifically for sprouting for human consumption.
    (Response 384) We acknowledge that some sprout growers may use 
seeds from growers that produce seed specifically for sprouting for 
human consumption, and we support and encourage those efforts. However, 
we are aware that the intended use of seed when it is grown (e.g., 
animal consumption or field cultivation) is not always commensurate 
with how it is ultimately used (Ref. 28).

L. Records of First Land-Based Receiving of Food Obtained From a 
Fishing Vessel (Sec.  1.1335)

    We proposed to require first receivers of seafood products on the 
FTL that were obtained from a fishing vessel to keep, in addition to 
records of receipt of food required under proposed Sec.  1.1335, 
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 (proposed 
Sec.  1.1330(b)). Included among the proposed KDEs for receivers of FTL 
foods was the location identifier and location description for the 
immediate previous source (other than a transporter) of the food 
(proposed Sec.  1.1335(a)), which for food obtained from a fishing 
vessel meant the vessel identification number or license number (both 
if available) for the fishing vessel (under the proposed definition of 
``location identifier'') and 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 (under the 
proposed definition of ``location description'') (see proposed Sec.  
1.1310).

[[Page 71020]]

    However, as previously discussed, we are deleting the proposed 
first receiver recordkeeping requirements and replacing them with 
requirements related to the initial packing of RACs other than food 
obtained from a fishing vessel (Sec.  1.1330) and the first land-based 
receiving of food obtained from a fishing vessel (Sec.  1.1335). As 
previously stated, the final rule defines ``first land-based receiver'' 
as the person taking possession of a food for the first time on land 
directly from a fishing vessel (see Sec.  1.1310). We are also removing 
the concept of a ``location identifier'' from the final rule (including 
the parts of that term that were specific to fishing vessels), and we 
are revising the definition of ``location description'' so that it no 
longer includes information specific to fishing vessels.
    Section 1.1335 of the final rule specifies that for each 
traceability lot of a food obtained from a fishing vessel for which a 
person is the first land-based receiver, such person must maintain 
records containing the following information and linking this 
information to the traceability lot:
     The traceability lot code they assigned (Sec.  1.1335(a));
     The species and/or acceptable market name for unpackaged 
food, or the product description for packaged food (Sec.  1.1335(b));
     The quantity and unit of measure of the food (e.g., 300 
kg) (Sec.  1.1335(c));
     The harvest date range and location (as identified under 
the National Marine Fisheries Service Ocean Geographic Code, the United 
Nations Food and Agriculture Organization Major Fishing Area list, or 
any other widely recognized geographical location standard) for the 
trip during which the food was caught (Sec.  1.1335(d));
     The location description for the first land-based receiver 
(i.e., the traceability lot code source), and (if applicable) the 
traceability lot code source reference (Sec.  1.1335(e));
     The date the food was landed (Sec.  1.1335(f)); and
     The reference document type and reference document number 
(Sec.  1.1335(g)).
    These records required for first land-based receivers of food 
obtained from a fishing vessel are similar to the records that first 
receivers of food obtained from a fishing vessel would have been 
required to keep under proposed Sec. Sec.  1.1330(b) and 1.1335, 
although as discussed below we have removed information that would have 
identified specific fishing vessels. In the following paragraphs, we 
discuss in more detail the requirements applicable to the first land-
based receivers of foods obtained from a fishing vessel in response to 
comments we received on the proposed requirements for first receivers 
of food obtained from a fishing vessel.
    (Comment 385) One comment maintains that because the first receiver 
in the shrimp industry will likely be the unloading dock or a fish 
house, it will be difficult for these entities to meet the requirements 
to create and maintain the required first receiver records.
    (Response 385) As previously stated, we have deleted the proposed 
first receiver requirements. If the shrimp was obtained from a fishing 
vessel, and an unloading dock or fish house is the first entity that 
takes possession of the shrimp on land, they would be required to 
comply with the requirements for first land-based receivers of food 
obtained from a fishing vessel in Sec.  1.1335. We think these entities 
will be well-positioned to comply with these requirements. Information 
regarding harvest location and harvest date ranges (Sec.  1.1335(d)) 
will be more readily available to the first land-based receiver because 
they are receiving fish directly from the vessels, and the unloading 
dock or fish house should readily know the other information required 
under Sec.  1.1335, which includes the traceability lot code they must 
assign (in accordance with Sec.  1.1320(a)) as the first land-based 
receiver of the food (Sec.  1.1335(a)), and the species and/or 
acceptable market name for unpackaged food or the product description 
for packaged food (Sec.  1.1335(b)). Species name is information often 
used to describe seafood, as is the acceptable market name, examples of 
which can be found in FDA's ``Guidance for Industry: The Seafood List'' 
(Ref. 29). The first land-based receiver also must keep a record of the 
quantity and unit of measure of the food received (Sec.  1.1335(c)) and 
the date the food was landed (Sec.  1.1335(f)), which is the date when 
the food is transferred for the first time from a fishing vessel to 
land. In addition, the first land-based receiver must keep a record of 
its own location description (Sec.  1.1335(e)), which is also the 
traceability lot code source (because the first land-based receiver 
assigns the traceability lot code to the food), and, if applicable, the 
traceability lot code source reference (if the first land-based 
receiver elects to provide a traceability lot code source reference to 
its customers when it ships the food) (see Sec.  1.1340(b) and Section 
V.F of this document). Lastly, the first land-based receiver must keep 
a record of the reference document type and number for the reference 
document (or documents) associated with their receipt of the food.
    (Comment 386) Several comments agree that the first receiver of 
seafood products should be the buyer or the first person (other than a 
fishing vessel or aquaculture farm) who purchases and takes physical 
possession of a food on the FTL. However, one comment asks that we 
allow fishing vessels that process fish and that are registered food 
facilities to fulfill the first receiver recordkeeping requirements 
because they are best suited to meet these requirements based on their 
role in the supply chain. This comment suggests that some companies may 
be integrated such that the food remains in their control from harvest 
through processing (first and secondary), and the end point of service 
may be the first transfer of ownership of the food.
    (Response 386) As discussed above, fishing vessels are exempt from 
most of the requirements of subpart S (see Sec.  1.1305(m)), and a 
fishing vessel, including one that processes on the vessel, would not 
meet the definition of a first land-based receiver. However, a fishing 
vessel could establish and maintain the required records on behalf of 
the first land-based receiver, in accordance with Sec.  1.1455(b). More 
generally, a fishing vessel could assign a lot code to the lot it 
processes and provide the lot code and other relevant information 
(e.g., harvest date range and location) to the first land-based 
receiver to assist that entity in meeting the requirements of Sec.  
1.1335. The first land-based receiver would then have the option of 
retaining the lot code assigned on the vessel as the traceability lot 
code for the food or assigning its own traceability lot code. Under 
either option, the first land-based receiver would be the traceability 
lot code source for the food.
    Regarding an integrated company such as is described in the 
comment, Sec.  1.1305(m)(1) specifies that (except as stated in Sec.  
1.1305(m)(2)) subpart S does not apply to entities that manufacture, 
process, pack, or hold food obtained from a fishing vessel until such 
time as the food is sold by the owner, operator, or agent in charge of 
the fishing vessel. Thus, in a situation where the owner, operator, or 
agent in charge of the fishing vessel retains ownership of the food 
obtained from the fishing vessel after the food is received on land, 
the partial exemption in Sec.  1.1305(m) would continue to apply even 
though the food is now on land. As discussed in Response 225, this may 
lead to situations where the first land-based receiver is partially 
exempt under Sec.  1.1305(m), and where a traceability lot code is 
therefore not required until the food is sold to a non-exempt receiver,

[[Page 71021]]

who would be required to assign a traceability lot code under Sec.  
1.1345(b)(1) (unless they are an RFE or restaurant). Similar to the 
discussion above, an integrated company of this sort could assign lot 
codes to the food it handles and could provide those lot codes and 
other relevant traceability information to the first non-exempt 
receiver to assist that entity in meeting the requirements of Sec.  
1.1345(b). More generally, we recognize that many integrated companies 
of this sort are adopting practices to improve traceability, and we 
encourage such efforts even in situations where a company's activities 
are partially exempt under Sec.  1.1305(m).
    (Comment 387) One comment asserts that for molluscan shellfish, the 
permitted dealer who makes the first purchase of the shellfish should 
be considered the first receiver under the rule. The comment maintains 
that if the permitted dealer is a harvester or aquaculture farmer, they 
would become the first receiver once the product is landed and taken to 
a land-based facility for processing and sale.
    (Response 387) If the permitted dealer described in the comment 
meets the definition of the first land-based receiver of the shellfish 
(i.e., it is the person taking possession of the food for the first 
time on land directly from the fishing vessel), that permitted dealer 
would be responsible for maintaining the relevant KDEs for the 
shellfish in accordance with Sec.  1.1335. However, we note that raw 
bivalve molluscan shellfish that meets the criteria in Sec.  1.1305(f) 
is exempt from the rule.
    (Comment 388) One comment states that transshipment of fish between 
vessels of different ownership is a common business practice in the 
seafood industry that increases the efficiency of fishing fleets, but 
may also be used to conceal illegal, unreported, and unregulated (IUU) 
catch. The comment asserts that, to combat IUU catch, many seafood 
industry leaders and retailers have published at-sea transshipment 
policies that require data collection on the occurrence of 
transshipment. The comment recommends that the first receiver KDEs 
include vessel identification numbers of both harvesting and 
transshipment vessels and dates of harvest and transshipment. The 
comment also suggests that mass balance recalculations be required at 
each CTE for the fish (i.e., accounting for the amount of fish before 
and after the event, including transformation of fish into another form 
(e.g., processing) and movement of fish out of a person's control 
(e.g., transfer to another boat)).
    (Response 388) As previously discussed, for food obtained from a 
fishing vessel, we have replaced the proposed first receiver 
requirements with the first land-based receiver requirements in Sec.  
1.1335. The KDEs for first land-based receivers include information on 
the harvest location and harvest date range for the food obtained from 
a fishing vessel (Sec.  1.1335(d)). However, we have deleted the 
proposed requirements to maintain information identifying the fishing 
vessel, whether a landing or transshipment vessel. Specifically, we 
have deleted the proposed requirements for first receivers of food 
obtained from fishing vessels to maintain the ordinary records of 
receipt of foods (see proposed Sec.  1.1330(b)), including the location 
identifier and location description for the immediate previous source 
(other than a transporter) of the food (proposed Sec.  1.1335(a)), 
which, under the definitions set forth in proposed Sec.  1.1310, would 
have included the name of the fishing vessel that caught the seafood, 
the vessel identification number or license number (both if available) 
for the fishing vessel, the country in which the fishing vessel's 
license (if any) was issued, and a point of contact for the fishing 
vessel. We conclude that it is not necessary to require first land-
based receivers to maintain information identifying the fishing vessel 
because that is generally not information we need to identify 
contaminated food during a traceback, and it is unlikely we would go to 
a fishing vessel during an investigation of foodborne illness. 
Moreover, we decline to adopt fishing vessel identification 
requirements to facilitate identification of IUU fishing because that 
concern is beyond the scope of subpart S, which is intended to assist 
with traceback and traceforward operations in response to foodborne 
illness outbreaks. However, we support efforts to combat IUU fishing 
practices, including efforts to maintain records beyond those required 
under subpart S that might provide additional information on the 
movement of seafood and seafood products.
    Regarding the request that we require mass balance calculations for 
fish at each CTE, the final rule requires the first land-based receiver 
to maintain a record of the quantity and unit of measure of food 
obtained from a fishing vessel (Sec.  1.1335(c)). Quantity and unit of 
measure are also required as part of the shipping, receiving, and 
transformation KDEs. However, we cannot require fishing vessels to keep 
information on the amount of fish that is transferred among vessels at 
sea, as fishing vessels are largely exempt from the subpart S 
requirements under Sec.  1.1305(m).
    (Comment 389) One comment recommends that a transshipment vessel 
capture first receiver KDEs, rather than designating the first receiver 
as the first person other than a fishing vessel or farm to take 
possession of the food. The comment maintains that some seafood 
products have long journeys before being landed with a first receiver, 
during which the seafood must be kept at a proper temperature to 
maintain freshness and prevent foodborne illness. Therefore, the 
comment suggests that first receivers be required to keep a record of 
the first frozen date and location and the packing date and location.
    (Response 389) Because section 204(d)(6)(C) of FSMA (codified in 
Sec.  1.1305(m) of the final rule) partially exempts owners, operators, 
and agents in charge of a fishing vessel from the subpart S 
recordkeeping requirements, we cannot require that operators of fishing 
vessels maintain the suggested KDEs. However, the rule requires the 
first land-based receivers of food obtained from a fishing vessel to 
maintain certain KDEs, including information on the harvest date range 
and harvest location of the food, the description of the food, and the 
quantity and unit of measure of the food, which could include 
information on whether the product was frozen and how it was packed. 
First land-based receivers are not required to record the dates of any 
freezing or packing of the food on the fishing vessel. However, 
information on any processing that occurs on vessels may need to be 
kept for compliance with other FDA regulations, such as the seafood 
HACCP regulation in part 123.
    (Comment 390) Some comments express concern that harvesters and 
initial buyers might be unlikely to know the final destination or 
market form of the fish they capture or purchase. The comments request 
additional information on how the rule would apply in this situation.
    (Response 390) As previously stated, the final rule requires that 
first land-based receivers of food obtained from a fishing vessel 
maintain certain KDEs about the food as it was caught (e.g., harvest 
date range and harvest location) and information on the food as it was 
handled by them (e.g., the quantity and unit of measure of the food, 
the date of landing). It is not necessary for entities such as 
harvesters and initial buyers to know the final destination or market 
form of the food to maintain the KDEs for which they are responsible. 
However, if such firms know that the

[[Page 71022]]

food they harvest or buy will eventually be subjected to a kill step or 
changed such that it is no longer on the FTL, they may be eligible for 
an exemption under Sec.  1.1305(d)(6) of the final rule if they enter 
into a written agreement specifying that a kill step will be applied or 
the food will be changed such that it is no longer on the FTL. 
Similarly, if the seafood is a RAC and they know that it will be 
commingled after it is harvested but before it is processed, they may 
be eligible for an exemption under Sec.  1.1305(h)(2), if they enter 
into a written agreement as set forth in that provision.
    (Comment 391) One comment recommends separately listing first 
receiver KDEs required for aquacultured products and seafood products 
from a fishing vessel to make the rule easier to understand. The 
comment also suggests specifying that the KDEs for harvesting and 
packing be considered ``as applicable'' because some may not apply to 
aquaculture.
    (Response 391) We agree that the requirements for food from 
aquaculture farms and food obtained from fishing vessels should be 
listed separately. As previously stated, the final rule deletes the 
proposed first receiver requirements and replaces them with 
requirements applicable to the initial packing of RACs other than food 
obtained from a fishing vessel, which includes food from aquaculture 
farms (see Sec.  1.1330(a)(6)), and requirements for the first land-
based receiving of food obtained from a fishing vessel (Sec.  1.1335). 
Under Sec.  1.1330(a), the initial packer of aquacultured food must 
keep information on the harvesting and packing (among other things) of 
food from aquaculture farms. We believe that all of the information 
required under Sec.  1.1330(a) is relevant to aquaculture (see Response 
122 for a discussion of initial packing of aquacultured food).
    (Comment 392) One comment suggests that ``location identifier'' be 
an optional requirement because most organizations do not assign 
``identifiers'' to locations that are referenced by their organization 
and their customers. The comment maintains that the proposed rule's 
reference to a fishing vessel as a ``location'' is confusing because of 
the artificial distinction between an identifier and a description. 
Another comment suggests that maintaining the location identifier and 
location description for a fishing vessel should only be required if 
there are hazards associated with the harvest location. Both comments 
ask why fishing vessels are the only location descriptions that require 
a point of contact. One comment also recommends that the location 
description for fishing vessels be any of the applicable proposed 
attributes, including vessel identification number, license number, 
name of the vessel, or the country in which the vessel is licensed.
    (Response 392) We agree with the comment that requiring both a 
location identifier and location description would be confusing for 
organizations that do not assign identifiers to locations or for 
locations with multiple location identifiers. Therefore, we have 
deleted the proposed definition for ``location identifier'' along with 
all proposed requirements to keep a record of the location identifier. 
With respect to fishing vessels, we have deleted the proposed 
definition of ``location description'' as specifically applicable to 
fishing vessels (i.e., 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), and we have 
deleted all proposed requirements to record fishing vessel 
identification information. Instead, the rule requires the first land-
based receiver of food obtained from a fishing vessel to maintain 
records linking the traceability lot to the harvest date range and 
locations (as identified under the National Marine Fisheries Service 
Ocean Geographic Code, the United Nations Food and Agriculture 
Organization Major Fishing Area list, or any other widely recognized 
geographical location standard) for the trip during which the food was 
caught. The first land-based receiver must maintain this information 
regardless of whether the relevant fishing waters are associated with 
known hazards.
    (Comment 393) Several comments state that seafood catches from 
multiple fishing vessels are commingled at various points in the supply 
chain, including while at sea, immediately following landing before 
receipt by a first receiver, or both. The comments assert that it will 
be challenging to maintain traceability information on the catches 
given the commingling opportunities, and they contend that it would be 
impossible to separate the catches from each other once they are 
commingled.
    (Response 393) As discussed in Section V.E.14 of this document, 
fishing vessels are largely exempt from the requirements of this rule 
(see Sec.  1.1305(m)). The first land-based receiver of food obtained 
from a fishing vessel is required to designate a traceability lot (or 
multiple traceability lots) of food obtained from the fishing vessel 
and assign a traceability lot code or codes to each traceability lot 
(Sec. Sec.  1.1320(a) and 1.1335). Among other KDEs, the first land-
based receiver must keep harvest information (location and date range) 
for each traceability lot. However, multiple harvest dates can be kept 
as a date range representing the entire catch on a vessel, rather than 
lists of dates of each catch. Similarly, multiple harvest locations can 
be kept as a single, larger harvest location, encompassing all of the 
locations of multiple catches. Thus, the rule does not require a vessel 
that has multiple catches to keep the fish separate or maintain 
information on dates or locations that is linked to a specific subset 
of fish on the vessel (i.e., there is no need to identify a date or 
location a given fish was caught if the vessel contains fish harvested 
over multiple dates at multiple locations). Finally, we note that there 
is a partial exemption from subpart S for commingled RACs (Sec.  
1.1305(h)), which for food obtained from a fishing vessel means that 
food from different landing vessels was combined or mixed after the 
vessels landed but before processing (see the definition of 
``commingled raw agricultural commodity'' in Sec.  1.1310).
    (Comment 394) Some comments assert that the harvest location for a 
fishing vessel trip should not be restricted to the National Marine 
Fisheries Service Ocean Geographic Code or geographical coordinates (as 
specified in proposed Sec.  1.1330(b)). The comments maintain that 
there are other methods used in the industry to identify harvest 
location, including Food and Agriculture Organization Fishing Areas or 
approved harvest areas used under the NSSP (which requires an area 
identifier code maintained by each state).
    (Response 394) We agree with the comments that other standards may 
be used to identify the harvest location for a fishing vessel trip. 
Section 1.1335(d) specifies that the harvest location for food obtained 
from a fishing vessel may be identified under the National Marine 
Fisheries Service Ocean Geographic Code, the United Nations Food and 
Agriculture Organization Major Fishing Area list, or any other widely 
recognized geographical location standard. With regard to the NSSP, we 
note that raw bivalve molluscan shellfish that are covered by the 
requirements of the NSSP are exempt from subpart S, as are all raw 
bivalve molluscan shellfish that meet the criteria in Sec.  1.1305(f).
    (Comment 395) One comment states that the location identifier, 
location description, and point of contact for the traceability lot 
code generator, which shippers of shellfish would be required

[[Page 71023]]

to keep under proposed Sec.  1.1350(a)(4), are all contained in the 
State Shellfish Control Authority Dealer permit, which uses the 
standards outlined by the NSSP to certify shellfish dealers to ship or 
process shellfish for shipment. The comment recommends that for raw 
bivalve molluscan shellfish covered by the requirements of the NSSP, 
the shellfish dealer should be regarded as the first receiver of the 
shellfish and the traceability lot code generator. The comment asserts 
that because FDA's Interstate Certified Shellfish Shippers List (ICSSL) 
already has the location and point of contact information for the 
shellfish dealer, a simple reference code containing the state, dealer 
type, and dealer number is all that would be needed to access the 
traceability lot code generator information for the first receiver.
    (Response 395) We agree that the NSSP requires robust traceability 
information for raw bivalve molluscan shellfish. We also understand 
that each Authority will certify shellfish facilities and subsequently 
request that FDA list them on the ICSSL via the form FDA 3038. This 
form does contain the dealer's name and a contact name and address. As 
previously stated, the final rule exempts from subpart S raw bivalve 
molluscan shellfish that is covered by the requirements of the NSSP 
(see Sec.  1.1305(f)).

M. Records of Shipping (Sec.  1.1340)

    We proposed to require that for each food on the FTL that is 
shipped, the shipper must establish and maintain records containing and 
linking the traceability lot code of 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 previously stated information (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)). As discussed below, in 
response to comments as well as on our own initiative (to align the 
shipping KDEs with other changes we are making to the proposed rule), 
we have deleted some of the proposed shipping KDEs and have revised 
others.
    In addition to the records that shippers of FTL foods must 
maintain, we proposed to require shippers to send records (in 
electronic or other written form) containing the information the 
shipper was required to keep (except for the information on reference 
record types and numbers) to the immediate subsequent recipient (other 
than a transporter) of each traceability lot shipped (proposed Sec.  
1.1350(b)(1)). We further proposed to require that farms must also send 
the following information to the recipient: a statement that the entity 
is a farm; the location identifier and location description of the 
originator of the food (if not the farm providing this information); 
the business name, point of contact, and phone number of the harvester 
of the food (if not the farm providing this information), and the 
date(s) and time(s) of harvesting; the location identifier and location 
description of the place where the food was cooled (if not the farm 
providing this information), and the date and time of cooling; and the 
location identifier and location description of the place where the 
food was packed (if not by the farm providing this information), and 
the date and time of packing (proposed Sec.  1.1350(b)(2)). As 
discussed below, we have maintained the proposed requirement specifying 
that for most of the KDEs that a shipper must maintain, they must also 
send that information to the recipient of the food; however, we have 
deleted the proposed requirement for farms to send additional, farm-
related information to the recipient.
    Finally, we have added a provision to the shipping CTE requirements 
to specify that these requirements do not apply to any shipment of food 
that occurs before the food is initially packed (if the food is a RAC 
not obtained from a fishing vessel). This change means that the 
recordkeeping requirements for shippers do not apply to farms (or other 
entities) that perform activities such as growing, harvesting, or 
cooling before a RAC is initially packed (unless the entity is also the 
initial packer, in which case it must keep records regarding the 
shipping of the packed food). Because fishing vessels are exempt under 
Sec.  1.1305(m) from most of the subpart S requirements, including the 
shipping CTEs, we did not think it was necessary to add a parallel 
provision stating that the shipping requirements under Sec.  1.1340 do 
not apply to the shipment of food that occurs before the first land-
based receiving of food obtained from a fishing vessel.
1. Records of Shipment That Must Be Maintained
    (Comment 396) One comment asks for clarification of the ``name of 
the transporter'' and whether that refers to a broker, a transport 
company, or the driver of the vehicle.
    (Response 396) By the ``name of the transporter,'' we meant the 
name of the transport company that transported the food. However, we 
have deleted the proposed requirements for shippers and receivers to 
maintain a record of the name of the transporter.
    In addition to this deletion to the proposed requirements for 
shipping, we also made the following changes:
     We moved the reference to the traceability lot codes from 
the ``introductory'' paragraph (proposed Sec.  1.1350(a)) to the 
listing of required KDEs;
     We deleted requirements related to the entry number 
assigned to imported food (as discussed below);
     We changed ``returnable plastic containers'' to ``reusable 
plastic containers'' (as discussed in Response 357);
     We deleted requirements concerning product identifiers and 
location identifiers (as discussed in Section V.F of this document);
     We deleted the requirement to record the time of shipment 
(as discussed in Response 366);
     We replaced the term ``traceability lot code generator'' 
with ``traceability lot code source,'' and we are allowing entities to 
provide to their customers a traceability lot code source reference 
instead of the location description for the traceability lot code 
source (as discussed in Section V.F of this document); and
     We changed ``reference record type(s)'' and ``reference 
record number(s)'' to ``reference document type'' and ``reference 
document number'' (as discussed in Section V.F of this document). (We 
note that we have deleted as unnecessary the use of ``(s)'' (indicating 
pluralization of terms as applicable) from all provisions in which we 
had proposed to include it (except with respect to the definition of 
``retail food establishment,'' where we have retained it so that the 
definition is the same as in other FDA regulations). However, having or 
using more than one

[[Page 71024]]

of such items is permissible; for example, a firm might use two 
different reference documents (with different numbers) to maintain the 
KDEs required for shipment of an FTL food, or a firm might have 
multiple points of contact who are tasked with traceability 
responsibilities.)
    As a result, Sec.  1.1340(a) of the final rule specifies that for 
each traceability lot of a food on the FTL that an entity ships, the 
entity must maintain records containing the following information and 
linking this information to the traceability lot:
     The traceability lot code for the food (Sec.  
1.1340(a)(1));
     The quantity and unit of measure of the food (e.g., 6 
cases, 25 reusable plastic containers, 100 tanks, 200 pounds) (Sec.  
1.1340(a)(2));
     The product description for the food (Sec.  1.1340(a)(3));
     The location description for the immediate subsequent 
recipient (other than a transporter) of the food (Sec.  1.1340(a)(4));
     The location description for the location from which the 
food was shipped (Sec.  1.1340(a)(5));
     The date the food was shipped (Sec.  1.1340(a)(6));
     The location description for the traceability lot code 
source or the traceability lot code source reference (Sec.  
1.1340(a)(7)); and
     The reference document type and reference document number 
(Sec.  1.1340(a)(8)).
    (Comment 397) Some comments suggest that we eliminate the proposed 
requirement for persons who ship a food on the FTL to establish and 
maintain records containing and linking the traceability lot code for 
the food to the entry number assigned to the food if the food is 
imported. One comment suggests that we make the requirement to maintain 
the entry number optional. Some comments assert that the entry numbers 
for food imports are irrelevant to the question of food traceability 
and that maintaining import entry numbers for FTL foods would be 
duplicative and unnecessary.
    (Response 397) We agree that it is not necessary to require 
shippers to keep records of the entry numbers for imported foods. 
Therefore, we have deleted this proposed requirement from the shipping 
KDEs.
    (Comment 398) Some comments suggest that requiring shippers and 
receivers to keep information on the traceability lot code generator is 
inconsistent with FSMA section 204(d)(1)(L)(i)'s prohibition against 
requiring a full pedigree because this information represents the point 
of origin of the food. One comment expresses concern about the extent 
of the responsibility of an entity to maintain information about 
previous CTEs associated with an FTL food they manufacture, process, 
pack, or hold. The comment urges us to make clear that companies do not 
have to maintain records for CTEs that occurred several steps back in 
the supply chain (which the comment refers to as a ``product 
pedigree'').
    (Response 398) The final rule does not require a full pedigree or a 
record of the complete previous distribution history of the food from 
the point of origin of such food. Under Sec.  1.1340(a)(7) and (b), the 
shipper of an FTL food must keep and provide to its customer the 
location description for the traceability lot code source or the 
traceability lot code source reference, which provides a means of 
identifying and locating the person who assigned the traceability lot 
code to the food. However, maintaining a record of the traceability lot 
code source or source reference is not the same as maintaining a full 
pedigree of the food, or a record of the complete previous distribution 
history of the food from the point of origin of such food. The 
traceability lot code source is just one part of a food's distribution 
history, and for most foods there will be other elements of the 
distribution history for which the shipper and receiver of the food 
will not be required to maintain records.
    (Comment 399) One comment recommends that phone numbers for 
traceability lot code generators not be required.
    (Response 399) We decline this request. Among the required KDEs for 
shipping (and other CTEs) is the location description for the 
traceability lot code source, which includes the phone number for the 
place where the traceability lot code was assigned to the food. We 
believe that the phone number for the traceability lot code source is a 
critical piece of information during an outbreak investigation or 
recall event because it enables FDA to communicate directly with the 
entity that assigned the traceability lot code to the food. As 
previously stated, a firm may keep and provide to customers a 
traceability lot code source reference instead of the location 
description for the traceability lot code source. A traceability lot 
code source reference will enable FDA to have access to the phone 
number and other key contact information for the traceability lot code 
source.
    (Comment 400) One comment asserts that the proposed rule is 
inconsistent with section 204(d)(1)(E) of FSMA (which specifies, in 
part, that the rule may 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) because the proposed 
requirement to maintain the reference record type and number would 
require duplication of existing records, such as invoices.
    (Response 400) We do not agree. We realize that the proposed 
requirements for covered entities to maintain the reference record type 
and reference record number for certain CTEs could have been 
interpreted as requiring duplicative records, but this is not our 
intent. As discussed in Section V.F of this document, we are deleting 
the terms ``reference record'' and ``reference record number'' from the 
rule and adding definitions of ``reference document'' and ``reference 
document number.'' Because they are KDEs for certain CTEs, firms would 
have to list the applicable reference document types and corresponding 
reference document numbers in any electronic sortable spreadsheet they 
might provide to FDA in accordance with Sec.  1.1455(c)(3)(ii) (see 
Section V.R of this document) to indicate the specific reference 
documents that contain the information included in the spreadsheet. For 
the CTEs, such as shipping, where this information is required, 
maintaining the reference document type and number does not require 
creation of a duplicate record because firms may rely on the reference 
document itself, such as a BOL, invoice, or ASN, to meet the 
requirement to keep a record of the reference document type and number. 
For example, if an invoice created by a shipper contains some of the 
information required under Sec.  1.1340, such as the date the food was 
shipped, the product description for the food, the quantity and unit of 
measure of the shipped food, and the traceability lot code for the 
shipped food, that invoice (which bears the corresponding invoice 
number) can itself serve to document the reference document type and 
reference document number. The shipper could also use another reference 
document, such as a BOL or PO, as a record for the remaining required 
shipping KDEs. (By also including the traceability lot code of the 
shipped product on this document, a linkage would be established 
between this document and the invoice that contains the other required 
KDEs for the same traceability lot.) If the firm's practice, as 
described in its traceability plan, is to retain these reference 
documents (i.e., the invoice and the BOL or PO) as a means of complying 
with Sec.  1.1340(a), then the documents themselves--each

[[Page 71025]]

of which presumably bears the relevant document number--would serve to 
satisfy Sec.  1.1340(a)(8). If a firm's practice, as described in its 
traceability plan, is to comply with subpart S without retaining 
specific business documents such as invoices and BOLs--for example, if 
a firm instead maintains a master database of all of the required KDEs, 
rather than relying on the related business documents--then the 
relevant portion (e.g., page, spreadsheet) of the database itself would 
be the reference document, and any sortable spreadsheet that might be 
requested under Sec.  1.1455(c)(3)(ii) could list the database entry 
number, spreadsheet number, etc., as the relevant reference document 
type or number.
    Consequently, the requirements to keep records of reference 
document types and reference document numbers do not necessitate 
maintenance of duplicate records. Existing records, such as invoices 
and BOLs with document numbers, or databases with spreadsheet numbers, 
can be maintained to meet the requirements of Sec.  1.1340(a)(8) and 
can be listed as the applicable reference document types and numbers 
(e.g., ``invoice 7534,'' ``BOL 227534,'' ``shipping spreadsheet 127'') 
in an electronic sortable spreadsheet that may be provided to FDA in 
accordance with Sec.  1.1455(c)(3)(ii). Note that under Sec.  
1.1455(a)(1), records (including reference documents) can be kept as 
original paper or electronic records or as true copies (such as 
photocopies, pictures, scanned copies, or other accurate reproductions 
of the original records).
    (Comment 401) One comment maintains that the most important 
information to link to the lot code is the firm that originated the 
product and the date when the product was produced. The comment cites 
feasibility studies that identified these pieces of information as most 
essential for traceability. The comment further maintains that lot 
codes should be linked to a firm's underlying records so that 
additional information can be provided for root-cause analysis, if 
necessary.
    (Response 401) We agree with the importance of linking a food's 
traceability lot code to information identifying the traceability lot 
code source, which is why this information is required under several of 
the CTEs, including the shipping CTE. We also agree that date of 
production is an important KDE, as reflected in Sec.  1.1330(a)(15) 
(date of initial packing) and Sec.  1.1350(a)(2)(iii) (date 
transformation was completed). We also think that other information 
about the food and its movement through the supply chain--such as the 
quantity and unit of measure of the food, the product description of 
the food, and the location description of the immediate subsequent 
recipient--is important not only for root-cause analysis, but also for 
traceability, which is why the final rule requires shippers and others 
to maintain this information. We agree that linkage of traceability lot 
codes to a firm's reference documents is a useful way to organize and 
maintain the relevant information.
    (Comment 402) One comment maintains that for the purpose of 
traceability, the product identifier and brand owner information, along 
with the lot code, would be more efficient KDEs than the lot code 
originator. The comment asserts that the lot code originator may not be 
with the same company or may not be authorized to speak to regulators. 
One comment maintains that the point of contact should be the person 
authorized to speak to regulators.
    (Response 402) The phrase ``lot code originator'' did not appear in 
the proposed rule, but as discussed in Section V.F of this document, we 
have replaced the term ``traceability lot code generator'' with the 
term ``traceability lot code source'' because we believe that the focus 
for traceability should be on the place where the lot code was 
assigned, rather than the specific individual or entity who assigned 
the code. We recognize that the traceability lot code source might not 
be the brand owner. We think that information regarding the location 
where the traceability lot code was assigned (which is generally the 
location where the food was initially packed, first received on land, 
or transformed) is more important for traceability than the name of the 
brand owner, because the goal of traceability is to follow the physical 
movement of the food through the supply chain. During outbreak 
situations, information about the traceability lot code source will 
allow FDA to more quickly identify key locations and prioritize where 
we need to collect tracing data, which in turn will help us more 
quickly identify the origin of contaminated foods. Therefore, the rule 
requires firms to keep a record of the location description for the 
traceability lot code source (or the traceability lot code source 
reference, which is an alternative method for providing FDA with access 
to that information). The location description includes the business 
name, phone number, physical location address (or geographic 
coordinates), and city, state, and zip code for domestic locations and 
comparable information for foreign locations, including country.
    However, we agree that it is also very important during outbreak 
investigations that firms make someone available to FDA who is 
knowledgeable about the firm's traceability operations. Therefore, a 
firm's traceability plan must include a statement identifying a point 
of contact for questions regarding the plan and associated records 
(Sec.  1.1315(a)(4)). During a traceback investigation, when we contact 
the traceability lot code source (by using the location description or 
the traceability lot code source reference that shippers and others are 
required to maintain), we expect the person we reach to be able to 
access the firm's traceability plan and put us in touch with the point 
of contact listed in the plan. The rule defines ``point of contact'' to 
mean an individual having familiarity with an entity's procedures for 
traceability, including their name and/or job title, and phone number 
(Sec.  1.1310). Speaking to this point of contact will allow us to 
conduct a more efficient investigation, and we expect the point of 
contact to be a person who is authorized to speak to FDA. A firm may 
choose to designate another person to speak with us during other 
discussions regarding an outbreak investigation or recall; however, for 
questions regarding traceability, speaking with the person most 
knowledgeable to assist in understanding the firm's internal tracing 
system will result in a more efficient investigation.
2. Information the Shipper Must Provide
    (Comment 403) Some comments request clarity on the format in which 
records can be sent (such as by sending a link to the required 
information electronically), especially as it pertains to electronic 
recordkeeping. Some comments specifically ask whether sending a link to 
the information required to be sent by the shipper to the subsequent 
recipient under proposed Sec.  1.1350(b) is sufficient. The comments 
recommend focusing on the outcome (that the information reaches the RFE 
or other point at the end of the supply chain) rather than how and by 
whom information is shared within the food supply chain. As an 
alternative, the comments also suggest that information could be shared 
through a central repository where the information is uploaded.
    (Response 403) We recognize that the industry uses numerous means, 
both paper-based and electronic, to share information between supply 
chain partners. The rule does not prescribe the manner in which 
shippers may meet the

[[Page 71026]]

requirement in Sec.  1.1340(b) to send information to the immediate 
subsequent recipient. Sections 1.1325(a)(2) and (b)(2) and 1.1340(b) 
specify that persons may provide information to other entities in the 
supply chain in electronic, paper, or other written form. We have also 
added language to Sec.  1.1455(a)(1), specifying that electronic 
records may include valid, working electronic links to the information 
required to be maintained under subpart S. Therefore, a shipper may 
provide the required information to the recipient by providing an 
electronic link through which the information can be obtained. A firm 
also could use a central data repository to provide the required 
information as long as the recipient was able to access the information 
through the repository. However, for purposes of tracing the product 
through the supply chain, we think it is important that the information 
somehow be provided to the immediate subsequent recipient of the food, 
as opposed to focusing solely on ensuring that the information reaches 
the end of the supply chain.
    (Comment 404) One comment maintains that a reference record is not 
the only method for communicating the traceability lot code and 
associated KDEs, and requests flexibility on when to use reference 
records and how to maintain and provide KDEs. Some comments generally 
support adding traceability lot codes to invoices, BOLs, ASNs, or other 
bill of sale documentation, while one comment expresses concern about 
this being a requirement.
    (Response 404) We agree there are multiple ways to communicate the 
traceability lot code and associated KDEs between shippers and 
receivers, and we have provided flexibility to do so in the final rule. 
The rule does not require firms to put traceability lot codes on 
documents such as BOLs or ASNs when shipping an FTL food. Covered 
entities may prefer to use other methods for documenting and providing 
the traceability lot code for a food, and for ensuring that all of the 
relevant KDEs are linked to the specific traceability lot. However, we 
believe that in most cases, including the traceability lot code on 
reference documents for FTL foods will be a useful practice to help 
ensure adequate traceability for that food.
    (Comment 405) One comment asserts that location identifiers and 
descriptions of the places where the food was cooled and packed should 
not be sent to the immediate subsequent recipient, although the comment 
does support sending the packing date. The comment maintains that 
cooling may happen more than once at multiple locations and that 
cooling information is maintained by the cooler, not the farm, and is 
typically not provided as the product is moved.
    (Response 405) In the final rule, we have deleted the requirements 
in proposed Sec.  1.1350(b)(2) for farms to send information on the 
originating, harvesting, cooling, and packing of the food for FTL foods 
they ship. We also note that the requirements for shippers of FTL foods 
in Sec.  1.1340 of the final rule do not apply to harvesters or to 
entities that cool food before it is initially packed (see Response 414 
below). However, we do not agree that cooling and packing locations are 
not critical for traceability. Therefore, entities that harvest, cool, 
or initially pack FTL foods must maintain information on the harvest 
location, cooling location, and packing location in accordance with 
Sec. Sec.  1.1325 and 1.1330 (as applicable), and harvesters and 
coolers are required to send information on their activities to the 
initial packer of the food in accordance with Sec.  1.1325(a)(2) and 
(b)(2), respectively.
    (Comment 406) Some comments ask why shippers should provide 
information to the subsequent recipient, including the location 
identifier and description of the subsequent recipient.
    (Response 406) As discussed in the preamble to the proposed rule 
(85 FR 59984 at 60012), requiring shippers of food to send certain 
information on the foods and the entities that have handled it is 
essential for ensuring traceability of the foods throughout the supply 
chain, particularly because under current business practices, firms do 
not always provide this information to their customers in a way that 
can easily be linked for traceability purposes. Therefore, Sec.  
1.1340(b) of the final rule requires covered entities who ship FTL 
foods to provide certain information in electronic, paper, or other 
written form to the immediate subsequent recipient of the food.
    We recognize that it may seem unnecessary for shippers to provide 
receivers with information that the receiver is already aware of, such 
as the receiver's own location description (as discussed in Response 
267, we have removed the requirements relating to location identifier). 
However, we have concluded that requiring shippers to send this 
information will promote more efficient traceback because it will 
ensure that the information is kept in the same way by both the shipper 
and the receiver, which will make it easier to link the information 
during a traceback. Furthermore, this approach reduces the burden on 
receivers because the required information will have already been 
provided to them in a format that aligns with the receiver's own 
subpart S requirements under Sec.  1.1345. Because shippers will be 
required to maintain this information under Sec.  1.1340(a)--and 
because many shippers already communicate much of this information in 
the course of their regular business practices, though not necessarily 
in a format that aligns with subpart S or that can easily be linked 
with the receiver's own records--we think that shippers will be well-
positioned to provide this information to the receiver.
    (Comment 407) One comment maintains that a responsible entity 
should only have to pass forward certain data, such as a lot code or 
GTIN, while other data (such as the case-level GTIN of the originator) 
could just be maintained.
    (Response 407) We disagree with the comment, which appears to 
suggest that the only information shippers should be required to 
provide to their customers is a lot code or GTIN for the food. As 
discussed above, we believe that providing all of the information 
required under Sec.  1.1340(b) is necessary to ensure adequate 
traceability.
    (Comment 408) One comment requests additional clarification 
regarding how traceability lot codes travel with a food through the 
supply chain. The comment asserts that proposed Sec.  1.1350(b) directs 
shippers to send electronic or written records to the immediate 
subsequent recipient but does not state when this information must be 
provided, relative to the physical shipment of the product (e.g., 
concurrently with each transaction, or batched with other transactions 
and sent daily or weekly).
    (Response 408) The final rule does not prescribe the manner in 
which a shipper must provide traceability lot codes and other KDEs to 
immediate subsequent recipients. A shipper could provide this 
information in one or more records, which could include product 
labeling or packaging as well as commonly used reference documents such 
as BOLs and ASNs. The information could also be sent in other ways, 
such as in a separate email or by embedding the information in a quick 
response (QR) code that appears on the packaging of the food or on a 
related document. The information would not have to physically 
accompany the food sent to the recipient but must be provided in a way 
that permits the receiver of the food to keep the records it is 
required to maintain under subpart S.

