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 1. Home
 2. Food
 3. Guidance & Regulation (Food and Dietary Supplements)
 4. Food Safety Modernization Act (FSMA)
 5. FSMA Proposed Rule for Food Traceability

 1. Food Safety Modernization Act (FSMA)


FSMA PROPOSED RULE FOR FOOD TRACEABILITY

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 * Federal Register Notice
 * Docket No. FDA-2014-N-0053
 * Public Meetings page

The FDA is proposing to establish additional traceability recordkeeping
requirements (beyond what is already required in existing regulations) for
persons who manufacture, process, pack, or hold foods the Agency has designated
for inclusion on the Food Traceability List. The proposed rule, “Requirements
for Additional Traceability Records for Certain Foods” (Food Traceability
Proposed Rule) is a key component of the FDA’s New Era of Smarter Food Safety
Blueprint and would implement Section 204(d) of the FDA Food Safety
Modernization Act (FSMA). The proposed requirements would help the FDA rapidly
and effectively identify recipients of those foods to prevent or mitigate
foodborne illness outbreaks and address credible threats of serious adverse
health consequences or death. The comment periods for the proposed rule and
information collection provisions have been extended and will now be available
for public comment until February 22, 2021.

At the core of this proposal is a requirement for those who manufacture,
process, pack or hold foods on the Food Traceability List (FTL) to establish and
maintain records containing Key Data Elements (KDEs) associated with different
Critical Tracking Events (CTEs).  While the proposed requirements would only
apply to those foods on the FTL, they were designed to be suitable for all
FDA-regulated food products. FDA would encourage the voluntary adoption of these
practices industry-wide.


FOOD TRACEABILITY LIST (FTL)

The FDA issued a Federal Register notice to solicit comments on our draft
approach for developing a list of high-risk foods in 2014.  Taking into
consideration the comments and other information submitted, we developed a draft
risk-ranking model and collected data to populate the model for chemical and
microbiological hazards associated with specific foods, with technical
assistance from external expert panels. Two separate peer-review panels of
independent external experts reviewed the draft model and the data used to
generate risk scores with the model, respectively. Subsequently, we refined the
model and updated the data, taking into consideration comments from the peer
reviews.

Using the results of the risk-ranking model, we tentatively identified foods for
the Food Traceability List for which additional traceability records will be
required, as shown in Table 1.0. The term “Food Traceability List” (FTL) refers
not only to the foods specifically listed, but also to any foods that contain
listed foods as ingredients. Each proposed requirement described below therefore
pertains to all such foods unless an exemption applies.

Table 1.0 Food Traceability List

Foods Description Cheeses, other than hard cheeses Includes all cheeses made
with either pasteurized or unpasteurized milk, other than hard cheeses. Includes
soft ripened/semi-soft cheeses (e.g., brie, camembert, feta, mozzarella,
taleggio, blue, brick, fontina, monterey jack, and muenster) and soft
unripened/fresh soft cheeses (e.g., cottage, chevre/goat, cream, mascarpone,
ricotta, queso blanco, queso fresco, queso de crema, and queso de puna). Shell
eggs Shell egg means the egg of the domesticated chicken Nut butter Includes all
types of tree nut and peanut butters; does not include soy or seed butters
Cucumbers (fresh) Includes all varieties of cucumbers Herbs (fresh) Includes all
types of herbs, such as parsley, cilantro, basil, etc. Leafy greens (fresh),
including fresh-cut leafy greens Includes all types of leafy greens, such as
lettuce, (e.g., iceberg, leaf and Romaine lettuces), kale, chicory, watercress,
chard, arugula, spinach, pak choi, sorrel, endive, etc. Melons (fresh) Includes
all types of melons, such as cantaloupe, honeydew, watermelon, etc. Peppers
(fresh) Includes all varieties of peppers Sprouts (fresh) Includes all varieties
of sprouts Tomatoes (fresh) Includes all varieties of tomatoes Tropical tree
fruits (fresh) Includes all types of tropical tree fruit, such as mango, papaya,
mamey, guava, lychee, jackfruit, starfruit, etc. Fruits and Vegetables
(fresh-cut) Includes all types of fresh-cut fruits and vegetables Finfish,
including smoked finfish Includes all finfish species, such as cod, haddock,
Alaska pollock, tuna, mahi mahi, mackerel, grouper, barracuda, salmon, etc.;
except does not include siluriformes fish, such as catfish [1] Crustaceans
Includes all crustacean species, such as shrimp, crab, lobster, crayfish, etc.
Mollusks, bivalves Includes all species of bivalve mollusks, such as oysters,
clams, mussels, etc.; does not include scallop adductor muscle. Ready-to-eat
deli salads Includes all types of ready-to-eat deli salads, such as egg salad,
potato salad, pasta salad, seafood salad, etc.; does not include meat salads

*UPDATED 1/12/2021: The FDA has updated the table above to add to the
descriptions of certain foods on the FTL. These edits were only made for clarity
and do not reflect a change in which foods are on the FTL. For additional
information about the specific edits, see the memo titled “Food Traceability
List for ‘Requirements for Additional Traceability Records for Certain Foods’
Proposed Rule- Clarified Language.”

The proposed rule sets forth a process for the FDA to update the Food
Traceability List if the agency concludes that updates are appropriate. Under
that process, FDA would publish a notice in the Federal Register stating any
proposed changes to the list and the reasons for the changes, and requesting
information and views on the proposal. After considering any information or
views submitted, the FDA would publish a second notice in the Federal Register,
stating whether any changes are being made, and the reason for the decision. Any
additions to the list would become effective one year after the date of the
second Federal Register notice, unless otherwise stated. Any deletions from the
list would become effective immediately.

Additional information about the FTL and the Risk-Ranking Model can be found on
the Food Traceability List webpage.

