rule because they hold food (such as distributors) might not currently
maintain tracing information. For example, a cold storage facility that
receives imported produce might not keep tracing records on such
produce because the importer of record, broker,

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

prevent or mitigate a foodborne illness outbreak, or to assist in the
implementation of a recall, or to otherwise address a threat to the
public health, including but not limited to situations where FDA has a
reasonable belief that an article of food (and any other article of
food that FDA reasonably believes is likely to be affected in a similar
manner) presents a threat of serious adverse health consequences or
death to humans or animals as a result of the food being adulterated
under section 402 of the FD&C Act or misbranded under section 403(w) of
the FD&C Act, persons subject to the subpart S requirements must make
available, within 24 hours of request by an authorized FDA
representative, an electronic sortable spreadsheet containing the
information in the records they are required to maintain under subpart
S, for the foods and date ranges specified in the request. Proposed
Sec.  1.1455(b)(3) further states that we will withdraw a request for
such a spreadsheet when necessary to accommodate a religious belief of
a person asked to provide a spreadsheet. (As previously discussed in
section V.B.7, under Option 2 of our co-proposal regarding proposed
Sec.  1.1305(g), we would exempt retail food establishments with 10 or
fewer full-time equivalent employees from this requirement.)
    We believe that this proposed requirement to provide an electronic
sortable spreadsheet containing traceability information on foods that