[[Page 71027]]

    (Comment 409) One comment recommends that we require packers or 
processors to print their business name and product lot code 
information on packaging. The comments suggest that for private label 
products, in addition to the packer or processor, the brand owner 
should be added to the packaging. The comment maintains that this 
approach would establish a linkage between the physical product and 
supporting records.
    (Response 409) We decline to require this approach. The final rule 
does not specify the manner in which required KDEs must be provided to 
the subsequent recipient of the food. In light of the wide range of 
different business practices, and the comments we received expressing 
different preferences for how to transmit the required information, we 
conclude that a flexible approach is warranted.
    (Comment 410) One comment maintains that less than half of the 
fresh produce cases they purchase include the packer's lot code in the 
form of a PTI label. The comment requests that the final rule require 
firms to place the traceability lot code on commercial documents such 
as BOLs for companies selling fresh produce.
    (Response 410) As previously stated, although the final rule does 
not require firms that ship FTL foods, including packers, to put the 
traceability lot code for the food on a reference document such as a 
BOL, shippers must by some means link the traceability lot code to the 
other information that must be provided to the recipient, and we 
anticipate that most shippers will do so by placing the traceability 
lot code on a reference document for the shipment. Firms that follow 
labeling standards outlined by traceability programs, such as the PTI, 
may use those standards in meeting their subpart S requirements as long 
as they include the information required under the rule.
    (Comment 411) One comment maintains that requiring the shipper to 
send the location identifier, location description, and point of 
contact for the traceability lot code generator will allow FDA to move 
quickly up the food chain during traceback investigations, thereby 
preventing illnesses, reducing death, and minimizing business impact.
    (Response 411) As discussed in Section V.F of this document, we 
have replaced the term ``traceability lot code generator'' with 
``traceability lot code source,'' and the final rule permits entities 
to provide to their customers a traceability lot code source reference 
instead of the location description for the traceability lot code 
source. We agree that providing recipients with information on the 
traceability lot code source will greatly assist firms and the Agency 
in conducting effective tracking and tracing of FTL foods.
    (Comment 412) Many comments maintain that a company's supply base 
represents significant investment and competitive advantage for some 
food businesses. Some comments express concern that this competitive 
advantage might be compromised by the proposed requirements to pass 
forward original, unchanged traceability lot codes and contact and 
location information for the traceability lot code generator (the 
supplier). The comments maintain that the requirements in the proposed 
rule would result in the disclosure of confidential information to 
supply chain partners, expose processing and/or manufacturing logistics 
information, reveal recipes to customers and third parties, and expose 
confidential supplier/buyer relationships as well as the identities of 
contract manufacturers for large branded and private labeled products. 
Many comments assert that having to pass confidential commercial 
information forward would adversely affect many supply chains and 
result in loss of business for some entities by revealing proprietary 
relationships. As examples, the comments state that first receivers 
would need to collect harvesting, cooling, and packing data from farm 
entities, and receivers would be required to keep location data of the 
shipping entity and a point of contact for the originator of the food. 
The comments express concern about what might happen when a first 
receiver or other receiving entity experiences a data breach and 
information is compromised, or a theft of information results in a 
major financial loss to the firm that supplied the information because 
the information is used to sabotage the business of an upstream entity.
    Some comments maintain that requiring businesses to share sensitive 
information violates section 204(d)(3) of FSMA, which directs FDA to 
take appropriate measures to ensure that there are effective procedures 
to prevent the unauthorized disclosure of any trade secret or 
confidential information obtained by FDA under the rule. One comment 
recommends that we consult with European Union (EU) stakeholders to 
ensure that data capture regulated by this rule does not conflict with 
the EU's General Data Protection Regulation (GDPR). Some comments 
suggest that the requirement to pass KDEs related to the traceability 
lot code generator be deleted, while other comments suggest that we 
permit the use of alternatives methods, such as encoding data into the 
traceability lot code or use of the GTIN to identify the brand owner. 
One comment suggests that requiring only the firm identity and the 
identity of the records to be linked to the lot code, rather than the 
critical information from the record itself or the names and contact 
information for knowledgeable individuals, would provide a less 
satisfying target for cybercrime. One comment suggests making the 
location identifier for the traceability lot code generator an optional 
KDE.
    (Response 412) The traceability lot code for a food and the 
location and contact information for its source are fundamental to 
effective traceability under this rule. However, we understand the 
concerns regarding the confidentiality of supplier data expressed in 
the comments. We are therefore deleting the proposed requirements for 
shippers to maintain and provide the location identifier, location 
description, and point of contact for the traceability lot code 
generator, and replacing them with requirements to keep and provide 
either the location description for the traceability lot code source or 
the traceability lot code source reference (see Sec.  1.1340(a)(7) and 
(b)). A traceability lot code source reference is a method for giving 
FDA access to the traceability lot code source location description 
required under subpart S without providing the traceability lot code 
source location information directly to subsequent recipients (Sec.  
1.1310). Examples of traceability lot code source reference types 
include, but are not limited to, the FDA Food Facility Registration 
Number assigned to the traceability lot code source or a web address 
that provides FDA with the location description for the traceability 
lot code source (Sec.  1.1310). To protect the confidentiality of 
business information, a shipper could choose to provide its customers 
with the traceability lot code source reference, instead of directly 
identifying the location description of the traceability lot code 
source of an FTL food they handle. If the firm uses a website as the 
traceability lot code source reference, the website may employ 
reasonable security measures, such as only being accessible to a 
government email address, provided the Agency has access to the 
information at no cost and without delay. We believe that the option to 
use a traceability lot code source reference is an appropriate measure 
for those entities concerned with sharing the traceability lot code 
source information through the supply chain.
    (Comment 413) One comment states that many food distribution 
centers are

[[Page 71028]]

well equipped to trace food without a lot code-based system by using 
inbound receiving reference records (e.g., BOLs, invoices, POs) in 
conjunction with pallet license plate numbers and location identifiers 
(pick slots) within a warehouse to connect to outbound shipping 
reference records.
    (Response 413) The tracing method described in the comment is not 
as efficient as the method set forth in subpart S. Traceability lot 
codes are critical to the subpart S traceability framework because they 
are the piece of information to which the other KDEs for a traceability 
event are linked, including the traceability lot code source. The 
traceability lot code (along with other linked KDEs) explicitly 
connects the food received by a distribution center with the food that 
is then shipped by the distribution center and received at an RFE or 
other establishment. Importantly, the traceability lot code also 
connects this food to the traceability lot code source (the place where 
the traceability lot code was assigned to the food), thus allowing FDA 
to identify that source at the first location we investigate (often an 
RFE or restaurant). During outbreak situations, this will allow us to 
more quickly identify the traceability lot code source location and 
prioritize where we need to collect tracing data, which in turn will 
help us more quickly identify the origin of potentially contaminated 
foods. Reference documents such as BOLs, POs, and invoices are 
primarily designed to describe a business transaction between two 
parties and may not include the lot code and contact information for 
the entity that assigned the lot code to the product. While existing 
business records may be used to satisfy subpart S, the information 
required under final Sec.  1.1340, including the traceability lot code 
and source, must be included within those documents or provided to the 
immediate subsequent recipient in some other manner. Communication of 
this information between supply chain partners is essential to ensuring 
adequate traceability.
3. Shipment of a Food That Occurs Before the Food Is Initially Packed
    (Comment 414) One comment requests clarification on whether 
movement of raw product from an orchard or field to a packinghouse 
constitutes shipping, when the grower maintains ownership.
    (Response 414) We conclude that it is not necessary or appropriate 
to apply the shipping recordkeeping requirements in Sec.  1.1340 to the 
movement of RACs before they are initially packed, including the 
movement of raw product from an orchard or field to a packinghouse. 
Therefore, Sec.  1.1340(c) specifies that the shipping CTE requirements 
do not apply to the shipment of a food that occurs before the food is 
initially packed (if the food is a RAC not obtained from a fishing 
vessel). As a result, any movement of RACs by farms, harvesters, 
coolers, or other entities that occurs before the food is initially 
packed is not subject to the requirements in Sec.  1.1340.
    (Comment 415) One comment requests that phone numbers be removed as 
a requirement for the lot code generator point of contact. The comment 
raises privacy concerns that some small farms may only have a home 
phone number, which would then be shared with other entities in a 
supply chain. The comment also notes that individuals may change 
positions and that the privacy of a named individual could be 
compromised in the event of a data breach at an operation later in the 
supply chain.
    (Response 415) Although the final rule deletes the proposed 
requirement (in proposed Sec.  1.1350(a)(4)) for shippers to provide 
immediate subsequent recipients with the point of contact for the 
traceability lot code generator (which would have included that 
individual's name and telephone number under the proposed definition of 
``point of contact''), the final rule includes a requirement to provide 
the immediate subsequent recipient with the phone number for the 
traceability lot code source. This is because shippers must provide the 
location description for the traceability lot code source (or else 
provide that information through a traceability lot code source 
reference), and the definition of ``location description'' includes, 
among other things, a phone number. We believe that having a phone 
number is essential to being able to contact the traceability lot code 
source when necessary for tracing purposes. However, as discussed in 
Section V.L.2 of this document, in response to comments expressing 
concern about privacy associated with sharing information on the 
traceability lot code generator (now the traceability lot code source), 
the final rule also allows firms to instead provide the recipient with 
a traceability lot code source reference, which is an alternative 
method for providing FDA with access to the location description for 
the traceability lot code source.
    We have removed the requirement for shippers to provide the 
recipient with a point of contact for the traceability lot code source. 
We believe that the phone number and other location description 
information is adequate for traceability purposes, and that once we 
contact the firm using that information, the firm will be able to 
provide us with the traceability point of contact listed in their 
traceability plan. Also, as discussed in Section V.F of this document, 
we have revised the definition of ``point of contact'' so that it no 
longer requires a specific individual's name.
    (Comment 416) Some comments suggest that it would be difficult for 
growers to access and verify for accuracy the shipping information 
required in proposed Sec.  1.1350(b)(2)(iii) through (v), which the 
comments characterize as the business name, point of contact, and phone 
number of the harvester, cooler, and packer of the food (if not the 
farm), and the date(s) and time(s) of harvesting, cooling, and packing, 
due to a lack of supply chain visibility.
    (Response 416) We have made modifications in the final rule in 
response to comments. In the final rule, shipping and receiving 
information is not required to be kept and shared until FTL foods from 
farms have been initially packed (see Sec. Sec.  1.1340(c) and 
1.1345(c)). Therefore, harvesters and coolers do not need to provide 
shipping and receiving information. Though we have changed the 
requirements in the final rule, we note that the proposed shipping 
provision referenced in the comment would not have required the grower 
to send information on harvesters, coolers, and packers unless they 
also performed those activities. However, the proposed rule would have 
required some farms (ones that were not growers) to pass along certain 
information about activities that they did not perform, e.g., a cooler 
that met the definition of a farm might have been required to pass 
along information about the harvester of the food. In the final rule, 
we have provided flexibility for information about harvesting and 
cooling to be sent either directly to the initial packer or passed 
through the supply chain (Sec.  1.1325(a)(2) and (b)(2)) (see Response 
350). We think this flexibility will help address concerns about the 
proposed rule's requirements regarding this information.

N. Records of Receiving (Sec.  1.1345)

    We proposed that for each food on the FTL received, the receiver 
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 the immediate previous 
source (other than a

[[Page 71029]]

transporter) of the food; the entry number(s) assigned to the food (if 
the food is imported); the location identifier and location description 
of where the food was received, and the date and time the food was 
received; the quantity and unit of measure of the food (e.g., 6 cases, 
25 returnable plastic containers, 100 tanks, 200 pounds); the 
traceability product identifier and traceability product description 
for the food; the location identifier, location description, and point 
of contact for the traceability lot code generator; the reference 
record type(s) and reference record number(s) (e.g., ``Invoice 750A,'' 
``BOL 042520 XYZ'') for the document(s) containing the previously 
stated information; and the name of the transporter who transported the 
food to the receiver (proposed Sec.  1.1335(a) through (h)). In 
response to comments and on our own initiative to align the 
requirements for receiving with other changes we are making in the 
final rule, we have deleted several of the proposed receiving KDEs and 
revised others.
    In addition to these changes to the proposed receiving 
requirements, we have added requirements for circumstances in which an 
entity receives an FTL food from a person to whom subpart S does not 
apply. Final Sec.  1.1345(b) states that for each traceability lot of a 
food on the FTL an entity receives from a person to whom this subpart 
does not apply (i.e., a person who is exempt from the rule), the entity 
must maintain records containing the following information and linking 
this information to the traceability lot: the traceability lot code for 
the food, which the entity must assign if one has not already been 
assigned (except that this requirement does not apply to RFEs and 
restaurants); the quantity and unit of measure of the food (e.g., 6 
cases, 25 reusable plastic containers, 100 tanks, 200 pounds); the 
product description for the food; the location description for the 
immediate previous source (other than a transporter) for the food; the 
location description for where the food was received (i.e., the 
traceability lot code source) and (if applicable) the traceability lot 
code source reference; the date the food was received; and the 
reference document type and reference document number. We also have 
added a provision (Sec.  1.1345(c)) specifying that the receiving 
requirements do not apply to the receipt of a food that occurs before 
the food is initially packed (if the food is a RAC not obtained from a 
fishing vessel) or to the receipt of a food by the first land-based 
receiver (if the food is obtained from a fishing vessel).
    We received several comments on the proposed requirements for 
receiving, to which we respond in the following paragraphs.
1. Records of Receiving of Foods
    (Comment 417) Some comments assert that it is effective for 
distribution centers to inform RFEs which traceability lot codes are 
supplied to which locations as well as which are subject to a recall. 
One comment requests that distributors and RFEs be required to keep 
traceability lot codes for purchased foods.
    (Response 417) We agree that distributors and RFEs should be 
required to keep traceability lot codes, and that it is effective for 
distribution centers to provide RFEs with the traceability lot codes of 
the foods they ship to those RFEs. As we had proposed, the final rule 
requires receivers of FTL foods, including distributors and RFEs, to 
keep a record of the traceability lot code for the received food. (We 
have moved the requirement to record the traceability lot code from the 
``introductory'' paragraph of proposed Sec.  1.1335 to the listing of 
required KDEs, specifically Sec.  1.1345(a)(1).) A receiver of an FTL 
food may not change the traceability lot code unless they transform the 
food (see Sec.  1.1320). Therefore, records maintained and provided by 
distributors and maintained by RFEs should include the same 
traceability lot code that was assigned by the initial packer of a RAC 
(other than food obtained from a fishing vessel), by the first land-
based receiver of a food obtained by a fishing vessel, or by an entity 
that transformed the food. However, as stated in Sec.  1.1345(b)(1), if 
a receiver (such as a distributor) receives the FTL food from an entity 
that is exempt from subpart S, the receiver must assign a traceability 
lot code if one has not already been assigned (except that this 
requirement does not apply to RFEs and restaurants).
    (Comment 418) One comment asks that we finalize the requirements 
for receivers of FTL foods as proposed. On the other hand, one comment 
states that the proposed list of receiving KDEs is too prescriptive and 
beyond what is necessary for traceability. The comment recommends that 
receivers should only be required to keep the traceability lot code, 
the GTIN, the location identifier (e.g., GLN) of the immediate previous 
source, the traceability lot code generator contact information, the 
quantity and unit of measure, and the name of the transporter. Some 
comments suggest that to simplify production of an electronic sortable 
spreadsheet (in accordance with proposed Sec.  1.1455(b)(3)) and reduce 
recordkeeping burden, the required receiving KDEs should be reduced to 
only those that are truly necessary for traceability. Therefore, the 
comments suggest deletion of the following KDEs: entry number, location 
identifier, point of contact for a traceability lot code generator, 
traceability lot code generator, location where the CTE occurred, name 
of the transporter, and time the event occurred. Another comment 
recommends that location identifier, import entry number, and time of 
receipt be optional, and suggests that the traceability lot code 
generator location identifier, description, and point of contact be 
required only if provided by the shipper.
    (Response 418) We agree that some of the proposed receiving KDEs 
are not absolutely necessary for tracing, and we agree that reducing 
the required KDEs will reduce the recordkeeping burden and simplify the 
production of the electronic sortable spreadsheet under Sec.  
1.1455(c)(3)(ii). Therefore, as requested by these comments (as well as 
comments that made similar points about these KDEs as they appeared in 
other proposed CTEs, as discussed elsewhere in this document), the 
final rule deletes the following proposed KDEs for receiving an FTL 
food: the entry number of the food (if imported); location identifiers; 
the traceability product identifier of the food; the time the food was 
received; the point of contact for the traceability lot code generator 
(under the final rule, the traceability lot code source); and the name 
of the transporter. In addition, as previously discussed, we have 
replaced the requirement to record location information about the 
traceability lot code generator with a requirement to record the 
location description for the traceability lot code source or the 
traceability lot code source reference.
    As a result of these changes, Sec.  1.1345(a) of the final rule 
specifies that, except as specified in Sec.  1.1345(b) and (c) 
(discussed below), for each traceability lot of a food on the FTL that 
an entity receives, the receiving entity must maintain records 
containing the following information and linking this information to 
the traceability lot:
     The traceability lot code for the food (Sec.  
1.1345(a)(1));
     The quantity and unit of measure of the food (e.g., 6 
cases, 25 reusable plastic containers, 100 tanks, 200 pounds) (Sec.  
1.1345(a)(2));
     The product description for the food (Sec.  1.1345(a)(3));
     The location description for the immediate previous source 
(other than a transporter) for the food (Sec.  1.1345(a)(4));

[[Page 71030]]

     The location description for where the food was received 
(Sec.  1.1345(a)(5));
     The date the food was received (Sec.  1.1345(a)(6));
     The location description for the traceability lot code 
source or the traceability lot code source reference (Sec.  
1.1345(a)(7)); and
     The reference document type and reference document number 
(Sec.  1.1345(a)(8)).
    (Comment 419) Some comments suggest that we eliminate the proposed 
requirement for persons who receive FTL foods to establish and maintain 
records containing and linking the traceability lot code for the food 
to the entry number assigned to the food if the food is imported. Some 
comments contend that maintaining import entry numbers would make 
recordkeeping requirements overly burdensome, would provide no 
additional meaningful traceability information, and would be 
duplicative and unnecessary given the maintenance of other KDEs.
    (Response 419) We agree and as stated in Response 396, we have 
deleted all proposed requirements to record the entry number for an 
imported FTL food.
    (Comment 420) One comment questions the value of requiring 
receivers to maintain records that identify the location where they 
received a food. The comment maintains that this information is not 
necessary because other information would be more relevant for 
traceability.
    (Response 420) We do not agree. Knowing the physical locations 
where a food on the FTL has been, including where a food has been 
received by an entity such as a distributor, RFE, or other firm subject 
to the receiving CTE requirements, is critical for traceability. If a 
food is contaminated, we need to be able to identify the source of that 
food and trace its movements accurately and efficiently.
    (Comment 421) One comment requests clarification on whether the 
date and time refers to the start or finish of the receiving process 
for an FTL food.
    (Response 421) As previously stated, we have deleted the proposed 
requirement to record the time of receipt, but we have retained the 
requirement to record the date of receipt. If the receiving process 
spans multiple days (e.g., if it starts shortly before midnight and 
ends after midnight), we recommend recording the date when the 
receiving process began.
    (Comment 422) One comment maintains that proposed Sec.  1.1335 
clearly outlines the required receiving records and is consistent with 
the 2012 IFT Final Report (Ref. 1), which recommends that any 
traceability regulations that FDA adopts should ensure the 
communication of needed information to promote accuracy.
    (Response 422) We agree with the comment that the requirements in 
proposed Sec.  1.1335 align with the 2012 IFT Final Report's 
recommendation to ensure the communication of needed information, and 
we believe the revisions to this section (final Sec.  1.1345) also 
remain in alignment with this recommendation. We believe that the 
requirements we are establishing for receivers of FTL foods as well as 
for others who manufacture, process, pack, or hold such foods should 
help to ensure the effective and accurate communication of needed 
traceability information throughout the supply chain and to the Agency.
    (Comment 423) Some comments express concern that the rule will 
prohibit a food industry practice of linking internal traceability 
identifiers to supplier-provided traceability lot codes, such as the 
GS1-128 barcode and associated human readable text.
    (Response 423) The rule does not prohibit covered entities from 
using internal identifiers to facilitate the internal storage and 
management of FTL foods they handle, provided that the traceability lot 
code and traceability lot code source information received is kept in 
accordance with the receiving CTE requirements and provided to the 
subsequent recipient in accordance with the shipping CTE requirements, 
and provided that new traceability lot codes are only assigned under 
the circumstances described in Sec.  1.1320. Considering the example in 
the comment, a covered entity that receives FTL foods may use a 
warehouse management system that links internal identifiers to 
supplier-provided traceability lot codes, such as the GS1-128 barcode 
and associated human readable text, provided that the entity maintains 
all of the KDEs required under subpart S, and the KDEs to be provided 
as required under Sec.  1.1340 are available to the next receiver of 
the FTL food.
    (Comment 424) Several comments request clarification on the 
applicable subpart S requirements when food is provided to a retailer 
through direct store delivery (DSD). The comments state that under the 
DSD system, a food vendor delivers food directly to a retail store 
location and stocks the retail shelves with the food. The comments 
further state that these products are not included in the retailer's 
inventory; the retailer only facilitates the sale of the products to 
the consumer, with the vendor's invoices being reconciled against the 
retailer's scanned sales data. The comments maintain that the retailer 
does not receive the food and therefore would not have access to 
traceability data for the food.
    (Response 424) We do not agree with the statement that a retailer 
of an FTL food obtained through DSD does not ``receive'' the food as 
that term is used in subpart S. The retailer of a food obtained through 
DSD is the receiver of the food, and is therefore responsible for the 
receiving KDEs in Sec.  1.1345. However, the DSD vendor could maintain 
the receiving records on behalf of the retailer. As discussed in 
Section V.R of this document, Sec.  1.1455(b) of the final rule 
specifies that a person may have another entity establish and maintain 
records required under subpart S on the person's behalf, but the person 
is responsible for ensuring that such records can be retrieved and 
provided onsite to FDA within 24 hours of our request. Therefore, a 
vendor and a retailer participating in a DSD system could make an 
arrangement under which the DSD vendor establishes and maintains the 
relevant receiving records on the retailer's behalf. However, the 
retailer would still be the entity that is subject to the receiving 
requirements of Sec.  1.1345, and as stated in Sec.  1.1455(b), the 
retailer would be responsible for ensuring that the records can be 
retrieved and provided onsite within 24 hours of request for official 
review.
2. Records of Receipt of Foods From Persons Not Subject to Subpart S
    (Comment 425) One comment asks that FDA clarify a receiver's 
recordkeeping responsibilities for FTL foods shipped by exempt and non-
compliant entities. The comment describes the potential challenges to 
meeting the receiving requirements if FTL foods are received from 
exempt entities that are not required to notify receivers that they are 
exempt, as in the case of foodservice distributors sourcing food from 
local entities that will not be subject to the rule. The comment asks 
that receivers be permitted to assume that suppliers who fail to 
provide the records required from shippers are subject to an exemption, 
and that FDA not hold downstream actors accountable for non-compliance 
if they rely in good faith on upstream actors providing the records 
required by the rule.
    (Response 425) We agree that the receiving requirements must take 
into account those situations in which an entity receives an FTL food 
from a person who is not subject to the rule, such as because they are 
exempt from subpart S under one of the exemptions set forth in Sec.  
1.1305. Therefore, we have added to the final rule Sec.  1.1345(b),

[[Page 71031]]

which specifies that for each traceability lot of a food on the FTL 
that is received from a person to whom subpart S does not apply, the 
receiver must maintain records containing the following information and 
linking this information to the traceability lot:
     The traceability lot code for the food, which the receiver 
must assign if one has not already been assigned (except that this 
requirement does not apply to RFEs and restaurants) (Sec.  
1.1345(b)(1));
     The quantity and unit of measure of the food (e.g., 6 
cases, 25 reusable plastic containers, 100 tanks, 200 pounds) (Sec.  
1.1345(b)(2));
     The product description for the food (Sec.  1.1345(b)(3));
     The location description for the immediate previous source 
(other than a transporter) for the food (Sec.  1.1345(b)(4));
     The location description for where the food was received 
(i.e., the traceability lot code source), and (if applicable) the 
traceability lot code source reference (Sec.  1.1345(b)(5));
     The date the food was received (Sec.  1.1345(b)(6)); and
     The reference document type and reference document number 
(Sec.  1.1345(b)(7)).
    Under Sec.  1.1345(b)(1), if the received FTL food does not already 
have a traceability lot code assigned, the receiver must assign one 
(unless the receiver is an RFE or restaurant; we conclude that it is 
not necessary to require assignment of a traceability lot code to food 
that has already reached the end of the supply chain). Section 
1.1345(b)(5) makes clear that the receiver (i.e., the place where the 
food is received) will also become the traceability lot code source for 
the food. (However, this is not the case if the receiver is an RFE or 
restaurant; such an entity would still record the location description 
for where the food was received, in accordance with Sec.  1.1345(b)(5). 
But because RFEs and restaurants that receive food from exempt entities 
are not required to assign a traceability lot code under Sec.  
1.1345(b)(1), that location description would not be the traceability 
lot code source.) It is important for the traceability lot code 
source--which serves a crucial function as discussed in Sections V.F 
and V.M of this document--to be an entity that is covered by subpart S.
    The rule does not allow receivers to assume that any received food 
for which the shipper did not provide the information required under 
Sec.  1.1340(b) was from an exempt entity. Instead, we expect receivers 
of FTL foods to work with their suppliers to be familiar with whether 
the suppliers are subject to the rule and, if so, to know what records 
they must provide to enable the receivers to meet their requirements 
under Sec.  1.1345.
    (Comment 426) One comment asks that we clarify the requirements for 
FTL foods received when traceability records provided by distributors 
are incomplete or inaccurate. The comment offers the example of a GS1-
128 barcode label that has been damaged, was not printed well 
initially, or was torn off the food packaging in transit. The comment 
asks if we will require suppliers to label multiple sides of food 
cases, and if retailers and restaurants will be required to verify 
received data, correct errors, and otherwise ``police'' distributors. 
Another comment maintains that there may be unavoidable errors during 
shipment or receiving due to human error or misprinted or damaged 
barcode labels.
    (Response 426) We expect persons who manufacture, process, pack, or 
hold any food covered by the final rule to be in compliance with these 
regulations (unless an exemption applies). If the immediate previous 
source of an FTL food is subject to the rule and provides the receiver 
with illegible or incomplete records, the receiver should ask the 
source to provide, in legible/readable form, the complete information 
required of the shipper under Sec.  1.1340(b). We note that the rule 
does not specify the manner in which shippers must provide the required 
information to their recipients, nor does it specify the manner in 
which shippers must label the FTL foods they ship.
    (Comment 427) Several comments ask that we clarify the 
responsibilities of a receiving entity whose supplier fails to comply 
with the requirements of subpart S or does not provide the receiving 
entity with accurate data. The comments request that we clarify how we 
will enforce the regulation against receiving entities in such 
circumstances. Specifically, some comments assert that RFEs are not 
able to verify the accuracy of data received from distributors and ask 
whether RFEs that provide supplier-generated data to FDA will be 
responsible for its accuracy. These comments maintain that entities 
upstream of RFEs have the logistical expertise and infrastructure (such 
as barcode scanners and management systems) required to implement 
traceability recordkeeping, and that to require RFEs to verify data 
from those firms would be complicated and inefficient.
    Some comments urge FDA to clarify that a receiving entity may 
continue to supply a food without being in violation of the regulation 
even if their supplier does not provide them with the information 
required under subpart S. These comments maintain that prohibiting a 
receiving entity from supplying food in such circumstances could lead 
to supply chain disruptions or food waste. Some comments suggest that 
even if a supplier does not provide the receiving entity with the 
necessary information, it does not mean that the food is adulterated or 
unsafe. Some comments request that we create a ``safe harbor'' that 
would allow a receiving entity to assume that the subpart S 
requirements do not apply if their supplier does not provide them with 
traceability information, the receiving entity has no knowledge that 
the food is covered by the regulation, or the receiving entity relies 
on a one-time, ongoing guarantee from the supplier that the supplier 
will provide traceability information when required. Some comments 
assert that because a receiving entity's ability to comply with subpart 
S depends on whether its supplier provides the required records, the 
receiver should not be held liable for its supplier's non-compliance.
    (Response 427) Receivers of FTL foods must maintain records of KDEs 
as specified in Sec.  1.1345, including records of certain information 
that shippers are required to provide to them under Sec.  1.1340(b). As 
discussed in Response 425, recognizing that a receiving entity's 
supplier might be exempt from subpart S, we have added to the final 
rule Sec.  1.1345(b), which specifies the information a receiver must 
maintain if they receive an FTL food from a person to whom subpart S 
does not apply. In circumstances where a receiver's supplier is subject 
to the rule, if the receiving entity has reason to believe that 
required information from the shipper is inaccurate or incomplete, the 
receiver should work with their supplier to ensure that appropriate and 
accurate records are provided. We expect firms will use the years 
leading up to the compliance date for the rule to work with their 
suppliers to ensure that all entities are ready to comply with the rule 
and to provide the necessary information to others within their supply 
chain, as required under the rule. Because of such efforts, we do not 
believe that adoption of these recordkeeping requirements will result 
in significant supply chain disruptions or food waste.
    We do not agree that the rule should provide a ``safe harbor'' that 
would allow a receiving entity to assume that subpart S requirements do 
not apply when their supplier does not provide them with traceability 
information, the

[[Page 71032]]

receiver has no knowledge that the food is covered by the rule, or the 
receiver relies on a one-time, ongoing guarantee from the supplier that 
the supplier will provide traceability information when required. As 
stated above, receivers are responsible for maintaining the records 
required under Sec.  1.1345. The requested ``safe harbor'' would 
relieve firms of that responsibility and encourage a head-in-the-sand 
approach that would seriously undermine the ability of the requirements 
to facilitate swift and effective traceability throughout the supply 
chain. Furthermore, with respect to the receiver's knowledge of whether 
a food is covered by the rule, we note that entities subject to the 
rule must have a traceability plan in place that includes a description 
of the procedures the entity uses to identify foods on the FTL that it 
manufactures, processes, packs, or holds (Sec.  1.1315(a)(2)). 
Consequently, receivers of FTL foods must have a procedure for knowing 
whether a particular food they receive is on the FTL.
3. Receipt of a Food That Occurs Before the Food Is Initially Packed
    As discussed in Sections V.M and V.N of this document, we have 
added provisions to the shipping and receiving CTE requirements to make 
clear that those requirements do not apply to the movement of food that 
occurs before the food is initially packed (for example, movement of a 
RAC from the harvester to a cooler, or from the cooler to the initial 
packer). While we noted that such language was not needed under the 
shipping CTE with respect to food obtained from a fishing vessel (due 
to the partial exemption for fishing vessels), we have added a 
provision to the receiving CTE to make clear that the first land-based 
receiver of food obtained from a fishing vessel does not need to keep 
the receiving records required under Sec.  1.1345. This is because the 
records required under Sec.  1.1335 already set forth the information 
we think is necessary for the first land-based receiver of a food 
obtained from a fishing vessel to maintain with respect to their 
receipt of that food. Therefore, Sec.  1.1345(c) specifies that the 
receiving requirements do not apply to receipt of a food that occurs 
before the food is initially packed (if the food is a RAC not obtained 
from a fishing vessel) or to the receipt of a food by the first land-
based receiver (if the food is obtained from a fishing vessel).

O. Records of Transformation (Sec.  1.1350)

    We proposed in Sec.  1.1340(a) that, except as specified in 
proposed Sec.  1.1340(b), for each new traceability lot of food 
produced through transformation, the person who transforms the food 
must establish and maintain records containing and linking the new 
traceability lot code of the food produced through transformed to 
certain information regarding the food on the FTL used in 
transformation and the food produced through transformation. For the 
food(s) on the FTL used in transformation, we proposed that the 
transformer would have to establish and maintain records containing the 
following information: the traceability lot code(s) for the food; the 
traceability product identifier and traceability product description 
for the food to which the traceability lot code applied; and the 
quantity of each traceability lot of the food (proposed Sec.  
1.1340(a)(1)(i) through (iii)). For the food produced through 
transformation, we proposed that records containing the following 
information would have to be established and maintained: the location 
identifier and location information for where the food was transformed 
(e.g., by a manufacturing/processing step), and the date transformation 
was completed; the new traceability product identifier and traceability 
product description for the food to which the new traceability lot code 
applied; and 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) (proposed Sec.  1.1340(a)(2)(i) through (iii)). 
The final required KDE we proposed was 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 in proposed 
Sec.  1.1340(a)(1) and (2) (proposed Sec.  1.1340(a)(3)). We further 
proposed that these transformation KDEs would not apply to RFEs with 
respect to foods they do not ship (e.g., foods they sell or send 
directly to consumers) (proposed Sec.  1.1340(b)).
    We also proposed to establish recordkeeping requirements for the 
creation of an FTL food. Because we proposed to define ``creating'' as 
making or producing a food on the FTL (e.g., through manufacturing or 
processing) using only ingredients that are not on the FTL, the creator 
of a listed food would not be required to maintain tracing records on 
the ingredients used to create the FTL food. Instead, we proposed that 
for each food on the FTL that was created, the creator of the food 
would have to establish and maintain records containing and linking the 
traceability lot code of the created food 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; the traceability product identifier and 
traceability product description for the food; the quantity and unit of 
measure of the food (e.g., 6 cases, 25 returnable plastic containers, 
100 tanks, 200 pounds); and the reference record type(s) and number(s) 
(e.g., ``Production Log 123,'' ``Batch Log 01202021'') for the 
document(s) containing the previously listed information (proposed 
Sec.  1.1345(a)(1) through (4)). As with the proposed requirements for 
transformation, we specified that proposed Sec.  1.1345(a) would not 
apply to RFEs with respect to foods they do not ship (e.g., foods they 
sell or send directly to consumers).
    In the final rule, we are combining the proposed requirements for 
transformation and creation of FTL foods into the requirements for 
transformation in Sec.  1.1350 and making minor changes to the proposed 
KDEs for transformation. We are retaining the concept that records only 
need to be kept regarding incoming ingredients if those incoming foods 
are on the FTL; thus, for foods that were ``created'' under the 
proposed rule, it is still the case that the required records will only 
relate to the finished product, not the incoming ingredients. We also 
are adding clarifying language (Sec.  1.1350(b)) specifying that the 
transformation KDEs do not apply when a RAC (other than a food obtained 
from a fishing vessel) is transformed before it is initially packed; 
instead, only the initial packing KDEs will apply. In addition, we are 
finalizing our proposed exclusion from the transformation requirements 
for RFEs and restaurants with respect to foods they do not ship. We 
respond to the comments on the proposed requirements for transformation 
and creation of FTL foods in the following paragraphs.
1. Records of Transformation (Sec.  1.1350(a))
    (Comment 428) Several comments support transformation as a CTE and 
maintain that the proposed requirements for transformation are well 
defined, including the requirement to include lot codes for inputs.
    (Response 428) We agree with the comments, and the final rule 
includes requirements for transformation, with certain changes to the 
proposed requirements discussed below.
    (Comment 429) A comment supports the ``creation'' CTE regarding the 
production of foods on the FTL from foods that are not on the FTL. The 
comment asks for clarification on which

[[Page 71033]]

KDEs would be required for the processing of whole apples, which are 
not on the FTL, into sliced apples, which are listed on the FTL as 
``Fruits and Vegetables (fresh-cut).'' One comment appreciates the 
clarification provided by FDA after the publication of the proposed 
rule that ingredient suppliers for FTL foods that are ``created'' would 
not be subject to subpart S because those ingredients are not on the 
FTL, and encourages the Agency to finalize this approach in the final 
rule.
    (Response 429) In the final rule, we have merged the CTE for 
creation of an FTL food into the CTE for transformation of an FTL food, 
so there is no longer a separate creation CTE. We believe that it is 
appropriate to use the term ``transformation'' to cover both the 
activities of ``creation'' and ``transformation'' (see Response 247). 
Given that the output of both the creation and the transformation CTEs 
is an FTL food and both CTEs are manufacturing events, we decided to 
simplify the number of CTEs and merge ``creation'' into 
``transformation.'' The revised definition of ``transformation'' more 
closely aligns with current industry practices as ``transformation'' is 
already a term used by industry while ``creation'' is not. As part of 
this change, Sec.  1.1350(a)(1) of the final rule, which relates to the 
incoming FTL foods that are used in transformation, has been revised to 
include the phrase ``if applicable.'' Consequently, Sec.  1.1350(a)(1) 
records are not required for foods that do not have any incoming FTL 
ingredients (i.e., foods regarded as ``created'' under the proposed 
rule).
    Regarding the transformation of whole apples into sliced apples, 
the apple farm, apple harvester, apple cooler, and initial packer of 
the whole apples would not be covered by the rule because whole apples 
are not on the FTL. Deliveries (shipping and receiving) from the apple 
packer to the fresh-cut processor would also not be subject to the 
rule. However, the fresh-cut processor who transforms the whole apples 
into apple slices (which are included on the FTL under ``Fruits and 
Vegetables (fresh-cut)'') and packages the sliced apples would be 
required to keep the transformation records specified under final Sec.  
1.1350(a)(2), as well as the shipping records (for shipment of the 
sliced apples) specified under final Sec.  1.1340. If the apples are 
sliced before initial packing, then, as specified under Sec.  
1.1350(b), the entity who transforms the whole apples into sliced 
apples would be required to keep the initial packing records specified 
under Sec.  1.1330(a) or (c), and would not be required to keep 
transformation records under Sec.  1.1350(a) (see Response 444 (434 
(creation CTE requirements would not apply to the creation of an FTL 
food solely for the purpose of being transformed into another food in 
continuous processing)).
    In addition to merging the proposed creation CTE requirements into 
the transformation CTE requirements, we are also making the following 
changes:
     We deleted requirements concerning product identifiers and 
location identifiers (as discussed in Sections V.F.46 and V.F.18 of 
this document);
     We added unit of measure to the requirement to specify the 
quantity of food used from each traceability lot of an FTL food used in 
transformation;
     Regarding the food produced through transformation, we 
moved the reference to the new traceability lot code from the 
``introductory'' paragraph (Sec.  1.1340(a)) to the listing of required 
KDEs;
     We clarified that the location description for where the 
food was transformed is the traceability lot code source, and we added 
that the traceability lot code source reference must also be recorded 
``if applicable''; and
     We changed ``returnable plastic containers'' to ``reusable 
plastic containers'' (as discussed in Section V.K.1 of this document).
    As a result of these changes, Sec.  1.1350(a)(1) and (2) of the 
final rule states that, except as specified in Sec.  1.1350(b) and (c), 
for each new traceability lot of food produced through transformation, 
the transformer of the food must maintain records containing the 
following information and linking this information to the new 
traceability lot:
     For the food on the FTL used in transformation (if 
applicable), the following information:
    [cir] The traceability lot code for the food;
    [cir] The product description for the food to which the 
traceability lot code applies; and
    [cir] For each traceability lot used, the quantity and unit of 
measure of the food used from that lot.
     For the food produced through transformation, the 
following information:
    [cir] The new traceability lot code for the food;
    [cir] The location description for where the food was transformed 
(i.e., the traceability lot code source), and (if applicable) the 
traceability lot code source reference;
    [cir] The date transformation was completed;
    [cir] The product description for the food;
    [cir] The quantity and unit of measure of the food (e.g., 6 cases, 
25 reusable plastic containers, 100 tanks, 200 pounds); and
    [cir] The reference document type and reference document number for 
the transformation event.
    (Comment 430) One comment requests that firms be required to link 
production input traceability lot codes to output traceability lot 
codes.
    (Response 430) We agree. As stated above, Sec.  1.1350(a) requires 
firms to document, among other KDEs, the traceability lot code for the 
FTL food used in transformation (if any) and the new traceability lot 
code for the food produced through transformation, and to link that 
information to the new traceability lot.
    (Comment 431) One comment asks that we clarify what is meant by the 
quantity used in transformation or the quantity of each traceability 
lot code.
    (Response 431) We recognize that the language used in proposed 
Sec.  1.1340(a)(1)(iii) (``[t]he quantity of each traceability lot of 
the food'') caused some confusion. Therefore, in response to comments, 
we have revised the language to be clearer. Final Sec.  
1.1350(a)(1)(iii) states that for each traceability lot used, the 
quantity and unit of measure of the food used from that lot must be 
maintained as part of the required transformation records. For example, 
if a person used multiple traceability lots of whole green peppers 
(which are on the FTL) to manufacture a single traceability lot of 
fresh-cut green peppers (which are also on the FTL), their records 
might indicate that the incoming ingredients consisted of 10 pounds of 
whole green peppers from traceability lot 1111, 10 pounds of whole 
green peppers from traceability lot 1112, and 5 pounds of whole green 
peppers from traceability lot 1113. (This might represent only half of 
traceability lot 1113, a fact that would be clear from the person's 
receiving records for that traceability lot.) If the manufactured 
product were a fresh-cut mixture of green and red peppers, the person's 
records might also indicate an incoming ingredient consisting of 10 
pounds of red peppers from traceability lot 2222.
    (Comment 432) One comment questions the value of requiring 
transformers and creators of FTL foods to maintain records identifying 
the location where the food was transformed/created. The comment 
maintains that this information is not necessary because other 
information is

[[Page 71034]]

more relevant for traceability, and asserts that deleting this 
requirement would also mean less information to compile for the 
electronic sortable spreadsheet.
    (Response 432) We disagree with the comment. If a food is 
contaminated, we need to be able to identify all of the locations where 
the food was handled (see Response 420). The location where the food 
was transformed is particularly important because contamination can be 
introduced during transformation. Furthermore, because a traceability 
lot code must be assigned whenever a food is transformed (see Sec.  
1.1320(a)), the place of transformation takes on additional 
significance as the traceability lot code source (see Sec.  
1.1350(a)(2)(ii)). Transformation records are crucial to traceability 
because they provide a connection between the incoming traceability 
lots of FTL foods (when applicable) and the outgoing traceability lots 
of the transformed FTL food. For all of these reasons, it is important 
for FDA to be able to quickly identify the location where 
transformation occurred.
    (Comment 433) One comment requests that location identifier be an 
optional KDE for the transformation CTE and that it not be required for 
creation events.
    (Response 433) We agree that location identifier is not necessary 
and have deleted it from the final rule (see Response 267). However, 
Sec.  1.1350(a)(2)(ii) requires transformers to keep a record of the 
location description for where the food was transformed. Under the 
definition of location description in Sec.  1.1310, this must include 
the business name, phone number, physical location address (or 
geographic coordinates), and city, state, and zip code for domestic 
locations and comparable information for foreign locations, including 
country.
2. Transformation of RACs Not Initially Packed Before Transformation 
(Sec.  1.1350(b))
    (Comment 434) Several comments ask that we clarify that the 
creation CTE requirements would not apply to the creation of an FTL 
food solely for the purpose of being transformed into another food in a 
continuous processing protocol. As examples of such continuous 
processing, the comments suggest a nut butter created by a confectioner 
solely for the purpose of being turned into confections, and cream 
cheese created solely to be further processed into dips or spreads. The 
comments maintain that FTL foods created solely for the purpose of 
being turned into another FTL food generally are not given separate 
identifiers or lot codes before transformation into the final FTL food. 
The comments contend that requiring creation CTE records for such 
continuous processing would serve no purpose and add unnecessary 
burden. Some comments request clarification on how traceability lot 
codes would apply to bulk and commingled ingredients used in continuous 
processing operations. The comments state that commodity ingredients 
often are received in bulk form and multiple lots of the same 
ingredient are stored together before being used in food production, 
often commingled with other lots of the same ingredient.
    (Response 434) As previously stated, we are combining the proposed 
CTEs for transformation and creation into one CTE for transformation. 
We recognize that continuous processing operations may present unique 
circumstances when transforming a food. In some continuous processing 
operations, a RAC is processed before it is initially packed. (For 
example, whole heads of lettuce are harvested, chopped, and then 
initially packed as chopped lettuce.) We conclude that in such 
situations, where a RAC (other than a food obtained from a fishing 
vessel) is transformed before it is initially packed, the KDEs relating 
to initial packing are more appropriate than the KDEs relating to 
transformation, in part because the incoming RAC has not yet been 
packed and will not yet have a traceability lot code. Therefore, Sec.  
1.1350(b) specifies that for each traceability lot produced through 
transformation of a RAC (other than a food obtained from a fishing 
vessel) on the FTL that was not initially packed prior to the 
transformation of the food, the person performing this transformation 
(which we assume will include packing of the finished product) must 
maintain records containing the information specified in Sec.  
1.1330(a) or (c) (the requirements for initial packers), and if the RAC 
is sprouts, the information specified in Sec.  1.1330(b).
    We are aware that there are other types of continuous processing 
operations that differ from this scenario. To address an example from 
the comments, if a food that is not on the FTL (e.g., nuts) is 
processed into an intermediate food that is on the FTL (e.g., nut 
butter) and is very soon thereafter fully processed at the same 
location into a finished food containing an FTL food that has not been 
subjected to a kill step (e.g., a confection with nut butter), we would 
consider this to be one processing event. The food produced through 
transformation would be the confection, which would be on the FTL 
because it contains nut butter. The incoming ingredients would include 
nuts, which are not on the FTL. Nut butter would not be considered an 
incoming ingredient because the manufacturing of the nut butter was 
incidental to the overall process of manufacturing the confection. 
Records under Sec.  1.1350(a)(1) would therefore not be required 
(assuming none of the other incoming ingredients are on the FTL), and 
the only records of the transformation event would be those required 
under Sec.  1.1350(a)(2). We think this approach is appropriate because 
as described in the comments, the nut butter that is manufactured as an 
intermediate step (as part of the process of manufacturing the 
confection) would generally not be given a separate identifier or lot 
code. We agree with the comments that requiring two sets of records in 
this situation--one for the manufacturing of the nut butter, and a 
second for the manufacturing of the confection--would add unnecessary 
burden.
    However, there are some situations where an ingredient such as nut 
butter is manufactured as a stand-alone product, and then later--not as 
part of a continuous processing operation--the nut butter is used as an 
ingredient in a confection. In such situations, the nut butter would 
have been packed in some way, and possibly stored before its 
incorporation into the confection. Factors such as these indicate that 
it was not a continuous processing operation, and that instead there 
were two separate manufacturing events (one for the nut butter, one for 
the confection). In that situation, transformation records would be 
kept for each manufacturing event, including the assigning of a 
traceability lot code to the nut butter and then assigning of a 
different traceability lot code to the confection containing the nut 
butter.
    In response to the request for clarification on how the 
transformation requirements would apply to bulk and commingled 
ingredients used in continuous processing operations, we note that the 
concerns expressed in the comment do not seem to be specific to 
continuous processing operations. In general, if bulk or commingled FTL 
foods are used as ingredients in another FTL food, the requirements of 
this subpart would apply. (However, note that some non-produce 
commingled RACs are partially exempt under Sec.  1.1305(h), and as 
discussed above there is a specific provision governing RACs (not 
obtained from a fishing vessel) that are transformed before they are 
initially packed.) The traceability lot codes for those FTL ingredients 
would