--------------------------------------------------------------------------------

[1] Data for catfish were excluded from the Risk-Ranking Model because
siluriformes fish (such as catfish) are primarily regulated by the U.S.
Department of Agriculture.


FREQUENTLY ASKED QUESTIONS ABOUT THE FOOD TRACEABILITY PROPOSED RULE

Available in PDF

Following publication of the proposed rule, "Requirements for Additional
Traceability Records for Certain Foods" (Food Traceability Proposed Rule) on
September 23, 2020, the FDA has received a number of questions from
stakeholders, including during the public meetings, through the Food Safety
Modernization Act Technical Assistance Network (FSMA TAN), and during other
outreach engagements. This FAQ, which is based on the proposed rule and its
references, is intended to address some of the most frequently asked questions
as an aid to stakeholders who are considering providing feedback during the
comment period for the proposed rule, which has been extended until February 22,
2021. Comments can be submitted at https://www.regulations.gov/ , Docket ID:
FDA-2014-N-0053. Those submitting comments to the proposed rule are encouraged
to provide real life examples and details about specific arrangements for
consideration.


FOOD TRACEABILITY LIST (FTL)

Is the proposed rule focused only on biological hazards?

The proposed rule only applies to those that manufacture, process, pack, or hold
foods on the FTL. To help determine which foods should be included on the FTL,
the FDA developed a risk-ranking model for food tracing (“the Model”) based on
the factors that Congress identified in Section 204 of the Food Safety
Modernization Act (FSMA). In developing the current version of the Model, FDA
focused on biological hazards and acute chemical toxins that present an
immediate public health risk and for which traceability would be necessary to
rapidly identify the source of contamination and prevent additional illnesses.
For more information about development of the Model, see Methodological Approach
to Developing a Risk-Ranking Model for Food Tracing FSMA Section 204.

Under the proposed rule, how could foods be added to or removed from the Food
Traceability List? How often will FDA review the FTL?

The proposed rule sets forth a process for FDA to update the FTL (see proposed
§ 1.1465). Under that proposed process, when FDA tentatively concludes that it
is appropriate to revise the FTL, we would publish a notice in the Federal
Register stating the proposed changes to the list and the reasons for these
changes, and requesting information and views on the proposed changes. After
considering any information and views that are submitted, FDA would publish a
notice in the Federal Register stating whether we were revising the list and the
reasons for the decision. Any deletions from the list would become effective
immediately, while any additions would become effective one year after
publication of the Federal Register notice, unless otherwise stated in that
notice. We would also publish the revised list on our website.

We have not set a schedule for considering updates to the FTL, but we plan to
perform a periodic review of new scientific data or other scientific information
that is relevant to the factors that Congress identified in FSMA Section 204 to
determine if updates would be appropriate. (See 85 FR 59984, 60019.)

Are dried spices on the FTL? What about dried vegetables?         

In the risk-ranking model for food tracing that FDA used to designate the FTL,
dried spices are included in the commodity “Spices,” which is not included on
the proposed FTL. Therefore, dried spices would not be covered under the Food
Traceability proposed rule. 

Similarly, dried vegetables are included in the
commodity “Vegetables (Dried),” which is not included in the proposed FTL and
therefore would not be covered under the Food Traceability proposed rule.  

See Table A-2 in Appendix A of FDA’s report, Methodological Approach to
Developing a Risk-Ranking Model for Food Tracing FSMA Section 204, for more
information. That table lists all of the commodities that were considered for
inclusion on the FTL, including commodities such as “Spices” and “Vegetables
(Dried)” that are not included on the proposed FTL. Seeing the full list of
commodities can be helpful in figuring out the commodity designation for a
specific product.

Collards are listed as an example of leafy greens on the FTL, but they are also
on the list of produce that is rarely consumed raw in the produce safety
regulation (21 CFR § 112.2(a)(1)). Would collards be covered under the proposed
rule?

Collards are a type of leafy green, which is why they were originally included
in the description of “leafy greens” on the FTL. However, we have proposed
to exempt all produce on the produce safety regulation’s “rarely consumed raw”
list – which includes collards – from the requirements of the
Food Traceability Rule (see proposed § 1.1305(e)). Collards would therefore not
be covered under the proposed requirements. We apologize for any confusion that
might have resulted from our inclusion of collards in the description of “leafy
greens” on the FTL, and we have updated the description of “leafy greens” on
our Food Traceability List webpage to remove collards. 

Why are all finfish grouped together on the FTL when there are different hazards
associated with different types of finfish?

The commodity risk score for each of three separate finfish commodities–
finfish, species not associated with histamine or ciguatoxin; open ocean finfish
(histamine-producing species); and reef finfish (potentially contaminated with
ciguatoxin) – were each sufficient for the commodity to be included on the FTL.
As a result, each of these three commodities was placed on the FTL. For
convenience of communicating the foods on the FTL, we grouped them together on
the list.

For more information about how commodity risk scores were determined, see
Methodological Approach to Developing a Risk-Ranking Model for Food Tracing FSMA
Section 204.


ORIGINATING

Would originators, such as growers of produce on the FTL, have to keep the
traceability program records that are described in proposed § 1.1315?

We have proposed to require that all entities who are subject to the rule must
establish and maintain the traceability program records that are described in
proposed § 1.1315. This would include all originators of foods on the FTL,
unless they are exempt from the rule under proposed § 1.1305.


GROWING

Would growers be required to provide the geographical coordinates of their
growing areas?

