[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
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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)
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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
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Abbreviation or acronym What it means
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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.
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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
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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
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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
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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
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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