[[Page 71035]]

need to be maintained when received from the shipper as specified in 
Sec.  1.1345. During transformation, for each traceability lot of the 
ingredient that is used, the quantity and unit of measure of the food 
used from that lot would need to be maintained (see Sec.  
1.1350(a)(1)(iii) and Response 431). If multiple lots of the same FTL 
ingredient are stored together before being transformed, entities will 
need to employ practices to ensure that the different traceability lot 
codes associated with the FTL ingredient are able to be identified and 
recorded as required under Sec.  1.1350.
    (Comment 435) One comment suggests that the owner of the food being 
repacked should be required to establish the traceability lot code, 
rather than a firm, such as a third-party logistics provider, who is 
under contract to repack or relabel the food.
    (Response 435) Subpart S applies to persons who manufacture, 
process, pack, or hold FTL foods (see Sec.  1.1300); this is true 
regardless of whether such person owns the food (see Response 155). 
Similarly, the requirement in Sec.  1.1320(a) to assign a traceability 
lot code when a food is transformed does not depend on ownership. Thus, 
in the example given in the comment, it is the entity that repacks the 
food (i.e., the third-party logistics provider) who is responsible for 
assigning the traceability lot code (and for maintaining the 
transformation KDEs under Sec.  1.1350). The third-party logistics 
provider could enter into an agreement with the owner of the food, 
under which the owner maintains the relevant KDEs and makes decisions 
relating to traceability lot codes. However, the third-party logistics 
provider would still retain the ultimate responsibility for compliance 
with the relevant portions of the rule. Also, as discussed in Response 
296, the traceability lot code source for the food would be the place 
where the food was transformed (e.g., the third-party logistics 
provider's repacking facility).
    (Comment 436) Several comments request that foods repacked on a 
farm within the same lot retain the same lot code. For example, a farm 
may repack 30 boxes of tomatoes from the same lot, sort them by size or 
quality, and retain the original lot code to maintain traceability to 
the grower.
    (Response 436) We agree that repacked product (regardless of 
whether it was repacked on a farm) could retain the traceability lot 
code from the original traceability lot as long as the food is repacked 
within the same traceability lot (repacking ``like into like''). An 
example is a single lot of tomatoes repacked so that it is still a 
single lot, but the individual tomatoes have been sorted into packages 
within that lot based on their size. In this situation, Sec.  1.1320 is 
being complied with because the person who transforms the food (i.e., 
the repacker) is assigning the traceability lot code (even though they 
are deciding to assign the same traceability lot code that had 
previously been assigned to the food). Furthermore, the definition of 
traceability lot code is being complied with, because the code uniquely 
identifies a single traceability lot within the firm's records. In this 
situation, the repacker would keep the required transformation records 
under Sec.  1.1350, with the lot codes in Sec.  1.1350(a)(1)(i) and 
(2)(i) being the same. Because the repacker in this scenario is 
required under Sec.  1.1320 to assign a traceability lot code to the 
food (even if it is the same code that was used previously), under the 
definition of traceability lot code source in Sec.  1.1310, the 
traceability lot code source would be changed to reflect the place 
where the repacking occurred. We think this approach is responsive to 
the concerns expressed in the comments while still allowing for 
effective and efficient traceability. Identifying the repacking 
facility as the traceability lot code source would make us aware that 
the repacking took place and allow us to contact the repacker in the 
event of an outbreak investigation. However, if a repacker combines or 
commingles lots, they cannot use the same traceability lot code, 
because it would no longer uniquely identify the lot. The repacker in 
this situation would be required to keep the transformation records 
under Sec.  1.1350, with the lot codes from the incoming product being 
identified in Sec.  1.1350(a)(1)(i) and the newly assigned lot code in 
Sec.  1.1350(a)(2)(i).
    (Comment 437) One comment expresses concern that traceability 
information will not be maintained if produce is repacked further down 
the supply chain.
    (Response 437) Unless they are exempt from subpart S, entities that 
engage in activities defined as transformation, including repacking, 
would be required to maintain records of receiving as specified in 
final Sec.  1.1345, to assign a new traceability lot code as specified 
in Sec.  1.1320, and to maintain records of transformation in 
accordance with Sec.  1.1350. In addition, shipping KDEs for the food 
produced through transformation would need to be maintained and 
provided to the immediate subsequent recipient of the food in 
accordance with Sec.  1.1340. We believe that compliance with these 
requirements will ensure that adequate traceability information on 
repacked produce will be available later in the supply chain.
    (Comment 438) Several comments ask that we provide further 
definitions and specific requirements for distributors, retailers, and 
food service operations regarding transformation.
    (Response 438) The terms ``distributor,'' ``retailer,'' and ``food 
service operation'' are not used in subpart S, and we therefore do not 
see a need to define them. We note that, as discussed in Section V.F of 
this document, the final rule defines the terms ``retail food 
establishment'' and ``restaurant.''
    In most cases, we do not anticipate that entities who identify as 
distributors would perform transformation. However, if they were to do 
so, they would need to keep the transformation records specified in 
Sec.  1.1350. As discussed in Section V.O.3 of this document, Sec.  
1.1350(c) states that the transformation KDEs do not apply to RFEs and 
restaurants with respect to foods they do not ship (e.g., foods they 
sell or send directly to consumers). However, if an RFE or restaurant 
transforms an FTL food which it then ships to an entity other than a 
consumer, it would be subject to the transformation requirements in 
Sec.  1.1350.
    (Comment 439) One comment asks whether RFEs will be held 
responsible for maintaining traceability information for foods they 
receive that are not identified with barcodes and other traceability 
lot code information. The comment states that produce vendors may 
divide up and repackage cases of produce for restaurants because they 
cannot always use the whole case, and those repackaged cases might not 
include barcodes or other traceability lot code information.
    (Response 439) In the situation described in the comment, the 
produce vendor would need to keep transformation records under Sec.  
1.1350 because they divided up the cases and repacked them. (As 
discussed in Response 436, the vendor might be able to retain the 
traceability lot code from the original traceability lot if they 
repacked ``like into like,'' but this would still be a transformation 
event.) When the vendor then ships the FTL food to the RFEs or 
restaurants, the vendor would need to comply with the requirements for 
shipping under Sec.  1.1340, including the requirement to provide the 
traceability lot code and other required information to the receiving 
RFE or restaurant (see Sec.  1.1340(b)). Shippers may use barcodes to 
provide the required information to RFEs and restaurants (or to any 
immediate subsequent recipient), but

[[Page 71036]]

the rule does not require them to do so. RFEs and restaurants should 
work with their suppliers if they believe they are not receiving the 
information required to be provided under Sec.  1.1340(b).
    (Comment 440) Some comments assert that the proposed rule would 
require seafood processors to keep individual shipments separate once 
processing begins, so that the traceability lot code for the 
transformed product would not correspond to a significant amount of 
product from a variety of sources. The comments maintain that if there 
is a public health issue with an individual shipment, the entire 
transformed lot would be implicated.
    (Response 440) Processing of seafood would be considered a 
transformation event. Therefore, unless an exemption applies, the 
seafood processor would be required to maintain records that link the 
traceability lot code (and the other KDEs listed in Sec.  1.1350(a)(1)) 
of the food being used in transformation (the input) to the new 
traceability lot code for the food produced through transformation. 
There is no requirement to limit the number of incoming lots in a 
transformation event. As noted in the comments, if a processor creates 
one traceability lot of product using input from a large number of 
different incoming traceability lots, it is possible that one 
contaminated incoming traceability lot could lead to contamination in 
the entire outgoing traceability lot. However, this risk of 
contaminating a large traceability lot of product exists regardless of 
whether traceability records are maintained. The maintenance of 
traceability records--and especially records of transformation such as 
those set forth in Sec.  1.1350--can help identify which traceability 
lots have been exposed to contamination in a situation such as the one 
described in the comments.
    We note that Sec.  1.1305(h) provides a partial exemption for 
certain commingled non-produce RACs (see Section V.E.9 of this 
document). See Response 208 for a description of when and how this 
partial exemption applies to seafood obtained from a fishing vessel, 
and to seafood that is raised in aquaculture operations. Processors of 
seafood who are subject to this partial exemption may nonetheless 
choose to maintain some form of transformation records (in addition to 
the one-up, one-back records that they may be required to maintain 
under Sec.  1.1305(h)(3)), for example if they are concerned that a 
lack of such records would lead to uncertainty about whether a product 
had been exposed to contamination.
3. Inapplicability of Transformation Requirements to RFEs and 
Restaurants With Respect to Foods They Do Not Ship (Sec.  1.1350(c))
    We proposed that the transformation and creation requirements would 
not apply to RFEs with respect to foods they do not ship (e.g., foods 
they sell or send directly to consumers). We stated in the preamble to 
the proposed rule (85 FR 59984 at 60011) that, as with records of sales 
of FTL foods by RFEs to consumers, we did not believe it was reasonable 
to require RFEs to keep records of transformation for foods they then 
sell directly to consumers (or that they donate or dispose of).
    (Comment 441) Some comments express support for exempting from the 
transformation requirements RFEs that transform food sold directly to 
consumers.
    (Response 441) We received no comments opposing the proposed 
exemption, and we are finalizing it essentially as proposed. Thus, 
Sec.  1.1350(c) specifies that Sec.  1.1350(a) and (b) do not apply to 
RFEs and restaurants with respect to foods they do not ship (e.g., 
foods they sell or send directly to consumers).
    (Comment 442) One comment asks whether restaurants, grocery stores, 
or other commercial kitchens would be considered to be ``transforming'' 
foods. The comment suggests that tracking FTL foods that are being 
transformed or used as an ingredient in another food would not be 
feasible in these locations because they can be ``wet areas'' where it 
is challenging to keep records. Other comments request clarification on 
whether the exemption from the transformation requirements for RFEs 
that sell food directly to consumers would apply to restaurants or 
retailers that operate ``central kitchens'' or commissaries, often 
under common ownership, that prepare food in a larger workspace for 
transfer (by sale or internal transfer) to nearby stores for sale to 
consumers or that provide prepared food to entities such as schools or 
corporate cafeterias for resale to consumers.
    (Response 442) As discussed above, under Sec.  1.1350(c) the 
transformation CTE requirements in Sec.  1.1350(a) and (b) do not apply 
to RFEs and restaurants with respect to food they do not ship. Shipping 
is defined in Sec.  1.1310 as an event in a food's supply chain in 
which a food is arranged for transport (e.g., by truck or ship) from 
one location to another location. The definition goes on to state that 
shipping does not include the sale or shipment of a food directly to a 
consumer or the donation of surplus food; and that shipping does 
include sending an intracompany shipment of food from one location at a 
particular street address of a firm to another location at a different 
street address of the firm. Thus, when an RFE or restaurant sells food 
directly to a consumer, the food is not ``shipped,'' and therefore 
under Sec.  1.1350(c) the transformation CTE requirements in Sec.  
1.1350(a) and (b) do not apply. However, when an entity such as a 
central kitchen prepares food and then ships the food to a restaurant 
or RFE, the exclusion in Sec.  1.1350(c) would not apply. Therefore, if 
the preparation of the food meets the definition of transformation, the 
required KDEs under Sec.  1.1350(a) or (b) would need to be maintained.
    We think this approach appropriately balances feasibility concerns 
with the need for robust traceability records. As previously stated, we 
do not believe it is reasonable to expect RFEs and restaurants to keep 
records on foods they transform and then sell directly to consumers 
(e.g., a salad prepared in a restaurant kitchen and then sold to a 
restaurant customer). However, an entity such as a central kitchen that 
transforms a food and ships it to a business is functioning as a 
manufacturer/processor, and should be well-positioned to keep the 
required records.
    (Comment 443) Some comments request that FDA explicitly state in 
the final rule that repackaging, such as into multipacks or variety 
packs, constitutes transformation and would require the establishment 
of a new traceability lot code. One comment asks whether repacking and 
repackaging are considered transformation events; the comment expresses 
concern that for firms that frequently divide and label lots into 
smaller groups, printing new tags each time could create opportunities 
for error.
    (Response 443) As previously stated, transformation includes 
changing a food (such as by commingling, repacking, or relabeling) or 
its packaging or packing when the output is a food on the FTL. Thus, 
repacking and repackaging are both considered transformation events. 
However, there are some situations (when repacking ``like into like'') 
where the incoming traceability lot code can be maintained (see 
Response 436).

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

    In accordance with section 204(d)(6)(E) and (F) of FSMA, we 
proposed to codify provisions allowing the Agency to modify the subpart 
S

[[Page 71037]]

recordkeeping requirements applicable to certain foods or types of 
entities, or to exempt foods or types of entities from the 
requirements, under certain circumstances. In the following paragraphs, 
we clarify certain aspects of the proposed provisions in response to 
comments we received, but we have made no changes to the provisions and 
are finalizing them as proposed.
1. Circumstances Under Which FDA Will Modify Requirements or Grant 
Exemptions (Sec.  1.1360)
a. General
    We proposed to codify the circumstances under which we would modify 
the requirements in subpart S that apply to a food or type of entity or 
exempt a food or type of entity from the requirements of subpart S. 
Under proposed Sec.  1.1360(a), except as stated in proposed Sec.  
1.1360(b) (discussed below), we would 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.
    We have made no changes to the provisions and are finalizing them 
as proposed.
    (Comment 444) One comment requests that FDA provide examples of how 
the modification and exemption provisions might be applied.
    (Response 444) The standards and procedures surrounding modified 
provisions and exemptions are set forth in Sec. Sec.  1.1360 through 
1.1400. As prescribed by Congress and as stated in Sec.  1.1360(a) of 
the final rule, we will provide modifications and exemptions for 
specific foods or types of entities if we determine that application of 
the relevant requirements is not necessary to protect the public 
health. It is difficult to anticipate all of the various circumstances 
that might lead to such a conclusion.
    (Comment 445) Some comments support the proposed procedures under 
which entities may request exemptions or modified requirements based on 
grounds that application of the requirements that would otherwise apply 
is ``not necessary to protect the public health.'' However, one comment 
maintains that modifications and exemptions based on these grounds 
would be problematic because it would result in inconsistent nationwide 
application and enforcement of the rule. Another comment asserts that 
modified requirements or exemptions in one part of the supply chain 
will affect other parts of the supply chain and may require additional 
modifications and exemptions. The comment requests that FDA consider in 
the preamble the impact on others in the supply chain relative to 
maintaining and sending traceability records/information when it grants 
requests for modified requirements and exemptions. Other comments 
request that we consider the financial impacts to the industry when 
modifying requirements.
    (Response 445) We agree that consistent application and enforcement 
of the rule is important, especially because subpart S depends on the 
sharing of traceability information through the supply chain. As 
provided in Sec.  1.1360(a), we will only grant a modification or 
exemption if we determine that the relevant requirements are not 
necessary to protect the public health. In making this determination, 
we will consider the effect that the modification or exemption would 
have on the entire supply chain, and thus on the traceability of the 
affected foods. A modification or exemption that could impair our 
ability to conduct timely and efficient traceback investigations could 
adversely affect our ability to protect public health, and thus likely 
would not be granted.
    Subpart S already contains several full and partial exemptions, in 
addition to allowing interested parties to petition for modified 
requirements and exemptions. As discussed in Section V.E, the final 
rule contains provisions to address the potential impact of these 
exemptions on other entities in the supply chain, and to clarify the 
responsibilities of entities that receive food from suppliers to whom 
subpart S does not apply. For example, recognizing that some firms 
might not be provided with certain traceability information they are 
required to keep because their suppliers are exempt from the rule, the 
final rule includes special requirements for initial packers (in Sec.  
1.1330(c)) and receivers (in Sec.  1.1345(b)) who receive food from 
persons not subject to subpart S. Under these provisions, we do not 
believe that industry members would be negatively impacted financially 
if we were to grant an exemption or modified requirements to a member 
of their supply chain.
    (Comment 446) One comment asks if retail chains with in-store food 
production will be able to petition for an exemption from 
transformation records.
    (Response 446) Any interested party may submit a citizen petition 
requesting modified requirements or an exemption from the subpart S 
requirements for a food or type of entity, as described in Sec. Sec.  
1.1365 and 1.1370. This may include a request for an exemption from the 
requirements for a particular CTE, such as transformation, as is 
described in the comment. However, we note that under Sec.  1.1350(c) 
of the final rule, RFEs and restaurants are not required to keep 
transformation records related to in-store processing of foods they do 
not ship (e.g., foods they sell or send directly to consumers) (see 
Response 441).
    (Comment 447) One comment suggests that the provisions allowing 
exemptions, modifications, and waivers be used broadly as we collect 
more data on small farms with short supply chains, and asks that these 
provisions of the rule be used to allow modifications and to ensure 
flexibility and appropriateness of scale.
    (Response 447) A specific type of entity, such as farms of a 
specific size that participate in a specific type of supply chain, can 
request an exemption/modified requirements or a waiver, using the 
procedures in Sec.  1.1370 or Sec.  1.1425, respectively, if they think 
they meet the relevant requirements. We agree that these procedures can 
help provide flexibility and appropriateness of scale, for example if a 
petitioner is able to demonstrate that some of the subpart S 
requirements are not necessary (or could be modified) for a certain 
type of entity, in light of the particular circumstances that apply to 
that type of entity. However, we note that these procedures are not 
meant to substitute for the decisions that were made regarding 
exemptions for small entities, as reflected in Sec.  1.1305(a) and (i), 
and Sec.  1.1455(b)(3)(iii).
b. Registered Facilities
    In accordance with section 204(d)(6)(E) and (F) of FSMA, we 
proposed that if a person to whom modified requirements or an exemption 
applied 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 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 (in the subpart J requirements). Proposed 
Sec.  1.1360(b) further stated that such records would have to be

[[Page 71038]]

maintained for 2 years. We are finalizing Sec.  1.1360(b) as proposed.
    (Comment 448) Some comments ask that we clarify in these provisions 
that entities with exemptions, modifications, or waivers still must 
register with FDA as a food facility under the Bioterrorism Act (and 
part 1, subpart H) and follow a ``one-up, one-back'' traceability 
standard.
    (Response 448) Section 1.1360(b), which we proposed in accordance 
with section 204(d)(6)(E) and (F) of FSMA, essentially requires that 
even if a person is subject to modified requirements or an exemption 
from subpart S under Sec.  1.1360(a), the person must keep ``one-up, 
one-back'' traceability records for the FTL foods it handles in 
accordance with Sec. Sec.  1.337 and 1.345 if it is required to 
register as a food facility with respect to the manufacturing, 
processing, packing, or holding of that food. In many cases this will 
not constitute a new requirement, because many entities that are 
required to register as food facilities under subpart H are also 
subject to subpart J, in which case they are already required to keep 
``one-up, one-back'' records under Sec. Sec.  1.337 and 1.345. However, 
under Sec.  1.1360(b), if a person to whom modified requirements or an 
exemption applies under Sec.  1.1360(a) is required to register as a 
food facility under subpart H and is not already subject to subpart J, 
such an entity would have a new obligation, as a result of Sec.  
1.1360(b), to keep ``one-up, one-back'' records in the manner that is 
specified in Sec. Sec.  1.337 and 1.345. Similar provisions in Sec.  
1.1305(h)(3) and (m)(2) operate in the same manner.
    Congress did not specify a similar requirement with respect to the 
waivers of the subpart S requirements that it authorized us to issue 
(see Section V.Q of this document), nor did we choose to create such a 
provision. If FDA waives one or more of the subpart S requirements in 
accordance with Sec.  1.1405, there is no requirement for the entity 
that received the waiver to begin keeping ``one-up, one-back'' records 
if it is not already required to do so. However, a waiver of subpart S 
requirements has no effect on the applicability of subpart J. 
Therefore, if the entity that receives the waiver is subject to subpart 
J, it must continue to comply with that regulation, including (if 
applicable) by keeping ``one-up, one-back'' records under Sec. Sec.  
1.337 and 1.345.
2. Means by Which FDA Will Consider Whether To Adopt Modified 
Requirements or Grant Exemptions (Sec.  1.1365)
    We proposed 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 Sec.  10.30 (21 CFR 10.30) by any 
interested party (proposed Sec.  1.1365). As stated in the preamble to 
the proposed rule (85 FR 59984 at 60013 and 60014), the citizen 
petition regulations in Sec.  10.30 provide standardized procedures for 
asking the Agency to take (or refrain from taking) an administrative 
action. We received no comments on this provision and are finalizing it 
as proposed.
3. Requirements for Citizen Petitions Requesting Modified Requirements 
or an Exemption (Sec.  1.1370)
    Proposed Sec.  1.1370 specified 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 must:
     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)).
    We received no comments on this section and are finalizing it as 
proposed.
4. Public Availability of Information in a Citizen Petition (Sec.  
1.1375)
    We proposed that we would 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 will be made public 
as part of the docket associated with the petition (proposed Sec.  
1.1375).
    We received no comments on this provision and are finalizing it as 
proposed.
5. Process for Citizen Petitions Requesting Modified Requirements or an 
Exemption (Sec.  1.1380)
    We proposed (in Sec.  1.1380) to establish a process for our 
handling of citizen petitions requesting modified requirements or an 
exemption from subpart S. Proposed Sec.  1.1380(a) provided 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) 
specified 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) provided 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)). Finally, proposed Sec.  
1.1380(d) specified that we would 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 received two comments requesting changes to this section. As 
discussed in the following paragraphs, we are declining these requests 
and finalizing the provisions as proposed, with one minor change. The 
only change is that the proposed rule used the word ``notification'' in 
places where the final rule uses the word ``notice'' to refer to a type 
of document published in the Federal Register. This revision, which we 
have made throughout the document on our own initiative, was made to 
align subpart S with the current terminology regarding Federal Register 
documents, and does not change the meaning of these provisions.
    (Comment 449) One comment recommends that we provide timeframes for 
review of petitions for modified requirements, exemptions, and waivers.
    (Response 449) As stated in Sec.  1.1380(a), in general the 
procedures set forth in Sec.  10.30 govern FDA's response to a petition 
requesting modified requirements or an exemption. (The same is true for 
petitions requesting a waiver for a type of entity under Sec.  
1.1435(a).) This includes the timeframes set forth in Sec.  10.30(e). 
We decline to codify different or more specific timeframes for review 
of petitions for modified requirements or exemptions, or for petitions 
requesting a

[[Page 71039]]

waiver for a type of entity. We also decline to codify specific 
timeframes for review of waiver requests for individual entities (see 
Sec. Sec.  1.1415 and 1.1420).
    We anticipate that the circumstances for each petition or waiver 
request will be unique and will likely result in wide variation in the 
time needed to thoroughly review and consider the petition or request. 
We will complete our review of such petitions and requests and issue 
responses as soon as possible given available Agency resources.
    (Comment 450) One comment requests that we announce denials of 
petitions to the public through a Federal Register notice with a 
justification for the denial. The comment asserts that it is not 
sufficient to identify a petition as denied on a list on a website 
without including the justification for the denial, and that providing 
a rationale for denial would allow stakeholders to gain insight into 
FDA's decision-making process and potentially improve subsequent 
petitions.
    (Response 450) We agree that stakeholders have a legitimate 
interest in understanding the rationale for a petition denial. In 
accordance with Sec.  10.30(e)(3), we will place our response to the 
petitioner (which will include the rationale for the denial) in the 
public docket file for the citizen petition. We think that this 
procedure, combined with periodically updating the status of each 
petition in accordance with Sec.  1.1380(d), will provide sufficient 
transparency regarding petition denials. Announcing all denials of 
petitions through a Federal Register notice would require additional 
resources that would not be justified in every case. That said, in 
keeping with Sec.  10.30(e)(3), we may decide in certain cases that it 
is appropriate to announce a denial of a petition through issuance of a 
Federal Register notice.
6. Adopting Modified Requirements or Granting an Exemption on FDA's Own 
Initiative (Sec.  1.1385)
    In proposed Sec.  1.1385 we specified the procedures we would 
follow if, on our own initiative, we adopted modified requirements or 
granted an exemption from the traceability recordkeeping requirements. 
Proposed Sec.  1.1385(a) provided 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 would establish a public docket so that 
interested persons may submit written comments on the proposal. 
Proposed Sec.  1.1385(b) provided 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.
    We received no comments on this section and are finalizing it as 
proposed.
7. When Modified Requirements and Exemptions Become Effective (Sec.  
1.1390)
    Proposed Sec.  1.1390 specified that any modified requirements that 
we adopt or any 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. 
We received no comments on this section and are finalizing it as 
proposed.
8. Circumstances Under Which FDA Might Revise or Revoke Modified 
Requirements or an Exemption (Sec.  1.1395)
    Proposed Sec.  1.1395 specified 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. We 
received no comments on this section and are finalizing it as proposed.
9. Procedures for Revision or Revocation of Modified Requirements or an 
Exemption (Sec.  1.1400)
    We proposed (in Sec.  1.1400(a)) that if we tentatively determine 
that modified requirements or an exemption should be revised or 
revoked, we will provide the following notifications:
     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 (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)).
    Proposed Sec.  1.1400(b) specified that 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. Proposed 
Sec.  1.1400(b) further stated 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.
    We received no comments on these provisions and are finalizing them 
as proposed.

Q. Waiver Procedures (Sec. Sec.  1.1405 to 1.1450)

    In accordance with section 204(d)(1)(I) of FSMA, we proposed to 
establish a process for the issuance of a waiver of the subpart S 
requirements if we determine that application of the requirements would 
result in an economic hardship for an individual entity or a type of 
entity. We received comments seeking clarifications of and 
modifications to these provisions, to which we respond in the following 
paragraphs.
1. Circumstances Under Which FDA Will Waive Requirements (Sec.  1.1405)
    Proposed Sec.  1.1405 specified 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)).
    We are finalizing this provision as proposed.
    (Comment 451) One comment requests that we define ``significantly 
impair'' as used in the waiver provisions and provide examples of what 
might constitute significant impairment of our ability to rapidly and 
effectively identify recipients of a food under the specified 
circumstances.
    (Response 451) We decline to formally define ``significantly 
impair.''

[[Page 71040]]

We anticipate a wide variety of circumstances that could lead to a 
request for a waiver, and we think it will be necessary to apply the 
three criteria set forth in Sec.  1.1405 on a case-by-case basis. The 
use of the phrase ``significantly impair'' in Sec.  1.1405(b) conveys 
that it is not necessary to demonstrate that the proposed waiver would 
have no effect at all on FDA's ability to trace any impacted foods. 
However, if the impact is significant, it would be grounds for denying 
the waiver request.
    (Comment 452) One comment asks that we define ``economic hardship'' 
for purposes of the waiver provisions.
    (Response 452) We decline to formally define ``economic hardship'' 
because the unique circumstances leading to a petition for a waiver on 
grounds of economic hardship may vary widely, and there are likely 
relevant circumstances that may arise that we cannot predict at the 
time of rulemaking. Under Sec.  1.1405(a), the economic hardship for 
the individual entity or type of entity must be due to its unique 
circumstances. In the preamble to the proposed rule (85 FR 59984 at 
60015), we stated that such circumstances might include, but are not 
limited to, issues related to unique business operations or 
geographical factors. We also stated 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. This is because the waiver process in Sec.  1.1405 is not 
meant to substitute for the decisions we made regarding the exemptions 
for small entities, as reflected in Sec.  1.1305(a) and (i), and Sec.  
1.1455(b)(3)(iii). In addition, we anticipate that we will typically 
grant waivers only for sustained or long-term circumstances, rather 
than short-term circumstances such as those some firms may experience 
during an economic downturn.
    (Comment 453) One comment requests that we address in the preamble 
how we will consider the impact of waivers of requirements on entities 
in other parts of the supply chain.
    (Response 453) Under Sec.  1.1405(b), we will only grant a waiver 
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 or misbranded (with respect to allergen 
labeling). In making this determination, we will consider the effect 
that the waiver would have on the entire supply chain, and thus on the 
traceability of the affected foods. We also note that, as discussed in 
Response 445, the final rule contains provisions to clarify the 
responsibilities of entities that receive food from suppliers to whom 
subpart S does not apply (which could include suppliers who are subject 
to a waiver).
    (Comment 454) One comment suggests that in the current economic 
circumstances and pandemic we might receive widespread waiver requests 
based on economic hardship. The comment also maintains that at the same 
time, people recovering from COVID-19 might face increased sensitivity 
to foodborne illness.
    (Response 454) We agree that we may receive a higher number of 
requests for waivers during an economic downturn, including, 
potentially, the circumstances brought on by the COVID-19 pandemic. 
(Though we note that, by the time entities must come into compliance 
with subpart S traceability requirements, the economic conditions 
brought on by the pandemic may have normalized.) In general, as stated 
in Response 452, we anticipate that we will typically grant waivers 
only for sustained or long-term circumstances, rather than short-term 
circumstances such as those some firms may experience during an 
economic downturn. Furthermore, under Sec.  1.1405(b) we will only 
grant a waiver 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 or misbranded with respect to 
allergen labeling; and under Sec.  1.1405(c) we will only grant a 
waiver request if the waiver will not otherwise be contrary to the 
public interest. In evaluating the impact of waivers on the public 
interest, we are cognizant of the fact that certain populations are 
particularly vulnerable to foodborne illness.
2. Mechanisms for Requesting a Waiver (Sec.  1.1410)
    We proposed in Sec.  1.1410 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)).
    We are finalizing this provision as proposed.
    (Comment 455) One comment asks that we define ``individual entity'' 
as to its meaning in the waiver provisions.
    (Response 455) We decline to formally define ``individual entity.'' 
Individual entities requesting a waiver will be able to self-identify 
as an individual entity. Examples of individual entities include, but 
are not limited to, a single farm, packer, distributor, or RFE.
    (Comment 456) One comment asks that we define ``type of entity.''
    (Response 456) We decline to formally define ``type of entity.'' 
Entities of a particular type requesting a waiver will be able to self-
identify as a ``type of entity.'' We note that, under Sec.  1.1425(a), 
a petition requesting a waiver for a type of entity must specify the 
type of entity to which the waiver would apply. In order for a waiver 
to be evaluated and (if granted) carried out, the type of entity must 
be sufficiently delineated so that FDA can clearly identify the 
entities to which the waiver applies.
    (Comment 457) One comment asserts that there should be public 
notice and comment for all waiver requests, regardless of how the 
waiver is sought. The comment maintains that establishing a process for 
consideration of waiver requests that does not allow for public comment 
is inconsistent with the FD&C Act and the APA. The comment asserts that 
section 416(d)(2) of the FD&C Act (21 U.S.C. 350e(d)(2)) requires the 
Secretary to publish waivers and any reasons for the waivers in the 
Federal Register. The comment maintains that by providing one process 
that requires public notice and comment and another that does not, we 
would receive requests that were not subject to public comment and 
would shield waiver decisions from public scrutiny.
    (Response 457) Although Sec.  1.1435 of the final rule provides for 
public notice and comment for waiver requests for a type of entity 
through publication of a Federal Register notice, we decline the 
request to provide for public notice and comment for waiver requests 
for individual entities. We note that section 416(d)(2) of the FD&C Act 
(cited by the comment) applies to requests for waiver from the 
requirements of FDA's regulation on sanitary transportation of foods; 
there is no comparable requirement (in either the FD&C Act or section 
204(d) of FSMA) to publish in

[[Page 71041]]

the Federal Register waiver requests from the food traceability 
recordkeeping requirements in subpart S. We do not believe it is 
necessary or appropriate for information on an individual entity 
seeking a waiver based on economic hardship to be publicized through 
submission of a citizen petition and subsequent publication of a 
Federal Register notice, as individual entity waiver requests will 
focus on the unique economic circumstances of the individual entity 
seeking a waiver, which could necessitate the submission of 
confidential commercial or financial information. We also do not 
believe public comment is necessary for our review of such waiver 
requests. On the other hand, as stated in the preamble to the proposed 
rule (85 FR 59984 at 60015), for waiver requests that concern a type of 
entity, 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 and a notification of the request be published in the 
Federal Register.
3. Requesting a Waiver for an Individual Entity (Sec.  1.1415)
    We proposed in Sec.  1.1415 to specify that a person 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)).
    On our own initiative, we have revised this provision to specify 
that a written request for a waiver for an individual entity must be 
submitted to FDA as described at www.fda.gov. Otherwise, we are 
finalizing this provision as proposed.
    (Comment 458) One comment asks that we provide a clear process for 
what information and documentation an entity will be required to 
provide to have their waiver request approved. The comment maintains 
that the process should be flexible and not cumbersome because 
applicants are likely already facing economic hardship.
    (Response 458) We agree that the process for requesting a waiver 
for an individual entity should be flexible and not cumbersome. We 
believe that Sec.  1.1415 of the final rule, which adopts the waiver 
submission requirements set forth in proposed Sec.  1.1415, adequately 
describes the information that persons seeking a waiver for an 
individual entity must submit to the Agency without prescribing the 
submission of particular documents or particular facts that may or may 
not be relevant to an individual entity's situation. As stated in the 
preamble to the proposed rule (85 FR 59984 at 60016), we anticipate 
that after we publish the final rule, we will establish an electronic 
mailbox to receive requests for waivers for individual entities. In 
addition, we expect to publish on our website information about how to 
submit materials to this electronic mailbox, as well as provide a 
physical FDA address to which waiver requests could be mailed.
4. Process for Request for a Waiver for Individual Entity (Sec.  
1.1420)
    We proposed in Sec.  1.1420(a) 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. In proposed Sec.  1.1420(b) 
we specified 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. We received no 
comments on these provisions and are finalizing them as proposed.
5. Citizen Petition for Waiver for Type of Entity (Sec.  1.1425)
    We proposed in Sec.  1.1425 to specify 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)).
    We received no comments on these provisions and are finalizing them 
as proposed.
6. Public Availability of Information in Citizen Petition Requesting 
Waiver (Sec.  1.1430)
    We proposed in Sec.  1.1430 to 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. We received no comments on this provision and are 
finalizing it as proposed.
7. Process for Citizen Petition Requesting a Waiver (Sec.  1.1435)
    We proposed in Sec.  1.1435(a) to 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

[[Page 71042]]

for a type of entity, including information and views from persons who 
could be affected by the waiver if the petition were to be granted.
    Proposed Sec.  1.1435(c) stated that 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)).
    Finally, proposed Sec.  1.1435(d) specified 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).
    We received two comments that relate both to these provisions and 
to the similar provisions in Sec.  1.1380 regarding the process for a 
petition requesting modified requirements or an exemption. Those 
comments are addressed above (see Section V.P.5 of this document). We 
are finalizing Sec.  1.1435 as proposed.
8. Process for Granting Waivers on FDA's Own Initiative (Sec.  1.1440)
    We proposed in Sec.  1.1440(a) 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 would establish a public 
docket so that interested persons may submit written comments on the 
proposal. Proposed Sec.  1.1440(b) specified 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 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.
    We received no comments on these provisions and are finalizing them 
as proposed.
9. Circumstances Under Which FDA May Modify or Revoke a Waiver (Sec.  
1.1445)
    We proposed in Sec.  1.1445 to specify 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)).
    As discussed in the paragraphs below, we received one comment on 
this provision. We are finalizing this provision as proposed.
    (Comment 459) One comment states that FDA should provide a citizen 
petition process for modifying and revoking waivers that allows 
presentation of data to the Agency for reconsidering waivers.
    (Response 459) FDA's citizen petition regulation in Sec.  10.30 
provides standardized procedures for requesting that we take (or 
refrain from taking) an administrative action. While we expect that 
under most circumstances we would initiate any effort to modify or 
revoke a waiver, a person could submit a citizen petition in accordance 
with Sec.  10.30(b) asking that we modify or revoke a waiver, and could 
include any data they wish to share with the Agency. Under Sec.  
10.30(d), any interested person could submit comments (including data) 
to the docket established for any such petition.
10. Procedures for Modification or Revocation of a Waiver (Sec.  
1.1450)
    As with procedures for requests for waivers, we proposed to 
establish different procedures for modifications and revocations of 
waivers for (1) individual entities and (2) types of entities. We 
proposed in Sec.  1.1450(a)(1) to specify 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. We further proposed that the notice will provide 
the waiver recipient 60 days in which to submit information stating why 
the waiver should not be modified or revoked. Under proposed Sec.  
1.1450(a)(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. The provision further stated 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) specified 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) 
specified that we will also 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 
provision further stated 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) provided that, 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. Proposed Sec.  1.1450(b)(2) further stated 
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.
    We received no comments on these provisions and are finalizing them 
as proposed.

R. Records Maintenance and Availability (Sec.  1.1455)

    We proposed to adopt several requirements concerning the 
maintenance and availability of records required under subpart S. In 
response to comments received and on our own initiative, we have made 
changes to some of these provisions, primarily those concerning records 
availability.
1. General Requirements for Records
    We proposed to 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)(1)). We also proposed to require that all 
records be legible and stored to prevent deterioration or loss 
(proposed Sec.  1.1455(a)(2)).
    On our own initiative, we have added to Sec.  1.1455(a)(1) a 
statement that electronic records may include valid,

[[Page 71043]]

working electronic links to the information required to be maintained 
under subpart S, to make clear that entities may use electronic links 
(e.g., to databases or websites) to meet their recordkeeping 
requirements under the rule.
    We respond to the comments we received on proposed Sec.  1.1455(a) 
in the following paragraphs.
    (Comment 460) Many comments assert that the proposed rule creates a 
de facto requirement for firms to maintain their records 
electronically, which the comments assert is contrary to section 
204(d)(1)(C) of FSMA. One comment maintains that retailers in 
particular would be unable to comply with the electronic sortable 
spreadsheet requirement (in proposed Sec.  1.1455(b)(3)) unless their 
suppliers keep electronic records and the retailer has a system to 
accept and store that electronic data. Another comment maintains that 
Congress intended for this rule to require only paper records in order 
to protect farmers who may lack access to computers and other 
technology. One comment points to the volume of information required in 
the KDEs and the preamble discussion of a master data plan as evidence 
that paper records would be inadequate and that electronic records are 
therefore a de facto requirement of the rule. Some comments reference 
the quantity of traceability information required to be gathered and 
stored by firms of all sizes and maintains that the estimates for one-
time capital investment in the Preliminary Regulatory Impact Analysis 
(PRIA) for the rule seems to imply that FDA assumes a firm will need to 
invest in technology. The comments note that section 204(d)(1)(G) of 
FSMA states that the recordkeeping requirements we adopt must, to the 
extent practicable, not require a facility to change business systems 
to comply with the requirements.
    (Response 460) We do not agree that the proposed rule creates a de 
facto requirement for firms to maintain their records electronically, 
nor do we think that the rule violates section 204(d)(1)(C) of FSMA, 
which states that the rule shall not prescribe specific technologies 
for the maintenance of records. Under Sec.  1.1455(a)(1) of the final 
rule, subpart S records may be maintained on paper, electronically, or 
as true copies. In certain circumstances when the public health is 
threatened, we may request that information about specific foods and 
specific date ranges (or traceability lot code ranges) be provided to 
us in an electronic sortable spreadsheet in accordance with Sec.  
1.1455(c)(3)(ii); but we believe that firms that maintain their records 
on paper will be able to create such a spreadsheet, using the 
information contained in their paper records, under those limited 
circumstances. Moreover, we note that Sec.  1.1455(c)(3)(ii) does not 
prescribe a specific technology for creating the sortable spreadsheet.
    Regarding FSMA section 204(d)(1)(G), although we recognize that 
there may be incentives or in some cases market pressures for entities 
to adopt electronic recordkeeping for traceability, and some entities 
may find it beneficial to invest in new technology to keep traceability 
records, the rule itself does not require entities to replace their 
paper-based systems with electronic records. Estimates of capital 
investment costs in section II.F of the FRIA assume that some (but not 
all) entities will choose to adopt new technologies or update their 
existing ones in light of the rule (Ref. 16). In particular, the 
capital investment cost estimates in the FRIA reflect a prediction that 
adoption of technologies for traceability will depend on a firm's size, 
industry, position in the supply chain, products, and existing 
traceability systems, as well as whether the firm decides to adopt an 
electronic recordkeeping system as a result of this rule.
    (Comment 461) One comment refers to FDA's statements in the 
preamble to the proposed rule encouraging the use of electronic records 
for traceability and maintains that regulators take preambles seriously 
(as the comment contends has occurred with the produce safety 
regulation), which the comment asserts is problematic due to an 
unconstitutional lack of notice and arbitrary enforcement of 
requirements. The comment maintains that a rule or statute is 
unconstitutional when it fails to provide the regulated entity or 
person with fair notice of the compliance requirements and/or allows 
for arbitrary and discriminatory enforcement. The comment asks that we 
include paper recordkeeping options especially for farms that may not 
have access to electronic recordkeeping technology. The comment also 
recommends that we delete the electronic spreadsheet requirement and 
ensure that additional technology is not included as a requirement in 
the final rule or encouraged in the preamble to the final rule.
    (Response 461) As stated in Response 460, the final rule does not 
require the use of electronic records. Although we continue to 
encourage all parts of the food industry to adopt electronic 
recordkeeping for traceability, firms are not required to do so, and we 
will not take any regulatory action against a firm for keeping required 
subpart S records in paper form. (Indeed, Sec.  1.1455(a)(1) makes it 
clear that we could not take any such action.) With respect to the 
electronic sortable spreadsheet requirement in Sec.  1.1455(c)(3)(ii) 
of the final rule, as discussed in Section V.R.3 of this document, this 
provision requires that information on certain FTL foods be provided to 
us in an electronic sortable spreadsheet format only in certain limited 
circumstances involving an outbreak investigation, a product recall, or 
some other public health threat; it does not require the maintenance of 
records in electronic form. We also note that the final rule includes 
exemptions from the sortable spreadsheet requirement (see Sec.  
1.1455(c)(3)(iii)), which we have included in response to comments 
arguing that smaller entities would have difficulty complying with this 
requirement. This includes an exemption in Sec.  1.1455(c)(3)(iii)(A) 
for farms with average annual sales of $250,000 or less (see Section 
V.R.3 of this document).
    (Comment 462) One comment asks whether paper records would also be 
required if a firm keeps records in electronic form.
    (Response 462) If a firm keeps records in electronic form, it is 
not also required to keep paper versions of those records. Under Sec.  
1.1315(a)(1), a firm's traceability plan must include a description of 
the procedures the firm uses to maintain the required subpart S 
records, including the format and location of such records. When FDA 
makes a records request under Sec.  1.1455(c), we will expect the 
records to be in the format described in the traceability plan. If the 
traceability plan states that the firm maintains its records 
electronically and the firm provides us with electronic records, we 
would not expect to also be provided with paper records.
    (Comment 463) One comment requests clarity on what information 
firms will be required to made available to FDA vs. what must be shared 
with the supply chain.
    (Response 463) All records required under the rule must be made 
available to the Agency upon request in accordance with Sec.  1.1455. 
This includes the traceability plan that is described in Sec.  1.1315, 
the records of CTEs that are described in Sec. Sec.  1.1325 through 
1.1350, and (under specified circumstances) the sortable spreadsheet 
that is described in Sec.  1.1455(c)(3)(ii).
    The only information that is required to be shared within the 
supply chain is the information for which this is explicitly stated in 
the rule.