Under proposed § 1.1325, growers of foods on the FTL (who are not exempt under
proposed § 1.1305) would be required to establish and maintain records that link
the traceability lot code of the food to the growing area coordinates. We have
proposed to define “growing area coordinates” to mean the geographical
coordinates (under the global positioning system or latitude/longitude) for the
entry point of the physical location where the food was grown and harvested.
However, please note that under proposed § 1.1350(b), growing area coordinates
are not among the key data elements that farms or other entities would be
required to send to the recipient of a shipment of food on the FTL. Growing area
coordinates therefore would only need to be maintained as part of a firm’s own
traceability records, and to be made available to FDA upon request, as set forth
in proposed § 1.1455(b); they would not need to be provided to subsequent
entities in the supply chain.


FIRST RECEIVER

Why was the term “first receiver” proposed?

The proposed rule would define “first receiver” to mean the first person (other
than a farm) who purchases and takes physical possession of a food on the FTL.
As discussed in the preamble to the proposed rule (see 85 FR 59984, 60008), we
proposed to establish this new term, and to require that first receivers keep
certain records that are not required for other receivers, because we concluded
that the first receiver is the person who is best positioned to maintain
comprehensive information about the origination and subsequent handling of a
food. 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. In some circumstances, 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.  In order to
ensure that comprehensive records relating to the origination and initial
handling of the food are maintained by a single person who both owns and
possesses the food, the first receiver of the food was identified as the entity
who would be responsible for maintaining certain KDEs relating to originated
foods (see proposed § 1.1330).  

Importantly, only foods that are originated (i.e., grown, raised, caught, or, in
the case of a non-produce commodity such as eggs, harvested) would have a first
receiver. Listed foods that are created (such as peanut butter that is made from
peanuts and salt, neither of which is on the FTL) would not have a first
receiver. First receivers would be required to maintain different KDEs depending
on whether the food was obtained from a fishing vessel or not. For additional
information and supply chain examples, see the First Receiver Examples.

The proposed definition of first receiver would state that you must purchase AND
take physical possession of a food on the Food Traceability List. What about
brokers who do not take physical possession? What if product is sold many times
before someone in the chain both purchases AND takes physical possession?

We proposed to define “first receiver” to mean the first person (other than a
farm) who purchases and takes physical possession of a listed food.  In a
situation where food is sold multiple times before it reaches someone who meets
the definition of a “first receiver,” the entities involved in such sales would
be required to follow any of the proposed recordkeeping requirements that apply
to them, such as requirements relating to shipping records (see proposed
§ 1.1350) and receiving records (see proposed § 1.1335). However, only the
person who meets the definition of a first receiver would be required to follow
the proposed recordkeeping requirements relating to first receivers (see
proposed § 1.1330).

Note that the proposed rule would only apply to entities that manufacture,
process, pack, or hold foods on the FTL. Food brokers who negotiate sales of
food from producers to wholesalers, retail stores, and others, but never
physically possess the food, would not be subject to the rule. See 85 FR 59984,
60000.

If a third-party cooler does not purchase the product being cooled, what
information would have to be maintained?

In this situation the cooler could not be considered a “first receiver,” because
we are proposing to define that term to mean the first person (other than a
farm) who purchases and takes physical possession of the food. “First receiver”
is the only term in the proposed rule whose definition in proposed § 1.1310
hinges on whether or not an entity is a purchaser. 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. Similarly, 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. A cooler would use these definitions to determine if their specific
situation constituted “receiving” and “shipping.” 

Note that in the preamble to the proposed rule, we state that persons subject to
the proposed requirements could enter into agreements with individuals or firms
to create and keep the records required under this rule on their behalf. Firms
could, for example, retain consultants or other outside entities to perform some
or all of their responsibilities under the proposal, or rely on their supply
chain partners, such as their brokers or suppliers, to establish and maintain
required records on their behalf, so long as the firm would be able to make the
records available to FDA upon request, as would be required under proposed
§ 1.1455(b)(1)-(2). We believe that allowing firms to enter into such agreements
would 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. See 85 FR 59984, 60004.

If an entity purchases a food on the FTL from a grower through a broker and the
broker doesn’t take physical possession, would the entity be the first receiver?

Under the proposed definition of “first receiver,” the entity would be the first
receiver if they were the first non-farm entity to purchase and take physical
possession of the food, even if they purchased the product through a broker.


TRANSFORMATION

Is “repacking” a transformation event that would require a new traceability lot
code?

Yes. Proposed § 1.1320 would require you to establish and assign a traceability
lot code when you originate, transform, or create a food on the FTL. We propose
to define “transformation” to mean an event in a food’s supply chain that
involves changing a food on the FTL, its package, and/or its label (regarding
the traceability lot code or traceability product identifier), such as by
combining ingredients or processing a food (e.g., by cutting, cooking,
commingling, repacking, or repackaging).  The definition would further specify
that transformation does not include the initial packing of a single-ingredient
food or creating a food. 


CREATION

Would a person who “creates” a food on the FTL need to keep records about the
ingredients used in creating the food (e.g., must information on the apples used
to make sliced apples be recorded)?

We propose to define “creating” to mean making or producing a food on the FTL
(e.g., through manufacturing or processing) using only ingredient(s) that are
not on the FTL. Because creation of a food on the FTL would 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. See 85 FR 59984, 60011.


MOVEMENT OF THE FOOD WITHIN THE SAME ORGANIZATION

Would movement of FTL foods to other locations of the same organization be
regarded as “shipping” under the proposed rule?

The proposed rule would define “shipping” as an event in a food’s supply chain
in which a food is arranged for transport (e.g., by truck or ship) from a
defined location to another defined location at a different farm, a first
receiver, or a subsequent receiver. The proposed rule would similarly 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 recognize the wide
range of business arrangements in the food industry, and we welcome comment on
how these proposed definitions would fit with different types of business
structures, bearing in mind the goal of efficient and effective traceability.

If a retail establishment received a created food that is on the FTL, would it
be required to keep traceability records? 