[[Page 71044]]

Specifically, certain information must be provided to other entities in 
the supply chain by harvesters and coolers of FTL foods in accordance 
with Sec.  1.1325(a)(2) and (b)(2) (see Section V.J of this document) 
and by shippers in accordance with Sec.  1.1340(b) (see Section V.M of 
this document).
    (Comment 464) Some comments urge us to provide a written request 
that includes the specific records that we request.
    (Response 464) As further discussed below, we have concluded that 
in the exigent circumstances described in Sec.  1.1455(c)(3), it may be 
necessary for us to make a records request by phone. Section 
1.1455(c)(3)(i) specifies that if the request is made by phone, we will 
also provide the request to the firm in writing if asked to do so by 
the firm. For requests that are made in person--either under the 
exigent circumstances described in Sec.  1.1455(c)(3) or during a 
routine inspection--we will work with the firm to ensure that the 
request is understood, including by providing the request in writing as 
needed.
2. Establishment and Maintenance of Records by Another Entity
    We received several comments asking whether third parties may keep 
records on behalf of a covered entity. In response to the comments, we 
are adding a provision to the codified (in Sec.  1.1455(b)) concerning 
establishment and maintenance of records by another entity, as 
discussed in the following paragraphs.
    (Comment 465) One comment requests clarity on the ability of 
previous handlers of the food to maintain records on an entity's behalf 
with the understanding that the records must be accessible within 24 
hours. Some comments express appreciation for FDA indicating in the 
preamble to the proposed rule that firms can enter into agreements with 
a third party to create records for them. One comment maintains that 
such agreements would be a viable option for entities that only hold 
FTL foods but do not own them. One comment asks if a shipper could 
maintain records of a product specifically grown for that shipper, or 
if both the grower and shipper had to maintain the records. Some 
comments request that we adopt a provision to accommodate agreements to 
keep records on behalf of entities subject to subpart S.
    (Response 465) As stated in the preamble to the proposed rule (85 
FR 59984 at 60004), we believe it is appropriate that persons subject 
to subpart S be allowed to enter into agreements with individuals or 
firms to create and keep the records they are required to maintain 
under the rule, including, but not limited to, records documenting KDEs 
for the CTEs the person performs. As we stated, this might entail firms 
hiring consultants or other outside entities to conduct their required 
recordkeeping, or relying on supply chain partners such as brokers or 
suppliers to establish and maintain records on their behalf. In 
response to comments requesting further clarity on this topic, Sec.  
1.1455(b) of the final rule specifies that a person subject to subpart 
S may have another entity establish and maintain records required under 
subpart S on that person's behalf, although the person subject to 
subpart S requirements is responsible for ensuring that such records 
can be retrieved and provided onsite within 24 hours of request for 
official review. In addition, it should be noted that if a person 
covered by the rule has another entity establish and maintain required 
subpart S records on its behalf, the covered person must include 
information on the arrangement in its traceability plan in accordance 
with Sec.  1.1315(a)(1).
    In response to the question about shippers maintaining records of a 
product grown specifically for the shipper, we note that the final rule 
no longer has requirements for the CTE of growing. However, Sec.  
1.1455(b) allows for the flexibility to make arrangements for any 
entity to establish and maintain records on behalf of a covered entity, 
as described above. This could include, for example, an arrangement 
between a shipper (who may also be the initial packer) and a harvester 
under which the shipper maintains the required harvesting records under 
Sec.  1.1325(a) on behalf of the harvester. If requested by FDA, it 
would still be the responsibility of the harvester to make the records 
available within 24 hours.
3. Record Availability (Sec.  1.1455(c))
a. Making Records Available Within 24 Hours of Request
    We proposed to require that persons make all records required under 
subpart S available to an authorized FDA representative as soon as 
possible but not later than 24 hours after the request (proposed Sec.  
1.1455(b)(1)).
    On our own initiative, we have added a clarification that records 
must be made available to an authorized FDA representative ``upon 
request.'' We also have added a requirement that, in addition to 
records required under subpart S, firms must make available any 
information needed to understand the records, such as internal or 
external coding systems, glossaries, abbreviations, and a description 
of how the records the firm provides correspond to the information 
required under subpart S. We conclude that it is more appropriate that 
this information be provided in response to our requests to review 
records under Sec.  1.1455(c) rather than maintained as a part of a 
firm's traceability plan (formerly ``traceability program records''), 
as would have been required under proposed Sec.  1.1315(a)(4).
    In response to comments received, we have made other changes to 
proposed Sec.  1.1455(b)(1) (finalized as Sec.  1.1455(c)(1)), as 
discussed in the following paragraphs.
    (Comment 466) One comment asserts that the proposed rule would 
permit FDA to request records only after a foodborne illness outbreak 
has occurred, limiting an entity's incentive to comply with the 
requirements of the rule and reducing FDA's ability to conduct an 
effective traceback in the event of an outbreak. The comment maintains 
that firms would be more likely to comply with the regulations if FDA 
were granted the authority to inspect records on a periodic basis. The 
comment further asserts that periodic inspections would help ensure the 
accuracy and efficiency of traceback investigations, which would 
improve public health, limit the scope of recalls, and limit 
unnecessary disposal of food.
    (Response 466) The comment misunderstands the proposed rule, which 
stated (in proposed Sec.  1.1455(b)(1)) that covered entities must make 
all records required under subpart S available to an authorized FDA 
representative as soon as possible but not later than 24 hours after 
the request. That provision was not limited to outbreak situations. 
Similarly, under Sec.  1.1455(c)(1) of the final rule, FDA may request 
review of a firm's subpart S records at any time, regardless of whether 
we have reason to believe that the firm might have handled an FTL food 
suspected of being a source of a foodborne illness outbreak. This is in 
keeping with section 204(d)(1)(H) of FSMA, which states that this 
rulemaking must allow covered entities 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 the 
Agency's request.
    We agree with the comment that periodic inspections of traceability 
records can have a positive impact on public health by ensuring that 
covered entities are appropriately maintaining the required records 
such that they will be available and complete when needed during a 
traceback investigation. As

[[Page 71045]]

discussed in Section V.U of this document, we expect to conduct routine 
records inspections to ensure that entities subject to the final rule 
are satisfying the rule's requirements.
    We note that Sec.  1.1455(c)(3) (discussed below) contains specific 
requirements that would only apply in the event of a foodborne illness 
outbreak, recall, or other public health threat. This includes the 
electronic sortable spreadsheet requirement set forth in Sec.  
1.1455(c)(3)(ii). Thus, covered entities would only be required to 
provide FDA with an electronic sortable spreadsheet during the 
circumstances described in Sec.  1.1455(c)(3). During a routine 
inspection that does not meet the conditions described in Sec.  
1.1455(c)(3), a covered entity would not be required to provide FDA 
with an electronic sortable spreadsheet.
    (Comment 467) Some comments ask that any request we make for 
traceability records maintained by a foreign entity and related to an 
imported food be communicated through the U.S. importer of the food. 
The comments express concern that we will place direct responsibility 
on foreign entities to comply with reporting obligations.
    (Response 467) We decline this request. For the subpart S 
requirements to function as intended, all covered supply chain 
entities, both domestic and foreign, must maintain and provide 
traceability information as required under the rule. FDA may conduct 
onsite inspections of foreign entities to determine compliance with 
regulatory requirements, including those in subpart S, and we may 
communicate directly with foreign entities during our evaluation of 
inspectional outcomes or corrective actions. During an outbreak 
investigation involving an FTL food, we might seek to obtain 
information directly from foreign entities in the food's supply chain, 
through the U.S. importer of the food, or through other means. All 
entities in the supply chain who manufacture, process, pack, or hold 
the FTL food, whether foreign or domestic, will need to determine how 
they will maintain required records and make them available to us upon 
request (unless the entity is subject to an exemption). As previously 
stated, Sec.  1.1455(b) of the final rule allows firms to have another 
entity establish and maintain subpart S records on their behalf, 
although covered firms remain responsible for ensuring that the records 
are provided onsite to us within 24 hours of our request for the 
records. Thus, foreign entities may enter into an agreement with their 
U.S. importer or another entity to maintain records on their behalf, 
while remaining responsible for compliance with applicable subpart S 
requirements.
    (Comment 468) Several comments request that the rule allow 48 hours 
rather than 24 hours in which to make requested records available.
    (Response 468) We continue to believe that in most cases 24 hours 
is an adequate length of time in which to make requested subpart S 
records available to us, and we note that this is in keeping with 
section 204(d)(1)(H) of FSMA, which states that this rulemaking must 
allow covered entities 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 the Agency's request. 
However, we recognize that additional time might be appropriate in 
certain situations, such as when we are requesting a particularly large 
volume of records. Therefore, Sec.  1.1455(c)(1) of the final rule 
specifies that records must be made available to us within 24 hours 
after our request or within some reasonable time to which FDA has 
agreed. Similar language has been added to Sec.  1.1455(c)(3), which 
addresses records requests that are 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. As discussed below, in the circumstances described in 
Sec.  1.1455(c), the 24-hour time period can begin with a remote 
request (e.g., a request made by phone).
    (Comment 469) Some comments ask who is responsible for providing 
records to FDA and who will receive records at FDA.
    (Response 469) The covered entity who receives a request for 
records from FDA is responsible for providing the records they are 
required to maintain under the rule. It is possible that we might 
request records for a particular FTL food from multiple covered 
entities in the same supply chain. Regardless of whether or not this is 
the case, each entity of whom we request records is required to provide 
us with the records they are required to maintain under subpart S. We 
will provide the firm from which we request records with a point of 
contact for submitting the records to us, as we currently do when we 
request records from industry. In many situations the point of contact 
is the local FDA office, but in some cases in might be the offices of 
our regulatory partners, such as a State regulatory agency. In 
accordance with section 204(c) of FSMA, we intend to establish a 
product tracing system for the receipt of food traceability 
information, which could include an electronic portal for the 
submission of information to the Agency.
b. Offsite Storage of Records
    We proposed that offsite storage of records would be permitted if 
such records can be retrieved and provided onsite within 24 hours of 
request for official review, and that electronic records would be 
considered onsite if they are accessible from an onsite location 
(proposed Sec.  1.1455(b)(2)). We did not receive any comments on this 
provision and are finalizing it (in Sec.  1.1455(c)(2)) as proposed.
c. Provision of Electronic Sortable Spreadsheet in Outbreak/Recall/
Public Health Threat Situation
    In Sec.  1.1455(b)(3), we proposed to require, 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 FD&C Act or misbranded under 
section 403(w) of the FD&C Act, that entities 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 FDA's request. We also proposed that we 
would withdraw a request for such a spreadsheet when necessary to 
accommodate a religious belief of a person asked to provide such a 
spreadsheet.
    In response to comments received, we have made several changes to 
these proposed requirements, including exempting certain small entities 
from the requirement to provide an electronic sortable spreadsheet, as 
discussed in the following paragraphs.
    (Comment 470) Many comments state that producing and providing an 
electronic sortable spreadsheet to FDA within 24 hours would be 
prohibitively difficult for entities of all sizes. One comment 
maintains that compiling location data into an electronic sortable 
spreadsheet in 24 hours is particularly burdensome. One comment 
maintains that the 24-hour deadline could result in data errors. Some 
comments urge us to create a mechanism by which industry

[[Page 71046]]

can request additional time to make the information available, 
particularly if the records request is large; alternatively, these 
comments ask that we consider prioritizing what information might be 
made available to us most quickly for a large request. Some comments 
recommend either removing the requirement entirely or providing more 
time to provide the spreadsheet. One comment asks that we consider 
exercising enforcement discretion regarding this requirement when 
entities make a good faith effort to comply in a timely manner.
    (Response 470) As discussed in the preamble to the proposed rule 
(85 FR 59984 at 60018), we believe that the electronic sortable 
spreadsheet requirement will be one of the most effective ways to 
improve the speed and efficiency of our traceback efforts during a 
foodborne illness outbreak or other threat to public health. We will 
only request an electronic sortable 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 otherwise address a threat to the public 
health, and we will only request information on the FTL foods that may 
be associated with the outbreak, recall, or other threat to public 
health.
    We believe 24 hours generally is a reasonable timeframe in which to 
provide a requested electronic sortable spreadsheet given the limited 
circumstances, limited scope, and urgent nature of these requests. Such 
spreadsheets can be created using software that is readily available 
and commonly used for other general business purposes. However, in some 
circumstances we agree it may be appropriate to provide a firm with 
additional time to make the electronic sortable spreadsheet available 
to FDA. For a large records request, for example, a firm that does not 
maintain records electronically may need to manually enter a 
considerable amount of information into such software to create an 
electronic sortable spreadsheet. We agree that it may be reasonable for 
FDA to extend the 24-hour timeframe in such circumstances, for some or 
all of the information we request. Therefore, Sec.  1.1455(c)(3) of the 
final rule specifies that, as under Sec.  1.1455(c)(1), the information 
requested in these exigent circumstances must be made available to us 
within 24 hours or within some reasonable time to which FDA has agreed. 
In determining what timeframes are reasonable, we will consider the 
specific circumstances, including an entity's effort to comply in a 
timely manner.
    However, we recognize that some smaller entities may be less likely 
to have the resources to produce the traceability information requested 
in these exigent circumstances in an electronic sortable spreadsheet 
format. Therefore, we are exempting certain smaller entities, including 
certain smaller farms, RFEs, restaurants, and other entities, from the 
requirement to provide the requested information in an electronic 
sortable spreadsheet. To make clear what information must be included 
in an electronic sortable spreadsheet while specifying that certain 
smaller entities may provide this information in a different form, 
Sec.  1.1455(c)(3)(ii) provides that except as specified in Sec.  
1.1455(c)(3)(iii) and (iv), when the information FDA requests under 
Sec.  1.1455(c)(3) is information a person is required to maintain 
under Sec. Sec.  1.1325 through 1.1350 (i.e., records of CTEs), the 
person must provide the information in an electronic sortable 
spreadsheet, along with any other information needed to understand the 
information in the spreadsheet. Under Sec.  1.1455(c)(3)(iii), a person 
may provide the information we request under Sec.  1.1455(c)(3) in a 
form other than an electronic sortable spreadsheet if they are:
     A farm whose average annual sum of the monetary value of 
their sales of RACs and the market value of RACs they manufacture, 
process, pack, or hold without sale (e.g., held for a fee) during the 
previous 3-year period is no more than $250,000 (on a rolling basis), 
adjusted for inflation using 2020 as the baseline year for calculating 
the adjustment (Sec.  1.1455(c)(3)(iii)(A));
     An RFE or restaurant with an average annual monetary value 
of food sold or provided during the previous 3-year period of no more 
than $1 million (on a rolling basis), adjusted for inflation using 2020 
as the baseline year for calculating the adjustment (Sec.  
1.1455(c)(3)(iii)(B)); or
     A person (other than a farm, RFE, or restaurant) whose 
average annual sum of the monetary value of their sales of food and the 
market value of food they manufacture, process, pack, or hold without 
sale (e.g., held for a fee) during the previous 3-year period is no 
more than $1 million (on a rolling basis), adjusted for inflation using 
2020 as the baseline year for calculating the adjustment (Sec.  
1.1455(c)(3)(iii)(C)).
    Entities not required to make the requested information available 
to us in an electronic sortable spreadsheet format must provide the 
information in a different form, such as paper records or electronic 
records that are not compiled in a sortable spreadsheet. For firms that 
are not exempt from the electronic sortable spreadsheet requirement in 
Sec.  1.1455(c)(3)(ii), we intend to provide guidance and technical 
assistance to help entities comply, including potentially providing an 
electronic template for entering information into a sortable 
spreadsheet format.
    (Comment 471) One comment requested flexibility for the requirement 
to provide electronic records to the FDA for firms that, for religious 
reasons, do not use electronic recordkeeping.
    (Response 471) As indicated in proposed Sec.  1.1455(b)(3), we 
agree that it is appropriate to accommodate the religious beliefs of 
persons asked to provide an electronic sortable spreadsheet. Therefore, 
the final rule specifies that we will withdraw a request for an 
electronic sortable spreadsheet under Sec.  1.1455(c)(3)(ii), as 
appropriate, to accommodate a religious belief of a person asked to 
provide such a spreadsheet (Sec.  1.1455(c)(3)(iv)).
    (Comment 472) One comment states that the electronic sortable 
spreadsheet requirement in proposed Sec.  1.1455(b)(1)(3) violates 
section 204(d)(1)(E) of FSMA, which states that the recordkeeping 
requirements for FTL foods must 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. The 
comment maintains that because the electronic sortable spreadsheet 
would have to be provided within 24 hours of request, some firms might 
be concerned with their ability to assemble such a spreadsheet in that 
timeframe and might therefore consolidate their records daily to be 
prepared for the possibility of a request, thereby creating duplicate 
records.
    (Response 472) We do not agree that the electronic sortable 
spreadsheet requirement necessitates the creation and maintenance of 
duplicate records. FDA may request an electronic sortable spreadsheet 
containing information on certain FTL foods in the limited exigent 
circumstance specified in Sec.  1.1455(c)(3). Firms are not required to 
prepare an electronic sortable spreadsheet daily or to otherwise 
consolidate or duplicate records in preparation for such a request. 
While we encourage firms to prepare for having to respond to a request 
for an electronic sortable spreadsheet under Sec.  1.1455(c)(3)(ii), 
including maintaining their records in an organized manner to 
facilitate the preparation of such a spreadsheet, we do not anticipate 
that firms will choose

[[Page 71047]]

to maintain their subpart S records in one manner and then duplicate 
those records each day to be prepared for a spreadsheet request from 
FDA.
    (Comment 473) One comment asks what information each firm will 
receive from FDA (e.g., during an outbreak investigation) to use for 
looking up the records they must include in their electronic sortable 
spreadsheet. Some comments suggest that our implementation of the rule 
should limit the scope of information requested and the number of 
requests.
    (Response 473) Under Sec.  1.1455(c)(3), when necessary to 
facilitate an outbreak investigation, assist in a recall, or otherwise 
address a threat to the public health, FDA will specify the particular 
FTL foods for which we need to review CTE/KDE records, focusing on 
particular dates on which the food was handled and/or particular 
traceability lot codes of such foods. Our request will make clear the 
specific foods and the date ranges (or traceability lot codes) for 
which we seek required traceability information. We will strive to 
tailor the information request as much as possible so that firms can 
focus their efforts on the most relevant information. As discussed 
below, we have concluded that in the exigent circumstances described in 
Sec.  1.1455(c)(3), it may be necessary for us to make a records 
request by phone. Section 1.1455(c)(3)(i) specifies that if the request 
is made by phone, we will also provide the request in writing upon the 
firm's request; however, the firm must provide the requested 
information within 24 hours (or within some reasonable time to which 
FDA has agreed) of the phone request. For requests that we make in 
person, we will work with the firm to ensure that the request is 
understood, including by providing the request in writing as needed.
    (Comment 474) Several comments ask that we clarify how we will 
request an electronic sortable spreadsheet containing the required 
information. Some comments ask whether we will make the request 
verbally or in writing. One comment asks that we clarify how an 
electronic sortable spreadsheet containing the information we request 
may be made available to FDA.
    (Response 474) We have revised the proposal to specify that our 
request for information under Sec.  1.1455(c)(3) of the final rule may 
be made in-person or remotely (e.g., by phone) by an authorized FDA 
representative. In addition, Sec.  1.1455(c)(3)(i) specifies that if 
our request for the information specified in Sec.  1.1455(c)(3) is made 
by phone, we will also provide the request in writing upon request; 
however, the requested information must be provided within 24 hours (or 
within some reasonable time to which FDA has agreed) of the phone 
request. This is the case for any information we request under the 
exigent circumstances described in Sec.  1.1455(c)(3), even if we are 
not requesting that the information be provided in an electronic 
sortable spreadsheet (e.g., if the entity is exempt from the electronic 
sortable spreadsheet requirement under Sec.  1.1455(c)(3)(iii)).
    We are currently considering various mechanisms by which electronic 
sortable spreadsheets, as well as digitized records and other requested 
information, can be made available to FDA. Approaches under 
consideration include sending requested information to a dedicated 
email box or through an online reporting mechanism, such as a web-based 
portal to allow for submission of traceability information that we 
might create in accordance with section 204(c) of FSMA (see Response 
522). A request for records under Sec.  1.1455(c)(3) will specify how 
the information may be shared with FDA. In addition, we expect to issue 
communication on how firms may make electronic sortable spreadsheets 
and records (whether in paper or electronic form) available to FDA.
    (Comment 475) Some comments ask that we clarify when the 24-hour 
deadline associated with the electronic sortable spreadsheet 
requirement begins.
    (Response 475) Under Sec.  1.1455(c)(3) of the final rule, the 24-
hour period (or other reasonable time to which FDA has agreed) in which 
the requested information must be provided begins when we issue the 
request, whether we do so in person or remotely (e.g., by phone).
    (Comment 476) Some comments assert that use of electronic 
spreadsheets might compromise data quality and impede analysis. The 
comments suggest that we specify a structured data format such as 
Extensible Markup Language (XML) or JavaScript Object Notation (JSON) 
to maintain accuracy and data integrity during large-scale information 
exchange.
    (Response 476) We do not agree that use of an electronic sortable 
spreadsheet will adversely affect the quality of firms' data or our 
ability to analyze the data. Although there is a potential for human 
error for firms that input information from paper records into an 
electronic spreadsheet, we do not believe this will be a particularly 
difficult or complex process, and any accuracy concerns will be far 
outweighed by the benefits of having access to comprehensive 
information in a sortable manner, considerably enhancing our ability to 
analyze the data more quickly and effectively. As discussed in Response 
400, one of the KDEs that we may request as part of the electronic 
sortable spreadsheet is the reference document type and number for a 
given CTE. This information will allow us to refer back to the original 
reference document (whether paper or electronic) where the information 
was maintained, which may help reconcile any data errors that may occur 
in the spreadsheet.
    We agree that structured data formats promote data accuracy and 
integrity, especially during large-scale information exchange. We will 
take this into consideration as an option as we work to develop a range 
of methods for providing the data required in the electronic sortable 
spreadsheet to FDA.
d. English Translation of Records in Another Language
    We proposed in Sec.  1.1455(b)(4) that upon FDA request, a person 
subject to the rule must provide within a reasonable time an English 
translation of records maintained in a language other than English. On 
our own initiative, we are adding language to clarify that proposed 
Sec.  1.1455(b)(4) (which is finalized as Sec.  1.1455(c)(4)) refers 
only to records required under subpart S. We are otherwise finalizing 
the provision as proposed.
    (Comment 477) One comment asserts that we made assumptions that 
downplay the complexity of the supply chain in putting together supply 
chain examples. The comment asserts that we assumed any required KDEs 
would be in English or easily understood as information passes through 
the supply chain, and maintains that some foods on the FTL, 
particularly seafood, move through many countries where English is not 
the first language.
    (Response 477) For the purposes of creating supply chain examples, 
we chose to provide examples in which all the KDEs were maintained in 
English. However, covered entities may keep records required under 
subpart S in any language, provided that, in accordance with Sec.  
1.1455(c)(4) of the final rule, the entity can make available to us 
within a reasonable time an English translation of subpart S records 
that are maintained in another language. Records in a language other 
than English have to be translated into English only if we request such 
a translation. We recognize that the fact that subpart S records may be 
maintained in any language may necessitate that firms work with their 
supply chain partners to ensure that information provided (such as by 
shippers to their customers) is readily

[[Page 71048]]

understood, but the need to understand information from other supply 
chain entities exists regardless of traceability recordkeeping 
requirements.
4. Record Retention
    We proposed to require, except as specified otherwise in subpart S, 
that persons subject to the rule maintain records containing the 
information required by subpart S for 2 years from the date the person 
created the records (proposed Sec.  1.1455(c)). We are finalizing this 
provision at Sec.  1.1455(d), with one minor edit as described below.
    (Comment 478) One comment recommends that FDA require only the 
program records to be maintained for 2 years. The comment suggests that 
all other traceability records should only be maintained for 1 year.
    (Response 478) We decline to make this change. As stated in the 
preamble to the proposed rule (85 FR 59984 at 60018), although 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 (WGS) and other 
evidence months or even years after the food was sold. Exposure and 
consumption information collected from illness cases can be compared to 
information from past cases of illness with the same WGS pattern, and 
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, reviewing food 
production records up to 2 years old could help us determine whether a 
current foodborne illness outbreak was part of a long-standing 
contamination problem with a food or firm. There are also some foods on 
the FTL with a long shelf life, such as various frozen seafood 
products. Therefore, Sec.  1.1455(d) of the final rule requires that, 
except as specified otherwise in subpart S (e.g., records maintained by 
an RFE or restaurant that is subject to the partial exemption in Sec.  
1.1305(j) because they purchase food directly from a farm), persons 
subject to the rule must maintain records containing the information 
required by subpart S for 2 years from the date the entity created or 
obtained the records. (On our own initiative, we added the reference to 
records ``obtained'' to reflect that in some situations firms may rely 
on records they receive from others rather than creating the records 
themselves.)
5. Electronic Records
    We proposed to specify 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) are exempt from 
the requirements of part 11 (21 CFR part 11), which concern electronic 
records and signatures (proposed Sec.  1.1455(d)). We further proposed 
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. We did 
not receive any comments on these provisions and are finalizing them 
(at Sec.  1.1455(e)) as proposed.
6. Use of Existing Records and Multiple Sets of Records
    We proposed to require that persons subject to the rule do not need 
to duplicate existing records (e.g., records kept in the ordinary 
course of business or maintained to comply with other Federal, State, 
Tribal, territorial, or local regulations) if they contain the 
information required by subpart S (proposed Sec.  1.1455(e)). We 
further proposed that a covered person may supplement any such existing 
records as necessary to include all of the information required by 
subpart S. Finally, we proposed that persons do not have to keep all of 
the information required by subpart S in one set of records, but they 
must indicate the different records in which the information is kept in 
accordance with proposed Sec.  1.1315(a)).
    In Sec.  1.1455(f) of the final rule, we are finalizing the 
provisions on the use of existing records as proposed. On our own 
initiative, we have moved the provision on the use of more than one set 
of records to a new paragraph, Sec.  1.1455(g), and revised it to align 
with changes we are making regarding traceability plans in Sec.  
1.1315. Therefore, Sec.  1.1455(g) specifies that a person subject to 
subpart S does not have to keep all of the information required by this 
subpart in a single set of records; however, the person's traceability 
plan must indicate the format and location of the records the person is 
required to keep under the subpart, in accordance with Sec.  
1.1315(a)(1).
    (Comment 479) Several comments request that FDA allow firms to 
leverage existing records.
    (Response 479) We agree with the comments. Under Sec.  1.1455(f) of 
the final rule, firms may use existing records they keep for other 
purposes to meet the requirements applicable to them under subpart S, 
provided those records contain the required information.
    (Comment 480) One comment urges us to coordinate with other 
government and non-governmental agencies to identify existing practices 
and records that might also satisfy traceability requirements.
    (Response 480) As stated in Response 536, FDA coordinates with 
State and other Federal agencies, where appropriate, in conducting its 
traceability operations. However, persons subject to the rule are 
responsible for keeping and providing the records required under 
subpart S. As previously stated, Sec.  1.1455(f) allows firms to use 
records they keep in accordance with other regulations or for any other 
purposes to meet their applicable recordkeeping requirements under the 
final rule.
7. Public Disclosure
    We did not propose requirements related to public disclosure but 
have added Sec.  1.1455(h) to the final rule in response to comments.
    (Comment 481) One comment asserts that FDA has a duty to protect 
from the disclosure of a company's trade secret or confidential 
commercial information under section 414(c) of the FD&C Act and 
questions whether we will be able to prevent disclosure if a Freedom of 
Information Act (FOIA) request is made for information related to 
subpart S. The comment requests that FDA explain how we intend to 
protect information from disclosure under FOIA.
    (Response 481) FDA protects confidential information from 
disclosure in accordance with all applicable statutes and regulations, 
including 5 U.S.C. 552(b)(4), 18 U.S.C. 1905, and part 20. Consistent 
with other FSMA regulations, we have added Sec.  1.1455(h), which 
states that records obtained by FDA in accordance with subpart S are 
subject to the disclosure requirements under part 20. This provision 
makes clear that traceability records that are provided to FDA under 
subpart S are subject to the information disclosure requirements in 
part 20, including, but not limited to, provisions protecting against 
the public disclosure of information concerning trade secrets and 
commercial or financial information that is privileged or confidential 
(see 21 CFR 20.61).

S. Consequences of Failure to Comply (Sec.  1.1460)

    We proposed to codify in subpart S certain FSMA provisions related 
to the consequences of failing to comply with these traceability 
recordkeeping requirements. Section 204(j)(1) of FSMA

[[Page 71049]]

amends section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to make it a 
prohibited act to violate any recordkeeping requirement under section 
204 of FSMA (except when such violation is committed by a farm). We 
therefore proposed, in Sec.  1.1460(a), to 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 
(21 U.S.C. 381(a)) 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. We 
therefore proposed, in Sec.  1.1460(b), to 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.
    Although we are finalizing these provisions as proposed, in the 
following paragraphs we respond to comments regarding actions FDA might 
take in response to the commission of prohibited acts under Sec.  
1.1460(a) and comments on implementation of the refusal of admission 
provision in Sec.  1.1460(b).
1. FDA Response To Commission of a Prohibited Act
    (Comment 482) Several comments ask that we specify the types of 
consequences that could result from failing to comply with the FTL 
traceability requirements. One comment asks whether we will follow a 
tiered approach to imposing consequences that progresses from issuing a 
warning letter, to levying a fine, to issuing a stop sale order. One 
comment recommends that we levy fines for producers that do not comply 
with the regulation. One comment requests clarification regarding the 
consequences of non-compliance by RFEs. One comment asks whether a 
State agency with an established produce safety program may determine 
the consequences for farms that fail to comply with subpart S.
    (Response 482) Under Sec.  1.1460(a) of the final rule, the 
violation of any recordkeeping requirement under section 204 of FSMA or 
subpart S (except when such violation is committed by a farm) is a 
prohibited act under section 301(e) of the FD&C Act. While we intend to 
work to educate industry before and while we regulate to assist 
industry in understanding and coming into compliance with the subpart S 
requirements, there are various actions the Federal government may take 
if an entity commits a prohibited act under section 301(e) of the FD&C 
Act. Depending on the nature of the violation, it is generally FDA's 
practice to give individuals and firms an opportunity to take prompt 
and voluntary corrective action before we initiate an enforcement 
action. We may issue advisory action letters, which include Untitled 
and Warning Letters, to notify firms of violations and to prompt 
voluntary compliance. When voluntary compliance is not forthcoming, the 
Federal government may bring a civil action in Federal court to enjoin 
persons who commit a prohibited act. The Federal government may also 
bring a criminal action in Federal court to prosecute persons who 
commit a prohibited act. (FDA does not have the authority to impose 
fines for violations of section 204 of FSMA or subpart S.) As 
appropriate, FDA may hold multiple entities responsible for the failure 
to maintain traceability records in accordance with subpart S.
    As discussed in Section V.U of this document, we are in the process 
of developing our compliance strategy for the traceability rule. We 
plan to work with our State, Local, Tribal, and Territorial (SLTT) and 
other regulatory partners to implement efficient enforcement of the 
rule, including coordinating actions or deferring to each other when a 
particular agency is best situated to act swiftly to protect consumers. 
We are still determining how we will work with our SLTT and other 
regulatory partners in the implementation and enforcement of the rule.
2. Refusal of Admission
    (Comment 483) One comment expresses support for proposed Sec.  
1.1460(b) and asserts that any seafood offered for importation by an 
importer that cannot meet the traceability requirements of proposed 
Sec.  1.1330(a)(2) (which were the proposed first receiver requirements 
relating to the harvesting of a food) should not be allowed entry into 
the United States. The comment maintains that there have been many 
instances in which a foreign shrimp exporter has been incapable of 
identifying the source of shrimp packaged for export, and the comment 
contends that FDA has identified this inability to trace imported 
seafood back to its source as a significant threat to the health of 
U.S. consumers. In contrast, one comment maintains that there seem to 
be harsher penalties for foreign entities than domestic entities that 
fail to comply with the rule, including the fact that imported food may 
be refused entry under proposed Sec.  1.1460(b). The comment asks that 
FDA be mindful of its obligations under the World Trade Organization 
(WTO) to ensure that foreign entities are not held to different 
standards than those applicable to domestic firms.
    (Response 483) As previously stated, Sec.  1.1460(b) incorporates 
into subpart S section 801(a)(4) of the FD&C Act, 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)) have not been complied with regarding such 
article. The ability to refuse admission to a food under section 
801(a)(4) of the FD&C Act is one of the tools Congress gave FDA to help 
ensure compliance with subpart S. Other tools available to FDA include 
those related to the prohibited act in section 301(e) of the FD&C Act 
(as referenced in Sec.  1.1460(a)), as discussed in Response 482. As 
discussed in Section V.U.3 of this document, we believe the final rule 
is consistent with U.S. international trade obligations, including 
those under the WTO, because the same traceability recordkeeping 
requirements that apply to foreign entities also apply to domestic 
entities.
    (Comment 484) One comment urges us not to require importers to 
ensure their supply chains are fully compliant with the rule as a 
condition of importation of their food. The comment asks whether we 
intend to check traceability records or conduct tracebacks as a 
condition of importation of their food.
    (Response 484) Importers that do not physically possess food on the 
FTL are not subject to subpart S requirements. The final rule does not 
require importers of FTL foods to verify that entities in their supply 
chain are in compliance with the subpart S requirements as a condition 
of importation. However, importers may wish to be aware of whether 
their suppliers are subject to, and in

[[Page 71050]]

compliance with, subpart S requirements because under section 801(a)(4) 
of the FD&C Act, an article of food is subject to refusal of admission 
if it appears that the requirements under subpart S have not been met 
for that food (see Sec.  1.1460(b)). We are still determining our 
approach to enforcement of the subpart S requirements and the 
appropriate circumstances regarding refusal of admission for non-
compliance with the rule.
    (Comment 485) One comment expresses concern that an overly wide 
range of foods may become subject to a refusal of admission under 
proposed Sec.  1.1460(b). The comment maintains that if a problem is 
detected in only one of many factories within the same company, it 
would not be reasonable to automatically reject all the foods from that 
company.
    (Response 485) The refusal of admission authority in section 
801(a)(4) of the FD&C Act (which is referenced in Sec.  1.1460(b)) 
applies to apparent non-compliance with the recordkeeping requirements 
under section 204 of FSMA (including subpart S), not any other FDA 
regulations. We agree that in general it would not be appropriate to 
deny admission to all foods from a company when a single factory 
associated with that company fails to meet applicable subpart S 
requirements for one or more FTL foods, particularly if the company 
works to address the noncompliance in a timely manner. Under section 
801(a)(4) of the FD&C Act, an article of food is subject to refusal of 
admission if it appears--either from examination of the food or 
otherwise--that the subpart S requirements have not been complied with. 
If a company has a history of non-compliance with subpart S at one or 
more of its locations, including a failure to come into compliance 
after subpart S violations were brought to the company's attention, we 
would consider this history in deciding whether to refuse admission to 
some or all of the company's FTL foods.
    (Comment 486) Some comments ask that we revise proposed Sec.  
1.1460(b) to provide a means for a foreign supplier's shipment to gain 
entry following an admission refusal. The comments suggest that 
importers could remedy a violation by verifying corrective actions 
taken by a foreign supplier.
    (Response 486) We decline to codify a procedure for requesting 
termination of a refusal of admission under Sec.  1.1460(b). To the 
extent that the comment is asking about procedures for removal of food 
from detention without physical examination (DWPE) under an import 
alert due to non-compliance with the subpart S recordkeeping 
requirements, existing procedures are likely to be applicable. An 
article of food may be subject to refusal and the food and covered 
entity placed on DWPE because information indicates the appearance of a 
violation of an applicable FDA regulation (such as subpart S). Our 
decision to remove a food and covered entity from an import alert is 
based on evidence establishing that the conditions that gave rise to 
the appearance of a violation have been resolved and we have confidence 
that future entries will be in compliance with the relevant 
requirements. FDA import alerts often provide information about 
obtaining removal from the import alert, in particular how to submit 
information that resolves the appearance of a violation. If we place 
any food and covered entity that failed to comply with subpart S on 
import alert, we plan to provide information in the import alert about 
removal from the alert. Depending on the nature of the violations at 
issue, we might specify that we will review traceability records from 
the covered entity responsible for the violation(s) of subpart S before 
granting removal. However, such a review might not always be necessary.
    (Comment 487) One comment requests that we create a unique 
violation code for food entry lines refused at the border in accordance 
with proposed Sec.  1.1460(b). The comment also asks that we establish 
a unique charge code to facilitate the public's ability to monitor our 
enforcement of the new traceability requirements as applicable to 
imported foods.
    (Response 487) As stated in Section V.U.4 of this document, we are 
developing our compliance and enforcement strategy for entities that 
fail to comply with subpart S. It is likely that we will establish a 
new charge code in FDA's import system for processing entries to 
identify food that is refused entry in accordance with section 
801(a)(4) of the FD&C Act and Sec.  1.1460(b). The publication of an 
import alert relating to violations of subpart S would then include 
this charge code, along with a description of the applicable laws and 
regulations. We currently publish an Import Refusal Report (IRR) on 
those products for which we determined to refuse admission, including 
the charge information that identifies the reason for Agency actions.

T. Updating the FTL (Sec.  1.1465)

    In accordance with section 204(d)(2)(B) of FSMA, we proposed in 
Sec.  1.1465 to establish procedures for updating the FTL to designate 
new foods on the list and remove foods from the list when appropriate. 
We received several comments on the proposed requirements for updating 
the FTL, to which we respond in the following paragraphs.
1. Procedure for Updating the FTL
    We proposed in Sec.  1.1465(a) that when we tentatively conclude, 
in accordance with section 204(d)(2) of FSMA, that it is appropriate to 
revise the FTL, we will publish a notice in the Federal Register 
stating the proposed changes to the list and the reasons for those 
changes and requesting public input on the proposed changes. We 
proposed in Sec.  1.1465(b) that after considering any information and 
views submitted on the proposed changes to the FTL, 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. We also proposed 
that if we revise the FTL, we will publish the revised list on our 
website. We are finalizing these procedures in Sec.  1.1465 as 
proposed.
    (Comment 488) Many comments suggest that updating the FTL should 
take place on a scheduled timetable to ensure that FDA takes into 
account changes in product safety, food safety improvements, current 
risk of foods, and consumer dietary changes, and to ensure that the FTL 
reflects the most recent science and knowledge from outbreaks. The 
comments also maintain that updating the FTL on a regular schedule 
would provide predictability to the food industry to prepare for 
potential changes to the FTL. The comments suggest a range of possible 
timeframes for updating the FTL, from quarterly to every 5 years.
    (Response 488) As part of our administration of the FTL, we will 
periodically review data and other information relevant to the seven 
criteria for commodity-hazard pairs in the RRM-FT, including the 
consideration of food safety improvements across commodities. We will 
also determine whether we should add new or revised commodity-hazard 
pairs to the Model. We agree with the comments that we should update 
the FTL on a consistent basis. Therefore, we have determined that we 
intend to update the FTL approximately every 5 years, subject to 
available resources. We conclude that this 5-year timeframe would allow 
for the time needed to update the RRM-FT with new data and information, 
develop a proposed revised FTL and accompanying materials, publish a 
notice in the Federal Register stating the proposed changes to the FTL 
and the reasons for these changes,

[[Page 71051]]

review comments from the public on the proposal, and publish a second 
notice in the Federal Register stating whether we are making any 
changes to the FTL and the reasons for the decision, as set forth in 
Sec.  1.1465. As part of this process and before proposing any changes 
to the FTL, we intend to provide stakeholders with a mechanism to 
submit relevant data for our consideration as part of our update to the 
RRM-FT.
    For the initial update to the FTL following the publication of the 
final rule, we will take into consideration the compliance date for the 
final rule when deciding when to begin the process outlined above.
    We agree with the comments that adopting a regular schedule for 
updating the FTL will provide consistency and help stakeholders be 
aware of any possible changes to the FTL. However, if substantial new 
data or information critical to public health emerges, we may decide to 
review the RRM-FT and the FTL more frequently than every 5 years. An 
example of such information might be the occurrence of multiple 
unrelated foodborne illness outbreaks involving a food not on the FTL 
within the same year. Conversely, we may also update the RRM-FT with 
new data and information and determine that no changes are needed to 
the FTL. In that case, we will inform the public that the RRM-FT was 
updated and the FTL has not changed.
    (Comment 489) Many comments request that we update the FTL through 
notice and comment rulemaking. Some comments assert that the APA 
requires that the FTL be updated through rulemaking because the FTL 
defines the scope of the rule, has substantive effects on industry, and 
acts as a regulation.
    (Response 489) Congress explicitly spoke to the process for 
updating the FTL, and Sec.  1.1465 is in keeping with what Congress 
provided. Section 204(d)(2)(B) of FSMA states that FDA may update the 
FTL to designate new foods and 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 section 204(d) and notice 
of the update is published in the Federal Register. Section 1.1465 of 
the final rule incorporates into subpart S the requirement to provide 
notice of an update of the FTL in the Federal Register. In accordance 
with Sec.  1.1465(a) and (b), when we tentatively conclude that it is 
appropriate to revise the FTL, we will publish a notice in the Federal 
Register stating the proposed changes and the reasons for those changes 
and requesting public input, after which we will review comments from 
the public and publish a second notice in the Federal Register stating 
whether we are making any changes to the FTL and the reasons for the 
decision. We conclude that this process is in keeping with section 
204(d)(2)(B) of FSMA and will give stakeholders sufficient opportunity 
to provide input on any potential changes to the FTL.
    (Comment 490) Several comments request that stakeholders be able to 
provide input into the development of the FTL. Some comments express 
interest in engaging with FDA to ensure the most recent data is 
available in developing the FTL. Many comments request that we develop 
a process by which stakeholders can request that a food be removed from 
or added to the FTL. One comment asks that we update the FTL upon a 
request from stakeholders, including industry, regulators, or public 
health officials.
    (Response 490) As described in Section V.B of this document, we 
solicited and considered public input into the development of the RRM-
FT, which provides the basis for identifying the foods included on the 
FTL. As discussed in Response 488, we intend to update the FTL 
approximately every 5 years, subject to available resources. This 
process will include updating the RRM-FT with new data and information, 
developing a proposed revised FTL and accompanying materials, and, if 
we tentatively conclude that it is appropriate to revise the FTL, 
following the procedures set forth in Sec.  1.1465. As part of this 
process and before proposing any changes to the FTL, we intend to 
provide stakeholders with a mechanism to submit relevant data for our 
consideration as part of our update to the RRM-FT. When updating the 
RRM-FT, we will use the most recent data available, depending on 
availability of data sources.
    We decline to create a process for stakeholders to request that we 
update the FTL. We believe that the approach of updating the FTL 
approximately every 5 years, subject to available resources, is more 
appropriate considering the time and resources that are needed for this 
process. We believe that the process set forth in Sec.  1.1465 will 
provide stakeholders sufficient opportunity to provide input on any 
changes to the FTL. If we were to set up a process for stakeholders to 
request updates to the FTL, it would introduce uncertainty about the 
frequency of updates and potentially necessitate the use of significant 
resources. To the extent that the comments are suggesting a process 
under which individual foods would be evaluated for addition to, or 
removal from, the FTL, we note that when updating the RRM-FT, we want 
to consistently apply new data and information across all commodities, 
rather than conducting analyses of individual foods, to help ensure the 
integrity of the RRM-FT and our analysis.
    (Comment 491) One comment recommends that we convene expert panels 
with representation from the food industry to advise the Agency on 
updating the FTL.
    (Response 491) At present we do not intend to convene expert panels 
to help update the FTL. We intend to update the FTL approximately every 
5 years, subject to available resources, following the process 
described in Response 488. As part of that process and before proposing 
any changes to the FTL, we intend to provide stakeholders with a 
mechanism to submit relevant data for our consideration as part of our 
update to the RRM-FT. We believe that this opportunity to submit 
relevant data, combined with the opportunity to submit comment on 
proposed changes to the FTL as described in Sec.  1.1465(a), will 
provide all stakeholders, including different parts of the food 
industry, sufficient opportunity to provide input.
    (Comment 492) A few comments request that we develop a system for 
farmers to know which foods are under consideration for being added to 
the FTL. The comments maintain that this would allow farmers to factor 
in this information when making planting decisions.
    (Response 492) As previously stated, we intend to update the FTL 
approximately every 5 years, subject to available resources. This 
should enable stakeholders, including farmers, to become aware of any 
new foods under consideration for being added to the FTL. Further, 
Sec.  1.1465(c) (discussed below) specifies that any additions to the 
FTL will become effective 2 years after the date of publication of the 
Federal Register notice announcing the revised list, unless otherwise 
stated in the notice. We believe this is sufficient time for entities 
to ensure they are ready to comply with the rule for any new foods on 
the FTL.
    (Comment 493) Several comments ask that we release to the public 
the risk scores for commodity-hazard pairs and data used in the Model 
for each food that is added to or removed from the FTL when it is 
updated in the future.
    (Response 493) When we update the FTL, 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, in accordance with Sec.  
1.1465(b). We also intend to make available the commodity and

[[Page 71052]]

commodity-hazard pair risk scores and additional information to provide 
the public with a clear understanding of why certain foods are on the 
FTL.
    (Comment 494) Many comments ask that we clarify how foods can be 
added to and removed from the FTL, as well as the factors we will 
consider when reanalyzing the FTL and the scientific basis to support 
updates to the FTL.
    (Response 494) As discussed in Response 5, to determine which foods 
should be included on the FTL, we developed a risk-ranking model for 
food tracing based on the factors that Congress identified in section 
204(d)(2)(A) of FSMA. To determine whether any foods should be added to 
or removed from the FTL, we intend to use the same approach we used 
when developing the initial FTL for the proposed rule. This includes 
use of the same factors specified in section 204(d)(2)(A) of FSMA as 
operationalized in the RRM-FT. We will update the RRM-FT with new data 
and information based on the criteria and approach outlined in the 
Methodological Approach Report.
    In the future, as additional data streams, risk assessment methods, 
and computational methods arise, we may decide to modify how we 
implement the factors in section 204(d)(2)(A) of FSMA into a risk-
ranking model. However, we do not anticipate developing a new model 
every 5 years.
    (Comment 495) Some comments ask that we exercise enforcement 
discretion for a food that we have proposed to remove from the FTL for 
the period of time that the proposal is pending notice and comment. The 
comments assert that unless we are seeking records for such a food to 
address a threat to the public health under proposed Sec.  
1.1455(b)(3), we should not enforce the recordkeeping requirements 
because the proposal to remove the food demonstrates that we no longer 
consider it to pose a high risk.
    (Response 495) We do not intend to exercise enforcement discretion 
as suggested, although we may consider the status of these foods as we 
prioritize limited inspection resources. In accordance with Sec.  
1.1465(a), when we tentatively conclude that it is appropriate to 
remove a food from the FTL, we will publish a notice in the Federal 
Register stating the proposed removal and the reasons for the change, 
and requesting information and views on the removal. Submitted comments 
may provide data or information that could change our mind about 
removing the food from the FTL. Any deletions from the FTL would become 
effective as soon as FDA updates the FTL, which would happen only after 
we had considered any information and views submitted on the proposed 
removal, and after we had published a notice in the Federal Register 
stating our decision to remove the food from the list (see Sec.  
1.1465(b) and (c)).
    (Comment 496) A few comments urge us to ensure the FTL is updated 
based on the most recent available data. One comment asks how we will 
address data gaps in updating the Model and the FTL.
    (Response 496) When updating the RRM-FT, we will use the most 
recent data available, depending on availability of data sources. For 
example, while we will use the most recent version of NHANES data 
available, those data reflect events from a few years before the public 
availability of the data based on how NHANES releases their data. As 
described in the Methodological Approach Report (Ref. 10), we scored 
the seven criteria in the Model based on available data, both 
quantitative and qualitative. If quantitative data was not available 
for a certain criterion, the criterion was scored based on qualitative 
data, which sometimes included expert elicitations. We plan to take a 
similar approach in the future.
    (Comment 497) A few comments maintain that as food safety 
technologies improve and adoption of them increases, and if risks 
decrease, we should seek to decrease the number of foods on the FTL.
    (Response 507) As discussed in Response 498, we will periodically 
review data and other information relevant to the seven criteria for 
commodity-hazard pairs in the RRM-FT. This could include the 
consideration of food safety improvements across commodities and 
information on any new technologies that may affect food safety for 
specific commodities or industries. Updating the Model might result in 
foods coming off the FTL, but that would depend on any changes we might 
make to the Model as well as the risk scores of the foods based on the 
data in the Model.
2. Timeframe for Implementation of FTL Changes
    We proposed in Sec.  1.1465(c) that when FDA updates the FTL, any 
deletions from the list will become effective immediately, while 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.
    (Comment 498) Many comments request that when a food is added to 
the FTL, entities be given 2 years, rather than just 1 year, before 
firms that manufacture, process, pack, or hold this food must be in 
compliance with the rule. The comments maintain that 2 years are needed 
to allow entities handling foods added to the FTL sufficient time to 
update their recordkeeping practices and make any relevant changes to 
their supply chains. The comments also maintain that supply chains for 
new foods added to the FTL will need the same transition time as the 
supply chains associated with foods on the first iteration of the FTL. 
Some comments maintain that some products may have a shelf life of more 
than 12 months, so that it would take longer than 1 year to go through 
any old product inventory in the supply chain.
    (Response 498) We agree that more than 1 year may be needed for 
firms to revise or update their traceability operations when new foods 
are added to the FTL, and we believe that 2 years will generally 
provide sufficient time in which to take these actions and come into 
compliance with the rule with respect to the added foods. Therefore, we 
have revised Sec.  1.1465(c) to specify that any additions to the FTL 
will become effective 2 years after the date of publication of the 
Federal Register notice announcing the revised list, unless otherwise 
stated in the notice. Section 1.1465(c) further states that any 
deletions from the FTL will become effective as soon as FDA updates the 
FTL.
    Although we do not anticipate that it would occur frequently, there 
may be situations in which we decide that the 2-year timeframe for the 
effective date of additions to the FTL should not apply. For example, 
in the case of an urgent public health concern related to a particular 
food that is added to the FTL, we might determine it is necessary to 
require firms handling that food to maintain and provide subpart S 
records sooner than 2 years. Conversely, if coming into compliance with 
subpart S within 2 years may be especially challenging for firms 
handling a particular food, we may determine that more time is needed 
for that industry to come into compliance. Any differences in the 
effective date from the standard 2-year timeframe would be stated 
specifically in the Federal Register notice announcing the revised FTL.
    We do not intend to conduct our first update to the FTL until after 
the initial compliance date for the final rule. This will allow 
industries with foods currently on the FTL to work towards compliance 
without concern about changes to the FTL before implementation. We 
describe our

[[Page 71053]]

process for updating the FTL in Response 488.
    We recognize that the final rule provides 3 years from the rule's 
effective date for firms to come into compliance, as discussed in 
Section VI of this document. We have concluded that it is appropriate 
for this initial compliance period to be longer than the 2 years we are 
providing in Sec.  1.1465(c) for additions to the FTL to become 
effective. Many of the traceability systems that will be 
operationalized in advance of the first compliance date will be in 
place when the FTL is updated. Therefore, we have determined that 2 
years for any new additions to the FTL will be sufficient.
    (Comment 499) One comment raises concerns about the impact of 
changes to the FTL on small farmers, which the comment asserts have 
less time and fewer resources than larger entities to come into 
compliance with the rule.
    (Response 499) We agree that some small farms might have fewer 
resources for traceability recordkeeping than some larger entities, 
although they also might handle fewer FTL foods than larger firms. As 
previously discussed, the final rule exempts some small farms from 
subpart S and adopts other exemptions that might apply to some smaller 
farms or certain FTL foods from these farms. As stated in Response 498, 
when we update the FTL, any additions to the list will not become 
effective until 2 years after we publish the revised list, so any 
smaller farms that are subject to the rule would have 2 years to 
prepare for compliance with subpart S with respect to the foods that 
have been added to the FTL. We believe this will provide sufficient 
time even for smaller entities to come into compliance with the rule 
regarding the FTL foods they handle.

U. Other Issues

    We received comments on several other matters related to the rule, 
including traceability technology and standards, international trade 
concerns, outreach and training, and implementation and enforcement of 
the rule. We respond to the comments in the following paragraphs.
1. Traceability Technology and Standards
    (Comment 500) Some comments maintain that entities would have to 
update their traceability systems to maintain and share the required 
KDEs. The comments further assert that this would have a financial 
impact on entities shipping FTL foods, as they will have to invest in 
technology to produce information whose format might not be compatible 
with that used by their customers. One comment asserts that this need 
to purchase technology would have an impact across the entire food 
industry but would especially affect small businesses, contrary to the 
directive in section 204(d)(1)(E) of FSMA that the traceability 
recordkeeping requirements be scale-appropriate and practicable for 
facilities of varying sizes and capabilities. One comment asserts that 
examples of sending tracing information to customers provided in the 
preamble to the proposed rule and at public meetings assume use of 
technology that may not be widely adopted in the seafood industry. One 
comment maintains that the proposed rule would force many companies to 
move to EDI ASNs, which the comment contends would be expensive to set 
up, validate, and maintain for businesses with thousands of suppliers. 
The comments ask that we modify the proposed rule to allow firms to 
comply with limited or no access to such technology.
    (Response 500) The final rule does not require covered entities to 
adopt new technologies to meet their subpart S requirements. While we 
recognize that some firms may want to invest in certain technological 
tools or systems, not all firms want to or are financially able to do 
so. Therefore, the final rule provides firms with considerable 
flexibility in how they can meet their requirements, including the 
ability to keep records in paper or electronic form and to use existing 
records to the extent that they contain required information (see Sec.  
1.1455(a) and (f)). We recognize that covered entities vary widely in 
their traceability procedures and practices, and that coming into 
compliance with subpart S might have a greater financial impact on 
certain entities, especially smaller ones. Consequently, the final rule 
fully exempts certain smaller entities from subpart S and exempts 
others from the requirement to provide an electronic sortable 
spreadsheet containing requested traceability information in certain 
circumstances.
    (Comment 501) Several comments suggest that traceability will be 
improved by the use of digitization and electronic records. One comment 
maintains that technologies can help address issues raised by farmers 
and food processors, including by easing the burden for small farms, 
reducing the burden of duplicative recordkeeping requirements by 
different regulatory bodies, and protecting against unnecessary 
exposure of trade secrets. One comment contends that the use of 
electronic records for traceability could reduce the scope of recalls 
and result in improved consumer confidence in producers. One comment 
asserts that the continued use of paper records may hinder information 
sharing or compromise accuracy during outbreak investigations. Some 
comments ask that the rule require electronic recordkeeping for 
traceability to facilitate sharing of data and information, while other 
comments assert that use of electronic records should be voluntary. 
Several comments ask that we encourage the use of electronic 
recordkeeping. On the other hand, some comments support the fact that 
all-digital systems are not required, and some assert that it will take 
years for some entities, even some larger ones, to adopt electronic 
recordkeeping.
    (Response 501) As stated in the preamble to the proposed rule (85 
FR 59984 at 60017), although we strongly encourage all entities in the 
supply chain to adopt electronic recordkeeping for traceability, we 
recognize that not all firms have systems in place to maintain and 
provide information in electronic form, and that adopting such systems 
to meet subpart S requirements could be burdensome for some firms. 
Therefore, the rule allows persons subject to subpart S to keep 
required records in either paper or electronic form (see Sec.  
1.1455(a)). Under FDA's New Era of Smarter Food Safety initiative, we 
will continue to explore ways to encourage entities to voluntarily 
adopt tracing technologies and harmonize tracing activities to support 
end-to-end traceability throughout the food safety system. Additional 
information on this initiative can be found in FDA's New Era of Smarter 
Food Safety Blueprint (Ref. 18).
    (Comment 502) One comment expresses concern that the proposed rule 
will be challenging for companies that rely on paper records, 
particularly small companies, due to the volume and type of KDEs 
required. The comment maintains that their direct suppliers can meet 
some of the proposed requirements but they may be challenged in 
collecting and passing along their suppliers' information due to the 
digitization effort required, particularly with respect to bulk 
ingredients received from distributors. The comment states that 
coordination by the industry is required to achieve the goal of rapid 
traceability under the rule.
    (Response 502) As previously stated, firms are not required to keep 
their records in electronic form or to digitize records they received 
in paper form. However, we recognize that firms that maintain records 
electronically may incur costs in digitizing information they receive 
in paper records, and that

[[Page 71054]]

procedures to identify and document FTL ingredients, regardless of 
whether or not they are in bulk form, might involve coordination with 
suppliers. We encourage coordination and communication by industry to 
ensure supply chain traceability for FTL foods and for entities to work 
with their supply chain partners to send and receive records to meet 
the requirements of subpart S. One option for coordinating and 
communicating the required traceability information to be shared 
between firms would be through contractual agreements often associated 
with commercial POs. By using options such as this, firms can clarify 
the KDEs that must be provided.
    (Comment 503) One comment asks that we address what systems firms 
should use to receive, store, and access digital traceability records. 
The comment also requests that we clarify how we will receive records 
from small businesses, including how we will secure the data and 
mitigate company privacy concerns.
    (Response 503) As previously stated, the rule does not prescribe 
specific technologies for records maintenance or communication with 
subsequent recipients or the Agency. For those firms wishing to keep 
subpart S records in electronic form, there are several systems and 
technologies they might consider using to help them meet their 
requirements under the rule. We will review firms' subpart S records 
when they are made available upon the request of an authorized FDA 
representative in accordance with Sec.  1.1455(c) of the final rule. We 
intend to develop materials addressing how firms can provide records 
and electronic sortable spreadsheets to us. As discussed in Section V.R 
of this document, in response to concerns about maintaining the 
confidentiality of traceability information provided to FDA, we are 
adding a provision (Sec.  1.1455(h)) specifying that records we obtain 
in accordance with subpart S are subject to the disclosure requirements 
in part 20 of FDA's regulations, which include provisions concerning 
the non-disclosure of trade secrets and commercial or financial 
information that is privileged or confidential.
    (Comment 504) One comment maintains that the proposed rule does not 
discuss the importance of data sharing among supply chain partners and 
focuses too narrowly on data collection between the covered entity and 
FDA. The comment asserts that sharing data and records is most widely 
and commonly facilitated using digital data-sharing standards such as 
GS1's GDSN for product information (Trade Item Data), EDI for 
transactional data, and GS1's EPCIS for physical event data. The 
comment asks FDA to highlight widely used marketplace standards for 
digital data sharing, such as GDSN, EDI, and EPCIS, in any FDA guidance 
that may accompany the final rule.
    (Response 504) We disagree that the rule does not acknowledge the 
importance of data sharing among supply chain partners. In fact, we 
recognize that such information sharing is vital to ensuring effective 
and efficient traceability. It is for this reason that the framework of 
the rule includes requirements outlining the specific KDEs for the 
different CTEs in the supply chain, and specifying which KDEs must be 
provided to an entity's supply chain partners (for example, by shippers 
to receivers). As previously stated, although we encourage firms to use 
available technologies to facilitate their sharing of information with 
supply chain partners, the rule does not require the use of electronic 
records and does not prescribe any specific technologies for records 
maintenance or sharing. Therefore, firms may use any system or 
standards that help them meet their requirements to keep and provide 
information under subpart S. We might consider addressing how firms 
might use existing systems and standards to meet subpart S requirements 
in future guidance for industry.
    (Comment 505) Some comments recommend that the rule address the use 
of product barcodes as a traceability tool. One comment suggests that 
we select a barcode type such as GS1-128 that would allow for 
distribution hubs and other locations to apply for numbers. Some 
comments request recognition that their implemented system for lot-
level tracking using a GS1-128 barcode applied to the shipping 
container would meet the subpart S requirements. One comment asserts 
that firms are using different barcodes and different dating systems, 
and contends that there must be some type of standard for the 
traceability rule to be effective. One comment states that the proposed 
rule does not address the importance of capturing product identities 
physically on food products for robust food traceability in conjunction 
with sharing traceability data. The comment maintains that automatic 
identification and data capture (AIDC) tools, such as barcodes and 
radio-frequency identification (RFID) tags, which capture food product 
identities and other pertinent data affixed to the physical object, 
play a vital role in ensuring congruence between traceability data 
exchanged and events in food supply chains, and asks FDA to recognize 
AIDC standards and encourage the use of AIDC tools in any guidance 
accompanying the final rule.
    (Response 505) While we recognize the utility of product barcodes 
and that having industry adopt standards for their use could enhance 
traceability, section 204(d)(1)(C) of FSMA prohibits us from 
prescribing specific technologies for the maintenance of records, while 
section 204(d)(1)(G) specifies that, to the extent practicable, the 
regulations must not require a facility to change business systems to 
comply with the requirements. Because the food industry has already 
developed and adopted the use of various data carriers, if we were to 
require use of a specific data carrier for any of the KDEs passed from 
shipper to receiver, a significant number of firms would have to 
replace their current systems (including firms that currently use 
paper-based systems). Moreover, if we were to require the use of a 
specific data carrier or to structure the rule around a specific 
carrier or type of technology, we would run the risk of having the rule 
become outdated as new technologies are developed. We have therefore 
opted to allow for significant flexibility in how firms choose to 
comply with the rule. We will consider the usefulness of issuing 
materials that address the use of existing technologies, including 
product barcodes, for the maintenance and sharing of traceability 
information.
    (Comment 506) One comment asks that we recognize the utility of 
serial shipping container codes (SSCC) to complement batch/lot level 
tracing of food products and include the SSCC in any guidance 
accompanying the final rule. The comment maintains that use of an SSCC 
aids in tracing the path of a food product in a traceback situation, 
working in conjunction with batch/lot level identification and without 
necessitating item-level serialization.
    (Response 516) 506) We recognize that the use of SSCCs can be a 
helpful tool for improving traceability, and firms may wish to use them 
together with the required traceability lot codes. While SSCCs are not 
required under subpart S, we encourage the use of any tools that will 
improve a firm's procedures for traceability and support the 
maintenance and sharing of the required traceability records under the 
final rule.
    (Comment 507) Several comments ask that we consider requiring the 
use of globally unique product identifiers (e.g., GS1 GTIN, GS1 GLN, 
unique resource locators (URL), universal unique identifiers (UUID)), 
assigned according to recognized industry standards (e.g.,

[[Page 71055]]

GS1, American National Standards Institute (ANSI), International 
Organization for Standards (ISO)), encoded into machine-readable data 
carriers (e.g., 1D and 2D barcodes, RFID, or internet-of-things devices 
(IoT)) and attached to traceable objects, to facilitate electronic 
capture of globally unique traceability lot codes and associated KDEs.
    (Response 507) We recognize that the use of globally unique product 
identifiers can be a helpful tool for improving traceability, and firms 
may wish to use them in establishing required traceability lot codes, 
including by encoding and attaching them as described in the comments. 
However, we are not making this a requirement under the final rule. We 
recognize that while some firms and systems may use these specific 
standards, not all firms and systems maintain and provide information 
in this way, and we want to allow sufficient flexibility for firms to 
maintain and provide the required KDEs based on their preferred 
systems. Therefore, the rule does not require traceability lot codes to 
be globally unique, nor does it require them to be encoded into 
machine-readable data carriers and attached to traceable objects. We 
believe that the traceability lot code for an FTL food combined with 
the product description and other required KDEs should be sufficiently 
unique for our traceability purposes during an outbreak investigation, 
and we believe there are a variety of ways that firms can provide the 
required KDEs to their supply chain partners.
    (Comment 508) One comment recommends that we require the use of 
case-level GTINs to identify the originator or brand owner of the food. 
Another comment suggests that the primary information needed for 
traceability is the lot number of the food, the identification of the 
product such as the GTIN, and contact information for the entity that 
assigned the lot number. The comment asserts that additional 
descriptors about the food are unnecessary if a GTIN is available.
    (Response 508) We recognize that GTINs can be a helpful tool for 
improving traceability, and firms may wish to use them as part of their 
traceability systems. However, we do not think it is appropriate to 
require their use. As discussed above, we have designed the rule to be 
flexible so that firms may use a range of methods or standards to 
comply.
    As discussed in Section V.C of this document, we believe that the 
KDEs we are requiring in the final rule are all necessary to ensure 
efficient and effective traceability of FTL foods. Regarding the 
comment that additional descriptors about the food are unnecessary if a 
GTIN is available, we recognize that some of the required KDEs, such as 
elements of the product description that may be contained within the 
GTIN trade item identification, may be linked to a GTIN in a database. 
When this is the case, firms would not need to maintain that 
information separately, provided they meet the requirements of the rule 
relating to those data elements (e.g., by maintaining the information 
for 2 years in accordance with Sec.  1.1455(d); and by providing the 
product description, as defined, to FDA upon request in accordance with 
Sec.  1.1455(c), and to immediate subsequent recipients in accordance 
with Sec.  1.1340(b)).
    (Comment 509) One comment requests that the final rule focus on 
permissioned access to data throughout the supply chain using data 
standards such as GS1 Digital Link and ISO/IEC 20248:2018 Digital 
Signature Meta Data Structure, together with AIDC.
    (Response 509) The final rule permits (but does not require) the 
use of permissioned access to data, for example in the context of 
shippers providing required KDEs to receivers under Sec.  1.1340(b). As 
discussed above, we have designed the rule to be flexible so that firms 
may use a range of methods or standards to comply.
    As discussed in Response 412, the final rule establishes the 
concept of the traceability lot code source reference, which is an 
alternative method through which information on the traceability lot 
code source could be made available to FDA while protecting the 
confidentiality of that information. Various methods for offering 
permissioned access to data, such as those described in the comments, 
could be used in this context. For example, a shipper of an FTL food 
may choose to use a web address in a QR code or a GS1 Digital Link as a 
traceability lot code source reference that they provide to the 
recipient of the food. Such a web address may employ reasonable 
security measures, such as only being accessible to a government email 
address, provided the Agency has access to the information at no cost 
and without delay.
    (Comment 510) One comment suggests that FDA work with producers to 
create a software program that would allow them to track and share 
traceability data. The comment suggests that the software could be in 
Excel or a unique software program.
    (Response 510) We intend to develop materials with examples on how 
firms can maintain and share with supply chain entities information 
required under subpart S. As part of FDA's New Era of Smarter Food 
Safety initiative, we sponsored a Low- or No-Cost Tech-Enabled 
Traceability Challenge (Ref. 30) to encourage the development of low- 
to no-cost traceability solutions to help enable food operations of all 
sizes to participate in traceability efforts in a scalable, cost-
effective way. However, at present we do not plan to develop a software 
program for use by persons subject to the rule.
    (Comment 511) Some comments request that we establish a single 
digital system or de-centralized database such as blockchain for 
storage of traceability information to simplify implementation, help 
producers obtain initial licensing rights, speed investigations and 
recalls, provide data uniformity, reduce manual data entry, and support 
the adoption of 2D QR codes linked to KDEs and CTEs to ease data 
communication. One comment asserts that lack of a single system for 
transaction data storage creating seamless electronic interoperability 
among many disparate and highly competitive entities has been a 
significant challenge for implementation of drug product tracing under 
the Drug Supply Chain Security Act (DSCSA) and would present a similar 
challenge for food traceability. On the other hand, one comment 
maintains that a single method for collecting all food supply chain 
data or a single repository for holding and sharing such information is 
neither feasible nor desirable.
    (Response 511) We do not believe it is necessary or appropriate to 
establish a single system or database to achieve the rule's purpose of 
facilitating traceability of FTL foods. Participating in such a system 
or database could be costly or otherwise infeasible for some covered 
entities because it would require electronic recordkeeping, and 
mandating participation in such a system or database may be 
inconsistent with section 204(d)(1)(C) and (E) of FSMA. We believe that 
the rule can achieve its intended goal of improving the traceability of 
FTL foods without requiring participation in a single electronic 
records system or database.
    (Comment 512) One comment asserts that although the proposed rule 
defines discrete CTEs, it does not require companies to indicate the 
CTEs in data submissions to FDA, which the comment maintains could be a 
critical aid for interpreting the data quickly. The comment asserts 
that EPCIS includes classifications of events to help

[[Page 71056]]

users and software tools quickly interpret the structure of data 
contained within the event.
    (Response 512) The rule requires covered persons to keep KDEs for 
particular CTEs involving an FTL food, and we may request that persons 
make subpart S records for particular FTL foods available to us in a 
manner that indicates the particular CTE to which maintained KDEs 
apply. We anticipate that grouping KDEs by CTE would be the most 
efficient and effective way for firms to provide us with information on 
specific FTL foods. We also note that under Sec.  1.1455(c)(3)(ii), we 
may request that firms provide to us in an electronic sortable 
spreadsheet the information they are required to keep under the CTE 
requirements in Sec. Sec.  1.1325 through 1.1350, for the foods and 
date ranges or traceability lot codes specified in our request.
    (Comment 513) One comment asserts that although the proposed 
exemptions for small entities will help reduce the pressure on small 
operations that currently have limited financial or technological 
resources, ultimately market demands, access to premium pricing, and 
other initiatives will require a more comprehensive traceability rule 
in the future with a focus on digitization.
    (Response 513) The final rule is intended to allow for traceability 
across the supply chain in a technologically neutral way, while 
providing certain exemptions (including for some small entities) for 
the reasons described in Section V.E of this document. The rule does 
not mandate digitization for the reasons discussed in Response 460. 
However, we recognize the importance of digitization in traceability, 
and under our New Era of Smarter Food Safety initiative we will 
continue to explore ways to encourage all entities in the supply chain 
to adopt tracing technologies and harmonize activities to support end-
to-end traceability throughout the food safety system, including 
enabling food producers of all sizes to participate in a scalable, 
cost-effective way. We do not currently have plans to issue a more 
comprehensive or digitally focused traceability rule in the future. We 
intend to focus on helping covered entities come into compliance with 
the final rule and then assessing the effectiveness of the subpart S 
requirements.
    (Comment 514) One comment compares this rule with the DSCSA, which 
outlines steps to build an electronic, interoperable system to identify 
and trace prescription drugs as they are distributed in the United 
States. The comment maintains that the DSCSA achieves its traceability 
goals through unique (serialized) product identifiers applied to all 
packages and homogeneous cases of covered products. The comment 
contends that the lot-level traceability envisioned by the proposed 
rule would not enable the same level of specificity as serialization. 
As an example, the comment describes a situation in which multiple 
deliveries of the same traceability lot code of a food to the same 
recipient would yield ambiguous results when trying to match a specific 
food in inventory at that recipient to a specific reference record and 
associated KDEs, such as date of receipt. The comment maintains that if 
food cases and items were serialized, it would be possible to link a 
specific case of food to a reference record and associated KDEs.
    (Response 514) We believe the comment's comparison of the DSCSA to 
subpart S is inapt because the goals and requirements of the provisions 
differ. The DSCSA is intended, in part, to protect consumers from 
exposure to drugs that may be counterfeit, diverted, stolen, or 
otherwise unfit for distribution. While serialization is an important 
tool for detecting counterfeit, diverted, or stolen packages or 
homogenous cases of drugs, lot-level traceability for foods is 
important to determine if contamination found in one package of a 
traceability lot of food could be present in another package from the 
same traceability lot or other lots of food from the same traceability 
lot code source and to help meet the goal of preventing or mitigating 
foodborne illness outbreaks as a result of contamination. Moreover, in 
contrast to the DSCSA, section 204(d)(1)(L)(iii) of FSMA prohibits 
requiring product tracing of FTL foods to the case level. Consequently, 
the final rule is designed to facilitate lot-level tracing of FTL 
foods, rather than tracing to the case level.
    (Comment 515) Many comments urge FDA to adopt existing global 
standards. One comment encourages us to adopt a digital traceability 
standard to minimize data capture and sharing errors, despite the 
initial costs to small growers and distributors. The comment maintains 
that without universal adoption of such a standard, effective food 
supply chain traceability will not be possible. Several comments assert 
that FDA has successfully partnered with a consensus-based standards 
group for the implementation of other healthcare laws, such those 
regarding unique device identifiers and the DSCSA. Several comments 
assert that GS1 sets forth a comprehensive set of standards that is 
widely used in the food industry, and the comments ask that FDA require 
or recommend the use of GS1 standards in meeting subpart S traceability 
requirements. Some comments assert that we have proposed requirements 
that are similar to but different from GS1 standards, and the comments 
maintain that these differences could create confusion and 
inefficiencies. One comment states that industry has worked with GS1 to 
establish a common language and standards for communication of product 
data among trading partners and has taken steps to use these standards 
to create a process for traceability with the PTI. The comment 
maintains that building on this existing platform would avoid confusion 
and provide a sound foundation for the implementation of the rule. Some 
comments recommend the use of EPCIS standards, maintaining that they 
would bring alignment with currently accepted taxonomy and enable more 
rapid adoption of new traceability requirements.
    One comment maintains that the final rule should accommodate 
different ``data sharing architectures'' within supply chains, 
including architectures that do not allow all actors to have access to 
full product pedigrees. The comment asserts that GDST interoperability 
standards are designed to enable rapid and direct verification of 
traceability data. The comment further states that the seafood industry 
uses multiple data sharing practices or architectures, some of which 
eschew sharing of all product pedigree information with all supply 
chain actors. The comment asserts that GDST's approach to 
interoperability through standardized CTEs/KDEs and data standards 
conducive to digital linking would provide a robust means of achieving 
the outcome-based results mandated by the rule while respecting the 
diversity of data sharing architectures necessary to the current 
business realities of the seafood sector. Therefore, the comment 
recommends that we include a reference to the use of GDST standards for 
information required under the rule for seafood.
    One comment maintains that although blockchain has been raised as a 
possibility for ensuring interoperability, it would be unrealistic to 
expect many supply chain entities who still use paper records to be 
able to install and operate a technology like blockchain within 2 
years. On the other hand, one comment asserts that a platform with 
blockchain characteristics and the support for records and 
transactional information to fit various production systems may 
minimize any data gaps and could lower barriers to entry or

[[Page 71057]]

other challenges that may decrease diversification. One comment 
suggests that BlockApps would provide a network blockchain-backed 
solution for traceability in the agriculture industry. One comment 
asserts that any business process that uses fielded data involving 
entities, actions, and interplay needs modeling of the data and 
associated relationships, and requests that FDA develop entity 
relationship diagrams for the proposed rule.
    (Response 515) Although we acknowledge the benefits to enhanced 
traceability that many of the systems and technologies discussed in the 
comments might provide, as previously stated we have decided to make 
subpart S technologically neutral. We think this approach provides 
firms with maximal flexibility, allows for changing approaches as new 
technology is developed, and is in keeping with Congress's intent as 
expressed in section 204(d) of FSMA. Under the final rule, firms may 
use any traceability standards or approaches that suit their needs 
(including paper records) as long as they enable firms to keep and 
provide the information specified under applicable subpart S 
requirements. However, we intend to participate in traceability 
governance and harmonization efforts with international regulatory 
counterparts, including in bodies such as GS1, as part of the New Era 
for Smarter Food Safety initiative.
    (Comment 516) Some comments assert that FDA has the statutory 
authority to recognize GS1 and other ``voluntary consensus standards'' 
under the National Technology Transfer and Advancement Act (NTTAA) 
(Pub. L. 104-113) and OMB Circular A-119, which the comments describe 
as requiring federal agencies to use voluntary consensus standards in 
lieu of government-unique standards in their procurement and regulatory 
activities, except where inconsistent with law or otherwise 
impractical.
    (Response 516) Although we agree that firms may use GS1 and other 
standards to facilitate compliance with their subpart S requirements, 
we are not prescribing specific standards for the maintenance or 
transmission of information required under subpart S. Regarding the 
NTTAA and OMB Circular A-119, we note that this rule does not establish 
government-unique standards in lieu of voluntary standards. Rather, we 
are not prescribing any specific technological standards for the 
maintenance and transmission of required traceability information. The 
approach we have taken is consistent with the Agency's options under 
the framework of the NTTAA and OMB Circular A-119, as well as the 
requirement in section 204(d)(1)(C) of FSMA that FDA not prescribe 
specific technologies for the maintenance of records.
    (Comment 517) One comment asserts that FDA should adopt category-
specific (e.g., field-grown leafy greens, seafood) global data 
standards to meet subpart S requirements, and asks that we convene 
meetings and technical working processes to develop these category-
specific global standards.
    (Response 517) To the extent that the comment asks us to adopt 
category-specific electronic data standards for use in subpart S, we 
decline to do so for the same reasons we decline to adopt specific 
electronic data standards more generally (see Response 515). However, 
we regularly participate in working groups and workshops that are 
engaged in the development of standards for traceability, which often 
discuss standards that are specific to certain commodities. We intend 
to continue participating in these efforts and providing relevant input 
as needed.
    (Comment 518) A few comments ask FDA to recognize approaches such 
as the PTI, which the comments maintain goes beyond the requirements of 
the rule and includes lot-level tracing via a barcode with a GTIN and 
lot number. The comments request that firms that are following other 
programs such as the PTI be considered compliant with the requirements 
in the final rule.
    (Response 518) Although conducting traceability operations 
consistent with the PTI or a similar program might help firms meet many 
applicable subpart S requirements, we will not regard such firms to be 
in compliance with those requirements simply because they follow such a 
program. The PTI and other programs were not designed to ensure 
compliance with subpart S, which is not yet in effect. Firms will need 
to ensure they are in compliance with applicable subpart S requirements 
by the compliance date regardless of their participation in the PTI or 
other traceability programs.
    (Comment 519) Several comments ask that FDA not regard the proposed 
rule as a component of the Agency's New Era of Smarter Food Safety 
initiative. The comments assert that the technology-enabled 
traceability envisioned under the New Era initiative will not be 
possible until data harmonization and interoperability standards are in 
place. Some comments maintain that the rule would prematurely 
incorporate recordkeeping requirements that reflect New Era 
capabilities without considering criticisms of the initiative itself. 
One comment asserts that the rule should not be used as a vehicle to 
promote the agenda of the New Era and, as a result, push smaller, 
limited-resource firms out of the food industry. Some comments maintain 
that there are significant challenges to overcome before the digital 
end-to-end traceability system for all foods envisioned in the New Era 
initiative can be achieved, including continued industry reliance on 
paper recordkeeping and significant diversity in electronic 
recordkeeping systems in use. However, one comment requests that we 
continue to assist regulated entities in electronic data migration, 
tracking, and management under the New Era initiative.
    (Response 519) As noted in our New Era of Smarter Food Safety 
Blueprint (Ref. 18), the final rule will serve as the foundation for 
much of our traceability work because it will harmonize the KDEs and 
CTEs needed for enhanced traceability. We believe that establishing 
this foundation for traceability will allow stakeholders in the supply 
chain to adopt and leverage digitally enabled technologies, foster 
improved data sharing, and introduce approaches that greatly reduce the 
time it takes to identify the origin of a contaminated food tied to an 
outbreak and/or recall. Although the rule does not require the use of 
electronic tracing records, we intend to work collaboratively with the 
food industry, including through the New Era of Smarter Food Safety 
initiative, to explore ways to encourage firms to voluntarily adopt 
tracing technologies and ways to harmonize tracing activities, which 
will support interoperability across a variety of technology solutions, 
working towards outcomes that are achievable for all sectors.
    (Comment 520) Several comments urge FDA to work with industry to 
define best practices and develop standards for interoperability that 
will facilitate effective, secure data sharing among all entities in 
the supply chain. Several comments urge us to adopt standards for 
language and data structure to help ensure that food traceability 
systems are interoperable, allowing for swift and accurate exchange of 
information throughout the supply chain. Some comments assert that 
although we have specified the information we believe is essential for 
effective traceability, failing to specify the language/terminology to 
be used and the structure/format for the retention and exchange of data 
would impair or even prevent effective traceability. One comment 
asserts that adopting a standard format would reduce human 
transcription errors, reduce database costs, and help prevent trade 
barriers.