The proposed recordkeeping requirements would apply to persons that manufacture,
process, pack, or hold foods on the FTL (see proposed § 1.1300), unless a
specific exemption applies. We have proposed to define “creating” to mean making
or producing a food on the FTL (e.g., through manufacturing or processing) using
only ingredient(s) that are not on the FTL. We have proposed specific
recordkeeping requirements on entities that create foods on the FTL (see
proposed § 1.1345). Once such a food has been created, it is on the FTL, and
subsequent entities in the supply chain would be required to keep records
relating to that food, just as they would for any other food on the FTL.


FARMS

Would farms be covered by the rule?

Generally, farms would be subject to the requirements in the proposed rule if
they manufacture, process, pack or hold foods on the FTL.  We have proposed an
exemption in proposed § 1.1305(a) for certain small originators (including
certain produce farms and certain egg farms), and other proposed exemptions
might apply to some farms. For farms that would be covered by the proposed rule,
the specific requirements would depend on the activities of the farm, e.g.,
growing, shipping, and/or receiving.

Is the proposed definition of farm in the traceability rule aligned with other
rules? 

We have proposed to define “farm” as that term is defined in 21 CFR § 1.328. 
This is the definition that is used for the existing recordkeeping requirements
in 21 CFR Part 1, subpart J, and it is the same as the definition of “farm” in
other FSMA rulemakings such as the Preventive Controls for Human Food Rule (21
CFR Part 117) and the Produce Safety Rule (21 CFR Part 112).  We have further
proposed that for producers of shell eggs, “farm” would mean all poultry houses
and grounds immediately surrounding the poultry houses covered under a single
biosecurity program. This is the same definition that is used in the shell egg
regulation (21 CFR Part 118).


RETAIL FOOD ESTABLISHMENTS (RFES)

If Option 2 of the co-proposal for RFEs were to be adopted, what would the small
RFEs need to supply, if not a sortable spreadsheet?

We have co-proposed two possible exemption options for retail food
establishments (RFEs) that employ 10 or fewer full-time equivalent employees.
(See proposed § 1.1305(g).) Option 1 would be a full exemption for such RFEs,
while Option 2 would specify that the sortable spreadsheet requirement in
proposed § 1.1455(b)(3) would not apply to such RFEs.

More specifically, if Option 2 of the co-proposal for proposed § 1.1305(g) were
adopted in the final rule, RFEs with 10 or fewer full-time equivalent employees
would be exempt from the requirement, in proposed § 1.1455(b)(3), to make
available to FDA within 24 hours, under specified circumstances, an electronic
sortable spreadsheet containing the information required to be maintained under
the rule for the FTL foods and date ranges specified in FDA’s request. Under
proposed 1.1455(b)(3), FDA could request such a sortable spreadsheet when
necessary to help us 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. If Option 2 were adopted in the final rule, and RFEs with 10
or fewer full-time equivalent employees were therefore exempt from proposed
§ 1.1455(b)(3), FDA would not require such RFEs to provide the sortable
spreadsheet described above. Under Option 2, all other requirements of the
proposed rule would apply to RFEs with 10 or fewer full-time equivalent
employees, including the requirement in proposed 1.1455(b)(1) to make all
required records available to an authorized FDA representative as soon as
possible but not later than 24 hours after the request. Such records could be
provided as paper records.

Would restaurants be considered retail food establishment under the proposed
rule?

Yes. As stated in the preamble to the proposed rule (see 85 FR 59984, 60002), we
regard restaurants as a type of retail food establishment, as that term would be
defined in proposed § 1.1310.


COMMINGLED RAW AGRICULTURAL COMMODITIES (RACS)

Could fish and fishery products be considered commingled raw agricultural
commodities that would be partially exempt from the rule?

In some situations, yes. Proposed § 1.1305(f) would provide a partial exemption
for “commingled raw agricultural commodities,” which would mean any commodity
that is combined or mixed after harvesting but before processing, except that
the term “commingled raw agricultural commodity” would not include any produce
that is subject to the produce safety rule. This proposed partial exemption is
consistent with what Congress required in section 204(d)(6)(D) of the FDA Food
Safety Modernization Act. As discussed in the preamble to the proposed rule (see
85 FR 59984, 59996-59997), shell eggs are an example of a raw agricultural
commodity that would be exempt from the proposed traceability recordkeeping
requirements if they were commingled.

There are also fish and fishery products on the FTL that could be eligible for
the exemption in proposed § 1.1305(f), provided that they are combined or mixed
after harvesting but before processing. Proposed § 1.1305(f) provides that a
commodity would be considered “combined or mixed” only when the combination or
mixing involves food from different farms, and that the term “processing” would
mean operations that alter the general state of the commodity, such as canning,
cooking, freezing, dehydration, milling, grinding, pasteurization, or
homogenization.  

Under proposed § 1.1305(f)(2), any entity that receives this partial exemption
and that is required to register through FDA’s Food Facility Registration system
would be required to maintain records identifying the immediate previous source
and the immediate subsequent recipient of the commingled raw agricultural
commodity, in accordance with 21 CFR §§ 1.337 and 1.345. Such records would have
to be maintained for 2 years.


TRACEABILITY LOT CODE

Could the traceability lot code be a lot code that a company would use already?

There are no proposed requirements regarding how a firm could create their
traceability lot codes. We propose to define the term “traceability lot code” to
mean a descriptor, often alphanumeric, used to identify a traceability lot. In
most situations, only firms that originate, transform or create a food on the
FTL would establish and assign a new traceability lot code (see proposed
§ 1.1320). Regardless of how a firm chooses to create their traceability lot
codes, the proposed rule would require that all key data elements be linked to
the traceability lot code to ensure traceability within the firm and across the
supply chain. The proposed rule would also require that a firm’s traceability
program records include a description of how the firm establishes and assigns
their traceability lot codes, when applicable (see proposed § 1.1315(a)(3)).

Could a business establish a lot code number or other code to identify a product
separate from the traceability lot code?