[[Page 71058]]

One comment asserts that the proposed rule appears not to recognize the 
necessary standardized data structures for rapid and effective food 
traceability and recall; the comment recommends the use of standards 
for both globally unique product identifiers and data structures (or 
syntax). The comment maintains that with such standards, once a product 
is uniquely identified, the data can be pieced together or structured 
in a specific order that conveys the history of that product and how it 
is transformed and moves through complex supply chains. But the comment 
maintains that globally unique identification is lost if this structure 
or syntax is garbled, just as the syntax is lost if the product lacks 
globally unique identification.
    Some comments maintain that, given the diversity in the food supply 
chain, interoperability is necessary for achieving scalability, 
lowering adoption costs, and preventing the exclusion or elimination of 
smaller supply chain participants. One comment asserts that to ensure 
continued market access for small producers, the technology for 
traceability must be accessible for all types of operations, and open 
source and cost-effective solutions should be promoted. One comment 
suggests that FDA encourage food traceability technology providers to 
develop solutions that will add little or no overhead so food retailers 
of all sizes can participate in a technologically based food safety 
system. One comment asserts that being overly prescriptive in the rule 
could impede technological evolution and the efficiency with which the 
rule is implemented; therefore, the comment suggests that we provide 
additional guidance on options for appropriate digital solutions to 
ease the burden of compliance and aid successful implementation.
    Some comments recommend that, consistent with GS1 standards, FDA 
should better define the need for both data and data structure in its 
final rule and acknowledge their shared importance in achieving 
interoperability and traceability across the supply chain. One comment 
maintains that although adoption of a universal traceability standard 
would cause hardship for several entities in the food supply chain, 
particularly small growers and even some small distributors, hardships 
would be borne across the supply chain and consumers would share in 
that cost. One comment maintains that providing support or a platform 
for electronic submissions that is secure, interoperable, and not 
limited in regard to regions, products, or otherwise may mitigate 
issues for scalability across complex supply chains and decrease the 
ambiguity of exemptions while addressing issues of technology 
implementation and data liability.
    (Response 520) As previously stated, the final rule provides 
flexibility to entities subject to subpart S regarding the format and 
manner in which required information is kept and provided to subsequent 
recipients. However, we recognize the importance of interoperability of 
standards and systems for food traceability to be conducted at an 
optimal level. We believe that establishing the KDE/CTE requirements 
for FTL foods in the final rule is a necessary first step in achieving 
standardization and interoperability between tracing systems. As 
previously stated, we intend to explore ways to encourage firms to 
voluntarily adopt tracing technologies and harmonize tracing 
activities, which should enhance interoperability and traceability 
throughout the supply chain.
    (Comment 521) Some comments express support for FDA-industry 
dialogue or partnerships to develop interoperability standards.
    (Response 521) As previously stated, through the New Era of Smarter 
Food Safety initiative and other efforts, we intend to explore ways to 
encourage firms to voluntarily adopt tracing technologies and to 
harmonize tracing activities to foster interoperability. We welcome all 
opportunities to work with the food industry and others to achieve 
these goals.
    (Comment 522) Several comments ask that we share information 
regarding the systems we will use to receive, store, and access 
traceability records required under the rule. The comments also ask for 
information on the interoperability of technology systems between FDA 
and small businesses, expressing concerns regarding the security and 
privacy of data submitted to the Agency.
    (Response 522) In accordance with section 204(c) of FSMA, we are in 
the process of developing a product tracing system that would allow 
information to be provided to FDA in a secure way and in a variety of 
formats similar to other FDA systems that allow industry to provide 
information to us. As we progress in the development of this system, we 
will keep stakeholders informed on the details of the system, including 
options for data formats and sharing the required records and 
electronic sortable spreadsheet with FDA. In addition, with respect to 
the concerns about the security and privacy of data we receive from 
industry, as previously stated, Sec.  1.1455(h) of the final rule 
specifies that records we obtain in accordance with subpart S are 
subject to the disclosure requirements in part 20, which include, among 
other things, provisions regarding the non-disclosure of trade secrets 
and commercial or financial information that is privileged or 
confidential.
2. Labeling Issues
    (Comment 523) Some comments request clarification on whether we 
will provide standards for labels or specify package labeling practices 
or label printing standards to ensure data integrity and quality. One 
comment encouraged us to require a lot code on consumer pre-packed 
products in accordance with the Codex General Standard for Labeling 
Prepackaged Foods, section 4.6.
    (Response 523) The rule does not establish labeling requirements 
for FTL foods, and in particular does not prescribe standards for 
labels or labeling that might include KDE information for FTL foods, 
including traceability lot codes. For example, although shippers of FTL 
foods are required to provide certain information, including the 
traceability lot code, to the immediate subsequent recipient of the 
food, the rule does not require that the information be stated on the 
label or package of the product.
    (Comment 524) Some comments suggest that we include requirements 
for food labels to facilitate traceability. One comment asserts that 
for food safety and insurance concerns, all products must be labeled in 
a way that is easily traceable to the producer. The comment suggests 
that this may be achieved in a variety of ways, such as through the use 
of twist ties, bags, food grade stickers, and labels on produce or on 
customer order forms. One comment maintains that label requirements 
should include at least the lot code, pack date, and brand of the 
product. One comment asserts that to allow for adequate tracing, firms 
must be required to label all ingredients. The comment maintains that 
permitting companies to group many ingredients into spices and natural 
flavors can make it impossible to conduct traceback when issues arise. 
One comment asserts that it is important that FDA remain technology-
neutral and not place undue requirements on specific data carried 
within labels and packaging, but instead retain flexibility for 
advances in the means to associate unique identification with 
corresponding event data in the database. The comment therefore 
encourages us to discuss and approve technology-neutral and ever-
evolving methods of complying with the recordkeeping requirements, but 
not to

[[Page 71059]]

specify how or where data are stored in data carriers.
    (Response 524) Although the rule includes requirements to provide 
certain information to receiving entities in the supply chain, it does 
not prescribe the form in which this information must be provided. We 
conclude that it is not necessary for the rule to require that 
traceability information be placed on food labels to ensure adequate 
traceability of FTL foods. Nevertheless, firms may use product labels 
to provide information required under subpart S to their supply chain 
partners if that suits their business practices.
3. U.S. International Obligations and Standards
    (Comment 525) One comment maintains that the proposed rule would 
establish higher standards than those in the Codex Principles for 
Traceability/Product Tracing as a Tool Within a Food Inspection and 
Certification System (CAC/GL 60-2006) (Ref. 31), and requests that we 
provide justification of the necessity of requiring higher levels in 
accordance with Article 3.3 of the WTO Agreement on the Application of 
Sanitary and Phytosanitary Measures (SPS Agreement). The comment 
asserts that although Article 6 of the Codex Principles for 
Traceability requires that exporting countries not be required to 
replicate the traceability/product tracing tools used by the importing 
country, the proposed rule would require exporting countries to adopt 
the same traceability standards as those used in the United States. The 
comment also maintains that while Article 12 of the Codex Principles 
for Traceability specifies that a traceability tool should be able to 
identify where the food came from and where it was sent, the proposed 
rule would go beyond one step forward/one step back tracing by 
requiring that traceability lot codes assigned at food origination be 
linked to the KDEs in all CTEs. In addition, the comment asserts that 
under Article 16 of the Codex Principles for Traceability, a food 
inspection and certification system within which a traceability tool is 
applied should not be more trade restrictive than necessary; under 
Article 17, application of the traceability tool should be practical, 
technically feasible, and economically viable; and under Article 19, a 
traceability tool should be implemented when appropriate on a case-by-
case basis. The comment maintains it is often unknown at the earliest 
point in the food chain whether foreign agricultural and fishery 
products eventually will be exported to the United States. But the 
comment asserts that under the proposed rule, all the stakeholders 
throughout the food chain must use the same traceability lot code even 
for products with only a slight possibility of being exported to the 
United States, which the comment contends would require all 
stakeholders to entirely update their traceability systems currently in 
place, resulting in practically, technically, and economically 
difficult situations.
    (Response 525) We believe the rule is consistent with CAC/GL 60-
2006. When developing our proposed rule and in considering comments 
when finalizing this rule, we took into account the Codex Principles 
for Traceability. To the extent that the rule adopts a more stringent 
standard than the Codex Principles for Traceability (CAC/GL 60-2006), 
the more stringent approach is limited to achieve the U.S. level of 
food safety protection and is based on principles of science and risk. 
We do not agree that the rule's recordkeeping requirements are in 
conflict with Article 12 because the rule's more extensive 
recordkeeping specifications are limited in their application and 
justified by risk. Specifically, these requirements apply only to foods 
on the FTL, which we developed using the RRM-FT in accordance with the 
risk-based factors specified in section 204(d)(2)(A) of FSMA. Also, the 
rule provides flexibility to domestic and foreign facilities in that it 
does not dictate any specific product or technology that persons 
subject to the rule must use to comply with its requirements.
    In addition, the rule's recordkeeping requirements are consistent 
with Article 6 of the Codex Principles for Traceability, and we do not 
agree with the comment that the rule requires exporting countries to 
adopt the same traceability standards as those used in the United 
States. Rather, the rule places additional recordkeeping requirements 
on specific persons who manufacture, process, pack, or hold foods on 
the FTL only if the food will be offered for sale in the United States. 
Food imported into the United States must comply with all applicable 
FDA requirements; the new traceability requirements would be no 
different. We believe that foreign entities are able to anticipate 
whether their products will be exported to the United States, and we 
note that several existing FDA regulations (such as those concerning 
produce safety, preventive controls for human food, egg safety, and 
seafood HACCP) apply to food that is imported into the United States. 
Because most of the entities that manufacture, process, pack, or hold 
foods on the FTL also perform activities that would be covered by one 
or more of these existing regulations (if the food is to be exported to 
the United States), we believe that these entities will already have 
procedures in place to identify whether or not their products will be 
exported to the United States. As discussed in Responses 103 and 335, 
we believe that U.S. importers will work with their foreign suppliers 
to help ensure there is an understanding of the potential for foods on 
the FTL to be exported to the United States and the traceability 
information required for these products.
    Further, we believe the rule is consistent with our international 
trade obligations because it is consistent with the Codex Principles 
for Traceability and, to the extent that the rule adopts a more 
stringent standard than the relevant Codex guidelines, the more 
stringent approach is limited to achieve the U.S. level of food safety 
protection and is based on principles of science and risk. For high-
risk foods, the rule sets a higher standard of protection and includes 
additional requirements. This approach is consistent with relevant 
trade obligations, and the more stringent approach that it takes is 
scientifically justified based on public health concerns associated 
with the foods subject to the rule, i.e., the foods on the FTL. We 
developed the FTL using our RRM-FT, which uses a semiquantitative, 
multicriteria decision analysis risk-ranking approach that is 
consistent with the factors specified in section 204(d)(2)(A) of FSMA 
for use in designating the foods that will be subject to the additional 
traceability recordkeeping requirements of the final rule, and which is 
operationalized with data relevant to those factors. Using the results 
of the RRM-FT, we identified foods to be placed on the FTL, which lists 
the foods for which additional traceability records are required under 
the final rule. This is consistent with Article 18 of the Codex 
Principles for Traceability, which recommends countries take into 
account the assessed food safety risks of food products, as well as 
Article 19, which states that a traceability tool should be 
implemented, when appropriate, on a case-by-case basis.
    The requirements we are establishing are necessary for the 
protection of human, animal, or plant life or health, and are 
consistent with our international trade obligations, including that the 
regulatory requirements are not more trade restrictive than necessary 
to achieve the level of food safety protection FDA has established for 
U.S. consumers (see also Article 16 of the Codex Principles for 
Traceability). The traceability

[[Page 71060]]

recordkeeping requirements in the final rule help FDA rapidly and 
effectively identify recipients of certain foods to prevent or mitigate 
foodborne illness outbreaks and address credible threats of serious 
adverse health consequences or death, are tailored to apply to only 
high-risk foods offered for sale in the U.S. market, and apply both to 
domestic and foreign firms. When developing the final rule, we also 
carefully considered the costs of compliance, as recommended by the 
Codex guideline, and we have provided flexibility in how firms may meet 
the rule's requirements. In addition, we recognize that meeting the 
rule's requirements may be especially burdensome for entities with 
limited resources, which is why the rule provides certain types of 
small entities with a full or partial exemption.
    (Comment 526) One comment, noting that part 5 (``Traceability'') of 
Canada's Safe Food for Canadians Regulations (SFCR) has tracing 
requirements for fresh produce, suggests that we work together with the 
Canadian Food Inspection Agency (CFIA) to standardize requirements on 
tracing to reduce the burden on the fresh produce industry.
    (Response 526) We will continue our close cooperation with our 
colleagues at the CFIA. As discussed in Response 479, Sec.  1.1455(f) 
of the final rule states that entities do not need to duplicate 
existing records so long as those records contain the information 
required by subpart S, and entities may supplement any such existing 
records as necessary to include only the specific information required 
by subpart S that is not already contained in their existing records. 
Thus, any records that entities maintain to comply with part 5 of the 
SFCR can be used to meet the requirements of subpart S, if those 
records contain or are amended to contain the required information.
    (Comment 527) One comment asserts that the competent authorities 
from other countries will not support the rule and will reciprocate 
with equally burdensome rules that will be different and create another 
unintended hurdle for U.S. firms that export products to those 
countries.
    (Response 527) As we have done throughout this entire rulemaking 
process, we intend to continue to work closely with our international 
regulatory counterparts, including working toward harmonizing 
approaches to traceability internationally. While we received comments 
from several countries that expressed concerns about certain aspects of 
the rule, such as how records should be maintained by supply chain 
entities, the role of importers, and the proposed compliance date, they 
nonetheless expressed support for the rule overall. Principally, we 
will continue to work with our regulatory counterparts in Codex and in 
other international fora to promote food safety by using efficient and 
effective global supply chain traceability measures, while minimizing 
the regulatory burden on exporters, to the extent practicable.
    (Comment 528) One comment, referencing the requirement in section 
204(d)(1)(K) of FSMA that FDA take into account international trade 
obligations in developing the proposed recordkeeping requirements, 
asserts that because the majority of the seafood consumed in the United 
States is globally sourced, the rule will have a major impact on U.S. 
trading partners.
    (Response 528) This final rule applies equally to domestic and 
foreign firms that manufacture, process, pack, or hold FTL foods 
intended for distribution in the United States. In certain industries, 
such as seafood, where the majority of the product consumed in the 
United States is imported, we recognize that many foreign firms will be 
affected. When proposing the rule and in considering comments before 
finalizing the rule, consistent with 204(d)(1)(K) of FSMA, we have 
taken into account international trade obligations and, as stated 
earlier, we believe the subpart S requirements are consistent with our 
international trade obligations. Also, as discussed earlier, the final 
rule provides flexibility in how firms comply with the requirements and 
affords a partial or full exemption to certain small entities, 
including foreign small entities.
    (Comment 529) One comment maintains that because data collection 
and maintenance require manpower, resources, and time, the requirement 
to collect and maintain detailed information may negatively impact 
trade and present a particular burden for small farms and businesses. 
To address these concerns, the comment suggests that we narrow the rule 
to require only records related to food safety concerns. For example, 
the comment suggests that information about raw material sources and 
suppliers should be adequate, while the quantity of material received 
may not be directly relevant to food safety and should not be required.
    (Response 529) Subpart S will enhance food safety by ensuring that 
covered entities maintain and provide information that will promote 
fast and effective traceability in response to foodborne illness 
outbreaks. As discussed in Sections III.C and V.C.5 of this document, 
in response to comments, the final rule includes several changes to 
streamline and better define the KDEs required for each CTE. The KDEs 
specified in the rule contain information that is essential for 
adequate traceability. With respect to the quantity of food received, 
we believe this information is important to record (regardless of 
whether the food is a raw material) because it helps us understand the 
amount of food we might need to locate in traceback and traceforward 
efforts when conducting an outbreak investigation or recall. We 
recognize that meeting the rule's requirements may not be feasible for 
certain entities with limited resources, which is why the rule affords 
certain entities a full or partial exemption.
4. Implementation and Enforcement
a. General
    (Comment 530) Several comments encourage FDA to adopt an ``educate 
while we regulate'' approach to enforcing the final rule, asserting 
that the rule is complex and will require much time and effort to come 
into compliance. Some comments express appreciation that we took this 
approach with other food safety regulations implemented in accordance 
with FSMA, such as the produce safety regulation, and request that we 
take a similar approach with this rule. One comment asserts that 
inspections that are educational in nature will encourage the 
development of a positive food safety culture. One comment asserts that 
meeting the requirements will be a significant undertaking for all 
covered entities, but particularly for smaller growers and producers. 
One comment maintains that our implementation of the rule will require 
further cooperation with industry and asserts that creating more 
interconnected recordkeeping systems will require time, resources, 
guidance, and patience.
    (Response 530) Consistent with our approach for other FSMA 
regulations, including those on produce safety, preventive controls for 
human and animal food, FSVP, and intentional adulteration, we intend to 
take the approach of educating before and while we regulate. We 
recognize that significant outreach, education, and technical 
assistance will be essential to facilitating industry's understanding 
of the rule. This approach of educating before and while we regulate 
aligns with the Agency's New Era of Smarter Food Safety blueprint (Ref. 
18), which envisions ongoing collaboration and dialogue between FDA and 
industry to enhance food traceability, support the food safety system, 
and improve food safety culture.
    We are currently considering the best approach for structuring and 
conducting

[[Page 71061]]

records inspections under this rule. Once the compliance date arrives, 
we expect to conduct routine records inspections to ensure that 
entities subject to subpart S are satisfying the basic requirements. 
Routine records inspections primarily will focus on understanding an 
entity's subpart S recordkeeping practices, identifying any gaps in 
compliance, and achieving compliance through prompt voluntary 
corrective actions if we observe deficiencies. In exigent circumstances 
(e.g., foodborne illness outbreaks, recalls, or other food safety 
emergencies), we may request specific subpart S records from covered 
entities to facilitate a traceback or traceforward operation. As with 
other FSMA regulations, we may consider taking appropriate compliance 
or enforcement action to address non-compliance when necessary to 
protect the public health.
    We recognize that complying with these traceability recordkeeping 
requirements may pose challenges for many persons subject to the rule, 
particularly smaller entities and entities in sectors of the supply 
chain that we do not regularly inspect. Section 204(h) of FSMA requires 
FDA to issue an SECG within 180 days of promulgation of the final rule 
to assist small entities, including farms and small businesses, in 
complying with the requirements of subpart S. We also expect to provide 
additional information to stakeholders about the rule, and to engage in 
outreach, education, and technical assistance to assist the affected 
sectors of the food industry. In response to comments regarding the 
length of time needed to come into compliance with the rule, we have 
extended the compliance period we initially proposed by 1 year, to 3 
years after the effective date of the final rule (see Section VI of 
this document).
    We have engaged with stakeholders throughout this rulemaking 
process and will continue to do so as firms prepare to come into 
compliance. Concurrent with issuance of the proposed rule, we provided 
information and supplementary materials on our website, such as 
information on exemptions, key terminology, supply chain examples, and 
a pre-recorded webinar discussing the proposed requirements. In 
accordance with section 204(d)(4) of FSMA, we held three public 
meetings during the comment period to provide persons in different 
regions an opportunity to comment. During these public meetings we 
discussed the Agency's commitment to educate industry before and while 
we regulate, in line with our overall approach to implementing FSMA. In 
addition to outreach and guidance we intend to provide (see Section 
V.U.5 of this document), we note that FDA's TAN is a resource for 
covered entities with questions related to this rule. Inquiries are 
answered by FDA information specialists or SMEs who provide a central 
source of information to support industry understanding and 
implementation of FSMA standards. The TAN staff have compiled answers 
to frequently asked questions on the proposed rule (available on our 
website) and will continue to respond to questions now that we have 
issued the final rule.
    (Comment 531) One comment maintains that the proposed rule seems 
similar to the FSVP regulation in that it can be monitored using 
document-based records requests. The comment asks that we publish a 
list of required records like the checklist the Agency published for 
FSVP.
    (Response 531) The ``Foreign Supplier Verification Programs for 
Importers of Food for Humans and Animals (FSVP) Regulation Records 
Requirements'' document to which the comment referred is a list of 
records required under the FSVP regulation, organized by sections of 
that rule, to help importers determine the records they are required to 
maintain under that regulation (Ref. 32). The FSVP regulation requires 
importers to verify that foods they import into the United States have 
been produced in a manner that meets applicable U.S. food safety 
standards, and requires importers to conduct a hazard analysis, 
supplier verification, and other activities, in addition to maintaining 
required records. In contrast, subpart S is entirely focused on the 
maintenance and provision of records relating to traceability. As 
previously stated, we intend to issue an SECG in accordance with 
section 204(h) of FSMA, as well as other materials to assist covered 
entities in understanding their obligations under subpart S. We 
anticipate that these materials will specify the KDEs and other records 
(such as a traceability plan) that entities are required to maintain 
and provide under subpart S, though the structure of these materials 
may differ from the FSVP document to which the comment refers.
    (Comment 532) One comment asserts that penalizing distributors for 
non-compliance with the recordkeeping requirements in subpart S would 
not help FDA conduct effective and timely traceback investigations.
    (Response 532) As previously stated, we are developing our 
compliance and enforcement strategy for the final rule. While any 
strategy we adopt will include taking compliance or enforcement action 
when needed to correct problems that put consumers at risk, it will 
also include actively supporting education and technical assistance 
efforts for persons subject to the rule. Where appropriate, regulatory 
actions we take in response to violations of subpart S, whether by 
distributors or any other type of entity subject to the rule, will be 
aimed at gaining compliance through voluntary corrective actions, as 
has been the case with our implementation of other FSMA regulations. As 
previously stated, we plan to educate industry before and while we 
regulate to assist firms in understanding the rule. We intend to use 
our standard regulatory inspection tools, including discussing 
violations at the time of our review of records, to inform covered 
entities of violations of the rule as they are observed and to provide 
firms with a reasonable opportunity to comply.
    (Comment 533) One comment requests that we clarify who may be held 
responsible if a traceback investigation fails during an outbreak.
    (Response 533) During an outbreak investigation, our objective is 
to obtain information as quickly as possible to help identify the 
source of contamination and remove potentially contaminated product 
from the marketplace. To effectively implement the final rule, it is 
important that all supply chain entities subject to subpart S comply 
with the applicable requirements of the rule. If we encounter non-
compliance with subpart S during the course of a traceback 
investigation, we will consider the specific circumstances of the case 
in deciding whether to take compliance or enforcement action. Some of 
the factors we look at in making this decision include whether the 
entity took prompt, voluntary corrective action when given the 
opportunity to do so, and whether the entity has a history of non-
compliance.
b. Jurisdictional Issues and Coordination With Other Regulatory 
Authorities
    (Comment 534) Some comments ask how we will coordinate with other 
federal agencies that share jurisdiction over seafood and use existing 
data systems to facilitate supply chain transparency and food 
traceability. The comments recommend that we enter into agreements with 
our federal partners to identify best practices and coordinate seafood 
oversight and inspection programs. The comments also suggest that we 
ensure interoperability between agency data

[[Page 71062]]

systems so that any data the seafood industry submits to the various 
systems is accessible to all federal agencies responsible for seafood 
oversight.
    (Response 534) We agree that coordination with other federal 
agencies, where appropriate, is important to effective regulation of 
seafood. FDA has a Memorandum of Understanding (MOU) with the National 
Marine Fishery Service's Seafood Inspection Program in NOAA (Ref. 33), 
which includes recognizing our mutual regulatory responsibilities and 
sharing information on regulatory priorities. As we proceed with 
implementation of subpart S, we will continue to collaborate with NOAA 
and other federal agencies on data and information sharing and 
integrating systems as appropriate.
    (Comment 535) Some comments ask that we clarify which regulatory 
authorities are responsible for compliance and enforcement activities 
regarding the rule. The comments assert that the subpart S requirements 
overlap with other regulations and implicate other regulatory 
authorities besides FDA, such as State agencies. Some comments request 
that we clarify the jurisdictional boundaries between FDA and State 
agencies and ensure coordination of inspections under the regulation to 
avoid overburdening farms and first receivers. One comment asks whether 
subpart S records will be inspected by FDA investigators or FDA-
credentialed State investigators. Some comments recommend that we place 
primary responsibility on State agencies to conduct oversight and 
enforcement activities at produce farms. These comments also request 
adequate training and funding for State agencies if we expect subpart S 
to be enforced during routine inspections of farms. Some comments 
assert that we will need to partner with State and local regulatory 
agencies to conduct oversight activities for growers and retailers, 
adding that it would be unfair and potentially counterproductive to the 
goals of the regulation if we limited our activities to the food 
facilities we typically inspect.
    (Response 535) We currently are considering the best approach for 
structuring and conducting inspections for compliance with the subpart 
S recordkeeping requirements, including the roles that FDA and State 
investigators should play. We recognize many entities may prefer that 
traceability rule inspections be conducted as part of an inspection for 
compliance with other regulatory requirements, such as the regulations 
on produce safety or preventive controls for human food, and we 
anticipate that we might seek to take this approach. Regarding RFEs and 
restaurants, we expect that we will work with our SLTT partners to 
consider mechanisms for conducting routine traceability records checks.
    With respect to inspections of farms, FDA has a Cooperative 
Agreement Program (CAP) with State agencies for implementing the 
produce safety regulation (referred to as the ``State CAP''). Not all 
50 States participate in inspections of farms under the CAP, and in 
those States that do not, FDA is responsible for inspections. We also 
are responsible for inspecting foreign farms, and we lead inspections 
of sprout growers. Incorporating review of traceability records into 
regular produce safety regulation inspections is one option for 
inspecting for compliance with subpart S. This could be accomplished, 
for example, by adding traceability inspections to the State CAP for 
produce and providing additional funding to the States to do this work. 
As we have done with regard to the produce safety regulation, we likely 
would offer training on the subpart S requirements to State regulators 
as appropriate to the inspection model. Even if a State CAP includes 
regulatory oversight and inspectional responsibilities, we might still 
be involved with compliance and enforcement. However, if a State CAP 
does not exist or a program does not include regulatory oversight, we 
would be responsible for conducting inspections and carrying out 
compliance and enforcement activities.
    (Comment 536) Some comments recommend that we work with State and 
Federal authorities to clarify the roles during foodborne illness 
investigations. These comments assert that the federal government 
should build on existing cooperative relationships to ensure the 
efficient enforcement of the subpart S requirements. The comments 
recommend that we develop codes to clarify responsibilities and to 
assist with enforcement and oversight by State regulators.
    (Response 536) Our SLTT and other regulatory partners play an 
important role in helping to ensure food safety in the United States. 
We routinely work with our regulatory partners to address activities 
affecting the safety of food, and we intend to continue to leverage 
existing partnerships and agreements as we implement the subpart S 
requirements. We will work with our regulatory partners to clarify 
oversight responsibilities, consider whether additional codes are 
necessary, reduce redundancy, and consider all tools that will promote 
effective implementation of the rule.
c. Retail
    (Comment 537) Some comments encourage us to conduct enforcement 
activities at the points of the supply chain where food products are 
provided to consumers; other comments request clarification on how we 
will monitor compliance at the retail level. Some comments assert that 
problems with traceability have historically arisen when foods are sold 
by restaurants, retailers, and on e-commerce platforms, which are 
entities that often have not been subject to previous FDA oversight. 
Some comments assert that enforcing the requirements at the ``last 
mile'' will improve traceability for products with short shelf-lives.
    (Response 537) Under Sec.  1.1345 of the final rule, RFEs and 
restaurants will be required to maintain KDEs as receivers of FTL foods 
unless they meet the criteria for an exemption from subpart S. Being 
able to trace an FTL food quickly through the supply chain from the 
point of service is a key purpose of the rule, and having access to the 
traceability lot code for a food at the end of the supply chain is 
critical to achieving that goal. We are considering several approaches 
to regulatory oversight at the retail level, including partnering with 
SLTT and other regulatory officials to conduct routine traceability 
records checks. As previously stated, we plan to educate industry 
before and while we regulate to assist firms, including RFEs and 
restaurants, in understanding the rule. We recognize the complexities 
of regulation at retail, and we intend to fully leverage our 
partnerships to help RFEs and restaurants understand and comply with 
the rule.
    (Comment 538) Some comments ask that we provide State and local 
agencies with resources to address the financial burden associated with 
oversight of RFEs if we expect those agencies to educate RFEs regarding 
the subpart S requirements and conduct monitoring and enforcement 
activities. Some comments ask when we will provide training for 
investigators and whether FDA investigators and state-credentialed 
investigators will receive the same training.
    (Response 538) We expect to build on our existing collaboration 
efforts and mechanisms with SLTT officials in the development of tools 
and training for use by inspectors and investigators. We appreciate the 
concerns about the potential resource needs associated with oversight, 
industry education, and staff training with our SLTT partners. We

[[Page 71063]]

will consider obtaining additional funding for our regulatory partners 
through various mechanisms, such as grant programs. We anticipate that 
FDA and State investigators, as well as other partners conducting 
inspections, will receive joint training and education on the subpart S 
requirements using existing training programs.
d. Regulatory Parity
    (Comment 539) Some comments ask us to administer the regulation 
equally across all segments of the food supply chain. The comments also 
request that we not focus our regulatory oversight activities solely on 
domestic entities that may already be familiar with traceability. The 
comments maintain that doing so would be unfair and could adversely 
affect the rule's ability to achieve one of its principal goals, that 
of ensuring faster product traceability during outbreaks.
    (Response 539) The final rule applies to all persons who 
manufacture, process, pack, or hold FTL foods, unless an exemption 
applies, including both persons in the United States and those in other 
countries. As with all of our FSMA-related enforcement efforts, we 
intend to apply our oversight resources for the traceability 
recordkeeping requirements in a risk-based manner, placing greater 
emphasis on violations that are more likely to result in harm to the 
public health. There are likely to be both domestic and foreign firms 
that will be considered higher priorities for oversight because of 
factors such as having a poor compliance history or handling a high 
volume of foods that pose significant safety risks. Although there are 
some differences in our enforcement tools and approaches for domestic 
and foreign entities, we will conduct our subpart S oversight 
activities in a manner that furthers the goals of the regulation 
without unfairly focusing on either domestic or foreign firms.
    (Comment 540) Some comments express concern that we will enforce 
the requirements against entities located in foreign countries and 
assert that, while all entities should follow the regulation, we should 
only hold U.S. importers directly responsible for violations.
    (Response 540) We do not agree. Foreign entities covered by subpart 
S are responsible for complying with the portions of the rule that 
apply to them, based on the CTEs they perform. As discussed in Response 
260, importers might not be subject to the rule, depending on whether 
they manufacture, process, pack, or hold any FTL foods; and if they are 
subject to the rule, they are only responsible for complying with the 
portions of the rule that apply to them, based on the CTEs they 
perform. The rule is not structured to hold an importer responsible for 
a violation that was committed by a different entity, such as a foreign 
supplier.
    When we encounter non-compliance with subpart S, either during a 
routine investigation or during an outbreak investigation, we will 
generally provide an opportunity for prompt, voluntary corrective 
action, as discussed in Response 482. Decisions about enforcement 
action--whether against a foreign or domestic entity--will be made on a 
case-by-case basis.
5. Outreach and Training
    As discussed in the following paragraphs, several comments request 
that FDA conduct outreach efforts and provide guidance, training, and 
funding to help entities subject to subpart S understand and comply 
with the rule.
a. Outreach and Training Efforts
    (Comment 541) Many comments ask that we provide education, 
training, and technical assistance to help industry, including 
particular sectors of industry (e.g., farms, RFEs, wholesale 
operations, and small and medium-sized firms generally), comply with 
the new traceability recordkeeping requirements for FTL foods. Some 
comments assert that educating industry will be vital because the rule 
will not be effective without industry's strict adherence to the new 
requirements. Several comments assert that small and medium-sized 
businesses, including farms, are likely to be adopting traceability 
systems for the first time and will therefore require training and 
technical assistance from FDA to help them comply with the rule. One 
comment maintains that because the rule introduces new terms (e.g., 
``key data element,'' ``critical tracking event''), compliance will 
require education and training. One comment maintains that any 
introduction of new terminology has consequences to industry and can be 
especially disruptive to small businesses that lack resources necessary 
to undergo extra training and hire consultants, and that may have a 
more limited capacity to adapt and implement new procedures. The 
comment asserts that the introduction of new requirements 
disproportionately benefits the largest producers because 
implementation requires investment in outside experts and management 
systems, adding that this is particularly concerning when new terms and 
rules are introduced without education, training, and support for small 
producers and independent retailers.
    (Response 541) We agree with the comments on the importance of 
conducting outreach to ensure that all sectors of the supply chain are 
aware of the traceability recordkeeping requirements for FTL foods, as 
well as providing education to help farms and firms come into 
compliance with the new requirements. To that end, we are developing 
communications and educational materials covering all aspects of the 
rule to assist covered entities of all types, sizes, and levels of 
traceability expertise. As previously stated, these educational 
materials will include an SECG setting forth in plain language the 
subpart S requirements to assist small entities, including farms and 
small businesses, in achieving compliance. Although we do not agree 
that this rule benefits larger firms to the disadvantage of smaller 
ones, we understand that smaller firms may need additional assistance 
in understanding and implementing some aspects of traceability that 
larger firms may already have adopted.
    (Comment 542) Some comments maintain that education and training is 
especially important for firms that have not been subject to other 
regulations adopted in accordance with FSMA. One comment states that it 
will be a challenge to identify all entities subject to the rule to 
ensure they receive appropriate education because the rule covers some 
entities that are not subject to other FSMA requirements, such as 
``qualified facilities'' under the produce safety regulation. Some 
comments suggest that outreach during implementation is essential 
because companies are at different stages of implementation of 
traceability recordkeeping due to various factors, including customer 
demand, compliance with trading partners, and other regulations.
    (Response 542) We agree that it will be particularly important to 
provide education and training to firms that have limited experience 
with other FSMA regulations and to firms that do not already have 
robust traceability systems, as well as firms that operate 
internationally and therefore might also be subject to traceability 
requirements of foreign countries that may differ from this rule. We 
also agree that it would be challenging for us to reach all covered 
entities directly. Therefore, we will extensively engage public and 
private entities such as State departments of agriculture, industry 
trade groups, and other stakeholders to share communications and 
outreach materials for the rule. Although we have tried to

[[Page 71064]]

align the subpart S requirements as much as possible with traceability 
systems, procedures, and terminology already used by industry, we 
realize that some firms keep different records and provide different 
tracing information to their customers, which heightens the importance 
of clearly explaining and illustrating the requirements in the final 
rule. Again, we intend to extensively engage with public and private 
entities to share information on the traceability regulations in a 
timely fashion to assist both domestic and international firms during 
implementation.
    (Comment 543) Some comments suggest that FDA provide training for 
the entire industry, including foreign firms, because new requirements 
differ from firms' current procedures and practices and from 
regulations in foreign countries. Some comments maintain that outreach 
to foreign firms is important because the compliance status of many 
U.S. businesses will depend on these firms, and that without such 
outreach the burden to educate, develop digital capabilities, and 
promote compliance will fall to industry. Some comments ask that we 
provide resource materials in multiple languages to help educate the 
international community about the rule.
    (Response 543) We agree there is a need to conduct outreach to 
foreign entities that will be subject to the subpart S requirements. 
Among other things, we intend to provide resource materials in multiple 
languages, work through entities such as the USDA Foreign Agricultural 
Service and interested embassies to provide outreach to covered foreign 
entities, and work through associations that serve the U.S. importer 
and U.S. agent communities, since they may be in dialogue with their 
foreign suppliers about the requirements of the rule.
    (Comment 544) One comment maintains that proper lot code 
stewardship throughout the supply chain is a departure from current 
business practices that will require targeted education and training to 
achieve.
    (Response 544) We agree. Given the importance of traceability lot 
codes in the subpart S requirements, we anticipate that assignment, 
maintenance, and provision to customers of traceability lot codes will 
be a key focus of education and training efforts regarding the rule.
    (Comment 545) One comment asks that we provide a timetable for the 
provision of training and resources to ensure compliance.
    (Response 545) We will begin to provide resource materials as soon 
as the final rule issues and will continue to do so up to and after the 
compliance date. We will try to provide as much outreach and training 
to covered entities as possible before the compliance date, and 
thereafter we will continue to engage with industry to promote a full 
understanding of the rule.
b. Guidance Documents, Templates, and Other Written Materials
    (Comment 546) Several comments ask that we provide industry with 
guidance, forms, spreadsheets, and other written materials to aid 
understanding of, and compliance with, the traceability recordkeeping 
requirements in the final rule. Several comments request that we issue 
a guidance document on the requirements; some comments ask that the 
guidance include model traceability information to demonstrate how to 
implement the rule. Some comments ask that we provide more examples and 
real-life scenarios in the preamble to the final rule or in guidance. 
Some comments request that we provide examples of the KDEs that would 
be required at each step in the supply chain for frozen fish products, 
for both wild-caught and farm-raised fish. One comment suggests that we 
identify appropriate SMEs for each FTL food to help develop 
implementation guidance.
    (Response 546) We agree that communication, training, and 
educational materials should take multiple forms and include industry-
specific examples and real-life scenarios. We intend to develop an 
array of materials, taking into consideration the suggestions provided 
in the comments.
    (Comment 547) One comment asks that we consider issuing guidance to 
link the traceability code with ultimate point of consumption data, 
such as shopper cards or credit card information. The comment maintains 
that being able to link a lot of a food with customer information is 
useful in limiting the scope of recalls, feasible given current 
practices, and would further protect public health by improving the 
ability to notify any impacted entities.
    (Response 547) We do not believe guidance on the use of consumer 
data is necessary because the rule does not require firms to keep 
information on sales to consumers and does not require maintenance of 
records linking traceability lot codes for FTL foods received from 
manufacturers or distributors with sales of such food to consumers. 
However, we recognize that individual RFEs and restaurants might choose 
to use customer data (e.g., data obtained from a membership card) to 
help with outbreak investigations and recall implementation. In general 
we encourage firms to consider adopting traceability practices that go 
beyond the requirements of subpart S, if such practices are suited to 
the firm's specific circumstances.
    (Comment 548) Several comments request that we develop and make 
available templates for records that firms might use to maintain and 
send traceability information required under the rule. Several comments 
ask that we develop an electronic spreadsheet that firms could use to 
record the KDEs for the relevant CTEs for their FTL foods, as well as 
to meet the requirement in proposed Sec.  1.1455(b)(3) to provide 
information in an electronic sortable spreadsheet in certain 
circumstances. The comments maintain that the availability of such a 
template would help FDA know where to look for critical information in 
an investigation and would provide guidance to firms as to what records 
they must keep under the rule. One comment asserts that the Leafy 
Greens Pilot completed in 2020 demonstrated the critical importance of 
template review and stakeholder education to maximize efficacy. Some 
comments ask that we develop spreadsheet templates that include 
examples of supply chains of different lengths and levels of 
complexity. One comment maintains that having examples for each FTL 
food category would be valuable to industry, as the supply chain 
realities for cantaloupes would be quite different than those for deli 
salads or finfish. This comment suggests that we issue a template that 
demonstrates how traceability lot codes are preserved alongside other 
adjacent business-relevant coding that may still be required for the 
effective operation of certain supply chains. One comment maintains 
that having an official template could influence software and business 
process design, including enterprise resource planning, traceability 
system design, and sourcing and procurement practices. One comment 
suggests that we provide electronic reporting templates that 
acknowledge the current digital reality, particularly regarding what it 
means to ``establish and maintain records.'' One comment requests that 
we provide sample forms and spreadsheets specifically for use by farms. 
One comment suggests that templates would be helpful in demonstrating 
third-party logistics companies' role in traceability.
    (Response 548) While we do not intend to issue an ``official'' 
template for an electronic sortable spreadsheet or any other document 
that all firms must use to meet subpart S requirements, we

[[Page 71065]]

understand that many firms might like to see examples of forms and 
formats they might use to comply with the rule, and we intend to make 
such examples available as part of the resource materials for 
compliance with the rule.
    (Comment 549) Some comments ask that we update the supporting 
materials for the proposed rule that we had posted on our website, 
while other comments ask that we incorporate into the final rule our 
responses to ``Frequently Asked Questions'' (FAQs) about the proposed 
rule (which we also have posted on our website).
    (Response 549) We have updated the materials on our website. We 
have addressed many issues raised in the FAQs in the preamble to the 
final rule, and we expect to continue to update our website as we 
develop additional materials (such as the SECG) and as we receive 
questions about the final rule.
    (Comment 550) One comment asks that we test the assumptions made in 
the PRIA and develop a return on investment (ROI) model with 
representative company types/sizes that we would provide to industry as 
a cost calculator to help encourage compliance with the rule.
    (Response 550) Although we have analyzed the benefits and costs of 
the rule in the FRIA (Ref. 16), it is not appropriate or feasible for 
FDA to develop an ROI model for persons subject to subpart S. Firms 
subject to the rule might wish to consider conducting their own ROI 
analyses to determine what approach (e.g., purchasing new software vs. 
updating current traceback SOPs) is most appropriate for their firm as 
they come into compliance with the rule.
c. Coordination of Training Efforts
    (Comment 551) Several comments recommend that we coordinate 
training efforts with industry associations, universities, and/or State 
and local regulatory authorities. For example, one comment suggests 
that, similar to the Produce Safety Alliance that has supported 
educational efforts for the produce safety regulation, FDA should 
establish a ``Traceability Alliance'' in partnership with land grant 
institutions and their extension services to ensure that stakeholders 
have an appropriate level of education on traceability to successfully 
implement the rule. The comment suggests that we collaborate with non-
governmental partners, industry associations, and non-profit technical 
organizations to assess industry educational needs and develop 
educational content to support the rule. Some comments suggest that we 
work with industry experts to assess current practices, infrastructure, 
and needs, as well as develop and disseminate implementation guidance. 
One comment asserts that FDA followed this approach in its development 
and use of the CORE Network. One comment offers to work with FDA and 
stakeholders to develop tools to facilitate understanding and 
implementation of the requirements, particularly to help less digitized 
and smaller-scale supply chain entities. One comment expresses support 
for FDA's ongoing work with the leafy greens industry and encourages 
similar work with the seafood, shell egg, and dairy/cheese industries. 
One comment suggests that we coordinate with cooperative extension 
services at the State level, the USDA's National Organic Program, and 
farm advocacy groups to develop sample materials and trainings. 
Regarding seafood, one comment suggests that we work with the National 
Sea Grant College Program of NOAA to develop outreach compliance 
programs for unloading docks and fish houses.
    (Response 551) We recognize the importance of partnerships in 
ensuring wide distribution and sufficient specificity of training and 
educational resources. We are currently developing our outreach and 
education approach, including consideration of partnerships with 
industry associations, universities, and/or federal, state, and local 
agencies on such efforts as appropriate. We will work to ensure that 
training materials and dissemination are suited to the needs of the 
various types of entities covered by this rule.
    (Comment 552) Some comments criticize the regulation for not 
addressing recall modernization. The comments ask that we provide 
guidance to industry on how to manage product recalls and request 
clarification on what data we will provide to help industry implement a 
product recall during a food safety incident. The comments also 
recommend that we collaborate on recalls with the direct-to-consumer 
and curbside delivery segments of the supply chain to learn about 
emerging business trends and potential food safety impacts regarding 
consumer-level food traceability.
    (Response 552) While this rulemaking does not address recall 
modernization directly, we are working on this issue through other 
initiatives. For instance, the New Era of Smarter Food Safety Blueprint 
(Ref. 18), which outlines the approach we will take over the next 10 
years to build on the work the Agency has done to implement FSMA, 
contains a section on ``Recall Modernization within Core Element 2: 
Tech-Enabled Traceability.'' Our goals for this initiative include 
developing best practices guidance on various consumer notification 
practices for different business models to facilitate product recalls.
d. Resources for Outreach and Training
    (Comment 553) Several comments request that we provide funding for 
outreach, education, and training efforts. One comment requests that we 
provide adequate resources to SLTT agencies to address the financial 
burden they will incur by providing educational, compliance, and 
enforcement activities regarding the rule for RFEs. One comment states 
that the education and outreach efforts conducted regarding the produce 
safety regulation have highlighted how important funding for education 
efforts is to the adoption of food safety practices. Some comments ask 
that we extend the existing CAP programs, including the Local Food 
Safety Collaborative and Native American Tribal Cooperative Agreement, 
to identify and educate small entities likely to be affected by the new 
traceability regulation, and to consider proposing and establishing a 
unique CAP for the regulation with the goal of developing appropriate 
programming to reach small and very small businesses. One comment 
expresses support for a program, similar to the On-Farm Readiness 
Reviews conducted by the National State Departments of Agriculture, 
that would help growers prepare for compliance with the rule. One 
comment requests that we provide funding to educational organizations 
to help growers become oriented to, aware of, and compliant with the 
rule, and recommends that we engage in this effort with existing 
national educational curricula organizations such as the Food Safety 
Preventive Controls Alliance and the Produce Safety Alliance. One 
comment suggests that we work with other U.S. agencies to provide 
resources to help industry comply. One comment maintains that while the 
rule is forward-thinking and important, it presents possible unfunded 
mandates.
    (Response 553) We are committed to working with our SLTT partners 
to address the resource needs associated with implementing the 
traceability final rule, including with respect to outreach, training, 
and enforcement. We are committed to providing guidance, education, and 
technical assistance to SLTT partners and will consider new and 
existing channels in an effort to lessen the burden associated with 
administering the rule. We also intend to work with other federal 
agencies as

[[Page 71066]]

needed to enhance education and outreach efforts.
    (Comment 554) One comment asserts that because most entities 
affected by the rule are small and medium-sized firms, the need for 
additional investment to aid compliance with the rule skews toward 
these firms. The comment suggests that because farmers often have 
little ability to negotiate higher prices for their commodities, FDA 
should work with industry and Congress to find ways to offset costs of 
compliance. One comment suggests that additional funding from Congress 
is needed to implement the rule, and that funding in the form of 
subsidies could also help producers, suppliers, and retailers be more 
compliant in tracing efforts.
    (Response 554) We carefully considered costs of compliance when 
developing the rule and have attempted to provide maximum flexibility 
to persons subject to the rule to meet applicable requirements. We also 
have concluded that meeting the requirements of the rule may not be 
feasible for some entities, so we have adopted exemptions for certain 
types of small entities. We cannot comment on efforts in Congress to 
provide funding for producers, suppliers, retailers, and other entities 
to improve their traceability capability.
e. Funding for Equipment and Technology
    (Comment 555) Several comments ask that we provide financial 
assistance to help entities subject to the rule purchase equipment 
(such as scanners), software, and training needed to comply with the 
rule. Some comments suggest that many farms and food producers may 
discover that they need to invest in alternate technology systems to 
meet the recordkeeping requirements. One comment maintains that if the 
electronic sortable spreadsheet is an integral part of FDA's approach 
to improved traceability, the Agency should provide funding for 
education for computer literacy and adoption of digital recordkeeping 
practices, or provide a 24-hour, third-party technical assistance 
service to help farms comply. One comment asks if we will provide 
financial assistance and training or grants to help firms purchase new 
equipment as part of the New Era for Smarter Food Safety initiative. 
Some comments suggest that we follow the model established by Canada, 
under which British Columbia Traceability Funding Programs refund up to 
70 percent of investments that firms need to make to comply with 
Canadian traceability requirements.
    (Response 555) FDA is not in a position to provide financial 
assistance to help covered entities purchase or upgrade equipment they 
might choose to use to comply with the rule. Nevertheless, we are 
exploring ways to assist firms in adopting tracing technologies and 
harmonizing tracing activities, such as the previously mentioned Low- 
or No-Cost Traceability Challenge, in which we encouraged stakeholders 
to develop traceability hardware, software, or data analytics platforms 
that are low-cost or no-cost to the end user. We will continue to 
search for and highlight these and other approaches to help provide 
economical options for traceability.
6. Grocery Returns
    (Comment 556) One comment expresses concern that because of 
advanced traceability, grocery returns may need to be eliminated to 
ensure accurate traceability, but doing so would result in more food 
waste going into landfills.
    (Response 556) Sales or shipments to consumers are not covered by 
the rule, so we do not anticipate that grocery returns will be impacted 
by the rule.
7. Performance Metrics
    (Comment 557) One comment asks that we identify metrics to measure 
the success of the food traceability rule. The comment suggests that 
expert panels and industry could use the metrics to understand how the 
rule is impacting public health and what foods should be included on 
the FTL.
    (Response 557) As we have done for other FSMA rules, we will 
consider appropriate performance metrics for the subpart S regulation 
as part of our implementation of the rule.
    (Comment 558) One comment states that all parties should feel that 
proprietary or otherwise sensitive company information can be protected 
in the data collection and submission process, and suggests that FDA 
provide a direct portal and set of application programming interfaces 
for submission of data, along with a list of approved third parties to 
facilitate compliance with the proposed rule, based on open and 
interoperable standards.
    (Response 558) As discussed in Response 412, we have made changes 
to the final rule to address concerns about disclosure of proprietary 
or sensitive information, in particular by including an option to 
provide receivers of FTL foods with a traceability lot code source 
reference instead of the traceability lot code source itself. We are 
developing a portal for submission of traceability information to us, 
which will protect the confidentiality of the information provided. We 
do not intend to ``approve'' or assess the capability of third parties 
who might perform recordkeeping or information transmission on behalf 
of entities subject to subpart S requirements.