Once a traceability lot code has been assigned, it could only be changed when
the food is transformed (see proposed § 1.1320. We recognize that there may be
situations where a firm would not be permitted to assign a new traceability lot
code under proposed § 1.1320, but the firm might nonetheless wish to assign
their own lot code or other code that is separate from the traceability lot
code. Nothing in the proposed rule would prohibit that, as long as the
traceability lot code were also maintained and linked to all key data elements,
as the proposed rule would require.

Would the traceability lot code have to be on the food’s packaging under the
proposed rule?

Under the proposed rule, firms that ship foods on the FTL would be required to
send certain information, including the traceability lot code, to the receiving
firm (see proposed § 1.1350(b)). The traceability lot code and the other
required information would not need to be written on the packaging of the
product. As discussed in the preamble to the proposed rule, we would encourage
firms to send the information electronically, such as in an email to their
customer or an advanced shipping notice. Shippers could also 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 bill of lading. (See 85 FR 59984, 60012.)

Under the proposal, would the traceability lot code stay the same as the food
moves through the supply chain?

Under proposed § 1.1320, you would be required to establish and assign a
traceability lot code when you originate, transform, or create a food on the
FTL; and you would not be permitted to establish a new traceability lot code
when you conduct other activities (except that if a food’s originator did not
assign a traceability lot code, for example because they are exempt, then the
first receiver would be required to do so, per proposed § 1.1330(c)). In other
words, the traceability lot code would be assigned when the food is first
originated or created (or by the first receiver, if the originator is exempt);
and a new traceability lot code would not be assigned unless the food were
subsequently transformed. If the food is transformed and a new traceability lot
code is therefore assigned, that new traceability lot code would not be changed
unless the food underwent another, subsequent transformation. Thus, the
traceability lot code would stay the same as the food moves through the supply
chain, except when transformation occurs.

Would originators always have to assign a traceability lot code?  In what
circumstances might a first receiver assign a traceability lot code?

Under proposed § 1.1320, originators of foods on the FTL would be required to
establish and assign a traceability lot code. However, under proposed
§ 1.1305(a), some originators would be exempt from the proposed requirements.
Proposed § 1.1330(c) would provide that if the originator of a food on the FTL
did not assign a traceability lot code, the first receiver must do so.


MISCELLANEOUS

For nut butters, if a kill step is applied to the nuts before they are made into
nut butter, would the proposed rule still apply?

Under proposed § 1.1355(a), if you apply a kill step to a food on the FTL, the
requirements of the proposed rule would not apply to your subsequent shipping of
the food, provided that you maintain a record of your application of the kill
step. However, there are not any nuts that are on the FTL. Therefore,
application of a kill step to nuts would not trigger proposed § 1.1355(a). Thus,
someone who creates a nut butter product would be subject to the requirements of
the proposed rule, regardless of whether the nuts had previously received a kill
step. However, because nut butters are on the FTL, application of a kill step to
a nut butter product would trigger proposed § 1.1355. Under that provision, the
requirements of the proposed rule would not apply to the subsequent shipping of
the nut butter by the person who applied the kill step, provided they maintain a
record of their application of the kill step; nor would the proposed rule’s
requirements apply to the subsequent movement of the nut butter through the
supply chain.

What are the requirements for entities who are in the supply chain after a kill
step is applied?

Under proposed § 1.1355(b), subsequent persons in the supply chain who receive a
food on the FTL to which a kill step has already been applied would not be
required to maintain any traceability records under the proposed rule.  

When would I need to comply with the rule, if finalized? 

The FDA has proposed that the compliance date for all covered entities would be
two years from the date that the final rule becomes effective.  We have proposed
that the rule become effective 60 days after the date on which the final rule is
published in the Federal Register.

Are there specific technologies/standards that would be required for
traceability under this proposal?

In accordance with FSMA 204(d)(1)(C), this proposed rule would not prescribe
specific technologies for the maintenance of records.

Why is this proposed rule needed, since subpart J already creates recordkeeping
requirements?

21 CFR Part 1, Subpart J, “Establishment, Maintenance, and Availability of
Records,” does already provide recordkeeping requirements for many persons who
manufacture, process, pack, transport, distribute, receive, hold, or import
food. However, as discussed in the preamble to the proposed rule (see 85 FR
59984, 59990), since implementation of the subpart J regulations more than 10
years ago, FDA has learned that those one-up, one-back recordkeeping
requirements do not capture all the information necessary to effectively and
rapidly link shipments of food through each point in the supply chain. Congress
recognized this when it passed the FDA Food Safety Modernization Act, which
required FDA to undertake this rulemaking to establish additional recordkeeping
requirements (beyond those in subpart J) for certain foods. The proposed rule
would attempt to address some of the most significant gaps in the subpart J
requirements, such as the lack of coverage for farms and restaurants, lack of
uniform data collection, and inability to link incoming with outgoing product
within a firm and from one point in the supply chain to the next. The proposed
rule would also allow FDA to go, in some cases, directly to the entity within
the supply chain that originated, created, or transformed the product,
potentially resulting in more efficient tracing.

Would the proposed rule apply to importers? 

Unless a specific exemption applies, the proposed rule would apply to all
persons who manufacture, process, pack, or hold foods on the FTL, including food
importers who engage in such activities. As discussed in the preamble to the
proposed rule, we believe that persons who do not physically possess food are
not engaged in “holding” of food within the meaning of the proposed rule. This
means that some persons who import food may not be subject to the rule because
they do not “hold” the food. For example, a person who coordinates the import of
a listed food but never takes physical possession of the food would not be
subject to the rule, while a person who imports a listed food they physically
possess would be subject to the rule unless an exemption applied. (See 85 FR
59984, 60000.)

In the Preliminary Regulatory Impact Analysis, does the number of affected
entities include foreign facilities?

The number of affected foreign entities is reported separately in  section II.H
(“International Effects”) of the Preliminary Regulatory Impact Analysis
(PRIA). It is not included in the total count of covered entities reported in
Table 5 of the PRIA (section II.D.3).  This is consistent with the guidance in
OMB Circular A-4 (2003), which states that international effects should
be reported separately from those occurring within the U.S. 

Where do the capital investment cost estimates in the Preliminary Regulatory
Impact Analysis come from? What assumptions went into those estimates?

As discussed in section II.F.3 of the PRIA, some entities may be able to comply
with the rule without additional capital investments, while others would need to
invest in traceability-related capital. The incremental costs of complying with
the proposed rule may be significantly less than the cost of a total system
upgrade, particularly because we believe many traceability systems are already
in place. Considering variation in needs across firms’ sector, size, and
existing capabilities, and synthesizing recent industry reports and vendor
estimates with input from subject matter experts (Ref. 34 of the PRIA), we
assumed that an affected covered firm would spend between $500 and $25,000 on
all additional capital investments to comply with the proposed rule, with a
primary estimate of $7,500. Because the majority of entities affected by the
proposed rule are small- and medium-sized firms, we assumed that the overall
range of additional investment needed skews toward these firms. We recognize
that there is substantial variability in investment, and we requested comment on
these assumptions. 

In the Preliminary Regulatory Impact Analysis, is the number of retail food
establishments the number of stores selling to consumers (the restaurants,
grocery stores etc.), or is it the number of corporations/brands (e.g., a
restaurant chain that may have 200 stores)?

In the PRIA, we report both the number of covered firms and the number of
covered establishments. One firm can operate several
establishments (facilities). Some costs are estimated per firm while other costs
are per establishment. To estimate the number of covered entities, we use
several sources. These include the U.S. Economic Census, the 2016 Statistics of
U.S. Businesses, FDA’s Food Facility Registration Module, and the 2017 Census of
Agriculture. (See section II.D.3 of the PRIA.)

FDA listed training as a one-time cost. Wouldn't training be a recurring cost as
new employees are hired and current employees re-trained?

In the PRIA, we assumed that all firms covered by the general records provision
would incur one-time costs to train employees and managers in new food
traceability practices. These costs may include hiring a food traceability
subject matter expert to train staff in person or via web seminars and the costs
of producing training materials. We assumed that the number of firms affected by
these training costs is equal to the number of firms affected by capital
investment costs. We expect operational changes on a day-to-day basis to be
disseminated through ongoing meetings and trainings, such that firms would not
face additional costs of training all employees. We requested comment on this
assumption. (See section II.F.4 of the PRIA.)


KEY FEATURES

1. Critical Tracking Events

The proposed rule identifies growing, receiving, transforming, creating, and
shipping as the CTEs for which records containing KDEs would be required. The
KDEs required would vary depending on the CTE that is being performed. The
records required at each CTE would need to contain and link the traceability lot
code of the food to the relevant KDEs.

Below is a brief description of each CTE. For a detailed description of the KDEs
that would be required for each CTE, see Which Key Data Elements Would Apply to
Me? In addition, we have made available interactive slides that describe a
number of supply chain examples, including the KDEs and CTEs that would be
associated with each commodity. As you view the slides, click on the colored
boxes for more detailed KDEs.

Growing

For products such as fruits and vegetables, growing is generally the first step
in the supply chain. In addition to the general KDEs for growing, sprout growers
would be required to establish and maintain additional growing KDEs that are
specific to sprouts.

Receiving

Receiving is 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. In addition to the
general KDEs for receiving, “first receivers” would need to establish and
maintain additional KDEs.

 * First Receiver
   
   A first receiver is the first person (other than a farm) who purchases and
   takes physical possession of a listed food. Only foods that are originated
   (i.e., grown, raised, caught, or, in the case of a non-produce commodity such
   as eggs, harvested) can have a first receiver. Listed foods that are created
   (such as a ready-to-eat deli salad that is not made from any listed
   ingredients) do not have a first receiver.
   
   We introduced the category of first receiver in this proposed rule. We are
   proposing this category in part because 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. In order to ensure that comprehensive records relating to the
   origination and initial handling of the food are maintained by a single
   person who both owns and possesses the food, the first receiver of the food
   was identified as the entity who would be responsible for maintaining certain
   KDEs relating to originated foods. First receivers are required to maintain
   different KDEs depending on whether the food was obtained from a fishing
   vessel or not.
   
   For additional information and supply chain examples, see the First Receiver
   factsheet (PDF).

Creating

Creating is the making or producing of a food on the Food Traceability List
(e.g., through manufacturing or processing) using only ingredient(s) that are
not on the Food Traceability List. Creating does not include originating or
transforming a food.

For additional information and supply chain example, see Creation and
Transformation (PDF).

Transformation

Transformation is an event in a food’s supply chain that involves changing a
food on the Food Traceability List, its package, and/or its label (regarding the
traceability lot code or traceability product identifier), such as by combining
ingredients or processing a food (e.g., by cutting, cooking, commingling,
repacking, or repackaging). Transformation does not include the initial packing
of a single-ingredient food or creating a food. 

For additional information and supply chain example, see Creation and
Transformation (PDF).

Shipping

Shipping is 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.

2. Traceability Program Records

In addition to requiring records of KDEs, as discussed above, the proposed rule
would require anyone subject to the rule to establish and maintain traceability
program records. These records are intended to help regulators understand an
entity’s traceability program, and include:

 * A description of relevant reference records
   
   A firm’s KDEs might be kept on various types of reference records, such as
   bills of lading, purchase orders, or production logs. A firm’s traceability
   program records would need to include a description of the reference records
   on which the firm maintains the required KDEs. This description would explain
   where on the reference record the traceability information appears, and if
   applicable, a description of how reference records for different tracing
   events for a food are linked.