VI. Effective and Compliance Dates

    In the proposed rule, we proposed that the final rule would become 
effective 60 days after the date on which the rule is published in the 
Federal Register. We also proposed that the compliance date for all 
persons subject to the subpart S recordkeeping requirements would be 2 
years after the effective date of the final rule.
    We received no comments opposing the proposed effective date for 
the final rule. As proposed, the final rule will become effective 60 
days after the date on which the rule is published in the Federal 
Register. However, in response to comments received, we are revising 
the compliance date to 3 years after the effective date of the final 
rule, as discussed in the following paragraphs.
    (Comment 559) Many comments request that we extend the proposed 2-
year compliance period after the effective date of the rule to other 
timeframes, including 3, 4, or 5 years after the effective date. The 
comments maintain that extending the compliance date would allow 
covered entities time to understand the requirements of the rule, 
purchase or update tracing technology, train staff, coordinate with 
supply chain partners, and establish or update recordkeeping systems. 
One comment maintains that a 3-year compliance date would be 
appropriate because it is the timeframe that the smallest covered 
entities had to comply with the final rule on preventive controls for 
human food. Comments requesting a 4-year compliance period or longer 
emphasize that data standardization would be time-consuming, including 
the time needed to invest in new technology systems, convert from paper 
to electronic, and ensure that foreign suppliers also have adequate 
systems. One comment maintains that a public-private partnership may be 
necessary to oversee data standardization, which would take time to 
establish. Several comments assert that 2 years is not enough time 
given all the preparation needed to comply but did not specify an 
alternative timeframe.
    (Response 559) We agree that persons subject to the rule should 
have additional time to come into compliance with the subpart S 
requirements. Therefore, we are revising the compliance date for all 
covered entities

[[Page 71067]]

to 3 years after the effective date of the final rule. We believe this 
3-year timeframe appropriately balances the public health gains through 
traceback efficiencies we expect to achieve through implementation of 
this rule against the need for covered entities to have adequate time 
to come into compliance with the new traceability requirements. The 
overwhelming majority of comments on the compliance date request more 
than 2 years to come into compliance, maintaining that they will need 
to work with suppliers to understand how information will be sent to 
them, possibly switch from paper to electronic records and/or purchase 
new equipment and software, redesign tracing systems to capture 
information that current systems do not, and work with foreign 
suppliers to ensure they understand the requirements for keeping and 
providing necessary records. Given the need for these activities, among 
others, to occur, we are persuaded that compliance in a 2-year 
timeframe would be challenging. Therefore, while the 3-year timeframe 
does postpone the anticipated public health gains from the rule by a 
year, we conclude that this postponement is justified. However, given 
the public health benefits expected from adoption of the new 
traceability requirements, we do not believe it would be appropriate to 
extend the compliance date beyond 3 years.
    FDA believes the 3-year compliance timeframe allows an appropriate 
amount of time for firms to conduct activities necessary for them to 
come into compliance. Covered entities can work with supply chain 
partners in the 3-year timeframe to understand how information will 
flow forward through the supply chain and work out any needed written 
agreements or protocols for how information will be shared among 
entities, such as between harvesters/coolers and those performing 
initial packing. The additional year beyond the proposed 2-year 
compliance date will extend the time in which industry can establish or 
make any changes to tracing systems and make decisions around 
purchasing new equipment--activities that cannot begin until there is 
an understanding of the requirements of the final rule. The additional 
year will also allow time for the development of software and related 
products aimed at facilitating compliance with the rule, which multiple 
technology companies have expressed an interest in developing. It is 
possible that the 3-year timeframe will mean that some of the costs for 
technology solutions will be reduced compared to a 2-year compliance 
date, given the additional development and implementation time. The 3-
year timeframe will also allow for time for any collaboration that 
industry might decide to undertake, to consider how they want to share 
information with each other; we will consider how we might assist 
industry with such efforts.
    The 3-year compliance period will also allow more time for us to 
develop and disseminate outreach and training materials to 
stakeholders, including webinars focused on various industry segments 
and materials specifically targeted to smaller covered entities. As we 
have done with the previous FSMA rules, we plan to provide a variety of 
outreach and training materials for this final rule. For all of the 
aforementioned reasons, we believe that a compliance date 3 years after 
the effective date (which itself is 60 days after the date of 
publication of the final rule) strikes the right balance between 
achieving traceback efficiencies as quickly as possible and allowing 
sufficient time for covered entities to come into compliance with the 
new tracing requirements.
    (Comment 560) Several comments request that the compliance date 
occur after FDA has issued all relevant guidance documents related to 
the rule so that covered entities can fully comply with regard to their 
own covered foods and also work with foreign suppliers.
    (Response 560) We will work to issue any guidance documents related 
to this rulemaking as expeditiously as possible. However, the process 
for issuing both draft and final guidance documents can be lengthy, and 
the timing is often beyond our control. Therefore, we are unable to 
ensure that all relevant guidance documents related to the rule will be 
issued before the compliance date. However, we note that section 204(h) 
of FSMA requires us to issue an SECG not later than 180 days after 
promulgation of this final rule. The SECG will set forth, in plain 
language, the requirements of subpart S, with the goal of assisting 
small entities, including farms and small businesses, in complying with 
these new requirements.
    (Comment 561) Several comments request that the compliance dates be 
phased in by business size. These comments state that extra time would 
be needed for small businesses to become educated about the rule and 
make investments, or seek assistance to make investments, in personnel 
and technology to come into compliance. Some comments suggest that 
small businesses be given 4 years to comply and all other businesses be 
given 3 years. Other comments suggest that certain categories of 
covered entities would need additional time to come into compliance, 
including the following: (1) importers who may need extra time to work 
with foreign suppliers; (2) retailers who may need additional time 
because they are at the end of the supply chain, and therefore need 
time to understand how information will come to them from a variety of 
sources and create systems to maintain the information; (3) grower/
packers who may need extra time to adopt new technology and 
distributors who may need time to understand how suppliers will be 
providing information and develop appropriate interoperable technology 
systems; and (4) the seafood industry, which might need additional time 
to develop software, conduct training activities, and translate 
materials due to the global nature of the seafood supply chain. One 
comment suggests that those entities that establish traceability lot 
codes should have to comply initially, and then entities that only ship 
and/or receive FTL foods should have a later compliance date; the 
comment maintains that this would provide that the nodes that will be 
producing most of the data would have to comply first. The comment 
further suggests that entities that establish traceability lot codes 
and have 500 or more employees should be expected to comply within 2 
years, while smaller businesses that establish traceability lot codes 
and have fewer than 500 employees could be afforded an additional year. 
Finally, the comment suggests that entities that solely receive and 
ship products be allowed another year after that to come into 
compliance.
    (Response 561) We decline to phase in the compliance date for the 
subpart S requirements by business size or type of covered entities. In 
the preamble to the proposed rule (85 FR 59984 at 60020), we explained 
that we could more effectively and efficiently implement the new 
requirements by having all covered persons come into compliance by the 
same date. Subpart S operates via a chain of information being 
maintained and passed forward through covered entities in the supply 
chain. If an entity in a supply chain did not provide the required 
information to their customer, the chain would be broken and the rule 
would operate less efficiently; this would be particularly true if the 
entities assigning the traceability lot codes had to comply first, but 
subsequent supply chain members were not yet required to pass the 
information forward through the supply chain. Even if the compliance

[[Page 71068]]

dates were staggered based on the type of food (such as the delayed 
compliance date for seafood that was suggested in the comments), we 
anticipate that complications would arise for entities that handle both 
FTL seafood and other FTL foods (or multi-ingredient foods with seafood 
ingredients), as well as fairness concerns from other industries that 
face challenges similar to those faced by the seafood industry.
    Staggering compliance dates would delay the benefits of the rule 
gained through efficient traceback until all covered entities reached 
their respective compliance date. Staggering the compliance dates would 
also make efficient implementation of the rule more challenging for 
covered entities, and might introduce additional complications and 
questions about who is required to comply when, and what ``compliance'' 
looks like when the compliance date has not yet arrived for a firm's 
supply chain partners. One of the reasons we are adding a year to the 
compliance date timeframe is to give covered entities more time to work 
together to understand how information will be shared under the rule; 
staggering the compliance dates would make that collaboration more 
difficult because covered entities would be at different stages in 
their compliance dates.
    (Comment 562) One comment suggests that retailers and other covered 
entities should not be made to comply until FDA has partnered with 
industry to conduct pilots related to interoperability and public-
private data sharing, such as testing approaches to implementing 
industry-wide traceability so that it is clear what covered entities 
need to do to successfully comply with the rule. Similarly, several 
comments suggest that because of the complexity of the rule and 
confusion about the scope and intended operation of the rule, we should 
implement the rule in phases by commodity, beginning with an initial 
test or pilot phase for the highest-risk commodities such as (according 
to the comments) leafy greens or some produce items. The comments 
suggest that compliance with the rule for all other commodities on the 
FTL would follow after experience has been gained with the initial 
commodities. The comments maintain that this initial phase would allow 
FDA and industry to establish traceability for the highest-risk 
commodities, while assessing whether the system will work as intended 
or whether further refinements need to be made before a second phase of 
implementation.
    (Response 562) We decline to delay the compliance date until pilot 
implementation tests have been conducted or to begin with a pilot phase 
with certain commodities. As discussed in Response 559, we are adopting 
a 3-year compliance date for all covered entities, and we believe that 
this time period will be sufficient for covered entities to 
successfully comply with the rule. While we may conduct pilot programs, 
any such programs are likely to happen during the 3-year compliance 
period. We conclude that delaying the compliance date for an 
indeterminate amount of time while pilots are conducted is not 
appropriate given the anticipated public health benefits to be gained 
through traceback efficiencies.
    (Comment 563) Several comments request that the compliance dates be 
phased in by node in the supply chain. These comments suggest that 
because downstream entities cannot comply until upstream entities send 
them information, the first compliance dates should be for the upstream 
entities, with downstream entities, particularly those handling product 
with a longer shelf life, assigned a later compliance date or given 
enforcement discretion until they have an opportunity to understand 
what type of information they will be receiving. One comment suggests 
that this would be similar to how FDA is implementing the DSCSA, and 
recommends that the Agency be guided by the DSCSA's stepwise approach 
and long implementation timeframe in establishing compliance dates for 
the food traceability rule. This comment asserts that because the food 
industry has fewer resources to devote to regulatory compliance than 
the pharmaceutical industry, the food industry should be allowed a 
longer time to comply with the tracing requirements. Some comments, 
which also reference the DSCSA, recommend a phased approach to 
implementation of subpart S that begins by focusing on the most 
significant gaps in the subpart J recordkeeping requirements.
    (Response 563) We decline to stagger the compliance date for the 
subpart S requirements by node in the supply chain. While it is true 
that information must flow ``down'' the supply chain to enable 
downstream entities to obtain information they must keep under the 
rule, we do not agree that this means the compliance dates for this 
rule should be staggered by nodes. The supply chains that are affected 
by subpart S vary greatly in terms of their length, complexity, and the 
types of activities they involve. An entity such as a distributor might 
be the first covered entity in the supply chain for some of the FTL 
foods they handle (e.g., for produce that was grown on an exempt farm), 
while simultaneously being in the middle of a chain of covered entities 
for other FTL foods they handle. There are also many covered entities 
that perform multiple CTEs with respect to the FTL foods they handle, 
including different CTEs for different FTL foods. Because of this 
variation and complexity in supply chains, it would be difficult to 
identify the nodes that would be subject to different compliance dates, 
and we anticipate that any effort to stagger compliance dates based on 
supply chain nodes would generate significant questions from 
stakeholders about their obligations for each compliance date. As 
discussed in Response 565, we recognize that when the compliance date 
arrives, there will be FTL foods in various stages of distribution, 
including on store shelves, for which there may not be complete tracing 
records, due to the fact that the product was produced before the 
compliance date. We will not expect these products to have subpart S 
records associated with them if the foods were already in distribution 
before the compliance date.
    Regarding the comments suggesting a phased approach to 
implementation of subpart S that begins by focusing on the most 
significant gaps in the subpart J recordkeeping requirements, we note 
that both farms and restaurants are excluded from subpart J (see Sec.  
1.327(a) and (b)). To the extent that the comments are recommending 
that subpart S compliance or implementation should begin with farms and 
restaurants before requiring compliance by other supply chain entities, 
we do not think such an approach would be feasible. As discussed in 
Response 561, subpart S operates via a chain of information being 
maintained and passed forward through covered entities in the supply 
chain. If farms and restaurants were required to comply with the rule 
before other supply chain entities, this chain would be broken and 
implementation of the rule would be more challenging.
    In the DSCSA, Congress specified different times (e.g., 4, 6, or 7 
years after the date of enactment) by which some requirements would 
have to be met by different types of entities, while other requirements 
generally would have to be met by all entities at the same time. 
Furthermore, DSCSA requirements concerning the interoperable, 
electronic tracing of product at the package level would go into effect 
10 years after the date of enactment. While this type of staggering may 
be appropriate in the drug tracing context, we decline to adopt it here 
for the reasons explained above. Regarding the argument that the food 
industry should be given a longer time to comply with subpart S than 
the

[[Page 71069]]

drug industry is being given to comply with the DSCSA, we do not think 
the comparison is apt. The DSCSA requires tracking to the individual 
drug package and homogenous case level with consequent labeling 
requirements, and also requires interoperable, electronic product 
tracing at the package level. Subpart S, by contrast, requires lot-
based recordkeeping that is in line with current industry best 
practices, and provides flexibility for individual entities to decide 
how they will keep and provide the relevant records, including whether 
or not they will choose to adopt electronic recordkeeping. We therefore 
think that a shorter compliance timeframe for subpart S is appropriate.
    (Comment 564) Some comments ask that we consider a phased approach 
to implementation that extends the compliance date for the electronics 
or table spreadsheet requirements in proposed Sec.  1.1455(b)(3) to 4 
years after the effective date of the final regulation. One comment 
argues that this two-phased approach would give covered entities time 
to adopt new terminology and make substantial changes to current 
systems. The comment suggests that the first phase of implementation 
would consist of entities bringing their records into compliance with 
the rule, such that, within 2 years of the effective date of the final 
rule, all covered entities would be required to establish and maintain 
the records required by the rule and these records would be available 
to FDA upon request. The comment maintains that this phased approach 
would provide covered entities sufficient time to work with their 
supply chain partners and develop the recordkeeping systems necessary 
to comply with the rule, while giving FDA access to tracing records in 
the proposed timeframe. The comment suggests that in the second phase 
of implementation, beginning 4 years after the effective date of the 
final rule, firms would have to comply with the requirement to produce 
information required by the rule in an electronic sortable spreadsheet. 
The comment maintains that a phased approach is preferable because it 
allows firms to get their traceability systems in place before 
developing a system able to deliver an electronic sortable spreadsheet 
to FDA within 24 hours.
    (Response 564) We decline to adopt a separate, extended compliance 
date for the electronic sortable spreadsheet requirement in Sec.  
1.1455(c)(3)(ii). The majority of the tracing information required 
under subpart S will be in the KDE records kept on FTL foods as they 
are initially packed or transformed and then shipped and received at 
various nodes in the supply chain. Firms will only be required to 
provide the electronic sortable 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 the 
implementation of a recall, or otherwise address a threat to the public 
health. Thus, the spreadsheet is not a routine record, but it will be a 
very helpful document to FDA during an outbreak or other public health 
threat, and it will be critical to achieving the public health gains 
anticipated for this rule. We believe allowing 3 years for all covered 
entities to establish their tracing protocols and records, including 
for generation of the electronic sortable spreadsheet, strikes an 
appropriate balance between public health and feasibility. However, we 
acknowledge that there is concern about producing the electronic 
sortable spreadsheet, including that this could be especially 
challenging for smaller entities who may have fewer resources and who 
may be more likely to use paper-based tracing systems. Therefore, the 
final rule provides exemptions for certain smaller entities from the 
electronic sortable spreadsheet requirement as specified in Sec.  
1.1455(c)(3)(iii).
    (Comment 565) Some comments ask that we clarify that the tracing 
records are not required until after the compliance date. The comments 
also note that it might take some time for downstream entities to begin 
receiving tracing records from their suppliers, and there will be 
products in inventory after the compliance date that were produced and 
received before the compliance date. Some comments request that we 
implement staggered compliance dates starting with entities at the 
beginning of the supply chain and exempt products already in commerce. 
Other comments ask us to exercise enforcement discretion for downstream 
entities who are unable to comply with the final rule because they do 
not have the required information from their suppliers.
    (Response 565) As discussed in Response 561, we decline to 
implement staggered compliance dates. We affirm that records required 
under subpart S will not have to be maintained until the compliance 
date. Furthermore, we recognize that it will take time for downstream 
covered entities in supply chains of FTL foods to receive the tracing 
records required under the rule for covered products and that, in the 
meantime, there will be FTL foods on store shelves and in stages of 
distribution for which there may not be complete tracing records, due 
to the fact that the product was produced before the compliance date. 
This may be of particular concern for FTL foods with a long shelf-life, 
such as peanut butter. We will not expect these products to have 
subpart S records associated with them if the foods were already in 
distribution before the compliance date. As the compliance date 
approaches, we will determine whether it is necessary to provide 
further clarification on our position regarding these products.
    (Comment 566) Some comments recommend that we encourage industry to 
adopt the requirements earlier and engage those companies that do so in 
a collaborative recall investigation process that benefits public 
health. These comments assert that such engagement could be used 
without regulatory action involving participating industry, absent any 
wrongdoing, and would incentivize early industry adoption of the 
additional recordkeeping practices and there by improve traceback 
investigations before the requirements take effect. One comment 
requests that any collaborative recall process have clearly defined 
roles and responsibilities for fact-finding and types of data sharing 
needed, as well as confidentiality during the investigation process.
    (Response 566) We decline to establish a formal process to 
recognize early adopters of the tracing requirements in this subpart. 
However, we encourage industry to adopt subpart S practices as soon as 
practicable, and we agree that implementation before the compliance 
date will further benefit public health. As previously stated, we will 
consider how we might assist industry with any collaborative efforts 
they might decide to undertake regarding information sharing among 
supply chain partners to comply with the rule.

VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, 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). 
The Office of Information and Regulatory Affairs has designated this 
final rule as an economically significant regulatory action as defined 
by Executive Order 12866.

[[Page 71070]]

    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 1 percent of their annual revenue, we find that the final 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 issuing ``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 $165 
million, using the most current (2021) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would result in an expenditure 
in at least one year that meets or exceeds this amount.
    This final rule will 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 recipients of the 
contaminated product. This rule will only apply to foods FDA has 
designated for inclusion on the FTL and foods that contain listed foods 
as ingredients that remain in the same form (e.g., fresh) in which they 
appear on the list. By allowing faster identification of contaminated 
foods and increasing rates of successful tracing completions, the rule 
results in public health benefits if foodborne illnesses directly 
related to those outbreaks are averted. This might 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 covered 
foods.
    The primary public health benefits of this rule are the value from 
the reduction of foodborne illnesses and deaths because records 
required by the rule are likely to reduce the time that a violative or 
contaminated covered food product is distributed in the market. 
Benefits from this rule are generated if the following two conditions 
hold: (1) a foodborne outbreak occurs and (2) the traceability records 
required by this rule help FDA to locate a commercially distributed 
violative product quickly and accurately and to ensure it is removed 
from the market.
    While the primary benefits from the rule are the value of the 
reduction of foodborne illnesses and deaths, we also examine non-health 
related benefits. Non-health related benefits of this rule will 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. Benefits 
from avoiding overly broad recalls may be realized only when recalls 
are initiated in response to an FDA public health advisory.
---------------------------------------------------------------------------

    \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 
recalls of insured products, which may have long-term consequences 
to retailers from increases in their insurance rates due to 
imprecise recalls.
---------------------------------------------------------------------------

    It is possible, but not certain, that both of these categories of 
benefits could be experienced to the extent quantified in table 2 and 
the underlying regulatory impact analysis. On the other hand, it is 
also possible that a given instance of baseline contamination would 
lead to a very broad recall (that could be narrowed by the final rule) 
or to illnesses (that could be avoided due to the final rule) but not 
both.
    Additional benefits of the rule 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; reduction of food waste; 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 
(Ref. 16 (Refs. 1, 2)).
    This rule will impose compliance costs on covered entities by 
increasing the number of records that are required for covered food 
products. Entities that manufacture, process, pack, or hold covered 
foods will incur costs to establish and maintain a traceability plan 
and traceability records. Some firms may also incur initial and 
recurring capital investment and training costs for systems that will 
enable them to keep, maintain, and make available to other supply chain 
entities (and to us upon our request) their traceability records. 
Moreover, firms will incur one-time costs of reading and understanding 
the rule.\2\
---------------------------------------------------------------------------

    \2\ The information flows brought about by the rule may prompt 
new protective actions--for example, in farming, manufacturing, or 
cooking processes--that could also have costs. We have not 
quantified these potential costs, but they would likely correlate 
with the realization of the health and longevity benefits of this 
rule.
---------------------------------------------------------------------------

    Table 2 summarizes the costs and benefits of the final rule. At a 7 
percent discount rate, 20-year annualized costs range from about $63 
million to $2.3 billion, with a primary estimate of $570 million per 
year. At a 3 percent discount rate, annualized costs range from about 
$53 million to $2.3 billion, with a primary estimate of $551 million 
per year. The present value of costs with 7 percent discounting over 20 
years (not shown in table 2) ranges from about $0.7 billion to $24.6 
billion, with a primary estimate of about $6 billion. The present value 
of costs with 3 percent discounting over 20 years (not shown in table 
2) ranges from about $0.8 billion to $33.7 billion, with a primary 
estimate of $8.2 billion.
    We estimate public health benefits using several case studies of 
outbreak tracebacks for four pathogens associated with illnesses caused 
by covered foods.\3\ We calculate these benefits based on an estimated 
83 percent reduction of traceback time resulting from the requirements 
of this rule. At a 7 percent discount rate over 20 years, the 
annualized monetized health benefits of the rule range from $59 million 
to $2.2 billion with a primary estimate of $780 million (table 2). At a 
3 percent discount rate over 20 years, the annualized monetized health 
benefits range from $61 million to $2.3 billion with a primary estimate 
of $810 million. The present value of health benefits with 7

[[Page 71071]]

percent discounting over 20 years (not shown in table 2) ranges from 
about $0.6 billion to $23.7 billion, with a primary estimate of $8.3 
billion. The present value of health benefits with 3 percent 
discounting over 20 years (not shown in table 2) ranges from about $0.9 
billion to $34.5 billion, with a primary estimate of $12.0 billion.
---------------------------------------------------------------------------

    \3\ This approach has a tendency toward underestimation of the 
total public health benefits because these four pathogens do not 
represent the total burden of all FTL-associated illnesses. However, 
adjustments made for undiagnosed and unattributed illnesses may have 
the opposite tendency of overstating both FTL-associated illnesses 
and benefits. 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 FRIA section II.E.1, Public Health 
Benefits from Averted Illnesses. 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.
---------------------------------------------------------------------------

    We estimate (non-health) benefits from avoiding overly broad 
recalls and market withdrawals. At a 7 percent discount rate over 20 
years, these annualized monetized benefits range from $233 million to 
$1.8 billion with a primary estimate of $575 million (table 2). At a 3 
percent discount rate over 20 years, these annualized monetized 
benefits range from $242 million to $1.8 billion with a primary 
estimate of $596 million. The present value of benefits from avoiding 
overly broad recalls with 7 percent discounting over 20 years (not 
shown in table 2) ranges from about $2.5 billion to $18.8 billion, with 
a primary estimate of $6.1 billion. The present value of these benefits 
with 3 percent discounting over 20 years (not shown in table 2) ranges 
from about $3.6 billion to $27.3 billion, with a primary estimate of 
$8.9 billion.

                                Table 2--Summary of Benefits, Costs and Distributional Effects of Final Rule ($Millions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                  Units
                                           Primary       Low        High    -------------------------------------------------
                Category                  estimate    estimate    estimate      Year      Discount                                       Notes
                                                                               dollars      rate          Period covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized Millions$/year        $780         $59      $2,238        2020          7%  20 years...............  Monetized health benefits
                                                810          61        2322        2020          3%  20 years...............   from an estimated 83%
                                                                                                                               improvement in traceback
                                                                                                                               time for four pathogens.
                                                                                                                               Additional (non-health)
                                                                                                                               benefits of avoiding
                                                                                                                               overly broad recalls
                                                                                                                               range from $233 million
                                                                                                                               to $1.8 billion, with a
                                                                                                                               primary estimate of $575
                                                                                                                               million (at 7% discount
                                                                                                                               rate) and from $242
                                                                                                                               million to $1.8 billion,
                                                                                                                               with a primary estimate
                                                                                                                               of $596 million (at 3%
                                                                                                                               discount rate).
    Annualized Quantified
                                        ----------------------------------------------------------------------------------------------------------------
    Qualitative........................  Additional potential benefits
                                         include increased food supply
                                         system efficiencies; more
                                         expedient initiation and
                                         completion of recalls; avoidance
                                         of costs due to unnecessary
                                         preventive actions; reduction of
                                         food waste; and other efficiencies
                                         from a standardized approach to
                                         traceability.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized Millions$/year         570          63       2,323        2020          7%  20 years...............  A portion of foreign costs
                                                551          53       2,267        2020          3%  20 years...............   could be passed on to
                                                                                                                               domestic consumers. We
                                                                                                                               estimate that up to $50.5
                                                                                                                               million in annualized
                                                                                                                               costs (7%, 20 years) to
                                                                                                                               foreign facilities could
                                                                                                                               be passed on to domestic
                                                                                                                               consumers.
    Annualized Quantified
    Qualitative........................  ..........  ..........  ..........  ..........  ..........  .......................  Costs of farming-,
                                                                                                                               manufacturing- or cooking-
                                                                                                                               related actions that, as
                                                                                                                               a result of new
                                                                                                                               information flows,
                                                                                                                               address risks of
                                                                                                                               foodborne illness.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 rule........................
    Wages: N/A..........................................................................................................................................
    Growth: N/A.........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive economic analysis document that 
assesses the impacts of the final rule and includes the Final 
Regulatory Impact Analysis, Final Regulatory Flexibility Analysis, and 
Unfunded Mandates Reform Act Analysis (Ref. 16). The full analysis of 
economic impacts is available in the docket for this final rule and at 
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. Analysis of Environmental Impacts

    We previously considered the environmental effects of this rule, as 
stated in the preamble to the proposed rule (85 FR 59984 at 60025). We 
stated that we had determined, under 21 CFR

[[Page 71072]]

25.30(h), that this action is of a type that does not individually or 
cumulatively have a significant effect on the human environment such 
that neither an environmental assessment (EA) nor an environmental 
impact statement (EIS) is required. We received comments on our 
tentative determination that this rule is categorically excluded from 
the requirement to prepare an EA or an EIS; we respond to these 
comments in the Categorical Exclusion Memorandum for this rulemaking 
(Ref. 24). We conclude that we have not received any new information or 
comments that would affect our previous determination.

IX. Paperwork Reduction Act of 1995

    This final 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 and recordkeeping burden associated 
with the final 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.
    Title: Establishment, Maintenance, and Availability of Records; 
Traceability Records for Certain Foods--OMB Control No. 0910-0560--
Revision.
    Description: The new regulations will establish recordkeeping 
requirements applicable to certain foods, to help effectively and 
rapidly identify recipients of a food to prevent or mitigate a 
foodborne illness outbreak. These recordkeeping requirements are 
intended to strengthen public health protections by documenting the 
movement of foods throughout the supply chain, enabling FDA to identify 
the source of contaminated foods and aid in the removal of contaminated 
products from the market. The regulations also help implement statutory 
provisions governing high-risk foods. Access to and utilization of 
traceability records better enables FDA to respond to and contain 
threats to the public health introduced through foods on the Food 
Traceability List (FTL) (``listed foods'').
    Description of Respondents: Respondents to the information 
collection are 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 (FSMA) (i.e., the FTL).
    In the following paragraphs, we describe and respond to the 
comments pertaining to the proposed information collection.
    (Comment 567) Some comments suggest that the estimate of entities 
that will be affected is too narrow because it includes only those 
entities that manufacture, process, pack, or hold listed foods or foods 
containing a listed food as an ingredient. The comments maintain that, 
in practice, the new requirements will likely affect entities handling 
all foods because covered entities will be required to revise their 
recordkeeping systems to comply with the rule, and it would be more 
time- and energy-intensive to maintain two sets of recordkeeping 
systems (one for listed foods and one for non-listed foods). The 
comments assert that covered entities will expand their recordkeeping 
systems to all foods they handle, which in turn will require that their 
suppliers comply with the rule for the foods they provide to covered 
entities, whether FTL foods or not (making those suppliers also likely 
to adopt the rule's requirements for all foods). One comment asserts 
that the estimates should consider nearly every entity along the food 
supply chain except the consumer.
    (Response 567) We regard recordkeeping by firms that do not handle 
covered foods, but that might choose to adopt traceability practices 
consistent with their business partners who do, as usual and customary 
and therefore assume no burden for this activity. When certain 
practices prove optimal on business grounds, or when large firms--
including those not subject to the rule--exert influence over supplier 
practices via market power, practices might converge over time for 
reasons other than regulatory compliance. Moreover, as documented in 
the 2012 IFT traceability pilot project (Ref. 1), firms with widely 
varying traceability practices already conduct business with each other 
while serving the traceability demands of downstream customers and 
industry initiatives without resulting convergence among the entities 
with regard to those traceability practices. Because the rule does not 
prescribe specific technologies for records maintenance and KDEs 
required under subpart S mostly consist of information already commonly 
communicated between business partners, we expect supply chains to 
continue to accommodate widely varying traceability practices.
    Concerning firms that handle both covered and non-covered foods, we 
do not believe implementation of KDE recordkeeping for non-covered 
foods would affect our estimates. First, our assumptions regarding new 
equipment, software, services, training, and procedures--which we 
acknowledge might necessarily displace existing systems rather than 
operate in parallel with them--considers these to be fixed costs with 
respect to the number of foods handled. Second, we estimate the 
variable costs of recordkeeping as labor, and we do not believe in 
general that requiring an employee to perform an action for certain 
foods creates a need to perform that action for all other foods. We 
would thus not attribute to the rule the additional labor cost of 
performing traceability recordkeeping on all other foods.
    As noted in the FRIA, after consideration of the comments, we 
examined more recent data sources on covered entities and modified our 
estimate of the entities that will be affected by the rule. We have 
adjusted the total number of respondents downward by approximately 
100,000, consistent with the updated data sources and our decision to 
exempt additional entities from the rule. While we expect that it will 
be possible for businesses to keep the requisite records just for FTL 
foods, we will continue to evaluate this aspect of the information 
collection in future updates.
    (Comment 568) Some comments state that the estimated time and cost 
to read and understand the rule is too low. One comment asserts that 
the estimate of 3.3 hours for each respondent to read and understand 
the new recordkeeping requirements is an immense understatement. The 
comment stated that the proposed rule was 55 three-column pages in the 
Federal Register and includes multiple cross-references to FSMA and 
existing FDA regulations, and there were three full-day public meetings 
and multiple supplemental materials to help stakeholders understand the 
rule, including a revision to the FTL and an FAQ document. Other 
comments assert that the estimate of 3.3 hours is perhaps the amount of 
time it would take to simply read the proposed rule, but it fails to 
account for the need to consider the rule's implications and how it 
would affect a particular entity. Some comments maintain that more than 
1 person per covered entity will need to read and understand the rule, 
that as many as 10 or more people might read the rule, and that the 
time needed to understand the rule is far more than 3.3 hours. One 
comment asserts that the estimate should be increased to a minimum of 
10 hours, which would roughly triple employee costs. The comment bases 
this assertion in part on their estimate that reading and

[[Page 71073]]

understanding the ``supplemental examples'' we posted in February 2021 
took 4 to 6 hours.
    (Response 568) Our basis for the estimated time to read and 
understand the rule remains consistent with methods used in previous 
FDA analyses and assumes an existing understanding of applicable 
regulations already effective under FSMA. However, we did increase the 
amount of time we attribute to reading and understanding the 
recordkeeping requirements from 3.3 hours to, on average, 16.8 hours, 
as both the final codified text and particularly the preamble to the 
final rule are longer than the proposed rule text. This estimate is an 
average over all firms, and now includes an assumption that in small 
firms one employee will read the rule and in large firms three 
employees will read the rule. The estimated average sum of the time 
spent reading and understanding the rule at each firm is 16.8 hours.
    With regard to the number of respondents, we account for multiple 
employees reading the rule at larger companies. While many small firms 
might not in fact read the full text of the preamble of the final rule 
and associated provisions of the Code of Federal Regulations (instead 
learning about the rule from simplified explanations via trade 
associations and publications), we assume that one employee will read 
the rule at small firms and that three employees will read the rule at 
large firms. Note also that we consider reading costs alone in Section 
II.F.2 (``Reading and Understanding the Rule'') of the FRIA to be 
separate from the costs to identify FTL products and plan for 
compliance, which we estimate in Section II.F.5.b (``Traceability 
Plan'') of the FRIA.
    (Comment 569) Some comments maintain that the estimated one-time 
set-up costs are far too low. Some comments assert that while the 
proposed rule estimates that most entities (other than distribution 
centers and warehouses) will be required to maintain records for 1,000 
FTL lots, the comments anticipate they will handle far more than 1,000 
lots. One comment estimates that for its products containing nut 
butters alone (i.e., not accounting for other ingredients potentially 
on the FTL), the firm handles more than 9,000 FTL lots per year. One 
comment asserts that because many if not most entities process numerous 
lots of hundreds of different SKUs each year, these entities will be 
required to establish and maintain records for far more than 1,000 FTL 
lots. The comment also asserts that even FDA's higher estimate for 
warehouses (48,333 lots annually) is still far too low. One comment 
maintains that entities other than distribution centers and warehouses 
will handle many thousands of food traceability lots (not just 1,000) 
on an annual basis, depending on their size, while distribution centers 
and warehouses likely will handle millions of such lots (not just 
190,000).
    (Response 569) To gain a better understanding of industry's 
possible adoption of new practices and systems in response to the rule 
and to better inform our estimates of the number of traceability lots 
handled by various covered entities by entity size and category, we 
contracted with consultants (the Eastern Research Group (ERG)) to 
elicit input from an external panel of industry experts (Ref. 34). We 
have incorporated their input in Section II.F.5 (``Traceability Plan'') 
of the FRIA, in which we estimate the costs of planning new procedures 
to comply with the final rule. In particular, our estimates now 
differentiate between small and large establishments. In most industry 
categories, our primary estimates of FTL lots undergoing initial 
packing, first land-based receiving, shipping, and transforming are now 
800 to 900 lots for small establishments and 1,400 to 5,500 lots for 
large establishments. For lots received by warehouses, distribution 
centers, restaurants, and non-restaurant retailers, our primary 
estimates are now 1,500 to 4,600 lots for small establishments and 
3,100 to 28,600 lots for large establishments.
    (Comment 570) Some comments state that the time and cost estimates 
for training for the rule are far too low. One comment asserts that 
although FDA projects that only a portion of firms will incur training 
costs and that such firms will need to conduct an average of 2 hours of 
training regarding an average of 3 records, because of the rule's 
complexity and the fundamental changes to current recordkeeping 
practices that would be required under the proposed rule, firms will 
need to conduct ongoing, company-wide trainings to ensure compliance. 
One comment asserts that under third-party auditing programs that 
members are currently involved in, they have a minimum of 8 to 10 hours 
of training per employee (which does not include annual retraining, 
verification, and any travel costs associated with training). Based on 
these assertions, the comments maintain that we should significantly 
increase the estimate of the training time and costs. One comment 
asserts that training estimates did not account for the significant 
volume of employees who will require training and the time needed to 
train them. The comment maintains that time required to train employees 
will vary depending on their role, and that larger retailers will have 
several hundred associates to train, while tens of thousands of 
employees will require training when they are onboarded. The comment 
estimates that training costs range from $15,000 to nearly $3 million. 
One comment asserts that firms will have annual training costs, not 
just a one-time cost. The comment further maintains that annually 
training employees on the requirements will take 5 hours of each 
employee's time, and that an annual review, commonly required by 
auditors, would need to be conducted, all adding to costs.
    (Response 570) In the PRIA, we assumed that training would be a 
one-time cost to train only a limited number of current employees on 
the new requirements and traceability practices. We also assumed that, 
for training new employees, some outdated training content will be 
replaced with training related to this rule, thus not incurring an 
additional training cost for those new employees. We note that comments 
did not provide additional data in support of alternative estimates. 
However, after reviewing the comments on our estimates of training 
costs, we determined a need for and sought additional data and 
information to improve our estimates. We contracted with consultants to 
survey a panel of external industry experts to further inform training 
costs to various covered entities based on their size and baseline 
industry practices (Ref. 34). In Section II.F.4 of the FRIA, we 
estimate the number of trainees for entities of different sizes across 
different industry sectors based on input by the expert panel. We now 
differentiate between small and large establishments across different 
industry categories. In general, hours stayed roughly the same or 
slightly increased (compared to the proposed estimates) for small 
establishments and increased for large establishments. The number of 
trainees increased significantly for both, so the per-establishment 
cost has gone up. However, we now estimate that far fewer 
establishments need training specifically for this rule because most 
establishments subject to the rule only receive FTL foods, which we 
have assumed to be a simple task on its own, so the total hours have 
gone down. As a result, we have revised the estimated one-time burden 
associated with training personnel as shown in table 3. In addition, we 
have added to the

[[Page 71074]]

estimated annual recordkeeping burden an estimate of recurring, or 
annual, training costs, as shown in table 5.
    (Comment 571) Some comments maintain that the time and cost 
estimates for annual recordkeeping are far too low. One comment asserts 
that they will need to hire people to create and maintain a database 
system for electronic recordkeeping, even if it can be an Excel 
spreadsheet that is made available to FDA upon request, because it is 
not clear what is needed for the spreadsheet. One comment asserts the 
proposed growing area coordinates requirement for growers will cause a 
paperwork hardship. One comment maintains that scanning a barcode vs. 
scanning and typing even three pieces of information such as brand, 
pack date, and lot code will take more than the estimated 0.004 hour. 
The comment further maintains that as a company receiving loads that 
have one-case quantities of some products and straight truckloads of 
other products, having to type in the identifying factors for hundreds 
of products each week will quickly become more costly than the 
software. One comment asserts that the ``high'' numbers noted in table 
31 in the PRIA for recurring recordkeeping costs were too low. The 
comment maintains that assuming 0.01 hours for each record (the high 
number in the table was 0.006 hours) is a truer estimate, simply 
adjusting the time needed to establish and maintain records and the 
time needed to send records would increase the costs by 67 percent. The 
comment further asserts that 5 minutes to type each transaction is a 
more reasonable estimate than the proposed rule's ``high'' estimate of 
3 minutes, and states that this change would increase costs by 67 
percent.
    (Response 571) We have updated our estimates of the number of 
covered entities and costs to reflect additional full exemptions for 
small entities and certain food, as well as the exemption of smaller 
entities from the requirement to provide an electronic, sortable 
spreadsheet in certain circumstances upon the Agency's request. 
Additionally, the final rule aims to simplify recordkeeping by aligning 
requisite elements more closely with data elements already captured and 
communicated in standard business practices. Therefore, we have updated 
our estimates of burden per traceability lot, accounting both for 
changes to the proposed rule and expert elicitation (Ref. 34). 
Additionally, section II.F.5 the FRIA distinguishes ``capturing'' from 
``submitting'' information and accounts for them as distinct 
activities.
    Regarding the proposed growing area coordinates requirement for 
growers of FTL foods, we note this is no longer a requirement of the 
rule. Instead, persons that grow or raise an FTL food (other than eggs) 
that are subject to the rule will need to keep, as part of their 
traceability plan, a farm map showing the area in which the FTL food 
was grown or raised. We have received farm maps with field names and 
coordinates during outbreak investigations, and because of the 
widespread availability and use of no-cost mapping and direction 
websites and web applications with GPS coordinate-plotting 
functionality, we expect most affected entities either already keep the 
required map or will be able to produce it in minutes.
    Regarding the comments specific to the estimates for scanning and 
typing information and the high estimates for annual recordkeeping, 
because our cost estimates include significant capital investment by 
manufacturers and wholesalers, our estimated average recordkeeping 
times therefore assume that many of these entities will significantly 
reduce manual data entry in recordkeeping. Since retailers need only 
keep the records provided to them by suppliers and do not generally 
need to use the information for further compliance activities, we do 
not expect retailers in general to perform data entry, manual or 
otherwise.
    (Comment 572) One comment maintains that when a raw product is 
transformed, it may become multiple products, therefore multiplying the 
number of required records. One comment maintains that counting a 
shipment as one traceability lot is inaccurate, asserting instead that 
most shipments contain multiple lots because of breakdowns into 
different sizes (e.g., 4-, 6-, 8-ounce sizes). The comment maintains 
that these multiple lots would necessitate multiple data entries for 
the same shipment, thus increasing costs.
    (Response 572) Based on expert elicitation (Ref. 34) in response to 
FDA outreach regarding this rulemaking, we have revised our estimate of 
the attendant recordkeeping burden upward to better reflect the scope 
of coverage. These revisions are discussed in detail in Section 
II.F.5.h of the FRIA.
    (Comment 573) A number of comments maintain that FDA has 
underestimated the time and cost attendant to proposed revisions to the 
FTL under proposed Sec.  1.1465(a); however, the comments did not 
include an alternative basis upon which we could form a burden 
estimate.
    (Response 573) It is challenging to estimate the burden associated 
with possible future revisions to the FTL, such as learning about the 
changes or submitting comments, because we do not know whether those 
revisions would reduce or increase the number of foods on the FTL or 
what the public response to the revisions would be. We remind 
respondents that we invite public comment at regular intervals on our 
information collection activities, including burden associated with 
recordkeeping requirements already required under part 1, subpart J. As 
we implement the subpart S requirements, we will continue to monitor 
and invite feedback regarding burden associated with revisions to the 
FTL.
Burden Tables
    Upon consideration of these comments, we estimate the burden of the 
information collection as follows:

                                Table 3--Estimated One-Time Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
            Activity               recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
Reading and understanding the            323,872               1         323,872        \1\ 16.8       5,441,050
 new recordkeeping requirements.
Sec.   1.1315; traceability plan         212,368               1         212,368             6.2       1,316,682
 (one-time set-up)..............
Training personnel..............          34,737            10.5         364,739             4.2       1,531,904
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       8,289,635
----------------------------------------------------------------------------------------------------------------
\1\ There is likely to be more than one reader at each large firm. The estimated average sum over all readers of
  the time spent reading and understanding the rule at each firm is 16.8 hours.