 * A List of foods on the FTL that are shipped
   
   The proposed rule would require anyone who ships food on the FTL to keep a
   list of which listed foods they ship, including the traceability product
   identifier and traceability product description for each food. This list
   would be part of a firm’s traceability program records.

 * A description of how traceability lot codes are assigned
   
   The proposed rule would require traceability lot codes to be established when
   a food on the FTL is originated, transformed, or created. The traceability
   lot code allows a food to be uniquely identified throughout the supply chain.
   As part of a firm’s traceability program records, firms would be required to
   describe how they establish and assign traceability lot codes. Because of the
   crucial role that traceability lot codes play in the proposed rule, it is
   important that regulators know how a firm created and assigned these codes,
   so that they can better understand the scope of the records they are
   reviewing.

 * Other information needed to understand data provided within the required
   records
   
   The proposed rule would require a firm’s traceability program records to
   include any other information needed to understand the data within their
   traceability records, such as internal or external coding systems or
   classification schemes, glossaries, and abbreviations. This will help
   regulators understand the terminology, methods, and systems a firm uses in
   its traceability operations.

3. Additional Requirements

The proposed rule would also require that:

 * records be maintained as either original paper records, electronic records,
   or true copies; they all must be legible and stored to prevent deterioration
   or loss.
 * traceability records be provided to FDA as soon as possible but no later than
   24 hours after a request is made. 
 * an electronic sortable spreadsheet containing relevant traceability
   information be provided to FDA within 24 hours of a request when necessary to
   assist FDA during an outbreak, recall or other threat to public health.


EXEMPTIONS AND MODIFIED REQUIREMENTS

The proposed rule includes exemptions for certain types of foods and certain
persons who manufacture, process, pack or hold foods on the Food Traceability
List. Some of these exemptions were provided by Congress, while others reflect
the FDA’s current thinking about the application of this rule to certain foods
and persons.

Exemption for Certain Types of Small Originators

The proposed rule would exempt certain farms and other originators (i.e.,
persons who grow, raise, or catch listed foods, or harvesters of non-produce
listed foods, such as eggs) because they produce relatively small quantities of
food. Specifically, the proposed rule would not apply to:

 * Farms (or the farm activities of farm mixed-type facilities) with respect to
   the produce they grow, when the farm is not subject to the Produce Safety
   Rule because it has no more than $25,000 in average annual produce sales as
   calculated under 21 CFR 112.4(a).
 * Shell egg producers with fewer than 3,000 laying hens at a particular farm,
   with respect to the shell eggs they produce at that farm.
 * Other originators of food whose average monetary value of food sold during
   the previous 3-year period was no more than $25,000 (on a rolling basis),
   adjusted for inflation.

Exemption for Farms That Sell Directly to Consumers

The proposed rule would exempt farms with respect to food they produce on their
farm that they sell directly to consumers. This would include sales at farmer’s
markets, roadside stands, over the internet, and through community-supported
agriculture programs (CSAs).

Exemption for Certain Food Produced and Packaged on a Farm

The proposed rule would not apply to food produced and packaged on a farm under
the following conditions:

 * The packaging of the food remains in place until the food reaches the
   consumer, the packaging maintains the integrity of the product, and it
   prevents subsequent contamination or alteration of the product*; and
 * The labeling of the food that reaches the consumer includes the name,
   complete address, and business phone number of the farm where the food was
   produced and packaged.

*Produce packed or packaged in containers such as clamshells with holes,
cardboard boxes, vented crates, plastic bags with holes, or netted bags would
not be eligible for this exemption because such packaging does not necessarily
maintain the product’s integrity and prevent subsequent contamination and
alteration.   

Exemption for Foods that Receive Certain Types of Processing

We propose exempting produce and shell eggs that undergo certain types of
processing. Specifically, the proposed rule would exempt:

 * Produce that receives commercial processing that adequately reduces the
   presence of microorganisms of public health significance, provided the
   conditions set forth for the commercial processing exemption in the Produce
   Safety Rule are met
 * Shell eggs when all eggs produced at the particular farm receive a treatment
   (as outlined in the Egg Safety Rule)

These exemptions would apply to the food throughout the supply chain, including
before the processing is performed.

In addition, if a person applies a kill step to any food on the FTL, they would
not be required to maintain records for their subsequent shipping of the food,
as long as they maintain a record documenting the application of the kill step.
Subsequent recipients of the food would not need to maintain records relating to
the food.

Exemption for Produce that is Rarely Consumed Raw

The proposed rule would exempt produce listed as “Rarely Consumed Raw” (RCR) in
the Produce Safety Rule. 

Partial Exemption for Commingled RACs

The proposed rule includes a partial exemption for certain commingled raw
agricultural commodities (RACs). This partial exemption would not apply to
fruits and vegetables that are subject to the Produce Safety Rule. Commingling
means that the commodity is combined or mixed after harvesting but before
processing. An example of a commingled RAC subject to this exemption would be
shell eggs that are mixed from separate farms under different management before
packing.

When this exemption applies, exempt entities that are required to register
through FDA’s Food Facility Registration system would be required to maintain
records identifying the immediate previous source and the immediate subsequent
recipient of the food, in accordance with 21 CFR §§ 1.337 and 1.345.  

Co-proposal for Small Retail Food Establishments

We are offering two proposals for how this rule would apply to small retail food
establishments (RFEs):  

 * Option 1 Full exemption: RFEs that employ 10 or fewer full-time equivalent
   employees (FTEs) would be exempt from the requirements of the rule
 * Option 2 Partial exemption: RFEs that employ 10 or fewer FTEs would be exempt
   from the requirement to provide FDA, under specified circumstances, with an
   electronic sortable spreadsheet containing certain traceability information;
   however, they would be required to comply with all other aspects of the rule.