[[Page 71075]]

    The Estimated One-Time Recordkeeping Burden table reflects several 
changes to the proposed information collection. The estimated number of 
respondents for reading and understanding the recordkeeping 
requirements decreased because of additional exemptions and revisions 
to exemptions added in the final rule and our use of more recent data 
sources on the number of covered entities. We also increased the 
average burden to read and understand the rule from 3.3 hours to 16.8 
hours because the length of the rule increased. The number of 
respondents for the one-time set up costs for the traceability plan 
(``traceability program records'' under the proposed rule) was updated 
based on updated overall coverage estimates for the number of firms, 
plus new data on the share of entities that will establish a 
traceability plan from the ERG expert elicitation study (Ref. 34). This 
is now a per-firm rather than per-establishment (facility) burden, and 
because we have moved from traceability program records to a 
traceability plan, the number of records per respondent has decreased 
to one. Finally, we have updated the number of respondents for training 
personnel based on updated coverage estimates plus newer data from the 
ERG expert elicitation study. Now training is per-establishment 
(facility) rather than per-firm. We have also updated the number of 
records per respondent for training personnel based on the ERG expert 
elicitation study.

                                   Table 4--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
       Reporting activity           respondents    responses per     responses     response (in     Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
1.1370; Requests for modified                  5               1               5              10              50
 requirements and exemptions....
1.1415 through 1.1425; Requests               15               1              15              10             150
 for waivers....................
1.1465(a); Comments on proposed                1               1               1               1               1
 revisions to the Food
 Traceability List..............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............              22  ..............             201
----------------------------------------------------------------------------------------------------------------

    As discussed above, we have made no changes to the estimated annual 
reporting burden associated with the final rule.

                                 Table 5--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average burden
     21 CFR recordkeeping          Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
Training personnel (recurring)          26,053            10.5         273,557  2.7.............         738,604
Sec.   1.1330(b); seed lot                  95             882          83,790  0.04 (2.4                  3,352
 records (sprout growers).                                                       minutes).
Sec.   1.1325; harvester......           6,058             578       3,501,524  0.03 (1.8                105,046
                                                                                 minutes).
Sec.   1.1325; cooler.........           3,511             572       2,008,292  0.03 (1.8                 60,249
                                                                                 minutes).
Sec.   1.1330(a) and (c);                4,218             861       3,631,698  0.02 (1.2                 72,634
 initial packer.                                                                 minutes).
Sec.   1.1335; first land-                 367           1,471         539,857  0.02 (1.1                 10,797
 based receiver.                                                                 minutes).
Sec.   1.1340; shipper........          31,434           5,032     158,175,888  0.006 (22                949,055
                                                                                 seconds).
Sec.   1.1345; receiver.......         470,580           5,968   2,808,421,440  0.003 (11              8,425,264
                                                                                 seconds).
Sec.   1.1350; transformer....           8,574           1,101       9,439,974  0.02 (1.2                188,799
                                                                                 minutes).
Sec.   1.1455(c)(3)(ii);                    75               1              75  16.0............           1,200
 electronic sortable
 spreadsheet upon request.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................      10,555,000
----------------------------------------------------------------------------------------------------------------

    The revised estimated annual recordkeeping burden in table 5 
reflects several changes we made to the proposed information 
collection. First, the list of provisions changed consistent with 
revisions we made to the CTEs and related annual activities such as 
training personnel. The number of recordkeepers generally decreased 
because of additional exemptions and revisions to exemptions we added 
in the final rule and our use of more recent data sources on the number 
of covered entities. We have also estimated the burden for training 
personnel as a recurring burden rather than a one-time burden and 
altered the number of records per recordkeeper for the various 
provisions based on information from the ERG expert elicitation study 
(Ref. 34). Finally, we have updated the average burden per 
recordkeeping based on information from the ERG expert elicitation 
study. Apart from changes to the proposed rule, we also newly estimated 
the annual burden of formatting traceability information as an 
electronic sortable spreadsheet upon request by FDA.
    Because we have deleted the requirements (in proposed Sec.  
1.1350(b)(2)) that farms disclose information (if applicable) about the 
origination, harvesting, cooling, and packing of food shipped by the 
farm, we have removed the disclosure burden previously included. Under 
Sec.  1.1325(a)(2) and (b)(2) of the final rule, harvesters and coolers 
of FTL foods must disclose certain information about those activities 
to the initial packers of such food. However, as we stated in the 
preamble to the proposed rule with respect to the disclosure burden for 
shippers of FTL foods (85 FR 59984 at 60027), we are including the 
estimate of burden we attribute to the disclosure requirements for 
harvesters and coolers

[[Page 71076]]

as part of our recordkeeping burden estimate for these provisions 
because we believe this disclosure burden will be minimal, since these 
respondents must maintain harvesting and cooling information in 
accordance with those provisions.
    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section 3507(d) of the 
Paperwork Reduction Act of 1995. Before the effective date of this 
final rule, FDA will publish a notice in the Federal Register 
announcing OMB's decision to approve, modify, or disapprove the 
information collection provisions in this final rule. An Agency may not 
conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB 
control number.

X. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the 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 rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects 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. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the Executive Order and, consequently, a 
tribal summary impact statement is not required.

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 also are 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, ``Pilot Projects for Improving 
Product Tracing Along the Food Supply System--Final Report,'' August 
2012.
2. 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).
3. * FDA, ``Food Traceability List for Requirements for Additional 
Traceability Records for Certain Foods Proposed Rule 2020,'' August 
12, 2020 (https://www.fda.gov/media/142283/download).
4. * FDA Memorandum, ``Methodological Approach to Developing a Risk-
Ranking Model for Food Tracing FSMA Section 204 (21 U.S.C. 2223),'' 
August 2020 (https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-reports-studies).
5. * FDA Memorandum, ``Designation of the Food Traceability List 
Using the Risk-Ranking Model for Food Tracing (2019 Version),'' 
September 2, 2020 (https://www.fda.gov/media/142282/download).
6. * Dewey-Mattia, D., et al. ``Surveillance for Foodborne Disease 
Outbreaks--United States, 2009-2015.'' Morbidity and Mortality 
Weekly Report. Surveillance Summaries (Washington, DC: 2002), vol. 
67,10 1-11. 27 July 2018, doi:10.15585/mmwr.ss6710a1.
7. Irvin, K., S. Viazis, A. Fields, et al., ``An Overview of 
Traceback Investigations and Three Case Studies of Recent Outbreaks 
of Escherichia coli O157:H7 Infections Linked to Romaine Lettuce,'' 
Journal of Food Protection, 84:1340-1356, 2021.
8. * FDA Memorandum, ``Food Traceability List for Requirements for 
Additional Traceability Records for Certain Foods Proposed Rule--
Clarified Language,'' January 12, 2021 (https://www.fda.gov/media/145050/download).
9. * 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 (https://www.fda.gov/science-research/peer-review-scientific-information-and-assessments/completed-peer-reviews and 
https://www.fda.gov/media/142280/download).
10. * FDA Memorandum, ``Methodological Approach to Developing a 
Risk-Ranking Model for Food Tracing FSMA Section 204 (21 U.S.C. 
2223),'' September 2022.
11. * FDA Memorandum, ``FDA Foodborne Illness Outbreak Data Used to 
Inform the `Requirements for Additional Traceability Records for 
Certain Foods' Proposed Rule,'' August 2020.
12. * FDA, ``Investigation Report: Factors Potentially Contributing 
to the Contamination of Packaged Leafy Greens Implicated in the 
Outbreak of Salmonella Typhimurium During the Summer of 2021,'' 
January 2022 (https://www.fda.gov/media/155402/download).
13. * 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 (https://www.fda.gov/science-research/peer-review-scientific-information-and-assessments/completed-peer-reviews and 
https://www.fda.gov/media/142281/download).
14. * Food and Agriculture Organization of the United Nations and 
World Health Organization (FAO/WHO), ``Microbiological Risk 
Assessment: Guidance for Food,'' Microbiological Risk Assessment 
Series 36, 2021 (https://www.fao.org/policy-support/tools-and-publications/resources-details/en/c/1412247/).
15. * FDA Memorandum, ``Designation of the Food Traceability List 
Using the Risk-Ranking Model for Food Tracing,'' October 2022.
16. * FDA, ``Final Regulatory Impact Analysis,'' Docket No. FDA-
2014-N-0053, November 2022.
17. * FDA, ``Risk-Ranking Model for Food Tracing: Web-based tool for 
Criteria and Results,'' 2022. (https://cfsanappsexternal.fda.gov/scripts/FDARiskRankingModelforFoodTracingfinalrule/).
18. * FDA, ``New Era of Smarter Food Safety Blueprint,'' July 2020 
(https://www.fda.gov/media/139868/download).
19. * FDA Memorandum, ``Food Traceability List for Requirements for 
Additional Traceability Records for Certain Foods Final Rule 2022,'' 
October 2022.
20. Scott, V.N., Y. Chen, T.A. Freier, et al., ``Control of 
Salmonella in Low-Moisture Foods I: Minimizing Entry of Salmonella 
into a Processing Facility,'' Food Protection Trends, 29:342-353, 
2009.
21. Chen, Y., V.N. Scott, T.A. Freier, et al., ``Control of 
Salmonella in Low-Moisture Foods II: Hygiene Practices To Minimize 
Salmonella Contamination and Growth,'' Food Protection Trends, 
29:435-445, 2009.
22. * FDA and Health Canada, ``Joint FDA/Health Canada Quantitative 
Assessment of the Risk of Listeriosis from Soft-Ripened Cheese 
Consumption in the United States and Canada: Report.,'' July 2015 
(https://www.fda.gov/food/cfsan-risk-safety-assessments/joint-fda-health-canada-quantitative-assessment-risk-listeriosis-soft-ripened-cheese-consumption).
23. * FDA, ``Fish and Fishery Products Hazards and Controls Guidance 
(June

[[Page 71077]]

2022 Edition),'' June 2022 (https://www.fda.gov/media/80637/download).
24. * FDA Memorandum, ``Categorical Exclusion--Requirements for 
Additional Traceability Records for Certain Foods,'' Docket No. FDA-
2014-N-0053,'' October 2022.
25. * FDA Memorandum, ``Inclusion of Retail Establishments of All 
Sizes Under FSMA Section 204,'' August 13, 2020.
26. * FDA, ``Guidance for Industry: Questions and Answers Regarding 
Food Facility Registration (Seventh Edition),'' August 2018 (https://www.fda.gov/media/85043/download).
27. * FDA, ``Draft Guidance for Industry: Classification of 
Activities as Harvesting, Packing, Holding, or Manufacturing/
Processing for Farms and Facilities,'' August 2016 (https://www.fda.gov/media/99911/download).
28. * FDA Memorandum, ``Seed Intended for Agricultural Purposes Sold 
for Sprouting,'' October 2022.
29. * FDA, ``Guidance for Industry: The Seafood List,'' July 2012 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-seafood-list).
30. * FDA, ``Low- or No-Cost Tech-Enabled Traceability Challenge,'' 
October 19, 2021. (https://precision.fda.gov/challenges/13).
31. * Codex Alimentarius Commission, ``Principles for Traceability/
Product Tracing as a Tool Within a Food Inspection and Certification 
System'' (CAC/GL 60-2006) (https://www.fao.org/fao-who-codexalimentarius/sh-proxy/tr/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXG%2B60-2006%252FCXG_060e.pdf).
32. * FDA, ``Foreign Supplier Verification Programs for Importers of 
Food for Humans and Animals (FSVP) Regulation Records Requirements'' 
(https://www.fda.gov/media/131229/download).
33. * FDA and National Oceanic and Atmospheric Administration, 
``Memorandum of Understanding Between the Food and Drug 
Administration, United States Department of Health and Human 
Services and the National Oceanic and Atmospheric Administration, 
United States Department of Commerce,'' 2009 (https://www.fda.gov/about-fda/domestic-mous/mou-225-09-0008).
34. * Eastern Research Group, ``Traceability Costs and Costs Savings 
From Avoiding Overly Broad Recalls,'' 2022.

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, 21 CFR part 
1 is 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, 342, 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 Plan

1.1315 What traceability plan must I have for foods on the Food 
Traceability List that I manufacture, process, pack, or hold?
1.1320 When must I assign traceability lot codes to foods on the 
Food Traceability List? Records of Critical Tracking Events
1.1325 What records must I keep and provide when I harvest or cool a 
raw agricultural commodity on the Food Traceability List?
1.1330 What records must I keep when I am performing the initial 
packing of a raw agricultural commodity (other than a food obtained 
from a fishing vessel) on the Food Traceability List?
1.1335 What records must I keep when I am the first land-based 
receiver of a food on the Food Traceability List that was obtained 
from a fishing vessel?
1.1340 What records must I keep and provide when I ship a food on 
the Food Traceability List?
1.1345 What records must I keep when I receive a food on the Food 
Traceability List?
1.1350 What records must I keep when I transform a food on the Food 
Traceability List?

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 and 
made available?

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 otherwise specified 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

[[Page 71078]]

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, www.fda.gov., 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 certain small producers. (1) Certain produce 
farms. (i) This subpart does not apply to farms or the farm activities 
of farm mixed-type facilities with respect to the produce 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,
    (ii) This subpart does not apply to produce farms when the average 
annual sum of the monetary value of their sales of produce and the 
market value of produce they manufacture, process, pack, or hold 
without sale (e.g., held for a fee) during the previous 3-year period 
is no more than $25,000 (on a rolling basis), adjusted for inflation 
using 2020 as the baseline year for calculating the adjustment.
    (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 producers of raw agricultural commodities. This 
subpart does not apply to producers of raw agricultural commodities 
other than produce or shell eggs (e.g., aquaculture operations) when 
the average annual sum of the monetary value of their sales of raw 
agricultural commodities and the market value of the raw agricultural 
commodities they manufacture, process, pack, or hold without sale 
(e.g., held for a fee) during the previous 3-year period is no more 
than $25,000 (on a rolling basis), adjusted for inflation using 2020 as 
the baseline year for calculating the adjustment.
    (b) Exemption for farms when food is sold or donated 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 or donated 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. 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) Exemptions and partial exemptions for foods that receive 
certain types of processing. This subpart does not apply to the 
following foods that receive certain types of 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;
    (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;
    (3) Food that you subject to a kill step, provided that you 
maintain records containing:
    (i) The information specified in Sec.  1.1345 for your receipt of 
the food to which you apply the kill step (unless you have entered into 
a written agreement concerning your application of a kill step to the 
food in accordance with paragraph (d)(6) of this section); and
    (ii) A record of your application of the kill step;
    (4) Food that you change such that the food is no longer on the 
Food Traceability List, provided that you maintain records containing 
the information specified in Sec.  1.1345 for your receipt of the food 
you change;
    (5) Food that you receive that has previously been subjected to a 
kill step or that has previously been changed such that the food is no 
longer on the Food Traceability List;
    (6) Food that will be subjected to a kill step by an entity other 
than a retail food establishment, restaurant, or consumer; or that will 
be changed by an entity other than a retail food establishment, 
restaurant, or consumer, such that the food will no longer be on the 
Food Traceability List, provided that:
    (i) There is a written agreement between the shipper of the food 
and the receiver stating that the receiver will apply a kill step to 
the food or change the food such that it is no longer on the Food 
Traceability List; or
    (ii) There is a written agreement between the shipper of the food 
and the receiver stating that an entity in the supply chain subsequent 
to the receiver will apply a kill step to the food or change the food 
such that it is no longer on the Food Traceability List and that the 
receiver will only ship the food to another entity that agrees, in 
writing, it will:
    (A) Apply a kill step to the food or change the food such that it 
is no longer on the Food Traceability List; or
    (B) Enter into a similar written agreement with a subsequent 
receiver stating that a kill step will be applied to the food or that 
the food will be changed such that it is no longer on the Food 
Traceability List.
    (iii) A written agreement entered into in accordance with paragraph 
(d)(6)(i) or (ii) of this section must include the effective date, 
printed names and signatures of the persons entering into the 
agreement, and the substance of the agreement; and
    (iv) A written agreement entered into in accordance with paragraph 
(d)(6)(i) or (ii) must be maintained by both parties for as long as it 
is in effect and must be renewed at least once every 3 years.
    (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) Exemption for raw bivalve molluscan shellfish. This subpart 
does not apply to raw bivalve molluscan shellfish that are covered by 
the requirements of the National Shellfish Sanitation Program, subject 
to the requirements of part 123, subpart C, and Sec.  1240.60 of this 
chapter, or covered by a final equivalence determination by FDA for raw 
bivalve molluscan shellfish.
    (g) Exemption for persons who manufacture, process, pack, or hold 
certain foods subject to regulation by the U.S. Department of 
Agriculture (USDA). This subpart does not apply to persons who 
manufacture, process, pack, or hold food on the Food Traceability List 
during or after the time when the food is within the exclusive 
jurisdiction of the USDA under the Federal Meat Inspection Act (21 
U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 
et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).
    (h) Partial exemption for commingled raw agricultural commodities. 
(1) Except as specified in paragraph (h)(3) of this section, this 
subpart does not apply to commingled raw agricultural commodities 
(which, as defined in

[[Page 71079]]

Sec.  1.1310, do not include types of fruits and vegetables to which 
the standards for the growing, harvesting, packing, and holding of 
produce for human consumption in part 112 of this chapter apply).
    (2) Except as specified in paragraph (h)(3) of this section, this 
subpart does not apply to a raw agricultural commodity that will become 
a commingled raw agricultural commodity, provided that:
    (i) There is a written agreement between the shipper of the raw 
agricultural commodity and the receiver stating that the receiver will 
include the commodity as part of a commingled raw agricultural 
commodity; or
    (ii) There is a written agreement between the shipper of the raw 
agricultural commodity and the receiver stating that an entity in the 
supply chain subsequent to the receiver will include the commodity as 
part of a commingled raw agricultural commodity and that the receiver 
will only ship the raw agricultural commodity to another entity that 
agrees, in writing, it will either:
    (A) Include the raw agricultural commodity as part of a commingled 
raw agricultural commodity; or
    (B) Enter into a similar written agreement with a subsequent 
receiver stating that the raw agricultural commodity will become part 
of a commingled raw agricultural commodity;
    (iii) A written agreement entered into in accordance with paragraph 
(h)(2)(i) or (ii) of this section must include the effective date, 
printed names and signatures of the persons entering into the 
agreement, and the substance of the agreement; and
    (iv) A written agreement entered into in accordance with paragraph 
(h)(2)(i) or (ii) must be maintained by both parties for as long as it 
is in effect and must be renewed at least once every 3 years;
    (3) With respect to a commingled raw agricultural commodity that 
qualifies for either of the exemptions set forth in paragraphs (h)(1) 
and (2) of this section, if a person who manufactures, processes, 
packs, or holds such 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, 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.
    (i) Exemption for small retail food establishments and small 
restaurants. This subpart does not apply to retail food establishments 
and restaurants with an average annual monetary value of food sold or 
provided during the previous 3-year period of no more than $250,000 (on 
a rolling basis), adjusted for inflation using 2020 as the baseline 
year for calculating the adjustment.
    (j) Partial exemption for retail food establishments and 
restaurants purchasing directly from a farm. (1) Except as specified in 
paragraph (j)(2) of this section, this subpart does not apply to a 
retail food establishment or restaurant with respect to a food that is 
produced on a farm (including food produced and packaged on the farm) 
and both sold and shipped directly to the retail food establishment or 
restaurant by the owner, operator, or agent in charge of that farm.
    (2) When a retail food establishment or restaurant purchases a food 
directly from a farm in accordance with paragraph (j)(1) of this 
section, the retail food establishment or restaurant must maintain a 
record documenting the name and address of the farm that was the source 
of the food. The retail food establishment or restaurant must maintain 
such a record for 180 days.
    (k) Partial exemption for retail food establishments and 
restaurants making certain purchases from another retail food 
establishment or restaurant. (1) Except as specified in paragraph 
(k)(2) of this section, this subpart does not apply to either entity 
when a purchase is made by a retail food establishment or restaurant 
from another retail food establishment or restaurant, and the purchase 
occurs on an ad hoc basis outside of the buyer's usual purchasing 
practice (e.g., not pursuant to a contractual agreement to purchase 
food from the seller).
    (2) When a retail food establishment or restaurant purchases a food 
on the Food Traceability List from another retail food establishment or 
restaurant in accordance with paragraph (k)(1) of this section, the 
retail food establishment or restaurant that makes the purchase must 
maintain a record (e.g., a sales receipt) documenting the name of the 
product purchased, the date of purchase, and the name and address of 
the place of purchase.
    (l) Partial exemption for farm to school and farm to institution 
programs. (1) Except as specified in paragraph (l)(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 or donated to the 
school or institution.
    (2) When a school or institution conducting a farm to school or 
farm to institution program obtains a food from a farm in accordance 
with paragraph (l)(1) of this section, the school food authority or 
relevant food procurement entity must 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 record for 180 days.
    (m) Partial exemption for owners, operators, or agents in charge of 
fishing vessels. (1) Except as specified in paragraph (m)(2) of this 
section, with respect to a food that is obtained from a fishing vessel, 
this subpart does not apply to the owner, operator, or agent in charge 
of the fishing vessel, and this subpart also does not apply to persons 
who manufacture, process, pack, or hold the food until such time as the 
food is sold by the owner, operator, or agent in charge of the fishing 
vessel.
    (2) With respect to any person who receives the partial exemption 
set forth in paragraph (m)(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 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.
    (n) Exemption for transporters. This subpart does not apply to 
transporters of food.
    (o) Exemption for nonprofit food establishments. This subpart does 
not apply to nonprofit food establishments.
    (p) 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.
    (q) 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

[[Page 71080]]

    (2) Are not in the business of distributing food.
    (r) Exemption for food for research or evaluation. This subpart 
does not apply to food for research or evaluation use, provided that 
such food:
    (1) Is not intended for retail sale and is not sold or distributed 
to the public; and
    (2) Is accompanied by the statement ``Food for research or 
evaluation use.''


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:
    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 
the purpose of this definition, a commodity is ``combined or mixed'' 
only when the combination or mixing involves food from different farms 
under different company management; except that for food obtained from 
a fishing vessel, a commodity is ``combined or mixed'' only when the 
combination or mixing involves food from different landing vessels and 
occurs after the vessels have landed. Also, for the purpose of this 
definition, the term ``processing'' means operations that alter the 
general state of the commodity, such as canning, cooking, freezing, 
dehydration, milling, grinding, pasteurization, or homogenization.
    Cooling means active temperature reduction of a raw agricultural 
commodity using hydrocooling, icing (except icing of seafood), forced 
air cooling, vacuum cooling, or a similar process.
    Critical tracking event means an event in the supply chain of a 
food involving the harvesting, cooling (before initial packing), 
initial packing of a raw agricultural commodity other than a food 
obtained from a fishing vessel, first land-based receiving of a food 
obtained from a fishing vessel, shipping, receiving, or transformation 
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 land-based receiver means the person taking possession of a 
food for the first time on land directly from a fishing vessel.
    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, as set forth in the Magnuson-Stevens 
Fishery Conservation and Management Act (16 U.S.C. 1802(18)).
    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 listed foods as ingredients, 
provided that the listed food that is used as an ingredient remains in 
the same form (e.g., fresh) in which it appears on the list.
    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 cooling, 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 could include warehouses, cold storage facilities, storage 
silos, grain elevators, and liquid storage tanks.
    Initial packing means packing a raw agricultural commodity (other 
than a food obtained from a fishing vessel) for the first time.
    Key data element means information associated with a critical 
tracking event for which a record must be maintained and/or provided in 
accordance with this subpart.
    Kill step means lethality processing that significantly minimizes 
pathogens in a food.
    Location description means key contact information for the location 
where a food is handled, specifically the business name, phone number, 
physical location address (or geographic coordinates), and city, State, 
and zip code for domestic locations and comparable information for 
foreign locations, including country.
    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 
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

[[Page 71081]]

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)).
    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 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.
    Point of contact means an individual having familiarity with an 
entity's procedures for traceability, including their name and/or job 
title, and their phone number.
    Produce means produce as defined in Sec.  112.3 of this chapter.
    Product description means a description of a food product and 
includes the product name (including, if applicable, the brand name, 
commodity, and variety), packaging size, and packaging style. For 
seafood, the product name may include the species and/or acceptable 
market name.
    Raw agricultural commodity means ``raw agricultural commodity'' as 
defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act.
    Receiving means an event in a food's supply chain in which a food 
is received by someone other than a consumer after being transported 
(e.g., by truck or ship) from another location. Receiving includes 
receipt of an intracompany shipment of food from one location at a 
particular street address of a firm to another location at a different 
street address of the firm.
    Reference document means a business transaction document, record, 
or message, in electronic or paper form, that may contain some or all 
of the key data elements for a critical tracking event in the supply 
chain of a food. A reference document may be established by you or 
obtained from another person. Reference document types may include, but 
are not limited to, bills of lading, purchase orders, advance shipping 
notices, work orders, invoices, database records, batch logs, 
production logs, field tags, catch certificates, and receipts.
    Reference document number means the identification number assigned 
to a specific reference document.
    Restaurant means a facility that prepares and sells food directly 
to consumers for immediate consumption. ``Restaurant'' does not include 
facilities that provide food to interstate conveyances, central 
kitchens, and other similar facilities that do not prepare and serve 
food directly to consumers.
    (1) Entities in which food is provided to humans, such as 
cafeterias, lunchrooms, cafes, bistros, fast food establishments, food 
stands, saloons, taverns, bars, lounges, catering facilities, hospital 
kitchens, day care kitchens, and nursing home kitchens are restaurants; 
and
    (2) Pet shelters, kennels, and veterinary facilities in which food 
is provided to animals are restaurants.
    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-operated 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 one location to 
another location. Shipping does not include the sale or shipment of a 
food directly to a consumer or the donation of surplus food. Shipping 
includes sending an

[[Page 71082]]

intracompany shipment of food from one location at a particular street 
address of a firm to another location at a different street address of 
the firm.
    Traceability lot means a batch or lot of food that has been 
initially packed (for raw agricultural commodities other than food 
obtained from a fishing vessel), received by the first land-based 
receiver (for food obtained from a fishing vessel), or transformed.
    Traceability lot code means a descriptor, often alphanumeric, used 
to uniquely identify a traceability lot within the records of the 
traceability lot code source.
    Traceability lot code source means the place where a food was 
assigned a traceability lot code.
    Traceability lot code source reference means an alternative method 
for providing FDA with access to the location description for the 
traceability lot code source as required under this subpart. Examples 
of a traceability lot code source reference include, but are not 
limited to, the FDA Food Facility Registration Number for the 
traceability lot code source or a web address that provides FDA with 
the location description for the traceability lot code source.
    Transformation means an event in a food's supply chain that 
involves manufacturing/processing a food or changing a food (e.g., by 
commingling, repacking, or relabeling) or its packaging or packing, 
when the output is a food on the Food Traceability List. Transformation 
does not include the initial packing of a food or activities preceding 
that event (e.g., harvesting, cooling).
    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.
    You means a person subject to this subpart under Sec.  1.1300.

Traceability Plan


Sec.  1.1315   What traceability plan 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 a traceability plan containing the 
following information:
    (1) A description of the procedures you use to maintain the records 
you are required to keep under this subpart, including the format and 
location of these records.
    (2) A description of the procedures you use to identify foods on 
the Food Traceability List that you manufacture, process, pack, or 
hold;
    (3) A description of how you assign traceability lot codes to foods 
on the Food Traceability List in accordance with Sec.  1.1320, if 
applicable;
    (4) A statement identifying a point of contact for questions 
regarding your traceability plan and records; and
    (5) If you grow or raise a food on the Food Traceability List 
(other than eggs), a farm map showing the areas in which you grow or 
raise such foods.
    (i) Except as specified in paragraph (a)(5)(ii) of this section, 
the farm map must show the location and name of each field (or other 
growing area) in which you grow a food on the Food Traceability List, 
including geographic coordinates and any other information needed to 
identify the location of each field or growing area.
    (ii) For aquaculture farms, the farm map must show the location and 
name of each container (e.g., pond, pool, tank, cage) in which you 
raise seafood on the Food Traceability List, including geographic 
coordinates and any other information needed to identify the location 
of each container.
    (b) You must update your traceability plan as needed to ensure that 
the information provided reflects your current practices and to ensure 
that you are in compliance with the requirements of this subpart. You 
must retain your previous traceability plan for 2 years after you 
update the plan.


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

    (a) You must assign a traceability lot code when you do any of the 
following: Initially pack a raw agricultural commodity other than a 
food obtained from a fishing vessel; perform the first land-based 
receiving of a food obtained from a fishing vessel; or transform a 
food.
    (b) Except as otherwise specified in this subpart, you must not 
establish a new traceability lot code when you conduct other activities 
(e.g., shipping) for a food on the Food Traceability List.

Records of Critical Tracking Events


Sec.  1.1325   What records must I keep and provide when I harvest or 
cool a raw agricultural commodity on the Food Traceability List?

    (a) Harvesting. (1) For each raw agricultural commodity (not 
obtained from a fishing vessel) on the Food Traceability List that you 
harvest, you must maintain records containing the following 
information:
    (i) The location description for the immediate subsequent recipient 
(other than a transporter) of the food;
    (ii) The commodity and, if applicable, variety of the food;
    (iii) The quantity and unit of measure of the food (e.g., 75 bins, 
200 pounds);
    (iv) The location description for the farm where the food was 
harvested;
    (v) For produce, the name of the field or other growing area from 
which the food was harvested (which must correspond to the name used by 
the grower), or other information identifying the harvest location at 
least as precisely as the field or other growing area name;
    (vi) For aquacultured food, the name of the container (e.g., pond, 
pool, tank, cage) from which the food was harvested (which must 
correspond to the container name used by the aquaculture farmer) or 
other information identifying the harvest location at least as 
precisely as the container name;
    (vii) The date of harvesting; and
    (viii) The reference document type and reference document number.
    (2) For each raw agricultural commodity (not obtained from a 
fishing vessel) on the Food Traceability List that you harvest, you 
must provide (in electronic, paper, or other written form) your 
business name, phone number, and the information in paragraphs 
(a)(1)(i) through (vii) of this section to the initial packer of the 
raw agricultural commodity you harvest, either directly or through the 
supply chain.
    (b) Cooling before initial packing. (1) For each raw agricultural 
commodity (not obtained from a fishing vessel) on the Food Traceability 
List that you cool before it is initially packed, you must maintain 
records containing the following information:
    (i) The location description for the immediate subsequent recipient 
(other than a transporter) of the food;
    (ii) The commodity and, if applicable, variety of the food;
    (iii) The quantity and unit of measure of the food (e.g., 75 bins, 
200 pounds);
    (iv) The location description for where you cooled the food;
    (v) The date of cooling;
    (vi) The location description for the farm where the food was 
harvested; and
    (vii) The reference document type and reference document number.
    (2) For each raw agricultural commodity (not obtained from a 
fishing vessel) on the Food Traceability List that you cool before it 
is initially packed, you must provide (in electronic, paper, or other 
written form) the information in paragraphs (b)(1)(i) through (vi) of 
this section to the initial packer of the raw agricultural commodity 
you cool, either directly or through the supply chain.

[[Page 71083]]

Sec.  1.1330   What records must I keep when I am performing the 
initial packing of a raw agricultural commodity (other than a food 
obtained from a fishing vessel) on the Food Traceability List?

    (a) Except as specified in paragraph (c) of this section, for each 
traceability lot of a raw agricultural commodity (other than a food 
obtained from a fishing vessel) on the Food Traceability List you 
initially pack, you must maintain records containing the following 
information and linking this information to the traceability lot:
    (1) The commodity and, if applicable, variety of the food received;
    (2) The date you received the food;
    (3) The quantity and unit of measure of the food received (e.g., 75 
bins, 200 pounds);
    (4) The location description for the farm where the food was 
harvested;
    (5) For produce, the name of the field or other growing area from 
which the food was harvested (which must correspond to the name used by 
the grower), or other information identifying the harvest location at 
least as precisely as the field or other growing area name;
    (6) For aquacultured food, the name of the container (e.g., pond, 
pool, tank, cage) from which the food was harvested (which must 
correspond to the container name used by the aquaculture farmer) or 
other information identifying the harvest location at least as 
precisely as the container name;
    (7) The business name and phone number for the harvester of the 
food;
    (8) The date of harvesting;
    (9) The location description for where the food was cooled (if 
applicable);
    (10) The date of cooling (if applicable);
    (11) The traceability lot code you assigned;
    (12) The product description of the packed food;
    (13) The quantity and unit of measure of the packed food (e.g., 6 
cases, 25 reusable plastic containers, 100 tanks, 200 pounds);
    (14) The location description for where you initially packed the 
food (i.e., the traceability lot code source), and (if applicable) the 
traceability lot code source reference;
    (15) The date of initial packing; and
    (16) The reference document type and reference document number.
    (b) For each traceability lot of sprouts (except soil- or 
substrate-grown sprouts harvested without their roots) you initially 
pack, you must also maintain records containing the following 
information and linking this information to the traceability lot:
    (1) The location description for the grower of seeds for sprouting 
and the date of seed harvesting, if either is available;
    (2) The location description for the seed conditioner or processor, 
the associated seed lot code, and the date of conditioning or 
processing;
    (3) The location description for the seed packinghouse (including 
any repackers), the date of packing (and of repacking, if applicable), 
and any associated seed lot code assigned by the seed packinghouse;
    (4) The location description for the seed supplier, any 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;
    (5) A description of the seeds, including the seed type or 
taxonomic name, growing specifications, type of packaging, and (if 
applicable) antimicrobial treatment;
    (6) The date of receipt of the seeds by the sprouter; and
    (7) The reference document type and reference document number.
    (c) For each traceability lot of a raw agricultural commodity 
(other than a food obtained from a fishing vessel) on the Food 
Traceability List you initially pack that you receive from a person to 
whom this subpart does not apply, you must maintain records containing 
the following information and linking this information to the 
traceability lot:
    (1) The commodity and, if applicable, variety of the food received;
    (2) The date you received the food;
    (3) The quantity and unit of measure of the food received (e.g., 75 
bins, 200 pounds);
    (4) The location description for the person from whom you received 
the food;
    (5) The traceability lot code you assigned;
    (6) The product description of the packed food;
    (7) The quantity and unit of measure of the packed food (e.g., 6 
cases, 25 reusable plastic containers, 100 tanks, 200 pounds);
    (8) The location description for where you initially packed the 
food (i.e., the traceability lot code source), and (if applicable) the 
traceability lot code source reference;
    (9) The date of initial packing; and
    (10) The reference document type and reference document number.


Sec.  1.1335   What records must I keep when I am the first land-based 
receiver of a food on the Food Traceability List that was obtained from 
a fishing vessel?

    For each traceability lot of a food obtained from a fishing vessel 
for which you are the first land-based receiver, you must maintain 
records containing the following information and linking this 
information to the traceability lot:
    (a) The traceability lot code you assigned;
    (b) The species and/or acceptable market name for unpackaged food, 
or the product description for packaged food;
    (c) The quantity and unit of measure of the food (e.g., 300 kg);
    (d) The harvest date range and locations (as identified under the 
National Marine Fisheries Service Ocean Geographic Code, the United 
Nations Food and Agriculture Organization Major Fishing Area list, or 
any other widely recognized geographical location standard) for the 
trip during which the food was caught;
    (e) The location description for the first land-based receiver 
(i.e., the traceability lot code source), and (if applicable) the 
traceability lot code source reference;
    (f) The date the food was landed; and
    (g) The reference document type and reference document number.


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

    (a) For each traceability lot of a food on the Food Traceability 
List you ship, you must maintain records containing the following 
information and linking this information to the traceability lot:
    (1) The traceability lot code for the food;
    (2) The quantity and unit of measure of the food (e.g., 6 cases, 25 
reusable plastic containers, 100 tanks, 200 pounds);
    (3) The product description for the food;
    (4) The location description for the immediate subsequent recipient 
(other than a transporter) of the food;
    (5) The location description for the location from which you 
shipped the food;
    (6) The date you shipped the food;
    (7) The location description for the traceability lot code source, 
or the traceability lot code source reference; and
    (8) The reference document type and reference document number.
    (b) You must provide (in electronic, paper, or other written form) 
the information in paragraphs (a)(1) through (7) of this section to the 
immediate subsequent recipient (other than a transporter) of each 
traceability lot that you ship.
    (c) This section does not apply to the shipment of a food that 
occurs before the food is initially packed (if the food is a raw 
agricultural commodity not obtained from a fishing vessel).

[[Page 71084]]

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

    (a) Except as specified in paragraphs (b) and (c) of this section, 
for each traceability lot of a food on the Food Traceability List you 
receive, you must maintain records containing the following information 
and linking this information to the traceability lot:
    (1) The traceability lot code for the food;
    (2) The quantity and unit of measure of the food (e.g., 6 cases, 25 
reusable plastic containers, 100 tanks, 200 pounds);
    (3) The product description for the food;
    (4) The location description for the immediate previous source 
(other than a transporter) for the food;
    (5) The location description for where the food was received;
    (6) The date you received the food;
    (7) The location description for the traceability lot code source, 
or the traceability lot code source reference; and
    (8) The reference document type and reference document number.
    (b) For each traceability lot of a food on the Food Traceability 
List you receive from a person to whom this subpart does not apply, you 
must maintain records containing the following information and linking 
this information to the traceability lot:
    (1) The traceability lot code for the food, which you must assign 
if one has not already been assigned (except that this paragraph does 
not apply if you are a retail food establishment or restaurant);
    (2) The quantity and unit of measure of the food (e.g., 6 cases, 25 
reusable plastic containers, 100 tanks, 200 pounds);
    (3) The product description for the food;
    (4) The location description for the immediate previous source 
(other than a transporter) for the food;
    (5) The location description for where the food was received (i.e., 
the traceability lot code source), and (if applicable) the traceability 
lot code source reference;
    (6) The date you received the food; and
    (7) The reference document type and reference document number.
    (c) This section does not apply to receipt of a food that occurs 
before the food is initially packed (if the food is a raw agricultural 
commodity not obtained from a fishing vessel) or to the receipt of a 
food by the first land-based receiver (if the food is obtained from a 
fishing vessel).


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

    (a) Except as specified in paragraphs (b) and (c) of this section, 
for each new traceability lot of food you produce through 
transformation, you must maintain records containing the following 
information and linking this information to the new traceability lot:
    (1) For the food on the Food Traceability List used in 
transformation (if applicable), the following information:
    (i) The traceability lot code for the food;
    (ii) The product description for the food to which the traceability 
lot code applies; and
    (iii) For each traceability lot used, the quantity and unit of 
measure of the food used from that lot.
    (2) For the food produced through transformation, the following 
information:
    (i) The new traceability lot code for the food;
    (ii) The location description for where you transformed the food 
(i.e., the traceability lot code source), and (if applicable) the 
traceability lot code source reference;
    (iii) The date transformation was completed;
    (iv) The product description for the food;
    (v) The quantity and unit of measure of the food (e.g., 6 cases, 25 
reusable plastic containers, 100 tanks, 200 pounds); and
    (vi) The reference document type and reference document number for 
the transformation event.
    (b) For each traceability lot produced through transformation of a 
raw agricultural commodity (other than a food obtained from a fishing 
vessel) on the Food Traceability List that was not initially packed 
prior to your transformation of the food, you must maintain records 
containing the information specified in Sec.  1.1330(a) or (c), and, if 
the raw agricultural commodity is sprouts, the information specified in 
Sec.  1.1330(b).
    (c) Paragraphs (a) and (b) of this section do not apply to retail 
food establishments and restaurants with respect to foods they do not 
ship (e.g., foods they sell or send directly to consumers).

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

[[Page 71085]]

    (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 
notice 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 notice 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 notice 
in the Federal Register setting forth the proposed modified 
requirements or exemption and the reasons for the proposal. The notice 
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 notice 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 notice.


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 a notice 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 notice will establish a public docket so that interested 
persons may submit written comments on our tentative determination.
    (b) After considering any comments timely submitted, we will 
publish a notice 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 notice, unless otherwise stated in the 
notice.

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 as described at www.fda.gov. 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

[[Page 71086]]

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 
notice 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 notice 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 notice in the Federal Register setting 
forth the proposed waiver and the reasons for such waiver. The notice 
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 notice 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 notice.


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 a notice in the Federal Register of our 
tentative determination that the waiver should be

[[Page 71087]]

modified or revoked and the reasons for our tentative decision. The 
notice 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 a notice 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 notice, unless otherwise 
stated in the notice.

Records Maintenance and Availability


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

    (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). Electronic records may include valid, working 
electronic links to the information required to be maintained under 
this subpart.
    (2) All records must be legible and stored to prevent deterioration 
or loss.
    (b) Establishment and maintenance of records by another entity. You 
may have another entity establish and maintain records required under 
this subpart on your behalf, but you are responsible for ensuring that 
such records can be retrieved and provided onsite within 24 hours of 
request for official review.
    (c) Record availability. (1) You must make all records required 
under this subpart available to an authorized FDA representative, upon 
request, within 24 hours (or within some reasonable time to which FDA 
has agreed) after the request, along with any information needed to 
understand these records, such as internal or external coding systems, 
glossaries, abbreviations, and a description of how the records you 
provide correspond to the information required under this subpart.
    (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 (or within some reasonable time to which FDA has agreed) of a 
request made in-person or remotely (e.g., by phone) by an authorized 
FDA representative, the information you are required to maintain under 
this subpart, for the foods and date ranges or traceability lot codes 
specified in the request.
    (i) If FDA's request for the information specified in paragraph 
(c)(3) of this section is made by phone, we will also provide the 
request to you in writing upon your request; however, you must provide 
the requested information within 24 hours (or within some reasonable 
time to which FDA has agreed) of the phone request.
    (ii) Except as specified in paragraph (c)(3)(iii) and (iv) of this 
section, when the information requested by FDA under paragraph (c)(3) 
of this section is information you are required to maintain under 
Sec. Sec.  1.1325 through 1.1350, you must provide such information in 
an electronic sortable spreadsheet, along with any other information 
needed to understand the information in the spreadsheet.
    (iii) You may provide the information requested by FDA under 
paragraph (c)(3) of this section in a form other than an electronic 
sortable spreadsheet if you are:
    (A) A farm whose average annual sum of the monetary value of their 
sales of raw agricultural commodities and the market value of raw 
agricultural commodities they manufacture, process, pack, or hold 
without sale (e.g., held for a fee) during the previous 3-year period 
is no more than $250,000 (on a rolling basis), adjusted for inflation 
using 2020 as the baseline year for calculating the adjustment;
    (B) A retail food establishment or restaurant with an average 
annual monetary value of food sold or provided during the previous 3-
year period of no more than $1 million (on a rolling basis), adjusted 
for inflation using 2020 as the baseline year for calculating the 
adjustment; or
    (C) A person (other than a farm, retail food establishment, or 
restaurant) whose average annual sum of the monetary value of their 
sales of food and the market value of food they manufacture, process, 
pack, or hold without sale (e.g., held for a fee) during the previous 
3-year period is no more than $1 million (on a rolling basis), adjusted 
for inflation using 2020 as the baseline year for calculating the 
adjustment.
    (iv) FDA will withdraw a request for an electronic sortable 
spreadsheet under paragraph (c)(3)(ii) of this section, as appropriate, 
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 required under this subpart maintained 
in a language other than English.
    (d) 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 or obtained the 
records.
    (e) 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 of this chapter, if not otherwise exempt.
    (f) 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.
    (g) Use of multiple sets of records. You do not have to keep all of 
the information required by this subpart in a single set of records. 
However, your traceability plan must indicate the format and location 
of the records you are required to keep under this subpart, in 
accordance with Sec.  1.1315(a)(1).
    (h) Public disclosure. Records obtained by FDA in accordance with 
this subpart are subject to the disclosure requirements under part 20 
of this chapter.

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

[[Page 71088]]

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 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 2 years 
after the date of publication of the Federal Register notice announcing 
the revised list, unless otherwise stated in the notice.

    Dated: November 3, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-24417 Filed 11-15-22; 11:15 am]
BILLING CODE 4164-01-P