The FDA is interested in hearing from stakeholders regarding these options
during the public comment period and public meetings.

Partial Exemption for Retail Food Establishments

The proposed rule includes a partial exemption for all RFEs with respect to food
on the FTL that they purchase directly from the farm that produced it. In such
situations, the RFE would only be required to establish and maintain for 180
days a record documenting the name and address of the farm that was the source
of the food.

Partial Exemption for Farm-to-School and Farm-to-Institution Programs

We propose a partial exemption for farm-to-school and farm-to-institution
programs operated under the auspices of USDA, State agencies or local
jurisdictions. This partial exemption would apply to food that is produced on a
farm and sold directly to the school or institution. In such situations, the
school food authority or relevant food procurement entity would be required to
establish and maintain for 180 days a record documenting the name and address of
the farm that was the source of the food.

Partial Exemption for Food from Fishing Vessels

The proposed rule would not apply to the owner, operator or agent in charge of a
fishing vessel with respect to a food that is produced through the use of the
fishing vessel. Under this partial exemption, activities of fishing vessels such
as harvesting, transporting, heading, eviscerating, and freezing fish would
generally not be subject to the proposed recordkeeping requirements. However, if
the owner, operator or agent in charge of the fishing vessel is required to
register through FDA’s Food Facility Registration system with respect to the
manufacturing, processing, packing or holding of the applicable food, they would
be required to maintain records identifying the immediate previous source and
the immediate subsequent recipient of the food, in accordance with 21 CFR §§
1.337 and 1.345.

Exemption for Transporters

The proposed rule would exempt transporters of food on the FTL.

Exemption for Nonprofit Food Establishments

The proposed rule would exempt nonprofit food establishments from the
requirements of this rule. This exemption would apply to charitable entities
that prepare or serve food including central food banks, soup kitchens and
nonprofit food delivery services. To be considered a nonprofit food
establishment, the establishment must meet the terms of section 501(c)(3) of the
U.S. Internal Revenue Code.

Exemption for Personal Consumption

The proposed rule would exempt persons who manufacture, process, pack or hold
food for personal consumption. We would consider food prepared in a private home
and transported for non-business purposed (e.g., to dinner with friends) to
qualify for this exemption.

Exemption for Persons who Hold Food for Individual Consumers

The proposed rule would exempt persons who hold food on behalf of specific
individual consumers, provided that they are not parties to the transaction and
are not in the business of distributing food. This exemption would cover persons
such as a hotel concierge, reception desk staff in an apartment building, and
staff at an office complex who may receive and store food.

Special Requirements for Foods Subjected to a Kill Step

As discussed above, under the proposal, if a person applies a kill step (i.e.,
processing that significantly minimizes pathogens, such as cooking or
pasteurization) to a food  on the FTL, they would not be required to maintain
the records required by this rule for their subsequent shipping of the food, as
long as they maintain a record documenting the application of the kill step.
Subsequent recipients of a food on the FTL to which a kill step has been applied
would not need to maintain records required by this rule.

In addition to the exemptions listed above, the proposed rule would allow the
FDA, on its own initiative or in response to a citizen petition, to create
modified requirements or exemptions if the FDA determines that the application
of the relevant requirements to a given food or type of entity is not necessary
to protect the public health. The proposed rule describes the process by which
such modified requirements and exemptions can be requested. The proposed rule
would also establish a process for the FDA to provide waivers when the agency
determines that the application of the requirements would result in economic
hardship for an individual entity or type of entity, due to the entity’s unique
circumstances.


IMPLEMENTATION

Compliance Dates

The FDA proposes that any final rule on additional traceability recordkeeping
requirements for foods on the FTL would become effective 60 days after it is
published in the Federal Register.

Because an effective traceability system requires all entities in a supply chain
to maintain traceability records, we believe all persons subject to the rule
should come into compliance by the same date.  We propose that the compliance
date for all persons subject to the recordkeeping requirements would be 2 years
after the effective date of the final regulation. 

Under section 301(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the
violation of any recordkeeping requirement under section 204 of FSMA is
prohibited, except when such violation is committed by a farm. This would apply
to the violation of any of the requirements of this proposed rule, if they are
finalized. Furthermore, an article of food is subject to refusal of admission
under section 801(a)(4) of the FD&C Act if it appears that the recordkeeping
requirements under section 204 of FSMA (including the requirements of this
proposed rule, if finalized) have not been complied with.


CONTACT US

The proposed rule will be available for public comment for 120 days. Comments
should be submitted to docket FDA-2014-N-0053 on regulations.gov.

Additional questions, and requests for meetings and speaking engagements can be
submitted via the links below. For meeting and speaker requests, please include
a request form when you contact us.

Inquiry/Information

Meeting Request Meeting Request Form

Speaker Request Speaker Request Form


SUPPLEMENTAL MATERIALS

 * Food Traceability Proposed Rule At-A-Glance
 * Food Traceability Proposed Rule Exemptions At-A-Glance
 * Who is the subject to the rule? Flowchart
 * Food Traceability List
 * Key Terms Glossary
 * Tracking and Tracing of Food
 * Which Key Data Elements Would Apply to Me?
 * Pre-recorded Webinar to Discuss Food Traceability Proposed Rule
 * Supply Chain Examples
 * First Receiver Examples
 * Creation and Transformation
 * Risk-ranking Model Results Tool


   CONTENT CURRENT AS OF:
   
   01/12/2021


 * REGULATED PRODUCT(S)
   
    * Food & Beverages

 * Food Safety Modernization Act (FSMA)
    * Frequently Asked Questions on FSMA
    * FSMA Rules & Guidance for Industry
    * What's New in FSMA
    * FSMA Training
    * FSMA Technical Assistance Network (TAN)
   
   




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